{"ID":90584,"post_author":"26","post_date":"2021-09-19 08:00:42","post_date_gmt":"2021-09-19 12:00:42","post_content":"","post_title":"COVID-19 Testing, Reporting, and Information Management in the Laboratory","post_excerpt":"","post_status":"publish","comment_status":"closed","ping_status":"closed","post_password":"","post_name":"covid-19-testing-reporting-and-information-management-in-the-laboratory","to_ping":"","pinged":"","post_modified":"2021-09-19 13:42:54","post_modified_gmt":"2021-09-19 17:42:54","post_content_filtered":"","post_parent":0,"guid":"https:\/\/www.limsforum.com\/?post_type=ebook&p=90584","menu_order":0,"post_type":"ebook","post_mime_type":"","comment_count":"0","filter":"","_ebook_metadata":{"enabled":"on","private":"0","guid":"5848F425-C00F-4505-902D-AC357B714328","title":"COVID-19 Testing, Reporting, and Information Management in the Laboratory","subtitle":"Fall 2021 Edition","cover_theme":"nico_3","cover_image":"https:\/\/www.limsforum.com\/wp-content\/plugins\/rdp-ebook-builder\/pl\/cover.php?cover_style=nico_3&subtitle=Fall+2021+Edition&editor=Shawn+Douglas&title=COVID-19+Testing%2C+Reporting%2C+and+Information+Management+in+the+Laboratory&title_image=https%3A%2F%2Fs3.limsforum.com%2Fwww.limsforum.com%2Fwp-content%2Fuploads%2FSARS-CoV-2_without_background.png&publisher=LabLynx+Press","editor":"Shawn Douglas","publisher":"LabLynx Press","author_id":"26","image_url":"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/8\/82\/SARS-CoV-2_without_background.png","items":{"0b73cac6fcb8696bd336a8cacb8dd8f4_type":"article","0b73cac6fcb8696bd336a8cacb8dd8f4_title":"5.7 Public health laboratory informatics vendors","0b73cac6fcb8696bd336a8cacb8dd8f4_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Public_health_laboratory_informatics_vendors","0b73cac6fcb8696bd336a8cacb8dd8f4_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Final thoughts and additional resources\/Public health laboratory informatics vendorsFrom LIMSWikiJump to navigationJump to search5.7 Public health laboratory informatics vendors \nThis is not a complete list but rather a representative sampling of vendors who explicitly discuss how their laboratory informatics solution helps public health laboratories.\n\nAbbott Informatics Corporation\nBGASoft, Inc.\nCliniSys Group Limited\nCommon Cents Systems, Inc.\nDeutsche Telekom Healthcare\nEusoft Srl\nLabLynx, Inc.\nLabWare, Inc.\nOrchard Software Corporation\nPolisystem Informatica Srl\nPromium, LLC\nSunquest Information Systems, Inc.\nCitation information for this chapter \nChapter: 5. Final thoughts and additional resources\nEdition: Fall 2021\nTitle: COVID-19 Testing, Reporting, and Information Management in the Laboratory\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: September 2021\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Public_health_laboratory_informatics_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Public_health_laboratory_informatics_vendors<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 19 September 2021, at 17:27.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 590 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","0b73cac6fcb8696bd336a8cacb8dd8f4_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Final_thoughts_and_additional_resources_Public_health_laboratory_informatics_vendors rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Final_thoughts_and_additional_resources_Public_health_laboratory_informatics_vendors skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Final thoughts and additional resources\/Public health laboratory informatics vendors<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><h3><span class=\"mw-headline\" id=\"5.7_Public_health_laboratory_informatics_vendors\">5.7 Public health laboratory informatics vendors<\/span><\/h3>\n<p>This is not a complete list but rather a representative sampling of vendors who explicitly discuss how their laboratory informatics solution helps public health laboratories.\n<\/p>\n<ul><li><a href=\"https:\/\/www.limswiki.org\/index.php\/Abbott_Informatics_Corporation\" title=\"Abbott Informatics Corporation\" class=\"wiki-link\" data-key=\"90479bab12020c96864541696a62156f\">Abbott Informatics Corporation<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/BGASoft,_Inc.\" title=\"BGASoft, Inc.\" class=\"wiki-link\" data-key=\"ccea591e377b4c7f4680f27c773e9c8a\">BGASoft, Inc.<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/CliniSys_Group_Limited\" title=\"CliniSys Group Limited\" class=\"wiki-link\" data-key=\"60736d95aeb73552a1c141c7cda72d2e\">CliniSys Group Limited<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Common_Cents_Systems,_Inc.\" title=\"Common Cents Systems, Inc.\" class=\"wiki-link\" data-key=\"6a1feb534350b460ef3eaa83ab477633\">Common Cents Systems, Inc.<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Deutsche_Telekom_Healthcare_Solutions_Netherlands_B.V.\" title=\"Deutsche Telekom Healthcare Solutions Netherlands B.V.\" class=\"wiki-link\" data-key=\"59d4d82d5ae163d75cd537be5e30e494\">Deutsche Telekom Healthcare<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Eusoft_Srl\" title=\"Eusoft Srl\" class=\"wiki-link\" data-key=\"b325934cae067817cae507c40d9e4e5c\">Eusoft Srl<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/LabLynx,_Inc.\" title=\"LabLynx, Inc.\" class=\"wiki-link\" data-key=\"da3f96536cf2c54de1960f26fe5712a1\">LabLynx, Inc.<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/LabWare,_Inc.\" title=\"LabWare, Inc.\" class=\"wiki-link\" data-key=\"34254ba2e2bbcd4ce616eba66db7d2f6\">LabWare, Inc.<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Orchard_Software_Corporation\" title=\"Orchard Software Corporation\" class=\"wiki-link\" data-key=\"7b7ed1ca87d09d6e32482f0a87ddfacd\">Orchard Software Corporation<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Polisystem_Informatica_Srl\" title=\"Polisystem Informatica Srl\" class=\"wiki-link\" data-key=\"d4b211475439098bb3a6e83408b9534c\">Polisystem Informatica Srl<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Promium,_LLC\" title=\"Promium, LLC\" class=\"wiki-link\" data-key=\"bd099d6b29039ad59a849f38770d01cc\">Promium, LLC<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Sunquest_Information_Systems,_Inc.\" title=\"Sunquest Information Systems, Inc.\" class=\"wiki-link\" data-key=\"f4a9158f6e03a611d3ceec4b5ff31702\">Sunquest Information Systems, Inc.<\/a><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"Citation_information_for_this_chapter\">Citation information for this chapter<\/span><\/h2>\n<p><b>Chapter<\/b>: 5. Final thoughts and additional resources\n<\/p><p><b>Edition<\/b>: Fall 2021\n<\/p><p><b>Title<\/b>: <i>COVID-19 Testing, Reporting, and Information Management in the Laboratory<\/i>\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: September 2021\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20210919172736\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.006 seconds\nReal time usage: 0.026 seconds\nPreprocessor visited node count: 7\/1000000\nPost\u2010expand include size: 646\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 3\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 2.429 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Public_health_laboratory_informatics_vendors\n100.00% 2.429 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11934-0!canonical and timestamp 20210919172738 and revision id 44139. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Public_health_laboratory_informatics_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Public_health_laboratory_informatics_vendors<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","0b73cac6fcb8696bd336a8cacb8dd8f4_images":[],"0b73cac6fcb8696bd336a8cacb8dd8f4_timestamp":1632073388,"e5ef92eec891ee7269763daf0379a045_type":"article","e5ef92eec891ee7269763daf0379a045_title":"5.6 Test kit and other resources","e5ef92eec891ee7269763daf0379a045_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Test_kit_and_other_resources","e5ef92eec891ee7269763daf0379a045_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Final thoughts and additional resources\/Test kit and other resourcesFrom LIMSWikiJump to navigationJump to search5.6 Test kit and other resources \nCOVID-19 Diagnostics in Context - Harvard Center for Systems Biology\nCOVID-19 Emergency Use Authorizations - U.S. FDA\nSARS-CoV-2 Test & Controls Database - AdVeritasDx\nSARS-CoV-2 Diagnostic Pipeline - Foundation for Innovative New Diagnostics\nSerology-based tests for COVID-19 - Johns Hopkins\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Test_kit_and_other_resources\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Test_kit_and_other_resources<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 3 May 2020, at 20:02.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 239 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","e5ef92eec891ee7269763daf0379a045_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Final_thoughts_and_additional_resources_Test_kit_and_other_resources rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Final_thoughts_and_additional_resources_Test_kit_and_other_resources skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Final thoughts and additional resources\/Test kit and other resources<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><h3><span class=\"mw-headline\" id=\"5.6_Test_kit_and_other_resources\">5.6 Test kit and other resources<\/span><\/h3>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csb.mgh.harvard.edu\/covid\" target=\"_blank\">COVID-19 Diagnostics in Context - Harvard Center for Systems Biology<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/medical-devices\/emergency-use-authorizations-medical-devices\/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\" target=\"_blank\">COVID-19 Emergency Use Authorizations - U.S. FDA<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/adveritasdx.com\/\" target=\"_blank\">SARS-CoV-2 Test & Controls Database - AdVeritasDx<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.finddx.org\/covid-19\/pipeline\/\" target=\"_blank\">SARS-CoV-2 Diagnostic Pipeline - Foundation for Innovative New Diagnostics<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.centerforhealthsecurity.org\/covid-19TestingToolkit\/serology\/Serology-based-tests-for-COVID-19.html\" target=\"_blank\">Serology-based tests for COVID-19 - Johns Hopkins<\/a><\/li><\/ul>\n<!-- \nNewPP limit report\nCached time: 20210919173031\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.003 seconds\nReal time usage: 0.004 seconds\nPreprocessor visited node count: 4\/1000000\nPost\u2010expand include size: 747\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 3\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 2.168 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Test_kit_and_other_resources\n100.00% 2.168 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11932-0!canonical and timestamp 20210919173031 and revision id 39259. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Test_kit_and_other_resources\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Test_kit_and_other_resources<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","e5ef92eec891ee7269763daf0379a045_images":[],"e5ef92eec891ee7269763daf0379a045_timestamp":1632073388,"63c7f0e82b0396dcfc8df5702f3dae66_type":"article","63c7f0e82b0396dcfc8df5702f3dae66_title":"5.5 Public health lab directory","63c7f0e82b0396dcfc8df5702f3dae66_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Public_health_lab_directory","63c7f0e82b0396dcfc8df5702f3dae66_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Final thoughts and additional resources\/Public health lab directoryFrom LIMSWikiJump to navigationJump to search5.5 Public health lab directory \nAlabama Bureau of Clinical Laboratories\nAlaska Division of Public Health Laboratories\nArizona Bureau of State Laboratory Services\nArkansas Public Health Laboratory\nCalifornia Department of Public Health Laboratory\nColorado Laboratory Services Division\nConnecticut Department of Public Health, Dr. Katherine A. Kelley Public Health Laboratory\nDelaware Public Health Laboratory\nDistrict of Columbia Public Health Laboratory\nFlorida Bureau of Public Health Laboratories\nGeorgia Public Health Laboratory\nHawaii State Laboratories Division\nIdaho Bureau of Laboratories\nIllinois Department of Public Health Laboratory\nIndiana State Department of Health Laboratories\nIowa, The University of, State Hygienic Laboratory\nKansas Health & Environmental Laboratories\nKentucky Division of Laboratory Services\nLouisiana Office of Public Health Laboratories\nMaine Health & Environmental Testing Laboratory\nMaryland Department of Health Laboratories Administration\nMassachusetts State Public Health Laboratory\nMichigan Bureau of Laboratories\nMinnesota Public Health Laboratory\nMississippi Public Health Laboratory\nMissouri State Public Health Laboratory\nMontana Laboratory Services Bureau\nNebraska Public Health Laboratory\nNevada State Public Health Laboratory\nNew Hampshire Public Health Laboratories\nNew Jersey Public Health and Environmental Laboratories\nNew Mexico Department of Health Scientific Laboratory Division\nNew York State Department of Health, Wadsworth Center\nNorth Carolina State Laboratory of Public Health\nNorth Dakota Division of Laboratory Services\nOhio Bureau of Public Health Laboratory\nOklahoma Public Health Laboratory\nOregon State Public Health Laboratory\nPennsylvania Bureau of Laboratories\nRhode Island Division of State Laboratories and Medical Examiners\nSouth Carolina Public Health Laboratory\nSouth Dakota State Public Health Laboratory\nTennessee Department of Health Laboratory Services\nTexas Department of State Health Services Lab\nUtah Public Health Laboratory\nVermont Department of Health Laboratory\nVirginia Division of Consolidated Laboratory Services\nWashington State Public Health Laboratories\nWest Virginia Office of Laboratory Services\nWisconsin State Laboratory of Hygiene\nWyoming Public Health Laboratory\nU.S. territories\n\nAmerican Samoa Department of Public Health\nCommonwealth of the Northern Mariana Islands, Commonwealth Healthcare Corporation Laboratory\nGuam Department of Public Health and Social Services Laboratory Services\nPuerto Rico Public Health Laboratory\nUnited States Virgin Islands Department of Health\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Public_health_lab_directory\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Public_health_lab_directory<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 3 May 2020, at 20:00.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 244 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","63c7f0e82b0396dcfc8df5702f3dae66_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Final_thoughts_and_additional_resources_Public_health_lab_directory rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Final_thoughts_and_additional_resources_Public_health_lab_directory skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Final thoughts and additional resources\/Public health lab directory<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><h3><span class=\"mw-headline\" id=\"5.5_Public_health_lab_directory\">5.5 Public health lab directory<\/span><\/h3>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.alabamapublichealth.gov\/bcl\/\" target=\"_blank\">Alabama Bureau of Clinical Laboratories<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dhss.alaska.gov\/pages\/default.aspx\" target=\"_blank\">Alaska Division of Public Health Laboratories<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.azdhs.gov\/preparedness\/state-laboratory\/index.php\" target=\"_blank\">Arizona Bureau of State Laboratory Services<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthy.arkansas.gov\/programs-services\/topics\/arkansas-public-health-laboratory\" target=\"_blank\">Arkansas Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdph.ca.gov\/Programs\/OSPHLD\/Pages\/Home.aspx\" target=\"_blank\">California Department of Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdphe.colorado.gov\/lab\" target=\"_blank\">Colorado Laboratory Services Division<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/portal.ct.gov\/DPH\/Laboratory\/Laboratory-Home\/Katherine-A-Kelley-State-Public-Health-Laboratory\" target=\"_blank\">Connecticut Department of Public Health, Dr. Katherine A. Kelley Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dhss.delaware.gov\/dph\/lab\/labs.html\" target=\"_blank\">Delaware Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dfs.dc.gov\/page\/public-health-laboratory-division-phl\" target=\"_blank\">District of Columbia Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.floridahealth.gov\/programs-and-services\/public-health-laboratories\/index.html\" target=\"_blank\">Florida Bureau of Public Health Laboratories<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dph.georgia.gov\/lab\" target=\"_blank\">Georgia Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.hawaii.gov\/statelab\/\" target=\"_blank\">Hawaii State Laboratories Division<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/healthandwelfare.idaho.gov\/providers\/idaho-laboratories-and-testing\/about-idaho-laboratories-and-testing\" target=\"_blank\">Idaho Bureau of Laboratories<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dph.illinois.gov\/topics-services\/lab-testing-services\" target=\"_blank\">Illinois Department of Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.in.gov\/health\/laboratories\/\" target=\"_blank\">Indiana State Department of Health Laboratories<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.shl.uiowa.edu\/\" target=\"_blank\">Iowa, The University of, State Hygienic Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.kdheks.gov\/labs\/\" target=\"_blank\">Kansas Health & Environmental Laboratories<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/chfs.ky.gov\/agencies\/dph\/dls\/Pages\/default.aspx\" target=\"_blank\">Kentucky Division of Laboratory Services<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ldh.la.gov\/index.cfm\/page\/483\" target=\"_blank\">Louisiana Office of Public Health Laboratories<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.maine.gov\/dhhs\/mecdc\/public-health-systems\/health-and-environmental-testing\/\" target=\"_blank\">Maine Health & Environmental Testing Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.maryland.gov\/laboratories\/Pages\/home.aspx\" target=\"_blank\">Maryland Department of Health Laboratories Administration<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mass.gov\/state-public-health-laboratory-services\" target=\"_blank\">Massachusetts State Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.michigan.gov\/mdhhs\/0,5885,7-339-71551_2945_5103---,00.html\" target=\"_blank\">Michigan Bureau of Laboratories<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.health.state.mn.us\/about\/org\/phl\/index.html\" target=\"_blank\">Minnesota Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.msdh.state.ms.us\/msdhsite\/_static\/14,0,188.html\" target=\"_blank\">Mississippi Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.mo.gov\/lab\/\" target=\"_blank\">Missouri State Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dphhs.mt.gov\/publichealth\/laboratoryservices\" target=\"_blank\">Montana Laboratory Services Bureau<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.nphl.org\/\" target=\"_blank\">Nebraska Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/med.unr.edu\/nsphl\" target=\"_blank\">Nevada State Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dhhs.nh.gov\/dphs\/lab\/index.htm\" target=\"_blank\">New Hampshire Public Health Laboratories<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.state.nj.us\/health\/phel\/index.shtml\" target=\"_blank\">New Jersey Public Health and Environmental Laboratories<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nmhealth.org\/about\/sld\/\" target=\"_blank\">New Mexico Department of Health Scientific Laboratory Division<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/\" target=\"_blank\">New York State Department of Health, Wadsworth Center<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/slph.ncpublichealth.com\/\" target=\"_blank\">North Carolina State Laboratory of Public Health<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ndhealth.gov\/LAB\/\" target=\"_blank\">North Dakota Division of Laboratory Services<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/odh.ohio.gov\/wps\/portal\/gov\/odh\/about-us\/offices-bureaus-and-departments\/bphl\/welcome-to\" target=\"_blank\">Ohio Bureau of Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/oklahoma.gov\/health\/prevention-and-preparedness\/public-health-laboratory.html\" target=\"_blank\">Oklahoma Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oregon.gov\/oha\/PH\/LABORATORYSERVICES\/Pages\/index.aspx\" target=\"_blank\">Oregon State Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.health.pa.gov\/topics\/Labs\/Pages\/Laboratories.aspx\" target=\"_blank\">Pennsylvania Bureau of Laboratories<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.ri.gov\/programs\/detail.php?pgm_id=146\" target=\"_blank\">Rhode Island Division of State Laboratories and Medical Examiners<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/scdhec.gov\/health-professionals\/public-health-laboratory-phl\" target=\"_blank\">South Carolina Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/doh.sd.gov\/Lab\/\" target=\"_blank\">South Dakota State Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.tn.gov\/health\/health-program-areas\/lab.html\" target=\"_blank\">Tennessee Department of Health Laboratory Services<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dshs.state.tx.us\/lab\/default.shtm\" target=\"_blank\">Texas Department of State Health Services Lab<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/uphl.utah.gov\/\" target=\"_blank\">Utah Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthvermont.gov\/lab\" target=\"_blank\">Vermont Department of Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dgs.virginia.gov\/division-of-consolidated-laboratory-services\" target=\"_blank\">Virginia Division of Consolidated Laboratory Services<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.doh.wa.gov\/ForPublicHealthandHealthcareProviders\/PublicHealthLaboratories\" target=\"_blank\">Washington State Public Health Laboratories<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dhhr.wv.gov\/ols\/Pages\/default.aspx\" target=\"_blank\">West Virginia Office of Laboratory Services<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.slh.wisc.edu\/\" target=\"_blank\">Wisconsin State Laboratory of Hygiene<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.wyo.gov\/publichealth\/lab\/\" target=\"_blank\">Wyoming Public Health Laboratory<\/a><\/li><\/ul>\n<p><b>U.S. territories<\/b>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.americansamoa.gov\/departments\" target=\"_blank\">American Samoa Department of Public Health<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.chcc.gov.mp\/laboratory.php\" target=\"_blank\">Commonwealth of the Northern Mariana Islands, Commonwealth Healthcare Corporation Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dphss.guam.gov\/laboratory-services\/\" target=\"_blank\">Guam Department of Public Health and Social Services Laboratory Services<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.salud.gov.pr\/\" target=\"_blank\">Puerto Rico Public Health Laboratory<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/doh.vi.gov\/\" target=\"_blank\">United States Virgin Islands Department of Health<\/a><\/li><\/ul>\n<!-- \nNewPP limit report\nCached time: 20210918184707\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.006 seconds\nReal time usage: 0.007 seconds\nPreprocessor visited node count: 4\/1000000\nPost\u2010expand include size: 5672\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 3\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 2.350 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Public_health_lab_directory\n100.00% 2.350 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11929-0!canonical and timestamp 20210918184707 and revision id 39255. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Public_health_lab_directory\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Public_health_lab_directory<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","63c7f0e82b0396dcfc8df5702f3dae66_images":[],"63c7f0e82b0396dcfc8df5702f3dae66_timestamp":1632073388,"b42dca8dd29ce9ed027b39c1d03953d8_type":"article","b42dca8dd29ce9ed027b39c1d03953d8_title":"5.4 Key journal articles","b42dca8dd29ce9ed027b39c1d03953d8_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles","b42dca8dd29ce9ed027b39c1d03953d8_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Final thoughts and additional resources\/Key journal articlesFrom LIMSWikiJump to navigationJump to search5.4 Key journal articles \nHadaya, J.; Schumm, M.; Livingston, E.H. (2020). \"Testing Individuals for Coronavirus Disease 2019 (COVID-19)\". JAMA. doi:10.1001\/jama.2020.5388. PMID 32236503.   \nIwen, P.C.; Stiles, K.L.; Pantella, M.A. (2020). \"Safety considerations in the laboratory testing of specimens suspected or known to contain the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)\". American Journal of Clinical Pathology: aqaa047. doi:10.1093\/ajcp\/aqaa047. PMID 32190890.   \nLoeffelholz, M.J.; Tang, T.-W. (2020). \"Laboratory diagnosis of emerging human coronavirus infections \u2013 The state of the art\". Emerging Microbes & Infections 9 (1): 747\u201356. doi:10.1080\/22221751.2020.1745095. PMID 32196430.   \nMina, M.J.; Andersen, K.G. (2021). \"COVID-19 testing: One size does not fit all\". Science 371 (6525): 126-127. doi:10.1126\/science.abe9187. PMID 33414210.   \nNature (2021). \"COVID research: A year of scientific milestones\". Nature. doi:10.1038\/d41586-020-00502-w. PMID 32221507.   \nReeves, J.J.; Pageler, N.M.; Wick, E.C. et al. (2021). \"The Clinical Information Systems Response to the COVID-19 Pandemic\". Yearbook of Medical Informatics 30 (1): 105\u201325. doi:10.1055\/s-0041-1726513. PMC PMC8416224. PMID 34479384. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8416224 .   \nRichter, A.; Plant, T.; Kidd, M. et al. (2020). \"How to establish an academic SARS-CoV-2 testing laboratory\". Nature Microbiology 5: 1452\u201354. doi:10.1038\/s41564-020-00818-3. PMID 33139885.   \nTan, S.S.; Yan, B.; Saw, S. et al. (2021). \"Practical laboratory considerations amidst the COVID-19 outbreak: Early experience from Singapore\". Journal of Clinical Pathology 74: 257-260. doi:10.1136\/jclinpath-2020-206563. PMID 32198190.   \nUdugama, B.; Kadhiresan, P.; Kozlowski, H.N. et al. (2020). \"Diagnosing COVID-19: The Disease and Tools for Detection\". ACS Nano 14 (4): 3822\u20133835. doi:10.1021\/acsnano.0c02624. PMC PMC7144809. PMID 32223179. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7144809 .   \nWeemaes, M.; Martens, S.; Cuypers, L. et al. (2020). \"Laboratory information system requirements to manage the COVID-19 pandemic: A report from the Belgian national reference testing center\". JAMIA: ocaa081. doi:10.1093\/jamia\/ocaa081. PMC PMC7197526. PMID 32348469. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7197526 .   \nWest, C.P.; Montori, V.M.; Sampathkumar, P. (2020). \"COVID-19 Testing: The Threat of False-Negative Results\". Mayo Clinic Proceedings 95 (6): 1127\u201329. doi:10.1016\/j.mayocp.2020.04.004. PMC PMC7151274. PMID 32376102. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7151274 .   \nYuen, K.-S.; Fung, S.-Y.; Chan, C.-P.; Jin, D.-Y. (2020). \"SARS-CoV-2 and COVID-19: The most important research questions\". Cell & Bioscience 10: 40. doi:10.1186\/s13578-020-00404-4. PMC PMC7074995. PMID 32190290. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7074995 .   \n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 3 May 2020, at 20:00.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 253 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","b42dca8dd29ce9ed027b39c1d03953d8_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Final_thoughts_and_additional_resources_Key_journal_articles rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Final_thoughts_and_additional_resources_Key_journal_articles skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Final thoughts and additional resources\/Key journal articles<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><h3><span class=\"mw-headline\" id=\"5.4_Key_journal_articles\">5.4 Key journal articles<\/span><\/h3>\n<ul><li><span class=\"citation Journal\">Hadaya, J.; Schumm, M.; Livingston, E.H. (2020). \"Testing Individuals for Coronavirus Disease 2019 (COVID-19)\". <i>JAMA<\/i>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1001%2Fjama.2020.5388\" target=\"_blank\">10.1001\/jama.2020.5388<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32236503\" target=\"_blank\">32236503<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Testing+Individuals+for+Coronavirus+Disease+2019+%28COVID-19%29&rft.jtitle=JAMA&rft.aulast=Hadaya%2C+J.%3B+Schumm%2C+M.%3B+Livingston%2C+E.H.&rft.au=Hadaya%2C+J.%3B+Schumm%2C+M.%3B+Livingston%2C+E.H.&rft.date=2020&rft_id=info:doi\/10.1001%2Fjama.2020.5388&rft_id=info:pmid\/32236503&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Iwen, P.C.; Stiles, K.L.; Pantella, M.A. (2020). \"Safety considerations in the laboratory testing of specimens suspected or known to contain the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)\". <i>American Journal of Clinical Pathology<\/i>: aqaa047. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1093%2Fajcp%2Faqaa047\" target=\"_blank\">10.1093\/ajcp\/aqaa047<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32190890\" target=\"_blank\">32190890<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Safety+considerations+in+the+laboratory+testing+of+specimens+suspected+or+known+to+contain+the+severe+acute+respiratory+syndrome+coronavirus+2+%28SARS-CoV-2%29&rft.jtitle=American+Journal+of+Clinical+Pathology&rft.aulast=Iwen%2C+P.C.%3B+Stiles%2C+K.L.%3B+Pantella%2C+M.A.&rft.au=Iwen%2C+P.C.%3B+Stiles%2C+K.L.%3B+Pantella%2C+M.A.&rft.date=2020&rft.pages=aqaa047&rft_id=info:doi\/10.1093%2Fajcp%2Faqaa047&rft_id=info:pmid\/32190890&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Loeffelholz, M.J.; Tang, T.-W. (2020). \"Laboratory diagnosis of emerging human coronavirus infections \u2013 The state of the art\". <i>Emerging Microbes & Infections<\/i> <b>9<\/b> (1): 747\u201356. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1080%2F22221751.2020.1745095\" target=\"_blank\">10.1080\/22221751.2020.1745095<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32196430\" target=\"_blank\">32196430<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Laboratory+diagnosis+of+emerging+human+coronavirus+infections+%E2%80%93+The+state+of+the+art&rft.jtitle=Emerging+Microbes+%26+Infections&rft.aulast=Loeffelholz%2C+M.J.%3B+Tang%2C+T.-W.&rft.au=Loeffelholz%2C+M.J.%3B+Tang%2C+T.-W.&rft.date=2020&rft.volume=9&rft.issue=1&rft.pages=747%E2%80%9356&rft_id=info:doi\/10.1080%2F22221751.2020.1745095&rft_id=info:pmid\/32196430&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Mina, M.J.; Andersen, K.G. (2021). \"COVID-19 testing: One size does not fit all\". <i>Science<\/i> <b>371<\/b> (6525): 126-127. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1126%2Fscience.abe9187\" target=\"_blank\">10.1126\/science.abe9187<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/33414210\" target=\"_blank\">33414210<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=COVID-19+testing%3A+One+size+does+not+fit+all&rft.jtitle=Science&rft.aulast=Mina%2C+M.J.%3B+Andersen%2C+K.G.&rft.au=Mina%2C+M.J.%3B+Andersen%2C+K.G.&rft.date=2021&rft.volume=371&rft.issue=6525&rft.pages=126-127&rft_id=info:doi\/10.1126%2Fscience.abe9187&rft_id=info:pmid\/33414210&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Nature (2021). \"COVID research: A year of scientific milestones\". <i>Nature<\/i>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1038%2Fd41586-020-00502-w\" target=\"_blank\">10.1038\/d41586-020-00502-w<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32221507\" target=\"_blank\">32221507<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=COVID+research%3A+A+year+of+scientific+milestones&rft.jtitle=Nature&rft.aulast=Nature&rft.au=Nature&rft.date=2021&rft_id=info:doi\/10.1038%2Fd41586-020-00502-w&rft_id=info:pmid\/32221507&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Reeves, J.J.; Pageler, N.M.; Wick, E.C. et al. (2021). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8416224\" target=\"_blank\">\"The Clinical Information Systems Response to the COVID-19 Pandemic\"<\/a>. <i>Yearbook of Medical Informatics<\/i> <b>30<\/b> (1): 105\u201325. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1055%2Fs-0041-1726513\" target=\"_blank\">10.1055\/s-0041-1726513<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8416224\/\" target=\"_blank\">PMC8416224<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/34479384\" target=\"_blank\">34479384<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8416224\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8416224<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Clinical+Information+Systems+Response+to+the+COVID-19+Pandemic&rft.jtitle=Yearbook+of+Medical+Informatics&rft.aulast=Reeves%2C+J.J.%3B+Pageler%2C+N.M.%3B+Wick%2C+E.C.+et+al.&rft.au=Reeves%2C+J.J.%3B+Pageler%2C+N.M.%3B+Wick%2C+E.C.+et+al.&rft.date=2021&rft.volume=30&rft.issue=1&rft.pages=105%E2%80%9325&rft_id=info:doi\/10.1055%2Fs-0041-1726513&rft_id=info:pmc\/PMC8416224&rft_id=info:pmid\/34479384&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC8416224&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Richter, A.; Plant, T.; Kidd, M. et al. (2020). \"How to establish an academic SARS-CoV-2 testing laboratory\". <i>Nature Microbiology<\/i> <b>5<\/b>: 1452\u201354. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1038%2Fs41564-020-00818-3\" target=\"_blank\">10.1038\/s41564-020-00818-3<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/33139885\" target=\"_blank\">33139885<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=How+to+establish+an+academic+SARS-CoV-2+testing+laboratory&rft.jtitle=Nature+Microbiology&rft.aulast=Richter%2C+A.%3B+Plant%2C+T.%3B+Kidd%2C+M.+et+al.&rft.au=Richter%2C+A.%3B+Plant%2C+T.%3B+Kidd%2C+M.+et+al.&rft.date=2020&rft.volume=5&rft.pages=1452%E2%80%9354&rft_id=info:doi\/10.1038%2Fs41564-020-00818-3&rft_id=info:pmid\/33139885&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Tan, S.S.; Yan, B.; Saw, S. et al. (2021). \"Practical laboratory considerations amidst the COVID-19 outbreak: Early experience from Singapore\". <i>Journal of Clinical Pathology<\/i> <b>74<\/b>: 257-260. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1136%2Fjclinpath-2020-206563\" target=\"_blank\">10.1136\/jclinpath-2020-206563<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32198190\" target=\"_blank\">32198190<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Practical+laboratory+considerations+amidst+the+COVID-19+outbreak%3A+Early+experience+from+Singapore&rft.jtitle=Journal+of+Clinical+Pathology&rft.aulast=Tan%2C+S.S.%3B+Yan%2C+B.%3B+Saw%2C+S.+et+al.&rft.au=Tan%2C+S.S.%3B+Yan%2C+B.%3B+Saw%2C+S.+et+al.&rft.date=2021&rft.volume=74&rft.pages=257-260&rft_id=info:doi\/10.1136%2Fjclinpath-2020-206563&rft_id=info:pmid\/32198190&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Udugama, B.; Kadhiresan, P.; Kozlowski, H.N. et al. (2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7144809\" target=\"_blank\">\"Diagnosing COVID-19: The Disease and Tools for Detection\"<\/a>. <i>ACS Nano<\/i> <b>14<\/b> (4): 3822\u20133835. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1021%2Facsnano.0c02624\" target=\"_blank\">10.1021\/acsnano.0c02624<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7144809\/\" target=\"_blank\">PMC7144809<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32223179\" target=\"_blank\">32223179<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7144809\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7144809<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Diagnosing+COVID-19%3A+The+Disease+and+Tools+for+Detection&rft.jtitle=ACS+Nano&rft.aulast=Udugama%2C+B.%3B+Kadhiresan%2C+P.%3B+Kozlowski%2C+H.N.+et+al.&rft.au=Udugama%2C+B.%3B+Kadhiresan%2C+P.%3B+Kozlowski%2C+H.N.+et+al.&rft.date=2020&rft.volume=14&rft.issue=4&rft.pages=3822%E2%80%933835&rft_id=info:doi\/10.1021%2Facsnano.0c02624&rft_id=info:pmc\/PMC7144809&rft_id=info:pmid\/32223179&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7144809&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Weemaes, M.; Martens, S.; Cuypers, L. et al. (2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7197526\" target=\"_blank\">\"Laboratory information system requirements to manage the COVID-19 pandemic: A report from the Belgian national reference testing center\"<\/a>. <i>JAMIA<\/i>: ocaa081. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1093%2Fjamia%2Focaa081\" target=\"_blank\">10.1093\/jamia\/ocaa081<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7197526\/\" target=\"_blank\">PMC7197526<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32348469\" target=\"_blank\">32348469<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7197526\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7197526<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Laboratory+information+system+requirements+to+manage+the+COVID-19+pandemic%3A+A+report+from+the+Belgian+national+reference+testing+center&rft.jtitle=JAMIA&rft.aulast=Weemaes%2C+M.%3B+Martens%2C+S.%3B+Cuypers%2C+L.+et+al.&rft.au=Weemaes%2C+M.%3B+Martens%2C+S.%3B+Cuypers%2C+L.+et+al.&rft.date=2020&rft.pages=ocaa081&rft_id=info:doi\/10.1093%2Fjamia%2Focaa081&rft_id=info:pmc\/PMC7197526&rft_id=info:pmid\/32348469&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7197526&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">West, C.P.; Montori, V.M.; Sampathkumar, P. (2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7151274\" target=\"_blank\">\"COVID-19 Testing: The Threat of False-Negative Results\"<\/a>. <i>Mayo Clinic Proceedings<\/i> <b>95<\/b> (6): 1127\u201329. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2Fj.mayocp.2020.04.004\" target=\"_blank\">10.1016\/j.mayocp.2020.04.004<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7151274\/\" target=\"_blank\">PMC7151274<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32376102\" target=\"_blank\">32376102<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7151274\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7151274<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=COVID-19+Testing%3A+The+Threat+of+False-Negative+Results&rft.jtitle=Mayo+Clinic+Proceedings&rft.aulast=West%2C+C.P.%3B+Montori%2C+V.M.%3B+Sampathkumar%2C+P.&rft.au=West%2C+C.P.%3B+Montori%2C+V.M.%3B+Sampathkumar%2C+P.&rft.date=2020&rft.volume=95&rft.issue=6&rft.pages=1127%E2%80%9329&rft_id=info:doi\/10.1016%2Fj.mayocp.2020.04.004&rft_id=info:pmc\/PMC7151274&rft_id=info:pmid\/32376102&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7151274&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Yuen, K.-S.; Fung, S.-Y.; Chan, C.-P.; Jin, D.-Y. (2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7074995\" target=\"_blank\">\"SARS-CoV-2 and COVID-19: The most important research questions\"<\/a>. <i>Cell & Bioscience<\/i> <b>10<\/b>: 40. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1186%2Fs13578-020-00404-4\" target=\"_blank\">10.1186\/s13578-020-00404-4<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7074995\/\" target=\"_blank\">PMC7074995<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32190290\" target=\"_blank\">32190290<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7074995\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7074995<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=SARS-CoV-2+and+COVID-19%3A+The+most+important+research+questions&rft.jtitle=Cell+%26+Bioscience&rft.aulast=Yuen%2C+K.-S.%3B+Fung%2C+S.-Y.%3B+Chan%2C+C.-P.%3B+Jin%2C+D.-Y.&rft.au=Yuen%2C+K.-S.%3B+Fung%2C+S.-Y.%3B+Chan%2C+C.-P.%3B+Jin%2C+D.-Y.&rft.date=2020&rft.volume=10&rft.pages=40&rft_id=info:doi\/10.1186%2Fs13578-020-00404-4&rft_id=info:pmc\/PMC7074995&rft_id=info:pmid\/32190290&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7074995&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n\n<!-- \nNewPP limit report\nCached time: 20210919173030\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.078 seconds\nReal time usage: 0.085 seconds\nPreprocessor visited node count: 9101\/1000000\nPost\u2010expand include size: 102750\/2097152 bytes\nTemplate argument size: 24306\/2097152 bytes\nHighest expansion depth: 19\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 461\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 74.342 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles\n100.00% 74.342 1 -total\n 96.55% 71.779 12 Template:Cite_journal\n 89.80% 66.759 12 Template:Citation\/core\n 19.58% 14.556 29 Template:Citation\/identifier\n 6.44% 4.788 63 Template:Hide_in_print\n 6.37% 4.733 12 Template:Citation\/make_link\n 5.16% 3.837 29 Template:Only_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11928-0!canonical and timestamp 20210919173030 and revision id 39254. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_journal_articles<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","b42dca8dd29ce9ed027b39c1d03953d8_images":[],"b42dca8dd29ce9ed027b39c1d03953d8_timestamp":1632073387,"3d15fb4b368164f7e0aa820c0f1fda28_type":"article","3d15fb4b368164f7e0aa820c0f1fda28_title":"5.3 Web portals","3d15fb4b368164f7e0aa820c0f1fda28_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Web_portals","3d15fb4b368164f7e0aa820c0f1fda28_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Final thoughts and additional resources\/Web portalsFrom LIMSWikiJump to navigationJump to searchContents \n\n1 5.3 Web portals \n\n1.1 5.3.1 U.S. agency portals \n1.2 5.3.2 U.S. state and territory portals \n1.3 5.3.3 Other national and multinational portals \n\n\n\n\n\n5.3 Web portals \n5.3.1 U.S. agency portals \nHealthcare Workers: Information on COVID-19 (CDC)\nInformation for Laboratories about Coronavirus (COVID-19) (CDC)\nCOVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders (FDA)\nCoronavirus (COVID-19) Response (FEMA)\n5.3.2 U.S. state and territory portals \nAlabama\nAlaska\nArizona\nArkansas\nCalifornia\nColorado\nConnecticut\nDelaware\nDistrict of Columbia\nFlorida\nGeorgia\nHawaii\nIdaho\nIllinois\nIndiana\nIowa\nKansas\nKentucky\nLouisiana\nMaine\nMaryland\nMassachusetts\nMichigan\nMinnesota\nMississippi\nMissouri\nMontana\nNebraska\nNevada\nNew Hampshire\nNew Jersey\nNew Mexico\nNew York\nNorth Carolina\nNorth Dakota\nOhio\nOklahoma\nOregon\nPennsylvania\nRhode Island\nSouth Carolina\nSouth Dakota\nTennessee\nTexas\nUtah\nVermont\nVirginia\nWashington\nWest Virginia\nWisconsin\nWyoming\nU.S. territories\n\nAmerican Samoa\nGuam\nNorthern Mariana Islands\nPuerto Rico\nVirgin Islands\n5.3.3 Other national and multinational portals \nAustralian Government\nEuropean CDC\nGovernment of Canada\nGovernment of Japan\nGovernment of M\u00e9xico\nWorld Health Organization (WHO) and regionals\n\nWHO\nWHO Africa\nWHO Americas\nWHO Eastern Mediterranean\nWHO Europe\nWHO South-East Asia\nWHO Western Pacific\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Web_portals\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Web_portals<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 3 May 2020, at 19:59.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 452 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","3d15fb4b368164f7e0aa820c0f1fda28_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Final_thoughts_and_additional_resources_Web_portals rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Final_thoughts_and_additional_resources_Web_portals skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Final thoughts and additional resources\/Web portals<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\">\n\n<h3><span class=\"mw-headline\" id=\"5.3_Web_portals\">5.3 Web portals<\/span><\/h3>\n<h4><span class=\"mw-headline\" id=\"5.3.1_U.S._agency_portals\">5.3.1 U.S. agency portals<\/span><\/h4>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/hcp\/index.html\" target=\"_blank\">Healthcare Workers: Information on COVID-19<\/a> (CDC)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-nCoV\/lab\/index.html\" target=\"_blank\">Information for Laboratories about Coronavirus (COVID-19)<\/a> (CDC)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/emergency-preparedness-and-response\/coronavirus-disease-2019-covid-19\/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders\" target=\"_blank\">COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders<\/a> (FDA)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fema.gov\/disaster\/coronavirus\" target=\"_blank\">Coronavirus (COVID-19) Response<\/a> (FEMA)<\/li><\/ul>\n<h4><span class=\"mw-headline\" id=\"5.3.2_U.S._state_and_territory_portals\">5.3.2 U.S. state and territory portals<\/span><\/h4>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/governor.alabama.gov\/newsroom\/covid-19\/\" target=\"_blank\">Alabama<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dhss.alaska.gov\/dph\/Epi\/id\/Pages\/COVID-19\/default.aspx\" target=\"_blank\">Alaska<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/az.gov\/government-0\" target=\"_blank\">Arizona<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/govstatus.egov.com\/ar-covid-19\" target=\"_blank\">Arkansas<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/covid19.ca.gov\/\" target=\"_blank\">California<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/covid19.colorado.gov\/\" target=\"_blank\">Colorado<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/portal.ct.gov\/coronavirus\" target=\"_blank\">Connecticut<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.delaware.gov\/\" target=\"_blank\">Delaware<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.dc.gov\/\" target=\"_blank\">District of Columbia<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/floridahealthcovid19.gov\/\" target=\"_blank\">Florida<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/georgia.gov\/covid-19-coronavirus-georgia\" target=\"_blank\">Georgia<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/hawaiicovid19.com\/\" target=\"_blank\">Hawaii<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.idaho.gov\/\" target=\"_blank\">Idaho<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.illinois.gov\/\" target=\"_blank\">Illinois<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.in.gov\/\" target=\"_blank\">Indiana<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.iowa.gov\/\" target=\"_blank\">Iowa<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.coronavirus.kdheks.gov\/\" target=\"_blank\">Kansas<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/govstatus.egov.com\/kycovid19\" target=\"_blank\">Kentucky<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/gov.louisiana.gov\/coronavirus\/\" target=\"_blank\">Louisiana<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.maine.gov\/covid19\/\" target=\"_blank\">Maine<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.maryland.gov\/\" target=\"_blank\">Maryland<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mass.gov\/covid-19-updates-and-information\" target=\"_blank\">Massachusetts<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.michigan.gov\/coronavirus\/\" target=\"_blank\">Michigan<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.health.state.mn.us\/diseases\/coronavirus\/index.html\" target=\"_blank\">Minnesota<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.coronavirus.ms.gov\/\" target=\"_blank\">Mississippi<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.mo.gov\/living\/healthcondiseases\/communicable\/novel-coronavirus\/\" target=\"_blank\">Missouri<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/covid19.mt.gov\/\" target=\"_blank\">Montana<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dhhs.ne.gov\/Pages\/Coronavirus.aspx\" target=\"_blank\">Nebraska<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvhealthresponse.nv.gov\/\" target=\"_blank\">Nevada<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.covid19.nh.gov\/\" target=\"_blank\">New Hampshire<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/covid19.nj.gov\/\" target=\"_blank\">New Jersey<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.newmexico.gov\/\" target=\"_blank\">New Mexico<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.health.ny.gov\/home\" target=\"_blank\">New York<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/covid19.ncdhhs.gov\/\" target=\"_blank\">North Carolina<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ndresponse.gov\/covid-19-resources\" target=\"_blank\">North Dakota<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.ohio.gov\/wps\/portal\/gov\/covid-19\/home\" target=\"_blank\">Ohio<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/oklahoma.gov\/covid19.html\" target=\"_blank\">Oklahoma<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.oregon.gov\/\" target=\"_blank\">Oregon<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pa.gov\/guides\/responding-to-covid-19\/\" target=\"_blank\">Pennsylvania<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/covid.ri.gov\/\" target=\"_blank\">Rhode Island<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/scdhec.gov\/covid19\" target=\"_blank\">South Carolina<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/covid.sd.gov\/\" target=\"_blank\">South Dakota<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/covid19.tn.gov\/\" target=\"_blank\">Tennessee<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.texas.gov\/covid19\/\" target=\"_blank\">Texas<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.utah.gov\/\" target=\"_blank\">Utah<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthvermont.gov\/covid-19\" target=\"_blank\">Vermont<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.virginia.gov\/coronavirus\/\" target=\"_blank\">Virginia<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.wa.gov\/\" target=\"_blank\">Washington<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dhhr.wv.gov\/COVID-19\/Pages\/default.aspx\" target=\"_blank\">West Virginia<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dhs.wisconsin.gov\/covid-19\/index.htm\" target=\"_blank\">Wisconsin<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/covid19.wyo.gov\/\" target=\"_blank\">Wyoming<\/a><\/li><\/ul>\n<p><b>U.S. territories<\/b>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.americansamoa.gov\/\" target=\"_blank\">American Samoa<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dphss.guam.gov\/covid-19\/\" target=\"_blank\">Guam<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.chcc.gov.mp\/coronavirusinformation.php\" target=\"_blank\">Northern Mariana Islands<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.salud.gov.pr\/CMS\/142\" target=\"_blank\">Puerto Rico<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.covid19usvi.com\/\" target=\"_blank\">Virgin Islands<\/a><\/li><\/ul>\n<h4><span class=\"mw-headline\" id=\"5.3.3_Other_national_and_multinational_portals\">5.3.3 Other national and multinational portals<\/span><\/h4>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/covid19inlanguage.homeaffairs.gov.au\/\" target=\"_blank\">Australian Government<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ecdc.europa.eu\/en\/covid-19\/latest-evidence\/diagnostic-testing\" target=\"_blank\">European CDC<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.canada.ca\/en\/public-health\/services\/diseases\/coronavirus-disease-covid-19.html\" target=\"_blank\">Government of Canada<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/newpage_00032.html\" target=\"_blank\">Government of Japan<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.gob.mx\/\" target=\"_blank\">Government of M\u00e9xico<\/a><\/li><\/ul>\n<p><b>World Health Organization (WHO) and regionals<\/b>\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/emergencies\/diseases\/novel-coronavirus-2019\" target=\"_blank\">WHO<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.afro.who.int\/health-topics\/coronavirus-covid-19\" target=\"_blank\">WHO Africa<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.paho.org\/en\/topics\/coronavirus-infections\/coronavirus-disease-covid-19-pandemic\" target=\"_blank\">WHO Americas<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.emro.who.int\/health-topics\/corona-virus\/index.html\" target=\"_blank\">WHO Eastern Mediterranean<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.euro.who.int\/en\/health-topics\/health-emergencies\/coronavirus-covid-19\" target=\"_blank\">WHO Europe<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/southeastasia\/outbreaks-and-emergencies\/covid-19\" target=\"_blank\">WHO South-East Asia<\/a><\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/westernpacific\/emergencies\/covid-19\" target=\"_blank\">WHO Western Pacific<\/a><\/li><\/ul>\n<!-- \nNewPP limit report\nCached time: 20210919173030\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.009 seconds\nReal time usage: 0.025 seconds\nPreprocessor visited node count: 7\/1000000\nPost\u2010expand include size: 4770\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 3\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 2.059 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Web_portals\n100.00% 2.059 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11926-0!canonical and timestamp 20210919173030 and revision id 39252. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Web_portals\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Web_portals<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","3d15fb4b368164f7e0aa820c0f1fda28_images":[],"3d15fb4b368164f7e0aa820c0f1fda28_timestamp":1632073387,"6e97707751babe6c117bd7311dfbef79_type":"article","6e97707751babe6c117bd7311dfbef79_title":"5.2 Key guidance documents","6e97707751babe6c117bd7311dfbef79_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents","6e97707751babe6c117bd7311dfbef79_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Final thoughts and additional resources\/Key guidance documentsFrom LIMSWikiJump to navigationJump to search5.2 Key guidance documents \nCenters for Disease Control and Prevention (16 September 2021). \"Contact Tracing\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/php\/contact-tracing\/index.html .   \nCenters for Disease Control and Prevention (8 July 2021). \"Guidance for SARS-CoV-2 Point-of-Care and Rapid Testing\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/point-of-care-testing.html .   \nCenters for Disease Control and Prevention (26 January 2021). \"How to Report COVID-19 Laboratory Data\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/reporting-lab-data.html .   \nCenters for Disease Control and Prevention (30 June 2021). \"Interim Guidance for Use of Pooling Procedures in SARS-CoV-2 Diagnostic and Screening Testing\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/pooling-procedures.html .   \nCenters for Disease Control and Prevention (26 February 2021). \"Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-nCoV\/lab\/guidelines-clinical-specimens.html .   \nCenters for Disease Control and Prevention (11 June 2021). \"Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19)\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-nCoV\/lab\/lab-biosafety-guidelines.html .   \nCenters for Disease Control and Prevention (2 August 2021). \"Overview of Testing for SARS-CoV-2 (COVID-19)\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/hcp\/testing-overview.html .   \nCenters for Disease Control and Prevention (13 August 2021). \"Testing Strategies for SARS-CoV-2\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/resources\/sars-cov2-testing-strategies.html .   \nCenters for Medicare & Medicaid Services (August 2021). \"ICD-10-CM Official Guidelines for Coding and Reporting - FY 2022\" (PDF). Centers for Medicare & Medicaid Services. https:\/\/www.cms.gov\/files\/document\/fy-2022-icd-10-cm-coding-guidelines.pdf .   \nEuropean Commission (19 October 2020). \"Coronavirus: EU interoperability gateway for contact tracing and warning apps \u2013 Questions and Answers\". European Union. https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/QANDA_20_1905 .   \nEuropean Data Protection Board (21 April 2020). \"Guidelines 04\/2020 on the use of location data and contact tracing tools in the context of the COVID-19 outbreak\" (PDF). European Union. https:\/\/edpb.europa.eu\/sites\/default\/files\/files\/file1\/edpb_guidelines_20200420_contact_tracing_covid_with_annex_en.pdf .   \nOccupational Safety and Health Administration (13 August 2021). \"Protecting Workers: Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace\". Occupational Safety and Health Administration. https:\/\/www.osha.gov\/coronavirus\/safework .   \nPan American Health Organization (8 July 2020). \"Laboratory Guidelines for the Detection and Diagnosis of COVID-19 Virus Infection\". Pan American Health Organization. https:\/\/iris.paho.org\/handle\/10665.2\/52458 .   \nPublic Health England (29 March 2021). \"COVID-19: Guidance for sampling and for diagnostic laboratories\". U.K Government. https:\/\/www.gov.uk\/government\/publications\/wuhan-novel-coronavirus-guidance-for-clinical-diagnostic-laboratories .   \nPublic Health Laboratory Network (22 June 2021). \"PHLN guidance on laboratory testing for SARS-CoV-2 (the virus that causes COVID-19)\". Department of Health, Australian Government. https:\/\/www.health.gov.au\/resources\/publications\/phln-guidance-on-laboratory-testing-for-sars-cov-2-the-virus-that-causes-covid-19 .   \nU.S. Food and Drug Administration (September 2021). \"Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)\". FDA-2020-D-1138. U.S. Food and Drug Administration. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/enforcement-policy-face-masks-barrier-face-coverings-face-shields-surgical-masks-and-respirators .   \nU.S. Food and Drug Administration (30 March 2020). \"Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency\". FDA-2020-D-1138-0023. U.S. Food and Drug Administration. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/enforcement-policy-gowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-health .   \nU.S. Food and Drug Administration (15 May 2020). \"Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)\". FDA-2020-D-0987-0049. U.S. Food and Drug Administration. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised .   \nWorld Health Organization, et al. (2 October 2020). \"Assessment tool for laboratories implementing SARS-CoV-2 testing: Interim guidance, 2 October 2020\". WHO\/2019-nCoV\/Lab_Assessment_Tool\/2020.2. World Health Organization. https:\/\/apps.who.int\/iris\/handle\/10665\/335843 .   \nWorld Health Organization, et al. (11 September 2020). \"Diagnostic testing for SARS-CoV-2: Interim guidance, 11 September 2020\". WHO\/2019-nCoV\/laboratory\/2020.6. World Health Organization. https:\/\/apps.who.int\/iris\/handle\/10665\/334254 .   \nWorld Health Organization, et al. (13 May 2020). \"Laboratory biosafety guidance related to coronavirus disease (COVID-19): Interim guidance, 13 May 2020\". WHO\/WPE\/GIH\/2020.3. World Health Organization. https:\/\/apps.who.int\/iris\/handle\/10665\/332076 .   \n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 3 May 2020, at 19:58.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 241 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","6e97707751babe6c117bd7311dfbef79_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Final_thoughts_and_additional_resources_Key_guidance_documents rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Final_thoughts_and_additional_resources_Key_guidance_documents skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Final thoughts and additional resources\/Key guidance documents<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><h3><span class=\"mw-headline\" id=\"5.2_Key_guidance_documents\">5.2 Key guidance documents<\/span><\/h3>\n<ul><li><span class=\"citation web\">Centers for Disease Control and Prevention (16 September 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/php\/contact-tracing\/index.html\" target=\"_blank\">\"Contact Tracing\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/php\/contact-tracing\/index.html\" target=\"_blank\">https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/php\/contact-tracing\/index.html<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Contact+Tracing&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=16+September+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fphp%2Fcontact-tracing%2Findex.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Centers for Disease Control and Prevention (8 July 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/point-of-care-testing.html\" target=\"_blank\">\"Guidance for SARS-CoV-2 Point-of-Care and Rapid Testing\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/point-of-care-testing.html\" target=\"_blank\">https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/point-of-care-testing.html<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Guidance+for+SARS-CoV-2+Point-of-Care+and+Rapid+Testing&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=8+July+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Flab%2Fpoint-of-care-testing.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Centers for Disease Control and Prevention (26 January 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/reporting-lab-data.html\" target=\"_blank\">\"How to Report COVID-19 Laboratory Data\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/reporting-lab-data.html\" target=\"_blank\">https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/reporting-lab-data.html<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+to+Report+COVID-19+Laboratory+Data&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=26+January+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Flab%2Freporting-lab-data.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Centers for Disease Control and Prevention (30 June 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/pooling-procedures.html\" target=\"_blank\">\"Interim Guidance for Use of Pooling Procedures in SARS-CoV-2 Diagnostic and Screening Testing\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/pooling-procedures.html\" target=\"_blank\">https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/pooling-procedures.html<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Interim+Guidance+for+Use+of+Pooling+Procedures+in+SARS-CoV-2+Diagnostic+and+Screening+Testing&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=30+June+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Flab%2Fpooling-procedures.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Centers for Disease Control and Prevention (26 February 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-nCoV\/lab\/guidelines-clinical-specimens.html\" target=\"_blank\">\"Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-nCoV\/lab\/guidelines-clinical-specimens.html\" target=\"_blank\">https:\/\/www.cdc.gov\/coronavirus\/2019-nCoV\/lab\/guidelines-clinical-specimens.html<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Interim+Guidelines+for+Collecting+and+Handling+of+Clinical+Specimens+for+COVID-19+Testing&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=26+February+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-nCoV%2Flab%2Fguidelines-clinical-specimens.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Centers for Disease Control and Prevention (11 June 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-nCoV\/lab\/lab-biosafety-guidelines.html\" target=\"_blank\">\"Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19)\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-nCoV\/lab\/lab-biosafety-guidelines.html\" target=\"_blank\">https:\/\/www.cdc.gov\/coronavirus\/2019-nCoV\/lab\/lab-biosafety-guidelines.html<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Interim+Laboratory+Biosafety+Guidelines+for+Handling+and+Processing+Specimens+Associated+with+Coronavirus+Disease+2019+%28COVID-19%29&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=11+June+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-nCoV%2Flab%2Flab-biosafety-guidelines.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Centers for Disease Control and Prevention (2 August 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/hcp\/testing-overview.html\" target=\"_blank\">\"Overview of Testing for SARS-CoV-2 (COVID-19)\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/hcp\/testing-overview.html\" target=\"_blank\">https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/hcp\/testing-overview.html<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Overview+of+Testing+for+SARS-CoV-2+%28COVID-19%29&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=2+August+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Ftesting-overview.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Centers for Disease Control and Prevention (13 August 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/resources\/sars-cov2-testing-strategies.html\" target=\"_blank\">\"Testing Strategies for SARS-CoV-2\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/resources\/sars-cov2-testing-strategies.html\" target=\"_blank\">https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/resources\/sars-cov2-testing-strategies.html<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Testing+Strategies+for+SARS-CoV-2&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=13+August+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Flab%2Fresources%2Fsars-cov2-testing-strategies.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Centers for Medicare & Medicaid Services (August 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/files\/document\/fy-2022-icd-10-cm-coding-guidelines.pdf\" target=\"_blank\">\"ICD-10-CM Official Guidelines for Coding and Reporting - FY 2022\"<\/a> (PDF). Centers for Medicare & Medicaid Services<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cms.gov\/files\/document\/fy-2022-icd-10-cm-coding-guidelines.pdf\" target=\"_blank\">https:\/\/www.cms.gov\/files\/document\/fy-2022-icd-10-cm-coding-guidelines.pdf<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=ICD-10-CM+Official+Guidelines+for+Coding+and+Reporting+-+FY+2022&rft.atitle=&rft.aulast=Centers+for+Medicare+%26+Medicaid+Services&rft.au=Centers+for+Medicare+%26+Medicaid+Services&rft.date=August+2021&rft.pub=Centers+for+Medicare+%26+Medicaid+Services&rft_id=https%3A%2F%2Fwww.cms.gov%2Ffiles%2Fdocument%2Ffy-2022-icd-10-cm-coding-guidelines.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">European Commission (19 October 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/QANDA_20_1905\" target=\"_blank\">\"Coronavirus: EU interoperability gateway for contact tracing and warning apps \u2013 Questions and Answers\"<\/a>. European Union<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/QANDA_20_1905\" target=\"_blank\">https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/QANDA_20_1905<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Coronavirus%3A+EU+interoperability+gateway+for+contact+tracing+and+warning+apps+%E2%80%93+Questions+and+Answers&rft.atitle=&rft.aulast=European+Commission&rft.au=European+Commission&rft.date=19+October+2020&rft.pub=European+Union&rft_id=https%3A%2F%2Fec.europa.eu%2Fcommission%2Fpresscorner%2Fdetail%2Fen%2FQANDA_20_1905&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">European Data Protection Board (21 April 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/edpb.europa.eu\/sites\/default\/files\/files\/file1\/edpb_guidelines_20200420_contact_tracing_covid_with_annex_en.pdf\" target=\"_blank\">\"Guidelines 04\/2020 on the use of location data and contact tracing tools in the context of the COVID-19 outbreak\"<\/a> (PDF). European Union<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/edpb.europa.eu\/sites\/default\/files\/files\/file1\/edpb_guidelines_20200420_contact_tracing_covid_with_annex_en.pdf\" target=\"_blank\">https:\/\/edpb.europa.eu\/sites\/default\/files\/files\/file1\/edpb_guidelines_20200420_contact_tracing_covid_with_annex_en.pdf<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Guidelines+04%2F2020+on+the+use+of+location+data+and+contact+tracing+tools+in+the+context+of+the+COVID-19+outbreak&rft.atitle=&rft.aulast=European+Data+Protection+Board&rft.au=European+Data+Protection+Board&rft.date=21+April+2020&rft.pub=European+Union&rft_id=https%3A%2F%2Fedpb.europa.eu%2Fsites%2Fdefault%2Ffiles%2Ffiles%2Ffile1%2Fedpb_guidelines_20200420_contact_tracing_covid_with_annex_en.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Occupational Safety and Health Administration (13 August 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/coronavirus\/safework\" target=\"_blank\">\"Protecting Workers: Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace\"<\/a>. Occupational Safety and Health Administration<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.osha.gov\/coronavirus\/safework\" target=\"_blank\">https:\/\/www.osha.gov\/coronavirus\/safework<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Protecting+Workers%3A+Guidance+on+Mitigating+and+Preventing+the+Spread+of+COVID-19+in+the+Workplace&rft.atitle=&rft.aulast=Occupational+Safety+and+Health+Administration&rft.au=Occupational+Safety+and+Health+Administration&rft.date=13+August+2021&rft.pub=Occupational+Safety+and+Health+Administration&rft_id=https%3A%2F%2Fwww.osha.gov%2Fcoronavirus%2Fsafework&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Pan American Health Organization (8 July 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/iris.paho.org\/handle\/10665.2\/52458\" target=\"_blank\">\"Laboratory Guidelines for the Detection and Diagnosis of COVID-19 Virus Infection\"<\/a>. Pan American Health Organization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/iris.paho.org\/handle\/10665.2\/52458\" target=\"_blank\">https:\/\/iris.paho.org\/handle\/10665.2\/52458<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Laboratory+Guidelines+for+the+Detection+and+Diagnosis+of+COVID-19+Virus+Infection&rft.atitle=&rft.aulast=Pan+American+Health+Organization&rft.au=Pan+American+Health+Organization&rft.date=8+July+2020&rft.pub=Pan+American+Health+Organization&rft_id=https%3A%2F%2Firis.paho.org%2Fhandle%2F10665.2%2F52458&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Public Health England (29 March 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gov.uk\/government\/publications\/wuhan-novel-coronavirus-guidance-for-clinical-diagnostic-laboratories\" target=\"_blank\">\"COVID-19: Guidance for sampling and for diagnostic laboratories\"<\/a>. U.K Government<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.gov.uk\/government\/publications\/wuhan-novel-coronavirus-guidance-for-clinical-diagnostic-laboratories\" target=\"_blank\">https:\/\/www.gov.uk\/government\/publications\/wuhan-novel-coronavirus-guidance-for-clinical-diagnostic-laboratories<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=COVID-19%3A+Guidance+for+sampling+and+for+diagnostic+laboratories&rft.atitle=&rft.aulast=Public+Health+England&rft.au=Public+Health+England&rft.date=29+March+2021&rft.pub=U.K+Government&rft_id=https%3A%2F%2Fwww.gov.uk%2Fgovernment%2Fpublications%2Fwuhan-novel-coronavirus-guidance-for-clinical-diagnostic-laboratories&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Public Health Laboratory Network (22 June 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.health.gov.au\/resources\/publications\/phln-guidance-on-laboratory-testing-for-sars-cov-2-the-virus-that-causes-covid-19\" target=\"_blank\">\"PHLN guidance on laboratory testing for SARS-CoV-2 (the virus that causes COVID-19)\"<\/a>. Department of Health, Australian Government<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.health.gov.au\/resources\/publications\/phln-guidance-on-laboratory-testing-for-sars-cov-2-the-virus-that-causes-covid-19\" target=\"_blank\">https:\/\/www.health.gov.au\/resources\/publications\/phln-guidance-on-laboratory-testing-for-sars-cov-2-the-virus-that-causes-covid-19<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=PHLN+guidance+on+laboratory+testing+for+SARS-CoV-2+%28the+virus+that+causes+COVID-19%29&rft.atitle=&rft.aulast=Public+Health+Laboratory+Network&rft.au=Public+Health+Laboratory+Network&rft.date=22+June+2021&rft.pub=Department+of+Health%2C+Australian+Government&rft_id=https%3A%2F%2Fwww.health.gov.au%2Fresources%2Fpublications%2Fphln-guidance-on-laboratory-testing-for-sars-cov-2-the-virus-that-causes-covid-19&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">U.S. Food and Drug Administration (September 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/enforcement-policy-face-masks-barrier-face-coverings-face-shields-surgical-masks-and-respirators\" target=\"_blank\">\"Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)\"<\/a>. <i>FDA-2020-D-1138<\/i>. U.S. Food and Drug Administration<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/enforcement-policy-face-masks-barrier-face-coverings-face-shields-surgical-masks-and-respirators\" target=\"_blank\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/enforcement-policy-face-masks-barrier-face-coverings-face-shields-surgical-masks-and-respirators<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Enforcement+Policy+for+Face+Masks%2C+Barrier+Face+Coverings%2C+Face+Shields%2C+Surgical+Masks%2C+and+Respirators+During+the+Coronavirus+Disease+%28COVID-19%29+Public+Health+Emergency+%28Revised%29&rft.atitle=FDA-2020-D-1138&rft.aulast=U.S.+Food+and+Drug+Administration&rft.au=U.S.+Food+and+Drug+Administration&rft.date=September+2021&rft.pub=U.S.+Food+and+Drug+Administration&rft_id=https%3A%2F%2Fwww.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Fenforcement-policy-face-masks-barrier-face-coverings-face-shields-surgical-masks-and-respirators&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">U.S. Food and Drug Administration (30 March 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/enforcement-policy-gowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-health\" target=\"_blank\">\"Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency\"<\/a>. <i>FDA-2020-D-1138-0023<\/i>. U.S. Food and Drug Administration<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/enforcement-policy-gowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-health\" target=\"_blank\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/enforcement-policy-gowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-health<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Enforcement+Policy+for+Gowns%2C+Other+Apparel%2C+and+Gloves+During+the+Coronavirus+Disease+%28COVID-19%29+Public+Health+Emergency&rft.atitle=FDA-2020-D-1138-0023&rft.aulast=U.S.+Food+and+Drug+Administration&rft.au=U.S.+Food+and+Drug+Administration&rft.date=30+March+2020&rft.pub=U.S.+Food+and+Drug+Administration&rft_id=https%3A%2F%2Fwww.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Fenforcement-policy-gowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-health&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">U.S. Food and Drug Administration (15 May 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised\" target=\"_blank\">\"Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)\"<\/a>. <i>FDA-2020-D-0987-0049<\/i>. U.S. Food and Drug Administration<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised\" target=\"_blank\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Policy+for+Coronavirus+Disease-2019+Tests+During+the+Public+Health+Emergency+%28Revised%29&rft.atitle=FDA-2020-D-0987-0049&rft.aulast=U.S.+Food+and+Drug+Administration&rft.au=U.S.+Food+and+Drug+Administration&rft.date=15+May+2020&rft.pub=U.S.+Food+and+Drug+Administration&rft_id=https%3A%2F%2Fwww.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Fpolicy-coronavirus-disease-2019-tests-during-public-health-emergency-revised&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">World Health Organization, et al. (2 October 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/apps.who.int\/iris\/handle\/10665\/335843\" target=\"_blank\">\"Assessment tool for laboratories implementing SARS-CoV-2 testing: Interim guidance, 2 October 2020\"<\/a>. <i>WHO\/2019-nCoV\/Lab_Assessment_Tool\/2020.2<\/i>. World Health Organization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/apps.who.int\/iris\/handle\/10665\/335843\" target=\"_blank\">https:\/\/apps.who.int\/iris\/handle\/10665\/335843<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Assessment+tool+for+laboratories+implementing+SARS-CoV-2+testing%3A+Interim+guidance%2C+2+October+2020&rft.atitle=WHO%2F2019-nCoV%2FLab_Assessment_Tool%2F2020.2&rft.aulast=World+Health+Organization%2C+et+al.&rft.au=World+Health+Organization%2C+et+al.&rft.date=2+October+2020&rft.pub=World+Health+Organization&rft_id=https%3A%2F%2Fapps.who.int%2Firis%2Fhandle%2F10665%2F335843&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">World Health Organization, et al. (11 September 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/apps.who.int\/iris\/handle\/10665\/334254\" target=\"_blank\">\"Diagnostic testing for SARS-CoV-2: Interim guidance, 11 September 2020\"<\/a>. <i>WHO\/2019-nCoV\/laboratory\/2020.6<\/i>. World Health Organization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/apps.who.int\/iris\/handle\/10665\/334254\" target=\"_blank\">https:\/\/apps.who.int\/iris\/handle\/10665\/334254<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Diagnostic+testing+for+SARS-CoV-2%3A+Interim+guidance%2C+11+September+2020&rft.atitle=WHO%2F2019-nCoV%2Flaboratory%2F2020.6&rft.aulast=World+Health+Organization%2C+et+al.&rft.au=World+Health+Organization%2C+et+al.&rft.date=11+September+2020&rft.pub=World+Health+Organization&rft_id=https%3A%2F%2Fapps.who.int%2Firis%2Fhandle%2F10665%2F334254&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">World Health Organization, et al. (13 May 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/apps.who.int\/iris\/handle\/10665\/332076\" target=\"_blank\">\"Laboratory biosafety guidance related to coronavirus disease (COVID-19): Interim guidance, 13 May 2020\"<\/a>. <i>WHO\/WPE\/GIH\/2020.3<\/i>. World Health Organization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/apps.who.int\/iris\/handle\/10665\/332076\" target=\"_blank\">https:\/\/apps.who.int\/iris\/handle\/10665\/332076<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Laboratory+biosafety+guidance+related+to+coronavirus+disease+%28COVID-19%29%3A+Interim+guidance%2C+13+May+2020&rft.atitle=WHO%2FWPE%2FGIH%2F2020.3&rft.aulast=World+Health+Organization%2C+et+al.&rft.au=World+Health+Organization%2C+et+al.&rft.date=13+May+2020&rft.pub=World+Health+Organization&rft_id=https%3A%2F%2Fapps.who.int%2Firis%2Fhandle%2F10665%2F332076&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n\n<!-- \nNewPP limit report\nCached time: 20210919173029\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.119 seconds\nReal time usage: 0.124 seconds\nPreprocessor visited node count: 14594\/1000000\nPost\u2010expand include size: 138689\/2097152 bytes\nTemplate argument size: 50323\/2097152 bytes\nHighest expansion depth: 17\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 114.554 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\n100.00% 114.554 1 -total\n 97.03% 111.146 21 Template:Cite_web\n 91.54% 104.868 21 Template:Citation\/core\n 23.52% 26.948 21 Template:Date\n 5.03% 5.762 27 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11924-0!canonical and timestamp 20210919173029 and revision id 39250. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Key_guidance_documents<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","6e97707751babe6c117bd7311dfbef79_images":[],"6e97707751babe6c117bd7311dfbef79_timestamp":1632073387,"6dc5ed53923251c9cec5bc04060b111f_type":"article","6dc5ed53923251c9cec5bc04060b111f_title":"5.1 Final thoughts","6dc5ed53923251c9cec5bc04060b111f_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Final_thoughts","6dc5ed53923251c9cec5bc04060b111f_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Final thoughts and additional resources\/Final thoughtsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n5. Final thoughts and additional resources \n5.1 Final thoughts \nSince it has started, the COVID-19 pandemic has brought with it numerous challenges for society to face. How poised is a state and national government to truly lend assistance to its citizens in the face of a crisis? How does the increasing divide between the \"haves\" and \"have nots,\" and the associated economic structures that lend to them, reveal the fragility of our society? What more can be done to fund epidemiology research? How can we improve our healthcare system to be better equipped to handle communicable disease response and better funded to provide more social services to a broader base of people? And what lessons can be learned from the successes and failures of providing accurate, responsive laboratory testing during pandemics?\nWe've learned that the family of coronaviruses can be disruptive to humanity, having had past brushes with SARS and MERS, yet we arguably haven't done enough to research these and similar viruses to be more prepared. We were perhaps fortunate in some ways that SARS wasn't worse than it proved to be. However, responses by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and other organizations and agencies around the world during the SARS and MERS outbreaks laid the foundations for laboratory testing a novel coronavirus like SARS-CoV-2. Reverse transcription PCR (RT-PCR) is again proving to be a useful diagnostic tool for identifying the virus in patient specimens. Other methods such as lateral flow assays (LFA) borrow from more rapid methods of identification, and other more rapid methods of testing such as antigen testing and reverse transcription loop-mediated isothermal amplification (RT-LAMP) lend additional support to testing. And while confusing\u2014particularly given the unknowns surrounding the predictive ability of antibodies conferring immunity\u2014serology antibody tests appear to have their place as well. \nThese and related tests can be complex, as evidenced by the CLIA approval status of a strong majority of emergency use authorized (EUA) test kits. Performing these tests on complex instruments and then effectively using the data they provide require clear workflows that can be at least partially automated. This is particularly vital given the paltry 13 percent of CLIA-certified U.S labs that are certified to perform moderate- and high-complexity testing. Additionally, given the value of test result data to governments agencies, epidemiological researchers, and patients, it's important that reporting is clear, timely, and moderated. Laboratory informatics systems such as laboratory information management systems (LIMS) and laboratory information systems (LIS) can go a long way towards ensuring laboratory testing and reporting of communicable diseases goes smoothly.\nChoosing just any informatics system and implementing it haphazardly in the laboratory doesn't automatically ensure improvements, however. Many elements of the system should be carefully considered. Does the system have a provider portal that is flexible in its ability to handle providers from many different healthcare facility types entering test orders and reviewing results? How well does it address the workflow of COVID-19 and other types of respiratory illness testing? Does it interface with the instruments you're using to test such illnesses, and at a reasonable cost? How well does it handle internal and external reporting requirements, as well as any data visualization and dashboarding you require? During outbreaks and pandemics, the system should improve your laboratory workflow, not slow you down. This includes the element of reporting, which is not only critical but also challenging even in relatively peaceful times of health. And how interoperable is the system with other clinical systems such as electronic health records (EHR) and radiology information systems (RIS)? As we found out, academic and research laboratories wanting to assist with testing have at times been locked out due to their informatics system not interfacing cleanly with a hospital EHR.\nHopefully this guide has provided important background in several areas, from COVID-19's historical impact and challenging health issues, to the current state of laboratory testing, reporting, and informatics applications being applied to fight its spread. As noted in the beginning, this pandemic and how humanity is dealing with it is rapidly changing us, as we try to keep up with ways to fend it off. That means information changes rapidly. An effort will be made to update this content as new information comes to light. In the meantime, stay safe and consider your informatics solutions with care.\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Final_thoughts\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Final_thoughts<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 3 May 2020, at 19:57.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 286 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","6dc5ed53923251c9cec5bc04060b111f_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Final_thoughts_and_additional_resources_Final_thoughts rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Final_thoughts_and_additional_resources_Final_thoughts skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Final thoughts and additional resources\/Final thoughts<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Introduction\" title=\"Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Introduction\" class=\"wiki-link\" data-key=\"d0faaf5a86a3ccb5b12357c8bd4fefe4\">the beginning<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"5._Final_thoughts_and_additional_resources\">5. Final thoughts and additional resources<\/span><\/h2>\n<h3><span class=\"mw-headline\" id=\"5.1_Final_thoughts\">5.1 Final thoughts<\/span><\/h3>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:COVID-22_Palmerston_North_posters_MRD.jpg\" class=\"image wiki-link\" data-key=\"fadcee8134ace5bfff7059503acb9845\"><img alt=\"COVID-22 Palmerston North posters MRD.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/c\/c8\/COVID-22_Palmerston_North_posters_MRD.jpg\" decoding=\"async\" width=\"280\" height=\"354\" \/><\/a><\/div><p>Since it has started, the <a href=\"https:\/\/www.limswiki.org\/index.php\/COVID-19\" class=\"mw-redirect wiki-link\" title=\"COVID-19\" data-key=\"da9bd20c492b2a17074ad66c2fe25652\">COVID-19<\/a> <a href=\"https:\/\/www.limswiki.org\/index.php\/Pandemic\" title=\"Pandemic\" class=\"wiki-link\" data-key=\"bd9a48e6c6e41b6d603ee703836b01f1\">pandemic<\/a> has brought with it numerous challenges for society to face. How poised is a state and national government to truly lend assistance to its citizens in the face of a crisis? How does the increasing divide between the \"haves\" and \"have nots,\" and the associated economic structures that lend to them, reveal the fragility of our society? What more can be done to fund epidemiology research? How can we improve our healthcare system to be better equipped to handle communicable disease response and better funded to provide more social services to a broader base of people? And what lessons can be learned from the successes and failures of providing accurate, responsive laboratory testing during pandemics?\n<\/p><p>We've learned that the family of <a href=\"https:\/\/www.limswiki.org\/index.php\/Coronavirus\" title=\"Coronavirus\" class=\"wiki-link\" data-key=\"86c887aaa85c1b2b96fd478c10703204\">coronaviruses<\/a> can be disruptive to humanity, having had past brushes with <a href=\"https:\/\/www.limswiki.org\/index.php\/SARS\" class=\"mw-redirect wiki-link\" title=\"SARS\" data-key=\"ed35453a4b76160d255cb4d1a02971c2\">SARS<\/a> and <a href=\"https:\/\/www.limswiki.org\/index.php\/MERS\" class=\"mw-redirect wiki-link\" title=\"MERS\" data-key=\"864add98def16b22ca2276221950de7a\">MERS<\/a>, yet we arguably <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.newscientist.com\/article\/mg24532724-700-we-were-warned-so-why-couldnt-we-prevent-the-coronavirus-outbreak\/\" target=\"_blank\">haven't done enough<\/a> to research these and similar viruses to be more prepared. We were perhaps <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/doi.org\/10.1098\/rstb.2004.1487\" target=\"_blank\">fortunate in some ways<\/a> that SARS wasn't worse than it proved to be. However, responses by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and other organizations and agencies around the world during the SARS and MERS outbreaks laid the foundations for <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a> testing a novel coronavirus like <a href=\"https:\/\/www.limswiki.org\/index.php\/SARS-CoV-2\" class=\"mw-redirect wiki-link\" title=\"SARS-CoV-2\" data-key=\"6c6b78479de2c640028696ed32948526\">SARS-CoV-2<\/a>. <a href=\"https:\/\/www.limswiki.org\/index.php\/Reverse_transcription_polymerase_chain_reaction\" title=\"Reverse transcription polymerase chain reaction\" class=\"wiki-link\" data-key=\"bb69657b45c41e6345baf4c8067c7aa3\">Reverse transcription PCR<\/a> (RT-PCR) is again proving to be a useful diagnostic tool for identifying the virus in patient specimens. Other methods such as <a href=\"https:\/\/www.limswiki.org\/index.php\/Lateral_flow_test\" title=\"Lateral flow test\" class=\"wiki-link\" data-key=\"c8e204476b567850c0ec03a045f16661\">lateral flow assays<\/a> (LFA) borrow from more rapid methods of identification, and other more rapid methods of testing such as antigen testing and reverse transcription <a href=\"https:\/\/www.limswiki.org\/index.php\/Loop-mediated_isothermal_amplification\" title=\"Loop-mediated isothermal amplification\" class=\"wiki-link\" data-key=\"e71e4c1cfffeaf6781dd13b0ac1cc2a9\">loop-mediated isothermal amplification<\/a> (RT-LAMP) lend additional support to testing. And while confusing\u2014particularly given the unknowns surrounding the predictive ability of antibodies conferring immunity\u2014serology antibody tests appear to have their place as well. \n<\/p><p>These and related tests can be complex, as evidenced by the CLIA approval status of a strong majority of emergency use authorized (EUA) test kits. Performing these tests on complex instruments and then effectively using the data they provide require clear <a href=\"https:\/\/www.limswiki.org\/index.php\/Workflow\" title=\"Workflow\" class=\"wiki-link\" data-key=\"92bd8748272e20d891008dcb8243e8a8\">workflows<\/a> that can be at least partially automated. This is particularly vital given the paltry 13 percent of CLIA-certified U.S labs that are certified to perform moderate- and high-complexity testing. Additionally, given the value of test result data to governments agencies, <a href=\"https:\/\/www.limswiki.org\/index.php\/Epidemiology\" title=\"Epidemiology\" class=\"wiki-link\" data-key=\"123badb8bf0b37a513182dbcfc3875bc\">epidemiological<\/a> researchers, and patients, it's important that reporting is clear, timely, and moderated. Laboratory informatics systems such as <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management systems<\/a> (LIMS) and <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system\" title=\"Laboratory information system\" class=\"wiki-link\" data-key=\"37add65b4d1c678b382a7d4817a9cf64\">laboratory information systems<\/a> (LIS) can go a long way towards ensuring laboratory testing and reporting of communicable diseases goes smoothly.\n<\/p><p>Choosing just any <a href=\"https:\/\/www.limswiki.org\/index.php\/Informatics_(academic_field)\" title=\"Informatics (academic field)\" class=\"wiki-link\" data-key=\"0391318826a5d9f9a1a1bcc88394739f\">informatics<\/a> system and implementing it haphazardly in the laboratory doesn't automatically ensure improvements, however. Many elements of the system should be carefully considered. Does the system have a provider portal that is flexible in its ability to handle providers from many different healthcare facility types entering test orders and reviewing results? How well does it address the workflow of COVID-19 and other types of respiratory illness testing? Does it interface with the instruments you're using to test such illnesses, and at a reasonable cost? How well does it handle internal and external reporting requirements, as well as any data visualization and dashboarding you require? During outbreaks and pandemics, the system should improve your laboratory workflow, not slow you down. This includes the element of reporting, which is not only critical but also challenging even in relatively peaceful times of health. And how interoperable is the system with other clinical systems such as <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_health_record\" title=\"Electronic health record\" class=\"wiki-link\" data-key=\"f2e31a73217185bb01389404c1fd5255\">electronic health records<\/a> (EHR) and <a href=\"https:\/\/www.limswiki.org\/index.php\/Radiology_information_system\" title=\"Radiology information system\" class=\"wiki-link\" data-key=\"62d0a667f8b27309ea38a46507cfb500\">radiology information systems<\/a> (RIS)? As we found out, academic and research laboratories wanting to assist with testing have at times been locked out due to their informatics system not interfacing cleanly with a hospital EHR.\n<\/p><p>Hopefully this guide has provided important background in several areas, from COVID-19's historical impact and challenging health issues, to the current state of laboratory testing, reporting, and informatics applications being applied to fight its spread. As noted in the beginning, this pandemic and how humanity is dealing with it is rapidly changing us, as we try to keep up with ways to fend it off. That means information changes rapidly. An effort will be made to update this content as new information comes to light. In the meantime, stay safe and consider your informatics solutions with care.\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20210919173029\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.009 seconds\nReal time usage: 0.017 seconds\nPreprocessor visited node count: 6\/1000000\nPost\u2010expand include size: 5211\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 3\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 1.873 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Final_thoughts\n100.00% 1.873 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11922-0!canonical and timestamp 20210919173029 and revision id 39248. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Final_thoughts\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Final_thoughts<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","6dc5ed53923251c9cec5bc04060b111f_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/c\/c8\/COVID-22_Palmerston_North_posters_MRD.jpg"],"6dc5ed53923251c9cec5bc04060b111f_timestamp":1632073387,"38734314415297e7ef1e374a32ba8612_type":"article","38734314415297e7ef1e374a32ba8612_title":"4.3 Additional benefits and challenges of informatics in disease testing and public health","38734314415297e7ef1e374a32ba8612_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health","38734314415297e7ef1e374a32ba8612_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Workflow and information management for COVID-19 (and other respiratory diseases)\/Additional benefits and challenges of informatics in disease testing and public healthFrom LIMSWikiJump to navigationJump to searchContents \n\n1 4.3 Additional benefits and challenges of laboratory informatics in disease testing and public health \n\n1.1 4.3.1 System interoperability \n1.2 4.3.2 Contact tracing \n\n\n2 References \n3 Citation information for this chapter \n\n\n\n4.3 Additional benefits and challenges of laboratory informatics in disease testing and public health \nCOVID-19 is at the forefront of the consciousness of humanity, by and large, and the informatics tools we implement for managing, treating, and surveilling the disease are of great import. From disease databases to electronic health records, from bioinformatics tools for peptide and protein modeling to laboratory tools such as LIMS and LIS, we continue to fight back against the threat of the SARS-CoV-2 virus. Yet despite the gravity of the pandemic, this is neither the first nor the last time laboratory and scientific informatics will play a positive role in testing for disease and improving public health outcomes.\nHealth informatics technology, when used responsibly, has already proven to be useful in studying and treating contagious diseases. In a 2013 research paper published in the journal BMJ Quality & Safety, El-Kareh et al. analyzed and described the state of diagnostic health information technology (HIT). They noted that without the aid of HIT, clinicians are more error-prone, leaving them \"vulnerable to fallible human memory, variable disease presentation, clinical processes plagued by communication lapses, and a series of well-documented \u2018heuristics,\u2019 biases, and disease-specific pitfalls.\"[1] Appropriate, well-designed HIT systems are capable of helping clinicians and laboratorians by providing more timely access to information, improved communication, better clinical reasoning and decision making, and improved workflows, as well as a reduction in diagnostic errors, and, as a result, improved patient safety and health outcomes.[2] \nFrom a public health perspective, the application of informatics to disease surveillance, reporting, and health habit promotion is also vital. Winters-Miner et al. note in particular the value of using informatics tools and methods to implement predictive analytics and data mining into public health. They use disease prevention and biosurveillance as major examples. We could, for example \"analyze large populations of people to quantify risks related to public health, and help physicians to develop intervention programs for those patients at highest risk of some ailment or medical condition.\"[3] Additionally, through the use of syndromic surveillance systems (tools aiding in the detection of indicators leading up to disease diagnosis for individuals and populations[4]), they suggest that outbreaks can be better detected at local and national levels, and public health measures can be better implemented, increasing public awareness and hindering the spread of disease.[3]\nIn the clinical laboratory, informatics systems have been influencing workflow improvements and improved service delivery for more than five decades.[5] And while improvements have been seen in the laboratory from not only the introduction of computerized systems[1][2][6] but also the realization of quality control[7] and point-of-care testing[8], more challenges remain. For example, quality management in the laboratory is still often a manual, time-consuming activity. While the LIMS and LIS have some tools to assist with this task, the inclusion of laboratory analytics and business intelligence tools into those systems may lead to even further improvements in quality and efficiency in the lab.[9] And in the realm of point-of-care testing, oversight and control of instruments can be lost when connectivity and training is lacking. Proper interfacing of these lab instruments could lead to improvements in those areas, says Siemens Healthineers' Daniel Gundler. \"Maintaining POC instruments and overseeing the operators performing POC tests would be much easier if all the information and data from each instrument were accessible through one user interface in which coordinators could manage both the instruments and operators.\"[10]\n\n4.3.1 System interoperability \nSystem interoperability also poses benefits and challenges to clinical disease testing and prevention. Interoperability is defined as \u201cthe ability of different information systems, devices and applications (\u2018systems\u2019) to access, exchange, integrate and cooperatively use data in a coordinated manner\u201d to ensure timely, portable information and improved health outcomes.[11] Improving interoperability among clinical informatics systems is recognized as an important step towards improving health outcomes.[12][13] The National Academies of Sciences, Engineering, and Medicine had much to say on this topic in their 2015 publication Improving Diagnosis in Health Care[2]:\nImproved interoperability across different health care organizations\u2014as well as across laboratory and radiology information systems\u2014is critical to improving the diagnostic process. Challenges to interoperability include the inconsistent and slow adoption of standards, particularly among organizations that are not subject to EHR certification programs, as well as a lack of incentives, including a business model that generates revenue for health IT vendors via fees associated with transmitting and receiving data.\nIn particular, they discuss an additional concern, one that still causes issues today: interfaces between electronic health records (EHR) and the laboratory and other clinical information systems that feed medical diagnostic information into the EHRs[2]:\n\nAdditionally, the interface between EHRs and laboratory and radiology information systems typically has limited clinical information, and the lack of sufficiently detailed information makes it difficult for a pathologist or radiologist to determine the proper context for interpreting findings or to decide whether diagnostic testing is appropriate. For example, one study found that important non-oncological conditions (such as Crohn\u2019s disease, human immunodeficiency virus, and diabetes) were not mentioned in 59 percent of radiology orders and the presence of cancer was not mentioned in 8 percent of orders, demonstrating that the complete patient context is not getting received. Insufficient clinical information can be problematic as radiologists and pathologists often use this information to inform their interpretations of diagnostic testing results and suggestions for next steps. In addition, the Centers for Disease Control and Prevention\u2019s Clinical Laboratory Improvement Advisory Committee (CLIAC) expressed concern over the patient safety risks regarding the interoperability of laboratory data and display discrepancies in EHRs. They recommended that laboratory health care professionals collaborate with other stakeholders to \u201cdevelop effective solutions to reduce identified patient safety risks in and improve the safety of EHR systems\u201d regarding laboratory data.\nIn fact, interoperability issues have come up during the global laboratory response to the COVID-19 pandemic. In early April 2020, a report from Nature revealed that academic research laboratories wanting to assist with COVID-19 testing efforts have at times been stymied by the incompatibility between academic informatics systems and hospital EHRs. Not only do hospitals use EHRs of differing types, but many of those EHRs were not designed to talk to other EHRs, let alone to academic and research laboratories' informatics systems. Combine this with strict account procedures and the costs of developing interfaces on-the-fly, more than a few medical systems have turned away the offer of help from academic and research labs.[14] As it turns out, HL7- and other standard-based interfaces have long been expensive for many vendors to implement[15], the cost justified typically when high volumes of samples are involved. Additionally, in more normal, non-pandemic circumstances, the requirement to interface with EHRs and hospital information systems (HIS) is almost exclusively found in the LIS and LIMS used in patient settings, i.e., in the hospitals, medical offices, and laboratories catering to diagnosing disease in patients. Academic labs have not been equipped at any level (software, hardware, or personnel) to do high volume clinical testing, nor have they had reason to ensure their informatics systems can interface with clinical systems.\nInteroperability benefits and challenges show up elsewhere too. Take for example the value of phenotypes, a representation of the genetic analysis of the collective observable traits of an organism, traits caused by the interaction of its genome with the environment. The value of patient phenotyping data is increasingly useful in the fight against known and novel viruses, as well as a broad variety of non-viral diseases. As Ausiello and Shaw note, in order for medicine to advance and produce improved patient outcomes, \"traditional clinical information must be combined with genetic data and non-traditional phenotypes and analyzed in a manner that yields actionable insights into disease diagnosis, prevention, or treatment.\"[16] Whether it's identifying \"the measurable phenotypic characteristics of patients that are most predictive of individual variation\" in treatment outcomes for chronic pain[17] or COVID-19[18][19], phenotypes have utility in the clinical sector. \nHere again interoperability between EHRs and laboratory informatics systems comes into play. In a 2019 paper published by Zhang et al. in nph Digital Medicine, the topic of extracting patient phenotypes from laboratory test results fed into EHRs is addressed.[20] The authors state that one of the more difficult aspects of their research is that while \"[l]aboratory tests have broad applicability for translational research ... EHR-based research using laboratory data have been challenging because of their diversity and the lack of standardization of reporting laboratory test results.\" They add[20]:\n\nDespite the great potential of EHR data, patient phenotyping from EHRs is still challenging because the phenotype information is distributed in many EHR locations (laboratories, notes, problem lists, imaging data, etc.) and since EHRs have vastly different structures across sites. This lack of integration represents a substantial barrier to widespread use of EHR data in translational research.\nThe answer to the clinical and laboratory interoperability question is unclear. A 2019 article in the American Association for Clinical Chemistry's CLN Stat addressed remaining roadblocks, including lack of standards development, data quality issues, clinical data matching, lack of incentivizing health IT optimization, text-based reporting formats, differences in terminology, and HL7 messaging issues. They add that proposals from the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services include possible fixes such as standardized application programming interfaces (API). They also note that middleware may pick up the slack in connecting more laboratory devices, rather than depending on the LIS to handle all the interfacing.[21] On a more positive note, the Office of the National Coordinator for Health Information Technology (ONC) updated its Interoperability Standards Advisory (ISA) Vocabulary\/Code Set\/Terminology page in November to better \"highlight critical public health interoperability needs on COVID-19 in an easily accessible way.\" Replying to the ONC, HIMSS's Senior Director Jeff Coughlin goes on to add[22]:\n\nThere is a growing need to consider data exchange for home settings and considerations around device interoperability. There are a number of applications in use and this setting requires work across a number of systems (emergency medical services, hospital electronic health records, telemedicine system [synchronous and asynchronous] and, remote patient monitoring and device management). ISA should provide guidance on specific standards to assist in exchange with this setting.\"\nEven so, it remains obvious that more work needs to be done in the development and standard use of clinical and laboratory informatics applications if the promise of personalized medicine and the need for improved disease testing and response are to be fulfilled. In particular, how we responsibly protect personal health information while putting its anonymized variants to beneficial use for disease testing and prevention remains a critical question that must be solved in order to better prepare for the next COVID-19.\n\n4.3.2 Contact tracing \nContact tracing is a public health process that involves the determination of who a patient had specific contact with while infectious, then informing, supporting, and maintaining contact with those effected individuals in order to reduce the spread of an infection.[23] The seeds of contact tracing may go as far back as late fifteenth and early sixteenth century efforts to control infection rates of syphilis among prostitutes in part of Europe.[24] However, the practice was adopted more vigorously in the late nineteenth and early twentieth century in Great Britain for tracking cases of communicable diseases such as measles[25] and sexually transmitted diseases like syphilis and gonorrhea.[26] Further inroads were made in the United States in the early 1930s with its efforts to reduce sexually transmitted diseases among U.S. troops.[27]\nThroughout it all, contract tracing has been predominately a manual effort. However, the technological age has brought with it both social promise and privacy questions in regards to the application of informatics to contact tracing. In the mid-2000s, the use of Wi-Fi and RFID technology in Singapore hospital settings \"to provide an alternative to tedious and error-prone manual contact tracing\" was being reported in academic literature.[28] Since then, the use of informatics tools in contact tracing has increased, seeing practical application in combating severe acute respiratory syndrome (SARS)[29], Ebola[30], and tuberculosis.[31] As such, it should not be surprising that early in the COVID-19 pandemic, contract tracing was also being discussed within the context of both manual and digital tracing efforts.[23][32][33][34]\nContact tracing using digital tools, however, comes with both benefits and challenges.[35][36] Digital contact tracing tools have the potential to make contract tracing quicker and more efficient than manual processes. People can forget who they may have been in close contact with, for example, but with digital tracing, past location data can be mined to provide a clearer picture. As a result, with more accurate data, local and state policy-making efforts can be more nimbly tailored to current needs, and the effectiveness of those efforts can be better monitored.[31][28][35][37] However, several challenges also exist, primarily with social and cultural perceptions of the technology's acceptability and the privacy concerns surrounding it.\nSocial acceptability and trust around the world\nThe social acceptability and trust put into contact tracing applications and the governments that use them is of significant concern. An April 2020 \"blitz\" survey of the Flemish Region of Belgium showed that only 51 percent of respondents had \"no objection to a CORONA-app, under strict conditions.\"[38] As legal researcher Domenico Orlando points out, many contact tracing applications like Italy's Immuni app, however, require at least 60 percent of the population to participate for it to be effective.[39] He adds that while whether or not \"trust and social acceptance will follow is an unknown variable\" when it comes to digital contact tracing, having a strong set of legal protections in place\u2014such as those found with E.U. data protection law and the efforts of the European Data Protection Board (EDPB) to create data protection guidelines for digital surveillance tools[40]\u2014at least makes the technology more feasible.[39] Political and cultural context also plays a role in social acceptance. Countries like South Korea and states like Taiwan\u2014in comparison to mainland China\u2014arguably have seen greater adoption of digital surveillance due to a more relaxed political context[41], though attempts by the citizenry to be vigilantes who shame and discriminate others based on contact tracing data may work counter to that overall adoption rate.[35] Recent past experiences with digitally tracing MERS and SARS outbreaks in both cases, however, have probably played an even greater role in the success of convincing those governments' citizenry to voluntarily participate.[37] Similar adoption success can be seen in a Singapore poll that showed 70 percent of respondents were open to installing its government's voluntary TraceTogether app, which is based on the privacy-preserving protocol BlueTrace.[37]\nChallenges in the U.S.\nIn the United States, adopted use of contract tracing apps has been much more sporadic. Several cultural factors contribute. First and foremost, Americans' reluctance to answer calls from unknown numbers is continuing to increase. A First Orion 2019 Spam Call Trends and Projections Report found that more than 40 percent of calls received are spam calls, and 70 percent of Americans do not answer calls from an unknown number.[42] A December 2019 TrueCaller report found that robocalls in the U.S. \"increased from 7% [in 2018] to a staggering 35% \u2013 which means that more than every third spam call a user gets is a robocall.\"[43] This issues get complicated even further by lack of enforcement on \"spoofing,\" the practice of making a phone number appear to originate locally, or from a specific business. Even if a call looks legitimate, it may actually not be.[42][44] As Vice writer Casey Johnston suggests, given spam and spoofing practices and the related lack of enforcement, \"until the United States takes its scam and spam call problem seriously, we\u2019re probably going to be in the contact-tracing dark ages for a very long time.\"[44] \nSecond, overall trust in the federal government to do what's best and resolve problems has some catching up to do. September 2020 polls by the Pew Research Center[45] and Gallup[46] showed faith in overall federal government near all-time lows. As Lydia Saad of Gallup concluded in her 2020 analysis: \"As the country is engaged in critical efforts to combat the medical, economic and societal effects of the global coronavirus pandemic, Americans' trust in the federal government to handle domestic issues is near its lowest point in Gallup trends since 1972, as is their trust in the executive and legislative branches, public officials generally, and the American people themselves.\"[46] A few positive signs have shown, with overall public trust in government making a small uptick and \"trust in the federal government to provide accurate information about COVID-19\" rising with the January 2021 presidency change.[47][48] Yet as long as overall trust in the federal government remains low, it will continue to be difficult to roll out any significant contract tracing efforts across the nation.\nThird, the ebbs and flows of case numbers\u2014with surges in November 2020 and again in the summer of 2021 with the delta variant[49][50]\u2014make the number of cases to track tough to overcome. This is often compounded by the time it takes to get results, often too long to stem the flow of new infections.[51] A lack of a clear and organized national strategy for contract tracing, unlike the European Union[52], punctuates the challenges of getting more people to use contact tracing apps.[53] \nPrivacy and other issues\nThe preservation of user privacy and sensitive identifying data are also vital considerations in digital tracing apps. The previously mentioned BlueTrace protocol and its open-source reference implementation OpenTrace strive to address most of those concerns when \"logging Bluetooth encounters between participating devices to facilitate contact tracing, while protecting the users\u2019 personal data and privacy.\" More specifically, it strives to limit collection of personally-identifiable information, locally store and lock down encounter history, prevent third-party tracking, and provide revocable consent to store and allow use of encounter data.[54] Ultimately, these and other such solutions must ensure the anonymity of tracing data doesn't become compromised. Lew and Anderson also note that \"[c]loud-based storage of anonymous identifier beacons may also threaten security, given that any centralized list of identifiers could theoretically be hacked and re-identified.\"[36] As noted previously, re-identified data, let alone leaked anonymized data, could lead to shaming and discrimination against individuals identified as being infected.[35] \nPrivacy is not solely a concern of application developers, however. Government entities should also be held responsible for better ensuring how informatics solutions are created and used for epidemiological tracking. The European Union's EDPB and its contact tracing guidelines, adopted in April 2020, offer a compromise between the societal needs of contact tracing and the individual needs of privacy. The EDPB addresses the topics of location data sources and anonymized use, as well as the recommendations and functional requirements of applications employing those data sources, concluding \"that one should not have to choose between an efficient response to the current crisis and the protection of our fundamental rights: we can achieve both.\"[40] The U.S. CDC is less eloquent with its COVID-19 digital contact tracing guidelines, though they still stress the preference for secure data transfer mechanisms, open-source architecture, need-to-know-only access to data for public health authorities, and the ability for users to revoke data access consent at any time.[32]\nFinally, most digital tracing solutions also suffer from a few additional downsides. Several researchers have expressed concerns about data accuracy and actionability issues in mobile devices that lead to false positives. These issues include[36][54]:\n\ninaccurate inter-device distance detection\ninaccurate exposure detection in high-density buildings with multiple walls\ninability to track duration of exposure (i.e., seconds or hours)\nfailures with the underlying technology itself, including BlueTooth or the operating system\nThe future\nDespite these and other drawbacks, various governments around the world have found greater success at managing the COVID-19 pandemic with digital contact tracing. Huang et al. in the Harvard Business Review wonder if the successes reported in South Korea, Taiwan, and other parts of the East could be replicated in the United States and other Western democracies[37]:\n\nCan Western democracies achieve the results seen in East Asia without emulating their means? Probably not. There is likely a fundamental conflict between these requirements and deeply entrenched Western liberal values, such as the expectation of privacy, consent, and the sanctity of individual rights ... At the time of publication, at least three local governments in the United States are considering adoption of a contact-tracing app developed in a project led by MIT, Reuters reports ... But for such technologies to be effective, compliance must be nearly universal. Without a government mandate in the U.S., it\u2019s hard to imagine universal voluntary adoption of even a privacy-protecting tracing app.\r\n \r\n\nMaybe Covid-19 is a sign of our future steady state. Different societies will make different choices about how to respond to the next pandemic. 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The Atlantic. https:\/\/www.theatlantic.com\/politics\/archive\/2020\/08\/contact-tracing-hr-6666-working-us\/615637\/ .   \n \n\n\u2191 European Commission (19 October 2020). \"Coronavirus: EU interoperability gateway for contact tracing and warning apps \u2013 Questions and Answers\". European Union. https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/QANDA_20_1905 . Retrieved 21 November 2020 .   \n \n\n\u2191 Uberti, D. (21 October 2020). \"Disjointed Covid-19 Apps Across U.S. Raise Questions About Tech\u2019s Role\". The Wall Street Journal. https:\/\/www.wsj.com\/articles\/disjointed-covid-19-apps-across-u-s-raise-questions-about-techs-role-11603272613 . Retrieved 21 November 2020 .   \n \n\n\u2191 54.0 54.1 Bay, J.; Kek, J.; Tan, A. et al. (2020). BlueTrace: A privacy-preserving protocol for community-driven contact tracing across borders. pp. 1\u20139. https:\/\/bluetrace.io\/static\/bluetrace_whitepaper-938063656596c104632def383eb33b3c.pdf .   \n \n\n\n\r\n\n\n-----Go to the next chapter of this guide-----\nCitation information for this chapter \nChapter: 4. Workflow and information management for COVID-19 (and other respiratory diseases)\nEdition: Fall 2021\nTitle: COVID-19 Testing, Reporting, and Information Management in the Laboratory\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: September 2021\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 19 September 2021, at 17:27.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 326 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","38734314415297e7ef1e374a32ba8612_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Workflow_and_information_management_for_COVID-19_and_other_respiratory_diseases_Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Workflow_and_information_management_for_COVID-19_and_other_respiratory_diseases_Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Workflow and information management for COVID-19 (and other respiratory diseases)\/Additional benefits and challenges of informatics in disease testing and public health<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\">\n\n<h3><span class=\"mw-headline\" id=\"4.3_Additional_benefits_and_challenges_of_laboratory_informatics_in_disease_testing_and_public_health\">4.3 Additional benefits and challenges of laboratory informatics in disease testing and public health<\/span><\/h3>\n<p>COVID-19 is at the forefront of the consciousness of humanity, by and large, and the informatics tools we implement for managing, treating, and surveilling the disease are of great import. From disease databases to <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_health_record\" title=\"Electronic health record\" class=\"wiki-link\" data-key=\"f2e31a73217185bb01389404c1fd5255\">electronic health records<\/a>, from <a href=\"https:\/\/www.limswiki.org\/index.php\/Bioinformatics\" title=\"Bioinformatics\" class=\"wiki-link\" data-key=\"8f506695fdbb26e3f314da308f8c053b\">bioinformatics<\/a> tools for peptide and protein modeling to laboratory tools such as LIMS and LIS, we continue to fight back against the threat of the SARS-CoV-2 virus. Yet despite the gravity of the pandemic, this is neither the first nor the last time <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory<\/a> and scientific informatics will play a positive role in testing for disease and improving public health outcomes.\n<\/p><p>Health informatics technology, when used responsibly, has already proven to be useful in studying and treating contagious diseases. In a 2013 research paper published in the journal <i>BMJ Quality & Safety<\/i>, El-Kareh <i>et al.<\/i> analyzed and described the state of diagnostic health information technology (HIT). They noted that without the aid of HIT, clinicians are more error-prone, leaving them \"vulnerable to fallible human memory, variable disease presentation, clinical processes plagued by communication lapses, and a series of well-documented \u2018heuristics,\u2019 biases, and disease-specific pitfalls.\"<sup id=\"rdp-ebb-cite_ref-El-KarehUseOf13_1-0\" class=\"reference\"><a href=\"#cite_note-El-KarehUseOf13-1\">[1]<\/a><\/sup> Appropriate, well-designed HIT systems are capable of helping clinicians and laboratorians by providing more timely access to information, improved communication, better clinical reasoning and decision making, and improved workflows, as well as a reduction in diagnostic errors, and, as a result, improved patient safety and health outcomes.<sup id=\"rdp-ebb-cite_ref-NASEMImprov15_2-0\" class=\"reference\"><a href=\"#cite_note-NASEMImprov15-2\">[2]<\/a><\/sup> \n<\/p><p>From a public health perspective, the application of informatics to disease surveillance, reporting, and health habit promotion is also vital. Winters-Miner <i>et al.<\/i> note in particular the value of using informatics tools and methods to implement predictive analytics and data mining into public health. They use disease prevention and biosurveillance as major examples. We could, for example \"analyze large populations of people to quantify risks related to public health, and help physicians to develop intervention programs for those patients at highest risk of some ailment or medical condition.\"<sup id=\"rdp-ebb-cite_ref-Winters-MinerBiomedical15_3-0\" class=\"reference\"><a href=\"#cite_note-Winters-MinerBiomedical15-3\">[3]<\/a><\/sup> Additionally, through the use of syndromic surveillance systems (tools aiding in the detection of indicators leading up to disease diagnosis for individuals and populations<sup id=\"rdp-ebb-cite_ref-MandlImplement04_4-0\" class=\"reference\"><a href=\"#cite_note-MandlImplement04-4\">[4]<\/a><\/sup>), they suggest that outbreaks can be better detected at local and national levels, and public health measures can be better implemented, increasing public awareness and hindering the spread of disease.<sup id=\"rdp-ebb-cite_ref-Winters-MinerBiomedical15_3-1\" class=\"reference\"><a href=\"#cite_note-Winters-MinerBiomedical15-3\">[3]<\/a><\/sup>\n<\/p><p>In the clinical laboratory, informatics systems have been influencing workflow improvements and improved service delivery for more than five decades.<sup id=\"rdp-ebb-cite_ref-JonesInform14_5-0\" class=\"reference\"><a href=\"#cite_note-JonesInform14-5\">[5]<\/a><\/sup> And while improvements have been seen in the laboratory from not only the introduction of computerized systems<sup id=\"rdp-ebb-cite_ref-El-KarehUseOf13_1-1\" class=\"reference\"><a href=\"#cite_note-El-KarehUseOf13-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-NASEMImprov15_2-1\" class=\"reference\"><a href=\"#cite_note-NASEMImprov15-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RaeenHowLab18_6-0\" class=\"reference\"><a href=\"#cite_note-RaeenHowLab18-6\">[6]<\/a><\/sup> but also the realization of quality control<sup id=\"rdp-ebb-cite_ref-ChawlaEval10_7-0\" class=\"reference\"><a href=\"#cite_note-ChawlaEval10-7\">[7]<\/a><\/sup> and point-of-care testing<sup id=\"rdp-ebb-cite_ref-PricePoint01_8-0\" class=\"reference\"><a href=\"#cite_note-PricePoint01-8\">[8]<\/a><\/sup>, more challenges remain. For example, quality management in the laboratory is still often a manual, time-consuming activity. While the LIMS and LIS have some tools to assist with this task, the inclusion of laboratory analytics and business intelligence tools into those systems may lead to even further improvements in quality and efficiency in the lab.<sup id=\"rdp-ebb-cite_ref-ZiaguraUsing19_9-0\" class=\"reference\"><a href=\"#cite_note-ZiaguraUsing19-9\">[9]<\/a><\/sup> And in the realm of point-of-care testing, oversight and control of instruments can be lost when connectivity and training is lacking. Proper interfacing of these lab instruments could lead to improvements in those areas, says Siemens Healthineers' Daniel Gundler. \"Maintaining POC instruments and overseeing the operators performing POC tests would be much easier if all the information and data from each instrument were accessible through one user interface in which coordinators could manage both the instruments and operators.\"<sup id=\"rdp-ebb-cite_ref-GundlerPOCT19_10-0\" class=\"reference\"><a href=\"#cite_note-GundlerPOCT19-10\">[10]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"4.3.1_System_interoperability\">4.3.1 System interoperability<\/span><\/h4>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Electronic_medical_record.jpg\" class=\"image wiki-link\" data-key=\"d84087a4a701864fa86a6e5b2a71df22\"><img alt=\"Electronic medical record.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/7\/74\/Electronic_medical_record.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>System interoperability also poses benefits and challenges to clinical disease testing and prevention. Interoperability is defined as \u201cthe ability of different information systems, devices and applications (\u2018systems\u2019) to access, exchange, integrate and cooperatively use data in a coordinated manner\u201d to ensure timely, portable information and improved health outcomes.<sup id=\"rdp-ebb-cite_ref-.E2.80.9DHIMSSInterop20.E2.80.9D_11-0\" class=\"reference\"><a href=\"#cite_note-.E2.80.9DHIMSSInterop20.E2.80.9D-11\">[11]<\/a><\/sup> Improving interoperability among clinical informatics systems is recognized as an important step towards improving health outcomes.<sup id=\"rdp-ebb-cite_ref-KunImprov08_12-0\" class=\"reference\"><a href=\"#cite_note-KunImprov08-12\">[12]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GCHIImproving_13-0\" class=\"reference\"><a href=\"#cite_note-GCHIImproving-13\">[13]<\/a><\/sup> The National Academies of Sciences, Engineering, and Medicine had much to say on this topic in their 2015 publication <i>Improving Diagnosis in Health Care<\/i><sup id=\"rdp-ebb-cite_ref-NASEMImprov15_2-2\" class=\"reference\"><a href=\"#cite_note-NASEMImprov15-2\">[2]<\/a><\/sup>:\n<\/p><blockquote><p>Improved interoperability across different health care organizations\u2014as well as across laboratory and <a href=\"https:\/\/www.limswiki.org\/index.php\/Radiology_information_system\" title=\"Radiology information system\" class=\"wiki-link\" data-key=\"62d0a667f8b27309ea38a46507cfb500\">radiology information systems<\/a>\u2014is critical to improving the diagnostic process. Challenges to interoperability include the inconsistent and slow adoption of standards, particularly among organizations that are not subject to EHR certification programs, as well as a lack of incentives, including a business model that generates revenue for health IT vendors via fees associated with transmitting and receiving data.<\/p><\/blockquote>\n<p>In particular, they discuss an additional concern, one that still causes issues today: interfaces between <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_health_record\" title=\"Electronic health record\" class=\"wiki-link\" data-key=\"f2e31a73217185bb01389404c1fd5255\">electronic health records<\/a> (EHR) and the laboratory and other clinical information systems that feed medical diagnostic information into the EHRs<sup id=\"rdp-ebb-cite_ref-NASEMImprov15_2-3\" class=\"reference\"><a href=\"#cite_note-NASEMImprov15-2\">[2]<\/a><\/sup>:\n<\/p>\n<blockquote><p>Additionally, the interface between EHRs and laboratory and radiology information systems typically has limited clinical information, and the lack of sufficiently detailed information makes it difficult for a pathologist or radiologist to determine the proper context for interpreting findings or to decide whether diagnostic testing is appropriate. For example, one study found that important non-oncological conditions (such as Crohn\u2019s disease, human immunodeficiency virus, and diabetes) were not mentioned in 59 percent of radiology orders and the presence of cancer was not mentioned in 8 percent of orders, demonstrating that the complete patient context is not getting received. Insufficient clinical information can be problematic as radiologists and pathologists often use this information to inform their interpretations of diagnostic testing results and suggestions for next steps. In addition, the Centers for Disease Control and Prevention\u2019s Clinical Laboratory Improvement Advisory Committee (CLIAC) expressed concern over the patient safety risks regarding the interoperability of laboratory data and display discrepancies in EHRs. They recommended that laboratory health care professionals collaborate with other stakeholders to \u201cdevelop effective solutions to reduce identified patient safety risks in and improve the safety of EHR systems\u201d regarding laboratory data.<\/p><\/blockquote>\n<p>In fact, interoperability issues have come up during the global laboratory response to the COVID-19 pandemic. In early April 2020, a report from <i>Nature<\/i> revealed that academic research laboratories wanting to assist with COVID-19 testing efforts have at times been stymied by the incompatibility between academic informatics systems and hospital EHRs. Not only do hospitals use EHRs of differing types, but many of those EHRs were not designed to talk to other EHRs, let alone to academic and research laboratories' informatics systems. Combine this with strict account procedures and the costs of developing interfaces on-the-fly, more than a few medical systems have turned away the offer of help from academic and research labs.<sup id=\"rdp-ebb-cite_ref-MaxmenThousands20_14-0\" class=\"reference\"><a href=\"#cite_note-MaxmenThousands20-14\">[14]<\/a><\/sup> As it turns out, <a href=\"https:\/\/www.limswiki.org\/index.php\/HL7\" class=\"mw-redirect wiki-link\" title=\"HL7\" data-key=\"944ec30acac5b7c05ef9ce3c1b4c22dc\">HL7<\/a>- and other standard-based interfaces have long been expensive for many vendors to implement<sup id=\"rdp-ebb-cite_ref-John3504HL7_11_15-0\" class=\"reference\"><a href=\"#cite_note-John3504HL7_11-15\">[15]<\/a><\/sup>, the cost justified typically when high volumes of samples are involved. Additionally, in more normal, non-pandemic circumstances, the requirement to interface with EHRs and <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital_information_system\" title=\"Hospital information system\" class=\"wiki-link\" data-key=\"d8385de7b1f39a39d793f8ce349b448d\">hospital information systems<\/a> (HIS) is almost exclusively found in the LIS and LIMS used in patient settings, i.e., in the hospitals, medical offices, and laboratories catering to diagnosing disease in patients. Academic labs have not been equipped at any level (software, hardware, or personnel) to do high volume clinical testing, nor have they had reason to ensure their informatics systems can interface with clinical systems.\n<\/p><p>Interoperability benefits and challenges show up elsewhere too. Take for example the value of phenotypes, a representation of the genetic analysis of the collective observable traits of an organism, traits caused by the interaction of its genome with the environment. The value of patient phenotyping data is increasingly useful in the fight against known and novel viruses, as well as a broad variety of non-viral diseases. As Ausiello and Shaw note, in order for medicine to advance and produce improved patient outcomes, \"traditional clinical information must be combined with genetic data and non-traditional phenotypes and analyzed in a manner that yields actionable insights into disease diagnosis, prevention, or treatment.\"<sup id=\"rdp-ebb-cite_ref-AusielloQuant14_16-0\" class=\"reference\"><a href=\"#cite_note-AusielloQuant14-16\">[16]<\/a><\/sup> Whether it's identifying \"the measurable phenotypic characteristics of patients that are most predictive of individual variation\" in treatment outcomes for chronic pain<sup id=\"rdp-ebb-cite_ref-EdwardsPatient16_17-0\" class=\"reference\"><a href=\"#cite_note-EdwardsPatient16-17\">[17]<\/a><\/sup> or COVID-19<sup id=\"rdp-ebb-cite_ref-MousavizadehGenotype20_18-0\" class=\"reference\"><a href=\"#cite_note-MousavizadehGenotype20-18\">[18]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GattinoniCOVID20_19-0\" class=\"reference\"><a href=\"#cite_note-GattinoniCOVID20-19\">[19]<\/a><\/sup>, phenotypes have utility in the clinical sector. \n<\/p><p>Here again interoperability between EHRs and laboratory informatics systems comes into play. In a 2019 paper published by Zhang <i>et al.<\/i> in <i>nph Digital Medicine<\/i>, the topic of extracting patient phenotypes from laboratory test results fed into EHRs is addressed.<sup id=\"rdp-ebb-cite_ref-ZhangSemantic19_20-0\" class=\"reference\"><a href=\"#cite_note-ZhangSemantic19-20\">[20]<\/a><\/sup> The authors state that one of the more difficult aspects of their research is that while \"[l]aboratory tests have broad applicability for translational research ... EHR-based research using laboratory data have been challenging because of their diversity and the lack of standardization of reporting laboratory test results.\" They add<sup id=\"rdp-ebb-cite_ref-ZhangSemantic19_20-1\" class=\"reference\"><a href=\"#cite_note-ZhangSemantic19-20\">[20]<\/a><\/sup>:\n<\/p>\n<blockquote><p>Despite the great potential of EHR data, patient phenotyping from EHRs is still challenging because the phenotype information is distributed in many EHR locations (laboratories, notes, problem lists, imaging data, etc.) and since EHRs have vastly different structures across sites. This lack of integration represents a substantial barrier to widespread use of EHR data in translational research.<\/p><\/blockquote>\n<p>The answer to the clinical and laboratory interoperability question is unclear. A 2019 article in the American Association for Clinical Chemistry's <i>CLN Stat<\/i> addressed remaining roadblocks, including lack of standards development, data quality issues, clinical data matching, lack of incentivizing health IT optimization, text-based reporting formats, differences in terminology, and HL7 messaging issues. They add that proposals from the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services include possible fixes such as standardized <a href=\"https:\/\/www.limswiki.org\/index.php\/Application_programming_interface\" title=\"Application programming interface\" class=\"wiki-link\" data-key=\"36fc319869eba4613cb0854b421b0934\">application programming interfaces<\/a> (API). They also note that middleware may pick up the slack in connecting more laboratory devices, rather than depending on the LIS to handle all the interfacing.<sup id=\"rdp-ebb-cite_ref-AACCStrength19_21-0\" class=\"reference\"><a href=\"#cite_note-AACCStrength19-21\">[21]<\/a><\/sup> On a more positive note, the Office of the National Coordinator for Health Information Technology (ONC) updated its Interoperability Standards Advisory (ISA) <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthit.gov\/isa\/covid-19\" target=\"_blank\">Vocabulary\/Code Set\/Terminology page<\/a> in November to better \"highlight critical public health interoperability needs on COVID-19 in an easily accessible way.\" Replying to the ONC, HIMSS's Senior Director Jeff Coughlin goes on to add<sup id=\"rdp-ebb-cite_ref-CoughlinCOVID20_22-0\" class=\"reference\"><a href=\"#cite_note-CoughlinCOVID20-22\">[22]<\/a><\/sup>:\n<\/p>\n<blockquote><p>There is a growing need to consider data exchange for home settings and considerations around device interoperability. There are a number of applications in use and this setting requires work across a number of systems (emergency medical services, hospital electronic health records, telemedicine system [synchronous and asynchronous] and, remote patient monitoring and device management). ISA should provide guidance on specific standards to assist in exchange with this setting.\"<\/p><\/blockquote>\n<p>Even so, it remains obvious that more work needs to be done in the development and standard use of clinical and laboratory informatics applications if the promise of personalized medicine and the need for improved disease testing and response are to be fulfilled. In particular, how we responsibly protect personal health information while putting its anonymized variants to beneficial use for disease testing and prevention remains a critical question that must be solved in order to better prepare for the next COVID-19.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"4.3.2_Contact_tracing\">4.3.2 Contact tracing<\/span><\/h4>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:What_is_contact_tracing_COVID-19.png\" class=\"image wiki-link\" data-key=\"b6d82aa7b3f8f7bdde496f4cec46524c\"><img alt=\"What is contact tracing COVID-19.png\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/e\/e4\/What_is_contact_tracing_COVID-19.png\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>Contact tracing is a public health process that involves the determination of who a patient had specific contact with while infectious, then informing, supporting, and maintaining contact with those effected individuals in order to reduce the spread of an infection.<sup id=\"rdp-ebb-cite_ref-CDCContact20_23-0\" class=\"reference\"><a href=\"#cite_note-CDCContact20-23\">[23]<\/a><\/sup> The seeds of contact tracing may go as far back as late fifteenth and early sixteenth century efforts to control infection rates of syphilis among prostitutes in part of Europe.<sup id=\"rdp-ebb-cite_ref-RosenAHistory15.22_24-0\" class=\"reference\"><a href=\"#cite_note-RosenAHistory15.22-24\">[24]<\/a><\/sup> However, the practice was adopted more vigorously in the late nineteenth and early twentieth century in Great Britain for tracking cases of communicable diseases such as measles<sup id=\"rdp-ebb-cite_ref-MooneyIntrusive15_25-0\" class=\"reference\"><a href=\"#cite_note-MooneyIntrusive15-25\">[25]<\/a><\/sup> and sexually transmitted diseases like syphilis and gonorrhea.<sup id=\"rdp-ebb-cite_ref-DavidsonSearching96_26-0\" class=\"reference\"><a href=\"#cite_note-DavidsonSearching96-26\">[26]<\/a><\/sup> Further inroads were made in the United States in the early 1930s with its efforts to reduce sexually transmitted diseases among U.S. troops.<sup id=\"rdp-ebb-cite_ref-Wigfield27Years72_27-0\" class=\"reference\"><a href=\"#cite_note-Wigfield27Years72-27\">[27]<\/a><\/sup>\n<\/p><p>Throughout it all, contract tracing has been predominately a manual effort. However, the technological age has brought with it both social promise and privacy questions in regards to the application of informatics to contact tracing. In the mid-2000s, the use of Wi-Fi and RFID technology in Singapore hospital settings \"to provide an alternative to tedious and error-prone manual contact tracing\" was being reported in academic literature.<sup id=\"rdp-ebb-cite_ref-LimDevelopment06_28-0\" class=\"reference\"><a href=\"#cite_note-LimDevelopment06-28\">[28]<\/a><\/sup> Since then, the use of informatics tools in contact tracing has increased, seeing practical application in combating <a href=\"https:\/\/www.limswiki.org\/index.php\/Severe_acute_respiratory_syndrome\" title=\"Severe acute respiratory syndrome\" class=\"wiki-link\" data-key=\"11abe2043ece64ad43ee0052402c5cec\">severe acute respiratory syndrome<\/a> (SARS)<sup id=\"rdp-ebb-cite_ref-ZhangBioPortal08_29-0\" class=\"reference\"><a href=\"#cite_note-ZhangBioPortal08-29\">[29]<\/a><\/sup>, Ebola<sup id=\"rdp-ebb-cite_ref-SchaferTheEpi16_30-0\" class=\"reference\"><a href=\"#cite_note-SchaferTheEpi16-30\">[30]<\/a><\/sup>, and tuberculosis.<sup id=\"rdp-ebb-cite_ref-HaEval16_31-0\" class=\"reference\"><a href=\"#cite_note-HaEval16-31\">[31]<\/a><\/sup> As such, it should not be surprising that early in the COVID-19 pandemic, contract tracing was also being discussed within the context of both manual and digital tracing efforts.<sup id=\"rdp-ebb-cite_ref-CDCContact20_23-1\" class=\"reference\"><a href=\"#cite_note-CDCContact20-23\">[23]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AHACDC20_32-0\" class=\"reference\"><a href=\"#cite_note-AHACDC20-32\">[32]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-YanContact20_33-0\" class=\"reference\"><a href=\"#cite_note-YanContact20-33\">[33]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FortinSoYou20_34-0\" class=\"reference\"><a href=\"#cite_note-FortinSoYou20-34\">[34]<\/a><\/sup>\n<\/p><p>Contact tracing using digital tools, however, comes with both benefits and challenges.<sup id=\"rdp-ebb-cite_ref-WaltzHalting20_35-0\" class=\"reference\"><a href=\"#cite_note-WaltzHalting20-35\">[35]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LewDigital20_36-0\" class=\"reference\"><a href=\"#cite_note-LewDigital20-36\">[36]<\/a><\/sup> Digital contact tracing tools have the potential to make contract tracing quicker and more efficient than manual processes. People can forget who they may have been in close contact with, for example, but with digital tracing, past location data can be mined to provide a clearer picture. As a result, with more accurate data, local and state policy-making efforts can be more nimbly tailored to current needs, and the effectiveness of those efforts can be better monitored.<sup id=\"rdp-ebb-cite_ref-HaEval16_31-1\" class=\"reference\"><a href=\"#cite_note-HaEval16-31\">[31]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LimDevelopment06_28-1\" class=\"reference\"><a href=\"#cite_note-LimDevelopment06-28\">[28]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WaltzHalting20_35-1\" class=\"reference\"><a href=\"#cite_note-WaltzHalting20-35\">[35]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HuangHow20_37-0\" class=\"reference\"><a href=\"#cite_note-HuangHow20-37\">[37]<\/a><\/sup> However, several challenges also exist, primarily with social and cultural perceptions of the technology's acceptability and the privacy concerns surrounding it.\n<\/p><p><b>Social acceptability and trust around the world<\/b>\n<\/p><p>The social acceptability and trust put into contact tracing applications and the governments that use them is of significant concern. An April 2020 \"blitz\" survey of the Flemish Region of Belgium showed that only 51 percent of respondents had \"no objection to a CORONA-app, under strict conditions.\"<sup id=\"rdp-ebb-cite_ref-KCDSSurvey20_38-0\" class=\"reference\"><a href=\"#cite_note-KCDSSurvey20-38\">[38]<\/a><\/sup> As legal researcher Domenico Orlando points out, many contact tracing applications like Italy's Immuni app, however, require at least 60 percent of the population to participate for it to be effective.<sup id=\"rdp-ebb-cite_ref-OrlandoTheEDPB20_39-0\" class=\"reference\"><a href=\"#cite_note-OrlandoTheEDPB20-39\">[39]<\/a><\/sup> He adds that while whether or not \"trust and social acceptance will follow is an unknown variable\" when it comes to digital contact tracing, having a strong set of legal protections in place\u2014such as those found with E.U. data protection law and the efforts of the European Data Protection Board (EDPB) to create data protection guidelines for digital surveillance tools<sup id=\"rdp-ebb-cite_ref-EDPBGuidelines20_40-0\" class=\"reference\"><a href=\"#cite_note-EDPBGuidelines20-40\">[40]<\/a><\/sup>\u2014at least makes the technology more feasible.<sup id=\"rdp-ebb-cite_ref-OrlandoTheEDPB20_39-1\" class=\"reference\"><a href=\"#cite_note-OrlandoTheEDPB20-39\">[39]<\/a><\/sup> Political and cultural context also plays a role in social acceptance. Countries like South Korea and states like Taiwan\u2014in comparison to mainland China\u2014arguably have seen greater adoption of digital surveillance due to a more relaxed political context<sup id=\"rdp-ebb-cite_ref-NazeerDigital20_41-0\" class=\"reference\"><a href=\"#cite_note-NazeerDigital20-41\">[41]<\/a><\/sup>, though attempts by the citizenry to be vigilantes who shame and discriminate others based on contact tracing data may work counter to that overall adoption rate.<sup id=\"rdp-ebb-cite_ref-WaltzHalting20_35-2\" class=\"reference\"><a href=\"#cite_note-WaltzHalting20-35\">[35]<\/a><\/sup> Recent past experiences with digitally tracing MERS and SARS outbreaks in both cases, however, have probably played an even greater role in the success of convincing those governments' citizenry to voluntarily participate.<sup id=\"rdp-ebb-cite_ref-HuangHow20_37-1\" class=\"reference\"><a href=\"#cite_note-HuangHow20-37\">[37]<\/a><\/sup> Similar adoption success can be seen in a Singapore poll that showed 70 percent of respondents were open to installing its government's voluntary TraceTogether app, which is based on the privacy-preserving protocol <a href=\"https:\/\/www.limswiki.org\/index.php\/Journal:BlueTrace:_A_privacy-preserving_protocol_for_community-driven_contact_tracing_across_borders\" title=\"Journal:BlueTrace: A privacy-preserving protocol for community-driven contact tracing across borders\" class=\"wiki-link\" data-key=\"6916dfabf162fd46a0d0c48e26b03db4\">BlueTrace<\/a>.<sup id=\"rdp-ebb-cite_ref-HuangHow20_37-2\" class=\"reference\"><a href=\"#cite_note-HuangHow20-37\">[37]<\/a><\/sup>\n<\/p><p><b>Challenges in the U.S.<\/b>\n<\/p><p>In the United States, adopted use of contract tracing apps has been much more sporadic. Several cultural factors contribute. First and foremost, Americans' reluctance to answer calls from unknown numbers is continuing to increase. A First Orion 2019 <i>Spam Call Trends and Projections Report<\/i> found that more than 40 percent of calls received are spam calls, and 70 percent of Americans do not answer calls from an unknown number.<sup id=\"rdp-ebb-cite_ref-FOScam19_42-0\" class=\"reference\"><a href=\"#cite_note-FOScam19-42\">[42]<\/a><\/sup> A December 2019 TrueCaller report found that robocalls in the U.S. \"increased from 7% [in 2018] to a staggering 35% \u2013 which means that more than every third spam call a user gets is a robocall.\"<sup id=\"rdp-ebb-cite_ref-KokTrue19_43-0\" class=\"reference\"><a href=\"#cite_note-KokTrue19-43\">[43]<\/a><\/sup> This issues get complicated even further by lack of enforcement on \"spoofing,\" the practice of making a phone number appear to originate locally, or from a specific business. Even if a call looks legitimate, it may actually not be.<sup id=\"rdp-ebb-cite_ref-FOScam19_42-1\" class=\"reference\"><a href=\"#cite_note-FOScam19-42\">[42]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-JohnstonTheReal20_44-0\" class=\"reference\"><a href=\"#cite_note-JohnstonTheReal20-44\">[44]<\/a><\/sup> As <i>Vice<\/i> writer Casey Johnston suggests, given spam and spoofing practices and the related lack of enforcement, \"until the United States takes its scam and spam call problem seriously, we\u2019re probably going to be in the contact-tracing dark ages for a very long time.\"<sup id=\"rdp-ebb-cite_ref-JohnstonTheReal20_44-1\" class=\"reference\"><a href=\"#cite_note-JohnstonTheReal20-44\">[44]<\/a><\/sup> \n<\/p><p>Second, overall trust in the federal government to do what's best and resolve problems has some catching up to do. September 2020 polls by the Pew Research Center<sup id=\"rdp-ebb-cite_ref-PewAmericans20_45-0\" class=\"reference\"><a href=\"#cite_note-PewAmericans20-45\">[45]<\/a><\/sup> and Gallup<sup id=\"rdp-ebb-cite_ref-SaadTrust20_46-0\" class=\"reference\"><a href=\"#cite_note-SaadTrust20-46\">[46]<\/a><\/sup> showed faith in overall federal government near all-time lows. As Lydia Saad of Gallup concluded in her 2020 analysis: \"As the country is engaged in critical efforts to combat the medical, economic and societal effects of the global coronavirus pandemic, Americans' trust in the federal government to handle domestic issues is near its lowest point in Gallup trends since 1972, as is their trust in the executive and legislative branches, public officials generally, and the American people themselves.\"<sup id=\"rdp-ebb-cite_ref-SaadTrust20_46-1\" class=\"reference\"><a href=\"#cite_note-SaadTrust20-46\">[46]<\/a><\/sup> A few positive signs have shown, with overall public trust in government making a small uptick and \"trust in the federal government to provide accurate information about COVID-19\" rising with the January 2021 presidency change.<sup id=\"rdp-ebb-cite_ref-PewPublic21_47-0\" class=\"reference\"><a href=\"#cite_note-PewPublic21-47\">[47]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DurkeeTrust21_48-0\" class=\"reference\"><a href=\"#cite_note-DurkeeTrust21-48\">[48]<\/a><\/sup> Yet as long as overall trust in the federal government remains low, it will continue to be difficult to roll out any significant contract tracing efforts across the nation.\n<\/p><p>Third, the ebbs and flows of case numbers\u2014with surges in November 2020 and again in the summer of 2021 with the delta variant<sup id=\"rdp-ebb-cite_ref-StoneHow20_49-0\" class=\"reference\"><a href=\"#cite_note-StoneHow20-49\">[49]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DohenyAsDelta21_50-0\" class=\"reference\"><a href=\"#cite_note-DohenyAsDelta21-50\">[50]<\/a><\/sup>\u2014make the number of cases to track tough to overcome. This is often compounded by the time it takes to get results, often too long to stem the flow of new infections.<sup id=\"rdp-ebb-cite_ref-KhazanTheMost20_51-0\" class=\"reference\"><a href=\"#cite_note-KhazanTheMost20-51\">[51]<\/a><\/sup> A lack of a clear and organized national strategy for contract tracing, unlike the European Union<sup id=\"rdp-ebb-cite_ref-EUCorona20_52-0\" class=\"reference\"><a href=\"#cite_note-EUCorona20-52\">[52]<\/a><\/sup>, punctuates the challenges of getting more people to use contact tracing apps.<sup id=\"rdp-ebb-cite_ref-UbertiDisjoint20_53-0\" class=\"reference\"><a href=\"#cite_note-UbertiDisjoint20-53\">[53]<\/a><\/sup> \n<\/p><p><b>Privacy and other issues<\/b>\n<\/p><p>The preservation of user privacy and sensitive identifying data are also vital considerations in digital tracing apps. The previously mentioned BlueTrace protocol and its open-source reference implementation OpenTrace strive to address most of those concerns when \"logging Bluetooth encounters between participating devices to facilitate contact tracing, while protecting the users\u2019 personal data and privacy.\" More specifically, it strives to limit collection of personally-identifiable information, locally store and lock down encounter history, prevent third-party tracking, and provide revocable consent to store and allow use of encounter data.<sup id=\"rdp-ebb-cite_ref-BayBlue20_54-0\" class=\"reference\"><a href=\"#cite_note-BayBlue20-54\">[54]<\/a><\/sup> Ultimately, these and other such solutions must ensure the anonymity of tracing data doesn't become compromised. Lew and Anderson also note that \"[c]loud-based storage of anonymous identifier beacons may also threaten security, given that any centralized list of identifiers could theoretically be hacked and re-identified.\"<sup id=\"rdp-ebb-cite_ref-LewDigital20_36-1\" class=\"reference\"><a href=\"#cite_note-LewDigital20-36\">[36]<\/a><\/sup> As noted previously, re-identified data, let alone leaked anonymized data, could lead to shaming and discrimination against individuals identified as being infected.<sup id=\"rdp-ebb-cite_ref-WaltzHalting20_35-3\" class=\"reference\"><a href=\"#cite_note-WaltzHalting20-35\">[35]<\/a><\/sup> \n<\/p><p>Privacy is not solely a concern of application developers, however. Government entities should also be held responsible for better ensuring how informatics solutions are created and used for epidemiological tracking. The European Union's EDPB and its contact tracing guidelines, adopted in April 2020, offer a compromise between the societal needs of contact tracing and the individual needs of privacy. The EDPB addresses the topics of location data sources and anonymized use, as well as the recommendations and functional requirements of applications employing those data sources, concluding \"that one should not have to choose between an efficient response to the current crisis and the protection of our fundamental rights: we can achieve both.\"<sup id=\"rdp-ebb-cite_ref-EDPBGuidelines20_40-1\" class=\"reference\"><a href=\"#cite_note-EDPBGuidelines20-40\">[40]<\/a><\/sup> The U.S. CDC is less eloquent with its COVID-19 digital contact tracing guidelines, though they still stress the preference for secure data transfer mechanisms, open-source architecture, need-to-know-only access to data for public health authorities, and the ability for users to revoke data access consent at any time.<sup id=\"rdp-ebb-cite_ref-AHACDC20_32-1\" class=\"reference\"><a href=\"#cite_note-AHACDC20-32\">[32]<\/a><\/sup>\n<\/p><p>Finally, most digital tracing solutions also suffer from a few additional downsides. Several researchers have expressed concerns about data accuracy and actionability issues in mobile devices that lead to false positives. These issues include<sup id=\"rdp-ebb-cite_ref-LewDigital20_36-2\" class=\"reference\"><a href=\"#cite_note-LewDigital20-36\">[36]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BayBlue20_54-1\" class=\"reference\"><a href=\"#cite_note-BayBlue20-54\">[54]<\/a><\/sup>:\n<\/p>\n<ul><li>inaccurate inter-device distance detection<\/li>\n<li>inaccurate exposure detection in high-density buildings with multiple walls<\/li>\n<li>inability to track duration of exposure (i.e., seconds or hours)<\/li>\n<li>failures with the underlying technology itself, including BlueTooth or the operating system<\/li><\/ul>\n<p><b>The future<\/b>\n<\/p><p>Despite these and other drawbacks, various governments around the world have found greater success at managing the COVID-19 pandemic with digital contact tracing. Huang <i>et al.<\/i> in the <i>Harvard Business Review<\/i> wonder if the successes reported in South Korea, Taiwan, and other parts of the East could be replicated in the United States and other Western democracies<sup id=\"rdp-ebb-cite_ref-HuangHow20_37-3\" class=\"reference\"><a href=\"#cite_note-HuangHow20-37\">[37]<\/a><\/sup>:\n<\/p>\n<blockquote><p>Can Western democracies achieve the results seen in East Asia without emulating their means? Probably not. There is likely a fundamental conflict between these requirements and deeply entrenched Western liberal values, such as the expectation of privacy, consent, and the sanctity of individual rights ... At the time of publication, at least three local governments in the United States are considering adoption of a contact-tracing app developed in a project led by MIT, Reuters reports ... But for such technologies to be effective, compliance must be nearly universal. Without a government mandate in the U.S., it\u2019s hard to imagine universal voluntary adoption of even a privacy-protecting tracing app.<br \/> <br \/>\nMaybe Covid-19 is a sign of our future steady state. Different societies will make different choices about how to respond to the next pandemic. For Western democracies the time has come to either rethink our values around the tradeoff between personal privacy and public safety in a pandemic or to accelerate technology innovation and policy development that can preserve both.<\/p><\/blockquote>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-El-KarehUseOf13-1\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-El-KarehUseOf13_1-0\">1.0<\/a><\/sup> <sup><a href=\"#cite_ref-El-KarehUseOf13_1-1\">1.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">El-Kareh, R.; Hasan, O.; Schiff, G.D. (2013). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC3786650\" target=\"_blank\">\"Use of health information technology to reduce diagnostic errors\"<\/a>. <i>BMJ Quality & Safety<\/i> <b>22<\/b> (Suppl. 2): ii40\u2013ii51. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1136%2Fbmjqs-2013-001884\" target=\"_blank\">10.1136\/bmjqs-2013-001884<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3786650\/\" target=\"_blank\">PMC3786650<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/23852973\" target=\"_blank\">23852973<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC3786650\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC3786650<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Use+of+health+information+technology+to+reduce+diagnostic+errors&rft.jtitle=BMJ+Quality+%26+Safety&rft.aulast=El-Kareh%2C+R.%3B+Hasan%2C+O.%3B+Schiff%2C+G.D.&rft.au=El-Kareh%2C+R.%3B+Hasan%2C+O.%3B+Schiff%2C+G.D.&rft.date=2013&rft.volume=22&rft.issue=Suppl.+2&rft.pages=ii40%E2%80%93ii51&rft_id=info:doi\/10.1136%2Fbmjqs-2013-001884&rft_id=info:pmc\/PMC3786650&rft_id=info:pmid\/23852973&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC3786650&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NASEMImprov15-2\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-NASEMImprov15_2-0\">2.0<\/a><\/sup> <sup><a href=\"#cite_ref-NASEMImprov15_2-1\">2.1<\/a><\/sup> <sup><a href=\"#cite_ref-NASEMImprov15_2-2\">2.2<\/a><\/sup> <sup><a href=\"#cite_ref-NASEMImprov15_2-3\">2.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">National Academies of Sciences, Engineering, and Medicine (2015). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nap.edu\/read\/21794\/chapter\/7\" target=\"_blank\">\"Chapter 5: Technology and Tools in the Diagnostic Process\"<\/a>. <i>Improving Diagnosis in Health Care<\/i>. The National Academies Press. pp. 217\u201362. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.17226%2F21794\" target=\"_blank\">10.17226\/21794<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9780309377720<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.nap.edu\/read\/21794\/chapter\/7\" target=\"_blank\">https:\/\/www.nap.edu\/read\/21794\/chapter\/7<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+5%3A+Technology+and+Tools+in+the+Diagnostic+Process&rft.atitle=Improving+Diagnosis+in+Health+Care&rft.aulast=National+Academies+of+Sciences%2C+Engineering%2C+and+Medicine&rft.au=National+Academies+of+Sciences%2C+Engineering%2C+and+Medicine&rft.date=2015&rft.pages=pp.%26nbsp%3B217%E2%80%9362&rft.pub=The+National+Academies+Press&rft_id=info:doi\/10.17226%2F21794&rft.isbn=9780309377720&rft_id=https%3A%2F%2Fwww.nap.edu%2Fread%2F21794%2Fchapter%2F7&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Winters-MinerBiomedical15-3\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-Winters-MinerBiomedical15_3-0\">3.0<\/a><\/sup> <sup><a href=\"#cite_ref-Winters-MinerBiomedical15_3-1\">3.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Winters-Miner, L.A.; Bolding, P.S.; Hilbe, J.M. et al. (2015). \"Chapter 3: Biomedical Informatics\". <i>Practical Predictive Analytics and Decisioning Systems for Medicine<\/i>. Academic Press. pp. 42\u201359. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2FB978-0-12-411643-6.00003-X\" target=\"_blank\">10.1016\/B978-0-12-411643-6.00003-X<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9780124116436.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+3%3A+Biomedical+Informatics&rft.atitle=Practical+Predictive+Analytics+and+Decisioning+Systems+for+Medicine&rft.aulast=Winters-Miner%2C+L.A.%3B+Bolding%2C+P.S.%3B+Hilbe%2C+J.M.+et+al.&rft.au=Winters-Miner%2C+L.A.%3B+Bolding%2C+P.S.%3B+Hilbe%2C+J.M.+et+al.&rft.date=2015&rft.pages=pp.%26nbsp%3B42%E2%80%9359&rft.pub=Academic+Press&rft_id=info:doi\/10.1016%2FB978-0-12-411643-6.00003-X&rft.isbn=9780124116436&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MandlImplement04-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MandlImplement04_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Mandl, K.D.; Overhage, J.M.; Wagner, M.M. et al. (2004). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC353021\" target=\"_blank\">\"Implementing syndromic surveillance: A practical guide informed by the early experience\"<\/a>. <i>JAMIA<\/i> <b>11<\/b> (2): 141\u201350. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1197%2Fjamia.M1356\" target=\"_blank\">10.1197\/jamia.M1356<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC353021\/\" target=\"_blank\">PMC353021<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/14633933\" target=\"_blank\">14633933<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC353021\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC353021<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Implementing+syndromic+surveillance%3A+A+practical+guide+informed+by+the+early+experience&rft.jtitle=JAMIA&rft.aulast=Mandl%2C+K.D.%3B+Overhage%2C+J.M.%3B+Wagner%2C+M.M.+et+al.&rft.au=Mandl%2C+K.D.%3B+Overhage%2C+J.M.%3B+Wagner%2C+M.M.+et+al.&rft.date=2004&rft.volume=11&rft.issue=2&rft.pages=141%E2%80%9350&rft_id=info:doi\/10.1197%2Fjamia.M1356&rft_id=info:pmc\/PMC353021&rft_id=info:pmid\/14633933&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC353021&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-JonesInform14-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-JonesInform14_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Jones, R.G.; Johnson, O.A.; Baststone, G. (2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4204239\" target=\"_blank\">\"Informatics and the Clinical Laboratory\"<\/a>. <i>The Clinical Biochemist Reviews<\/i> <b>35<\/b> (3): 177\u2013192. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4204239\/\" target=\"_blank\">PMC4204239<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/25336763\" target=\"_blank\">25336763<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4204239\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4204239<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Informatics+and+the+Clinical+Laboratory&rft.jtitle=The+Clinical+Biochemist+Reviews&rft.aulast=Jones%2C+R.G.%3B+Johnson%2C+O.A.%3B+Baststone%2C+G.&rft.au=Jones%2C+R.G.%3B+Johnson%2C+O.A.%3B+Baststone%2C+G.&rft.date=2014&rft.volume=35&rft.issue=3&rft.pages=177%E2%80%93192&rft_id=info:pmc\/PMC4204239&rft_id=info:pmid\/25336763&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC4204239&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RaeenHowLab18-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RaeenHowLab18_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Raeen, M.R. 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Retrieved 17 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Improving+Patient+Care+through+Interoperability&rft.atitle=&rft.aulast=Global+Center+for+Health+Innovation&rft.au=Global+Center+for+Health+Innovation&rft.date=19+September+2021&rft.pub=Global+Center+for+Health+Innovation&rft_id=http%3A%2F%2Fs3.amazonaws.com%2Frdcms-himss%2Ffiles%2Fproduction%2Fpublic%2FImproving-Patient-Carethrough-Interoperability.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MaxmenThousands20-14\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MaxmenThousands20_14-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Maxmen, A. 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(2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7138183\" target=\"_blank\">\"Genotype and phenotype of COVID-19: Their roles in pathogenesis\"<\/a>. <i>Journal of Microbiology, Immunology, and Infection<\/i>: 30082-7. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2Fj.jmii.2020.03.022\" target=\"_blank\">10.1016\/j.jmii.2020.03.022<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7138183\/\" target=\"_blank\">PMC7138183<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32265180\" target=\"_blank\">32265180<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7138183\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7138183<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Genotype+and+phenotype+of+COVID-19%3A+Their+roles+in+pathogenesis&rft.jtitle=Journal+of+Microbiology%2C+Immunology%2C+and+Infection&rft.aulast=Mousavizadeh%2C+L.%3B+Ghasemi%2C+S.&rft.au=Mousavizadeh%2C+L.%3B+Ghasemi%2C+S.&rft.date=2020&rft.pages=30082-7&rft_id=info:doi\/10.1016%2Fj.jmii.2020.03.022&rft_id=info:pmc\/PMC7138183&rft_id=info:pmid\/32265180&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7138183&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GattinoniCOVID20-19\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GattinoniCOVID20_19-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Gattinoni, L.; Chiumello, D.; Caironi, P. (2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7154064\" target=\"_blank\">\"COVID-19 pneumonia: Different respiratory treatments for different phenotypes?\"<\/a>. <i>Intensive Care Medicine<\/i>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2Fs00134-020-06033-2\" target=\"_blank\">10.1007\/s00134-020-06033-2<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7154064\/\" target=\"_blank\">PMC7154064<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32291463\" target=\"_blank\">32291463<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7154064\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7154064<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=COVID-19+pneumonia%3A+Different+respiratory+treatments+for+different+phenotypes%3F&rft.jtitle=Intensive+Care+Medicine&rft.aulast=Gattinoni%2C+L.%3B+Chiumello%2C+D.%3B+Caironi%2C+P.&rft.au=Gattinoni%2C+L.%3B+Chiumello%2C+D.%3B+Caironi%2C+P.&rft.date=2020&rft_id=info:doi\/10.1007%2Fs00134-020-06033-2&rft_id=info:pmc\/PMC7154064&rft_id=info:pmid\/32291463&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7154064&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ZhangSemantic19-20\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-ZhangSemantic19_20-0\">20.0<\/a><\/sup> <sup><a href=\"#cite_ref-ZhangSemantic19_20-1\">20.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Zhang, X.A.; Yates, A.; Vasilevsky, N. et al. (2019). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6527418\" target=\"_blank\">\"Semantic integration of clinical laboratory tests from electronic health records for deep phenotyping and biomarker discovery\"<\/a>. <i>npj Digital Medicine<\/i> <b>2<\/b>: 32. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1038%2Fs41746-019-0110-4\" target=\"_blank\">10.1038\/s41746-019-0110-4<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6527418\/\" target=\"_blank\">PMC6527418<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/31119199\" target=\"_blank\">31119199<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6527418\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6527418<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Semantic+integration+of+clinical+laboratory+tests+from+electronic+health+records+for+deep+phenotyping+and+biomarker+discovery&rft.jtitle=npj+Digital+Medicine&rft.aulast=Zhang%2C+X.A.%3B+Yates%2C+A.%3B+Vasilevsky%2C+N.+et+al.&rft.au=Zhang%2C+X.A.%3B+Yates%2C+A.%3B+Vasilevsky%2C+N.+et+al.&rft.date=2019&rft.volume=2&rft.pages=32&rft_id=info:doi\/10.1038%2Fs41746-019-0110-4&rft_id=info:pmc\/PMC6527418&rft_id=info:pmid\/31119199&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC6527418&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AACCStrength19-21\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AACCStrength19_21-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">American Association for Clinical Chemistry (21 February 2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aacc.org\/cln\/cln-stat\/2019\/february\/21\/strengthening-the-chain-of-interoperability\" target=\"_blank\">\"Strengthening the Chain of Interoperability\"<\/a>. <i>CLN Stat<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.aacc.org\/cln\/cln-stat\/2019\/february\/21\/strengthening-the-chain-of-interoperability\" target=\"_blank\">https:\/\/www.aacc.org\/cln\/cln-stat\/2019\/february\/21\/strengthening-the-chain-of-interoperability<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 17 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Strengthening+the+Chain+of+Interoperability&rft.atitle=CLN+Stat&rft.aulast=American+Association+for+Clinical+Chemistry&rft.au=American+Association+for+Clinical+Chemistry&rft.date=21+February+2019&rft_id=https%3A%2F%2Fwww.aacc.org%2Fcln%2Fcln-stat%2F2019%2Ffebruary%2F21%2Fstrengthening-the-chain-of-interoperability&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CoughlinCOVID20-22\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CoughlinCOVID20_22-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Coughlin, J.. <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20201110225342\/https:\/\/www.healthit.gov\/isa\/covid-19\" target=\"_blank\">\"COVID-19 Novel Coronavirus Pandemic\"<\/a>. <i>ISA - Vocabulary\/Code Set\/Terminology<\/i>. Office of the National Coordinator. Archived from <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthit.gov\/isa\/covid-19\" target=\"_blank\">the original<\/a> on 10 November 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20201110225342\/https:\/\/www.healthit.gov\/isa\/covid-19\" target=\"_blank\">https:\/\/web.archive.org\/web\/20201110225342\/https:\/\/www.healthit.gov\/isa\/covid-19<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 17 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=COVID-19+Novel+Coronavirus+Pandemic&rft.atitle=ISA+-+Vocabulary%2FCode+Set%2FTerminology&rft.aulast=Coughlin%2C+J.&rft.au=Coughlin%2C+J.&rft.pub=Office+of+the+National+Coordinator&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20201110225342%2Fhttps%3A%2F%2Fwww.healthit.gov%2Fisa%2Fcovid-19&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCContact20-23\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CDCContact20_23-0\">23.0<\/a><\/sup> <sup><a href=\"#cite_ref-CDCContact20_23-1\">23.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Disease Control and Prevention (3 December 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/php\/principles-contact-tracing.html\" target=\"_blank\">\"Case Investigation and Contact Tracing : Part of a Multipronged Approach to Fight the COVID-19 Pandemic\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/php\/principles-contact-tracing.html\" target=\"_blank\">https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/php\/principles-contact-tracing.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 17 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Case+Investigation+and+Contact+Tracing+%3A+Part+of+a+Multipronged+Approach+to+Fight+the+COVID-19+Pandemic&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=3+December+2020&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fphp%2Fprinciples-contact-tracing.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RosenAHistory15.22-24\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RosenAHistory15.22_24-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Rosen, G. (2015). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=q5yeBgAAQBAJ&pg=PA46\" target=\"_blank\"><i>A History of Public Health<\/i><\/a> (Revised Expanded ed.). Johns Hopkins University Press. pp. 46\u201347. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9781421416021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=q5yeBgAAQBAJ&pg=PA46\" target=\"_blank\">https:\/\/books.google.com\/books?id=q5yeBgAAQBAJ&pg=PA46<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=A+History+of+Public+Health&rft.aulast=Rosen%2C+G.&rft.au=Rosen%2C+G.&rft.date=2015&rft.pages=pp.%26nbsp%3B46%E2%80%9347&rft.edition=Revised+Expanded&rft.pub=Johns+Hopkins+University+Press&rft.isbn=9781421416021&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3Dq5yeBgAAQBAJ%26pg%3DPA46&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MooneyIntrusive15-25\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MooneyIntrusive15_25-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Mooney, G. (2015). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=P1W3CgAAQBAJ&pg=PA93\" target=\"_blank\">\"Chapter Four: Combustible Material - Classrooms, Contact Tracing, and Following-Up\"<\/a>. <i>Intrusive Interventions: Public Health, Domestic Space, and Infectious Disease Surveillance in England, 1840\u20131914<\/i>. University of Rochester Press. pp. 93\u2013120. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9781580465274<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=P1W3CgAAQBAJ&pg=PA93\" target=\"_blank\">https:\/\/books.google.com\/books?id=P1W3CgAAQBAJ&pg=PA93<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+Four%3A+Combustible+Material+-+Classrooms%2C+Contact+Tracing%2C+and+Following-Up&rft.atitle=Intrusive+Interventions%3A+Public+Health%2C+Domestic+Space%2C+and+Infectious+Disease+Surveillance+in+England%2C+1840%E2%80%931914&rft.aulast=Mooney%2C+G.&rft.au=Mooney%2C+G.&rft.date=2015&rft.pages=pp.%26nbsp%3B93%E2%80%93120&rft.pub=University+of+Rochester+Press&rft.isbn=9781580465274&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DP1W3CgAAQBAJ%26pg%3DPA93&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DavidsonSearching96-26\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DavidsonSearching96_26-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Davidson, R. (1996). \"\u2018Searching for Mary, Glasgow\u2019: Contact Tracing for Sexually Transmitted Diseases in Twentieth-Century Scotland\". <i>Social History of Medicine<\/i> <b>9<\/b> (2): 195\u2013214. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1093%2Fshm%2F9.2.195\" target=\"_blank\">10.1093\/shm\/9.2.195<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=%E2%80%98Searching+for+Mary%2C+Glasgow%E2%80%99%3A+Contact+Tracing+for+Sexually+Transmitted+Diseases+in+Twentieth-Century+Scotland&rft.jtitle=Social+History+of+Medicine&rft.aulast=Davidson%2C+R.&rft.au=Davidson%2C+R.&rft.date=1996&rft.volume=9&rft.issue=2&rft.pages=195%E2%80%93214&rft_id=info:doi\/10.1093%2Fshm%2F9.2.195&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Wigfield27Years72-27\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Wigfield27Years72_27-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Wigfield, A.S. (1972). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC1048270\" target=\"_blank\">\"27 Years of Uninterrupted Contact Tracing: The 'Tyneside Scheme'\"<\/a>. <i>British Journal of Venereal Diseases<\/i> <b>48<\/b> (1): 37\u201350. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1136%2Fsti.48.1.37\" target=\"_blank\">10.1136\/sti.48.1.37<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC1048270\/\" target=\"_blank\">PMC1048270<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/5067063\" target=\"_blank\">5067063<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC1048270\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC1048270<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=27+Years+of+Uninterrupted+Contact+Tracing%3A+The+%27Tyneside+Scheme%27&rft.jtitle=British+Journal+of+Venereal+Diseases&rft.aulast=Wigfield%2C+A.S.&rft.au=Wigfield%2C+A.S.&rft.date=1972&rft.volume=48&rft.issue=1&rft.pages=37%E2%80%9350&rft_id=info:doi\/10.1136%2Fsti.48.1.37&rft_id=info:pmc\/PMC1048270&rft_id=info:pmid\/5067063&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC1048270&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LimDevelopment06-28\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-LimDevelopment06_28-0\">28.0<\/a><\/sup> <sup><a href=\"#cite_ref-LimDevelopment06_28-1\">28.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Lim, W.T.L. (2006). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.apami.org\/apami2006\/papers\/wlim(sg).pdf\" target=\"_blank\">\"Development of Medical Informatics in Singapore - Keeping Pace with Healthcare Challenges\"<\/a> (PDF). <i>Proceedings from the 2006 Meeting of the Asia Pacific Association for Medical Informatics<\/i>: 1\u20134<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.apami.org\/apami2006\/papers\/wlim(sg).pdf\" target=\"_blank\">https:\/\/www.apami.org\/apami2006\/papers\/wlim(sg).pdf<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Development+of+Medical+Informatics+in+Singapore+-+Keeping+Pace+with+Healthcare+Challenges&rft.jtitle=Proceedings+from+the+2006+Meeting+of+the+Asia+Pacific+Association+for+Medical+Informatics&rft.aulast=Lim%2C+W.T.L.&rft.au=Lim%2C+W.T.L.&rft.date=2006&rft.pages=1%E2%80%934&rft_id=https%3A%2F%2Fwww.apami.org%2Fapami2006%2Fpapers%2Fwlim%28sg%29.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ZhangBioPortal08-29\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ZhangBioPortal08_29-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Zhang, Y.; Dang, Y.; Chen, Y.-D. et al. (2008). \"BioPortal Infectious Disease Informatics research: Disease surveillance and situational awareness\". <i>Proceedings of the 2008 International Conference on Digital Government Research<\/i>: 393\u201394. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.5555%2F1367832.1367909\" target=\"_blank\">10.5555\/1367832.1367909<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=BioPortal+Infectious+Disease+Informatics+research%3A+Disease+surveillance+and+situational+awareness&rft.jtitle=Proceedings+of+the+2008+International+Conference+on+Digital+Government+Research&rft.aulast=Zhang%2C+Y.%3B+Dang%2C+Y.%3B+Chen%2C+Y.-D.+et+al.&rft.au=Zhang%2C+Y.%3B+Dang%2C+Y.%3B+Chen%2C+Y.-D.+et+al.&rft.date=2008&rft.pages=393%E2%80%9394&rft_id=info:doi\/10.5555%2F1367832.1367909&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SchaferTheEpi16-30\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SchaferTheEpi16_30-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Schafer, I.J.; Knudsen, E.; McNamara, L.A. et al. (2016). \"The Epi Info Viral Hemorrhagic Fever (VHF) Application: A Resource for Outbreak Data Management and Contact Tracing in the 2014\u20132016 West Africa Ebola Epidemic\". <i>The Journal of Infectious Diseases<\/i> <b>214<\/b> (Suppl. 3): S122\u2013S136. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1093%2Finfdis%2Fjiw272\" target=\"_blank\">10.1093\/infdis\/jiw272<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/27587635\" target=\"_blank\">27587635<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Epi+Info+Viral+Hemorrhagic+Fever+%28VHF%29+Application%3A+A+Resource+for+Outbreak+Data+Management+and+Contact+Tracing+in+the+2014%E2%80%932016+West+Africa+Ebola+Epidemic&rft.jtitle=The+Journal+of+Infectious+Diseases&rft.aulast=Schafer%2C+I.J.%3B+Knudsen%2C+E.%3B+McNamara%2C+L.A.+et+al.&rft.au=Schafer%2C+I.J.%3B+Knudsen%2C+E.%3B+McNamara%2C+L.A.+et+al.&rft.date=2016&rft.volume=214&rft.issue=Suppl.+3&rft.pages=S122%E2%80%93S136&rft_id=info:doi\/10.1093%2Finfdis%2Fjiw272&rft_id=info:pmid\/27587635&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HaEval16-31\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HaEval16_31-0\">31.0<\/a><\/sup> <sup><a href=\"#cite_ref-HaEval16_31-1\">31.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Ha, Y.P.; Tesfalul, M.A.; Littman-Quinn, R. et al. (2016). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6238947\" target=\"_blank\">\"Evaluation of a Mobile Health Approach to Tuberculosis Contact Tracing in Botswana\"<\/a>. <i>Journal of Health Communication<\/i> <b>21<\/b> (10): 1115-21. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1080%2F10810730.2016.1222035\" target=\"_blank\">10.1080\/10810730.2016.1222035<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6238947\/\" target=\"_blank\">PMC6238947<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/27668973\" target=\"_blank\">27668973<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6238947\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6238947<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Evaluation+of+a+Mobile+Health+Approach+to+Tuberculosis+Contact+Tracing+in+Botswana&rft.jtitle=Journal+of+Health+Communication&rft.aulast=Ha%2C+Y.P.%3B+Tesfalul%2C+M.A.%3B+Littman-Quinn%2C+R.+et+al.&rft.au=Ha%2C+Y.P.%3B+Tesfalul%2C+M.A.%3B+Littman-Quinn%2C+R.+et+al.&rft.date=2016&rft.volume=21&rft.issue=10&rft.pages=1115-21&rft_id=info:doi\/10.1080%2F10810730.2016.1222035&rft_id=info:pmc\/PMC6238947&rft_id=info:pmid\/27668973&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC6238947&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AHACDC20-32\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-AHACDC20_32-0\">32.0<\/a><\/sup> <sup><a href=\"#cite_ref-AHACDC20_32-1\">32.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">American Hospital Association (4 May 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aha.org\/news\/headline\/2020-05-04-cdc-sets-preliminary-standards-digital-covid-19-contact-tracing-tools\" target=\"_blank\">\"CDC sets preliminary standards for digital COVID-19 contact tracing tools\"<\/a>. American Hospital Association<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.aha.org\/news\/headline\/2020-05-04-cdc-sets-preliminary-standards-digital-covid-19-contact-tracing-tools\" target=\"_blank\">https:\/\/www.aha.org\/news\/headline\/2020-05-04-cdc-sets-preliminary-standards-digital-covid-19-contact-tracing-tools<\/a><\/span><span class=\"reference-accessdate\">. 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(15 May 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cnn.com\/2020\/04\/27\/health\/contact-tracing-explainer-coronavirus\/index.html\" target=\"_blank\">\"Contact tracing 101: How it works, who could get hired, and why it's so critical in fighting coronavirus now\"<\/a>. <i>CNN Health<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cnn.com\/2020\/04\/27\/health\/contact-tracing-explainer-coronavirus\/index.html\" target=\"_blank\">https:\/\/www.cnn.com\/2020\/04\/27\/health\/contact-tracing-explainer-coronavirus\/index.html<\/a><\/span><span class=\"reference-accessdate\">. 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Retrieved 21 November 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+Real+Reason+Contact+Tracing+Is+Doomed+in+the+US%3A+Spam+Calls&rft.atitle=Vice&rft.aulast=Johnston%2C+C.&rft.au=Johnston%2C+C.&rft.date=31+August+2020&rft_id=https%3A%2F%2Fwww.vice.com%2Fen%2Farticle%2F935vvz%2Fthe-real-reason-contact-tracing-is-doomed-in-the-us-spam-calls&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PewAmericans20-45\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PewAmericans20_45-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pew Research Center (14 September 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pewresearch.org\/politics\/2020\/09\/14\/americans-views-of-government-low-trust-but-some-positive-performance-ratings\/\" target=\"_blank\">\"Americans\u2019 Views of Government: Low Trust, but Some Positive Performance Ratings\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.pewresearch.org\/politics\/2020\/09\/14\/americans-views-of-government-low-trust-but-some-positive-performance-ratings\/\" target=\"_blank\">https:\/\/www.pewresearch.org\/politics\/2020\/09\/14\/americans-views-of-government-low-trust-but-some-positive-performance-ratings\/<\/a><\/span><span class=\"reference-accessdate\">. 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(29 September 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/news.gallup.com\/poll\/321119\/trust-federal-government-competence-remains-low.aspx\" target=\"_blank\">\"Trust in Federal Government's Competence Remains Low\"<\/a>. <i>Gallup<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/news.gallup.com\/poll\/321119\/trust-federal-government-competence-remains-low.aspx\" target=\"_blank\">https:\/\/news.gallup.com\/poll\/321119\/trust-federal-government-competence-remains-low.aspx<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 November 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Trust+in+Federal+Government%27s+Competence+Remains+Low&rft.atitle=Gallup&rft.aulast=Saad%2C+L.&rft.au=Saad%2C+L.&rft.date=29+September+2020&rft_id=https%3A%2F%2Fnews.gallup.com%2Fpoll%2F321119%2Ftrust-federal-government-competence-remains-low.aspx&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PewPublic21-47\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PewPublic21_47-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pew Research Center (17 May 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pewresearch.org\/politics\/2021\/05\/17\/public-trust-in-government-1958-2021\/\" target=\"_blank\">\"Public Trust in Government: 1958-2021\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.pewresearch.org\/politics\/2021\/05\/17\/public-trust-in-government-1958-2021\/\" target=\"_blank\">https:\/\/www.pewresearch.org\/politics\/2021\/05\/17\/public-trust-in-government-1958-2021\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 17 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Public+Trust+in+Government%3A+1958-2021&rft.atitle=&rft.aulast=Pew+Research+Center&rft.au=Pew+Research+Center&rft.date=17+May+2021&rft_id=https%3A%2F%2Fwww.pewresearch.org%2Fpolitics%2F2021%2F05%2F17%2Fpublic-trust-in-government-1958-2021%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DurkeeTrust21-48\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DurkeeTrust21_48-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Durkee, A. (26 January 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20210126160459\/https:\/\/www.forbes.com\/sites\/alisondurkee\/2021\/01\/26\/trust-in-government-information-on-covid-19-surges-under-biden-poll-reports\/\" target=\"_blank\">\"Trust In Government Information On Covid Surges Under Biden, Poll Reports\"<\/a>. <i>Forbes<\/i>. Archived from <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.forbes.com\/sites\/alisondurkee\/2021\/01\/26\/trust-in-government-information-on-covid-19-surges-under-biden-poll-reports\/\" target=\"_blank\">the original<\/a> on 26 January 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20210126160459\/https:\/\/www.forbes.com\/sites\/alisondurkee\/2021\/01\/26\/trust-in-government-information-on-covid-19-surges-under-biden-poll-reports\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20210126160459\/https:\/\/www.forbes.com\/sites\/alisondurkee\/2021\/01\/26\/trust-in-government-information-on-covid-19-surges-under-biden-poll-reports\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 17 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Trust+In+Government+Information+On+Covid+Surges+Under+Biden%2C+Poll+Reports&rft.atitle=Forbes&rft.aulast=Durkee%2C+A.&rft.au=Durkee%2C+A.&rft.date=26+January+2021&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20210126160459%2Fhttps%3A%2F%2Fwww.forbes.com%2Fsites%2Falisondurkee%2F2021%2F01%2F26%2Ftrust-in-government-information-on-covid-19-surges-under-biden-poll-reports%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-StoneHow20-49\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-StoneHow20_49-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Stone, W. (24 November 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.npr.org\/sections\/health-shots\/2020\/11\/24\/937178668\/are-more-lockdowns-inevitable-or-can-other-measures-stop-the-surge\" target=\"_blank\">\"How Do We Stop This Surge? Here's What Experts Say Could Help\"<\/a>. <i>NPR Shots<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.npr.org\/sections\/health-shots\/2020\/11\/24\/937178668\/are-more-lockdowns-inevitable-or-can-other-measures-stop-the-surge\" target=\"_blank\">https:\/\/www.npr.org\/sections\/health-shots\/2020\/11\/24\/937178668\/are-more-lockdowns-inevitable-or-can-other-measures-stop-the-surge<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 17 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+Do+We+Stop+This+Surge%3F+Here%27s+What+Experts+Say+Could+Help&rft.atitle=NPR+Shots&rft.aulast=Stone%2C+W.&rft.au=Stone%2C+W.&rft.date=24+November+2021&rft_id=https%3A%2F%2Fwww.npr.org%2Fsections%2Fhealth-shots%2F2020%2F11%2F24%2F937178668%2Fare-more-lockdowns-inevitable-or-can-other-measures-stop-the-surge&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DohenyAsDelta21-50\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DohenyAsDelta21_50-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Doheny, K. (31 August 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.webmd.com\/lung\/news\/20210831\/delta-surge-contact-tracing\" target=\"_blank\">\"As Delta Surges, Contact Tracing Re-Takes COVID Center Stage\"<\/a>. <i>WebMD Health News<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.webmd.com\/lung\/news\/20210831\/delta-surge-contact-tracing\" target=\"_blank\">https:\/\/www.webmd.com\/lung\/news\/20210831\/delta-surge-contact-tracing<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 17 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=As+Delta+Surges%2C+Contact+Tracing+Re-Takes+COVID+Center+Stage&rft.atitle=WebMD+Health+News&rft.aulast=Doheny%2C+K.&rft.au=Doheny%2C+K.&rft.date=31+August+2021&rft_id=https%3A%2F%2Fwww.webmd.com%2Flung%2Fnews%2F20210831%2Fdelta-surge-contact-tracing&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-KhazanTheMost20-51\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-KhazanTheMost20_51-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Khazan, O. (31 August 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.theatlantic.com\/politics\/archive\/2020\/08\/contact-tracing-hr-6666-working-us\/615637\/\" target=\"_blank\">\"The Most American COVID-19 Failure Yet\"<\/a>. <i>The Atlantic<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.theatlantic.com\/politics\/archive\/2020\/08\/contact-tracing-hr-6666-working-us\/615637\/\" target=\"_blank\">https:\/\/www.theatlantic.com\/politics\/archive\/2020\/08\/contact-tracing-hr-6666-working-us\/615637\/<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+Most+American+COVID-19+Failure+Yet&rft.atitle=The+Atlantic&rft.aulast=Khazan%2C+O.&rft.au=Khazan%2C+O.&rft.date=31+August+2020&rft_id=https%3A%2F%2Fwww.theatlantic.com%2Fpolitics%2Farchive%2F2020%2F08%2Fcontact-tracing-hr-6666-working-us%2F615637%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-EUCorona20-52\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-EUCorona20_52-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">European Commission (19 October 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/QANDA_20_1905\" target=\"_blank\">\"Coronavirus: EU interoperability gateway for contact tracing and warning apps \u2013 Questions and Answers\"<\/a>. European Union<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/QANDA_20_1905\" target=\"_blank\">https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/QANDA_20_1905<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 November 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Coronavirus%3A+EU+interoperability+gateway+for+contact+tracing+and+warning+apps+%E2%80%93+Questions+and+Answers&rft.atitle=&rft.aulast=European+Commission&rft.au=European+Commission&rft.date=19+October+2020&rft.pub=European+Union&rft_id=https%3A%2F%2Fec.europa.eu%2Fcommission%2Fpresscorner%2Fdetail%2Fen%2FQANDA_20_1905&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-UbertiDisjoint20-53\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-UbertiDisjoint20_53-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Uberti, D. (21 October 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wsj.com\/articles\/disjointed-covid-19-apps-across-u-s-raise-questions-about-techs-role-11603272613\" target=\"_blank\">\"Disjointed Covid-19 Apps Across U.S. Raise Questions About Tech\u2019s Role\"<\/a>. <i>The Wall Street Journal<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.wsj.com\/articles\/disjointed-covid-19-apps-across-u-s-raise-questions-about-techs-role-11603272613\" target=\"_blank\">https:\/\/www.wsj.com\/articles\/disjointed-covid-19-apps-across-u-s-raise-questions-about-techs-role-11603272613<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 November 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Disjointed+Covid-19+Apps+Across+U.S.+Raise+Questions+About+Tech%E2%80%99s+Role&rft.atitle=The+Wall+Street+Journal&rft.aulast=Uberti%2C+D.&rft.au=Uberti%2C+D.&rft.date=21+October+2020&rft_id=https%3A%2F%2Fwww.wsj.com%2Farticles%2Fdisjointed-covid-19-apps-across-u-s-raise-questions-about-techs-role-11603272613&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BayBlue20-54\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-BayBlue20_54-0\">54.0<\/a><\/sup> <sup><a href=\"#cite_ref-BayBlue20_54-1\">54.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Bay, J.; Kek, J.; Tan, A. et al. (2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/bluetrace.io\/static\/bluetrace_whitepaper-938063656596c104632def383eb33b3c.pdf\" target=\"_blank\"><i>BlueTrace: A privacy-preserving protocol for community-driven contact tracing across borders<\/i><\/a>. pp. 1\u20139<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/bluetrace.io\/static\/bluetrace_whitepaper-938063656596c104632def383eb33b3c.pdf\" target=\"_blank\">https:\/\/bluetrace.io\/static\/bluetrace_whitepaper-938063656596c104632def383eb33b3c.pdf<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=BlueTrace%3A+A+privacy-preserving+protocol+for+community-driven+contact+tracing+across+borders&rft.aulast=Bay%2C+J.%3B+Kek%2C+J.%3B+Tan%2C+A.+et+al.&rft.au=Bay%2C+J.%3B+Kek%2C+J.%3B+Tan%2C+A.+et+al.&rft.date=2020&rft.pages=pp.+1%E2%80%939&rft_id=https%3A%2F%2Fbluetrace.io%2Fstatic%2Fbluetrace_whitepaper-938063656596c104632def383eb33b3c.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<p><br \/>\n<\/p>\n<div align=\"center\">-----Go to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\/Final_thoughts\" title=\"Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Final thoughts and additional resources\/Final thoughts\" class=\"wiki-link\" data-key=\"6dc5ed53923251c9cec5bc04060b111f\">the next chapter<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"Citation_information_for_this_chapter\">Citation information for this chapter<\/span><\/h2>\n<p><b>Chapter<\/b>: 4. Workflow and information management for COVID-19 (and other respiratory diseases)\n<\/p><p><b>Edition<\/b>: Fall 2021\n<\/p><p><b>Title<\/b>: <i>COVID-19 Testing, Reporting, and Information Management in the Laboratory<\/i>\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: September 2021\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20210919172712\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.368 seconds\nReal time usage: 0.431 seconds\nPreprocessor visited node count: 39624\/1000000\nPost\u2010expand include size: 374140\/2097152 bytes\nTemplate argument size: 121562\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 115148\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 343.395 1 -total\n 90.80% 311.817 1 Template:Reflist\n 75.53% 259.374 54 Template:Citation\/core\n 43.75% 150.241 30 Template:Cite_web\n 31.24% 107.290 20 Template:Cite_journal\n 10.16% 34.873 29 Template:Date\n 9.17% 31.497 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\n 6.17% 21.197 4 Template:Cite_book\n 5.46% 18.756 46 Template:Citation\/identifier\n 5.29% 18.158 79 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11971-0!canonical and timestamp 20210919172714 and revision id 44138. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","38734314415297e7ef1e374a32ba8612_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/7\/74\/Electronic_medical_record.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/e\/e4\/What_is_contact_tracing_COVID-19.png"],"38734314415297e7ef1e374a32ba8612_timestamp":1632073386,"500f43f0e2f5122484d8d18d8e4145c4_type":"article","500f43f0e2f5122484d8d18d8e4145c4_title":"4.2 Laboratory informatics and reporting requirements","500f43f0e2f5122484d8d18d8e4145c4_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements","500f43f0e2f5122484d8d18d8e4145c4_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Workflow and information management for COVID-19 (and other respiratory diseases)\/Laboratory informatics and reporting requirementsFrom LIMSWikiJump to navigationJump to searchContents \n\n1 4.2 Laboratory informatics and reporting requirements \n\n1.1 4.2.1 ICD, CPT, and HCPCS coding \n1.2 4.2.2 Reporting to local and regional health departments \n\n\n2 References \n\n\n\n4.2 Laboratory informatics and reporting requirements \nBefore we can talk about the details of COVID-19 reporting, we first must briefly discuss the science of epidemiology. The CDC defines epidemiology as \"the method used to find the causes of health outcomes and diseases in populations.\"[1] As we'll soon learn, finding those causes depends on quality data and reporting.\nEpidemiology can broadly be split into two categories: descriptive epidemiology and analytical epidemiology. Descriptive epidemiology involves studies and other activities that deal with geographical comparisons and temporal trend descriptions of disease. As such, the collection and use of quality incidence data is vital to developing hypotheses.[2] Analytical epidemiology allows for the testing of those hypotheses using both experimental and observational studies, as well as control groups. Similarly, the collection and use of quality experimental and observational data is vital for proving or disproving hypotheses.[3] In both cases, proper reporting of public health data is critical to the success of epidemiologists' response to outbreaks and pandemics, as well as the credibility of their research.[4][5][6] This includes point-of-care and at-home testing results, which are at times more difficult to capture.[6]\nThe proper reporting of COVID-19 case data is no exception. In the United States, the Centers for Disease Control and Prevention (CDC) has taken a standardized approach to collecting reports on individuals with \"lab-confirmed and probable cases of COVID-19,\"[7][8] noting that as of April 21, 2021, all state, territorial, and tribal jurisdictions were onboard with electronic laboratory reporting to the CDC.[9] Their COVID-19 Surveillance Worksheet (formerly Case Report Form) is designed to collect a wide variety of information about a COVID-19 case, including patient demographics, epidemiological characteristics, exposure and contact history, clinical diagnosis, treatment procedures, and vaccination history. Currently, the CDC is asking healthcare providers and laboratories that are operating as testing sites to \"report data for all diagnostic and screening testing completed, which includes molecular, antigen, and antibody testing, for each individual tested\" on a daily basis, \"within 24 hours of test completion.\"[10] Local, state, tribal, and territorial public health departments are then asked to submit case reports etc. to the CDC. Electronic reporting using the CDC's system is preferred, but they have a protocol for those areas unable to submit electronically. Recognizing the disparate reporting mechanisms across various state health departments and the problems this causes, particularly during an epidemic, funding efforts are under way to assist the CDC\u2014as well as state, local, and tribal governments\u2014better report disease information through a modernized, centralized public health data management platform.[6][11]\nElsewhere, Canada has similar reporting expectations to the U.S. CDC, with their own case report form and electronic data submission process through the Public Health Agency of Canada.[12] And in the European Union, member countries and the U.K. are asked to report through the Early Warning and Response System, with \"additional enhanced surveillance ... established through The European Surveillance System - TESSy.\"[13]\n\n 4.2.1 ICD, CPT, and HCPCS coding \nRelated are any test reporting and billing requirements in labs and medical facilities. The International Statistical Classification of Diseases and Related Health Problems (ICD) is a commonly used system of diagnostic codes for classifying diseases, including nuanced classifications of a wide variety of signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or disease. Their ICD-10-CM code set has been modified to include lab testing codes for COVID-19, as has the Current Procedural Terminology (CPT) code set. This guide provides basic information about these codes (which should not be considered legally binding advice); however, see the referenced material (and following citations) for more details concerning those codes[14][15][16][17][18]:\nThe CPT code 87635 has the long descriptor of \"Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique.\" The American Medical Association's CPT Assistant fact sheet for SARS-CoV-2 reporting proves useful in supplying assistance on how and when to apply this CPT code in reporting.\nSince the pandemic has progressed, numerous other CPT codes have become available. This includes a series of parent and child codes for antibody testing, neutralizing antibody screens, antigen testing, and vaccination. Resources for guidance concerning these codes include the American Medical Association and the American Society of Clinical Oncology (PDF).\nThe U.S. government-adopted ICD-10-CM\u2014an authorized version of WHO's ICD-10[19]\u2014has been updated by the CDC and the National Center for Healthcare Statistics. It includes not only codes for conditions associated with COVID-19, but also codes for exposure, screening, and vaccination. The principal diagnosis code \"U07.1, COVID-19\" is sequenced first for a confirmed COVID-19 diagnosis, followed by any appropriate codes for associated manifestations (though there is an obstetrics exception). CMS's coding guidelines, as well as American Medical Association guidance, may prove useful in choosing the correct codes. The American Society of Clinical Oncology (PDF) is also maintaining a document with ICD-10-CM information.\nSince the pandemic started, new HCPCS codes have been released by the Centers for Medicare & Medicaid Services (CMS). These are to be used solely for Medicare claims. The American Society of Clinical Oncology (PDF) is maintaining a helpful document with that information.\nLaboratories analyzing specimens for SARS-CoV-2 must be equipped to implement and handle analytical testing and test orders using the new test codes. However, they also must be able to quickly and accurately transfer vital case information to the appropriate health authority. This may include using other types of codes such as Logical Observation Identifiers Names and Codes (LOINC) and SNOMED-CT codes, which are briefly discussed in the next subsection.\n\n4.2.2 Reporting to local and regional health departments \nGiven the valuable nature of case reports during an epidemic[4][5], health care providers, facilities, and laboratories are being held responsible for sending case data to their local and regional health departments. That information then feeds up to the state-level health department, which then makes its way to the national-level entity responsible for handling epidemiology (in the case of the U.S., the CDC). Significant decisions are typically based on that data. For example, the U.S. CDC has been conducting seroprevalance (determination of the \"percentages of people who were previously infected with SARS-CoV-2\") surveys of various regions of the United States.[20] The insights and decisions the CDC makes depends on cooperation and proper reporting by state and local health departments.\nHowever, acquiring standardized data at the national level can still be challenging. In the case of the U.S., general disease reporting requirements vary from state to state, with many states encouraging full electronic laboratory reporting (ELR), while some still encourage faxed or emailed reports. Add in the urgency and confusion associated with a pandemic, and COVID-19 reporting requirements prove to vary just as much. Some states' health departments have taken a proactive approach to reporting. For example, Iowa's Department of Public Health has issued several mandatory COVID-19 reporting orders meant to supplement existing reporting rules, including an order requiring all Iowa health care providers and public, private, and hospital laboratories \"to immediately report all positive and negative Coronavirus Disease 2019 (COVID-19) testing results to the department.\"[21] Other states have not been as clear on their reporting requirements, in some cases not having any guidance documents or clear information on their health department website for how providers, facilities, and labs should report COVID-19. In those cases, the presumption is that most labs have contacted the health department for advice or are reporting COVID-19 cases as immediately reportable, based upon the state's existing reporting requirements for immediately reportable diseases. \nThe CDC, however, maintains a page concerning how to report COVID-19 laboratory data. It's important to note their take on using standard terminology, which is based on their mapping tool LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests[10]:\n\nThis specification supports the use of standardized LOINC and SNOMED Clinical Terms (CT) codes to improve the accuracy of reporting tests for the SARS-CoV-2 virus. Using these harmonized LOINC and SNOMED-CT codes helps ensure that the same type of test is represented uniformly across the United States ... LOINC codes must be used to represent the \u201cquestion\u201d a test asks of a specimen (e.g., does this specimen have SARS-CoV-2 RNA?), and SNOMED-CT codes must be used to represent the diagnostic \u201canswer\u201d (e.g., what was detected?).\nThe CDC's Excel-based mapping tool lists the current (and previous) FDA EUAed diagnostic tests with codes for LOINC test order, LOINC test result, SNOMED-CT test description, SNOMED-CT specimen source, and Device Identifier. Ensure that your laboratory is using these LOINC and SNOMED-CT codes for reporting to your local and state health departments.\nTable 1 addresses the reporting requirements for the United States' 50 states, while Table 2 covers U.S. territories. If clear reporting guidance specific to COVID-19 could be found, it was described. If no such guidance could be found, then the state's existing guidance and rules regarding disease reporting were referenced. In some cases, the state health departments don't clearly spell out whether a faxed or mailed report is required after immediately phoning in a report. In other cases, it's not clear if ELR\u2014though it exists\u2014is an acceptable form of reporting COVID-19 cases. This ambiguity is stated in the form of a \"(?)\" found next to the \"Y\" and \"N\" for electronic filing and faxing. In all cases, if there is any doubt about reporting requirements, call your local health department to confirm.\n\n\n\n\n\n\n\nTable 1. U.S. state-based COVID-19 reporting requirements\n\n\nState\n\nElectronic, including email? (Y\/N)\n\nFax? (Y\/N)\n\nForms for reporting\n\nContact\n\nAdditional details\n\n\nAlabama\n\nY\n\nN\n\nNovel Coronavirus Report Card\n\nALNEDSSsupport@adph.state.al.us\n\nUse the Report Card \"to submit laboratory-confirmed (or pre-approved epidemiologically-linked) cases or deaths of Novel Coronavirus (COVID-19) to the Alabama Department of Public Health.\" (Though long-term care facilities and correctional facilities should used different forms.) \"Performing laboratories are required to report all negative and positive COVID-19 virus test results electronically (faxes do not count). If not already enrolled, laboratories will need to manually enter test results directly into the surveillance system.\" Email the contact to enroll staff access to the system.\n\n \n\n\nAlaska\n\nY\n\nY\n\nConfidential Infectious Disease Report Form\n\nCOVID Reporting Hotline: 1-877-469-8067\r\n \r\nUrgent situation: 907-269-8000 or 800-478-0084 (after-hours)\r\n \r\nELR: megan.tompkins@alaska.gov\n\n\"Providers must report laboratory-confirmed cases of COVID-19 to SOE via fax (907-563-7868) using the standard Infectious Disease report form or via electronic means. The reporting hotline has been discontinued.\" \"All results (i.e., positive, negative, indeterminate, etc.) must be reported via either integration into existing electronic laboratory reporting (ELR) data feeds, submission of a standard format CSV via SFTP, or fax (907-563-7868). Please email Megan Tompkins ... to inform us about how your facility will report.\" (See Guidance for Coronavirus Disease 2019 (COVID-19) Testing in Alaska for more.)\n\n \n\n\nArizona\n\nY\n\nN\n\nSample ADHS CSV File\r\nSample ADHS Excel File\n\nELR: elr@azdhs.gov\n\n\"Facilities performing laboratory tests for COVID-19 are required to report both positive and negative results for COVID-19 directly to ADHS pursuant to Executive Order 2021-14. Laboratory is defined in A.R.S. \u00a7 36-451(4). Facilities shall report using an electronic format, described below.\" Consult the laboratory information page for details of all reporting options.\n\n \n\n\nArkansas\n\nY\n\nY (?)\n\nCommunicable Disease Reporting Form\n\nPhone: (501) 537-8969 or 1-800-554-5738 after-hours\n\nArkansas Department of Health doesn't appear to have published any information about specific COVID-19 reporting requirements. As of September 2021, the DoH still hasn't updated its list of mandatory reportable diseases. The state is presumably treating \"suspected or confirmed\" COVID-19 cases as an immediately reportable event that \"are to be reported immediately to the ADH.\" The language used on its reportable disease instructions suggests that a follow-up fax of the case report isn't required; however, call and confirm with the DoH. The only mention of ELR is a plain page labelled \"Public Health Reporting.\" It would appear users can submit reports via this tool, though registration may be required if new to the tool.\n\n \n\n\nCalifornia\n\nY\n\nN (?)\n\nConfidential Morbidity Report\n\nContact: Local health officers\r\n \r\nCalREDIE: CalREDIEHelp@cdph.ca.gov or (866) 866-1428\n\nThe DPH added COVID-19 to its Reportable Diseases and Conditions lists for health care providers and laboratories early in the pandemic. This health care provider document indicates that a \"case or suspected case\" of COVID-19 should be reported immediately by phone. The document makes no mention of requiring a follow-up fax or digital report by health care providers. The laboratory document indicates \"[l]aboratories must report any initial findings as well as any subsequent findings. \u201dAny laboratories approved to test for SARS-CoV-2 must report all positive and non-positive (negative, indeterminate, and specimen unsatisfactory) test results from both antigen\/molecular and antibody\/serology tests for SARS-CoV-2.\" Laboratory findings are \"are reportable to the local health officer of the health jurisdiction where the patient resides by telephone within one (1) hour ... from the time that the laboratory notifies the health care provider or other person authorized to receive the report.\" Labs are asked to also subsequently report results electronically (ELR) to the California Reportable Disease Information Exchange (CalREDIE) \"within one working day of identification.\"\n\n \n\n\nColorado\n\nY\n\nN\n\nNone\n\nCEDRS: lavelle.fernandez@state.co.us\r\n \r\nELR: andrew.horvath@state.co.us\n\n\"All test results (e.g., positive, negative, and inconclusive) for rapid point-of-care COVID-19 tests must be reported to public health\" officials by providers. Additionally, \"[a]ll positive, negative, and inconclusive SARS-CoV-2 test results must be reported electronically by laboratories.\" The disease reporting form and fax methods should not be used. A list of required reporting components and descriptions of digital reporting options are available on the state's COVID-19 reporting page.\n\n \n\n\nConnecticut\n\nY\n\nY\n\n2019 Novel Coronavirus (COVID-19) Case Report Form\r\n \r\nReportable Laboratory Findings, Form OL-15C\n\nFax: (860) 629-6962\r\n \r\nELR: dph.elr@ct.gov\n\nPresumably, laboratories are reporting COVID-19 as is required for any communicable disease. This has traditionally been done using Form OL-15C sent through mail or fax, as well as ELR, which appears to be the preferred method. As for other healthcare providers, per the DPH's COVID-19 response portal: \"Providers can now submit a COVID-19 case report online. This is the preferred way to submit COVID-19 case reports.\"\n\n \n\n\nDelaware\n\nY\n\nN\n\nNone\n\nCall: 1-888-295-5156\r\n \r\nEmail: reportdisease@delaware.gov\n\n\"The Department of Health and Social Service\u2019s March 10, 2020 order requiring all labs to immediately report all tests and all results to the Division of Public Health (DPH) remains in effect. All COVID results, positive AND negative are reportable.\" \"All COVID-19 test results from any laboratory must be reported to DPH via the\nDelaware Electronic Reporting Surveillance System (DERSS). Providers must confirm with their designated laboratories that they have the ability to transmit results to DERSS through approved methods.\" Review the provider lab reporting requirements for further details.\n\n\n \n\n\nDistrict of Columbia\n\nY\n\nN\n\nNotifiable Disease and Condition Case Report Form\n\nELR: informatics.epi@dc.gov\r\n \r\nReporting questions: coronavirus@dc.gov\n\n\"... healthcare providers must report negative and positive test results for all COVID-19 diagnostic and serologic testing, including point-of-care testing. Reports should be submitted electronically using DC Reporting and Surveillance Center (DCRC), our online reporting system.\" \"Laboratories are recommended to submit COVID-19 results via Electronic Lab Reporting. Please email informatics.epi@dc.gov to initiate the process. Hospitals, skilled nursing facilities, and assisted living facilities should report cases in patients\/residents via daily line lists to DC Health.\"\n\n \n\n\nFlorida\n\nY\n\nN\n\nNone\n\nELR: ELRPortalSupport@flhealth.gov\n\n\"Mandatory reporting requirements are outlined by Florida Department of Health Executive Order 20-013, section 381.0031, Florida Statutes, and Florida Administrative Code Chapter 64D-3, and state all health care practitioners, laboratories and facilities, including long-term care facilities, must report both negative and positive COVID-19 test results, including point-of-care rapid test results, within 24 hours of the result being known.\" As of September 2021, the documentation found on floridahealth.gov appears outdated, however, as the links to the report portal that are indicated are broken. A site, flhealthsource.gov, was found, and it appears to be the current report portal for health care providers and facilities.\n\n \n\n\nGeorgia\n\nY\n\nY\n\nNotifiable Disease Report Form\n\nFax: Based on District Health Office\r\n \r\nCall: 1-866-782-4584\n\nGeorgia lists COVID-19 as an immediately reportable disease condition. \"All Georgia physicians, laboratories, and other health care providers\" are encouraged to call their District Health Office or the main number. The state is also accepting COVID-19 reports through its SendSS online application.\n\n \n\n\nHawaii\n\nY\n\nN (?)\n\nHuman Infection with 2019 Novel Coronavirus Short Form\n\nFax: (808) 586-4595\r\n \r\nELR: helpdesk@hawaiihie.org\n\nPer the Director of Health: \"Pursuant to section 325-2, Hawaii Revised Statutes, every physician or health care professional having a client affected by or suspected of being affected by COVID-19 (SARS-CoV-2) and every laboratory director having laboratory data regarding an individual affected by or suspected of being affected by COVID-19 (SARS-CoV-2) shall report the incidence or suspected incidence of COVID-19 (SARS-CoV-2) to the Department of Health in the manner specified by the Department of Health. At this time, all test results shall be reported via the electronic laboratory reporting system.\" That system is presumed to be this portal. Faxing may no longer be an option; confirm with the Department of Health.\n\n \n\n\nIdaho\n\nN\n\nY\n\nNo standardized COVID-19 reporting form\n\nPhone: (208) 334-5939\r\n \r\nFax: (208) 332-7307\r\n \r\nELR: PublicHealthMU@dhw.idaho.gov\n\nThe Idaho Department of Health and Welfare doesn't appear to have published any information about COVID-19 reporting requirements. As of September 2021, the state has not added COVID-19 to its mandatory reportable diseases list. They simply state that \"Labs report their test results to the state, and the number of tests done and the number of people who test positive are posted on this website each day.\" Presumably this means that labs should be following the state's reportable diseases protocol for reporting \"within one working day of identification or suspicion\" using phone or fax. No standardized reporting form appears to exist. It's not clear if ELR is being used to report COVID-19 cases.\n\n \n\n\nIllinois\n\nY\n\nY\n\nIDPH Coronavirus Novel 2019 Case Report Form\n\nFax: Based on Local Health Department\r\n \r\nELR: dph.elrresp@illinois.gov\n\n\"All providers and testing sites must report to Public Health all individuals tested for COVID-19, in accordance with the Illinois Control of Communicable Diseases Code (77 Ill. Adm. Code 690.200(a)(5)). Mandated reporters, such as health care providers, hospitals and laboratories, by law must report probable or confirmed cases of COVID-19 electronically through Illinois\u2019 National Electronic Disease Surveillance System (I-NEDSS) within 24 hours. If they do not have access to I-NEDSS, they can report by mail, telephone or fax to the local health department ... or, if no local health department is available, to the Illinois Department of Public Health Division of Infectious Diseases at 217-785-7165, TTY (hearing impaired use only) 800-547-0466.\"\n\n \n\n\nIndiana\n\nY\n\nY\n\nConfidential Report of Communicable Diseases\n\nELR: (317) 233-7684 or ijameson@isdh.in.gov\r\n \r\nFax: (317) 233-7747\n\n\"CDC requires every COVID-19 testing site to report every diagnostic and screening test performed to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (e.g., molecular, antigen, antibody) to the appropriate state or local public health department, based on the individual\u2019s residence. All testing sites must report diagnostics and screening tests within 24 hours of test completion to the appropriate state or local public health department.\" Their guidance suggest three reporting methods: ELR, REDCap, and Fax. Examine the guidance for further information.\n\n \n\n\nIowa\n\nY\n\nN\n\nNone\n\nELR: Jill Newland\n\n\"All Iowa health care providers and public, private, and hospital laboratories are required to immediately report all positive and negative SARS-CoV-2 testing results to the department. Immediate reporting is defined as reporting within one day of the test being performed, a standard utilized by the department since its initial March 19, 2020, Mandatory Reporting Order. Reports must be made electronically through the Iowa Disease Surveillance System (IDSS) or other electronic means as directed by the department.\"\n\n \n\n\nKansas\n\nY\n\nN (?)\n\nKansas Reportable Disease Portal\n\nPhone: (877) 427-7317\r\n \r\nFax: (877) 427-7318\r\n \r\nELR: kdhe.epitraxadmin@ks.gov\n\n\"Report antigen or PCR point of care results, positive and negative, directly to KDHE via the Kansas Reportable Disease Portal https:\/\/diseasereporting.kdhe.ks.gov\/ within 24 hours ... For facilities that do not perform point of care antigen or PCR testing, for antigen or PCR testing done through a reference laboratory or in-hospital laboratory, your facility does not need to report result to KDHE. The laboratory conducting the SARS-CoV-2 test is required to report results to KDHE.\" Faxing forms appears to be discouraged: \"Clinics\/hospital systems: if possible, please modify electronic health record systems to cease sending notifiable disease forms to KDHE via email and fax. If your facility uses Epic for its electronic medical records, you may be able to submit reports to KDHE automatically.\"\n\n \n\n\nKentucky\n\nY\n\nN\n\nNone\n\nEmail: COVIDKYLAB@ky.gov\n\n\"If you are a healthcare organization resulting any type of COVID-19 test, you are required to report both positive and negative results to the Kentucky Department for Public Health (KDPH) ... If you are resulting labs at your facility, KDPH requires you to report results through Kentucky Health Information Exchange (KHIE), either electronically through an interface connection or by manually entering results. If you are not currently electronically connected to KHIE, you must manually report these results through KHIE's Direct Data Entry (Lab) feature located in the ePartnerViewer ... You are required to report all positive results within 24 hours of resulting ... You are required to report all negative results within 7 days of resulting.\"\n\n \n\n\nLouisiana\n\nY\n\nN\n\nNone\n\nPhone: (504) 568-8295\r\n \r\nELR: elr@la.gov\n\n\"All facilities performing testing for COVID-19\/SARS-CoV-2 are required to report all COVID-19\/SARS-CoV-2 results to LDH. This includes rapid testing, point-of-care testing, antibody testing, or any other testing performed for COVID-19. Electronic laboratory reporting (ELR) in HL7 or CSV format is the preferred mechanism for reporting results ... Note: COVID-19 test results sent via ELR should include all results of testing (i.e., positive, negative, indeterminate, etc.).\" Also, if you do not have ELR set up or for some reason can't report electronically: \"The ELR team will work with you to set up ELR or an alternative reporting method.\"\n\n \n\n\nMaine\n\nY\n\nN (?)\n\nNone\n\nPhone: 800-821-5821\r\n \r\nEmail: disease.reporting@maine.gov\n\nA February 2021 update to the state's Control of Notifiable Conditions and Notifiable Conditions List mandates that health care providers and labs must report COVID-19 test results. It mandates that \"[l]aboratory reporting must be done electronically through HL7 messaging as specified in this subsection. Electronic reporting required for laboratories is in addition to other reporting requirements specified in this rule.\" Consult the \"New Rules for the Control of Notifiable Conditions\" PDF on the disease reporting page for details. It appears COVID-19 should no longer be reported by fax.\n\n \n\n\nMaryland\n\nY\n\nN (?)\n\nConfidential Report: Laboratory Evidence of Certain Communicable Diseases\n\nContact: Local health department\n\nThe only reporting requirement to be found are in a PDF, item No. MDH 2020-10-01-01, which largely addresses point-of-care testing. Presumably this extends to other types of testing, but it's not clear what other types of testing. It mentions that \"[p]ositive, negative, and inconclusive point of care test results shall be reported.\" The document goes on to explain that electronic reporting is preferred, especially for those labs that are already set up to so do so. Some other electronic format like a CSV file is next preferred, and then, \"[i]f the results cannot be sent by HL-7 format or another approved electronic format, they must be immediately submitted to the appropriate local health officer in a manner designated by MDH.\"\n\n \n\n\nMassachusetts\n\nN\n\nY\n\nNo standardized COVID-19 reporting form\n\nContact: Local health departments\r\n \r\nMDPH phone: (617) 983-6800\r\n \r\nMDPH fax: (617) 983-6813\n\nThe State of Massachusetts doesn't appear to have published any collection of information about specific COVID-19 reporting requirements. The state is presumably treating COVID-19 \"suspected and confirmed cases\" as an immediately reportable event that \"should be reported to your local board of health\" by phone, or if unavailable, to the Massachusetts Department of Public Health by phone or fax. The MDPH disease reporting web page makes no mention of ELR.\n\n \n\n\nMichigan\n\nY\n\nY\n\nNo standardized COVID-19 reporting form\n\nMDSS: Support contacts\r\n \r\nContact: Local health department list in reporting guide\n\nThe Michigan Department of Health & Human Services has updated its Health Care Professional's Guide to Disease Reporting in Michigan to include detections of SARS-CoV-2. They note that \"if the agent is identified by clinical or laboratory diagnosis,\" the detection (by both healthcare providers and laboratories) \"must be reported to the Michigan Disease Surveillance System (MDSS) or local health department within 24 hours.\" As for how: \"Mandatory reporting of communicable diseases can (and, whenever possible, should) be accomplished via the MDSS. The MDSS is a web-based communicable disease reporting system developed for the state of Michigan.\" If unable to electronically report, contact the local health department using the directory in the disease reporting guide.\n\n \n\n\nMinnesota\n\nY\n\nY\n\nCOVID-19 Case Report Form\n\nFax: (651) 201-5743\r\n \r\nPhone: (651) 201-5414 or (877) 676-5414\r\n \r\nELR: health.ELRmeaningfuluse@state.mn.us\n\n\"The Minnesota Department of Health (MDH) is requiring all mandated reporters to report any cases and deaths due to SARS-CoV-2 to MDH within one working day.\" This includes health care facilities, medical laboratories, and in special cases veterinary laboratories. Case report forms can be faxed or case reports submitted by phone. On a separate page discussing laboratories, the DoH further discusses ELR. Read that for more details.\n\n \n\n\nMississippi\n\nY (?)\n\nN\n\nReportable Diseases and Conditions form\n\nPhone: (601) 576-7725 or 1-800-556-0003; for weekends, holidays and after 5pm: (601) 576-7400; Email: clia-msdh@msdh.ms.gov\n\nThe Mississippi State Department of Health states: \"All COVID-19 results must be reported to the Mississippi State Department of Health at this time.\" However, it gives no further guidance specifically for commercial laboratories or health care providers testing for SARS-CoV-2. Presumably the MSDH is considering COVID-19 a Class 1A disease, required to be \"reported directly to the Department of Health by telephone within 24 hours of first knowledge or suspicion.\" The MSDH also has an online disease reporting tool (account required); however, it's not clear if it is equipped to received COVID-19 reports.\n\n \n\n\nMissouri\n\nY\n\nY\n\nsFTP Excel template\r\n \r\nDisease Case Report form\n\nsFTP: (573) 526-5271\r\n \r\nFax: (573) 751-6417\r\n \r\nELR: ELR@health.mo.gov\n\nThe Missouri Department of Health and Senior Services has officially added COVID-19 to its list of immediately reportable conditions, including a waiver \"to require that all positive and negative results for COVID-19 are sent directly to DHSS. Now, all laboratories must report directly to DHSS.\" They add that \"[l]aboratories are encouraged to report via electronic means.\" Alternatively, labs may also submit a report to the Bureau of Reportable Disease Informatics (BRDI) via fax. \"[M]edical providers (non-laboratories) also have an obligation to submit disease case reports (form CD-1) to DHSS. However, under the current suspension, providers do not have to report negative results if those results are being reported by an outside lab. Providers are expected to submit a case report on any non-negative results as the additional information on the case report is required for public health intervention.\"\n\n \n\n\nMontana\n\nN\n\nY (?)\n\nNo standardized COVID-19 reporting form\n\nContact: Local health department\r\n \r\nDPHHS phone: (406) 444-0273\n\nThe Montana Department of Public Health and Human Services doesn't appear to have published any information about specific COVID-19 reporting requirements. The state is presumably treating COVID-19 like its other reportable diseases: \"whether suspected or confirmed\" the case \"must be reported immediately to your local health jurisdiction as required by the Administrative Rules of Montana.\" If the local public health jurisdiction is unavailable, a call can be placed to the MDPHHS. It is not clear if laboratories should report both positive and negative results, though news reports have shown that the DPHHS is reporting both positive and negatives. The disease reporting web page makes no mention of ELR.\n\n \n\n\nNebraska\n\nN\n\nN\n\nHealth Care Provider Confidential Communication form\r\n \r\nLaboratory Summary of Reportable Diseases, Poisonings and Organisms\n\nPhone: Based on county\n\nThe Nebraska Department of Health and Human Services provides little in the way of specific guidance for reporting COVID-19. They simply state: \"Any patient (+) for COVID-19 virus should be immediately reported to local\/state public health office.\" They define \"immediate notification\" as \"required to call by telephone to a live public health surveillance official within 24 hours of detection.\" This apparently includes providers currently on ELR. Labs and healthcare providers should verify if any additional reporting (fax, ELR) is required. As the pandemic has progressed, reporting transparency and requirements have also changed, becoming more controversial; contact your local health department for the latest requirements.\n\n \n\n\nNevada\n\nN\n\nY\n\nConfidential Disease Reporting Form\n\nContact: Local health department list in reporting form\n\nNevada DHHS guidance states \"all in-state and out-of-state laboratories who are processing and testing samples from Nevada residents are required under severe penalties to report all COVID-19 test results to the Division of Public and Behavioral Health within 24 hours from analysis.\" Its guidance appears to suggest a phone call for such notification. According to the state's disease reporting form, this phone call should be done in addition to faxing a report. \"All cases, suspect cases, and carriers\nmust be reported within 24 hours.\" It's not clear if ELR is being accepted for COVID-19 reporting.\n\n\n \n\n\nNew Hampshire\n\nN\n\nY\n\nCOVID-19 Case Report Form\n\nPhone: (603) 271-4496\r\n \r\nFax: (603) 271-0545\n\nHealth care providers and laboratories should immediately report suspect and confirmed cases of COVID-19 to the New Hampshire Department of Health and Human Services. It seems likely the DPHHS prefers both a phone call and a faxed report, though it's not explicitly stated. The case should likely be \"reported within 24 hours of diagnosis or suspicion of diagnosis.\" The NHDHHS disease reporting web page makes no mention of ELR. An online test result reporting form is available, per the state's General Provider COVID-19 Resources page.\n\n \n\n\nNew Jersey\n\nY\n\nN (?)\n\nNo standardized COVID-19 reporting form\n\nELR: See quick-start guide\r\n \r\nLocal health departments\n\n\"[T]he New Jersey Domestic Security Preparedness Task Force hereby directs that commercial laboratories operating in New Jersey report all COVID-19 test results to the New Jersey Department of Health beginning March 23, 2020. The results of all COVID-19 tests performed before this date shall be included in the initial report. Subsequently, results shall be sent daily, and included results not previously reported. Information shall be transmitted no later than 8:00 p.m. each day through the Department of Health\u2019s CDRSS platform. Specific data reported shall include positive, negative, and inconclusive test results. This directive shall supplement, not supplant, any other existing reporting requirements.\" From that statement, it's not clear if laboratories should also be immediately phoning their results to the health department in addition to ELR over CDRSS.\n\n \n\n\nNew Mexico\n\nN\n\nY (?)\n\nNotifiable Condition Report Form\n\nPhone: (505) 827-0006\r\n \r\nFax: (505) 827-0013\n\nThe New Mexico Department of Health doesn't appear to have published any information about specific COVID-19 reporting requirements. The DoH is presumably treating \"confirmed or suspected\" COVID-19 cases as an immediately reportable event that \"require immediate reporting by telephone to Epidemiology and Response Division.\" It's not clear if a faxed report is also required. The DoH disease reporting web page makes no mention of ELR.\n\n\n \n\n\nNew York\n\nY\n\nN\n\nConfidential Case Report - DOH-389\r\n \r\nUniversal Reporting Form - PD-16\n\nContact: Local health departments\r\n \r\nECLRS: eclrs@health.ny.gov\n\nThe New York Department of Health states: \"Positive results must be immediately reported to the local Department of Health by the laboratory performing the test, per established guidance, and all test results should be reported by the laboratories into New York State Department of Health\u2019s Electronic Clinical Laboratory Reporting System (ECLRS) four times a day.\" The established guidance appears to be found in the state's updated reporting instructions, which now includes COVID-19 as a disease that \"should be reported immediately to local health departments by phone followed by submission of the confidential case report form (DOH-389). In NYC use case report form PD-16.\" This means \"within 24 hours of diagnosis.\" The instructions indicate case reports should be mailed. Both health care facilities and laboratories should report.\n\n \n\n\nNorth Carolina\n\nY\n\nY\n\nCOVID-19 Confidential Communicable Disease Report\n\nContact: Local health departments\r\n \r\nFax: (919) 733-0490\n\nPer NCDHHS's clinical diagnostic laboratory guidance: \"each person in charge of a laboratory providing diagnostic service in this State and any other health care provider licensed in this State that provides diagnostic service [is required] to report the results of all COVID-19 testing to the Department of Health and Human Services.\" An electronic reporting process appears to have been added later in 2020.\n\n \n\n\nOhio\n\nY\n\nY\n\nOhio Confidential Reportable Disease form\n\nContact: Local health districts\r\n \r\nELR: ELR@odh.ohio.gov\n\nIn March 2020, the Ohio Department of Health ordered \"confirmed cases of COVID-19 be reported immediately as a Class A disease pursuant to Ohio Adm. Code 3701-3-02(A) to the local health district in which the person resides (or the local health district wherein the person is being medically evaluated if the person's residence is unknown or not in Ohio).\" Physicians, medical care facilities, and laboratories are encouraged to report positive cases. Per the state's communicable disease requirements, Class A diseases should be reported immediately by phone, with a follow-up HEA 3334 Ohio Confidential Reportable Disease form. That requirements doc also states \"follow-up reports can also be made electronically through direct entry into the Ohio Disease Reporting System (ODRS) or through Electronic Laboratory Reporting.\"\n\n \n\n\nOklahoma\n\nY\n\nY\n\nReportable Disease Card for Healthcare Providers (Blue Card)\r\n \r\nReportable Disease Card for Laboratories (Yellow Card)\n\nPHIDDO: adservice@health.ok.gov\r\n \r\nPhone: (405) 271-4060\r\nFax: (405) 271-6680\r\n \r\nELR: AnthonyL@health.ok.gov\n\nAccording the DoH's COVID-19 reporting page, COVID-19 cases should optimally be reported by some digital means (HL7, manually entered CSV, exported CSV from information system). The DoH is presumably treating \"laboratory results indicating\" (i.e., \"upon suspicion, diagnosis, or positive test\") COVID-19 as an immediately reportable event. This also holds true for healthcare providers. The Public Health Investigation and Disease Detection of Oklahoma (PHIDDO) system is apparently the preferred method.\n\n \n\n\nOregon\n\nY\n\nY\n\nCOVID-19 Report Form\n\nContact: Local public health authority\r\n \r\nFax: (971) 673-1100\r\n \r\nOregon COVID-19 Reporting Portal or ELR: (971) 673-1111\n\n\"The Oregon Health Authority (OHA), Public Health Division, is temporarily adopting OAR 333-017-0800 and OAR 333-018-900, which add a definition of COVID-19 and adds COVID-19 to the list of diseases reportable to public health authorities within 24 hours. Positive test results for COVID-19 must be reported within 24 hours and negative COVID-19 results within one working day.\" \"Both medical laboratories and health care providers are required to report COVID-19 test results to the state and local public health authorities.\" According to state law, reports should be initially submitted by phone call, with a follow-up report either through the Oregon COVID-19 Reporting Portal or a fax. ELR is also an option.\n\n \n\n\nPennsylvania\n\nY\n\nN\n\nNo standardized COVID-19 reporting form (use PA-NEDDS)\n\nPA-NEDSS: 1-877-724-3258\n\nFrom the Pennsylvania Department of Health: \"All entities conducting testing to identify SARS-CoV-2, the virus that causes COVID-19, are required to report positive, inconclusive\/indeterminate, and negative results to PA-NEDSS within 24 hours of test completion. PA-NEDSS is a secure, web-based system used in Pennsylvania for disease reporting and surveillance.\"\n\n \n\n\nRhode Island\n\nY\n\nY\n\nNone\n\nPhone: (401) 222-2577 or (401) 276-8046 after hours\r\n \r\nFax: (401) 222-2488\n\nPer the Rhode Island Department of Health: \"For reporting positive results from testing you have ordered and sent out through a laboratory system, report positive results only.\" You may report by secure email or fax. \"For reporting point-of-care and rapid test results performed at your site, report all positive and negative results.\" Note the specific email addresses depending on the test type. ELR is not mentioned.\n\n \n\n\nSouth Carolina\n\nY\n\nY (?)\n\nNo standardized COVID-19 reporting form\n\nContact: Local public health office\r\n \r\nELR: MUHELPDESK@dhec.sc.gov or SCIONHELP@dhec.sc.gov\n\nPer the South Carolina Department of Health and Environmental Control: \"Please notify DHEC of positive results. COVID-19 cases and deaths are urgently reportable per the South Carolina List of Reportable Conditions. They must be reported by phone within 24 hours to the appropriate regional health department.\" Supplemental guidance: \"Positive and negative test results for COVID-19 must be reported to DHEC urgently within 24 hours by all entities performing testing, including testing at point-of-care or at-home specimen collections processed by laboratories.\" That guidance adds: \"Facilities that are not already submitting results via Electronic Lab Reporting (ELR) or DHEC's secure reporting portal (SCIONx) should contact MUHELPDESK@dhec.sc.gov to inquire about ELR submission, or SCIONHELP@dhec.sc.gov to inquire about other reporting options.\"\n\n \n\n\nSouth Dakota\n\nY\n\nY\n\nSouth Dakota Confidential Disease Report (online\/HTML)\n\nPhone: (605) 773-3737 or 800-592-1861\r\n \r\nFax: (605) 773-5509\n\n\"SD-DOH would like to remind medical providers, hospitals, and laboratories that cases of COVID-19, caused by the SARS-CoV-2 virus, are considered immediately reportable in South Dakota (under Coronavirus Respiratory syndromes).\" The SD-DOH and the state laws don't make clear what reporting method is best for Category I diseases, only that they should be reported immediately. Under \"how to report,\" they list, in order, online reporting, phone, fax, and mail. The SD-DOH disease reporting web page makes no mention of ELR.\n\n \n\n\nTennessee\n\nY\n\nY\n\nPH-1600 Case Report Form\n\nFax: (615) 741-3857\r\n \r\nPhone: (615) 741-7247\r\n \r\nELR: ceds.informatics@tn.gov\n\n\"Healthcare providers who receive positive COVID-19 test results on their patients or patients in their facility [should report].\" \"Laboratories performing COVID-19 testing should be reporting these results electronically via ELR or our emergency spreadsheet template. If you are a laboratory that needs to report via one of these methods, please email ceds.informatics@tn.gov.\" These entities \"should report within 24 hours of receiving a COVID-19 diagnosis, positive lab report on a patient, and\/or becoming aware of a suspected or confirmed COVID-19 associated death.\" Please submit a case report by filling out the PH-1600 form on all NAAT, PCR and antigen positive COVID-19 test results from facility or commercial labs (this includes any NAAT, PCR or antigen positive patients tested via Point of Care testing); you do not need to submit further information on a lab result from the TDH Public Health Laboratory.\" The Tennessee Department of Health lists two reporting options: faxing the PH-1600 form and positive lab report or sending it electronically (via Morbidity Report or ELR).\n\n \n\n\nTexas\n\nY\n\nY\n\nInfectious Disease Report (Single case)\r\n \r\nInfectious Disease Report (Multiple cases)\n\nContact: Local health department\r\n \r\nELR: COVID\u201119ELR@dshs.texas.gov\n\n\"On July 29, 2021, Governor Greg Abbott ordered every public or private entity that is utilizing an FDA-approved test, including an emergency use authorization test, for human diagnostic purposes of COVID-19, shall continue to submit to DSHS, as well as to the local health department, daily reports of all test results.\" This includes positive, negative, and indeterminate results. \"To comply with the Governor\u2019s orders, DSHS is expediting an alternative method of accepting specific CSV formatted files for submitters who are unable to submit via HL7 format.\" ELR registration can be performed online.\n\n \n\n\nUtah\n\nY\n\nY\n\nUtah Public Health Confidential Morbidity Report\n\nFax: (801) 538-9923\r\n \r\nEmail: reporting@utah.gov\r\n \r\nPhone: 1-888-EPI-UTAH\r\n \r\nELR: edx@utah.gov\n\nThe Utah Department of Health added COVID-19 to its reportable conditions in May 2020 for both manual and electronic reporters. \"All test results are reportable. This includes positive\/reactive, indeterminate, equivocal, and negative\/non-reactive.\" \"Electronic reporters must report laboratory results within 24 hours of finalization. Manual reporters must report immediately notifiable conditions within 24 hours of identification and standard notifiable conditions within three business days of identification.\" Details on ELR are limited, though an ELR guide for hospitals can be found here.\n\n \n\n\nVermont\n\nY (?)\n\nY\n\nNo standardized COVID-19 reporting form\n\nPhone: (802) 863-7240\r\n \r\nFax: (802) 951-4061\r\n \r\nELR: (802) 651-1619 or AHS.VDHELRSupport@vermont.gov\n\nThe Vermont Department of Health states: \"All COVID-19 results (positive, negative, etc.) are required to be reported to the Vermont Department of Health within 24 hours of test report completion\" Its April 2021 guidance adds: \"The report shall be made by telephone, in writing, or electronically to the Department of Health, Epidemiology Program.\" Additional details can be found here.\n\n \n\n\nVirginia\n\nY\n\nN\n\nSee portals linked below\n\nContact: Local health department\n\nThe VDH states: \"All COVID-19 reports from clinicians or facilities based on point-of-care tests should be reported using the VDH Point-of-Care (POC) Portal, not the Confidential Morbidity Portal. For other reports not involving POC testing, healthcare providers should continue to report patients with suspected or confirmed COVID-19 through the Confidential Morbidity Portal.\" They add that \"[a]ll COVID-19 test results should be reported to VDH within 24 hours.\"\n\n \n\n\nWashington\n\nY\n\nN\n\nNone\n\nContact: Local health jurisdiction\n\nThe Washington State Department of Health has adopted several emergency rules to ensure reporting compliance. The DoH notes: \"Facilities administering point-of-care (POC) testing for COVID-19 must report all their COVID-19 testing results to the Washington State Department of Health.\" (See here for more about POC reporting requirements.) \"Washington State (under WAC 246-101) requires laboratories to report all COVID-19 results (including positive, negative, inconclusive; and other results based on State Health Officer Letters) to the LHJ of the patient's residence. ELR, national flat file, and electronic case reporting options are available for labs.\n\n \n\n\nWest Virginia\n\nN (?)\n\nY\n\n2019 Novel Coronavirus (COVID-19) Case Report Form\n\nContact: Local health departments\n\n\"Report suspect or confirmed cases immediately to the local health department by phone and follow up with written report.\" \"Providers and LHDs should submit this report to the Division of Infectious Disease Epidemiology by fax at 304-558-8736 for all cases of COVID-19.\" It's not clear if ELR is an acceptable form of reporting COVID-19 cases.\n\n \n\n\nWisconsin\n\nY\n\nY\n\nWisconsin COVID-19 Patient Information F-02700\n\nContact: [hhttps:\/\/www.dhs.wisconsin.gov\/lh-depts\/counties.htm Local health department]\r\n \r\nWEDSS: DHSWEDSS@wisconsin.gov\n\n\"The state epidemiologist declared COVID-19 a Category I reportable disease per a memo issued on Feb. 4, 2020. Health care providers and laboratories must report confirmed or suspected cases to the Department of Health Services (DHS) within 24 hours of detection. To relieve the reporting burden, DHS waived the requirement (April 6 Memo) for notifying local health departments by telephone of suspected and confirmed cases as long as cases are reported to the Wisconsin Electronic Disease Surveillance System (WEDSS).\" Additional rules apply. See \"Reporting and surveillance guidance\" here.\n\n \n\n\nWyoming\n\nN\n\nY\n\nConfidential Disease Report form\n\nPhone: 1-888-996-9104\r\n \r\nFax: (307) 777-5573\n\n\"Providers and laboratories must report positive [SARS-CoV-2] laboratory tests from commercial reference laboratories to WDH by faxing copies of the laboratory report form to 307-777-5573.\" According to Wyoming's Reportable Diseases and Conditions List, this faxed report would be in addition to immediate notification by phone. Additionally, \"[h]ospital and reference labs with ELR capacity must report positive and negative results,\" as well as viral detection and serology results. According to that document, COVID-19 isn't a disease preferred for ELR. Confirm with the health department.\n\n\n\n\n\n\n\n\n\nTable 2. U.S. territory-based COVID-19 reporting requirements\n\n\nTerritory\n\nElectronic, including email? (Y\/N)\n\nFax? (Y\/N)\n\nForms for reporting\n\nContact\n\nAdditional details\n\n \n\n\nAmerican Samoa\n\nN\n\nN (?)\n\nCan't locate the AMS COVID-19 Investigation Form\n\nContact: Facebook page\r\n \r\nPhone: (684) 633-5871 or (684) 633-5872\n\nAccording to American Samoa's report Territory of American Samoa's Response and Action Plan to Combat the Cornoavirus Pandemic, resources for testing are unfortunately thin. It makes mention that the American Samoa Department of Health should be notified \"immediately of probable or confirmed cases of COVID-19.\" It also mentions completing an \"AMS COVID-19 Investigation Form.\" \"If there is more than one case of novel coronavirus in a household, local area or facility, or an outbreak is suspects, notify Command Post immediately at (684) 633-5871 or (684) 633-5872.\"\n\n \n\n\nGuam\n\nN\n\nY (?)\n\nNo standardized COVID-19 reporting form\n\nContact: Office of Epidemiology and Research - Phone: (671) 735-7289, Fax: (671) 734-2066\n\nIt's clear that Guam is having laboratories report cases of COVID-19, but no reporting requirements for COVID-19 (or any other diseases) can be located on the Department of Public Health and Social Services website. Perhaps contact the Office of Epidemiology and Research for more information.\n\n \n\n\nNorthern Mariana Islands\n\nN\n\nN\n\nNo standardized COVID-19 reporting form\n\nContact: CHCC laboratory\n\nThe CNMI Department of Public Health has indicated that laboratory testing has been primarily been performed by the Guam Public Health Laboratory, but due to them not being able to meet demand, the CNMI DPH will ship samples to Diagnostic Laboratory Services in Honolulu, Hawaii. Presumably those labs are responsible, in part, for reporting results back to the CNMI.\n\n \n\n\nPuerto Rico\n\nUnknown\n\nUnknown\n\nUnknown\n\nPhone: (787) 765-2929\r\n \r\nEmail: contactus@salud.pr.gov\n\nThe Departamento de Salud de Puerto Rico has a relevant document OA 440 Sobre la distribuci\u00f3n, manejo, administraci\u00f3n y reporte de los resultados de las pruebas de COVID-19 concerning reporting results.\n\n \n\n\nU.S. Virgin Islands\n\nN\n\nY\n\nNotification of Infectious Disease Form\n\nPhone: (340) 626-1654\r\n \r\nTerritorial fax: 1-888-400-8620\n\n\"Make an IMMEDIATE telephone report to the USVI Department of Health at 626-1654 then send the completed\nform IMMEDIATELY (within 24 hrs) by fax to 1-888-400-8620. If an immediate report is required after regular working hours, please call 626-1654.\" Additional COVID-19 information here.\n\n\n\n\nReferences \n\n\n\u2191 \"What is Epidemiology?\". Teacher Roadmap. Centers for Disease Control and Prevention. 17 June 2016. https:\/\/www.cdc.gov\/careerpaths\/k12teacherroadmap\/epidemiology.html . Retrieved 14 September 2021 .   \n \n\n\u2191 Naito, M. (2014). \"Utilization and application of public health data in descriptive epidemiology\". Journal of Epidemiology 24 (6): 435\u20136. doi:10.2188\/jea.je20140182. PMC PMC4213216. PMID 25327184. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4213216 .   \n \n\n\u2191 Centers for Disease Control and Prevention (2012) (PDF). Principles of Epidemiology in Public Health Practice (3rd ed.). Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/csels\/dsepd\/ss1978\/SS1978.pdf . Retrieved 11 April 2020 .   \n \n\n\u2191 4.0 4.1 Hamilton, J.J.; Hopkins, R.S. (2019). \"Chapter 5: Using Technologies for Data Collection and Management\". In Rasmussen, S.A.; Goodman, R.A.. The CDC Field Epidemiology Manual (4th ed.). Oxford University Press. pp. 71\u2013104. ISBN 9780190933692.   \n \n\n\u2191 5.0 5.1 von Elm, E.; Altman, D.G.; Egger, M. et al. (2007). \"The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: Guidelines for reporting observational studies\". PLoS Medicine 4 (10): e296. doi:10.1371\/journal.pmed.0040296. PMC PMC2020495. PMID 17941714. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC2020495 .   \n \n\n\u2191 6.0 6.1 6.2 Crear-Perry, J. (5 November 2020). \"The hidden public health hazard of rapid Covid-19 tests\". STAT. https:\/\/www.statnews.com\/2020\/11\/05\/rapid-covid-19-tests-hidden-public-health-hazard\/ . Retrieved 21 November 2020 .   \n \n\n\u2191 Centers for Disease Control and Prevention (1 May 2020). \"Instructions for Completing the Human Infection with 2019 Novel Coronavirus (COVID-19) Case Report Form\" (PDF). Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/downloads\/COVID-19-Persons-Under-Investigation-and-Case-Report-Form-Instructions.pdf . Retrieved 21 November 2020 .   \n \n\n\u2191 Centers for Disease Control and Prevention (5 May 2020). \"Information for Health Departments on Reporting Cases of COVID-19\". Coronavirus Disease 2019 (COVID-19). Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/php\/reporting-pui.html . Retrieved 21 November 2020 .   \n \n\n\u2191 Centers for Disease Control and Prevention (20 April 2021). \"COVID-19 Electronic Laboratory Reporting Implementation by State\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/electronic-reporting-map.html . Retrieved 19 September 2021 .   \n \n\n\u2191 10.0 10.1 Centers for Disease Control and Prevention (26 January 2021). \"How to Report COVID-19 Laboratory Data\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/reporting-lab-data.html . Retrieved 14 September 2021 .   \n \n\n\u2191 Centers for Disease Control and Prevention (16 November 2020). \"Centralized National Reporting Mechanism for COVID-19 Laboratory Tests Results and Other Reportable Conditions, United States\". SAM.gov. https:\/\/sam.gov\/opp\/f0fc727c642640ed829d98fc880d4713\/view . Retrieved 14 September 2021 .   \n \n\n\u2191 Government of Canada (19 March 2021). \"National surveillance for Coronavirus disease (COVID-19)\". Government of Canada. https:\/\/www.canada.ca\/en\/public-health\/services\/diseases\/2019-novel-coronavirus-infection\/health-professionals\/interim-guidance-surveillance-human-infection.html . Retrieved 14 September 2021 .   \n \n\n\u2191 European Centre for Disease Prevention and Control (29 May 2020). \"EU level surveillance of COVID19\". COVID-19 Portal. European Centre for Disease Prevention and Control. https:\/\/www.ecdc.europa.eu\/en\/covid-19\/surveillance . Retrieved 21 November 2020 .   \n \n\n\u2191 American Medical Association. \"COVID-19 CPT coding and guidance\". COVID-19 CPT codes. https:\/\/www.ama-assn.org\/practice-management\/cpt\/covid-19-cpt-coding-and-guidance . Retrieved 14 September 2021 .   \n \n\n\u2191 \"Frequently Asked Questions Regarding ICD-10-CM Coding for COVID-19\". AHA Coding Clinic Advisor. American Hospital Association. 27 August 2021. https:\/\/www.codingclinicadvisor.com\/faqs-icd-10-cm-coding-covid-19 . Retrieved 14 September 2021 .   \n \n\n\u2191 Centers for Medicare and Medicaid Services (10 August 2021). \"ICD-10-CM Official Guidelines for Coding and Reporting FY 2022\" (PDF). https:\/\/www.cms.gov\/files\/document\/fy-2022-icd-10-cm-coding-guidelines.pdf . Retrieved 14 September 2021 .   \n \n\n\u2191 \"COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing\" (PDF). Centers for Medicare and Medicaid Services. 2 July 2021. https:\/\/www.cms.gov\/files\/document\/03092020-covid-19-faqs-508.pdf . Retrieved 14 September 2021 .   \n \n\n\u2191 \"COVID-19 Coding and Reporting Information New CPT, HCPCS, and ICD-10 CM Codes\" (PDF). American Society of Clinical Oncology. 26 August 2021. https:\/\/www.asco.org\/sites\/new-www.asco.org\/files\/content-files\/advocacy-and-policy\/documents\/2020-COVID19-Billing-and-Coding-Resource.pdf . Retrieved 14 September 2021 .   \n \n\n\u2191 National Center for Health Statistics (30 July 2021). \"International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM)\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/nchs\/icd\/icd10cm.htm . Retrieved 14 September 2021 .   \n \n\n\u2191 Centers for Disease Control and Prevention (1 December 2020). \"Commercial Laboratory Seroprevalence Surveys\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/cases-updates\/commercial-lab-surveys.html . Retrieved 14 September 2021 .   \n \n\n\u2191 Garcia, K.; Pedati, C. (31 December 2020). \"Temporary Novel Coronavirus Disease 2019 (COVID-19) Mandatory Reporting Order\" (PDF). Iowa Department of Public Health. https:\/\/idph.iowa.gov\/Portals\/1\/userfiles\/61\/covid19\/Mandatory%20Reporting%20Order.pdf . Retrieved 14 September 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 3 May 2020, at 19:50.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 396 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","500f43f0e2f5122484d8d18d8e4145c4_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Workflow_and_information_management_for_COVID-19_and_other_respiratory_diseases_Laboratory_informatics_and_reporting_requirements rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Workflow_and_information_management_for_COVID-19_and_other_respiratory_diseases_Laboratory_informatics_and_reporting_requirements skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Workflow and information management for COVID-19 (and other respiratory diseases)\/Laboratory informatics and reporting requirements<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\">\n\n<h3><span class=\"mw-headline\" id=\"4.2_Laboratory_informatics_and_reporting_requirements\">4.2 Laboratory informatics and reporting requirements<\/span><\/h3>\n<p>Before we can talk about the details of COVID-19 reporting, we first must briefly discuss the science of epidemiology. The CDC defines epidemiology as \"the method used to find the causes of health outcomes and diseases in populations.\"<sup id=\"rdp-ebb-cite_ref-CDCWhatIs16_1-0\" class=\"reference\"><a href=\"#cite_note-CDCWhatIs16-1\">[1]<\/a><\/sup> As we'll soon learn, finding those causes depends on quality data and reporting.\n<\/p><p>Epidemiology can broadly be split into two categories: descriptive epidemiology and analytical epidemiology. Descriptive epidemiology involves studies and other activities that deal with geographical comparisons and temporal trend descriptions of disease. As such, the collection and use of quality incidence data is vital to developing hypotheses.<sup id=\"rdp-ebb-cite_ref-NaitoUtil14_2-0\" class=\"reference\"><a href=\"#cite_note-NaitoUtil14-2\">[2]<\/a><\/sup> Analytical epidemiology allows for the testing of those hypotheses using both experimental and observational studies, as well as control groups. Similarly, the collection and use of quality experimental and observational data is vital for proving or disproving hypotheses.<sup id=\"rdp-ebb-cite_ref-CDCPrinc12_3-0\" class=\"reference\"><a href=\"#cite_note-CDCPrinc12-3\">[3]<\/a><\/sup> In both cases, proper reporting of public health data is critical to the success of epidemiologists' response to outbreaks and pandemics, as well as the credibility of their research.<sup id=\"rdp-ebb-cite_ref-HamiltonUsing19_4-0\" class=\"reference\"><a href=\"#cite_note-HamiltonUsing19-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-vonElmTheStren07_5-0\" class=\"reference\"><a href=\"#cite_note-vonElmTheStren07-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Crear-PerryTheHid20_6-0\" class=\"reference\"><a href=\"#cite_note-Crear-PerryTheHid20-6\">[6]<\/a><\/sup> This includes point-of-care and at-home testing results, which are at times more difficult to capture.<sup id=\"rdp-ebb-cite_ref-Crear-PerryTheHid20_6-1\" class=\"reference\"><a href=\"#cite_note-Crear-PerryTheHid20-6\">[6]<\/a><\/sup>\n<\/p><p>The proper reporting of COVID-19 case data is no exception. In the United States, the <a href=\"https:\/\/www.limswiki.org\/index.php\/Centers_for_Disease_Control_and_Prevention\" title=\"Centers for Disease Control and Prevention\" class=\"wiki-link\" data-key=\"176aa9c9513251c328d864d1e724e814\">Centers for Disease Control and Prevention<\/a> (CDC) has taken a standardized approach to collecting reports on individuals with \"lab-confirmed and probable cases of COVID-19,\"<sup id=\"rdp-ebb-cite_ref-CDCInstruct20_7-0\" class=\"reference\"><a href=\"#cite_note-CDCInstruct20-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CDCInformRepo20_8-0\" class=\"reference\"><a href=\"#cite_note-CDCInformRepo20-8\">[8]<\/a><\/sup> noting that as of April 21, 2021, all state, territorial, and tribal jurisdictions were onboard with electronic laboratory reporting to the CDC.<sup id=\"rdp-ebb-cite_ref-CDCCOVIDELR21_9-0\" class=\"reference\"><a href=\"#cite_note-CDCCOVIDELR21-9\">[9]<\/a><\/sup> Their COVID-19 Surveillance Worksheet (formerly Case Report Form) is designed to collect a wide variety of information about a COVID-19 case, including patient demographics, epidemiological characteristics, exposure and contact history, clinical diagnosis, treatment procedures, and vaccination history. Currently, the CDC is asking healthcare providers and <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratories<\/a> that are operating as testing sites to \"report data for all diagnostic and screening testing completed, which includes molecular, antigen, and antibody testing, for each individual tested\" on a daily basis, \"within 24 hours of test completion.\"<sup id=\"rdp-ebb-cite_ref-CDCHowToRep20_10-0\" class=\"reference\"><a href=\"#cite_note-CDCHowToRep20-10\">[10]<\/a><\/sup> Local, state, tribal, and territorial public health departments are then asked to submit case reports etc. to the CDC. Electronic reporting using the CDC's system is preferred, but they have a protocol for those areas unable to submit electronically. Recognizing the disparate reporting mechanisms across various state health departments and the problems this causes, particularly during an epidemic, funding efforts are under way to assist the CDC\u2014as well as state, local, and tribal governments\u2014better report disease information through a modernized, centralized public health data management platform.<sup id=\"rdp-ebb-cite_ref-Crear-PerryTheHid20_6-2\" class=\"reference\"><a href=\"#cite_note-Crear-PerryTheHid20-6\">[6]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CDCCentral20_11-0\" class=\"reference\"><a href=\"#cite_note-CDCCentral20-11\">[11]<\/a><\/sup>\n<\/p><p>Elsewhere, Canada has similar reporting expectations to the U.S. CDC, with their own case report form and electronic data submission process through the Public Health Agency of Canada.<sup id=\"rdp-ebb-cite_ref-CanadaInterim20_12-0\" class=\"reference\"><a href=\"#cite_note-CanadaInterim20-12\">[12]<\/a><\/sup> And in the European Union, member countries and the U.K. are asked to report through the Early Warning and Response System, with \"additional enhanced surveillance ... established through The European Surveillance System - TESSy.\"<sup id=\"rdp-ebb-cite_ref-ECDCCaseDef20_13-0\" class=\"reference\"><a href=\"#cite_note-ECDCCaseDef20-13\">[13]<\/a><\/sup>\n<\/p>\n<h4><span id=\"rdp-ebb-4.2.1_ICD,_CPT,_and_HCPCS_coding\"><\/span><span class=\"mw-headline\" id=\"4.2.1_ICD.2C_CPT.2C_and_HCPCS_coding\">4.2.1 ICD, CPT, and HCPCS coding<\/span><\/h4>\n<div class=\"floatleft\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Icd10codeslogo.png\" class=\"image wiki-link\" data-key=\"596cb2d9668eaac4d13fbe8f515bb685\"><img alt=\"Icd10codeslogo.png\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/a\/a4\/Icd10codeslogo.png\" decoding=\"async\" width=\"240\" height=\"120\" \/><\/a><\/div><p>Related are any test reporting and billing requirements in labs and medical facilities. The <a href=\"https:\/\/www.limswiki.org\/index.php\/International_Statistical_Classification_of_Diseases_and_Related_Health_Problems\" title=\"International Statistical Classification of Diseases and Related Health Problems\" class=\"wiki-link\" data-key=\"1de9af67005dfe2895e5d8cf6de57d4a\">International Statistical Classification of Diseases and Related Health Problems<\/a> (ICD) is a commonly used system of diagnostic codes for classifying diseases, including nuanced classifications of a wide variety of signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or disease. Their ICD-10-CM code set has been modified to include lab testing codes for COVID-19, as has the <a href=\"https:\/\/www.limswiki.org\/index.php\/Current_Procedural_Terminology\" title=\"Current Procedural Terminology\" class=\"wiki-link\" data-key=\"c5cc3e305001a68af1f9c5aa568d6260\">Current Procedural Terminology<\/a> (CPT) code set. This guide provides basic information about these codes (which should not be considered legally binding advice); however, see the referenced material (and following citations) for more details concerning those codes<sup id=\"rdp-ebb-cite_ref-AMA-COVIDCPT_14-0\" class=\"reference\"><a href=\"#cite_note-AMA-COVIDCPT-14\">[14]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AHAFreq21_15-0\" class=\"reference\"><a href=\"#cite_note-AHAFreq21-15\">[15]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CMS-ICD10CM21_16-0\" class=\"reference\"><a href=\"#cite_note-CMS-ICD10CM21-16\">[16]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CMS-COVIDFAQFFS21_17-0\" class=\"reference\"><a href=\"#cite_note-CMS-COVIDFAQFFS21-17\">[17]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ASCO-COVIDReport21_18-0\" class=\"reference\"><a href=\"#cite_note-ASCO-COVIDReport21-18\">[18]<\/a><\/sup>:\n<\/p><ul><li>The CPT code 87635 has the long descriptor of \"Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique.\" The American Medical Association's <i>CPT Assistant<\/i> <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ama-assn.org\/practice-management\/cpt\/covid-19-cpt-coding-and-guidance\" target=\"_blank\">fact sheet<\/a> for SARS-CoV-2 reporting proves useful in supplying assistance on how and when to apply this CPT code in reporting.<\/li><\/ul>\n<ul><li>Since the pandemic has progressed, numerous other CPT codes have become available. This includes a series of parent and child codes for antibody testing, neutralizing antibody screens, antigen testing, and vaccination. Resources for guidance concerning these codes include the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ama-assn.org\/practice-management\/cpt\/covid-19-cpt-coding-and-guidance\" target=\"_blank\">American Medical Association<\/a> and the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.asco.org\/sites\/new-www.asco.org\/files\/content-files\/advocacy-and-policy\/documents\/2020-COVID19-Billing-and-Coding-Resource.pdf\" target=\"_blank\">American Society of Clinical Oncology<\/a> (PDF).<\/li><\/ul>\n<ul><li>The U.S. government-adopted ICD-10-CM\u2014an authorized version of WHO's ICD-10<sup id=\"rdp-ebb-cite_ref-CDCIntern20_19-0\" class=\"reference\"><a href=\"#cite_note-CDCIntern20-19\">[19]<\/a><\/sup>\u2014has been updated by the CDC and the National Center for Healthcare Statistics. It includes not only codes for conditions associated with COVID-19, but also codes for exposure, screening, and vaccination. The principal diagnosis code \"U07.1, COVID-19\" is sequenced first for a confirmed COVID-19 diagnosis, followed by any appropriate codes for associated manifestations (though there is an obstetrics exception). CMS's <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/files\/document\/fy-2022-icd-10-cm-coding-guidelines.pdf\" target=\"_blank\">coding guidelines<\/a>, as well as <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ama-assn.org\/practice-management\/cpt\/covid-19-cpt-coding-and-guidance\" target=\"_blank\">American Medical Association<\/a> guidance, may prove useful in choosing the correct codes. The <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.asco.org\/sites\/new-www.asco.org\/files\/content-files\/advocacy-and-policy\/documents\/2020-COVID19-Billing-and-Coding-Resource.pdf\" target=\"_blank\">American Society of Clinical Oncology<\/a> (PDF) is also maintaining a document with ICD-10-CM information.<\/li><\/ul>\n<ul><li>Since the pandemic started, new HCPCS codes have been released by the Centers for Medicare & Medicaid Services (CMS). These are to be used solely for Medicare claims. The <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.asco.org\/sites\/new-www.asco.org\/files\/content-files\/advocacy-and-policy\/documents\/2020-COVID19-Billing-and-Coding-Resource.pdf\" target=\"_blank\">American Society of Clinical Oncology<\/a> (PDF) is maintaining a helpful document with that information.<\/li><\/ul>\n<p>Laboratories analyzing specimens for SARS-CoV-2 must be equipped to implement and handle analytical testing and test orders using the new test codes. However, they also must be able to quickly and accurately transfer vital case information to the appropriate health authority. This may include using other types of codes such as Logical Observation Identifiers Names and Codes (<a href=\"https:\/\/www.limswiki.org\/index.php\/LOINC\" title=\"LOINC\" class=\"wiki-link\" data-key=\"b20c83dbfab36194bab6c223e31ebfdc\">LOINC<\/a>) and , which are briefly discussed in the next subsection.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"4.2.2_Reporting_to_local_and_regional_health_departments\">4.2.2 Reporting to local and regional health departments<\/span><\/h4>\n<p>Given the valuable nature of case reports during an epidemic<sup id=\"rdp-ebb-cite_ref-HamiltonUsing19_4-1\" class=\"reference\"><a href=\"#cite_note-HamiltonUsing19-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-vonElmTheStren07_5-1\" class=\"reference\"><a href=\"#cite_note-vonElmTheStren07-5\">[5]<\/a><\/sup>, health care providers, facilities, and laboratories are being held responsible for sending case data to their local and regional health departments. That information then feeds up to the state-level health department, which then makes its way to the national-level entity responsible for handling epidemiology (in the case of the U.S., the CDC). Significant decisions are typically based on that data. For example, the U.S. CDC has been conducting seroprevalance (determination of the \"percentages of people who were previously infected with SARS-CoV-2\") surveys of various regions of the United States.<sup id=\"rdp-ebb-cite_ref-CDCCommercial20_20-0\" class=\"reference\"><a href=\"#cite_note-CDCCommercial20-20\">[20]<\/a><\/sup> The insights and decisions the CDC makes depends on cooperation and proper reporting by state and local health departments.\n<\/p><p>However, acquiring standardized data at the national level can still be challenging. In the case of the U.S., general disease reporting requirements vary from state to state, with many states encouraging full electronic laboratory reporting (ELR), while some still encourage faxed or emailed reports. Add in the urgency and confusion associated with a pandemic, and COVID-19 reporting requirements prove to vary just as much. Some states' health departments have taken a proactive approach to reporting. For example, Iowa's Department of Public Health has issued several mandatory COVID-19 reporting orders meant to supplement existing reporting rules, including an order requiring all Iowa health care providers and public, private, and hospital laboratories \"to immediately report all positive and negative Coronavirus Disease 2019 (COVID-19) testing results to the department.\"<sup id=\"rdp-ebb-cite_ref-ClabaughRescind20_21-0\" class=\"reference\"><a href=\"#cite_note-ClabaughRescind20-21\">[21]<\/a><\/sup> Other states have not been as clear on their reporting requirements, in some cases not having any guidance documents or clear information on their health department website for how providers, facilities, and labs should report COVID-19. In those cases, the presumption is that most labs have contacted the health department for advice or are reporting COVID-19 cases as immediately reportable, based upon the state's existing reporting requirements for immediately reportable diseases. \n<\/p><p>The CDC, however, <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/reporting-lab-data.html\" target=\"_blank\">maintains a page<\/a> concerning how to report COVID-19 laboratory data. It's important to note their take on using standard terminology, which is based on <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/csels\/dls\/sars-cov-2-livd-codes.html\" target=\"_blank\">their mapping tool<\/a> <i>LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests<\/i><sup id=\"rdp-ebb-cite_ref-CDCHowToRep20_10-1\" class=\"reference\"><a href=\"#cite_note-CDCHowToRep20-10\">[10]<\/a><\/sup>:\n<\/p>\n<blockquote><p>This specification supports the use of standardized LOINC and SNOMED Clinical Terms (CT) codes to improve the accuracy of reporting tests for the SARS-CoV-2 virus. Using these harmonized LOINC and SNOMED-CT codes helps ensure that the same type of test is represented uniformly across the United States ... LOINC codes must be used to represent the \u201cquestion\u201d a test asks of a specimen (e.g., does this specimen have SARS-CoV-2 RNA?), and SNOMED-CT codes must be used to represent the diagnostic \u201canswer\u201d (e.g., what was detected?).<\/p><\/blockquote>\n<p>The CDC's Excel-based mapping tool lists the current (and previous) FDA EUAed diagnostic tests with codes for LOINC test order, LOINC test result, SNOMED-CT test description, SNOMED-CT specimen source, and Device Identifier. Ensure that your laboratory is using these LOINC and SNOMED-CT codes for reporting to your local and state health departments.\n<\/p><p>Table 1 addresses the reporting requirements for the United States' 50 states, while Table 2 covers U.S. territories. If clear reporting guidance specific to COVID-19 could be found, it was described. If no such guidance could be found, then the state's existing guidance and rules regarding disease reporting were referenced. In some cases, the state health departments don't clearly spell out whether a faxed or mailed report is required after immediately phoning in a report. In other cases, it's not clear if ELR\u2014though it exists\u2014is an acceptable form of reporting COVID-19 cases. This ambiguity is stated in the form of a \"(?)\" found next to the \"Y\" and \"N\" for electronic filing and faxing. In <b>all<\/b> cases, if there is any doubt about reporting requirements, call your local health department to confirm.\n<\/p>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable\" border=\"1\" cellpadding=\"5\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\" colspan=\"6\"><b>Table 1.<\/b> U.S. state-based COVID-19 reporting requirements\n<\/td><\/tr>\n<tr>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">State\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Electronic, including email? (Y\/N)\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Fax? (Y\/N)\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Forms for reporting\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Contact\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Additional details\n<\/th><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.alabamapublichealth.gov\/covid19\/healthcare.html\" target=\"_blank\">Alabama<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/epiweb.adph.state.al.us\/redcap\/surveys\/?s=WK7TY9PT7J\" target=\"_blank\">Novel Coronavirus Report Card<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">ALNEDSSsupport@adph.state.al.us\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Use the Report Card \"to submit laboratory-confirmed (or pre-approved epidemiologically-linked) cases or deaths of Novel Coronavirus (COVID-19) to the Alabama Department of Public Health.\" (Though long-term care facilities and correctional facilities should used different forms.) \"Performing laboratories are required to report all negative and positive COVID-19 virus test results electronically (faxes do not count). If not already enrolled, laboratories will need to manually enter test results directly into the surveillance system.\" Email the contact to enroll staff access to the system.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dhss.alaska.gov\/dph\/Epi\/id\/Pages\/COVID-19\/healthcare.aspx\" target=\"_blank\">Alaska<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dhss.alaska.gov\/dph\/Epi\/Documents\/pubs\/conditions\/frmInfect.pdf\" target=\"_blank\">Confidential Infectious Disease Report Form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">COVID Reporting Hotline: 1-877-469-8067<br \/> <br \/>Urgent situation: 907-269-8000 or 800-478-0084 (after-hours)<br \/> <br \/>ELR: megan.tompkins@alaska.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"Providers must report laboratory-confirmed cases of COVID-19 to SOE via fax (907-563-7868) using the standard Infectious Disease report form or via electronic means. The reporting hotline has been discontinued.\" \"All results (i.e., positive, negative, indeterminate, etc.) must be reported via either integration into existing electronic laboratory reporting (ELR) data feeds, submission of a standard format CSV via SFTP, or fax (907-563-7868). Please email Megan Tompkins ... to inform us about how your facility will report.\" (See <i><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dhss.alaska.gov\/dph\/Epi\/id\/siteassets\/pages\/humanCOV\/AKCOVIDTestingGuidance.pdf\" target=\"_blank\">Guidance for Coronavirus Disease 2019 (COVID-19) Testing in Alaska<\/a><\/i> for more.)\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.azdhs.gov\/covid19\/index.php#healthcare-providers-lab-info\" target=\"_blank\">Arizona<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.azdhs.gov\/covid19\/documents\/healthcare-providers-lab-info\/sample-adhs-csv-file.csv\" target=\"_blank\">Sample ADHS CSV File<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.azdhs.gov\/covid19\/documents\/healthcare-providers-lab-info\/sample-adhs-excel-file.xlsx\" target=\"_blank\">Sample ADHS Excel File<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">ELR: elr@azdhs.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"Facilities performing laboratory tests for COVID-19 are required to report both positive and negative results for COVID-19 directly to ADHS pursuant to Executive Order 2021-14. Laboratory is defined in A.R.S. \u00a7 36-451(4). Facilities shall report using an electronic format, described below.\" Consult the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.azdhs.gov\/covid19\/index.php#healthcare-providers-lab-info\" target=\"_blank\">laboratory information page<\/a> for details of all reporting options.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthy.arkansas.gov\/programs-services\/topics\/epidemiology\" target=\"_blank\">Arkansas<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y (?)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthy.arkansas.gov\/images\/uploads\/pdf\/CommunicableDiseaseReportingForm.pdf\" target=\"_blank\">Communicable Disease Reporting Form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Phone: (501) 537-8969 or 1-800-554-5738 after-hours\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Arkansas Department of Health doesn't appear to have published any information about specific COVID-19 reporting requirements. As of September 2021, the DoH still hasn't updated its <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthy.arkansas.gov\/images\/uploads\/pdf\/List_and_Instructions_Reportable_Diseases.pdf\" target=\"_blank\">list of mandatory reportable diseases<\/a>. The state is presumably treating \"suspected or confirmed\" COVID-19 cases as an immediately reportable event that \"are to be reported immediately to the ADH.\" The language used on its reportable disease instructions suggests that a follow-up fax of the case report isn't required; however, call and confirm with the DoH. The only mention of ELR is a plain page labelled \"<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthy.arkansas.gov\/programs-services\/topics\/public-health-reporting\" target=\"_blank\">Public Health Reporting<\/a>.\" It would appear users can submit reports via this tool, though registration may be required if new to the tool.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdph.ca.gov\/Programs\/CID\/DCDC\/Pages\/Reportable-Disease-and-Conditions.aspx\" target=\"_blank\">California<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N (?)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdph.ca.gov\/CDPH%20Document%20Library\/ControlledForms\/cdph110a.pdf\" target=\"_blank\">Confidential Morbidity Report<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdph.ca.gov\/Programs\/CCLHO\/Pages\/CCLHO-Health-Officer-Directory.aspx\" target=\"_blank\">Local health officers<\/a><br \/> <br \/>CalREDIE: CalREDIEHelp@cdph.ca.gov or (866) 866-1428\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">The DPH <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdph.ca.gov\/Programs\/OSPHLD\/LFS\/CDPH%20Document%20Library\/LFSCOVID19ltr-1.pdf\" target=\"_blank\">added<\/a> COVID-19 to its Reportable Diseases and Conditions lists for <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdph.ca.gov\/Programs\/CID\/DCDC\/CDPH%20Document%20Library\/ReportableDiseases.pdf\" target=\"_blank\">health care providers<\/a> and <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdph.ca.gov\/Programs\/CID\/DCDC\/CDPH%20Document%20Library\/LabReportableDiseases.pdf\" target=\"_blank\">laboratories<\/a> early in the pandemic. This health care provider document indicates that a \"case or suspected case\" of COVID-19 should be reported immediately by phone. The document makes no mention of requiring a follow-up fax or digital report by health care providers. The laboratory document indicates \"[l]aboratories must report any initial findings as well as any subsequent findings. \u201dAny laboratories approved to test for SARS-CoV-2 must report all positive and non-positive (negative, indeterminate, and specimen unsatisfactory) test results from both antigen\/molecular and antibody\/serology tests for SARS-CoV-2.\" Laboratory findings are \"are reportable to the local health officer of the health jurisdiction where the patient resides by telephone within one (1) hour ... from the time that the laboratory notifies the health care provider or other person authorized to receive the report.\" Labs are asked to also subsequently report results electronically (ELR) to the California Reportable Disease Information Exchange (CalREDIE) \"within one working day of identification.\"\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdphe.colorado.gov\/report-a-disease\/covid\" target=\"_blank\">Colorado<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">None\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">CEDRS: lavelle.fernandez@state.co.us<br \/> <br \/>ELR: andrew.horvath@state.co.us\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"All test results (e.g., positive, negative, and inconclusive) for rapid point-of-care COVID-19 tests must be reported to public health\" officials by providers. Additionally, \"[a]ll positive, negative, and inconclusive SARS-CoV-2 test results must be reported electronically by laboratories.\" The disease reporting form and fax methods should not be used. A list of required reporting components and descriptions of digital reporting options are available on the state's <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdphe.colorado.gov\/report-a-disease\/covid\" target=\"_blank\">COVID-19 reporting page<\/a>.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/portal.ct.gov\/DPH\/Epidemiology-and-Emerging-Infections\/Laboratory-Reporting\" target=\"_blank\">Connecticut<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/portal.ct.gov\/-\/media\/DPH\/EEIP\/Forms\/nCoV_-PUI_Form.pdf?la=en\" target=\"_blank\">2019 Novel Coronavirus (COVID-19) Case Report Form<\/a><br \/> <br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/portal.ct.gov\/-\/media\/Departments-and-Agencies\/DPH\/dph\/infectious_diseases\/pdf_forms_\/OL15C_Form.pdf?la=en\" target=\"_blank\">Reportable Laboratory Findings, Form OL-15C<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Fax: (860) 629-6962<br \/> <br \/>ELR: dph.elr@ct.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Presumably, laboratories are reporting COVID-19 as is required for any communicable disease. This has traditionally been done using Form OL-15C sent through <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/portal.ct.gov\/DPH\/Epidemiology-and-Emerging-Infections\/Laboratory-Reporting\" target=\"_blank\">mail or fax<\/a>, as well as <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/portal.ct.gov\/DPH\/Epidemiology-and-Emerging-Infections\/Electronic-Laboratory-Reporting\" target=\"_blank\">ELR<\/a>, which appears to be the preferred method. As for other healthcare providers, per the DPH's <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/portal.ct.gov\/Coronavirus\/Pages\/Public-Health-Resources\/Healthcare-Professionals\" target=\"_blank\">COVID-19 response portal<\/a>: \"Providers can now submit a COVID-19 case report <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dphsubmissions.ct.gov\/Covid\/InitiateCovidReport\" target=\"_blank\">online<\/a>. This is the preferred way to submit COVID-19 case reports.\"\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.delaware.gov\/medical-providers\/#reporting-requirements\" target=\"_blank\">Delaware<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">None\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Call: 1-888-295-5156<br \/> <br \/>Email: reportdisease@delaware.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"The Department of Health and Social Service\u2019s March 10, 2020 order requiring all labs to immediately report all tests and all results to the Division of Public Health (DPH) remains in effect. All COVID results, positive AND negative are reportable.\" \"All COVID-19 test results from any laboratory must be reported to DPH via the\n<p>Delaware Electronic Reporting Surveillance System (DERSS). Providers must confirm with their designated laboratories that they have the ability to transmit results to DERSS through approved methods.\" Review the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.delaware.gov\/wp-content\/uploads\/sites\/177\/2020\/09\/Provider-and-Lab-Reporting-Requirements-and-Penalties-letter_9.28.20.pdf\" target=\"_blank\">provider lab reporting requirements<\/a> for further details.\n<\/p>\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dchealth.dc.gov\/node\/1487006\" target=\"_blank\">District of Columbia<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dccovid.force.com\/provider\/s\/\" target=\"_blank\">Notifiable Disease and Condition Case Report Form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">ELR: informatics.epi@dc.gov<br \/> <br \/>Reporting questions: coronavirus@dc.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"... healthcare providers must report negative and positive test results for all COVID-19 diagnostic and serologic testing, including point-of-care testing. Reports should be submitted electronically using DC Reporting and Surveillance Center (DCRC), our <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dccovid.force.com\/provider\/s\/\" target=\"_blank\">online reporting system<\/a>.\" \"Laboratories are recommended to submit COVID-19 results via Electronic Lab Reporting. Please email informatics.epi@dc.gov to initiate the process. Hospitals, skilled nursing facilities, and assisted living facilities should report cases in patients\/residents via daily line lists to DC Health.\"\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.floridahealth.gov\/diseases-and-conditions\/disease-reporting-and-management\/disease-reporting-and-surveillance\/surveillance-and-investigation-guidance\/index.html\" target=\"_blank\">Florida<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">None\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">ELR: ELRPortalSupport@flhealth.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"Mandatory reporting requirements are outlined by Florida Department of Health Executive Order 20-013, section 381.0031, Florida Statutes, and Florida Administrative Code Chapter 64D-3, and state all health care practitioners, laboratories and facilities, including long-term care facilities, must report both negative and positive COVID-19 test results, including point-of-care rapid test results, within 24 hours of the result being known.\" As of September 2021, the documentation found on floridahealth.gov appears outdated, however, as the links to the report portal that are indicated are broken. A site, <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.flhealthsource.gov\/covid19-reporting\" target=\"_blank\">flhealthsource.gov<\/a>, was found, and it appears to be the current report portal for health care providers and facilities.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dph.georgia.gov\/epidemiology\/disease-reporting\" target=\"_blank\">Georgia<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dph.georgia.gov\/document\/document\/notifiable-disease-report-form\/download\" target=\"_blank\">Notifiable Disease Report Form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Fax: Based on <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dph.georgia.gov\/about-dph\/contact-dph\/public-health-districts\" target=\"_blank\">District Health Office<\/a><br \/> <br \/>Call: 1-866-782-4584\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Georgia lists COVID-19 as an immediately reportable disease condition. \"All Georgia physicians, laboratories, and other health care providers\" are encouraged to call their District Health Office or the main number. The state is also accepting COVID-19 reports through its <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/sendss.state.ga.us\/sendss\/login.screen\" target=\"_blank\">SendSS<\/a> online application.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.hawaii.gov\/coronavirusdisease2019\/for-clinicians\/evaluating-puis\/\" target=\"_blank\">Hawaii<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N (?)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.hawaii.gov\/docd\/files\/2020\/01\/COVID-19_Short-Form_Fillable_For_Physicians.pdf\" target=\"_blank\">Human Infection with 2019 Novel Coronavirus Short Form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Fax: (808) 586-4595<br \/> <br \/>ELR: helpdesk@hawaiihie.org\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.hawaii.gov\/coronavirusdisease2019\/files\/2021\/08\/DOH-DIR-Declaration-08-06-21.pdf\" target=\"_blank\">Per the Director of Health<\/a>: \"Pursuant to section 325-2, Hawaii Revised Statutes, every physician or health care professional having a client affected by or suspected of being affected by COVID-19 (SARS-CoV-2) and every laboratory director having laboratory data regarding an individual affected by or suspected of being affected by COVID-19 (SARS-CoV-2) shall report the incidence or suspected incidence of COVID-19 (SARS-CoV-2) to the Department of Health in the manner specified by the Department of Health. At this time, all test results shall be reported via the electronic laboratory reporting system.\" That system is presumed to be <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/lrp.health.hawaii.gov\/#\/\" target=\"_blank\">this portal<\/a>. Faxing may no longer be an option; confirm with the Department of Health.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/healthandwelfare.idaho.gov\/Health\/Epidemiology\/tabid\/111\/Default.aspx\" target=\"_blank\">Idaho<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No standardized COVID-19 reporting form\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Phone: (208) 334-5939<br \/> <br \/>Fax: (208) 332-7307<br \/> <br \/>ELR: PublicHealthMU@dhw.idaho.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">The Idaho Department of Health and Welfare doesn't appear to have published any information about COVID-19 reporting requirements. As of September 2021, the state has not added COVID-19 to its <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/publicdocuments.dhw.idaho.gov\/WebLink\/DocView.aspx?id=6797&dbid=0&repo=PUBLIC-DOCUMENTS\" target=\"_blank\">mandatory reportable diseases list<\/a>. They <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.idaho.gov\/frequently-asked-questions\/\" target=\"_blank\">simply state<\/a> that \"Labs report their test results to the state, and the number of tests done and the number of people who test positive are posted on this website each day.\" Presumably this means that labs should be following the state's reportable diseases protocol for reporting \"within one working day of identification or suspicion\" using phone or fax. No standardized reporting form appears to exist. It's not clear if <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/healthandwelfare.idaho.gov\/providers\/electronic-health-records-ehr\/meaningful-use-electronic-health-records-and-idaho-public\" target=\"_blank\">ELR<\/a> is being used to report COVID-19 cases.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dph.illinois.gov\/covid19\/health-care-providers\" target=\"_blank\">Illinois<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.dph.illinois.gov\/sites\/default\/files\/COVID19\/COVID19%20Case%20Report%20Form%204.23.20.pdf\" target=\"_blank\">IDPH Coronavirus Novel 2019 Case Report Form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Fax: Based on <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.idph.state.il.us\/LHDMap\/HealthRegions.aspx\" target=\"_blank\">Local Health Department<\/a><br \/> <br \/>ELR: dph.elrresp@illinois.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"All providers and testing sites must report to Public Health all individuals tested for COVID-19, in accordance with the Illinois Control of Communicable Diseases Code (77 Ill. Adm. Code 690.200(a)(5)). Mandated reporters, such as health care providers, hospitals and laboratories, by law must report probable or confirmed cases of COVID-19 electronically through Illinois\u2019 National Electronic Disease Surveillance System (I-NEDSS) within 24 hours. If they do not have access to I-NEDSS, they can report by mail, telephone or fax to the local health department ... or, if no local health department is available, to the Illinois Department of Public Health Division of Infectious Diseases at 217-785-7165, TTY (hearing impaired use only) 800-547-0466.\"\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.coronavirus.in.gov\/files\/COVID-19%20Reporting%20Methods%2010.19.20.pdf\" target=\"_blank\">Indiana<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/forms.in.gov\/Download.aspx?id=5082\" target=\"_blank\">Confidential Report of Communicable Diseases<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">ELR: (317) 233-7684 or ijameson@isdh.in.gov<br \/> <br \/>Fax: (317) 233-7747\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"CDC requires every COVID-19 testing site to report every diagnostic and screening test performed to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (e.g., molecular, antigen, antibody) to the appropriate state or local public health department, based on the individual\u2019s residence. All testing sites must report diagnostics and screening tests within 24 hours of test completion to the appropriate state or local public health department.\" Their guidance suggest three reporting methods: ELR, REDCap, and Fax. Examine <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.coronavirus.in.gov\/files\/COVID-19%20Reporting%20Methods%2010.19.20.pdf\" target=\"_blank\">the guidance<\/a> for further information.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/idph.iowa.gov\/cade\/idss\" target=\"_blank\">Iowa<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">None\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">ELR: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/idph.iowa.gov\/cade\/idss\" target=\"_blank\">Jill Newland<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"All Iowa health care providers and public, private, and hospital laboratories are <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/idph.iowa.gov\/Portals\/1\/userfiles\/61\/covid19\/Mandatory%20Reporting%20Order.pdf\" target=\"_blank\">required<\/a> to immediately report all positive and negative SARS-CoV-2 testing results to the department. Immediate reporting is defined as reporting within one day of the test being performed, a standard utilized by the department since its initial March 19, 2020, Mandatory Reporting Order. Reports must be made electronically through the Iowa Disease Surveillance System (IDSS) or other electronic means as directed by the department.\"\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.kdheks.gov\/epi\/covid_reporting.htm\" target=\"_blank\">Kansas<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N (?)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/diseasereporting.kdhe.ks.gov\/\" target=\"_blank\">Kansas Reportable Disease Portal<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Phone: (877) 427-7317<br \/> <br \/>Fax: (877) 427-7318<br \/> <br \/>ELR: kdhe.epitraxadmin@ks.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"Report antigen or PCR point of care results, positive and negative, directly to KDHE via the Kansas Reportable Disease Portal <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/diseasereporting.kdhe.ks.gov\/\" target=\"_blank\">https:\/\/diseasereporting.kdhe.ks.gov\/<\/a> within 24 hours ... For facilities that do not perform point of care antigen or PCR testing, for antigen or PCR testing done through a reference laboratory or in-hospital laboratory, your facility does not need to report result to KDHE. The laboratory conducting the SARS-CoV-2 test is required to report results to KDHE.\" Faxing forms appears to be discouraged: \"Clinics\/hospital systems: if possible, please modify electronic health record systems to cease sending notifiable disease forms to KDHE via email and fax. If your facility uses Epic for its electronic medical records, you may be able to submit reports to KDHE automatically.\"\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/khie.ky.gov\/COVID-19\/Pages\/Reporting-Requirements-COVID-19.aspx\" target=\"_blank\">Kentucky<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">None\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Email: COVIDKYLAB@ky.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"If you are a healthcare organization resulting any type of COVID-19 test, you are required to report both positive and negative results to the Kentucky Department for Public Health (KDPH) ... If you are resulting labs at your facility, KDPH requires you to report results through <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/khie.ky.gov\/Pages\/index.aspx\" target=\"_blank\">Kentucky Health Information Exchange (KHIE)<\/a>, either electronically through an interface connection or by manually entering results. If you are not currently electronically connected to KHIE, you must manually report these results through KHIE's Direct Data Entry (Lab) feature located in the ePartnerViewer ... You are required to report all positive results within 24 hours of resulting ... You are required to report all negative results within 7 days of resulting.\"\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/ldh.la.gov\/index.cfm\/page\/1013\" target=\"_blank\">Louisiana<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">None\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Phone: (504) 568-8295<br \/> <br \/>ELR: elr@la.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"All facilities performing testing for COVID-19\/SARS-CoV-2 are required to report all COVID-19\/SARS-CoV-2 results to LDH. This includes rapid testing, point-of-care testing, antibody testing, or any other testing performed for COVID-19. Electronic laboratory reporting (ELR) in HL7 or CSV format is the preferred mechanism for reporting results ... Note: COVID-19 test results sent via ELR should include all results of testing (i.e., positive, negative, indeterminate, etc.).\" Also, if you do not have ELR set up or for some reason can't report electronically: \"The ELR team will work with you to set up ELR or an alternative reporting method.\"\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.maine.gov\/dhhs\/mecdc\/infectious-disease\/epi\/disease-reporting\/index.shtml\" target=\"_blank\">Maine<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N (?)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">None\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Phone: 800-821-5821<br \/> <br \/>Email: disease.reporting@maine.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">A February 2021 update to the state's Control of Notifiable Conditions and Notifiable Conditions List mandates that health care providers and labs must report COVID-19 test results. It mandates that \"[l]aboratory reporting must be done electronically through HL7 messaging as specified in this subsection. Electronic reporting required for laboratories is in addition to other reporting requirements specified in this rule.\" Consult the \"New Rules for the Control of Notifiable Conditions\" PDF on the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.maine.gov\/dhhs\/mecdc\/infectious-disease\/epi\/disease-reporting\/index.shtml\" target=\"_blank\">disease reporting<\/a> page for details. It appears COVID-19 should no longer be reported by fax.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/phpa.health.maryland.gov\/Pages\/what-to-report.aspx\" target=\"_blank\">Maryland<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N (?)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.maryland.gov\/phpa\/Documents\/DHMH-1281.pdf\" target=\"_blank\">Confidential Report: Laboratory Evidence of Certain Communicable Diseases<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.maryland.gov\/Pages\/departments.ASPX\" target=\"_blank\">Local health department<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">The only reporting requirement to be found are in a PDF, item <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.maryland.gov\/phpa\/Documents\/2020100101_MDH%20Order_Amended%20Various_Health_Care_Matters_Order%20POC2.pdf\" target=\"_blank\">No. MDH 2020-10-01-01<\/a>, which largely addresses point-of-care testing. Presumably this extends to other types of testing, but it's not clear what other types of testing. It mentions that \"[p]ositive, negative, and inconclusive point of care test results shall be reported.\" The document goes on to explain that electronic reporting is preferred, especially for those labs that are already set up to so do so. Some other electronic format like a CSV file is next preferred, and then, \"[i]f the results cannot be sent by HL-7 format or another approved electronic format, they must be immediately submitted to the appropriate local health officer in a manner designated by MDH.\"\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mass.gov\/lists\/infectious-disease-reporting-and-regulations-for-health-care-providers-and-laboratories\" target=\"_blank\">Massachusetts<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No standardized COVID-19 reporting form\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.naccho.org\/membership\/lhd-directory?searchType=standard&lhd-state=MA#card-filter\" target=\"_blank\">Local health departments<\/a><br \/> <br \/>MDPH phone: (617) 983-6800<br \/> <br \/>MDPH fax: (617) 983-6813\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">The State of Massachusetts doesn't appear to have published any collection of information about specific COVID-19 reporting requirements. The state is <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mass.gov\/doc\/list-of-diseases-reportable-by-healthcare-providers\/download\" target=\"_blank\">presumably<\/a> treating COVID-19 \"suspected and confirmed cases\" as an immediately reportable event that \"should be reported to your local board of health\" by phone, or if unavailable, to the Massachusetts Department of Public Health by phone or fax. The MDPH disease reporting web page makes no mention of ELR.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.michigan.gov\/mdhhs\/0,5885,7-339-71550_5104_53072---,00.html\" target=\"_blank\">Michigan<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No standardized COVID-19 reporting form\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">MDSS: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.michigan.gov\/documents\/MDSS_Support_Resources_87777_7.pdf\" target=\"_blank\">Support contacts<\/a><br \/> <br \/>Contact: Local health department list in reporting guide\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">The Michigan Department of Health & Human Services has updated its <i><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.michigan.gov\/documents\/mdhhs\/MDHHS_Brick_Book_609755_7.pdf\" target=\"_blank\">Health Care Professional's Guide to Disease Reporting in Michigan<\/a><\/i> to include detections of SARS-CoV-2. They note that \"if the agent is identified by clinical or laboratory diagnosis,\" the detection (by both healthcare providers and laboratories) \"must be reported to the Michigan Disease Surveillance System (MDSS) or local health department within 24 hours.\" As for how: \"Mandatory reporting of communicable diseases can (and, whenever possible, should) be accomplished via the MDSS. The MDSS is a web-based communicable disease reporting system developed for the state of Michigan.\" If unable to electronically report, contact the local health department using the directory in the disease reporting guide.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.health.state.mn.us\/diseases\/coronavirus\/hcp\/report.html\" target=\"_blank\">Minnesota<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.health.state.mn.us\/diseases\/coronavirus\/hcp\/covidreportform.pdf\" target=\"_blank\">COVID-19 Case Report Form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Fax: (651) 201-5743<br \/> <br \/>Phone: (651) 201-5414 or (877) 676-5414<br \/> <br \/>ELR: health.ELRmeaningfuluse@state.mn.us\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"The Minnesota Department of Health (MDH) is requiring all mandated reporters to report any cases and deaths due to SARS-CoV-2 to MDH within one working day.\" This includes health care facilities, medical laboratories, and in special cases veterinary laboratories. Case report forms can be faxed or case reports submitted by phone. On a <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.health.state.mn.us\/diseases\/coronavirus\/hcp\/reportlab.html\" target=\"_blank\">separate page discussing laboratories<\/a>, the DoH further discusses ELR. Read that for more details.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/msdh.ms.gov\/msdhsite\/_static\/14,0,194.html\" target=\"_blank\">Mississippi<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y (?)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/msdh.ms.gov\/msdhsite\/_static\/resources\/5072.pdf\" target=\"_blank\">Reportable Diseases and Conditions form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Phone: (601) 576-7725 or 1-800-556-0003; for weekends, holidays and after 5pm: (601) 576-7400; Email: clia-msdh@msdh.ms.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">The Mississippi State Department of Health <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/msdh.ms.gov\/msdhsite\/_static\/14,21911,420,874.html\" target=\"_blank\">states<\/a>: \"All COVID-19 results must be reported to the Mississippi State Department of Health at this time.\" However, it gives no further guidance specifically for commercial laboratories or health care providers testing for SARS-CoV-2. Presumably the MSDH is considering COVID-19 a Class 1A disease, <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/msdh.ms.gov\/msdhsite\/_static\/resources\/1719.pdf\" target=\"_blank\">required<\/a> to be \"reported directly to the Department of Health by telephone within 24 hours of first knowledge or suspicion.\" The MSDH also has an <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/msdh.ms.gov\/msdhsite\/_static\/14,0,194.html\" target=\"_blank\">online disease reporting tool<\/a> (account required); however, it's not clear if it is equipped to received COVID-19 reports.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.mo.gov\/living\/healthcondiseases\/communicable\/novel-coronavirus\/how-to-report-lab-results.php\" target=\"_blank\">Missouri<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.mo.gov\/living\/healthcondiseases\/communicable\/novel-coronavirus\/xls\/lab-result-reporting-template.xlsx\" target=\"_blank\">sFTP Excel template<\/a><br \/> <br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.mo.gov\/living\/healthcondiseases\/communicable\/communicabledisease\/cdmanual\/pdf\/CD-1.pdf\" target=\"_blank\">Disease Case Report form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">sFTP: (573) 526-5271<br \/> <br \/>Fax: (573) 751-6417<br \/> <br \/>ELR: ELR@health.mo.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">The Missouri Department of Health and Senior Services has officially added COVID-19 to its list of immediately reportable conditions, including a waiver \"to require that all positive and negative results for COVID-19 are sent directly to DHSS. Now, all laboratories must report directly to DHSS.\" They add that \"[l]aboratories are encouraged to report via electronic means.\" Alternatively, labs may also submit a report to the Bureau of Reportable Disease Informatics (BRDI) via fax. \"[M]edical providers (non-laboratories) also have an obligation to submit disease case reports (form CD-1) to DHSS. However, under the current suspension, providers do not have to report negative results if those results are being reported by an outside lab. Providers are expected to submit a case report on any non-negative results as the additional information on the case report is required for public health intervention.\"\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dphhs.mt.gov\/publichealth\/cdepi\/reporting\" target=\"_blank\">Montana<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y (?)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No standardized COVID-19 reporting form\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dphhs.mt.gov\/publichealth\/FCSS\/countytribalhealthdepts\" target=\"_blank\">Local health department<\/a><br \/> <br \/>DPHHS phone: (406) 444-0273\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">The Montana Department of Public Health and Human Services doesn't appear to have published any information about specific COVID-19 reporting requirements. The state is <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dphhs.mt.gov\/assets\/publichealth\/CDEpi\/DiseaseReporting\/lhjreportablediseaselistdec2019dphhs.pdf\" target=\"_blank\">presumably<\/a> treating COVID-19 like its other reportable diseases: \"whether suspected or confirmed\" the case \"must be reported immediately to your local health jurisdiction as required by the Administrative Rules of Montana.\" If the local public health jurisdiction is unavailable, a call can be placed to the MDPHHS. It is not clear if laboratories should report both positive and negative results, though <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.kpax.com\/news\/coronavirus\/covid-19-cases-in-montana-rise-to-9\" target=\"_blank\">news reports<\/a> have shown that the DPHHS is reporting both positive and negatives. The disease reporting web page makes no mention of ELR.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dhhs.ne.gov\/Pages\/Disease-Reporting.aspx\" target=\"_blank\">Nebraska<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dhhs.ne.gov\/epi%20docs\/ReportableDiseaseCaseReportForm.pdf\" target=\"_blank\">Health Care Provider Confidential Communication form<\/a><br \/> <br \/><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dhhs.ne.gov\/epi%20docs\/ReportableDiseaseLabForm.pdf\" target=\"_blank\">Laboratory Summary of Reportable Diseases, Poisonings and Organisms<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Phone: <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dhhs.ne.gov\/Pages\/Disease-Reporting.aspx\" target=\"_blank\">Based on county<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">The Nebraska Department of Health and Human Services provides little in the way of specific guidance for reporting COVID-19. They simply <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dhhs.ne.gov\/han%20Documents\/UPDATE03132020.pdf\" target=\"_blank\">state<\/a>: \"Any patient (+) for COVID-19 virus should be immediately reported to local\/state public health office.\" They define \"immediate notification\" as \"required to call by telephone to a live public health surveillance official within 24 hours of detection.\" This apparently includes providers currently on ELR. Labs and healthcare providers should verify if any additional reporting (fax, ELR) is required. As the pandemic has progressed, reporting transparency and requirements have also changed, <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20210803232240\/https:\/\/journalstar.com\/lifestyles\/health-med-fit\/health\/nebraskas-reporting-of-covid-19-data-takes-another-hit\/article_14443b64-fe19-5516-b46e-a125920fa4ae.html\" target=\"_blank\">becoming more controversial<\/a>; contact your local health department for the latest requirements.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dpbh.nv.gov\/Programs\/OPHIE\/Public_Health_Informatics_and_Epidemiology_-_Home\/\" target=\"_blank\">Nevada<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dpbh.nv.gov\/Programs\/OPHIE\/Docs\/Updated_Morbidity_Form_-_BP_4_2016\/\" target=\"_blank\">Confidential Disease Reporting Form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: Local health department list in reporting form\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Nevada DHHS guidance <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nvhealthresponse.nv.gov\/wp-content\/uploads\/2020\/06\/6.24.2020_COVID-19-Laboratory-Test-Reporting-Technical-BulletinUPDATED.pdf\" target=\"_blank\">states<\/a> \"all in-state and out-of-state laboratories who are processing and testing samples from Nevada residents are required under severe penalties to report all COVID-19 test results to the Division of Public and Behavioral Health within 24 hours from analysis.\" Its guidance appears to suggest a phone call for such notification. According to the state's <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dpbh.nv.gov\/Programs\/OPHIE\/Docs\/Updated_Morbidity_Form_-_BP_4_2016\/\" target=\"_blank\">disease reporting form<\/a>, this phone call should be done in addition to faxing a report. \"All cases, suspect cases, and carriers\n<p>must be reported within 24 hours.\" It's not clear if ELR is being accepted for COVID-19 reporting.\n<\/p>\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dhhs.nh.gov\/dphs\/cdcs\/forms.htm\" target=\"_blank\">New Hampshire<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dhhs.nh.gov\/dphs\/cdcs\/covid19\/covid19-reporting-form.pdf\" target=\"_blank\">COVID-19 Case Report Form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Phone: (603) 271-4496<br \/> <br \/>Fax: (603) 271-0545\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Health care providers and laboratories should immediately report suspect and confirmed cases of COVID-19 to the New Hampshire Department of Health and Human Services. It seems likely the DPHHS prefers both a phone call and a faxed report, though it's not explicitly stated. The case should likely be \"reported within 24 hours of diagnosis or suspicion of diagnosis.\" The NHDHHS disease reporting web page makes no mention of ELR. An online test result reporting form is available, per the state's <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.covid19.nh.gov\/resources\/general-provider-covid-19-resources-and-information\" target=\"_blank\">General Provider COVID-19 Resources page<\/a>.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nj.gov\/health\/cd\/reporting\/\" target=\"_blank\">New Jersey<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N (?)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No standardized COVID-19 reporting form\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">ELR: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdrs.doh.state.nj.us\/cdrss\/login\/loginPage\" target=\"_blank\">See quick-start guide<\/a><br \/> <br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nj.gov\/health\/cd\/reporting\/index.shtml\" target=\"_blank\">Local health departments<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"[T]he New Jersey Domestic Security Preparedness Task Force <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nj.gov\/governor\/news\/news\/562020\/approved\/20200323c.shtml\" target=\"_blank\">hereby directs<\/a> that commercial laboratories operating in New Jersey report all COVID-19 test results to the New Jersey Department of Health beginning March 23, 2020. The results of all COVID-19 tests performed before this date shall be included in the initial report. Subsequently, results shall be sent daily, and included results not previously reported. Information shall be transmitted no later than 8:00 p.m. each day through the Department of Health\u2019s CDRSS platform. Specific data reported shall include positive, negative, and inconclusive test results. This directive shall supplement, not supplant, any other existing reporting requirements.\" From that statement, it's not clear if laboratories should also be immediately phoning their results to the health department in addition to ELR over CDRSS.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nmhealth.org\/about\/erd\/ideb\/ids\/\" target=\"_blank\">New Mexico<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y (?)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nmhealth.org\/publication\/view\/form\/3288\/\" target=\"_blank\">Notifiable Condition Report Form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Phone: (505) 827-0006<br \/> <br \/>Fax: (505) 827-0013\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">The New Mexico Department of Health doesn't appear to have published any information about specific COVID-19 reporting requirements. The DoH is <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nmhealth.org\/publication\/view\/policy\/372\/\" target=\"_blank\">presumably<\/a> treating \"confirmed or suspected\" COVID-19 cases as an immediately reportable event that \"require immediate reporting by telephone to Epidemiology and Response Division.\" It's not clear if a faxed report is also required. The DoH disease reporting web page makes no mention of ELR.\n<\/td><\/tr>\n\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.health.ny.gov\/professionals\/diseases\/reporting\/communicable\/\" target=\"_blank\">New York<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.health.ny.gov\/forms\/doh-389.pdf\" target=\"_blank\">Confidential Case Report - DOH-389<\/a><br \/> <br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www1.nyc.gov\/assets\/doh\/downloads\/pdf\/hcp\/urf-0803.pdf\" target=\"_blank\">Universal Reporting Form - PD-16<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nysacho.org\/directory\/\" target=\"_blank\">Local health departments<\/a><br \/> <br \/>ECLRS: eclrs@health.ny.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">The New York Department of Health <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.health.ny.gov\/system\/files\/documents\/2020\/04\/doh_covid19_privatepracticesamplingsites_041920.pdf\" target=\"_blank\">states<\/a>: \"Positive results must be immediately reported to the local Department of Health by the laboratory performing the test, per established guidance, and all test results should be reported by the laboratories into New York State Department of Health\u2019s Electronic Clinical Laboratory Reporting System (ECLRS) four times a day.\" The established guidance appears to be found in the state's <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.ny.gov\/forms\/instructions\/doh-389_instructions.pdf\" target=\"_blank\">updated reporting instructions<\/a>, which now includes COVID-19 as a disease that \"should be reported immediately to local health departments by phone followed by submission of the confidential case report form (DOH-389). In NYC use case report form PD-16.\" This means \"within 24 hours of diagnosis.\" The instructions indicate case reports should be mailed. Both health care facilities and laboratories should report.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/epi.dph.ncdhhs.gov\/cd\/report.html\" target=\"_blank\">North Carolina<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/epi.dph.ncdhhs.gov\/cd\/lhds\/manuals\/cd\/reportforms\/COVID19_part2.pdf\" target=\"_blank\">COVID-19 Confidential Communicable Disease Report<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ncalhd.org\/directors\/\" target=\"_blank\">Local health departments<\/a><br \/> <br \/>Fax: (919) 733-0490\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Per NCDHHS's clinical diagnostic <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/slph.ncpublichealth.com\/bioterrorism\/2019-ncov.asp\" target=\"_blank\">laboratory guidance<\/a>: \"each person in charge of a laboratory providing diagnostic service in this State and any other health care provider licensed in this State that provides diagnostic service [is required] to report the results of all COVID-19 testing to the Department of Health and Human Services.\" An <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/slph.ncpublichealth.com\/doc\/NCCOVID-19LabDataAutomation-CLDA-ProcessIntroduction.pdf\" target=\"_blank\">electronic reporting process<\/a> appears to have been added later in 2020.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/odh.ohio.gov\/wps\/portal\/gov\/odh\/know-our-programs\/infectious-diseases\/infectious-diseases\" target=\"_blank\">Ohio<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/odh.ohio.gov\/wps\/wcm\/connect\/gov\/8a5539e9-f823-480d-a2c7-a30e80c33d62\/form-confidential-reportable-disease.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=ROOTWORKSPACE.Z18_M1HGGIK0N0JO00QO9DDDDM3000-8a5539e9-f823-480d-a2c7-a30e80c33d62-mR0PC0i\" target=\"_blank\">Ohio Confidential Reportable Disease form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/odh.ohio.gov\/wps\/portal\/gov\/odh\/find-local-health-districts\" target=\"_blank\">Local health districts<\/a><br \/> <br \/>ELR: ELR@odh.ohio.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">In March 2020, the Ohio Department of Health <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/coronavirus.ohio.gov\/wps\/wcm\/connect\/gov\/b2581867-6e9d-433a-9eb6-1174eee07276\/Director%27s+Journal+Entry+on+Updated+COVID-19+Reporting+Requirements.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=ROOTWORKSPACE.Z18_M1HGGIK0N0JO00QO9DDDDM3000-b2581867-6e9d-433a-9eb6-1174eee07276-n5829m-\" target=\"_blank\">ordered<\/a> \"confirmed cases of COVID-19 be reported immediately as a Class A disease pursuant to Ohio Adm. Code 3701-3-02(A) to the local health district in which the person resides (or the local health district wherein the person is being medically evaluated if the person's residence is unknown or not in Ohio).\" Physicians, medical care facilities, and laboratories are encouraged to report positive cases. Per the state's <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/odh.ohio.gov\/wps\/wcm\/connect\/gov\/84ffece4-16f1-4602-9b93-7ce4eeb34680\/section-1-reporting.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=ROOTWORKSPACE.Z18_M1HGGIK0N0JO00QO9DDDDM3000-84ffece4-16f1-4602-9b93-7ce4eeb34680-mI9Bggz\" target=\"_blank\">communicable disease requirements<\/a>, Class A diseases should be reported immediately by phone, with a follow-up HEA 3334 Ohio Confidential Reportable Disease form. That requirements doc also states \"follow-up reports can also be made electronically through direct entry into the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/odh.ohio.gov\/wps\/portal\/gov\/odh\/know-our-programs\/ohio-disease-reporting-system\/ohio-disease-reporting-system\" target=\"_blank\">Ohio Disease Reporting System<\/a> (ODRS) or through <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/odh.ohio.gov\/wps\/portal\/gov\/odh\/know-our-programs\/electronic-laboratory-reporting\/electronic-laboratory-reporting\" target=\"_blank\">Electronic Laboratory Reporting<\/a>.\"\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/oklahoma.gov\/health\/prevention-and-preparedness\/acute-disease-service\/disease-reporting\/how-to-report.html\" target=\"_blank\">Oklahoma<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ok.gov\/health2\/documents\/Reportable%20Condition%20Poster%20Blue%20Card%202018.pdf\" target=\"_blank\">Reportable Disease Card for Healthcare Providers (Blue Card)<\/a><br \/> <br \/><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ok.gov\/health2\/documents\/Reportable%20Pathogen%20Poster%20Yellow%20Card%202018.pdf\" target=\"_blank\">Reportable Disease Card for Laboratories (Yellow Card)<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">PHIDDO: adservice@health.ok.gov<br \/> <br \/>Phone: (405) 271-4060<br \/>Fax: (405) 271-6680<br \/> <br \/>ELR: AnthonyL@health.ok.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">According the DoH's <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/oklahoma.gov\/health\/prevention-and-preparedness\/acute-disease-service\/disease-reporting\/how-to-report.html\" target=\"_blank\">COVID-19 reporting page<\/a>, COVID-19 cases should optimally be reported by some digital means (HL7, manually entered CSV, exported CSV from information system). The DoH is <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ok.gov\/health2\/documents\/Updated%20--%20Reportable%20Pathogen%20Poster%202019.pdf\" target=\"_blank\">presumably<\/a> treating \"laboratory results indicating\" (i.e., \"upon suspicion, diagnosis, or positive test\") COVID-19 as an immediately reportable event. This also holds true for healthcare providers. The Public Health Investigation and Disease Detection of Oklahoma (PHIDDO) system is apparently the preferred method.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oregon.gov\/oha\/PH\/DISEASESCONDITIONS\/COMMUNICABLEDISEASE\/REPORTINGCOMMUNICABLEDISEASE\/Pages\/index.aspx\" target=\"_blank\">Oregon<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oregon.gov\/oha\/PH\/DISEASESCONDITIONS\/COMMUNICABLEDISEASE\/REPORTINGCOMMUNICABLEDISEASE\/Pages\/counties.aspx\" target=\"_blank\">COVID-19 Report Form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oregon.gov\/OHA\/PH\/ProviderPartnerResources\/LocalHealthDepartmentResources\/Pages\/lhd.aspx\" target=\"_blank\">Local public health authority<\/a><br \/> <br \/>Fax: (971) 673-1100<br \/> <br \/>Oregon COVID-19 Reporting Portal or ELR: (971) 673-1111\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"The Oregon Health Authority (OHA), Public Health Division, is <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oregon.gov\/oha\/PH\/DISEASESCONDITIONS\/COMMUNICABLEDISEASE\/REPORTINGCOMMUNICABLEDISEASE\/Pages\/rules.aspx\" target=\"_blank\">temporarily adopting<\/a> OAR 333-017-0800 and OAR 333-018-900, which add a definition of COVID-19 and adds COVID-19 to the list of diseases reportable to public health authorities within 24 hours. Positive test results for COVID-19 must be reported within 24 hours and negative COVID-19 results within one working day.\" \"Both medical laboratories and health care providers are <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/sharedsystems.dhsoha.state.or.us\/DHSForms\/Served\/le2290.pdf\" target=\"_blank\">required<\/a> to report COVID-19 test results to the state and local public health authorities.\" According to <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/secure.sos.state.or.us\/oard\/displayDivisionRules.action?selectedDivision=1233\" target=\"_blank\">state law<\/a>, reports should be initially submitted by phone call, with a follow-up report either through the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oregon.gov\/oha\/PH\/DISEASESCONDITIONS\/COMMUNICABLEDISEASE\/REPORTINGCOMMUNICABLEDISEASE\/Pages\/counties.aspx\" target=\"_blank\">Oregon COVID-19 Reporting Portal<\/a> or a fax. ELR is <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oregon.gov\/oha\/PH\/DISEASESCONDITIONS\/COMMUNICABLEDISEASE\/REPORTINGCOMMUNICABLEDISEASE\/ELECTRONICLABREPORTING\/Pages\/index.aspx\" target=\"_blank\">also an option<\/a>.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.health.pa.gov\/topics\/Reporting-Registries\/Pages\/Reporting-Registries.aspx\" target=\"_blank\">Pennsylvania<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No standardized COVID-19 reporting form (use PA-NEDDS)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">PA-NEDSS: 1-877-724-3258\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.health.pa.gov\/topics\/Documents\/HAN\/2020-PAHAN-531-10-8-ADV-COVID_labrep.pdf\" target=\"_blank\">From<\/a> the Pennsylvania Department of Health: \"All entities conducting testing to identify SARS-CoV-2, the virus that causes COVID-19, are required to report positive, inconclusive\/indeterminate, and negative results to PA-NEDSS within 24 hours of test completion. PA-NEDSS is a secure, web-based system used in Pennsylvania for disease reporting and surveillance.\"\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.ri.gov\/diseases\/about\/reporting\/\" target=\"_blank\">Rhode Island<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">None\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Phone: (401) 222-2577 or (401) 276-8046 after hours<br \/> <br \/>Fax: (401) 222-2488\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/covid.ri.gov\/healthcare-professionals\/healthcare-providers\" target=\"_blank\">Per<\/a> the Rhode Island Department of Health: \"For reporting positive results from testing you have ordered and sent out through a laboratory system, report positive results only.\" You may report by secure email or fax. \"For reporting point-of-care and rapid test results performed at your site, report all positive and negative results.\" Note the specific email addresses depending on the test type. ELR is not mentioned.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.scdhec.gov\/health-professionals\/south-carolina-list-reportable-conditions\" target=\"_blank\">South Carolina<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y (?)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No standardized COVID-19 reporting form\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/scdhec.gov\/sites\/default\/files\/Library\/CR-009025.pdf\" target=\"_blank\">Local public health office<\/a><br \/> <br \/>ELR: MUHELPDESK@dhec.sc.gov or SCIONHELP@dhec.sc.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/scdhec.gov\/covid19\/guidance-healthcare-professionals-covid-19\/physicians-frequently-asked-questions-covid\" target=\"_blank\">Per<\/a> the South Carolina Department of Health and Environmental Control: \"Please notify DHEC of positive results. COVID-19 cases and deaths are urgently reportable per the South Carolina List of Reportable Conditions. They must be reported by phone within 24 hours to the appropriate regional health department.\" <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/scdhec.gov\/sites\/default\/files\/media\/document\/10472-DHU-08-29-2020-COVID-19.pdf\" target=\"_blank\">Supplemental guidance<\/a>: \"Positive and negative test results for COVID-19 must be reported to DHEC urgently within 24 hours by all entities performing testing, including testing at point-of-care or at-home specimen collections processed by laboratories.\" That guidance adds: \"Facilities that are not already submitting results via Electronic Lab Reporting (ELR) or DHEC's secure reporting portal (SCIONx) should contact MUHELPDESK@dhec.sc.gov to inquire about ELR submission, or SCIONHELP@dhec.sc.gov to inquire about other reporting options.\"\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/doh.sd.gov\/diseases\/infectious\/Reporting.aspx\" target=\"_blank\">South Dakota<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/sd.gov\/diseasereport\" target=\"_blank\">South Dakota Confidential Disease Report<\/a> (online\/HTML)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Phone: (605) 773-3737 or 800-592-1861<br \/> <br \/>Fax: (605) 773-5509\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"SD-DOH would like to <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/doh.sd.gov\/COVID\/Providers\/\" target=\"_blank\">remind<\/a> medical providers, hospitals, and laboratories that cases of COVID-19, caused by the SARS-CoV-2 virus, are considered immediately reportable in South Dakota (under Coronavirus Respiratory syndromes).\" The SD-DOH and the state laws don't make clear what reporting method is best for Category I diseases, only that they should be reported immediately. Under \"how to report,\" they list, in order, <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/sd.gov\/diseasereport\" target=\"_blank\">online reporting<\/a>, phone, fax, and mail. The SD-DOH disease reporting web page makes no mention of ELR.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.tn.gov\/content\/dam\/tn\/health\/documents\/cedep\/novel-coronavirus\/CaseReportingGuidance.pdf\" target=\"_blank\">Tennessee<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.tn.gov\/content\/dam\/tn\/health\/documents\/reportable-diseases\/PH-1600.pdf\" target=\"_blank\">PH-1600 Case Report Form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Fax: (615) 741-3857<br \/> <br \/>Phone: (615) 741-7247<br \/> <br \/>ELR: ceds.informatics@tn.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"Healthcare providers who receive positive COVID-19 test results on their patients or patients in their facility [should report].\" \"Laboratories performing COVID-19 testing should be reporting these results electronically via ELR or our emergency spreadsheet template. If you are a laboratory that needs to report via one of these methods, please email ceds.informatics@tn.gov.\" These entities \"should report within 24 hours of receiving a COVID-19 diagnosis, positive lab report on a patient, and\/or becoming aware of a suspected or confirmed COVID-19 associated death.\" Please submit a case report by filling out the PH-1600 form on all NAAT, PCR and antigen positive COVID-19 test results from facility or commercial labs (this includes any NAAT, PCR or antigen positive patients tested via Point of Care testing); you do not need to submit further information on a lab result from the TDH Public Health Laboratory.\" The Tennessee Department of Health lists two reporting options: faxing the PH-1600 form and positive lab report or sending it electronically (via <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/hssi.tn.gov\/auth\/login\" target=\"_blank\">Morbidity Report<\/a> or ELR).\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dshs.texas.gov\/idcu\/investigation\/conditions\/\" target=\"_blank\">Texas<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dshs.texas.gov\/IDCU\/investigation\/Reporting-forms\/2017-EPI-2.pdf\" target=\"_blank\">Infectious Disease Report<\/a> (Single case)<br \/> <br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dshs.texas.gov\/IDCU\/investigation\/Reporting-forms\/EPI-1-2017.pdf\" target=\"_blank\">Infectious Disease Report<\/a> (Multiple cases)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dshs.texas.gov\/idcu\/investigation\/conditions\/contacts\/\" target=\"_blank\">Local health department<\/a><br \/> <br \/>ELR: COVID\u201119ELR@dshs.texas.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"On July 29, 2021, Governor Greg Abbott <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dshs.texas.gov\/coronavirus\/labs.aspx\" target=\"_blank\">ordered<\/a> every public or private entity that is utilizing an FDA-approved test, including an emergency use authorization test, for human diagnostic purposes of COVID-19, shall continue to submit to DSHS, as well as to the local health department, daily reports of all test results.\" This <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dshs.texas.gov\/coronavirus\/lab-reporting.aspx\" target=\"_blank\">includes<\/a> positive, negative, and indeterminate results. \"To comply with the Governor\u2019s orders, DSHS is expediting an alternative method of accepting specific CSV formatted files for submitters who are unable to submit via HL7 format.\" ELR registration can be <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dshs.texas.gov\/coronavirus\/forms\/registerlab.aspx\" target=\"_blank\">performed online<\/a>.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/epi.health.utah.gov\/disease-reporting\/\" target=\"_blank\">Utah<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/health.utah.gov\/epi\/reporting\/UDOH_CMR.pdf\" target=\"_blank\">Utah Public Health Confidential Morbidity Report<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Fax: (801) 538-9923<br \/> <br \/>Email: reporting@utah.gov<br \/> <br \/>Phone: 1-888-EPI-UTAH<br \/> <br \/>ELR: edx@utah.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">The Utah Department of Health added COVID-19 to its reportable conditions in May 2020 for both manual and electronic reporters. \"All test results <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/epi.health.utah.gov\/wp-content\/uploads\/2021\/04\/Reporting-Specifications-Electronic-1.4.pdf\" target=\"_blank\">are reportable<\/a>. This includes positive\/reactive, indeterminate, equivocal, and negative\/non-reactive.\" \"Electronic reporters <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/epi.health.utah.gov\/wp-content\/uploads\/2019\/08\/CD_Rule_Overview.pdf\" target=\"_blank\">must report<\/a> laboratory results within 24 hours of finalization. Manual reporters must report immediately notifiable conditions within 24 hours of identification and standard notifiable conditions within three business days of identification.\" Details on ELR are limited, though an ELR guide for hospitals can be <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.utah.gov\/phaccess\/public\/elr\/stage3.php\" target=\"_blank\">found here<\/a>.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthvermont.gov\/disease-control\/disease-reporting\/lab-result-reporting\" target=\"_blank\">Vermont<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y (?)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No standardized COVID-19 reporting form\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Phone: (802) 863-7240<br \/> <br \/>Fax: (802) 951-4061<br \/> <br \/>ELR: (802) 651-1619 or AHS.VDHELRSupport@vermont.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">The Vermont Department of Health <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthvermont.gov\/disease-control\/disease-reporting\/lab-result-reporting#requirements\" target=\"_blank\">states<\/a>: \"All COVID-19 results (positive, negative, etc.) are required to be reported to the Vermont Department of Health within 24 hours of test report completion\" Its April 2021 guidance adds: \"The report shall be made by telephone, in writing, or electronically to the Department of Health, Epidemiology Program.\" Additional details can be <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healthvermont.gov\/disease-control\/disease-reporting\/lab-result-reporting#requirements\" target=\"_blank\">found here<\/a>.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.vdh.virginia.gov\/epidemiology\/\" target=\"_blank\">Virginia<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">See portals linked below\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.vdh.virginia.gov\/local-health-districts\/\" target=\"_blank\">Local health department<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">The VDH <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.vdh.virginia.gov\/coronavirus\/health-professionals\/testing-laboratory-and-therapeutics\/\" target=\"_blank\">states<\/a>: \"All COVID-19 reports from clinicians or facilities based on point-of-care tests should be reported using the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/apps.vdh.virginia.gov\/POCreporting\" target=\"_blank\">VDH Point-of-Care<\/a> (POC) Portal, not the Confidential Morbidity Portal. For other reports not involving POC testing, healthcare providers should continue to report patients with suspected or confirmed COVID-19 through the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/redcap.vdh.virginia.gov\/redcap\/surveys\/?s=NYKYR7W47M\" target=\"_blank\">Confidential Morbidity Portal<\/a>.\" They add that \"[a]ll COVID-19 test results should be reported to VDH within 24 hours.\"\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.doh.wa.gov\/ForPublicHealthandHealthcareProviders\/NotifiableConditions\" target=\"_blank\">Washington<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">None\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.doh.wa.gov\/AboutUs\/PublicHealthSystem\/LocalHealthJurisdictions\" target=\"_blank\">Local health jurisdiction<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">The Washington State Department of Health has adopted several emergency rules to ensure reporting compliance. The DoH <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.doh.wa.gov\/Emergencies\/COVID19\/HealthcareProviders\/ReportingTestResults\" target=\"_blank\">notes<\/a>: \"Facilities administering point-of-care (POC) testing for COVID-19 must report all their COVID-19 testing results to the Washington State Department of Health.\" (See <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.doh.wa.gov\/Emergencies\/COVID19\/HealthcareProviders\/ReportingTestResults\/ReportingCOVID19TestResultsforPointofCareTestingFacilities\" target=\"_blank\">here<\/a> for more about POC reporting requirements.) \"Washington State (under WAC 246-101) requires laboratories to report all COVID-19 results (including positive, negative, inconclusive; and other results based on State Health Officer Letters) to the LHJ of the patient's residence. ELR, national flat file, and electronic case reporting options are available for labs.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/oeps.wv.gov\/reporting\/Pages\/default.aspx\" target=\"_blank\">West Virginia<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N (?)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dhhr.wv.gov\/COVID-19\/documents\/hcp\/covid19_report_form.pdf\" target=\"_blank\">2019 Novel Coronavirus (COVID-19) Case Report Form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dhhr.wv.gov\/localhealth\/pages\/map.aspx\" target=\"_blank\">Local health departments<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"Report <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/dhhr.wv.gov\/COVID-19\/Pages\/Provider-Resources.aspx\" target=\"_blank\">suspect or confirmed cases<\/a> immediately to the local health department by phone and follow up with written report.\" \"Providers and LHDs should submit this report to the Division of Infectious Disease Epidemiology by fax at 304-558-8736 for all cases of COVID-19.\" It's not clear if ELR is an acceptable form of reporting COVID-19 cases.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dhs.wisconsin.gov\/disease\/diseasereporting.htm\" target=\"_blank\">Wisconsin<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dhs.wisconsin.gov\/forms\/f02700.pdf\" target=\"_blank\">Wisconsin COVID-19 Patient Information F-02700<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: [hhttps:\/\/www.dhs.wisconsin.gov\/lh-depts\/counties.htm Local health department]<br \/> <br \/>WEDSS: DHSWEDSS@wisconsin.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"The state epidemiologist declared COVID-19 a Category I reportable disease per a memo issued on Feb. 4, 2020. Health care providers and laboratories must report confirmed or suspected cases to the Department of Health Services (DHS) within 24 hours of detection. To relieve the reporting burden, DHS waived the requirement (April 6 Memo) for notifying local health departments by telephone of suspected and confirmed cases as long as cases are reported to the Wisconsin Electronic Disease Surveillance System (WEDSS).\" Additional rules apply. See \"Reporting and surveillance guidance\" <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dhs.wisconsin.gov\/covid-19\/providers.htm\" target=\"_blank\">here<\/a>.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.wyo.gov\/publichealth\/infectious-disease-epidemiology-unit\/reporting\/\" target=\"_blank\">Wyoming<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.wyo.gov\/wp-content\/uploads\/2016\/04\/22-12940_FillinDiseaseReportForm_2012.pdf\" target=\"_blank\">Confidential Disease Report form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Phone: 1-888-996-9104<br \/> <br \/>Fax: (307) 777-5573\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"Providers and laboratories <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.wyo.gov\/wp-content\/uploads\/2020\/06\/COVID-19-Guidance-for-WPHL-website_06222020.pdf\" target=\"_blank\">must report<\/a> positive [SARS-CoV-2] laboratory tests from commercial reference laboratories to WDH by faxing copies of the laboratory report form to 307-777-5573.\" According to Wyoming's <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.wyo.gov\/wp-content\/uploads\/2020\/04\/2020ReportableListrevised-1.pdf\" target=\"_blank\">Reportable Diseases and Conditions List<\/a>, this faxed report would be in addition to immediate notification by phone. Additionally, \"[h]ospital and reference labs with ELR capacity must report positive and negative results,\" as well as viral detection and serology results. According to that document, COVID-19 isn't a disease preferred for ELR. Confirm with the health department.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable\" border=\"1\" cellpadding=\"5\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\" colspan=\"6\"><b>Table 2.<\/b> U.S. territory-based COVID-19 reporting requirements\n<\/td><\/tr>\n<tr>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Territory\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Electronic, including email? (Y\/N)\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Fax? (Y\/N)\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Forms for reporting\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Contact\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Additional details\n<\/th><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.americansamoa.gov\/\" target=\"_blank\">American Samoa<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N (?)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Can't locate the AMS COVID-19 Investigation Form\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.facebook.com\/pg\/asdoh.hotline\/about\" target=\"_blank\">Facebook page<\/a><br \/> <br \/>Phone: (684) 633-5871 or (684) 633-5872\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">According to <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/6fe16cc8-c42f-411f-9950-4abb1763c703.filesusr.com\/ugd\/4bfff9_8201b0412f8d4e9ea6f32116ee883b29.pdf\" target=\"_blank\">American Samoa's report<\/a> <i>Territory of American Samoa's Response and Action Plan to Combat the Cornoavirus Pandemic<\/i>, resources for testing are unfortunately thin. It makes mention that the American Samoa Department of Health should be notified \"immediately of probable or confirmed cases of COVID-19.\" It also mentions completing an \"AMS COVID-19 Investigation Form.\" \"If there is more than one case of novel coronavirus in a household, local area or facility, or an outbreak is suspects, notify Command Post immediately at (684) 633-5871 or (684) 633-5872.\"\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dphss.guam.gov\/covid-19\/\" target=\"_blank\">Guam<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y (?)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No standardized COVID-19 reporting form\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: Office of Epidemiology and Research - Phone: (671) 735-7289, Fax: (671) 734-2066\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">It's clear that Guam is having laboratories <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dphss.guam.gov\/covid-19\/\" target=\"_blank\">report cases<\/a> of COVID-19, but no reporting requirements for COVID-19 (or any other diseases) can be located on the Department of Public Health and Social Services website. Perhaps contact the Office of Epidemiology and Research for more information.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/governor.gov.mp\/covid-19\/\" target=\"_blank\">Northern Mariana Islands<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No standardized COVID-19 reporting form\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Contact: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.chcc.gov.mp\/laboratory.php\" target=\"_blank\">CHCC laboratory<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">The CNMI Department of Public Health <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/drive.google.com\/file\/d\/19Somy68fPQwTBIcBEiCYyZGo2tboeVgn\/view\" target=\"_blank\">has indicated<\/a> that laboratory testing has been primarily been performed by the Guam Public Health Laboratory, but due to them not being able to meet demand, the CNMI DPH will ship samples to Diagnostic Laboratory Services in Honolulu, Hawaii. Presumably those labs are responsible, in part, for reporting results back to the CNMI.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.salud.gov.pr\/CMS\/142\" target=\"_blank\">Puerto Rico<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Unknown\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Unknown\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Unknown\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Phone: (787) 765-2929<br \/> <br \/>Email: contactus@salud.pr.gov\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">The Departamento de Salud de Puerto Rico <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.salud.gov.pr\/CMS\/3\" target=\"_blank\">has<\/a> a relevant document <i>OA 440 Sobre la distribuci\u00f3n, manejo, administraci\u00f3n y reporte de los resultados de las pruebas de COVID-19<\/i> <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.salud.gov.pr\/CMS\/DOWNLOAD\/3836\" target=\"_blank\">concerning<\/a> reporting results.\n<\/td><\/tr>\n \n\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/doh.vi.gov\/programs\/epidemiology-disease-reporting\" target=\"_blank\">U.S. Virgin Islands<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Y\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/bit.ly\/epivi-surveillance\" target=\"_blank\">Notification of Infectious Disease Form<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Phone: (340) 626-1654<br \/> <br \/>Territorial fax: 1-888-400-8620\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"Make an IMMEDIATE telephone report to the USVI Department of Health at 626-1654 then send the completed\n<p>form IMMEDIATELY (within 24 hrs) by fax to 1-888-400-8620. If an immediate report is required after regular working hours, please call 626-1654.\" Additional COVID-19 information <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.covid19usvi.com\/\" target=\"_blank\">here<\/a>.\n<\/p>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-CDCWhatIs16-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCWhatIs16_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/careerpaths\/k12teacherroadmap\/epidemiology.html\" target=\"_blank\">\"What is Epidemiology?\"<\/a>. <i>Teacher Roadmap<\/i>. Centers for Disease Control and Prevention. 17 June 2016<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/careerpaths\/k12teacherroadmap\/epidemiology.html\" target=\"_blank\">https:\/\/www.cdc.gov\/careerpaths\/k12teacherroadmap\/epidemiology.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=What+is+Epidemiology%3F&rft.atitle=Teacher+Roadmap&rft.date=17+June+2016&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcareerpaths%2Fk12teacherroadmap%2Fepidemiology.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NaitoUtil14-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NaitoUtil14_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Naito, M. (2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4213216\" target=\"_blank\">\"Utilization and application of public health data in descriptive epidemiology\"<\/a>. <i>Journal of Epidemiology<\/i> <b>24<\/b> (6): 435\u20136. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.2188%2Fjea.je20140182\" target=\"_blank\">10.2188\/jea.je20140182<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4213216\/\" target=\"_blank\">PMC4213216<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/25327184\" target=\"_blank\">25327184<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4213216\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4213216<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Utilization+and+application+of+public+health+data+in+descriptive+epidemiology&rft.jtitle=Journal+of+Epidemiology&rft.aulast=Naito%2C+M.&rft.au=Naito%2C+M.&rft.date=2014&rft.volume=24&rft.issue=6&rft.pages=435%E2%80%936&rft_id=info:doi\/10.2188%2Fjea.je20140182&rft_id=info:pmc\/PMC4213216&rft_id=info:pmid\/25327184&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC4213216&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCPrinc12-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCPrinc12_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Centers for Disease Control and Prevention (2012) (PDF). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/csels\/dsepd\/ss1978\/SS1978.pdf\" target=\"_blank\"><i>Principles of Epidemiology in Public Health Practice<\/i><\/a> (3rd ed.). Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/csels\/dsepd\/ss1978\/SS1978.pdf\" target=\"_blank\">https:\/\/www.cdc.gov\/csels\/dsepd\/ss1978\/SS1978.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Principles+of+Epidemiology+in+Public+Health+Practice&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=2012&rft.edition=3rd&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcsels%2Fdsepd%2Fss1978%2FSS1978.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HamiltonUsing19-4\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HamiltonUsing19_4-0\">4.0<\/a><\/sup> <sup><a href=\"#cite_ref-HamiltonUsing19_4-1\">4.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Hamilton, J.J.; Hopkins, R.S. (2019). \"Chapter 5: Using Technologies for Data Collection and Management\". In Rasmussen, S.A.; Goodman, R.A.. <i>The CDC Field Epidemiology Manual<\/i> (4th ed.). Oxford University Press. pp. 71\u2013104. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9780190933692.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+5%3A+Using+Technologies+for+Data+Collection+and+Management&rft.atitle=The+CDC+Field+Epidemiology+Manual&rft.aulast=Hamilton%2C+J.J.%3B+Hopkins%2C+R.S.&rft.au=Hamilton%2C+J.J.%3B+Hopkins%2C+R.S.&rft.date=2019&rft.pages=pp.%26nbsp%3B71%E2%80%93104&rft.edition=4th&rft.pub=Oxford+University+Press&rft.isbn=9780190933692&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-vonElmTheStren07-5\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-vonElmTheStren07_5-0\">5.0<\/a><\/sup> <sup><a href=\"#cite_ref-vonElmTheStren07_5-1\">5.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">von Elm, E.; Altman, D.G.; Egger, M. et al. (2007). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC2020495\" target=\"_blank\">\"The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: Guidelines for reporting observational studies\"<\/a>. <i>PLoS Medicine<\/i> <b>4<\/b> (10): e296. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1371%2Fjournal.pmed.0040296\" target=\"_blank\">10.1371\/journal.pmed.0040296<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2020495\/\" target=\"_blank\">PMC2020495<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/17941714\" target=\"_blank\">17941714<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC2020495\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC2020495<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Strengthening+the+Reporting+of+Observational+Studies+in+Epidemiology+%28STROBE%29+statement%3A+Guidelines+for+reporting+observational+studies&rft.jtitle=PLoS+Medicine&rft.aulast=von+Elm%2C+E.%3B+Altman%2C+D.G.%3B+Egger%2C+M.+et+al.&rft.au=von+Elm%2C+E.%3B+Altman%2C+D.G.%3B+Egger%2C+M.+et+al.&rft.date=2007&rft.volume=4&rft.issue=10&rft.pages=e296&rft_id=info:doi\/10.1371%2Fjournal.pmed.0040296&rft_id=info:pmc\/PMC2020495&rft_id=info:pmid\/17941714&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC2020495&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Crear-PerryTheHid20-6\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-Crear-PerryTheHid20_6-0\">6.0<\/a><\/sup> <sup><a href=\"#cite_ref-Crear-PerryTheHid20_6-1\">6.1<\/a><\/sup> <sup><a href=\"#cite_ref-Crear-PerryTheHid20_6-2\">6.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Crear-Perry, J. 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Retrieved 14 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Frequently+Asked+Questions+Regarding+ICD-10-CM+Coding+for+COVID-19&rft.atitle=AHA+Coding+Clinic+Advisor&rft.date=27+August+2021&rft.pub=American+Hospital+Association&rft_id=https%3A%2F%2Fwww.codingclinicadvisor.com%2Ffaqs-icd-10-cm-coding-covid-19&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CMS-ICD10CM21-16\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CMS-ICD10CM21_16-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Medicare and Medicaid Services (10 August 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/files\/document\/fy-2022-icd-10-cm-coding-guidelines.pdf\" target=\"_blank\">\"ICD-10-CM Official Guidelines for Coding and Reporting FY 2022\"<\/a> (PDF)<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cms.gov\/files\/document\/fy-2022-icd-10-cm-coding-guidelines.pdf\" target=\"_blank\">https:\/\/www.cms.gov\/files\/document\/fy-2022-icd-10-cm-coding-guidelines.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=ICD-10-CM+Official+Guidelines+for+Coding+and+Reporting+FY+2022&rft.atitle=&rft.aulast=Centers+for+Medicare+and+Medicaid+Services&rft.au=Centers+for+Medicare+and+Medicaid+Services&rft.date=10+August+2021&rft_id=https%3A%2F%2Fwww.cms.gov%2Ffiles%2Fdocument%2Ffy-2022-icd-10-cm-coding-guidelines.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CMS-COVIDFAQFFS21-17\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CMS-COVIDFAQFFS21_17-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/files\/document\/03092020-covid-19-faqs-508.pdf\" target=\"_blank\">\"COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing\"<\/a> (PDF). Centers for Medicare and Medicaid Services. 2 July 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cms.gov\/files\/document\/03092020-covid-19-faqs-508.pdf\" target=\"_blank\">https:\/\/www.cms.gov\/files\/document\/03092020-covid-19-faqs-508.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=COVID-19+Frequently+Asked+Questions+%28FAQs%29+on+Medicare+Fee-for-Service+%28FFS%29+Billing&rft.atitle=&rft.date=2+July+2021&rft.pub=Centers+for+Medicare+and+Medicaid+Services&rft_id=https%3A%2F%2Fwww.cms.gov%2Ffiles%2Fdocument%2F03092020-covid-19-faqs-508.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ASCO-COVIDReport21-18\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ASCO-COVIDReport21_18-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.asco.org\/sites\/new-www.asco.org\/files\/content-files\/advocacy-and-policy\/documents\/2020-COVID19-Billing-and-Coding-Resource.pdf\" target=\"_blank\">\"COVID-19 Coding and Reporting Information New CPT, HCPCS, and ICD-10 CM Codes\"<\/a> (PDF). American Society of Clinical Oncology. 26 August 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.asco.org\/sites\/new-www.asco.org\/files\/content-files\/advocacy-and-policy\/documents\/2020-COVID19-Billing-and-Coding-Resource.pdf\" target=\"_blank\">https:\/\/www.asco.org\/sites\/new-www.asco.org\/files\/content-files\/advocacy-and-policy\/documents\/2020-COVID19-Billing-and-Coding-Resource.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=COVID-19+Coding+and+Reporting+Information+New+CPT%2C+HCPCS%2C+and+ICD-10+CM+Codes&rft.atitle=&rft.date=26+August+2021&rft.pub=American+Society+of+Clinical+Oncology&rft_id=https%3A%2F%2Fwww.asco.org%2Fsites%2Fnew-www.asco.org%2Ffiles%2Fcontent-files%2Fadvocacy-and-policy%2Fdocuments%2F2020-COVID19-Billing-and-Coding-Resource.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCIntern20-19\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCIntern20_19-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">National Center for Health Statistics (30 July 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/nchs\/icd\/icd10cm.htm\" target=\"_blank\">\"International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM)\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/nchs\/icd\/icd10cm.htm\" target=\"_blank\">https:\/\/www.cdc.gov\/nchs\/icd\/icd10cm.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=International+Classification+of+Diseases%2C+Tenth+Revision%2C+Clinical+Modification+%28ICD-10-CM%29&rft.atitle=&rft.aulast=National+Center+for+Health+Statistics&rft.au=National+Center+for+Health+Statistics&rft.date=30+July+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fnchs%2Ficd%2Ficd10cm.htm&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCCommercial20-20\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCCommercial20_20-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Disease Control and Prevention (1 December 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/cases-updates\/commercial-lab-surveys.html\" target=\"_blank\">\"Commercial Laboratory Seroprevalence Surveys\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/cases-updates\/commercial-lab-surveys.html\" target=\"_blank\">https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/cases-updates\/commercial-lab-surveys.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Commercial+Laboratory+Seroprevalence+Surveys&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=1+December+2020&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fcases-updates%2Fcommercial-lab-surveys.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ClabaughRescind20-21\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ClabaughRescind20_21-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Garcia, K.; Pedati, C. (31 December 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/idph.iowa.gov\/Portals\/1\/userfiles\/61\/covid19\/Mandatory%20Reporting%20Order.pdf\" target=\"_blank\">\"Temporary Novel Coronavirus Disease 2019 (COVID-19) Mandatory Reporting Order\"<\/a> (PDF). Iowa Department of Public Health<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/idph.iowa.gov\/Portals\/1\/userfiles\/61\/covid19\/Mandatory%20Reporting%20Order.pdf\" target=\"_blank\">https:\/\/idph.iowa.gov\/Portals\/1\/userfiles\/61\/covid19\/Mandatory%20Reporting%20Order.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 14 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Temporary+Novel+Coronavirus+Disease+2019+%28COVID-19%29+Mandatory+Reporting+Order&rft.atitle=&rft.aulast=Garcia%2C+K.%3B+Pedati%2C+C.&rft.au=Garcia%2C+K.%3B+Pedati%2C+C.&rft.date=31+December+2020&rft.pub=Iowa+Department+of+Public+Health&rft_id=https%3A%2F%2Fidph.iowa.gov%2FPortals%2F1%2Fuserfiles%2F61%2Fcovid19%2FMandatory%2520Reporting%2520Order.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20210919173028\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.201 seconds\nReal time usage: 0.280 seconds\nPreprocessor visited node count: 15135\/1000000\nPost\u2010expand include size: 218141\/2097152 bytes\nTemplate argument size: 45505\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 39872\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 162.697 1 -total\n 87.03% 141.591 1 Template:Reflist\n 69.56% 113.167 21 Template:Citation\/core\n 57.72% 93.903 17 Template:Cite_web\n 13.68% 22.250 16 Template:Date\n 12.90% 20.994 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements\n 12.02% 19.554 2 Template:Cite_journal\n 7.70% 12.522 2 Template:Cite_book\n 5.24% 8.532 29 Template:Citation\/make_link\n 3.66% 5.948 7 Template:Citation\/identifier\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11918-0!canonical and timestamp 20210919173028 and revision id 39244. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","500f43f0e2f5122484d8d18d8e4145c4_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/a\/a4\/Icd10codeslogo.png"],"500f43f0e2f5122484d8d18d8e4145c4_timestamp":1632073386,"ca4c291ccc7893b51eae4a43ed892dc8_type":"article","ca4c291ccc7893b51eae4a43ed892dc8_title":"4.1 Laboratory informatics and workflow management","ca4c291ccc7893b51eae4a43ed892dc8_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_workflow_management","ca4c291ccc7893b51eae4a43ed892dc8_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Workflow and information management for COVID-19 (and other respiratory diseases)\/Laboratory informatics and workflow managementFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 4. Workflow and information management for COVID-19 (and other pandemics) \n\n1.1 4.1 Laboratory informatics and workflow management \n\n1.1.1 4.1.1 Does the system provide a flexible provider portal? \n1.1.2 4.1.2 Does the system allow for the flexible addition of users, providers, and patients? \n1.1.3 4.1.3 Does the system allow for laboratory workflows sympathetic to COVID-19 and other types of respiratory illness testing? \n1.1.4 4.1.4 Does the system allow for interfacing with most instruments currently used for testing for COVID-19? \n1.1.5 4.1.5 Does the system allow for versatile viewing and reporting of COVID-19 results? \n\n\n\n\n2 References \n\n\n\n 4. Workflow and information management for COVID-19 (and other pandemics) \n4.1 Laboratory informatics and workflow management \nLaboratory computing has positively affected clinical service delivery and laboratory management for decades.[1] These benefits are achieved through automation elements that reduce data entry errors, reduce workloads, collect laboratory instrument data, and check for common errors like duplicate test orders.[2][3] In the world of epidemiological testing, those same laboratory informatics applications\u2014such as laboratory information management systems (LIMS), laboratory information systems (LIS), and hospital information systems (HIS)\u2014provide similar value. \nPandemic response realizes benefits through crisis and risk management systems, syndromic surveillance systems, and medical diagnostic tools. As Norwegian researchers Wilson and Jumbert note about humanitarian technologies and pandemics, \"collecting information is central to the implementation of an efficient response, including situational information, needs assessment, and operational information.\"[4] At the response's core is the valuable reporting of public health data (discussed in the next section). As such, those labs and healthcare systems performing disease testing see numerous benefits in adopting and applying informatics solutions to their workflow: improved operations and positive contributions to disease reporting. If those informatics solutions are cloud-based and mobile-friendly, those labs and healthcare systems may see additional benefits such as being able to test people anywhere, making testing more flexible and rapid as a result.[5][6]\nHowever, just purchasing a random laboratory informatics solution and putting it to use is no guarantee towards realizing the technology's actual benefits. Careful consideration, discussion, training, and policy adjustment are required to get the most of any new system. It would be beyond the scope of this guide to offer complete advice on acquiring and implementing laboratory informatics solutions. That information can be found in the Association of Public Health Laboratories' Laboratory Information Systems Project Management: A Guidebook for International Implementations or Joe Liscouski's A Guide for Management: Successfully Applying Laboratory Systems to Your Organization's Work. What follows instead are considerations to make when selecting a solution to assist your organization with COVID-19 (and other types of disease) testing workflows.\n\n 4.1.1 Does the system provide a flexible provider portal? \nWhat types of providers are ordering COVID-19 tests? From surgeons ordering for pre-operation procedures and emergency room physicians for ER patients, to pathology groups and home health care or assisted living centers ordering for their patients, a wide variety of provider types exist. Those provider types and their special needs should be addressed. For example, physicians of record for home health care clients may not only require support for digital signatures in order entry, but additional verbal authorization of the test may also be required. The system should have a means for verifying that these order entry components are entered by the provider. \nHealthcare facilities may also require additional flexibility for portal account creation and use. For example, they may find it useful to have portal log-ins tied to a facility rather than a specific physician. An entity may even wish to provide in-house staff or other related workers access to their COVID-19 test report via the portal, requiring role-based permissions to be built into the portal. Be sure to consider who needs access to what information and whether or not the LIMS or LIS can securely meet those needs.\nSome healthcare systems will require the order entry portion of the provider portal make disease-specific checks or require disease-specific patient symptoms to be entered as part of the order. In the case of COVID-19, a wide majority of healthcare settings are still requiring the patient to be indicating clinical and\/or epidemiological evidence of SARS-CoV-2 infection before testing may begin. Does the system provide checks for testing requirements or, at a minimum, allow documentation of patient aspects such as body temperature, symptoms, travel history, and existing health conditions as part of order entry? This may be implemented through something as simple as comment boxes or through a more refined form with checkboxes and other input areas. These checkboxes and test requirements can further aid with automated triaging.[7]\n\n 4.1.2 Does the system allow for the flexible addition of users, providers, and patients? \nProviders ordering COVID-19 tests may work at more than one facility, ordering tests at a hospital one day, and ordering tests as a physician of record for a patient in a home health care setting the next. Having one system account for the provider while maintaining the ability to select the location associated with a test order is incredibly useful. In addition, being able to view test orders and reports by location has utility. As such, the system should not only make it easy to add providers and other users, but also allow the assignment of locations to those providers. Of course, the system should also allow for more granular assignments of system roles to users. The system should also allow patients to be added to the system as entities.\n\n 4.1.3 Does the system allow for laboratory workflows sympathetic to COVID-19 and other types of respiratory illness testing? \nPre-registration\nFor purposes of both federal reporting and for more rapid reimbursement, having a pre-registration system for patients being tested may prove useful in COVID-19 workflow. A clear preregistration process should capture critical patient and facility information such as name, data of birth, gender, race, ethnicity, demographics, ordering physician or attending health care provider (if applicable), the facility's National Provider Identifier (NPI), and patient insurance information (if insured). Additionally, any national reporting questions should be addressed. For example, in the U.S. federal reporting wants labs to capture whether or not it's the patient's first test, if the patient lives in a congregate care setting, if they are a healthcare worker, and if they are pregnant.\nSample reception and tracking\nSample reception should support single-sample orders as well as sample lots. The system should also allow for multiple sample types to be added. For COVID-19, this has typically involved nasopharyngeal swabs in a sterile viral transport container. However, other sample types such as sputum, blood, or saliva\u2014and other container types such as a sterile container with saline, a sterile dry collection cup, or blood collection tubes\u2014should also be supported. Sometimes samples won't be available at the same time the test order arrives because sampling needs to be scheduled. This requires scheduling of patients to provide samples in intervals of time. Does the informatics system provide a means for providers and laboratory personnel to schedule sample collection associated with test orders? Can it send appointment reminders to scheduled patients, and can it send alerts if the patient doesn't arrive, completes sampling procedures, or views their patient results? The system should also be able to carefully track sample status throughout the workflow. As many COVID-19 testing labs will be dealing with hundreds or even thousands of samples, that tracking should optimally be queue-based, ensuring that no sample leaves a specific queue until it is loaded, tested, and\/or reported.[5]\nOrder and sample management\nViewing and managing test orders specific to COVID-19 and other illnesses should be painless. The system should make it clear in what workflow step a requested test sample is located, from received but not processed, to in-analysis, in-retest, or requiring results approval. If tests for multiple diseases are ordered, the system should allow users to filter tests and related samples by specific test type, such as \"SARS-CoV-2 rRT-PCR,\" or by test result (e.g., \"Negative\" or \"Positive\") or testing location (e.g., molecular pathology, serology, \"Lab 2-B\"). The system should also have the flexibility to show which analyst or instrument is assigned. In the case of retesting, the informatics solution should be able to support testing of both the original sample analysis and one or more associated retests at the same time.[5]\nWorkflow or \"batch\" management\nLaboratories have their own workflows, and the informatics system they use should be flexible enough to allow users to manage the various steps or \"batches\" in the workflow. The lab may require a few simple preparation and analysis steps, or it may require a more complex, specific set of steps. This requires system functionality that can readily support the workflow. For example, can specific instruments be assigned to a workflow step? Can the system automatically add quality control (QC) or duplicate samples to a step? Can they be added manually? Despite slightly relaxed quality control frequencies by professional groups such as the College of American Pathologists during the COVID-19 pandemic, they still require quality control tests as described on COVID-19 test kit package inserts.[8]\nAn example laboratory workflow for molecular detection using one-step real-time reverse transcription PCR (rRT-PCR) of SARS-CoV-2 in one or more samples might look something like this[9][10][11][12]:\n\nPrepare the batching for the ordered rRT-PCR tests, including who is involved, when it is scheduled, and any additional unique identifiers.\nExtract, purify, and assess the quality of nucleic acids from a complex biological sample.\nPrepare and assemble rRT-PCR components (including reverse transcriptase enzyme, primers, and nucleotides) and reactions to plates or tubes.\nRun the analysis using the appropriate quantification method.\nReview and take action on the analytical results.\nEnsure the laboratory informatics solution developer can explain how that workflow can be further optimized and tracked within the informatics solution.\nResults approval\nAs orders move through the various steps of a lab's workflow, approval processes may be required. With COVID-19 diagnoses in particular, taking appropriate steps to limit the number of false-negative test results is vital[13], requiring careful results review and approval processes. Laboratory analysts may approve the samples through the initial workflow steps, or those steps may be automated. Eventually, however, the analytical steps are completed, and results ready for review. \nDepending on the tests being run, the initial default value for a test that hasn't been run should be configurable in the system, either as a \"negative\" result or an empty or null value. Upon completion of the analysis, the system then should make it abundantly clear which samples in a batch are within and out of test limits, as well as sufficiently easy to manage approval of results. Ideally, tested samples that are within limits will still show the initial default value or, if the initial default was null, show an appropriate value such as \"negative.\" Results that are out of limit should not only show a \"positive\" or other appropriate result state, but also color coding, flags, or other visual cues that make the outlier status of the sample clear to the analyst.\nFinally, can the system handle reflex testing automatically when results are produced? For example, the lab may want a presumptive positive for COVID-19 to trigger the system to automatically add confirmation tests to the test queue for the associated patient. The correct people will also need to be notified of such reflex test creation in the system.\n\n 4.1.4 Does the system allow for interfacing with most instruments currently used for testing for COVID-19? \nInstrument interfaces (discussed later in this chapter) are typically a non-trivial monetary investment for laboratories[14] as the developer has to take into account compliance requirements, the required analytical outcomes, and the instrument itself, as well as its available connections.[15] Yet a laboratory informatics vendor with experience has likely already set up interfaces to the instruments used in testing COVID-19 and other respiratory illnesses. RT-PCR systems like Hologic's Panther Fusion[16] and Abbot's RealTime m2000[17] represent a few of the systems being used to test for COVID-19 right now. Is the laboratory informatics system able to interface with these and other lab-based and point-of-care (POC) instruments you may require, at a reasonable cost? If so, also ensure the ease of assigning those instruments to specific tests or samples in the system. You should also be able to document well numbers for the analysis, as well as later view which samples are associated with a particular instrument. (In some cases, an instrument may be solely allocated to one specific test type.)\n\n 4.1.5 Does the system allow for versatile viewing and reporting of COVID-19 results? \nAlready mentioned was the process of results approval and the importance of being able to clearly view those results both within and out of test limits. Of course, this information has to be reported for internal and external purposes. Internally, the laboratory or healthcare entity using the informatics system will want to understand their test volume and associated details. If there's any chance the information can be used internally for medical research insights, data mining tools may also be a welcome addition to the system.[7] Additionally, a laboratory results report for SARS-CoV-2 infection will also have to be distributed to the local or state health department along with a case report. Externally, ordering physicians and other external customers\u2014including patients\u2014will require clear and timely results in the form of a report. How does the laboratory informatics solution help with these and other reporting requirements? Can it assist with any external electronic reporting requirements (such as those with the Centers for Medicare & Medicaid Services) you may have? \nThe system's reporting tools should be configurable to the lab's needs. The reporting itself should provide fields for the addition of comments and consultation notes from the lab and the physician, as the stakeholders need to give clinical and diagnostic guidance based on not only the results but also critical comments. In some cases, a lab or healthcare system may require the addition of comments at different stages of reporting. Perhaps an initial results report is created by the lab and sent to the provider via the provider portal, but a pathologist needs to review the report and add additional commentary concerning future treatment or concerns about the test results. This requires the system be flexible enough to allow additional steps before a report is finalized. Whether or not the system is capable of automating the reporting process may also be worthy of consideration.[7]\nFinally, some solutions may include a disease- or test-specific dashboard that can show all samples related to a test, any positives, any negatives, pending results, tests per day, etc. Having this information available in one location can help facilitate reporting to government entities (e.g., reporting statistics to FEMA during emergencies[18] While not strictly necessary, ensure the solution can fulfill your needs with displaying real-time and near-time information to better support rapid decision making.\n\nReferences \n\n\n\u2191 Jones, R.G.; Johnson, O.A.; Baststone, G. (2014). \"Informatics and the Clinical Laboratory\". The Clinical Biochemist Reviews 35 (3): 177\u2013192. PMC PMC4204239. PMID 25336763. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4204239 .   \n \n\n\u2191 Pitkus, A. (2018). \"Laboratory Informatics: An Increasingly Valuable Commodity Emerging from Today's Laboratories\". ASCLS Today 32 (2). https:\/\/ascls.org\/laboratory-informatics-an-increasingly-valuable-commodity-emerging-from-today-s-laboratories\/ . Retrieved 13 September 2021 .   \n \n\n\u2191 Raeen, M.R. (2018). \"How laboratory informatics has impacted healthcare overall\". Applied Research Projects 54. doi:10.21007\/chp.hiim.0056. https:\/\/dc.uthsc.edu\/hiimappliedresearch\/54 .   \n \n\n\u2191 Wilson, C.; Jumbert, M.G. (2018). \"The new informatics of pandemic response: humanitarian technology, efficiency, and the subtle retreat of national agency\". Journal of International Humanitarian Action 3: 8. doi:10.1186\/s41018-018-0036-5. PMC PMC7149122. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7149122 .   \n \n\n\u2191 5.0 5.1 5.2 Third Wave Analytics (5 September 2021). \"The 8 Essential Features for a Sample Management LIMS in a COVID-19 Testing Lab\". Third Wave Analytics. https:\/\/thirdwaveanalytics.com\/blog\/8-essential-features-sample-management-lims-in-a-covid-19-testing-lab\/ . Retrieved 17 September 2021 .   \n \n\n\u2191 Tony, J. (3 August 2021). \"COVID-19 PCR Testing Labs Go Mobile by Leveraging LIMS\". Labcompare. https:\/\/www.labcompare.com\/10-Featured-Articles\/578098-COVID-19-Testing-Labs-Go-Mobile-by-Leveraging-LIMS\/ . Retrieved 17 September 2021 .   \n \n\n\u2191 7.0 7.1 7.2 Weemaes, M.; Martens, S.; Cuypers, L. et al. (2020). \"Laboratory information system requirements to manage the COVID-19 pandemic: A report from the Belgian national reference testing center\". JAMIA: ocaa081. doi:10.1093\/jamia\/ocaa081. PMC PMC7197526. PMID 32348469. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7197526 .   \n \n\n\u2191 College of American Pathologists (7 April 2020). \"Guidance for COVID-19 Testing for CAP-Accredited Laboratories\". College of American Pathologists. https:\/\/www.cap.org\/laboratory-improvement\/news-and-updates\/guidance-for-covid-19-testing-for-cap-accredited-laboratories . Retrieved 30 April 2020 .   \n \n\n\u2191 Life Technologies Corporation (August 2012). \"Real-time PCR handbook\" (PDF). Life Technologies Corporation. https:\/\/www.gene-quantification.de\/real-time-pcr-handbook-life-technologies-update-flr.pdf . Retrieved 30 April 2020 .   \n \n\n\u2191 Starita, L. (1 April 2020). \"COVID-19 SCAN molecular workflow\". protocols.io. https:\/\/www.protocols.io\/view\/covid-19-scan-molecular-workflow-bebkjakw . Retrieved 30 April 2020 .   \n \n\n\u2191 Udugama, B.; Kadhiresan, P.; Kozlowski, H.N. et al. (2020). \"Diagnosing COVID-19: The Disease and Tools for Detection\". ACS Nano 14 (4): 3822\u20133835. doi:10.1021\/acsnano.0c02624. PMC PMC7144809. PMID 32223179. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7144809 .   \n \n\n\u2191 Pendergraph, G.E. (2020). \"Reverse Transcriptase PCR (RT-PCR)\". HIV: Structure, Replication, and Detection. https:\/\/www.labce.com\/spg605456_reverse_transcriptase_pcr_rt_pcr.aspx . Retrieved 20 April 2020 .   \n \n\n\u2191 Prinzi, A. (27 April 2020). \"False Negatives and Reinfections: the Challenges of SARS-CoV-2 RT-PCR Testing\". American Society for Microbiology. https:\/\/asm.org\/Articles\/2020\/April\/False-Negatives-and-Reinfections-the-Challenges-of . Retrieved 30 April 2020 .   \n \n\n\u2191 John3504 (7 December 2011). \"HL7 Interface cost and maintenance\". Spiceworks. https:\/\/community.spiceworks.com\/topic\/175107-hl7-interface-cost-and-maintenance . Retrieved 25 April 2020 .   \n \n\n\u2191 Strauss, D. (8 July 2018). \"Connecting Lab Instruments: Interface Strategies Depend Upon Compliance Requirements\". Lab Manager. https:\/\/www.labmanager.com\/laboratory-technology\/connecting-lab-instruments-interface-strategies-depend-upon-compliance-requirements-2034 . Retrieved 30 April 2020 .   \n \n\n\u2191 Hologic (17 March 2020). \"Hologic\u2019s Molecular Test for the Novel Coronavirus, SARS-CoV-2, Receives FDA Emergency Use Authorization\". Hologic, Inc. https:\/\/www.hologic.com\/coronavirus-test . Retrieved 30 April 2020 .   \n \n\n\u2191 Abbott. \"Abbott RealTime SARS-CoV-2 Assay\". Abbott Laboratories. https:\/\/www.molecular.abbott\/us\/en\/products\/infectious-disease\/RealTime-SARS-CoV-2-Assay . Retrieved 30 April 2020 .   \n \n\n\u2191 Azar, A.M. (10 April 2020). \"Coronavirus (COVID-19) Pandemic: HHS Letter to Hospital Administrators\". FEMA. https:\/\/www.fema.gov\/press-release\/20210318\/coronavirus-covid-19-pandemic-hhs-letter-hospital-administrators . Retrieved 13 September 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_workflow_management\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_workflow_management<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 3 May 2020, at 19:48.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 398 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","ca4c291ccc7893b51eae4a43ed892dc8_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Workflow_and_information_management_for_COVID-19_and_other_respiratory_diseases_Laboratory_informatics_and_workflow_management rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Workflow_and_information_management_for_COVID-19_and_other_respiratory_diseases_Laboratory_informatics_and_workflow_management skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Workflow and information management for COVID-19 (and other respiratory diseases)\/Laboratory informatics and workflow management<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Introduction\" title=\"Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Introduction\" class=\"wiki-link\" data-key=\"d0faaf5a86a3ccb5b12357c8bd4fefe4\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h2><span id=\"rdp-ebb-4._Workflow_and_information_management_for_COVID-19_(and_other_pandemics)\"><\/span><span class=\"mw-headline\" id=\"4._Workflow_and_information_management_for_COVID-19_.28and_other_pandemics.29\">4. Workflow and information management for COVID-19 (and other pandemics)<\/span><\/h2>\n<h3><span class=\"mw-headline\" id=\"4.1_Laboratory_informatics_and_workflow_management\">4.1 Laboratory informatics and workflow management<\/span><\/h3>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Molecular_diagnostics_qia_symphony.jpg\" class=\"image wiki-link\" data-key=\"c427e41f0b453537f1436bba5ed6abc3\"><img alt=\"Molecular diagnostics qia symphony.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/a\/ad\/Molecular_diagnostics_qia_symphony.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>Laboratory computing has positively affected clinical service delivery and laboratory management for decades.<sup id=\"rdp-ebb-cite_ref-JonesInform14_1-0\" class=\"reference\"><a href=\"#cite_note-JonesInform14-1\">[1]<\/a><\/sup> These benefits are achieved through automation elements that reduce data entry errors, reduce workloads, collect laboratory instrument data, and check for common errors like duplicate test orders.<sup id=\"rdp-ebb-cite_ref-PitkusLab18_2-0\" class=\"reference\"><a href=\"#cite_note-PitkusLab18-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RaeenHowLab18_3-0\" class=\"reference\"><a href=\"#cite_note-RaeenHowLab18-3\">[3]<\/a><\/sup> In the world of <a href=\"https:\/\/www.limswiki.org\/index.php\/Epidemiology\" title=\"Epidemiology\" class=\"wiki-link\" data-key=\"123badb8bf0b37a513182dbcfc3875bc\">epidemiological<\/a> testing, those same <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> applications\u2014such as <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management systems<\/a> (LIMS), <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system\" title=\"Laboratory information system\" class=\"wiki-link\" data-key=\"37add65b4d1c678b382a7d4817a9cf64\">laboratory information systems<\/a> (LIS), and <a href=\"https:\/\/www.limswiki.org\/index.php\/Hospital_information_system\" title=\"Hospital information system\" class=\"wiki-link\" data-key=\"d8385de7b1f39a39d793f8ce349b448d\">hospital information systems<\/a> (HIS)\u2014provide similar value. \n<\/p><p>Pandemic response realizes benefits through crisis and risk management systems, syndromic surveillance systems, and medical diagnostic tools. As Norwegian researchers Wilson and Jumbert note about humanitarian technologies and pandemics, \"collecting information is central to the implementation of an efficient response, including situational information, needs assessment, and operational information.\"<sup id=\"rdp-ebb-cite_ref-WilsonTheNew18_4-0\" class=\"reference\"><a href=\"#cite_note-WilsonTheNew18-4\">[4]<\/a><\/sup> At the response's core is the valuable reporting of public health data (discussed in the next section). As such, those labs and healthcare systems performing disease testing see numerous benefits in adopting and applying informatics solutions to their workflow: improved operations and positive contributions to disease reporting. If those informatics solutions are <a href=\"https:\/\/www.limswiki.org\/index.php\/Cloud_computing\" title=\"Cloud computing\" class=\"wiki-link\" data-key=\"fcfe5882eaa018d920cedb88398b604f\">cloud-based<\/a> and mobile-friendly, those labs and healthcare systems may see additional benefits such as being able to test people anywhere, making testing more flexible and rapid as a result.<sup id=\"rdp-ebb-cite_ref-TWATheEight21_5-0\" class=\"reference\"><a href=\"#cite_note-TWATheEight21-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-TonyCOVID21_6-0\" class=\"reference\"><a href=\"#cite_note-TonyCOVID21-6\">[6]<\/a><\/sup>\n<\/p><p>However, just purchasing a random laboratory informatics solution and putting it to use is no guarantee towards realizing the technology's actual benefits. Careful consideration, discussion, training, and policy adjustment are required to get the most of any new system. It would be beyond the scope of this guide to offer complete advice on acquiring and implementing laboratory informatics solutions. That information can be found in the Association of Public Health Laboratories' <i><a href=\"https:\/\/www.limswiki.org\/index.php\/LII:Laboratory_Information_Systems_Project_Management:_A_Guidebook_for_International_Implementations\" title=\"LII:Laboratory Information Systems Project Management: A Guidebook for International Implementations\" class=\"wiki-link\" data-key=\"de9b2109f3975a703634052af790b2d1\">Laboratory Information Systems Project Management: A Guidebook for International Implementations<\/a><\/i> or Joe Liscouski's <i><a href=\"https:\/\/www.limswiki.org\/index.php\/LII:A_Guide_for_Management:_Successfully_Applying_Laboratory_Systems_to_Your_Organization%27s_Work\" title=\"LII:A Guide for Management: Successfully Applying Laboratory Systems to Your Organization's Work\" class=\"wiki-link\" data-key=\"00b300565027cb0518bcb0410d6df360\">A Guide for Management: Successfully Applying Laboratory Systems to Your Organization's Work<\/a><\/i>. What follows instead are considerations to make when selecting a solution to assist your organization with <a href=\"https:\/\/www.limswiki.org\/index.php\/COVID-19\" class=\"mw-redirect wiki-link\" title=\"COVID-19\" data-key=\"da9bd20c492b2a17074ad66c2fe25652\">COVID-19<\/a> (and other types of disease) testing workflows.\n<\/p>\n<h4><span id=\"rdp-ebb-4.1.1_Does_the_system_provide_a_flexible_provider_portal?\"><\/span><span class=\"mw-headline\" id=\"4.1.1_Does_the_system_provide_a_flexible_provider_portal.3F\">4.1.1 Does the system provide a flexible provider portal?<\/span><\/h4>\n<p>What types of providers are ordering COVID-19 tests? From surgeons ordering for pre-operation procedures and emergency room physicians for ER patients, to pathology groups and home health care or assisted living centers ordering for their patients, a wide variety of provider types exist. Those provider types and their special needs should be addressed. For example, physicians of record for home health care clients may not only require support for digital signatures in order entry, but additional verbal authorization of the test may also be required. The system should have a means for verifying that these order entry components are entered by the provider. \n<\/p><p>Healthcare facilities may also require additional flexibility for portal account creation and use. For example, they may find it useful to have portal log-ins tied to a facility rather than a specific physician. An entity may even wish to provide in-house staff or other related workers access to their COVID-19 test report via the portal, requiring role-based permissions to be built into the portal. Be sure to consider who needs access to what information and whether or not the LIMS or LIS can securely meet those needs.\n<\/p><p>Some healthcare systems will require the order entry portion of the provider portal make disease-specific checks or require disease-specific patient symptoms to be entered as part of the order. In the case of COVID-19, a wide majority of healthcare settings are still requiring the patient to be indicating clinical and\/or epidemiological evidence of <a href=\"https:\/\/www.limswiki.org\/index.php\/SARS-CoV-2\" class=\"mw-redirect wiki-link\" title=\"SARS-CoV-2\" data-key=\"6c6b78479de2c640028696ed32948526\">SARS-CoV-2<\/a> infection before testing may begin. Does the system provide checks for testing requirements or, at a minimum, allow documentation of patient aspects such as body temperature, symptoms, travel history, and existing health conditions as part of order entry? This may be implemented through something as simple as comment boxes or through a more refined form with checkboxes and other input areas. These checkboxes and test requirements can further aid with automated triaging.<sup id=\"rdp-ebb-cite_ref-WeemaesLab20_7-0\" class=\"reference\"><a href=\"#cite_note-WeemaesLab20-7\">[7]<\/a><\/sup>\n<\/p>\n<h4><span id=\"rdp-ebb-4.1.2_Does_the_system_allow_for_the_flexible_addition_of_users,_providers,_and_patients?\"><\/span><span class=\"mw-headline\" id=\"4.1.2_Does_the_system_allow_for_the_flexible_addition_of_users.2C_providers.2C_and_patients.3F\">4.1.2 Does the system allow for the flexible addition of users, providers, and patients?<\/span><\/h4>\n<p>Providers ordering COVID-19 tests may work at more than one facility, ordering tests at a hospital one day, and ordering tests as a physician of record for a patient in a home health care setting the next. Having one system account for the provider while maintaining the ability to select the location associated with a test order is incredibly useful. In addition, being able to view test orders and reports by location has utility. As such, the system should not only make it easy to add providers and other users, but also allow the assignment of locations to those providers. Of course, the system should also allow for more granular assignments of system roles to users. The system should also allow patients to be added to the system as entities.\n<\/p>\n<h4><span id=\"rdp-ebb-4.1.3_Does_the_system_allow_for_laboratory_workflows_sympathetic_to_COVID-19_and_other_types_of_respiratory_illness_testing?\"><\/span><span class=\"mw-headline\" id=\"4.1.3_Does_the_system_allow_for_laboratory_workflows_sympathetic_to_COVID-19_and_other_types_of_respiratory_illness_testing.3F\">4.1.3 Does the system allow for laboratory workflows sympathetic to COVID-19 and other types of respiratory illness testing?<\/span><\/h4>\n<p><b>Pre-registration<\/b>\nFor purposes of both federal reporting and for more rapid reimbursement, having a pre-registration system for patients being tested may prove useful in COVID-19 <a href=\"https:\/\/www.limswiki.org\/index.php\/Workflow\" title=\"Workflow\" class=\"wiki-link\" data-key=\"92bd8748272e20d891008dcb8243e8a8\">workflow<\/a>. A clear preregistration process should capture critical patient and facility information such as name, data of birth, gender, race, ethnicity, demographics, ordering physician or attending health care provider (if applicable), the facility's National Provider Identifier (NPI), and patient insurance information (if insured). Additionally, any national reporting questions should be addressed. For example, in the U.S. federal reporting wants labs to capture whether or not it's the patient's first test, if the patient lives in a congregate care setting, if they are a healthcare worker, and if they are pregnant.\n<\/p><p><b>Sample reception and tracking<\/b>\n<\/p><p>Sample reception should support single-sample orders as well as sample lots. The system should also allow for multiple sample types to be added. For COVID-19, this has typically involved nasopharyngeal swabs in a sterile viral transport container. However, other sample types such as sputum, blood, or saliva\u2014and other container types such as a sterile container with saline, a sterile dry collection cup, or blood collection tubes\u2014should also be supported. Sometimes samples won't be available at the same time the test order arrives because sampling needs to be scheduled. This requires scheduling of patients to provide samples in intervals of time. Does the informatics system provide a means for providers and laboratory personnel to schedule sample collection associated with test orders? Can it send appointment reminders to scheduled patients, and can it send alerts if the patient doesn't arrive, completes sampling procedures, or views their patient results? The system should also be able to carefully track sample status throughout the workflow. As many COVID-19 testing labs will be dealing with hundreds or even thousands of samples, that tracking should optimally be queue-based, ensuring that no sample leaves a specific queue until it is loaded, tested, and\/or reported.<sup id=\"rdp-ebb-cite_ref-TWATheEight21_5-1\" class=\"reference\"><a href=\"#cite_note-TWATheEight21-5\">[5]<\/a><\/sup>\n<\/p><p><b>Order and sample management<\/b>\n<\/p><p>Viewing and managing test orders specific to COVID-19 and other illnesses should be painless. The system should make it clear in what workflow step a requested test sample is located, from received but not processed, to in-analysis, in-retest, or requiring results approval. If tests for multiple diseases are ordered, the system should allow users to filter tests and related samples by specific test type, such as \"SARS-CoV-2 rRT-PCR,\" or by test result (e.g., \"Negative\" or \"Positive\") or testing location (e.g., molecular pathology, serology, \"Lab 2-B\"). The system should also have the flexibility to show which analyst or instrument is assigned. In the case of retesting, the informatics solution should be able to support testing of both the original sample analysis and one or more associated retests at the same time.<sup id=\"rdp-ebb-cite_ref-TWATheEight21_5-2\" class=\"reference\"><a href=\"#cite_note-TWATheEight21-5\">[5]<\/a><\/sup>\n<\/p><p><b>Workflow or \"batch\" management<\/b>\n<\/p><p>Laboratories have their own workflows, and the informatics system they use should be flexible enough to allow users to manage the various steps or \"batches\" in the workflow. The lab may require a few simple preparation and analysis steps, or it may require a more complex, specific set of steps. This requires system functionality that can readily support the workflow. For example, can specific instruments be assigned to a workflow step? Can the system automatically add <a href=\"https:\/\/www.limswiki.org\/index.php\/Quality_control\" title=\"Quality control\" class=\"wiki-link\" data-key=\"1e0e0c2eb3e45aff02f5d61799821f0f\">quality control<\/a> (QC) or duplicate samples to a step? Can they be added manually? Despite slightly relaxed quality control frequencies by professional groups such as the College of American Pathologists during the COVID-19 pandemic, they still require quality control tests as described on COVID-19 test kit package inserts.<sup id=\"rdp-ebb-cite_ref-CAPGuidance20_8-0\" class=\"reference\"><a href=\"#cite_note-CAPGuidance20-8\">[8]<\/a><\/sup>\n<\/p><p>An example laboratory workflow for molecular detection using one-step real-time reverse transcription PCR (rRT-PCR) of SARS-CoV-2 in one or more samples might look something like this<sup id=\"rdp-ebb-cite_ref-LTCReal12_9-0\" class=\"reference\"><a href=\"#cite_note-LTCReal12-9\">[9]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-StaritaCOVID20_10-0\" class=\"reference\"><a href=\"#cite_note-StaritaCOVID20-10\">[10]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-UdugamaDiag20_11-0\" class=\"reference\"><a href=\"#cite_note-UdugamaDiag20-11\">[11]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PendergraphHIV20_12-0\" class=\"reference\"><a href=\"#cite_note-PendergraphHIV20-12\">[12]<\/a><\/sup>:\n<\/p>\n<ol><li>Prepare the batching for the ordered rRT-PCR tests, including who is involved, when it is scheduled, and any additional unique identifiers.<\/li>\n<li>Extract, purify, and assess the quality of nucleic acids from a complex biological sample.<\/li>\n<li>Prepare and assemble rRT-PCR components (including reverse transcriptase enzyme, primers, and nucleotides) and reactions to plates or tubes.<\/li>\n<li>Run the analysis using the appropriate quantification method.<\/li>\n<li>Review and take action on the analytical results.<\/li><\/ol>\n<p>Ensure the laboratory informatics solution developer can explain how that workflow can be further optimized and tracked within the informatics solution.\n<\/p><p><b>Results approval<\/b>\n<\/p><p>As orders move through the various steps of a lab's workflow, approval processes may be required. With COVID-19 diagnoses in particular, taking appropriate steps to limit the number of false-negative test results is vital<sup id=\"rdp-ebb-cite_ref-PrinziFalse20_13-0\" class=\"reference\"><a href=\"#cite_note-PrinziFalse20-13\">[13]<\/a><\/sup>, requiring careful results review and approval processes. Laboratory analysts may approve the samples through the initial workflow steps, or those steps may be automated. Eventually, however, the analytical steps are completed, and results ready for review. \n<\/p><p>Depending on the tests being run, the initial default value for a test that hasn't been run should be configurable in the system, either as a \"negative\" result or an empty or null value. Upon completion of the analysis, the system then should make it abundantly clear which samples in a batch are within and out of test limits, as well as sufficiently easy to manage approval of results. Ideally, tested samples that are within limits will still show the initial default value or, if the initial default was null, show an appropriate value such as \"negative.\" Results that are out of limit should not only show a \"positive\" or other appropriate result state, but also color coding, flags, or other visual cues that make the outlier status of the sample clear to the analyst.\n<\/p><p>Finally, can the system handle reflex testing automatically when results are produced? For example, the lab may want a presumptive positive for COVID-19 to trigger the system to automatically add confirmation tests to the test queue for the associated patient. The correct people will also need to be notified of such reflex test creation in the system.\n<\/p>\n<h4><span id=\"rdp-ebb-4.1.4_Does_the_system_allow_for_interfacing_with_most_instruments_currently_used_for_testing_for_COVID-19?\"><\/span><span class=\"mw-headline\" id=\"4.1.4_Does_the_system_allow_for_interfacing_with_most_instruments_currently_used_for_testing_for_COVID-19.3F\">4.1.4 Does the system allow for interfacing with most instruments currently used for testing for COVID-19?<\/span><\/h4>\n<p>Instrument interfaces (discussed later in this chapter) are typically a non-trivial monetary investment for laboratories<sup id=\"rdp-ebb-cite_ref-John3504HL7_11_14-0\" class=\"reference\"><a href=\"#cite_note-John3504HL7_11-14\">[14]<\/a><\/sup> as the developer has to take into account compliance requirements, the required analytical outcomes, and the instrument itself, as well as its available connections.<sup id=\"rdp-ebb-cite_ref-StraussConnect18_15-0\" class=\"reference\"><a href=\"#cite_note-StraussConnect18-15\">[15]<\/a><\/sup> Yet a laboratory informatics vendor with experience has likely already set up interfaces to the instruments used in testing COVID-19 and other respiratory illnesses. RT-PCR systems like Hologic's Panther Fusion<sup id=\"rdp-ebb-cite_ref-HologicPantherFusion20_16-0\" class=\"reference\"><a href=\"#cite_note-HologicPantherFusion20-16\">[16]<\/a><\/sup> and Abbot's RealTime m2000<sup id=\"rdp-ebb-cite_ref-AbbottRealTime20_17-0\" class=\"reference\"><a href=\"#cite_note-AbbottRealTime20-17\">[17]<\/a><\/sup> represent a few of the systems being used to test for COVID-19 right now. Is the laboratory informatics system able to interface with these and other lab-based and point-of-care (POC) instruments you may require, at a reasonable cost? If so, also ensure the ease of assigning those instruments to specific tests or samples in the system. You should also be able to document well numbers for the analysis, as well as later view which samples are associated with a particular instrument. (In some cases, an instrument may be solely allocated to one specific test type.)\n<\/p>\n<h4><span id=\"rdp-ebb-4.1.5_Does_the_system_allow_for_versatile_viewing_and_reporting_of_COVID-19_results?\"><\/span><span class=\"mw-headline\" id=\"4.1.5_Does_the_system_allow_for_versatile_viewing_and_reporting_of_COVID-19_results.3F\">4.1.5 Does the system allow for versatile viewing and reporting of COVID-19 results?<\/span><\/h4>\n<p>Already mentioned was the process of results approval and the importance of being able to clearly view those results both within and out of test limits. Of course, this information has to be reported for internal and external purposes. Internally, the laboratory or healthcare entity using the informatics system will want to understand their test volume and associated details. If there's any chance the information can be used internally for medical research insights, <a href=\"https:\/\/www.limswiki.org\/index.php\/Data_mining\" title=\"Data mining\" class=\"wiki-link\" data-key=\"be09d3680fe1608addedf6f62692ee47\">data mining<\/a> tools may also be a welcome addition to the system.<sup id=\"rdp-ebb-cite_ref-WeemaesLab20_7-1\" class=\"reference\"><a href=\"#cite_note-WeemaesLab20-7\">[7]<\/a><\/sup> Additionally, a laboratory results report for SARS-CoV-2 infection will also have to be distributed to the local or state health department along with a case report. Externally, ordering physicians and other external customers\u2014including patients\u2014will require clear and timely results in the form of a report. How does the laboratory informatics solution help with these and other reporting requirements? Can it assist with any external electronic reporting requirements (such as those with the Centers for Medicare & Medicaid Services) you may have? \n<\/p><p>The system's reporting tools should be configurable to the lab's needs. The reporting itself should provide fields for the addition of comments and consultation notes from the lab and the physician, as the stakeholders need to give clinical and diagnostic guidance based on not only the results but also critical comments. In some cases, a lab or healthcare system may require the addition of comments at different stages of reporting. Perhaps an initial results report is created by the lab and sent to the provider via the provider portal, but a pathologist needs to review the report and add additional commentary concerning future treatment or concerns about the test results. This requires the system be flexible enough to allow additional steps before a report is finalized. Whether or not the system is capable of automating the reporting process may also be worthy of consideration.<sup id=\"rdp-ebb-cite_ref-WeemaesLab20_7-2\" class=\"reference\"><a href=\"#cite_note-WeemaesLab20-7\">[7]<\/a><\/sup>\n<\/p><p>Finally, some solutions may include a disease- or test-specific dashboard that can show all samples related to a test, any positives, any negatives, pending results, tests per day, etc. Having this information available in one location can help facilitate reporting to government entities (e.g., reporting statistics to FEMA during emergencies<sup id=\"rdp-ebb-cite_ref-FEMACorona20_18-0\" class=\"reference\"><a href=\"#cite_note-FEMACorona20-18\">[18]<\/a><\/sup> While not strictly necessary, ensure the solution can fulfill your needs with displaying real-time and near-time information to better support rapid decision making.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-JonesInform14-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-JonesInform14_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Jones, R.G.; Johnson, O.A.; Baststone, G. (2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4204239\" target=\"_blank\">\"Informatics and the Clinical Laboratory\"<\/a>. <i>The Clinical Biochemist Reviews<\/i> <b>35<\/b> (3): 177\u2013192. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4204239\/\" target=\"_blank\">PMC4204239<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/25336763\" target=\"_blank\">25336763<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4204239\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4204239<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Informatics+and+the+Clinical+Laboratory&rft.jtitle=The+Clinical+Biochemist+Reviews&rft.aulast=Jones%2C+R.G.%3B+Johnson%2C+O.A.%3B+Baststone%2C+G.&rft.au=Jones%2C+R.G.%3B+Johnson%2C+O.A.%3B+Baststone%2C+G.&rft.date=2014&rft.volume=35&rft.issue=3&rft.pages=177%E2%80%93192&rft_id=info:pmc\/PMC4204239&rft_id=info:pmid\/25336763&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC4204239&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_workflow_management\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PitkusLab18-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PitkusLab18_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Pitkus, A. 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(2018). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7149122\" target=\"_blank\">\"The new informatics of pandemic response: humanitarian technology, efficiency, and the subtle retreat of national agency\"<\/a>. <i>Journal of International Humanitarian Action<\/i> <b>3<\/b>: 8. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1186%2Fs41018-018-0036-5\" target=\"_blank\">10.1186\/s41018-018-0036-5<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7149122\/\" target=\"_blank\">PMC7149122<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7149122\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7149122<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+new+informatics+of+pandemic+response%3A+humanitarian+technology%2C+efficiency%2C+and+the+subtle+retreat+of+national+agency&rft.jtitle=Journal+of+International+Humanitarian+Action&rft.aulast=Wilson%2C+C.%3B+Jumbert%2C+M.G.&rft.au=Wilson%2C+C.%3B+Jumbert%2C+M.G.&rft.date=2018&rft.volume=3&rft.pages=8&rft_id=info:doi\/10.1186%2Fs41018-018-0036-5&rft_id=info:pmc\/PMC7149122&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7149122&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_workflow_management\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-TWATheEight21-5\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-TWATheEight21_5-0\">5.0<\/a><\/sup> <sup><a href=\"#cite_ref-TWATheEight21_5-1\">5.1<\/a><\/sup> <sup><a href=\"#cite_ref-TWATheEight21_5-2\">5.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Third Wave Analytics (5 September 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/thirdwaveanalytics.com\/blog\/8-essential-features-sample-management-lims-in-a-covid-19-testing-lab\/\" target=\"_blank\">\"The 8 Essential Features for a Sample Management LIMS in a COVID-19 Testing Lab\"<\/a>. 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Retrieved 30 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Hologic%E2%80%99s+Molecular+Test+for+the+Novel+Coronavirus%2C+SARS-CoV-2%2C+Receives+FDA+Emergency+Use+Authorization&rft.atitle=&rft.aulast=Hologic&rft.au=Hologic&rft.date=17+March+2020&rft.pub=Hologic%2C+Inc&rft_id=https%3A%2F%2Fwww.hologic.com%2Fcoronavirus-test&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_workflow_management\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AbbottRealTime20-17\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AbbottRealTime20_17-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Abbott. <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.molecular.abbott\/us\/en\/products\/infectious-disease\/RealTime-SARS-CoV-2-Assay\" target=\"_blank\">\"Abbott RealTime SARS-CoV-2 Assay\"<\/a>. Abbott Laboratories<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.molecular.abbott\/us\/en\/products\/infectious-disease\/RealTime-SARS-CoV-2-Assay\" target=\"_blank\">https:\/\/www.molecular.abbott\/us\/en\/products\/infectious-disease\/RealTime-SARS-CoV-2-Assay<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 30 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Abbott+RealTime+SARS-CoV-2+Assay&rft.atitle=&rft.aulast=Abbott&rft.au=Abbott&rft.pub=Abbott+Laboratories&rft_id=https%3A%2F%2Fwww.molecular.abbott%2Fus%2Fen%2Fproducts%2Finfectious-disease%2FRealTime-SARS-CoV-2-Assay&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_workflow_management\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FEMACorona20-18\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FEMACorona20_18-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Azar, A.M. (10 April 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fema.gov\/press-release\/20210318\/coronavirus-covid-19-pandemic-hhs-letter-hospital-administrators\" target=\"_blank\">\"Coronavirus (COVID-19) Pandemic: HHS Letter to Hospital Administrators\"<\/a>. FEMA<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.fema.gov\/press-release\/20210318\/coronavirus-covid-19-pandemic-hhs-letter-hospital-administrators\" target=\"_blank\">https:\/\/www.fema.gov\/press-release\/20210318\/coronavirus-covid-19-pandemic-hhs-letter-hospital-administrators<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 13 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Coronavirus+%28COVID-19%29+Pandemic%3A+HHS+Letter+to+Hospital+Administrators&rft.atitle=&rft.aulast=Azar%2C+A.M.&rft.au=Azar%2C+A.M.&rft.date=10+April+2020&rft.pub=FEMA&rft_id=https%3A%2F%2Fwww.fema.gov%2Fpress-release%2F20210318%2Fcoronavirus-covid-19-pandemic-hhs-letter-hospital-administrators&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_workflow_management\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20210918214901\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.165 seconds\nReal time usage: 0.240 seconds\nPreprocessor visited node count: 13042\/1000000\nPost\u2010expand include size: 125300\/2097152 bytes\nTemplate argument size: 37746\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 35653\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 154.729 1 -total\n 89.00% 137.715 1 Template:Reflist\n 72.03% 111.444 18 Template:Citation\/core\n 45.31% 70.104 12 Template:Cite_web\n 34.16% 52.849 6 Template:Cite_journal\n 11.14% 17.236 11 Template:Date\n 10.94% 16.935 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_workflow_management\n 5.73% 8.862 23 Template:Citation\/make_link\n 5.48% 8.478 11 Template:Citation\/identifier\n 2.10% 3.243 26 Template:Hide_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11916-0!canonical and timestamp 20210918214901 and revision id 39242. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_workflow_management\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_workflow_management<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","ca4c291ccc7893b51eae4a43ed892dc8_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/a\/ad\/Molecular_diagnostics_qia_symphony.jpg"],"ca4c291ccc7893b51eae4a43ed892dc8_timestamp":1632073386,"34c3276514d9f10cb02cbbef9c7fc276_type":"article","34c3276514d9f10cb02cbbef9c7fc276_title":"3.3 What other considerations should be made?","34c3276514d9f10cb02cbbef9c7fc276_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_other_considerations_should_be_made%3F","34c3276514d9f10cb02cbbef9c7fc276_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Adding COVID-19 and other virus testing to your laboratory\/What other considerations should be made?From LIMSWikiJump to navigationJump to searchContents \n\n1 3.3 What other considerations should be made? \n\n1.1 3.3.1 U.S. regulatory compliance \n1.2 3.3.2 Reporting \n1.3 3.3.3 Billing, Medicare, and Medicaid \n1.4 3.3.4 Biosafety \n\n\n2 References \n3 Citation information for this chapter \n\n\n\n 3.3 What other considerations should be made? \n3.3.1 U.S. regulatory compliance \nIn the previous chapter, the regulatory hurdles of the Health Insurance Portability and Accountability Act (HIPAA) and the Clinical Laboratory Improvement Amendments (CLIA) were addressed. For those laboratories that are already operating in the clinical laboratory sphere, it should be relatively simple to address the additional considerations and pandemic-specific changes to those two regulations as described previously. In addition to that information, you can always periodically check the U.S. Department of Health & Human Services' (HHS') Office for Civil Rights and their COVID-19 announcements and guidance, as well as the Centers for Medicare & Medicaid Services (CMS) emergencies page.\nIf for some reason you're not a clinical lab\u2014or want to start a new lab\u2014and want to take on COVID-19 and other clinical testing, you're going to need to get fast tracked into the CLIA program, for starters. Fortunately, CMS has already displayed a willingness to help labs wanting to perform COVID-19 testing receive their CLIA certificate rapidly. Form CMS-116 will need to be completed and submitted to your state survey agency contact. Of course, while you're waiting, you'll also want to become familiar with the trappings of CLIA by tapping into resources like the CMS page for CLIA, CDC page for CLIA, and resources available from professional organizations like the American Academy of Family Physicians. If all goes as planned, and directions are followed, you should have your CLIA certificate in no time. CMS adds[1]:\n\nWe want to ensure that laboratories located in the United States applying for a CLIA certificate are able to begin testing for COVID-19 as quickly as possible. Once the laboratory has identified a qualified laboratory director and has provided all required information on the CMS-116 application, a CLIA number will be assigned. Once the CLIA number has been assigned, the laboratory can begin testing as long as applicable CLIA requirements have been met (e.g., establishing performance specifications).\nOn the HIPAA side of things, you'll want to tap into resources such as the HHS' HIPAA training materials and resources, as well as their previously mentioned COVID-19 announcements and guidance.\nOther considerations include[2][3][4][5]:\n\ntaking the time to get accredited to ISO 15189:2012 Medical laboratories \u2014 Requirements for quality and competence, \"used by medical laboratories in developing their quality management systems and assessing their own competence\"[6];\nunderstanding and training on packaging (e.g., UN3373 Biological Substance, Category B) and shipping COVID-19 specimens (e.g., International Air Transport Association (IATA) Dangerous Goods Regulations), if you will be conducting such activities;\nunderstanding the significance of and validating workflow procedures to at least Biosafety Level 2 (note there is no single U.S. government entity which has total responsibility for enforcing biosafety levels[7]); and\nunderstanding and training on Occupational Safety and Health Administration (OSHA) requirements for laboratory workers and employers for COVID-19.\n3.3.2 Reporting \nThe topic of reporting COVID-19 results to local and regional health departments\u2014as well as any internal medical reporting\u2014is covered in detail in the next chapter. You'll want to be sure you and your team understand your state's health department reporting requirements, as well as what code sets (e.g., LOINC, SNOMED, ICD, and CPT) to use. The success of epidemiologists' response to outbreaks and pandemics depends on quality data reporting, and using the correct code sets helps labs meet reporting requirements, as well as ensure proper payment. The U.S. Centers for Disease Control and Prevention provides guidance on how to report COVID-19 laboratory data, which also makes for necessary reading.\n\n 3.3.3 Billing, Medicare, and Medicaid \nThe COVID-19 pandemic has unquestionably put the U.S. health care system in a tough spot. That health care system, with all its warts[8][9][10], has arguably not done well to handle so many unanticipated health issues from a broad portion of the population.[10][11][12][13][14][15] From a provider side, proper reimbursement for COVID-19 testing is among the many issues that must be addressed. One key aspect of ensuring proper reimbursement in a reasonable time frame is first making sure a clear preregistration process that captures critical patient and facility information is conducted. (This can be facilitated and made easier as a first-step process in a clinical informatics solution, for example.) Critical patient and facility information includes (but is not limited to):\n\nname, date of birth, and gender\nrace and ethnicity\ndemographic information such as full address and phone number\nordering physician or attending health care provider for test (if applicable)\nfacility's National Provider Identifier (NPI)\npatient insurance company name, policy ID, group ID, insured's name, and insured relationship to patient (if insured)\nwhether or not it's the patient's first test (federal reporting requirement)\nwhether or not the patient is a resident of a congregate care setting (federal reporting requirement; also, e.g., additional Medicaid reimbursement may be available in some states[16])\nwhether or not the patient is a healthcare worker (federal reporting requirement; also, e.g., may affect the patient's worker's compensation claim[17][18])\nwhether or not the patient is pregnant (federal reporting requirement; also, e.g., Medicare will only accept a COVID-19 code as secondary if the primary diagnosis code is viral disease complicating pregnancy, childbirth, or puerperium[19][20])\nSecondarily, it's also important to have a plan in place for testing the uninsured. While the Families First and Coronavirus Relief Act (FFCRA) and the National Disaster Management System (NDMS) have historically provided legal mechanisms for reimbursement for what should otherwise be free patient testing for SARS-CoV-2 and the associated visit, ambiguities of these mechanisms and how they were enforced still managed to cause problems.[21] For example, while providers could turn to the NDMS (until funds ran out) to pay uninsured claims at 110% of Medicare rates\u2014with states' opting to cover those costs through their Medicaid program\u2014providers were not obligated by the law to seek reimbursement from those entities and could optionally bill the uninsured patient directly, which was against the spirit of the FFCRA.[21][22][23] Given these past problems and any lingering questions about existing programs like the HHS and HRSA coverage assistance programs[19], it's important to know what your lab's policy will be on managing uninsured patient claims. How will you get reimbursed if you're accepting uninsured patients? Resources that may help with these decisions include the Health Resources & Services Administration's information page and associated FAQ.\nFor Medicare, Medicaid, and otherwise insured patients, the lab will likely have (or presumably acquire) someone on hand with billing experience. However, the preregistration information previously mentioned will still be important to implement. And staying up-to-date regarding billing issues is also important (e.g., CMS' October 2020 announcement about payment for high-throughput COVID-19 tests and turnaround times[24] \nFor further guidance on billing issues, you may wish to consult with CMS' extensive document titled COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing. Also, the next chapter addresses code sets for reporting and billing, which may prove useful.\n\n3.3.4 Biosafety \nLike any other communicable disease, laboratories handling specimens that are suspected or confirmed of containing the SARS-CoV-2 virus must take appropriate precautions to protect all stakeholders. This involves not only any in-house protocols for preventing contamination but also any official guidance that goes beyond or supersedes in-house protocols. Examples of guidance documents include the World Health Organization's Laboratory biosafety guidance related to coronavirus disease (COVID-19), the CDC's Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19), and the CDC's Guidance for General Laboratory Safety Practices during the COVID-19 Pandemic. Additionally, it may be helpful to look to what other laboratories are doing. In a brief article published in The Lancet Microbe, Choy highlights an International Federation of Clinical Chemistry and Laboratory Medicine Taskforce survey of biochemistry labs and how they've been mitigating biohazard risks associated with SARS-CoV-2. Actions include[25]:\n\nrestricting laboratorian access to testing of suspected and confirmed COVID-19 patient samples;\ntightening of delivery and shipping procedures of suspected and confirmed COVID-19 patient samples;\nlimiting add-on test requests for suspected and confirmed COVID-19 patients;\nincreasing the frequency of disinfection; and\nconsidering the expanded use of autoclaving before sample disposition.\nAdditional aspects of operations that laboratory managers may wish to implement include \"number of shifts per day, the number of staff per shift, total number of staff accessible to work in the laboratory, shift change frequency, team-splitting arrangements, and fixed work\u2013rest days.\"[25] Arranging staff into smaller teams while reducing the consecutive number of shifts worked may reduce risks; however, managers of labs struggling to meet turnaround times may feel like this isn't realistically possible. In the end, the safety of personnel must be of highest importance, even while trying to rapidly and accurately conduct COVID-19 testing.[25]\n\nReferences \n\n\n\u2191 Centers for Medicare and Medicaid Services. \"Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency\" (PDF). https:\/\/www.cms.gov\/files\/document\/clia-laboratory-covid-19-emergency-frequently-asked-questions.pdf . Retrieved 20 August 2020 .   \n \n\n\u2191 Paul, S. (29 May 2020). \"A Guide to Setting up a Coronavirus (COVID-19) Clinical Diagnostic Testing Laboratory\". Clinical Lab Manager. https:\/\/www.clinicallabmanager.com\/insight\/a-guide-to-setting-up-a-coronavirus-covid-19-clinical-diagnostic-testing-laboratory-22850 . Retrieved 13 September 2021 .   \n \n\n\u2191 Buchan, B.W.; Mahlen, S.D.; Relich, R.F. (January 2019). \"Interim Clinical Laboratory Guideline for Biological Safety\" (PDF). The American Society for Microbiology. https:\/\/asm.org\/ASM\/media\/Policy-and-Advocacy\/Biosafety-white-paper-2019.pdf . Retrieved 20 August 2020 .   \n \n\n\u2191 Centers for Disease Control and Prevention (24 August 2021). \"Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/faqs.html . Retrieved 13 September 2021 .   \n \n\n\u2191 \"COVID-19 - Control and Prevention - Laboratory Workers and Employers\". Occupational Safety and Health Administration. https:\/\/www.osha.gov\/coronavirus\/control-prevention\/laboratory . Retrieved 13 September 2021 .   \n \n\n\u2191 \"ISO 15189:2012 Medical laboratories \u2014 Requirements for quality and competence\". International Organization for Standardization. August 2014. https:\/\/www.iso.org\/standard\/56115.html . Retrieved 20 August 2020 .   \n \n\n\u2191 National Academy of Sciences and National Research Council (2012). \"Appendix E - Country and Region Overviews\". Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories: Summary of a Workshop. National Academies Press. pp. 193\u2013204. doi:10.17226\/13315. ISBN 9780309225786. https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK196149\/ .   \n \n\n\u2191 Preskitt, J.T. (2008). \"Health care reimbursement: Clemens to Clinton\". Baylor University Medical Center Proceedings 21 (1): 40\u20134. doi:10.1080\/08998280.2008.11928358. PMC PMC2190551. PMID 18209755. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC2190551 .   \n \n\n\u2191 Fifer, R. (July 2016). \"Health Care Economics: The Real Source of Reimbursement Problems\". American Speech-Language-Hearing Association. https:\/\/www.asha.org\/Articles\/Health-Care-Economics-The-Real-Source-of-Reimbursement-Problems\/ . Retrieved 21 August 2020 .   \n \n\n\u2191 10.0 10.1 Huckman, R.S. (7 April 2020). \"What Will U.S. Health Care Look Like After the Pandemic?\". Harvard Business Review. https:\/\/hbr.org\/2020\/04\/what-will-u-s-health-care-look-like-after-the-pandemic . Retrieved 21 August 2020 .   \n \n\n\u2191 Dorsett, M. (2020). \"Point of no return: COVID-19 and the U.S. healthcare system: An emergency physician\u2019s perspective\". Science Advances 6 (26): eabc5354. doi:10.1126\/sciadv.abc5354. PMC PMC7319747. PMID 32637627. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7319747 .   \n \n\n\u2191 Slotkin, J.R.; Murphy, K.; Ryu, J. (11 June 2020). \"How One Health System Is Transforming in Response to Covid-19\". Harvard Business Review. https:\/\/hbr.org\/2020\/06\/how-one-health-system-is-transforming-in-response-to-covid-19 . Retrieved 21 August 2020 .   \n \n\n\u2191 Mendelson, D. (30 June 2020). \"The Impact Of COVID-19 On Providers: Risk, Recession And Reimbursement\". Forbes. https:\/\/www.forbes.com\/sites\/danielmendelson\/2020\/06\/30\/the-impact-of-covid-19-on-providers-risk-recession-and-reimbursement\/ . Retrieved 21 August 2020 .   \n \n\n\u2191 \"What has the pandemic revealed about the US health care system \u2014 and what needs to change?\". MIT News. Massachusetts Institute of Technology. 5 April 2021. https:\/\/news.mit.edu\/2021\/what-has-pandemic-revealed-about-us-health-care-what-needs-change-0405 . Retrieved 13 September 2021 .   \n \n\n\u2191 Scott, D. (6 July 2021). \"The US health system was already falling short. Then Covid-19 happened.\". Vox. https:\/\/www.vox.com\/policy-and-politics\/22555949\/us-health-care-system-ranking-covid-19-pandemic . Retrieved 13 September 2021 .   \n \n\n\u2191 Flinn, B. (12 June 2020). \"States Leverage Medicaid to Provide Nursing Homes a Lifeline through COVID-19\". LeadingAge. https:\/\/www.leadingage.org\/regulation\/states-leverage-medicaid-provide-nursing-homes-lifeline-through-covid-19 . Retrieved 21 August 2020 .   \n \n\n\u2191 Division of Federal Employees' Compensation (6 May 2021). \"Claims under the Federal Employees' Compensation Act due to the 2019 Novel Coronavirus (COVID-19)\". U.S. Department of Labor. https:\/\/www.dol.gov\/agencies\/owcp\/FECA\/InfoFECACoverageCoronavirus . Retrieved 13 September 2021 .   \n \n\n\u2191 Department of Attorney General (2020). \"Worker's Compensation for First Responders\". State of Michigan. Archived from the original on 21 August 2021. https:\/\/web.archive.org\/web\/20200821194015\/https:\/\/www.michigan.gov\/ag\/0,4534,7-359-98784_98791-523085--,00.html . Retrieved 13 September 2021 .   \n \n\n\u2191 19.0 19.1 \"COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured\". Health Resources & Services Administration. May 2020. https:\/\/www.hrsa.gov\/CovidUninsuredClaim . Retrieved 21 August 2020 .   \n \n\n\u2191 \"Coding Guidance for COVID-19\". American College of Emergency Physicians. 2020. https:\/\/www.acep.org\/administration\/reimbursement\/covid-19\/ . Retrieved 21 August 2020 .   \n \n\n\u2191 21.0 21.1 Adler, L.; Young, C.L. (13 July 2020). \"The laws governing COVID-19 test payment and how to improve them\". USC-Brookings Schaeffer Initiative for Health Policy. Brookings Institution. https:\/\/www.brookings.edu\/blog\/usc-brookings-schaeffer-on-health-policy\/2020\/07\/13\/the-laws-governing-covid-19-test-payment-and-how-to-improve-them\/ . Retrieved 21 August 2020 .   \n \n\n\u2191 Dawson, L. (22 April 2020). \"The National Disaster Medical System (NDMS) and the COVID-19 Pandemic\". KFF. https:\/\/www.kff.org\/coronavirus-covid-19\/issue-brief\/the-national-disaster-medical-system-ndms-and-the-covid-19-pandemic\/ . Retrieved 21 August 2020 .   \n \n\n\u2191 Congressional Research Service (17 April 2020). \"Health Care Provisions in the Families First Coronavirus Response Act, P.L. 116-127\". https:\/\/crsreports.congress.gov\/product\/pdf\/R\/R46316 . Retrieved 21 August 2020 .   \n \n\n\u2191 \"CMS Changes Medicare Payment to Support Faster COVID-19 Diagnostic Testing\". CMS Newsroom. Centers for Medicare & Medicaid Services. 15 October 2020. https:\/\/www.cms.gov\/newsroom\/press-releases\/cms-changes-medicare-payment-support-faster-covid-19-diagnostic-testing . Retrieved 20 November 2020 .   \n \n\n\u2191 25.0 25.1 25.2 Choy, K.W. (2020). \"Changes in clinical laboratory operations and biosafety measures to mitigate biohazard risks during the COVID-19 pandemic\". The Lancet Microbe 1 (7): E273-E274. doi:10.1016\/S2666-5247(20)30168-3.   \n \n\n\n\r\n\n\n-----Go to the next chapter of this guide-----\nCitation information for this chapter \nChapter: 3. Adding COVID-19 and other virus testing to your laboratory\nEdition: Fall 2021\nTitle: COVID-19 Testing, Reporting, and Information Management in the Laboratory\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: September 2021\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_other_considerations_should_be_made%3F\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_other_considerations_should_be_made%3F<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 19 September 2021, at 17:24.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 261 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","34c3276514d9f10cb02cbbef9c7fc276_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Adding_COVID-19_and_other_virus_testing_to_your_laboratory_What_other_considerations_should_be_made rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Adding_COVID-19_and_other_virus_testing_to_your_laboratory_What_other_considerations_should_be_made skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Adding COVID-19 and other virus testing to your laboratory\/What other considerations should be made?<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\">\n\n<h3><span id=\"rdp-ebb-3.3_What_other_considerations_should_be_made?\"><\/span><span class=\"mw-headline\" id=\"3.3_What_other_considerations_should_be_made.3F\">3.3 What other considerations should be made?<\/span><\/h3>\n<h4><span class=\"mw-headline\" id=\"3.3.1_U.S._regulatory_compliance\">3.3.1 U.S. regulatory compliance<\/span><\/h4>\n<p>In the previous chapter, the regulatory hurdles of the <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_Insurance_Portability_and_Accountability_Act\" title=\"Health Insurance Portability and Accountability Act\" class=\"wiki-link\" data-key=\"b70673a0117c21576016cb7498867153\">Health Insurance Portability and Accountability Act<\/a> (HIPAA) and the <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments\" title=\"Clinical Laboratory Improvement Amendments\" class=\"wiki-link\" data-key=\"64bdae1dc17c40c28e0c560396a6ae35\">Clinical Laboratory Improvement Amendments<\/a> (CLIA) were addressed. For those laboratories that are already operating in the clinical laboratory sphere, it should be relatively simple to address the additional considerations and pandemic-specific changes to those two regulations as described previously. In addition to that information, you can always periodically check the U.S. Department of Health & Human Services' (HHS') <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hhs.gov\/hipaa\/for-professionals\/special-topics\/hipaa-covid19\/index.html\" target=\"_blank\">Office for Civil Rights<\/a> and their COVID-19 announcements and guidance, as well as the Centers for Medicare & Medicaid Services (CMS) <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/About-CMS\/Agency-Information\/Emergency\/EPRO\/Current-Emergencies\/Current-Emergencies-page\" target=\"_blank\">emergencies page<\/a>.\n<\/p><p>If for some reason you're not a clinical lab\u2014or want to start a new lab\u2014and want to take on COVID-19 and other clinical testing, you're going to need to get fast tracked into the CLIA program, for starters. Fortunately, CMS has already displayed a willingness to help labs wanting to perform COVID-19 testing receive their CLIA certificate rapidly. <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/Medicare\/CMS-Forms\/CMS-Forms\/Downloads\/CMS116.pdf\" target=\"_blank\">Form CMS-116<\/a> will need to be completed and submitted to your <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/CLIA\/Downloads\/CLIASA.pdf\" target=\"_blank\">state survey agency contact<\/a>. Of course, while you're waiting, you'll also want to become familiar with the trappings of CLIA by tapping into resources like the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/regulations-and-guidance\/legislation\/clia\" target=\"_blank\">CMS page for CLIA<\/a>, <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/clia\/quick-tips.html\" target=\"_blank\">CDC page for CLIA<\/a>, and resources available from professional organizations like the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafp.org\/family-physician\/practice-and-career\/managing-your-practice\/clia.html\" target=\"_blank\">American Academy of Family Physicians<\/a>. If all goes as planned, and directions are followed, you should have your CLIA certificate in no time. CMS adds<sup id=\"rdp-ebb-cite_ref-CMSFAQ_1-0\" class=\"reference\"><a href=\"#cite_note-CMSFAQ-1\">[1]<\/a><\/sup>:\n<\/p>\n<blockquote><p>We want to ensure that laboratories located in the United States applying for a CLIA certificate are able to begin testing for COVID-19 as quickly as possible. Once the laboratory has identified a qualified laboratory director and has provided all required information on the CMS-116 application, a CLIA number will be assigned. Once the CLIA number has been assigned, the laboratory can begin testing as long as applicable CLIA requirements have been met (e.g., establishing performance specifications).<\/p><\/blockquote>\n<p>On the HIPAA side of things, you'll want to tap into resources such as the HHS' <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hhs.gov\/hipaa\/for-professionals\/training\/index.html\" target=\"_blank\">HIPAA training materials and resources<\/a>, as well as their previously mentioned COVID-19 announcements and guidance.\n<\/p><p>Other considerations include<sup id=\"rdp-ebb-cite_ref-PaulAGuide20_2-0\" class=\"reference\"><a href=\"#cite_note-PaulAGuide20-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BuchanInterim19_3-0\" class=\"reference\"><a href=\"#cite_note-BuchanInterim19-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CDCFrequently20_4-0\" class=\"reference\"><a href=\"#cite_note-CDCFrequently20-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-OSHACOVID20_5-0\" class=\"reference\"><a href=\"#cite_note-OSHACOVID20-5\">[5]<\/a><\/sup>:\n<\/p>\n<ul><li>taking the time to get accredited to ISO 15189:2012 Medical laboratories \u2014 Requirements for quality and competence, \"used by medical laboratories in developing their quality management systems and assessing their own competence\"<sup id=\"rdp-ebb-cite_ref-ISO15189_6-0\" class=\"reference\"><a href=\"#cite_note-ISO15189-6\">[6]<\/a><\/sup>;<\/li>\n<li>understanding and training on packaging (e.g., UN3373 Biological Substance, Category B) and shipping COVID-19 specimens (e.g., International Air Transport Association (IATA) Dangerous Goods Regulations), if you will be conducting such activities;<\/li>\n<li>understanding the significance of and validating workflow procedures to at least Biosafety Level 2 (note there is no single U.S. government entity which has total responsibility for enforcing biosafety levels<sup id=\"rdp-ebb-cite_ref-NASNRCBiosec12_7-0\" class=\"reference\"><a href=\"#cite_note-NASNRCBiosec12-7\">[7]<\/a><\/sup>); and<\/li>\n<li>understanding and training on Occupational Safety and Health Administration (OSHA) requirements for laboratory workers and employers for COVID-19.<\/li><\/ul>\n<h4><span class=\"mw-headline\" id=\"3.3.2_Reporting\">3.3.2 Reporting<\/span><\/h4>\n<p>The topic of reporting COVID-19 results to local and regional health departments\u2014as well as any internal medical reporting\u2014is covered in detail in the next chapter. You'll want to be sure you and your team understand your state's health department reporting requirements, as well as what code sets (e.g., <a href=\"https:\/\/www.limswiki.org\/index.php\/LOINC\" title=\"LOINC\" class=\"wiki-link\" data-key=\"b20c83dbfab36194bab6c223e31ebfdc\">LOINC<\/a>, <a href=\"https:\/\/www.limswiki.org\/index.php\/SNOMED_CT\" title=\"SNOMED CT\" class=\"wiki-link\" data-key=\"a04000c818ae954bf52cfea5efdf020d\">SNOMED<\/a>, <a href=\"https:\/\/www.limswiki.org\/index.php\/International_Statistical_Classification_of_Diseases_and_Related_Health_Problems\" title=\"International Statistical Classification of Diseases and Related Health Problems\" class=\"wiki-link\" data-key=\"1de9af67005dfe2895e5d8cf6de57d4a\">ICD<\/a>, and <a href=\"https:\/\/www.limswiki.org\/index.php\/Current_Procedural_Terminology\" title=\"Current Procedural Terminology\" class=\"wiki-link\" data-key=\"c5cc3e305001a68af1f9c5aa568d6260\">CPT<\/a>) to use. The success of epidemiologists' response to outbreaks and pandemics depends on quality data reporting, and using the correct code sets helps labs meet reporting requirements, as well as ensure proper payment. The U.S. Centers for Disease Control and Prevention provides guidance on how to <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/reporting-lab-data.html\" target=\"_blank\">report COVID-19 laboratory data<\/a>, which also makes for necessary reading.\n<\/p>\n<h4><span id=\"rdp-ebb-3.3.3_Billing,_Medicare,_and_Medicaid\"><\/span><span class=\"mw-headline\" id=\"3.3.3_Billing.2C_Medicare.2C_and_Medicaid\">3.3.3 Billing, Medicare, and Medicaid<\/span><\/h4>\n<p>The COVID-19 pandemic has unquestionably put the U.S. health care system in a tough spot. That health care system, with all its warts<sup id=\"rdp-ebb-cite_ref-PreskittHealth08_8-0\" class=\"reference\"><a href=\"#cite_note-PreskittHealth08-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FiferHealth16_9-0\" class=\"reference\"><a href=\"#cite_note-FiferHealth16-9\">[9]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HuckmanWhat20_10-0\" class=\"reference\"><a href=\"#cite_note-HuckmanWhat20-10\">[10]<\/a><\/sup>, has arguably not done well to handle so many unanticipated health issues from a broad portion of the population.<sup id=\"rdp-ebb-cite_ref-HuckmanWhat20_10-1\" class=\"reference\"><a href=\"#cite_note-HuckmanWhat20-10\">[10]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DorsettPoint20_11-0\" class=\"reference\"><a href=\"#cite_note-DorsettPoint20-11\">[11]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SlotkinHow20_12-0\" class=\"reference\"><a href=\"#cite_note-SlotkinHow20-12\">[12]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MendelsonProvid20_13-0\" class=\"reference\"><a href=\"#cite_note-MendelsonProvid20-13\">[13]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MITWhat21_14-0\" class=\"reference\"><a href=\"#cite_note-MITWhat21-14\">[14]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ScottTheUS21_15-0\" class=\"reference\"><a href=\"#cite_note-ScottTheUS21-15\">[15]<\/a><\/sup> From a provider side, proper reimbursement for COVID-19 testing is among the many issues that must be addressed. One key aspect of ensuring proper reimbursement in a reasonable time frame is first making sure a clear preregistration process that captures critical patient and facility information is conducted. (This can be facilitated and made easier as a first-step process in a clinical informatics solution, for example.) Critical patient and facility information includes (but is not limited to):\n<\/p>\n<ul><li>name, date of birth, and gender<\/li>\n<li>race and ethnicity<\/li>\n<li>demographic information such as full address and phone number<\/li>\n<li>ordering physician or attending health care provider for test (if applicable)<\/li>\n<li>facility's National Provider Identifier (NPI)<\/li>\n<li>patient insurance company name, policy ID, group ID, insured's name, and insured relationship to patient (if insured)<\/li>\n<li>whether or not it's the patient's first test (federal reporting requirement)<\/li>\n<li>whether or not the patient is a resident of a congregate care setting (federal reporting requirement; also, e.g., additional Medicaid reimbursement may be available in some states<sup id=\"rdp-ebb-cite_ref-FlinnStates20_16-0\" class=\"reference\"><a href=\"#cite_note-FlinnStates20-16\">[16]<\/a><\/sup>)<\/li>\n<li>whether or not the patient is a healthcare worker (federal reporting requirement; also, e.g., may affect the patient's worker's compensation claim<sup id=\"rdp-ebb-cite_ref-DOLClaimsUnder20_17-0\" class=\"reference\"><a href=\"#cite_note-DOLClaimsUnder20-17\">[17]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MichiganWorkers20_18-0\" class=\"reference\"><a href=\"#cite_note-MichiganWorkers20-18\">[18]<\/a><\/sup>)<\/li>\n<li>whether or not the patient is pregnant (federal reporting requirement; also, e.g., Medicare will <i>only<\/i> accept a COVID-19 code as secondary if the primary diagnosis code is viral disease complicating pregnancy, childbirth, or puerperium<sup id=\"rdp-ebb-cite_ref-HSRACOVID20_19-0\" class=\"reference\"><a href=\"#cite_note-HSRACOVID20-19\">[19]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ACEPCoding20_20-0\" class=\"reference\"><a href=\"#cite_note-ACEPCoding20-20\">[20]<\/a><\/sup>)<\/li><\/ul>\n<p>Secondarily, it's also important to have a plan in place for testing the uninsured. While the Families First and Coronavirus Relief Act (FFCRA) and the National Disaster Management System (NDMS) have historically provided legal mechanisms for reimbursement for what should otherwise be free patient testing for SARS-CoV-2 and the associated visit, ambiguities of these mechanisms and how they were enforced still managed to cause problems.<sup id=\"rdp-ebb-cite_ref-AdlerTheLaws20_21-0\" class=\"reference\"><a href=\"#cite_note-AdlerTheLaws20-21\">[21]<\/a><\/sup> For example, while providers could turn to the NDMS (until funds ran out) to pay uninsured claims at 110% of Medicare rates\u2014with states' opting to cover those costs through their Medicaid program\u2014providers were not obligated by the law to seek reimbursement from those entities and could optionally bill the uninsured patient directly, which was against the spirit of the FFCRA.<sup id=\"rdp-ebb-cite_ref-AdlerTheLaws20_21-1\" class=\"reference\"><a href=\"#cite_note-AdlerTheLaws20-21\">[21]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DawsonTheNat20_22-0\" class=\"reference\"><a href=\"#cite_note-DawsonTheNat20-22\">[22]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CRSHealth20_23-0\" class=\"reference\"><a href=\"#cite_note-CRSHealth20-23\">[23]<\/a><\/sup> Given these past problems and any lingering questions about existing programs like the HHS and HRSA coverage assistance programs<sup id=\"rdp-ebb-cite_ref-HSRACOVID20_19-1\" class=\"reference\"><a href=\"#cite_note-HSRACOVID20-19\">[19]<\/a><\/sup>, it's important to know what your lab's policy will be on managing uninsured patient claims. How will you get reimbursed if you're accepting uninsured patients? Resources that may help with these decisions include the Health Resources & Services Administration's <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hrsa.gov\/CovidUninsuredClaim\" target=\"_blank\">information page<\/a> and <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hrsa.gov\/coviduninsuredclaim\/frequently-asked-questions\" target=\"_blank\">associated FAQ<\/a>.\n<\/p><p>For Medicare, Medicaid, and otherwise insured patients, the lab will likely have (or presumably acquire) someone on hand with billing experience. However, the preregistration information previously mentioned will still be important to implement. And staying up-to-date regarding billing issues is also important (e.g., CMS' October 2020 announcement about payment for high-throughput COVID-19 tests and turnaround times<sup id=\"rdp-ebb-cite_ref-CMSChanges20_24-0\" class=\"reference\"><a href=\"#cite_note-CMSChanges20-24\">[24]<\/a><\/sup> \n<\/p><p>For further guidance on billing issues, you may wish to consult with CMS' <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/files\/document\/03092020-covid-19-faqs-508.pdf\" target=\"_blank\">extensive document<\/a> titled <i>COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing<\/i>. Also, the next chapter addresses code sets for reporting and billing, which may prove useful.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"3.3.4_Biosafety\">3.3.4 Biosafety<\/span><\/h4>\n<p>Like any other communicable disease, laboratories handling specimens that are suspected or confirmed of containing the SARS-CoV-2 virus must take appropriate precautions to protect all stakeholders. This involves not only any in-house protocols for preventing contamination but also any official guidance that goes beyond or supersedes in-house protocols. Examples of guidance documents include the World Health Organization's <i><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/publications\/i\/item\/WHO-WPE-GIH-2021.1\" target=\"_blank\">Laboratory biosafety guidance related to coronavirus disease (COVID-19)<\/a><\/i>, the CDC's <i><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-nCoV\/lab\/lab-biosafety-guidelines.html\" target=\"_blank\">Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19)<\/a><\/i>, and the CDC's <i><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/lab-safety-practices.html\" target=\"_blank\">Guidance for General Laboratory Safety Practices during the COVID-19 Pandemic<\/a><\/i>. Additionally, it may be helpful to look to what other laboratories are doing. In a brief article published in <i>The Lancet Microbe<\/i>, Choy highlights an International Federation of Clinical Chemistry and Laboratory Medicine Taskforce survey of biochemistry labs and how they've been mitigating biohazard risks associated with SARS-CoV-2. Actions include<sup id=\"rdp-ebb-cite_ref-ChoyChanges20_25-0\" class=\"reference\"><a href=\"#cite_note-ChoyChanges20-25\">[25]<\/a><\/sup>:\n<\/p>\n<ul><li>restricting laboratorian access to testing of suspected and confirmed COVID-19 patient samples;<\/li>\n<li>tightening of delivery and shipping procedures of suspected and confirmed COVID-19 patient samples;<\/li>\n<li>limiting add-on test requests for suspected and confirmed COVID-19 patients;<\/li>\n<li>increasing the frequency of disinfection; and<\/li>\n<li>considering the expanded use of autoclaving before sample disposition.<\/li><\/ul>\n<p>Additional aspects of operations that laboratory managers may wish to implement include \"number of shifts per day, the number of staff per shift, total number of staff accessible to work in the laboratory, shift change frequency, team-splitting arrangements, and fixed work\u2013rest days.\"<sup id=\"rdp-ebb-cite_ref-ChoyChanges20_25-1\" class=\"reference\"><a href=\"#cite_note-ChoyChanges20-25\">[25]<\/a><\/sup> Arranging staff into smaller teams while reducing the consecutive number of shifts worked may reduce risks; however, managers of labs struggling to meet turnaround times may feel like this isn't realistically possible. In the end, the safety of personnel must be of highest importance, even while trying to rapidly and accurately conduct COVID-19 testing.<sup id=\"rdp-ebb-cite_ref-ChoyChanges20_25-2\" class=\"reference\"><a href=\"#cite_note-ChoyChanges20-25\">[25]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-CMSFAQ-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CMSFAQ_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Medicare and Medicaid Services. <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/files\/document\/clia-laboratory-covid-19-emergency-frequently-asked-questions.pdf\" target=\"_blank\">\"Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency\"<\/a> (PDF)<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cms.gov\/files\/document\/clia-laboratory-covid-19-emergency-frequently-asked-questions.pdf\" target=\"_blank\">https:\/\/www.cms.gov\/files\/document\/clia-laboratory-covid-19-emergency-frequently-asked-questions.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 20 August 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Frequently+Asked+Questions+%28FAQs%29%2C+CLIA+Guidance+During+the+COVID-19+Emergency&rft.atitle=&rft.aulast=Centers+for+Medicare+and+Medicaid+Services&rft.au=Centers+for+Medicare+and+Medicaid+Services&rft_id=https%3A%2F%2Fwww.cms.gov%2Ffiles%2Fdocument%2Fclia-laboratory-covid-19-emergency-frequently-asked-questions.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_other_considerations_should_be_made%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PaulAGuide20-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PaulAGuide20_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Paul, S. (29 May 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.clinicallabmanager.com\/insight\/a-guide-to-setting-up-a-coronavirus-covid-19-clinical-diagnostic-testing-laboratory-22850\" target=\"_blank\">\"A Guide to Setting up a Coronavirus (COVID-19) Clinical Diagnostic Testing Laboratory\"<\/a>. <i>Clinical Lab Manager<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.clinicallabmanager.com\/insight\/a-guide-to-setting-up-a-coronavirus-covid-19-clinical-diagnostic-testing-laboratory-22850\" target=\"_blank\">https:\/\/www.clinicallabmanager.com\/insight\/a-guide-to-setting-up-a-coronavirus-covid-19-clinical-diagnostic-testing-laboratory-22850<\/a><\/span><span class=\"reference-accessdate\">. 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Retrieved 21 August 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+laws+governing+COVID-19+test+payment+and+how+to+improve+them&rft.atitle=USC-Brookings+Schaeffer+Initiative+for+Health+Policy&rft.aulast=Adler%2C+L.%3B+Young%2C+C.L.&rft.au=Adler%2C+L.%3B+Young%2C+C.L.&rft.date=13+July+2020&rft.pub=Brookings+Institution&rft_id=https%3A%2F%2Fwww.brookings.edu%2Fblog%2Fusc-brookings-schaeffer-on-health-policy%2F2020%2F07%2F13%2Fthe-laws-governing-covid-19-test-payment-and-how-to-improve-them%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_other_considerations_should_be_made%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DawsonTheNat20-22\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DawsonTheNat20_22-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Dawson, L. (22 April 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.kff.org\/coronavirus-covid-19\/issue-brief\/the-national-disaster-medical-system-ndms-and-the-covid-19-pandemic\/\" target=\"_blank\">\"The National Disaster Medical System (NDMS) and the COVID-19 Pandemic\"<\/a>. <i>KFF<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.kff.org\/coronavirus-covid-19\/issue-brief\/the-national-disaster-medical-system-ndms-and-the-covid-19-pandemic\/\" target=\"_blank\">https:\/\/www.kff.org\/coronavirus-covid-19\/issue-brief\/the-national-disaster-medical-system-ndms-and-the-covid-19-pandemic\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 August 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+National+Disaster+Medical+System+%28NDMS%29+and+the+COVID-19+Pandemic&rft.atitle=KFF&rft.aulast=Dawson%2C+L.&rft.au=Dawson%2C+L.&rft.date=22+April+2020&rft_id=https%3A%2F%2Fwww.kff.org%2Fcoronavirus-covid-19%2Fissue-brief%2Fthe-national-disaster-medical-system-ndms-and-the-covid-19-pandemic%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_other_considerations_should_be_made%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CRSHealth20-23\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CRSHealth20_23-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Congressional Research Service (17 April 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/crsreports.congress.gov\/product\/pdf\/R\/R46316\" target=\"_blank\">\"Health Care Provisions in the Families First Coronavirus Response Act, P.L. 116-127\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/crsreports.congress.gov\/product\/pdf\/R\/R46316\" target=\"_blank\">https:\/\/crsreports.congress.gov\/product\/pdf\/R\/R46316<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 21 August 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Health+Care+Provisions+in+the+Families+First+Coronavirus+Response+Act%2C+P.L.+116-127&rft.atitle=&rft.aulast=Congressional+Research+Service&rft.au=Congressional+Research+Service&rft.date=17+April+2020&rft_id=https%3A%2F%2Fcrsreports.congress.gov%2Fproduct%2Fpdf%2FR%2FR46316&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_other_considerations_should_be_made%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CMSChanges20-24\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CMSChanges20_24-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/newsroom\/press-releases\/cms-changes-medicare-payment-support-faster-covid-19-diagnostic-testing\" target=\"_blank\">\"CMS Changes Medicare Payment to Support Faster COVID-19 Diagnostic Testing\"<\/a>. <i>CMS Newsroom<\/i>. Centers for Medicare & Medicaid Services. 15 October 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cms.gov\/newsroom\/press-releases\/cms-changes-medicare-payment-support-faster-covid-19-diagnostic-testing\" target=\"_blank\">https:\/\/www.cms.gov\/newsroom\/press-releases\/cms-changes-medicare-payment-support-faster-covid-19-diagnostic-testing<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 20 November 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=CMS+Changes+Medicare+Payment+to+Support+Faster+COVID-19+Diagnostic+Testing&rft.atitle=CMS+Newsroom&rft.date=15+October+2020&rft.pub=Centers+for+Medicare+%26+Medicaid+Services&rft_id=https%3A%2F%2Fwww.cms.gov%2Fnewsroom%2Fpress-releases%2Fcms-changes-medicare-payment-support-faster-covid-19-diagnostic-testing&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_other_considerations_should_be_made%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ChoyChanges20-25\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-ChoyChanges20_25-0\">25.0<\/a><\/sup> <sup><a href=\"#cite_ref-ChoyChanges20_25-1\">25.1<\/a><\/sup> <sup><a href=\"#cite_ref-ChoyChanges20_25-2\">25.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Choy, K.W. (2020). \"Changes in clinical laboratory operations and biosafety measures to mitigate biohazard risks during the COVID-19 pandemic\". <i>The Lancet Microbe<\/i> <b>1<\/b> (7): E273-E274. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2FS2666-5247%2820%2930168-3\" target=\"_blank\">10.1016\/S2666-5247(20)30168-3<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Changes+in+clinical+laboratory+operations+and+biosafety+measures+to+mitigate+biohazard+risks+during+the+COVID-19+pandemic&rft.jtitle=The+Lancet+Microbe&rft.aulast=Choy%2C+K.W.&rft.au=Choy%2C+K.W.&rft.date=2020&rft.volume=1&rft.issue=7&rft.pages=E273-E274&rft_id=info:doi\/10.1016%2FS2666-5247%2820%2930168-3&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_other_considerations_should_be_made%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<p><br \/>\n<\/p>\n<div align=\"center\">-----Go to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_workflow_management\" title=\"Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Workflow and information management for COVID-19 (and other respiratory diseases)\/Laboratory informatics and workflow management\" class=\"wiki-link\" data-key=\"ca4c291ccc7893b51eae4a43ed892dc8\">the next chapter<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"Citation_information_for_this_chapter\">Citation information for this chapter<\/span><\/h2>\n<p><b>Chapter<\/b>: 3. Adding COVID-19 and other virus testing to your laboratory\n<\/p><p><b>Edition<\/b>: Fall 2021\n<\/p><p><b>Title<\/b>: <i>COVID-19 Testing, Reporting, and Information Management in the Laboratory<\/i>\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: September 2021\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20210919172414\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.185 seconds\nReal time usage: 0.221 seconds\nPreprocessor visited node count: 17772\/1000000\nPost\u2010expand include size: 155763\/2097152 bytes\nTemplate argument size: 55660\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 46572\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 183.718 1 -total\n 88.89% 163.312 1 Template:Reflist\n 71.37% 131.127 25 Template:Citation\/core\n 60.70% 111.515 21 Template:Cite_web\n 13.16% 24.172 19 Template:Date\n 11.05% 20.309 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_other_considerations_should_be_made?\n 9.88% 18.149 3 Template:Cite_journal\n 8.60% 15.804 1 Template:Cite_book\n 5.96% 10.942 9 Template:Citation\/identifier\n 4.28% 7.869 37 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12144-0!canonical and timestamp 20210919172415 and revision id 44134. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_other_considerations_should_be_made%3F\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_other_considerations_should_be_made%3F<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","34c3276514d9f10cb02cbbef9c7fc276_images":[],"34c3276514d9f10cb02cbbef9c7fc276_timestamp":1632073385,"5c08823bef2028cb17c7a3612075ff8e_type":"article","5c08823bef2028cb17c7a3612075ff8e_title":"3.2 What kind of space, equipment, and supplies will you need?","5c08823bef2028cb17c7a3612075ff8e_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F","5c08823bef2028cb17c7a3612075ff8e_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Adding COVID-19 and other virus testing to your laboratory\/What kind of space, equipment, and supplies will you need?From LIMSWikiJump to navigationJump to searchContents \n\n1 3.2 What kind of space, equipment, and supplies will you need? \n\n1.1 3.2.1 Laboratory space arrangements \n1.2 3.2.2 Instruments and assays \n1.3 3.2.3 Reagents \n1.4 3.2.4 Consumables \n1.5 3.2.5 Software and services \n1.6 3.2.6 Major vendors and consultants \n\n\n2 References \n\n\n\n 3.2 What kind of space, equipment, and supplies will you need? \n3.2.1 Laboratory space arrangements \nPCR considerations\nWhether adding PCR to your existing laboratory, modifying existing PCR workflows, or starting from scratch, preventing contamination is a top priority. As PCR can effectively amplify even the tiniest of quantities of DNA and RNA, the risk of amplifying a contaminant and ruining the validity of an assay is very real.[1][2][3][4][5][6][7] Contamination typically comes from non-amplified environmental substances such as aerosols, and from carryover contamination of amplicons from earlier PCR cycles. As such, not only do best-practice processes and procedures (P&P) need to be followed (e.g., unidirectional workflow, thorough cleaning procedures, proper preparation and disposal), but also where to place PCR-related equipment must be carefully considered.[1][2][4][6] \nWhen possible, separate rooms for sample preparation, PCR setup, and post-PCR activities, each with their own airflow control, are encouraged.[1][2][5][6][7] However, the laboratory attempting to add PCR to an already small clinical diagnostic lab may not have the luxury of having multiple rooms. In that case, a single-room setup may suffice, if the workflow areas remain demarcated or physically partitioned. Additionally, a single-room setup must also have stricter P&P and design controls to offset the space constraints. For example, the sample preparation area of the room should have a laminar flow hood with UV light that is regularly cleaned, and post-PCR analysis may need to occur later in the day after cleanup from prior steps.[1][3][7] Of course, always maintaining unidirectional workflow\u2014regardless of number of rooms\u2014is also critical to minimizing contamination. For example, technicians shouldn't be transporting amplified materials into the DNA extraction area. \nAlthough dated, Roche Diagnostics' 2006 PCR Applications Manual[2] provides a detailed breakdown of setting up the laboratory for PCR. Das et al.[6] and Dr. Jennifer Redig[4] provide additional valuable insight. The World Health Organization (WHO) also provides guidance for setting up molecular testing in the lab.[7]\nIsothermal amplification considerations\nSimilarly, because DNA and RNR amplification is involved, contamination concerns exist with isothermal amplification techniques. Multiple pipetting steps and repeated freezing and thawing of reagents can still lead to cross-contamination[8], as does opening the reaction chamber after reaction is completed.[9] However, the advent of microfluidics and lateral flow technologies in isothermal amplification processes has seen the development of \"fully enclosed microstructured devices into which performing the isothermal amplification reduces the risk of sample contamination and allows integration and portable device realization.\"[10][11] Even more cutting-edge techniques to reduce contamination such as the CUT-LAMP technique of Bao et al.[12] or the dUTP\/UDG system for COVID-19 RT-LAMP reactions of Kellner et al.[13] hold further promise in making isothermal amplification processes in the laboratory easier to manage. That said, labs running isothermal amplification processes such as LAMP requiring analysis with agarose gel electrophoresis or a method requiring the opening of reaction vessels will preferably have a secondary area set up for analysis steps so as to minimize the chances of contamination.[14][15]\n\n3.2.2 Instruments and assays \n Eppendorf Mastercycler Pro S, a thermal cycler for PCR and other applications\nHigh- and moderate-complexity CLIA testing\nThermal cyclers are the standard instruments for PCR testing. Today, real-time or quantitative (qPCR) systems largely fill this niche. However, digital and droplet digital PCR systems are emerging, and they have the benefit of producing even more rapid, precise, sensitive, accurate, and reproducible results, and they are capable of direct quantification and multiplexing. Other instruments and accessories for PCR workflows include proper power supplies, analytical balances, electrophoresis chambers, water and\/or dry baths, and mini\/micro centrifuges. However, if you're considering the addition of PCR workflow to your laboratory, the thermal cycler is typically where the largest up-front cost will be. As such, it's important to ask yourself critical questions to help guide your acquisition decisions.\nAs part of their June 2018 survey on PCR equipment, Lab Manager posed five questions potential buyers should ask before making PCR purchases[16]:\n\nDo your current and long-term needs require basic PCR systems, qPCR systems, or digital PCR systems?\nWhat sample formats do you anticipate using?\nWhat throughput requirements do you have now and anticipate in the near future?\nWhat are you willing to sacrifice in regards to temperature ramp up and cool down times and accuracies?\nDo you anticipate needing to run more than one independent PCR at the same time (multiblock PCR)?\nGiven the considerable investment that goes into these and other life science instruments, you may want to seek vendors who have a strong track record of supporting and supplying parts for instruments they manufacture and distribute years after the instruments are introduced.[17]\nAs for PCR-based assays, the U.S. FDA has issued EUAs for more than 200 of them. The most up-to-date listing is of course found at the FDA website. However, sorting through the extra details can be tedious. The Center for Systems Biology at Harvard has been maintaining a contextual PDF chart of the various COVID-19 diagnostic tests, which includes information such as run time, manufacturer-supplied data, and published clinical data (when available). This may prove useful in deciding on one or more particular tests. As with many aspects of this pandemic, other factors that may influence your choice of test kit include overall availability, cost, reagents included with the assay, and reagents separately required and their availability.\nIsothermal amplification techniques have the advantage of not requiring an expensive thermal cycler.[18] Instrument-appropriate reaction vessels, baths, heating units, turbidimeters, thermocyclers, etc. may be required, depending on what type of amplification you're doing. Companies like Meridian Bioscience offer LAMP-based molecular platforms, though they may not offer a specific COVID-19 assay to run on the platform.[19] As can be seen in Table 1, two isothermal amplification assays that run on their own proprietary instrument have received EUAs and are CLIA-waved, with a third potentially on the way. Using these systems and their COVID-19 assays at the point of care provides a somewhat more attractive option for laboratories wanting to add COVID-19 or even multiplex viral assays to their offerings.\n\r\n\nCLIA-waived testing\nIf you're running a POL, or attempting to provide COVID-19 testing at the point of care, you'll be looking at the following molecular diagnostic assays (Table 1) and antigen diagnostic assays (Table 2), depending on the level of accuracy and purpose of use required in your POL. Remember that\u2014broadly speaking\u2014antigen tests tend to have lower sensitivities than molecular tests, leaving antigen tests best used as surveillance or repeat screening tools.[20][21][22] For example, the directions for the BD Veritor System for Rapid Detection of SARS-CoV-2 manufactured by Becton, Dickinson and Company state: \"Sensitivity of the test after the first five days of the onset of symptoms has been demonstrated to decrease as compared to a RT-PCR SARS-CoV-2 assay.\"[23]\n\n\n\n\n\n\n\nTable 1. CLIA-waived COVID-19-related in vitro molecular diagnostic tests (e.g., RT-PCR, LAMP, isothermal amplification) receiving U.S. FDA Emergency Use Authorizations (EUAs)\n\n\nFirst date EUA issued\n\nManufacturer\n\nName of test or assay\n\nRequired instrument\n\nTechnology (Method)\n\nMulti-analyte?\n\nRADx-funded?\n\nApproved for at-home?\n\nAdditional comments\n\n\n20 March 2020\n\nCepheid\n\nXpert Xpress SARS-CoV-2 test\n\nGeneXpert Xpress System (Tablet and Hub Configurations)\n\nMolecular (RT-PCR)\n\nNo\n\nNo\n\nNo\n\nHas largely received positive review of sensitivity and specificity.[24][25][26]\n\n\n23 March 2020\n\nMesa Biotech Inc.\n\nAccula SARS-CoV-2 test\n\nAccula Dock or the Sekisui Diagnostics Silaris Dock (discontinued)\n\nMolecular (RT-PCR)\n\nNo\n\nYes\n\nNo\n\nHas received only minor scrutiny[27], with only several dozen FDA complaints\/reports[28]\n\n\n27 March 2020\n\nAbbott Diagnostics Scarborough, Inc.\n\nID NOW COVID-19\n\nID NOW\n\nMolecular (isothermal amplification)\n\nNo\n\nNo\n\nNo\n\nTargets \"a unique region of the RNA-dependent RNA polymerase (RdRP) gene.\"[29]Device and test were target of FDA scrutiny due to sensitivity issues reported in 2020 and into 2021[30][31][32][33] In October 2020, Abbott released additional study data showing overall sensitivity of 93.3% and specificity of 98.4%, emphasizing the ID NOW's best use with samples taken within seven days of symptom onset.[34] In 2020, some 393 complaints were reported to the FDA, with 1,492 complains being reported in 2021 (through July 31) according to an FDA MAUDE (Manufacturer and User Facility Device Experience) search.[35] On August 27, 2021, the FDA re-issued its EUA for the ID NOW with updated in silico inclusivity analysis results (among other things)[36], but it's not clear if the FDA is continuing to work with Abbott on the test's accuracy claims.\n\n\n10 June 2020\n\nCue Health Inc.\n\nCue COVID-19 Test Cartridge\n\nCue Health Monitoring System\n\nMolecular (isothermal amplification)\n\nNo\n\nNo\n\nNo\n\n\"Test primers amplify the nucleocapsid (N) region of the gene\"[37]\n\n\n14 September 2020\n\nRoche Molecular Systems, Inc.\n\ncobas SARS-CoV-2 & Influenza A\/B Assay\n\ncobas Liat PCR System\n\nMolecular (RT-PCR)\n\nYes\n\nNo\n\nNo\n\nEveritt et al. offer some discussion and citations concerning research related to the cobas LIAT PCR system and its assays.[38]\n\n\n24 September 2020\n\nCepheid\n\nXpert Xpress SARS-CoV-2\/Flu\/RSV test\n\nGeneXpert Xpress System (Tablet and Hub Configurations)\n\nMolecular (RT-PCR)\n\nYes\n\nNo\n\nNo\n\nDevelopment of this multiplex assay for SARS-CoV-2, Flu A, Flu B, and RSV was announced in June 2020.[39] After receiving its EUA in September 2020, received advanced development support through the Department of Health and Human Services and the Department of Defense.[40]\n\n\n02 October 2020\n\nBioFire Diagnostics, LLC\n\nBioFire Respiratory 2.1 (RP2.1) Panel\n\nBioFire FilmArray Systems\n\nMolecular (RT-PCR)\n\nYes\n\nNo\n\nNo\n\nFrom the manufacturer: \"The BioFire RP2.1 Panel (EUA) detects 22 respiratory pathogens, including SARS-CoV-2, to help clinicians quickly rule in and rule out common causes of respiratory illness in about 45 minutes.\"[41] Creager et al. reported their evaluation findings in the Journal of Clinical Virology, stating that the panel \"has similar performance to high throughput assays used for the detection of COVID-19.\"[42]\n\n\n17 November 2020\n\nLucira Health, Inc.\n\nLucira COVID-19 All-In-One Test Kit\n\nN\/A\n\nMolecular (RT-LAMP)\n\nNo\n\nNo\n\nYes\n\nFirst complete at-home COVID test kit receiving EUA. For CLIA-waived labs and prescription at-home use. Test device is apparently one-time-use and not reusable.[43]\n\n\n27 November 2020\n\nCepheid\n\nXpert Omni SARS-CoV-2 test\n\nGeneXpert Omni System\n\nMolecular (RT-PCR)\n\nNo\n\nNo\n\nNo\n\nFor CLIA-waived testing, the test is limited to nasopharyngeal, anterior nasal, or mid-turbinate swab specimens.[44] Product status unclear, as it was listed on website in January 2021[45], but not listed there as of September 2021.\n\n\n08 February 2021\n\nVisby Medical, Inc.\n\nVisby Medical COVID-19 Point of Care Test\n\nN\/A\n\nMolecular (RT-PCR)\n\nNo\n\nYes\n\nNo\n\n\"By shrinking rapid PCR technology to palm-sized dimensions and eliminating the need for an additional instrument or reader, Visby Medical\u2019s test provides fast, accurate, and actionable results at the point of need.\"[46]\n\n\n05 March 2021\n\nCue Health Inc.\n\nCue COVID-19 Test for Home and Over The Counter Use\n\nCue Health Monitoring System\n\nMolecular (isothermal amplification)\n\nNo\n\nNo\n\nYes\n\nDescribed as \"the nation\u2019s first molecular diagnostic test available without a prescription to consumers for home use and to enterprise users and healthcare professionals without CLIA certification.\"[47] It is also able to be used for screening purposes.\n\n\n09 April 2021\n\nLucira Health, Inc.\n\nLucira CHECK-IT COVID-19 Test Kit\n\nN\/A\n\nMolecular (RT-LAMP)\n\nNo\n\nNo\n\nYes\n\nAppears to be an over-the-counter (vs. prescription) version of its Lucira COVID-19 All-In-One Test Kit from November 2020. Also able to be used for screening.\n\n\n17 June 2021\n\nRoche Molecular Systems, Inc.\n\ncobas SARS-CoV-2 Assay\n\ncobas Liat PCR System\n\nMolecular (RT-PCR)\n\nNo\n\nNo\n\nNo\n\nAppears to be similar to its multi-analyte product from 2020 but solely for COVID-19, and also able to be used for screening.[48]\n\n\nN\/A (Anticipated)\n\nTalis Biomedical\n\nTalis One Cartridge\n\nTalis One Instrument\n\nMolecular (RT-LAMP)\n\nNo\n\nYes\n\nTo be determined\n\nExpectations are that it will receive an FDA EUA and be CLIA-waived[49], but yet to be determined. As of August 2021, it was still awaiting FDA authorization.[50]\n\n\n\n\n\n\n\n\n\nTable 2. CLIA-waived COVID-19-related in vitro antigen diagnostic tests (e.g., lateral flow, immunoassay, etc.) receiving U.S. FDA Emergency Use Authorizations (EUAs); OTC = Over the counter\n\n\nFirst date EUA issued\n\nManufacturer\n\nName of test or assay\n\nRequired instrument\n\nTechnology (Method)\n\nMulti-analyte?\n\nRADx-funded?\n\nApproved for at-home?\n\nAdditional comments\n\n\n08 May 2020\n\nQuidel Corporation\n\nSofia SARS Antigen FIA\n\nSofia 2\n\nAntigen (Lateral flow)\n\nNo\n\nYes\n\nNo\n\nSARS-CoV-2 Sensitivity (PPA): 96.7%; SARS-CoV-2 Specificity (NPA): 100%[51]\n\n\n02 July 2020\n\nBecton, Dickinson and Company\n\nBD Veritor System for Rapid Detection of SARS-CoV-2\n\nBD Veritor Plus\n\nAntigen (Immunoassay)\n\nNo\n\nNo\n\nNo\n\nSARS-CoV-2 Sensitivity (PPA): 83.9%; SARS-CoV-2 Specificity (NPA): 100%[23]\n\n\n18 August 2020\n\nLumiraDx UK Ltd.\n\nLumiraDx SARS-CoV-2 Ag Test\n\nLumiraDx Platform\n\nAntigen (Microfluidic)\n\nNo\n\nNo\n\nNo\n\nSARS-CoV-2 Sensitivity (PPA): 97.6%; SARS-CoV-2 Specificity (NPA): 96.6%.[52] As of September 2021, at least one performance evaluation study is in-process.[53]\n\n\n26 August 2020\n\nAbbott Diagnostics Scarborough, Inc.\n\nBinaxNOW COVID-19 Ag Card\n\nNAVICA mobile system\n\nAntigen (Lateral flow)\n\nNo\n\nNo\n\nNo\n\nSARS-CoV-2 Sensitivity (PPA): 84.6%; SARS-CoV-2 Specificity (NPA): 98.5%[54]\n\n\n02 October 2020\n\nQuidel Corporation\n\nSofia 2 Flu + SARS Antigen FIA\n\nSofia 2\n\nAntigen (Lateral flow)\n\nYes\n\nYes\n\nNo\n\nSARS-CoV-2 Sensitivity (PPA): 95.2%; SARS-CoV-2 Specificity (NPA): 100%[55]\n\n\n08 October 2020\n\nAccess Bio, Inc.\n\nCareStart COVID-19 Antigen\n\nN\/A\n\nAntigen (Lateral flow)\n\nNo\n\nNo\n\nNo\n\nSARS-CoV-2 Sensitivity (PPA): 90.47%; SARS-CoV-2 Specificity (NPA): 99.66% (Note: average of swab types)[56]\n\n\n07 December 2020\n\nLuminostics, Inc.\n\nClip COVID Rapid Antigen Test\n\nClip Analyzer (PDF)\n\nAntigen (Lateral flow)\n\nNo\n\nYes\n\nNo\n\nSARS-CoV-2 Sensitivity (PPA): 96.9%; SARS-CoV-2 Specificity (NPA): 100%[57]\n\n\n15 December 2020\n\nEllume Limited\n\nEllume COVID-19 Home Test\n\nA mobile phone that supports their app\n\nAntigen (Lateral flow)\n\nNo\n\nYes\n\nYes (OTC)\n\nSARS-CoV-2 Sensitivity (PPA): 94.6%; SARS-CoV-2 Specificity (NPA): 96.9%[58]\n\n\n16 December 2020\n\nAbbott Diagnostics Scarborough, Inc.\n\nBinaxNOW COVID-19 Ag Card Home Test\n\nA mobile phone that supports their NAVICA app\n\nAntigen (Lateral flow)\n\nNo\n\nNo\n\nYes (Prescription)\n\nSARS-CoV-2 Sensitivity (PPA): 91.7%; SARS-CoV-2 Specificity (NPA): 100%[59]\n\n\n18 December 2020\n\nQuidel Corporation\n\nQuickVue SARS Antigen Test\n\nN\/A\n\nAntigen (Lateral flow)\n\nNo\n\nNo\n\nNo\n\nSARS-CoV-2 Sensitivity (PPA): 96.6%; SARS-CoV-2 Specificity (NPA): 99.3%[60]\n\n\n04 February 2021\n\nPrinceton BioMeditech Corp.\n\nStatus COVID-19\/Flu A&B\n\nN\/A\n\nAntigen (Lateral flow)\n\nYes\n\nNo\n\nNo\n\nSARS-CoV-2 Sensitivity (PPA): 93.9%; SARS-CoV-2 Specificity (NPA): 100%[61]\n\n\n01 March 2021\n\nQuidel Corporation\n\nQuickVue At-Home COVID-19 Test\n\nN\/A\n\nAntigen (Lateral flow)\n\nNo\n\nNo\n\nYes (Prescription)\n\nSARS-CoV-2 Sensitivity (PPA): 84.8%; SARS-CoV-2 Specificity (NPA): 99.1%[62]\n\n\n31 March 2021\n\nQuidel Corporation\n\nQuickVue At-Home OTC COVID-19 Test\n\nN\/A\n\nAntigen (Lateral flow)\n\nNo\n\nNo\n\nYes (OTC)\n\nSARS-CoV-2 Sensitivity (PPA): 83.5%; SARS-CoV-2 Specificity (NPA): 99.2%[63]\n\n\n31 March 2021\n\nAbbott Diagnostics Scarborough, Inc.\n\nBinaxNOW COVID-19 Ag Card 2 Home Test\n\nN\/A\n\nAntigen (Lateral flow)\n\nNo\n\nNo\n\nYes\n\nSARS-CoV-2 Sensitivity (PPA): 91.7%; SARS-CoV-2 Specificity (NPA): 100%[64]\n\n\n16 April 2021\n\nCelltrion USA, Inc.\n\nCelltrion DiaTrust COVID-19 Ag Rapid Test\n\nN\/A\n\nAntigen (Lateral flow)\n\nNo\n\nNo\n\nNo\n\nSARS-CoV-2 Sensitivity (PPA): 93.33%; SARS-CoV-2 Specificity (NPA): 99.03%[65]\n\n\n06 May 2021\n\nInBios International, Inc.\n\nSCoV-2 Ag Detect Rapid Test\n\nN\/A\n\nAntigen (Lateral flow)\n\nNo\n\nNo\n\nNo\n\nSARS-CoV-2 Sensitivity (PPA): 86.67%; SARS-CoV-2 Specificity (NPA): 100%[66]\n\n\n20 May 2021\n\nSalofa Oy\n\nSienna-Clarity COVID-19 Antigen Rapid Test Cassette\n\nN\/A\n\nAntigen (Lateral flow)\n\nNo\n\nNo\n\nNo\n\nSARS-CoV-2 Relative Sensitivity: 87.5%; SARS-CoV-2 Relative Specificity: 98.9% (note that it's relative)[67]\n\n\n04 June 2021\n\nOraSure Technologies, Inc.\n\nInteliSwab COVID-19 Rapid Test\n\nN\/A\n\nAntigen (Lateral flow)\n\nNo\n\nNo\n\nYes (OTC)\n\nSARS-CoV-2 Sensitivity (PPA): 84.3%; SARS-CoV-2 Specificity (NPA): 97.9%[68]\n\n\n04 June 2021\n\nOraSure Technologies, Inc.\n\nInteliSwab COVID-19 Rapid Test Rx\n\nN\/A\n\nAntigen (Lateral flow)\n\nNo\n\nNo\n\nYes (Prescription)\n\nSARS-CoV-2 Sensitivity (PPA): 84.3%; SARS-CoV-2 Specificity (NPA): 97.9%[69]\n\n\n04 June 2021\n\nOraSure Technologies, Inc.\n\nInteliSwab COVID-19 Rapid Test Pro\n\nN\/A\n\nAntigen (Lateral flow)\n\nNo\n\nNo\n\nNo\n\nSARS-CoV-2 Sensitivity (PPA): 84.3%; SARS-CoV-2 Specificity (NPA): 97.9%[70]\n\n\n08 July 2021\n\nEllume Limited\n\nellume.lab COVID Antigen Test\n\nellume.lab digital device\n\nAntigen (Lateral flow)\n\nNo\n\nYes\n\nNo\n\nSARS-CoV-2 Sensitivity (PPA): 81.8%; SARS-CoV-2 Specificity (NPA): 100%[71]\n\n\n13 July 2021\n\nGenBody Inc.\n\nGenBody COVID-19 Ag\n\nN\/A\n\nAntigen (Lateral flow)\n\nNo\n\nNo\n\nNo\n\nSARS-CoV-2 Sensitivity (PPA): 96.0%; SARS-CoV-2 Specificity (NPA): 99.28%[72]\n\n\n28 July 2021\n\nPHASE Scientific International, Ltd.\n\nINDICAID COVID-19 Rapid Antigen Test\n\nN\/A\n\nAntigen (Lateral flow)\n\nNo\n\nNo\n\nNo\n\nSARS-CoV-2 Sensitivity (PPA): 84.4%; SARS-CoV-2 Specificity (NPA): 96.6% (average of health-care-provider-collected and self-collected)[73]\n\n\n02 August 2021\n\nAccess Bio, Inc.\n\nCareStart COVID-19 Antigen Home Test (Not on website yet)\n\nN\/A\n\nAntigen (Lateral flow)\n\nNo\n\nNo\n\nYes (OTC)\n\nSARS-CoV-2 Sensitivity (PPA): 86.6%; SARS-CoV-2 Specificity (NPA): 97.6% (Note: average of swab types)[74]\n\n\n24 August 2021\n\nBecton, Dickinson and Company\n\nBD Veritor At-Home COVID-19 Test (Not on website yet)\n\nN\/A\n\nAntigen (Lateral flow)\n\nNo\n\nNo\n\nYes\n\nSARS-CoV-2 Sensitivity (PPA): 84.6%; SARS-CoV-2 Specificity (NPA): 99.8%[75]\n\n\n\n3.2.3 Reagents \nHigh- and moderate-complexity CLIA testing\nAt various times during the pandemic, reagent shortages have hampered many efforts to expand testing in parts of the world, including the United States. For the attentive laboratory wanting to remain agile in its testing, the laboratory's reagent choices will likely be closely tied to both the assays it chooses to implement and how reliably the supplier can get them to the lab. This in turn is likely driven by whether the lab is using a lab-developed test or a test kit. In some cases, e.g., the Xiamen Zeesan Biotech SARS-CoV-2 Test Kit (Real-time PCR), all but the Virus RNA Extraction Kit is included.[76] On the other hand, Biomeme's SARS-CoV-2 Real-Time RT-PCR Test requires the separate acquisition of PCR buffer and external controls other than the exogenous RNA Process Control that comes with the kit.[77] Yale's SalivaDirect is a more flexible test, validated for use with multiple instruments and reagents that are not proprietary to Yale.[78][79] Pay close attention to what comes with the assay, typically by reviewing the instructions for use (IFU; found on the FDA's EUA page).\nFor PCR, the five basic reagents are template DNA, PCR primers, nucleotides, PCR buffer, and thermostable DNA polymerase. Some of these components can be acquired pre-mixed as a \"master mix.\" For example, Thermo Fisher's PCR Master Mix contains a thermostable DNA polymerase called Taq, nucleotides called deoxynucleotide triphosphates (dNTPs), and a buffer, which \"saves time and reduces contamination due to a reduced number of pipetting steps.\"[80]\nReagent cost and usage for isothermal amplification methods such as LAMP are similar, though buffers and primers specific to the method are required.[8][14][81][82]\nCLIA-waived testing\nThe FDA EUA devices (Table 1 and 2) all come with the necessary reagents, with the exception of any controls or references you may require. Refer to the IFU for the waived test kit to determine what additional consumables you'll require.\n\n3.2.4 Consumables \nHigh- and moderate-complexity CLIA testing\nNon-reagent consumables for high- and moderate-complexity CLIA testing include PCR tubes and plates; pipettes and tips; films, foils, and sealing mats; swabs; and viral transport media, among others. Some like Kellner et al. have experimented with methods to make isothermal amplifications methods more approachable in resource-poor environments by, for example, developing a pipette-free version of LAMP.[13]\nCLIA-waived testing\nThe FDA EUA devices (Table 1 and 2) may require a few extra consumables. For example, the Accula SARS-CoV-2 test kit comes with swabs[83] and the Xpert Xpress SARS-CoV-2 kit comes with disposable transfer pipettes.[84] Refer to the IFU for the waived test kit to determine what additional consumables you'll require.\n\n3.2.5 Software and services \nA June 2020 report by Weemaes et al. in the Journal of the American Medical Informatics Association describes the bottlenecks they encountered in their test workflows at the Belgian National Reference Center, and how they updated their LIS with functionality to resolve those bottlenecks.[85] In addition to adding a COVID-19\u2013specific order set into the computerized physician order entry (CPOE) module integrated with both their LIS and electronic health record (EHR), they included an up-to-date triage criteria component, a tool for optimizing sampling and packaging, a COVID-19 status button, and improved reporting modules for automating reference testing and epidemiological reporting. They also added extra database and data mining functionality to facilitate research and insights into epidemiologies and treatments. Their conclusion: \"Rapidly developed, agile extendable LIS functionality and its meaningful use alleviates the administrative burden on laboratory personnel and improves turnaround time of SARS-CoV-2 testing.\"[85] The Association of Public Health Laboratories comes to a similar conclusion in regard to laboratory informatics solutions and public health laboratories' COVID-19 testing.[86]\nAs such, adding COVID-19 and other respiratory illness testing to your workflow may necessitate an information management system, or an upgrade of your existing software systems. You may experience many of the same bottlenecks the Belgian National Reference Center experienced, especially if you're still working primarily with paper-based test ordering. Those researchers found that paper-based COVID-19 test requests often[85]:\n\nomitted critical clinical status and contact information;\nslowed down epidemiological and research studies;\nhindered proper pre-analytical biosafety procedures; and\nimpeded rapid response to evolving test criteria and clinical insights through test ordering protocols.\nHow interoperable your laboratory software solution is with other systems such as EHRs is also worth consideration. The next chapter addresses system interoperability in greater detail, but it's worth mentioning it here in the context of adding software to improve testing workflows for SARS-CoV-2 and other respiratory viruses. Broadly speaking, improving interoperability among clinical informatics systems\u2014whether at the point of care or within a specific laboratory\u2014is recognized as an important step towards improving health outcomes.[87][88] However, while developers of EHRs and other clinical informatics systems have intended to improve their software's interoperability, the COVID-19 pandemic has, at times, unfortunately shown the inadequacies still inherent in that software's overall design.[89][90][91][92] As such, any research into acquiring a laboratory information management system (LIMS), LIS, or other clinical information management solution should take into account how well that solution is able to integrate with your other clinical systems, as well as any other third-party systems like physician or hospital EHRs. And it's not just the software solutions you'll want to consider. Will the new instruments you add for getting your lab rolling with clinical respiratory illness testing integrate with your software?\nFinally, although rare, you may find you don't have the in-house expertise to fully implement a COVID-19 testing line to your laboratory. In such a case, you may need to turn to a laboratory services consultancy with experience in SARS-CoV-2 test method validation, instrument procurement and implementation, and legal matters. (See the next section for a representative example of consultants advertising COVID-19 testing knowledge and services for labs.)\n\n3.2.6 Major vendors and consultants \nTable 3 lists the major vendors developing and selling PCR, isothermal amplification, and NGS supplies, instruments, and software for both clinical diagnostics and life science research. \"Research use only\" equipment like Siemens Healthcare's Fast Track Cycler was ignored for completing the table. The vendor list was largely compiled from vendors identified in a handful of online market reports on PCR, with an added sprinkling of a few additional reagent vendors (e.g., Jena Bioscience, LGC, and New England BioLabs) who address isothermal amplification supplies in addition to PCR. Note that this is not an endorsement for any particular vendor.\n\n\n\n\n\n\n\nTable 3. Major players operating in the global diagnostic PCR, isothermal amplification, and NGS market\n\n\nVendor\n\nShop all products\n\nPCR machines\n\nNucleic acid extraction\r\nand purification machines\n\nImmunoassay analyzers\r\nand assays\n\nPCR and qPCR assays\n\nPCR and qPCR enzymes\r\nand master mixes\n\nDNA\/RNA purification,\r\nquantitation, and\r\namplification supplies\n\nLAMP assays\n\nIsothermal amplification\r\nenzymes and \r\nmaster mixes\n\nNGS supplies\n\nSupporting labware\r\nand supplies\n\nSoftware\n\n\nAbbott\n\nAbbott products\n\n\u2713\n\n-\n\n-\n\n\u2713\n\n\u2713\n\n-\n\n-\n\n-\n\n-\n\n\u2713\n\n\u2713\n\n\nAgilent Technologies\n\nAgilent products\n\n\u2713\n\n-\n\n-\n\n\u2713\n\n\u2713\n\n\u2713\n\n-\n\n-\n\n\u2713\n\n\u2713\n\n\u2713\n\n\nBecton, Dickinson and Company\n\nBD products\n\n\u2713\n\n-\n\n-\n\n\u2713\n\n-\n\n-\n\n-\n\n-\n\n-\n\n\u2713\n\n-\n\n\nBio-Rad Laboratories, Inc.\n\nBio-Rad products\n\n\u2713\n\n-\n\n\u2713\n\n\u2713\n\n\u2713\n\n\u2713\n\n-\n\n-\n\n\u2713\n\n\u2713\n\n-\n\n\nbioM\u00e9rieux SA\n\nbioM\u00e9rieux products\n\n-\n\n\u2713\n\n\u2713\n\n\u2713\n\n-\n\n-\n\n-\n\n-\n\n-\n\n\u2713\n\n\u2713\n\n\nDanaher Corporation and its companies\n\nCepheid products,\r\nBeckman Coulter products, and\r\nBeckman Life Sciences products\n\n\u2713\n\n-\n\n\u2713\n\n\u2713\n\n-\n\n\u2713\n\n-\n\n-\n\n-\n\n\u2713\n\n-\n\n\nF. Hoffmann-La Roche AG\n\nRoche Diagnostics products\n\n\u2713\n\n\u2713\n\n-\n\n\u2713\n\n\u2713\n\n\u2713\n\n-\n\n-\n\n\u2713\n\n-\n\n\u2713\n\n\nJena Bioscience GmbH\n\nJena Bioscience products\n\n-\n\n-\n\n-\n\n\u2713\n\n\u2713\n\n\u2713\n\n\u2713\n\n\u2713\n\n\u2713\n\n-\n\n-\n\n\nLGC Limited and its companies\n\nLucigen products\n\n-\n\n-\n\n-\n\n\u2713\n\n\u2713\n\n\u2713\n\n-\n\n\u2713\n\n\u2713\n\n-\n\n-\n\n\nMerck KGaA\n\nSigma-Aldrich products and\r\nMillipore Sigma products\n\n-\n\n-\n\n-\n\n\u2713\n\n\u2713\n\n\u2713\n\n-\n\n-\n\n\u2713\n\n\u2713\n\n-\n\n\nNew England BioLabs, Inc.\n\nNEB products\n\n-\n\n-\n\n-\n\n\u2713\n\n\u2713\n\n\u2713\n\n\u2713\n\n\u2713\n\n\u2713\n\n-\n\n-\n\n\nPromega\n\nPromega products and catalog\n\n-\n\n\u2713\n\n-\n\n\u2713\n\n\u2713\n\n\u2713\n\n-\n\n-\n\n\u2713\n\n-\n\n-\n\n\nQIAGEN N.V.\n\nQIAGEN products\n\n\u2713\n\n\u2713\n\n-\n\n\u2713\n\n\u2713\n\n\u2713\n\n-\n\n-\n\n\u2713\n\n-\n\n\u2713\n\n\nSiemens Healthcare GmbH\n\nSiemens Healthcare products\n\n-\n\n\u2713\n\n-\n\n\u2713\n\n-\n\n\u2713\n\n-\n\n-\n\n-\n\n-\n\n\u2713\n\n\nThermo Fisher Scientific, Inc.\n\nThermo Fisher products and\r\nFisher Scientific products\n\n\u2713\n\n\u2713\n\n-\n\n\u2713\n\n\u2713\n\n\u2713\n\n-\n\n\u2713\n\n\u2713\n\n\u2713\n\n\u2713\n\n\n\nThe \"Software\" column of Table 3 represents whether or not the vendor offers laboratory informatics software such as a LIMS or LIS. Those vendors' solutions may or may not be tailored to handle the specific requirements of a clinical diagnostic or virology lab handling COVID-19 and other viruses. (See the next chapter for more in-depth information about working an informatics solution into COVID-19 and other viral testing workflow.) A non-endorsed, representative example of vendors who do include:\n\nAbbott Informatics Corporation - STARLIMS LIMS\nAgileBio - COVID-19 LC\nAutoscribe Informatics, Inc. - Matrix Covid LIMS\nBioSoft Integrators, LLC - LabOptimize LIMS for COVID-19\nCloudLIMS.com, LLC - CloudLIMS for COVID-19\nCommon Cents Systems, Inc. - Apollo LIMS for COVID-19\nComp Pro Med, Inc. - COVID-19 Rapid Deployment LIS\nIllumina, Inc. - BaseSpace Clarity LIMS for COVID-19\nJunction Concepts, Inc. - QBench\nLabLynx, Inc. - COVIDLiMS\nLabVantage Solutions, Inc. - LabVantage COVID-19 LIMS\nPhysion, LLC - Ovation LIMS for COVID-19\nSunquest Information Systems, Inc. - Mitogen LIMS for COVID-19 (PDF)\nThird Wave Analytics, Inc. - Lockbox LIMS for SARS-CoV-2 Clinical Testing\nAdditionally, when in-house knowledge is lacking, a consultant may be required. These consultants are meant to be representative examples of those laboratory consulting firms indicating they have the knowledge to help a laboratory with COVID-19-related testing and other issues. This list is not an endorsement for any particular consultant:\n\nARUP Laboratories (Utah)\nColaborate (Florida)\nElite Diagnostics (North Carolina)\nFreed Associates (California)\nLighthouse Lab Services (North Carolina)\nOptimum Healthcare IT (Florida)\nThe COVID Consultants (Colorado)\nTriumverate Environmental (Massachusetts)\nReferences \n\n\n\u2191 1.0 1.1 1.2 1.3 Mifflin, T.E. (2003). \"Chapter 1: Setting Up a PCR Laboratory\". In Dieffenbach, C.; Dveksler, G. (PDF). PCR Primer (2nd ed.). Cold Spring Harbor Laboratory Press. pp. 5\u201314. ISBN 9780879696542. http:\/\/www.biosupplynet.com\/pdf\/01_pcr_primer_p.5_14.pdf . Retrieved 13 August 2020 .   \n \n\n\u2191 2.0 2.1 2.2 2.3 Degen, H.-J.; Deufel, A.; Eisel, D. et al., ed. (2006). \"Chapter 2: General Guidelines\" (PDF). 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(2008). \"Improving outcomes with interoperable EHRs and secure global health information infrastructure\". Studies in Health Technology and Informatics 137: 68\u201379. PMID 18560070.   \n \n\n\u2191 Global Center for Health Innovation (19 September 2021). \"Improving Patient Care through Interoperability\" (PDF). Global Center for Health Innovation. http:\/\/s3.amazonaws.com\/rdcms-himss\/files\/production\/public\/Improving-Patient-Carethrough-Interoperability.pdf . Retrieved 16 August 2020 .   \n \n\n\u2191 Glaser, J. (12 June 2020). \"It\u2019s Time for a New Kind of Electronic Health Record\". Harvard Business Review. https:\/\/hbr.org\/2020\/06\/its-time-for-a-new-kind-of-electronic-health-record . Retrieved 18 August 2020 .   \n \n\n\u2191 Limoli, C.; Papathomas, G. (7 July 2020). \"Physicians deserve better software: Covid-19 has shown why medical records need to adapt\". MedCity News. https:\/\/medcitynews.com\/2020\/07\/physicians-deserve-better-software-covid-19-has-shown-why-medical-records-need-to-adapt\/ . Retrieved 18 August 2020 .   \n \n\n\u2191 Jason, C. (23 July 2020). \"EHR Optimization, Health IT Projects Needed After COVID-19 Surge\". EHR Intelligence. https:\/\/ehrintelligence.com\/news\/ehr-optimization-health-it-projects-needed-after-covid-19-surge . Retrieved 18 August 2020 .   \n \n\n\u2191 Reeves, J.J.; Pageler, N.M.; Wick, E.C. et al. (2021). \"The Clinical Information Systems Response to the COVID-19 Pandemic\". Yearbook of Medical Informatics 30 (1): 105\u201325. doi:10.1055\/s-0041-1726513. PMC PMC8416224. PMID 34479384. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8416224 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 23 August 2020, at 19:29.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 271 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","5c08823bef2028cb17c7a3612075ff8e_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Adding_COVID-19_and_other_virus_testing_to_your_laboratory_What_kind_of_space_equipment_and_supplies_will_you_need rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Adding_COVID-19_and_other_virus_testing_to_your_laboratory_What_kind_of_space_equipment_and_supplies_will_you_need skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Adding COVID-19 and other virus testing to your laboratory\/What kind of space, equipment, and supplies will you need?<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\">\n\n<h3><span id=\"rdp-ebb-3.2_What_kind_of_space,_equipment,_and_supplies_will_you_need?\"><\/span><span class=\"mw-headline\" id=\"3.2_What_kind_of_space.2C_equipment.2C_and_supplies_will_you_need.3F\">3.2 What kind of space, equipment, and supplies will you need?<\/span><\/h3>\n<h4><span class=\"mw-headline\" id=\"3.2.1_Laboratory_space_arrangements\">3.2.1 Laboratory space arrangements<\/span><\/h4>\n<p><b>PCR considerations<\/b>\n<\/p><p>Whether adding PCR to your existing laboratory, modifying existing PCR workflows, or starting from scratch, preventing contamination is a top priority. As PCR can effectively amplify even the tiniest of quantities of DNA and RNA, the risk of amplifying a contaminant and ruining the validity of an assay is very real.<sup id=\"rdp-ebb-cite_ref-MifflinSetting03_1-0\" class=\"reference\"><a href=\"#cite_note-MifflinSetting03-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RochePCR06_2-0\" class=\"reference\"><a href=\"#cite_note-RochePCR06-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AhmedSetting14_3-0\" class=\"reference\"><a href=\"#cite_note-AhmedSetting14-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RedigTheDevil14_4-0\" class=\"reference\"><a href=\"#cite_note-RedigTheDevil14-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BioChekTheBasics18_5-0\" class=\"reference\"><a href=\"#cite_note-BioChekTheBasics18-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DasMitig18_6-0\" class=\"reference\"><a href=\"#cite_note-DasMitig18-6\">[6]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WHODos18_7-0\" class=\"reference\"><a href=\"#cite_note-WHODos18-7\">[7]<\/a><\/sup> Contamination typically comes from non-amplified environmental substances such as aerosols, and from carryover contamination of amplicons from earlier PCR cycles. As such, not only do best-practice processes and procedures (P&P) need to be followed (e.g., unidirectional workflow, thorough cleaning procedures, proper preparation and disposal), but also where to place PCR-related equipment must be carefully considered.<sup id=\"rdp-ebb-cite_ref-MifflinSetting03_1-1\" class=\"reference\"><a href=\"#cite_note-MifflinSetting03-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RochePCR06_2-1\" class=\"reference\"><a href=\"#cite_note-RochePCR06-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RedigTheDevil14_4-1\" class=\"reference\"><a href=\"#cite_note-RedigTheDevil14-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DasMitig18_6-1\" class=\"reference\"><a href=\"#cite_note-DasMitig18-6\">[6]<\/a><\/sup> \n<\/p><p>When possible, separate rooms for sample preparation, PCR setup, and post-PCR activities, each with their own airflow control, are encouraged.<sup id=\"rdp-ebb-cite_ref-MifflinSetting03_1-2\" class=\"reference\"><a href=\"#cite_note-MifflinSetting03-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RochePCR06_2-2\" class=\"reference\"><a href=\"#cite_note-RochePCR06-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BioChekTheBasics18_5-1\" class=\"reference\"><a href=\"#cite_note-BioChekTheBasics18-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DasMitig18_6-2\" class=\"reference\"><a href=\"#cite_note-DasMitig18-6\">[6]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WHODos18_7-1\" class=\"reference\"><a href=\"#cite_note-WHODos18-7\">[7]<\/a><\/sup> However, the laboratory attempting to add PCR to an already small clinical diagnostic lab may not have the luxury of having multiple rooms. In that case, a single-room setup may suffice, if the workflow areas remain demarcated or physically partitioned. Additionally, a single-room setup must also have stricter P&P and design controls to offset the space constraints. For example, the sample preparation area of the room should have a laminar flow hood with UV light that is regularly cleaned, and post-PCR analysis may need to occur later in the day after cleanup from prior steps.<sup id=\"rdp-ebb-cite_ref-MifflinSetting03_1-3\" class=\"reference\"><a href=\"#cite_note-MifflinSetting03-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AhmedSetting14_3-1\" class=\"reference\"><a href=\"#cite_note-AhmedSetting14-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WHODos18_7-2\" class=\"reference\"><a href=\"#cite_note-WHODos18-7\">[7]<\/a><\/sup> Of course, always maintaining unidirectional workflow\u2014regardless of number of rooms\u2014is also critical to minimizing contamination. For example, technicians shouldn't be transporting amplified materials into the DNA extraction area. \n<\/p><p>Although dated, Roche Diagnostics' 2006 <i><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gene-quantification.de\/ras-pcr-application-manual-3rd-ed.pdf\" target=\"_blank\">PCR Applications Manual<\/a><\/i><sup id=\"rdp-ebb-cite_ref-RochePCR06_2-3\" class=\"reference\"><a href=\"#cite_note-RochePCR06-2\">[2]<\/a><\/sup> provides a detailed breakdown of setting up the laboratory for PCR. <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.longdom.org\/open-access\/mitigating-pcr-amplicon-contamination-in-a-high-risk-high-burden-mycobacterial-reference-laboratory-in-a-resource-limited-setting-2161-1068-1000261.pdf\" target=\"_blank\">Das <i>et al.<\/i><\/a><sup id=\"rdp-ebb-cite_ref-DasMitig18_6-3\" class=\"reference\"><a href=\"#cite_note-DasMitig18-6\">[6]<\/a><\/sup> and <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/bitesizebio.com\/19880\/the-devil-is-in-the-details-how-to-setup-a-pcr-laboratory\/\" target=\"_blank\">Dr. Jennifer Redig<\/a><sup id=\"rdp-ebb-cite_ref-RedigTheDevil14_4-2\" class=\"reference\"><a href=\"#cite_note-RedigTheDevil14-4\">[4]<\/a><\/sup> provide additional valuable insight. The World Health Organization (WHO) also provides <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/teams\/global-malaria-programme\/case-management\/diagnosis\/nucleic-acid-amplification-based-diagnostics\/dos-and-don-ts-for-molecular-testing\" target=\"_blank\">guidance<\/a> for setting up molecular testing in the lab.<sup id=\"rdp-ebb-cite_ref-WHODos18_7-3\" class=\"reference\"><a href=\"#cite_note-WHODos18-7\">[7]<\/a><\/sup>\n<\/p><p><b>Isothermal amplification considerations<\/b>\n<\/p><p>Similarly, because DNA and RNR amplification is involved, contamination concerns exist with isothermal amplification techniques. Multiple pipetting steps and repeated freezing and thawing of reagents can still lead to cross-contamination<sup id=\"rdp-ebb-cite_ref-DiegoProgress19_8-0\" class=\"reference\"><a href=\"#cite_note-DiegoProgress19-8\">[8]<\/a><\/sup>, as does opening the reaction chamber after reaction is completed.<sup id=\"rdp-ebb-cite_ref-MartzyChall19_9-0\" class=\"reference\"><a href=\"#cite_note-MartzyChall19-9\">[9]<\/a><\/sup> However, the advent of microfluidics and lateral flow technologies in isothermal amplification processes has seen the development of \"fully enclosed microstructured devices into which performing the isothermal amplification reduces the risk of sample contamination and allows integration and portable device realization.\"<sup id=\"rdp-ebb-cite_ref-ZanoliIsotherm13_10-0\" class=\"reference\"><a href=\"#cite_note-ZanoliIsotherm13-10\">[10]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RoskosSimple13_11-0\" class=\"reference\"><a href=\"#cite_note-RoskosSimple13-11\">[11]<\/a><\/sup> Even more cutting-edge techniques to reduce contamination such as the CUT-LAMP technique of Bao <i>et al.<\/i><sup id=\"rdp-ebb-cite_ref-BaoCUT20_12-0\" class=\"reference\"><a href=\"#cite_note-BaoCUT20-12\">[12]<\/a><\/sup> or the dUTP\/UDG system for COVID-19 RT-LAMP reactions of Kellner <i>et al.<\/i><sup id=\"rdp-ebb-cite_ref-KellnerARapid20_13-0\" class=\"reference\"><a href=\"#cite_note-KellnerARapid20-13\">[13]<\/a><\/sup> hold further promise in making isothermal amplification processes in the laboratory easier to manage. That said, labs running isothermal amplification processes such as LAMP requiring analysis with agarose gel electrophoresis or a method requiring the opening of reaction vessels will preferably have a secondary area set up for analysis steps so as to minimize the chances of contamination.<sup id=\"rdp-ebb-cite_ref-NEBLoop14_14-0\" class=\"reference\"><a href=\"#cite_note-NEBLoop14-14\">[14]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Fern.C3.A1ndez-SotoDevelop14_15-0\" class=\"reference\"><a href=\"#cite_note-Fern.C3.A1ndez-SotoDevelop14-15\">[15]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"3.2.2_Instruments_and_assays\">3.2.2 Instruments and assays<\/span><\/h4>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:402px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Eppendorf_Mastercycler_Pro_S.jpg\" class=\"image wiki-link\" data-key=\"7402027d757b2fadce790c55156e44c3\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/a\/a5\/Eppendorf_Mastercycler_Pro_S.jpg\" decoding=\"async\" class=\"thumbimage\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Eppendorf_Mastercycler_Pro_S.jpg\" class=\"internal wiki-link\" title=\"Enlarge\" data-key=\"7402027d757b2fadce790c55156e44c3\"><\/a><\/div>Eppendorf Mastercycler Pro S, a thermal cycler for PCR and other applications<\/div><\/div><\/div>\n<p><b>High- and moderate-complexity CLIA testing<\/b>\n<\/p><p>Thermal cyclers are the standard instruments for PCR testing. Today, real-time or quantitative (qPCR) systems largely fill this niche. However, <a href=\"https:\/\/www.limswiki.org\/index.php\/Digital_polymerase_chain_reaction\" title=\"Digital polymerase chain reaction\" class=\"wiki-link\" data-key=\"78753503df4c394f2f1548de7e3aeddb\">digital and droplet digital PCR<\/a> systems are emerging, and they have the benefit of producing even more rapid, precise, sensitive, accurate, and reproducible results, and they are capable of direct quantification and multiplexing. Other instruments and accessories for PCR workflows include proper power supplies, analytical balances, electrophoresis chambers, water and\/or dry baths, and mini\/micro centrifuges. However, if you're considering the addition of PCR workflow to your laboratory, the thermal cycler is typically where the largest up-front cost will be. As such, it's important to ask yourself critical questions to help guide your acquisition decisions.\n<\/p><p>As part of their June 2018 survey on PCR equipment, <i>Lab Manager<\/i> posed five questions potential buyers should ask before making PCR purchases<sup id=\"rdp-ebb-cite_ref-KerkhofPCR18_16-0\" class=\"reference\"><a href=\"#cite_note-KerkhofPCR18-16\">[16]<\/a><\/sup>:\n<\/p>\n<ol><li>Do your current and long-term needs require basic PCR systems, qPCR systems, or digital PCR systems?<\/li>\n<li>What sample formats do you anticipate using?<\/li>\n<li>What throughput requirements do you have now and anticipate in the near future?<\/li>\n<li>What are you willing to sacrifice in regards to temperature ramp up and cool down times and accuracies?<\/li>\n<li>Do you anticipate needing to run more than one independent PCR at the same time (multiblock PCR)?<\/li><\/ol>\n<p>Given the considerable investment that goes into these and other life science instruments, you may want to seek vendors who have a strong track record of supporting and supplying parts for instruments they manufacture and distribute years after the instruments are introduced.<sup id=\"rdp-ebb-cite_ref-LMResults20_17-0\" class=\"reference\"><a href=\"#cite_note-LMResults20-17\">[17]<\/a><\/sup>\n<\/p><p>As for PCR-based assays, the U.S. FDA has issued EUAs for more than 200 of them. The most up-to-date listing is of course found at the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/medical-devices\/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\/in-vitro-diagnostics-euas\" target=\"_blank\">FDA website<\/a>. However, sorting through the extra details can be tedious. The Center for Systems Biology at Harvard has been maintaining a <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csb.mgh.harvard.edu\/covid\" target=\"_blank\">contextual PDF chart<\/a> of the various COVID-19 diagnostic tests, which includes information such as run time, manufacturer-supplied data, and published clinical data (when available). This may prove useful in deciding on one or more particular tests. As with many aspects of this pandemic, other factors that may influence your choice of test kit include overall availability, cost, reagents included with the assay, and reagents separately required and their availability.\n<\/p><p>Isothermal amplification techniques have the advantage of not requiring an expensive thermal cycler.<sup id=\"rdp-ebb-cite_ref-ThiAColor20_18-0\" class=\"reference\"><a href=\"#cite_note-ThiAColor20-18\">[18]<\/a><\/sup> Instrument-appropriate reaction vessels, baths, heating units, turbidimeters, thermocyclers, etc. may be required, depending on what type of amplification you're doing. Companies like Meridian Bioscience offer LAMP-based molecular platforms, though they may not offer a specific COVID-19 assay to run on the platform.<sup id=\"rdp-ebb-cite_ref-MBAlethia_19-0\" class=\"reference\"><a href=\"#cite_note-MBAlethia-19\">[19]<\/a><\/sup> As can be seen in Table 1, two isothermal amplification assays that run on their own proprietary instrument have received EUAs and are CLIA-waved, with a third potentially on the way. Using these systems and their COVID-19 assays at the point of care provides a somewhat more attractive option for laboratories wanting to add COVID-19 or even multiplex viral assays to their offerings.\n<\/p><p><br \/>\n<b>CLIA-waived testing<\/b>\n<\/p><p>If you're running a POL, or attempting to provide COVID-19 testing at the point of care, you'll be looking at the following molecular diagnostic assays (Table 1) and antigen diagnostic assays (Table 2), depending on the level of accuracy and purpose of use required in your POL. Remember that\u2014broadly speaking\u2014antigen tests tend to have lower sensitivities than molecular tests, leaving antigen tests best used as surveillance or repeat screening tools.<sup id=\"rdp-ebb-cite_ref-ServiceRadical2020_20-0\" class=\"reference\"><a href=\"#cite_note-ServiceRadical2020-20\">[20]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GuglielmiTheExp20_21-0\" class=\"reference\"><a href=\"#cite_note-GuglielmiTheExp20-21\">[21]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-TaylorFDA20_22-0\" class=\"reference\"><a href=\"#cite_note-TaylorFDA20-22\">[22]<\/a><\/sup> For example, the directions for the BD Veritor System for Rapid Detection of SARS-CoV-2 manufactured by Becton, Dickinson and Company state: \"Sensitivity of the test after the first five days of the onset of symptoms has been demonstrated to decrease as compared to a RT-PCR SARS-CoV-2 assay.\"<sup id=\"rdp-ebb-cite_ref-BDVeritor21_23-0\" class=\"reference\"><a href=\"#cite_note-BDVeritor21-23\">[23]<\/a><\/sup>\n<\/p>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable\" border=\"1\" cellpadding=\"5\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\" colspan=\"9\"><b>Table 1.<\/b> CLIA-waived COVID-19-related <i>in vitro<\/i> molecular diagnostic tests (e.g., RT-PCR, LAMP, isothermal amplification) receiving U.S. FDA Emergency Use Authorizations (EUAs)\n<\/td><\/tr>\n<tr>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">First date EUA issued\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Manufacturer\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Name of test or assay\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Required instrument\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Technology (Method)\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Multi-analyte?\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">RADx-funded?\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Approved for at-home?\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Additional comments\n<\/th><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">20 March 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Cepheid\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cepheid.com\/coronavirus\" target=\"_blank\">Xpert Xpress SARS-CoV-2 test<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cepheid.com\/en_US\/systems\/GeneXpert-Family-of-Systems\/GeneXpert-Xpress\" target=\"_blank\">GeneXpert Xpress System (Tablet and Hub Configurations)<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Molecular (RT-PCR)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Has largely received positive review of sensitivity and specificity.<sup id=\"rdp-ebb-cite_ref-MoranDetect20_24-0\" class=\"reference\"><a href=\"#cite_note-MoranDetect20-24\">[24]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LoeffelholzMulti20_25-0\" class=\"reference\"><a href=\"#cite_note-LoeffelholzMulti20-25\">[25]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GoldenbergerBrief20_26-0\" class=\"reference\"><a href=\"#cite_note-GoldenbergerBrief20-26\">[26]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">23 March 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Mesa Biotech Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mesabiotech.com\/#featured-sarscov-section\" target=\"_blank\">Accula SARS-CoV-2 test<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mesabiotech.com\/#products-section\" target=\"_blank\">Accula Dock<\/a> or the Sekisui Diagnostics Silaris Dock (discontinued)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Molecular (RT-PCR)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Has received only minor scrutiny<sup id=\"rdp-ebb-cite_ref-HoganComp20_27-0\" class=\"reference\"><a href=\"#cite_note-HoganComp20-27\">[27]<\/a><\/sup>, with only several dozen FDA complaints\/reports<sup id=\"rdp-ebb-cite_ref-FDAMAUDE1_28-0\" class=\"reference\"><a href=\"#cite_note-FDAMAUDE1-28\">[28]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">27 March 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Abbott Diagnostics Scarborough, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.globalpointofcare.abbott\/en\/product-details\/id-now-covid-19.html\" target=\"_blank\">ID NOW COVID-19<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.globalpointofcare.abbott\/en\/product-details\/id-now.html\" target=\"_blank\">ID NOW<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Molecular (isothermal amplification)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Targets \"a unique region of the RNA-dependent RNA polymerase (RdRP) gene.\"<sup id=\"rdp-ebb-cite_ref-RaviDiag20_29-0\" class=\"reference\"><a href=\"#cite_note-RaviDiag20-29\">[29]<\/a><\/sup>Device and test were target of FDA scrutiny due to sensitivity issues reported in 2020 and into 2021<sup id=\"rdp-ebb-cite_ref-DevineCorona20_30-0\" class=\"reference\"><a href=\"#cite_note-DevineCorona20-30\">[30]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PerroneFDA20_31-0\" class=\"reference\"><a href=\"#cite_note-PerroneFDA20-31\">[31]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BasuPerform20_32-0\" class=\"reference\"><a href=\"#cite_note-BasuPerform20-32\">[32]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MitchellEval20_33-0\" class=\"reference\"><a href=\"#cite_note-MitchellEval20-33\">[33]<\/a><\/sup> In October 2020, Abbott released additional study data showing overall sensitivity of 93.3% and specificity of 98.4%, emphasizing the ID NOW's best use with samples taken within seven days of symptom onset.<sup id=\"rdp-ebb-cite_ref-TaylorAbbot20_34-0\" class=\"reference\"><a href=\"#cite_note-TaylorAbbot20-34\">[34]<\/a><\/sup> In 2020, some 393 complaints were reported to the FDA, with 1,492 complains being reported in 2021 (through July 31) according to an FDA MAUDE (Manufacturer and User Facility Device Experience) search.<sup id=\"rdp-ebb-cite_ref-FDAMAUDE2_35-0\" class=\"reference\"><a href=\"#cite_note-FDAMAUDE2-35\">[35]<\/a><\/sup> On August 27, 2021, the FDA re-issued its EUA for the ID NOW with updated <i>in silico<\/i> inclusivity analysis results (among other things)<sup id=\"rdp-ebb-cite_ref-HintonIDNOWAug21_36-0\" class=\"reference\"><a href=\"#cite_note-HintonIDNOWAug21-36\">[36]<\/a><\/sup>, but it's not clear if the FDA is continuing to work with Abbott on the test's accuracy claims.\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">10 June 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Cue Health Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cuehealth.com\/products\/how-cue-detects-covid-19\/\" target=\"_blank\">Cue COVID-19 Test Cartridge<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cuehealth.com\/products\/how-cue-detects-covid-19\/\" target=\"_blank\">Cue Health Monitoring System<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Molecular (isothermal amplification)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"Test primers amplify the nucleocapsid (N) region of the gene\"<sup id=\"rdp-ebb-cite_ref-CueCOVID19Inst_37-0\" class=\"reference\"><a href=\"#cite_note-CueCOVID19Inst-37\">[37]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">14 September 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Roche Molecular Systems, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/diagnostics.roche.com\/us\/en\/products\/params\/cobas-sars-cov-2-influenza-a-b-nucleic-acid-test.html\" target=\"_blank\">cobas SARS-CoV-2 & Influenza A\/B Assay<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/diagnostics.roche.com\/global\/en\/products\/instruments\/cobas-liat.html\" target=\"_blank\">cobas Liat PCR System<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Molecular (RT-PCR)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Everitt <i>et al.<\/i> offer some discussion and citations concerning research related to the cobas LIAT PCR system and its assays.<sup id=\"rdp-ebb-cite_ref-EverittACritical20_38-0\" class=\"reference\"><a href=\"#cite_note-EverittACritical20-38\">[38]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">24 September 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Cepheid\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cepheid.com\/coronavirus\" target=\"_blank\">Xpert Xpress SARS-CoV-2\/Flu\/RSV test<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cepheid.com\/en_US\/systems\/GeneXpert-Family-of-Systems\/GeneXpert-Xpress\" target=\"_blank\">GeneXpert Xpress System (Tablet and Hub Configurations)<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Molecular (RT-PCR)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Development of this multiplex assay for SARS-CoV-2, Flu A, Flu B, and RSV was announced in June 2020.<sup id=\"rdp-ebb-cite_ref-PRNCepheidAnn20_39-0\" class=\"reference\"><a href=\"#cite_note-PRNCepheidAnn20-39\">[39]<\/a><\/sup> After receiving its EUA in September 2020, received advanced development support through the Department of Health and Human Services and the Department of Defense.<sup id=\"rdp-ebb-cite_ref-GBS_BARDA20_40-0\" class=\"reference\"><a href=\"#cite_note-GBS_BARDA20-40\">[40]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">02 October 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">BioFire Diagnostics, LLC\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.biofiredx.com\/covid-19\/\" target=\"_blank\">BioFire Respiratory 2.1 (RP2.1) Panel<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.biofiredx.com\/products\/filmarray\/\" target=\"_blank\">BioFire FilmArray Systems<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Molecular (RT-PCR)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">From the manufacturer: \"The BioFire RP2.1 Panel (EUA) detects 22 respiratory pathogens, including SARS-CoV-2, to help clinicians quickly rule in and rule out common causes of respiratory illness in about 45 minutes.\"<sup id=\"rdp-ebb-cite_ref-BioFireResp20_41-0\" class=\"reference\"><a href=\"#cite_note-BioFireResp20-41\">[41]<\/a><\/sup> Creager <i>et al.<\/i> reported their evaluation findings in the <i>Journal of Clinical Virology<\/i>, stating that the panel \"has similar performance to high throughput assays used for the detection of COVID-19.\"<sup id=\"rdp-ebb-cite_ref-CreagerClinical20_42-0\" class=\"reference\"><a href=\"#cite_note-CreagerClinical20-42\">[42]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">17 November 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Lucira Health, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lucirahealth.com\/\" target=\"_blank\">Lucira COVID-19 All-In-One Test Kit<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Molecular (RT-LAMP)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">First complete at-home COVID test kit receiving EUA. For CLIA-waived labs and prescription at-home use. Test device is apparently one-time-use and not reusable.<sup id=\"rdp-ebb-cite_ref-FDALuciraIFU20_43-0\" class=\"reference\"><a href=\"#cite_note-FDALuciraIFU20-43\">[43]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">27 November 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Cepheid\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cepheid.widen.net\/s\/wt962cbqtf\" target=\"_blank\">Xpert Omni SARS-CoV-2 test<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cepheid.widen.net\/s\/wt962cbqtf\" target=\"_blank\">GeneXpert Omni System<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Molecular (RT-PCR)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">For CLIA-waived testing, the test is limited to nasopharyngeal, anterior nasal, or mid-turbinate swab specimens.<sup id=\"rdp-ebb-cite_ref-CepheidXpertOmni21_44-0\" class=\"reference\"><a href=\"#cite_note-CepheidXpertOmni21-44\">[44]<\/a><\/sup> Product status unclear, as it was listed on website in January 2021<sup id=\"rdp-ebb-cite_ref-GeneXpertOmniArch_45-0\" class=\"reference\"><a href=\"#cite_note-GeneXpertOmniArch-45\">[45]<\/a><\/sup>, but not listed there as of September 2021.\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">08 February 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Visby Medical, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.visbymedical.com\/covid-19-test\/\" target=\"_blank\">Visby Medical COVID-19 Point of Care Test<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Molecular (RT-PCR)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\"By shrinking rapid PCR technology to palm-sized dimensions and eliminating the need for an additional instrument or reader, Visby Medical\u2019s test provides fast, accurate, and actionable results at the point of need.\"<sup id=\"rdp-ebb-cite_ref-VisbyMed21_46-0\" class=\"reference\"><a href=\"#cite_note-VisbyMed21-46\">[46]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">05 March 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Cue Health Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cuehealth.com\/products\/how-cue-detects-covid-19\/\" target=\"_blank\">Cue COVID-19 Test for Home and Over The Counter Use<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cuehealth.com\/products\/how-cue-detects-covid-19\/\" target=\"_blank\">Cue Health Monitoring System<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Molecular (isothermal amplification)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Described as \"the nation\u2019s first molecular diagnostic test available without a prescription to consumers for home use and to enterprise users and healthcare professionals without CLIA certification.\"<sup id=\"rdp-ebb-cite_ref-CueCovid_47-0\" class=\"reference\"><a href=\"#cite_note-CueCovid-47\">[47]<\/a><\/sup> It is also able to be used for screening purposes.\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">09 April 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Lucira Health, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lucirahealth.com\/\" target=\"_blank\">Lucira CHECK-IT COVID-19 Test Kit<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Molecular (RT-LAMP)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Appears to be an over-the-counter (vs. prescription) version of its Lucira COVID-19 All-In-One Test Kit from November 2020. Also able to be used for screening.\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">17 June 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Roche Molecular Systems, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/diagnostics.roche.com\/us\/en\/products\/params\/cobas-sars-cov-2-test.html\" target=\"_blank\">cobas SARS-CoV-2 Assay<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/diagnostics.roche.com\/global\/en\/products\/instruments\/cobas-liat.html\" target=\"_blank\">cobas Liat PCR System<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Molecular (RT-PCR)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Appears to be similar to its multi-analyte product from 2020 but solely for COVID-19, and also able to be used for screening.<sup id=\"rdp-ebb-cite_ref-RocheCobas20_48-0\" class=\"reference\"><a href=\"#cite_note-RocheCobas20-48\">[48]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A (Anticipated)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Talis Biomedical\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/talisbio.com\/talis-one-covid-19-assay\/\" target=\"_blank\">Talis One Cartridge<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/talisbio.com\/talis-one-point-of-care-instrument\/\" target=\"_blank\">Talis One Instrument<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Molecular (RT-LAMP)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">To be determined\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Expectations are that it will receive an FDA EUA and be CLIA-waived<sup id=\"rdp-ebb-cite_ref-TalisOne_49-0\" class=\"reference\"><a href=\"#cite_note-TalisOne-49\">[49]<\/a><\/sup>, but yet to be determined. As of August 2021, it was still awaiting FDA authorization.<sup id=\"rdp-ebb-cite_ref-O.27ConnorDespite21_50-0\" class=\"reference\"><a href=\"#cite_note-O.27ConnorDespite21-50\">[50]<\/a><\/sup>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable\" border=\"1\" cellpadding=\"5\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\" colspan=\"9\"><b>Table 2.<\/b> CLIA-waived COVID-19-related <i>in vitro<\/i> antigen diagnostic tests (e.g., lateral flow, immunoassay, etc.) receiving U.S. FDA Emergency Use Authorizations (EUAs); OTC = Over the counter\n<\/td><\/tr>\n<tr>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">First date EUA issued\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Manufacturer\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Name of test or assay\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Required instrument\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Technology (Method)\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Multi-analyte?\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">RADx-funded?\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Approved for at-home?\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Additional comments\n<\/th><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">08 May 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Quidel Corporation\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.quidel.com\/immunoassays\/rapid-sars-tests\/sofia-sars-antigen-fia\" target=\"_blank\">Sofia SARS Antigen FIA<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.quidel.com\/immunoassays\/sofia-tests-kits\/sofia-2-analyzer\" target=\"_blank\">Sofia 2<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 96.7%; SARS-CoV-2 Specificity (NPA): 100%<sup id=\"rdp-ebb-cite_ref-QuidelSofiaSARS_51-0\" class=\"reference\"><a href=\"#cite_note-QuidelSofiaSARS-51\">[51]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">02 July 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Becton, Dickinson and Company\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/bdveritor.bd.com\/en-us\/rapid-antigen-testing\/covid-19\" target=\"_blank\">BD Veritor System for Rapid Detection of SARS-CoV-2<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/bdveritor.bd.com\/en-us\/bd-veritor-plus-system\" target=\"_blank\">BD Veritor Plus<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Immunoassay)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 83.9%; SARS-CoV-2 Specificity (NPA): 100%<sup id=\"rdp-ebb-cite_ref-BDVeritor21_23-1\" class=\"reference\"><a href=\"#cite_note-BDVeritor21-23\">[23]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">18 August 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">LumiraDx UK Ltd.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lumiradx.com\/us-en\/what-we-do\/diagnostics\/test-technology\/antigen-test\" target=\"_blank\">LumiraDx SARS-CoV-2 Ag Test<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lumiradx.com\/us-en\/what-we-do\/diagnostics\/platform-technology\" target=\"_blank\">LumiraDx Platform<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Microfluidic)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 97.6%; SARS-CoV-2 Specificity (NPA): 96.6%.<sup id=\"rdp-ebb-cite_ref-LimiraDxCOVIDAntigen_52-0\" class=\"reference\"><a href=\"#cite_note-LimiraDxCOVIDAntigen-52\">[52]<\/a><\/sup> As of September 2021, at least one performance evaluation study is in-process.<sup id=\"rdp-ebb-cite_ref-NIHPerformance20_53-0\" class=\"reference\"><a href=\"#cite_note-NIHPerformance20-53\">[53]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">26 August 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Abbott Diagnostics Scarborough, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.globalpointofcare.abbott\/en\/product-details\/binaxnow-covid-19-home-test-us.html\" target=\"_blank\">BinaxNOW COVID-19 Ag Card<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.globalpointofcare.abbott\/en\/product-details\/navica.html\" target=\"_blank\">NAVICA mobile system<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 84.6%; SARS-CoV-2 Specificity (NPA): 98.5%<sup id=\"rdp-ebb-cite_ref-AbbottBinaxNOW20_54-0\" class=\"reference\"><a href=\"#cite_note-AbbottBinaxNOW20-54\">[54]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">02 October 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Quidel Corporation\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.quidel.com\/immunoassays\/sofia-2-flu-sars-antigen-fia\" target=\"_blank\">Sofia 2 Flu + SARS Antigen FIA<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.quidel.com\/immunoassays\/sofia-tests-kits\/sofia-2-analyzer\" target=\"_blank\">Sofia 2<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 95.2%; SARS-CoV-2 Specificity (NPA): 100%<sup id=\"rdp-ebb-cite_ref-QuidelSofiaSARSFlu_55-0\" class=\"reference\"><a href=\"#cite_note-QuidelSofiaSARSFlu-55\">[55]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">08 October 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Access Bio, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/accessbiodiagnostics.net\/carestart-covid-19-antigen\/\" target=\"_blank\">CareStart COVID-19 Antigen<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 90.47%; SARS-CoV-2 Specificity (NPA): 99.66% (Note: average of swab types)<sup id=\"rdp-ebb-cite_ref-AccessBioCOVID19Antigen_56-0\" class=\"reference\"><a href=\"#cite_note-AccessBioCOVID19Antigen-56\">[56]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">07 December 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Luminostics, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/luminostics.com\/\" target=\"_blank\">Clip COVID Rapid Antigen Test<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/lib.umso.co\/lib_XCpfHrGtBDMqBGId\/05k9nl44ty7t61sj.pdf\" target=\"_blank\">Clip Analyzer<\/a> (PDF)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 96.9%; SARS-CoV-2 Specificity (NPA): 100%<sup id=\"rdp-ebb-cite_ref-LuminosticsClip21_57-0\" class=\"reference\"><a href=\"#cite_note-LuminosticsClip21-57\">[57]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">15 December 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Ellume Limited\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ellumehealth.com\/products\/consumer-products\/covid-home-test\/\" target=\"_blank\">Ellume COVID-19 Home Test<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ellumehealth.com\/products\/consumer-products\/covid-home-test\/\" target=\"_blank\">A mobile phone that supports their app<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes (OTC)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 94.6%; SARS-CoV-2 Specificity (NPA): 96.9%<sup id=\"rdp-ebb-cite_ref-EllumeCOVIDHome_58-0\" class=\"reference\"><a href=\"#cite_note-EllumeCOVIDHome-58\">[58]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">16 December 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Abbott Diagnostics Scarborough, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.globalpointofcare.abbott\/en\/product-details\/binaxnow-covid-19-home-test-us.html\" target=\"_blank\">BinaxNOW COVID-19 Ag Card Home Test<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.globalpointofcare.abbott\/en\/product-details\/binaxnow-covid-19-home-test-us.html\" target=\"_blank\">A mobile phone that supports their NAVICA app<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes (Prescription)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 91.7%; SARS-CoV-2 Specificity (NPA): 100%<sup id=\"rdp-ebb-cite_ref-AbbottBinaxNOWHome21_59-0\" class=\"reference\"><a href=\"#cite_note-AbbottBinaxNOWHome21-59\">[59]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">18 December 2020\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Quidel Corporation\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.quidel.com\/immunoassays\/quickvue-sars-antigen-test\" target=\"_blank\">QuickVue SARS Antigen Test<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 96.6%; SARS-CoV-2 Specificity (NPA): 99.3%<sup id=\"rdp-ebb-cite_ref-QuidelQuickVue_60-0\" class=\"reference\"><a href=\"#cite_note-QuidelQuickVue-60\">[60]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">04 February 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Princeton BioMeditech Corp.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pbmc.com\/products\/covid.shtm\" target=\"_blank\">Status COVID-19\/Flu A&B<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 93.9%; SARS-CoV-2 Specificity (NPA): 100%<sup id=\"rdp-ebb-cite_ref-PrincetonStatus_61-0\" class=\"reference\"><a href=\"#cite_note-PrincetonStatus-61\">[61]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">01 March 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Quidel Corporation\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">QuickVue At-Home COVID-19 Test\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes (Prescription)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 84.8%; SARS-CoV-2 Specificity (NPA): 99.1%<sup id=\"rdp-ebb-cite_ref-QuidelQuickVueAtHome21_62-0\" class=\"reference\"><a href=\"#cite_note-QuidelQuickVueAtHome21-62\">[62]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">31 March 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Quidel Corporation\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/quickvueathome.com\/\" target=\"_blank\">QuickVue At-Home OTC COVID-19 Test<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes (OTC)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 83.5%; SARS-CoV-2 Specificity (NPA): 99.2%<sup id=\"rdp-ebb-cite_ref-QuidelQuickVueAtHomeOTC21_63-0\" class=\"reference\"><a href=\"#cite_note-QuidelQuickVueAtHomeOTC21-63\">[63]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">31 March 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Abbott Diagnostics Scarborough, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abbott.com\/corpnewsroom\/diagnostics-testing\/over-the-counter-rapid-COVID-19-testing-in-your-hands.html\" target=\"_blank\">BinaxNOW COVID-19 Ag Card 2 Home Test<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 91.7%; SARS-CoV-2 Specificity (NPA): 100%<sup id=\"rdp-ebb-cite_ref-AbbottBinaxNOWHomeTwo21_64-0\" class=\"reference\"><a href=\"#cite_note-AbbottBinaxNOWHomeTwo21-64\">[64]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">16 April 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Celltrion USA, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.celltrion.com\/en-us\/kit\/DiatrustAg\" target=\"_blank\">Celltrion DiaTrust COVID-19 Ag Rapid Test<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 93.33%; SARS-CoV-2 Specificity (NPA): 99.03%<sup id=\"rdp-ebb-cite_ref-CelltrionDiaTrust_65-0\" class=\"reference\"><a href=\"#cite_note-CelltrionDiaTrust-65\">[65]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">06 May 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">InBios International, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.celltrion.com\/en-us\/kit\/DiatrustAg\" target=\"_blank\">SCoV-2 Ag Detect Rapid Test<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 86.67%; SARS-CoV-2 Specificity (NPA): 100%<sup id=\"rdp-ebb-cite_ref-InBiosSCoV2_66-0\" class=\"reference\"><a href=\"#cite_note-InBiosSCoV2-66\">[66]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">20 May 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Salofa Oy\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.celltrion.com\/en-us\/kit\/DiatrustAg\" target=\"_blank\">Sienna-Clarity COVID-19 Antigen Rapid Test Cassette<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Relative Sensitivity: 87.5%; SARS-CoV-2 Relative Specificity: 98.9% (note that it's relative)<sup id=\"rdp-ebb-cite_ref-SalofaSiennaClarity_67-0\" class=\"reference\"><a href=\"#cite_note-SalofaSiennaClarity-67\">[67]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">04 June 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">OraSure Technologies, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/inteliswab.com\/\" target=\"_blank\">InteliSwab COVID-19 Rapid Test<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes (OTC)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 84.3%; SARS-CoV-2 Specificity (NPA): 97.9%<sup id=\"rdp-ebb-cite_ref-OraSureInteliSwabRapid_68-0\" class=\"reference\"><a href=\"#cite_note-OraSureInteliSwabRapid-68\">[68]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">04 June 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">OraSure Technologies, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/inteliswab.com\/\" target=\"_blank\">InteliSwab COVID-19 Rapid Test Rx<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes (Prescription)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 84.3%; SARS-CoV-2 Specificity (NPA): 97.9%<sup id=\"rdp-ebb-cite_ref-OraSureInteliSwabRapidRx_69-0\" class=\"reference\"><a href=\"#cite_note-OraSureInteliSwabRapidRx-69\">[69]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">04 June 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">OraSure Technologies, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/inteliswab.com\/\" target=\"_blank\">InteliSwab COVID-19 Rapid Test Pro<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 84.3%; SARS-CoV-2 Specificity (NPA): 97.9%<sup id=\"rdp-ebb-cite_ref-OraSureInteliSwabPro_70-0\" class=\"reference\"><a href=\"#cite_note-OraSureInteliSwabPro-70\">[70]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">08 July 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Ellume Limited\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ellumehealth.com\/products\/professional-products\/ellumelab\/\" target=\"_blank\">ellume.lab COVID Antigen Test<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ellumehealth.com\/products\/professional-products\/ellumelab\/\" target=\"_blank\">ellume.lab digital device<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 81.8%; SARS-CoV-2 Specificity (NPA): 100%<sup id=\"rdp-ebb-cite_ref-EllumeCOVID_71-0\" class=\"reference\"><a href=\"#cite_note-EllumeCOVID-71\">[71]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">13 July 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">GenBody Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/genbody.co.kr\/bbs\/board.php?bo_table=human01&wr_id=22\" target=\"_blank\">GenBody COVID-19 Ag<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 96.0%; SARS-CoV-2 Specificity (NPA): 99.28%<sup id=\"rdp-ebb-cite_ref-GenBodyCOVIDAg_72-0\" class=\"reference\"><a href=\"#cite_note-GenBodyCOVIDAg-72\">[72]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">28 July 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">PHASE Scientific International, Ltd.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/us.phasescientific.com\/antigen-test\/\" target=\"_blank\">INDICAID COVID-19 Rapid Antigen Test<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 84.4%; SARS-CoV-2 Specificity (NPA): 96.6% (average of health-care-provider-collected and self-collected)<sup id=\"rdp-ebb-cite_ref-PHASEIndicaid21_73-0\" class=\"reference\"><a href=\"#cite_note-PHASEIndicaid21-73\">[73]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">02 August 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Access Bio, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">CareStart COVID-19 Antigen Home Test (Not on website yet)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes (OTC)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 86.6%; SARS-CoV-2 Specificity (NPA): 97.6% (Note: average of swab types)<sup id=\"rdp-ebb-cite_ref-AccessBioCOVID19AntigenHome21_74-0\" class=\"reference\"><a href=\"#cite_note-AccessBioCOVID19AntigenHome21-74\">[74]<\/a><\/sup>\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">24 August 2021\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Becton, Dickinson and Company\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">BD Veritor At-Home COVID-19 Test (Not on website yet)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">N\/A\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Antigen (Lateral flow)\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">No\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Yes\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">SARS-CoV-2 Sensitivity (PPA): 84.6%; SARS-CoV-2 Specificity (NPA): 99.8%<sup id=\"rdp-ebb-cite_ref-BDVeritorAtHome21_75-0\" class=\"reference\"><a href=\"#cite_note-BDVeritorAtHome21-75\">[75]<\/a><\/sup>\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h4><span class=\"mw-headline\" id=\"3.2.3_Reagents\">3.2.3 Reagents<\/span><\/h4>\n<p><b>High- and moderate-complexity CLIA testing<\/b>\n<\/p><p>At various times during the pandemic, reagent shortages have hampered many efforts to expand testing in parts of the world, including the United States. For the attentive laboratory wanting to remain agile in its testing, the laboratory's reagent choices will likely be closely tied to both the assays it chooses to implement and how reliably the supplier can get them to the lab. This in turn is likely driven by whether the lab is using a lab-developed test or a test kit. In some cases, e.g., the Xiamen Zeesan Biotech SARS-CoV-2 Test Kit (Real-time PCR), all but the Virus RNA Extraction Kit is included.<sup id=\"rdp-ebb-cite_ref-FDAXiamenSARS20_76-0\" class=\"reference\"><a href=\"#cite_note-FDAXiamenSARS20-76\">[76]<\/a><\/sup> On the other hand, Biomeme's SARS-CoV-2 Real-Time RT-PCR Test requires the separate acquisition of PCR buffer and external controls other than the exogenous RNA Process Control that comes with the kit.<sup id=\"rdp-ebb-cite_ref-FDABiomemeSARS20_77-0\" class=\"reference\"><a href=\"#cite_note-FDABiomemeSARS20-77\">[77]<\/a><\/sup> Yale's SalivaDirect is a more flexible test, validated for use with multiple instruments and reagents that are not proprietary to Yale.<sup id=\"rdp-ebb-cite_ref-GallagherFDA20_78-0\" class=\"reference\"><a href=\"#cite_note-GallagherFDA20-78\">[78]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ZillgittFDA20_79-0\" class=\"reference\"><a href=\"#cite_note-ZillgittFDA20-79\">[79]<\/a><\/sup> Pay close attention to what comes with the assay, typically by reviewing the instructions for use (IFU; found on the FDA's EUA page).\n<\/p><p>For PCR, the five basic reagents are template DNA, PCR primers, nucleotides, PCR buffer, and thermostable DNA polymerase. Some of these components can be acquired pre-mixed as a \"master mix.\" For example, Thermo Fisher's PCR Master Mix contains a thermostable DNA polymerase called <i>Taq<\/i>, nucleotides called deoxynucleotide triphosphates (dNTPs), and a buffer, which \"saves time and reduces contamination due to a reduced number of pipetting steps.\"<sup id=\"rdp-ebb-cite_ref-TFSPCRMaster_80-0\" class=\"reference\"><a href=\"#cite_note-TFSPCRMaster-80\">[80]<\/a><\/sup>\n<\/p><p>Reagent cost and usage for isothermal amplification methods such as LAMP are similar, though buffers and primers specific to the method are required.<sup id=\"rdp-ebb-cite_ref-DiegoProgress19_8-1\" class=\"reference\"><a href=\"#cite_note-DiegoProgress19-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-NEBLoop14_14-1\" class=\"reference\"><a href=\"#cite_note-NEBLoop14-14\">[14]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-OGIsoth_81-0\" class=\"reference\"><a href=\"#cite_note-OGIsoth-81\">[81]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KashirLoop20_82-0\" class=\"reference\"><a href=\"#cite_note-KashirLoop20-82\">[82]<\/a><\/sup>\n<\/p><p><b>CLIA-waived testing<\/b>\n<\/p><p>The FDA EUA devices (Table 1 and 2) all come with the necessary reagents, with the exception of any controls or references you may require. Refer to the IFU for the waived test kit to determine what additional consumables you'll require.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"3.2.4_Consumables\">3.2.4 Consumables<\/span><\/h4>\n<p><b>High- and moderate-complexity CLIA testing<\/b>\n<\/p><p>Non-reagent consumables for high- and moderate-complexity CLIA testing include PCR tubes and plates; pipettes and tips; films, foils, and sealing mats; swabs; and viral transport media, among others. Some like Kellner <i>et al.<\/i> have experimented with methods to make isothermal amplifications methods more approachable in resource-poor environments by, for example, developing a pipette-free version of LAMP.<sup id=\"rdp-ebb-cite_ref-KellnerARapid20_13-1\" class=\"reference\"><a href=\"#cite_note-KellnerARapid20-13\">[13]<\/a><\/sup>\n<\/p><p><b>CLIA-waived testing<\/b>\n<\/p><p>The FDA EUA devices (Table 1 and 2) may require a few extra consumables. For example, the Accula SARS-CoV-2 test kit comes with swabs<sup id=\"rdp-ebb-cite_ref-MBAccula20_83-0\" class=\"reference\"><a href=\"#cite_note-MBAccula20-83\">[83]<\/a><\/sup> and the Xpert Xpress SARS-CoV-2 kit comes with disposable transfer pipettes.<sup id=\"rdp-ebb-cite_ref-CepheidXpert20_84-0\" class=\"reference\"><a href=\"#cite_note-CepheidXpert20-84\">[84]<\/a><\/sup> Refer to the IFU for the waived test kit to determine what additional consumables you'll require.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"3.2.5_Software_and_services\">3.2.5 Software and services<\/span><\/h4>\n<p>A June 2020 report by Weemaes <i>et al.<\/i> in the <i>Journal of the American Medical Informatics Association<\/i> describes the bottlenecks they encountered in their test workflows at the Belgian National Reference Center, and how they updated their LIS with functionality to resolve those bottlenecks.<sup id=\"rdp-ebb-cite_ref-WeemaesLab20_85-0\" class=\"reference\"><a href=\"#cite_note-WeemaesLab20-85\">[85]<\/a><\/sup> In addition to adding a COVID-19\u2013specific order set into the <a href=\"https:\/\/www.limswiki.org\/index.php\/Computerized_physician_order_entry\" title=\"Computerized physician order entry\" class=\"wiki-link\" data-key=\"f9e67e685f2b29f79e9b0991330f2b10\">computerized physician order entry<\/a> (CPOE) module integrated with both their LIS and <a href=\"https:\/\/www.limswiki.org\/index.php\/Electronic_health_record\" title=\"Electronic health record\" class=\"wiki-link\" data-key=\"f2e31a73217185bb01389404c1fd5255\">electronic health record<\/a> (EHR), they included an up-to-date triage criteria component, a tool for optimizing sampling and packaging, a COVID-19 status button, and improved reporting modules for automating reference testing and epidemiological reporting. They also added extra database and data mining functionality to facilitate research and insights into epidemiologies and treatments. Their conclusion: \"Rapidly developed, agile extendable LIS functionality and its meaningful use alleviates the administrative burden on laboratory personnel and improves turnaround time of SARS-CoV-2 testing.\"<sup id=\"rdp-ebb-cite_ref-WeemaesLab20_85-1\" class=\"reference\"><a href=\"#cite_note-WeemaesLab20-85\">[85]<\/a><\/sup> The Association of Public Health Laboratories comes to a similar conclusion in regard to laboratory informatics solutions and public health laboratories' COVID-19 testing.<sup id=\"rdp-ebb-cite_ref-APHLLIMS20_86-0\" class=\"reference\"><a href=\"#cite_note-APHLLIMS20-86\">[86]<\/a><\/sup>\n<\/p><p>As such, adding COVID-19 and other respiratory illness testing to your workflow may necessitate an information management system, or an upgrade of your existing software systems. You may experience many of the same bottlenecks the Belgian National Reference Center experienced, especially if you're still working primarily with paper-based test ordering. Those researchers found that paper-based COVID-19 test requests often<sup id=\"rdp-ebb-cite_ref-WeemaesLab20_85-2\" class=\"reference\"><a href=\"#cite_note-WeemaesLab20-85\">[85]<\/a><\/sup>:\n<\/p>\n<ul><li>omitted critical clinical status and contact information;<\/li>\n<li>slowed down epidemiological and research studies;<\/li>\n<li>hindered proper pre-analytical biosafety procedures; and<\/li>\n<li>impeded rapid response to evolving test criteria and clinical insights through test ordering protocols.<\/li><\/ul>\n<p>How interoperable your laboratory software solution is with other systems such as EHRs is also worth consideration. The next chapter addresses system interoperability in greater detail, but it's worth mentioning it here in the context of adding software to improve testing workflows for SARS-CoV-2 and other respiratory viruses. Broadly speaking, improving interoperability among <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_informatics\" class=\"mw-redirect wiki-link\" title=\"Clinical informatics\" data-key=\"bda8123083aecb94afe79afec9ae4686\">clinical informatics<\/a> systems\u2014whether at the point of care or within a specific laboratory\u2014is recognized as an important step towards improving health outcomes.<sup id=\"rdp-ebb-cite_ref-KunImprov08_87-0\" class=\"reference\"><a href=\"#cite_note-KunImprov08-87\">[87]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GCHIImproving_88-0\" class=\"reference\"><a href=\"#cite_note-GCHIImproving-88\">[88]<\/a><\/sup> However, while developers of EHRs and other clinical informatics systems have intended to improve their software's interoperability, the COVID-19 pandemic has, at times, unfortunately shown the inadequacies still inherent in that software's overall design.<sup id=\"rdp-ebb-cite_ref-GlaserItsTime20_89-0\" class=\"reference\"><a href=\"#cite_note-GlaserItsTime20-89\">[89]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LimoliPhys20_90-0\" class=\"reference\"><a href=\"#cite_note-LimoliPhys20-90\">[90]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-JasonEHR20_91-0\" class=\"reference\"><a href=\"#cite_note-JasonEHR20-91\">[91]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ReevesTheClin21_92-0\" class=\"reference\"><a href=\"#cite_note-ReevesTheClin21-92\">[92]<\/a><\/sup> As such, any research into acquiring a <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management system<\/a> (LIMS), LIS, or other clinical information management solution should take into account how well that solution is able to integrate with your other clinical systems, as well as any other third-party systems like physician or hospital EHRs. And it's not just the software solutions you'll want to consider. Will the new instruments you add for getting your lab rolling with clinical respiratory illness testing integrate with your software?\n<\/p><p>Finally, although rare, you may find you don't have the in-house expertise to fully implement a COVID-19 testing line to your laboratory. In such a case, you may need to turn to a laboratory services consultancy with experience in SARS-CoV-2 test method validation, instrument procurement and implementation, and legal matters. (See the next section for a representative example of consultants advertising COVID-19 testing knowledge and services for labs.)\n<\/p>\n<h4><span class=\"mw-headline\" id=\"3.2.6_Major_vendors_and_consultants\">3.2.6 Major vendors and consultants<\/span><\/h4>\n<p>Table 3 lists the major vendors developing and selling PCR, isothermal amplification, and NGS supplies, instruments, and software for both clinical diagnostics and life science research. \"Research use only\" equipment like Siemens Healthcare's Fast Track Cycler was ignored for completing the table. The vendor list was largely compiled from vendors identified in a handful of online market reports on PCR, with an added sprinkling of a few additional reagent vendors (e.g., Jena Bioscience, LGC, and New England BioLabs) who address isothermal amplification supplies in addition to PCR. Note that this is not an endorsement for any particular vendor.\n<\/p>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable sortable\" border=\"1\" cellpadding=\"5\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th style=\"background-color:white; text-align:left; font-weight: normal; padding-left:10px; padding-right:10px;\" colspan=\"13\"><b>Table 3.<\/b> Major players operating in the global diagnostic PCR, isothermal amplification, and NGS market\n<\/th><\/tr>\n<tr>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Vendor\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Shop all products\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">PCR machines\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Nucleic acid extraction<br \/>and purification machines\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Immunoassay analyzers<br \/>and assays\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">PCR and qPCR assays\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">PCR and qPCR enzymes<br \/>and master mixes\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">DNA\/RNA purification,<br \/>quantitation, and<br \/>amplification supplies\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">LAMP assays\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Isothermal amplification<br \/>enzymes and <br \/>master mixes\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">NGS supplies\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Supporting labware<br \/>and supplies\n<\/th>\n<th style=\"background-color:#e2e2e2; padding-left:10px; padding-right:10px;\">Software\n<\/th><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Abbott\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.molecular.abbott\/us\/en\/offerings\/products\" target=\"_blank\">Abbott products<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Agilent Technologies\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.agilent.com\/en-us\/products\" target=\"_blank\">Agilent products<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Becton, Dickinson and Company\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bd.com\/en-us\/offerings\/capabilities\" target=\"_blank\">BD products<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Bio-Rad Laboratories, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bio-rad.com\/en-us\/life-science-research?ID=1100\" target=\"_blank\">Bio-Rad products<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">bioM\u00e9rieux SA\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.biomerieux-usa.com\/az\" target=\"_blank\">bioM\u00e9rieux products<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Danaher Corporation and its companies\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cepheid.com\/\" target=\"_blank\">Cepheid products<\/a>,<br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.beckmancoulter.com\/en\/products\" target=\"_blank\">Beckman Coulter products<\/a>, and<br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.beckman.com\/\" target=\"_blank\">Beckman Life Sciences products<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">F. Hoffmann-La Roche AG\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.roche.com\/products\/diagnostics-portfolio.htm\" target=\"_blank\">Roche Diagnostics products<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Jena Bioscience GmbH\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.jenabioscience.com\/\" target=\"_blank\">Jena Bioscience products<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">LGC Limited and its companies\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lucigen.com\/products.html\" target=\"_blank\">Lucigen products<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Merck KGaA\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sigmaaldrich.com\/US\/en\/life-science\/covid\" target=\"_blank\">Sigma-Aldrich products<\/a> and<br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.emdmillipore.com\/US\/en\/products\/vMqb.qB.GdEAAAE_Mhd3.Lxj,nav\" target=\"_blank\">Millipore Sigma products<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">New England BioLabs, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.neb.com\/products\" target=\"_blank\">NEB products<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Promega\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.promega.com\/products\/\" target=\"_blank\">Promega products<\/a> and <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.promega.com\/products\/catalog\/\" target=\"_blank\">catalog<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">QIAGEN N.V.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.qiagen.com\/us\/products\/\" target=\"_blank\">QIAGEN products<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Siemens Healthcare GmbH\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.siemens-healthineers.com\/products-services\" target=\"_blank\">Siemens Healthcare products<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td><\/tr>\n<tr>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">Thermo Fisher Scientific, Inc.\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.thermofisher.com\/us\/en\/home\/order.html\" target=\"_blank\">Thermo Fisher products<\/a> and<br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fishersci.com\/us\/en\/browse\/90217008\/pcr-equipment-and-supplies\" target=\"_blank\">Fisher Scientific products<\/a>\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">-\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td>\n<td style=\"background-color:white; padding-left:10px; padding-right:10px;\">\u2713\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<p>The \"Software\" column of Table 3 represents whether or not the vendor offers laboratory informatics software such as a LIMS or LIS. Those vendors' solutions may or may not be tailored to handle the specific requirements of a clinical diagnostic or virology lab handling COVID-19 and other viruses. (See the next chapter for more in-depth information about working an informatics solution into COVID-19 and other viral testing workflow.) A non-endorsed, representative example of vendors who do include:\n<\/p>\n<ul><li><a href=\"https:\/\/www.limswiki.org\/index.php\/Abbott_Informatics_Corporation\" title=\"Abbott Informatics Corporation\" class=\"wiki-link\" data-key=\"90479bab12020c96864541696a62156f\">Abbott Informatics Corporation<\/a> - <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.starlims.com\/us\/en\/covid19-testing-and-reporting\/starlims-covid19\" target=\"_blank\">STARLIMS LIMS<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/AgileBio\" title=\"AgileBio\" class=\"wiki-link\" data-key=\"c34addf58af91e53114eed40843f5e6e\">AgileBio<\/a> - <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/labcollector.com\/solutions\/applications\/lp-covid19-pack\/\" target=\"_blank\">COVID-19 LC<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Autoscribe_Informatics,_Inc.\" class=\"mw-redirect wiki-link\" title=\"Autoscribe Informatics, Inc.\" data-key=\"a187eaeb93bae7889be44009f869fc9c\">Autoscribe Informatics, Inc.<\/a> - <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.autoscribeinformatics.com\/lims\/matrix-covid-lims\" target=\"_blank\">Matrix Covid LIMS<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/BioSoft_Integrators,_LLC\" title=\"BioSoft Integrators, LLC\" class=\"wiki-link\" data-key=\"c53828a0bc7dd9162251b66d5b901d07\">BioSoft Integrators, LLC<\/a> - <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/biosoftintegrators.com\/covid-19\/\" target=\"_blank\">LabOptimize LIMS for COVID-19<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/CloudLIMS.com,_LLC\" title=\"CloudLIMS.com, LLC\" class=\"wiki-link\" data-key=\"1fd0120f26ee0671738287a672cb5d7f\">CloudLIMS.com, LLC<\/a> - <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cloudlims.com\/industries\/covid-19-lims-software.html\" target=\"_blank\">CloudLIMS for COVID-19<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Common_Cents_Systems,_Inc.\" title=\"Common Cents Systems, Inc.\" class=\"wiki-link\" data-key=\"6a1feb534350b460ef3eaa83ab477633\">Common Cents Systems, Inc.<\/a> - <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/resources.apollolims.com\/blog\/covid-19-testing-and-the-important-role-of-a-lims\" target=\"_blank\">Apollo LIMS for COVID-19<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Comp_Pro_Med,_Inc.\" title=\"Comp Pro Med, Inc.\" class=\"wiki-link\" data-key=\"125d4f0bc055e5b0d874dfe9f4b1b354\">Comp Pro Med, Inc.<\/a> - <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.comppromed.com\/covid-19-rapid-deployment-lis\/\" target=\"_blank\">COVID-19 Rapid Deployment LIS<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Illumina,_Inc.\" title=\"Illumina, Inc.\" class=\"wiki-link\" data-key=\"ca3eee9e7b220194a53536295b15ba2b\">Illumina, Inc.<\/a> - <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.software.illumina.com\/2020\/04\/14\/efficient-accurate-lab-management-for-covid-19-research\/\" target=\"_blank\">BaseSpace Clarity LIMS for COVID-19<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Junction_Concepts,_Inc.\" title=\"Junction Concepts, Inc.\" class=\"wiki-link\" data-key=\"db728c00d9a437cf664e26d88af95fc4\">Junction Concepts, Inc.<\/a> - <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/qbench.net\/qbench-covid-19-lims-laboratory-information-management-system\/\" target=\"_blank\">QBench<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/LabLynx,_Inc.\" title=\"LabLynx, Inc.\" class=\"wiki-link\" data-key=\"da3f96536cf2c54de1960f26fe5712a1\">LabLynx, Inc.<\/a> - <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.covidlims.com\/\" target=\"_blank\">COVIDLiMS<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/LabVantage_Solutions,_Inc.\" title=\"LabVantage Solutions, Inc.\" class=\"wiki-link\" data-key=\"1855d5158d4dd8f748e925e626daf5ee\">LabVantage Solutions, Inc.<\/a> - <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.labvantage.com\/your-lab-type\/labvantage-covid-19-lims\/\" target=\"_blank\">LabVantage COVID-19 LIMS<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Physion,_LLC\" title=\"Physion, LLC\" class=\"wiki-link\" data-key=\"4fd65fb6a62a94e917ee0114feffa9f6\">Physion, LLC<\/a> - <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ovation.io\/covid-19\/\" target=\"_blank\">Ovation LIMS for COVID-19<\/a><\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Sunquest_Information_Systems,_Inc.\" title=\"Sunquest Information Systems, Inc.\" class=\"wiki-link\" data-key=\"f4a9158f6e03a611d3ceec4b5ff31702\">Sunquest Information Systems, Inc.<\/a> - <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sunquestinfo.com\/docs\/sunquest-covid19-mitogen-lims-product-focus.pdf\" target=\"_blank\">Mitogen LIMS for COVID-19<\/a> (PDF)<\/li>\n<li><a href=\"https:\/\/www.limswiki.org\/index.php\/Third_Wave_Analytics,_Inc.\" title=\"Third Wave Analytics, Inc.\" class=\"wiki-link\" data-key=\"337ec8bf9e153e3ab81930dd7727b2c9\">Third Wave Analytics, Inc.<\/a> - <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/thirdwaveanalytics.com\/covid19\/\" target=\"_blank\">Lockbox LIMS for SARS-CoV-2 Clinical Testing<\/a><\/li><\/ul>\n<p>Additionally, when in-house knowledge is lacking, a consultant may be required. These consultants are meant to be representative examples of those laboratory consulting firms indicating they have the knowledge to help a laboratory with COVID-19-related testing and other issues. This list is not an endorsement for any particular consultant:\n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aruplab.com\/consulting\" target=\"_blank\">ARUP Laboratories<\/a> (Utah)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.colaborate.com\/covid-19-lab-consulting\/\" target=\"_blank\">Colaborate<\/a> (Florida)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elitediagnostics.com\/verticals\/infectious-disease\/\" target=\"_blank\">Elite Diagnostics<\/a> (North Carolina)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.freedassociates.com\/news\/freed-associates-launches-a-covid-19-consulting-service-for-health-care-organizations\/\" target=\"_blank\">Freed Associates<\/a> (California)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lighthouselabservices.com\/consulting\/infectious-disease\/\" target=\"_blank\">Lighthouse Lab Services<\/a> (North Carolina)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/optimumhit.com\/ehr-services\/covid-19-support\/\" target=\"_blank\">Optimum Healthcare IT<\/a> (Florida)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/thecovidconsultants.com\/\" target=\"_blank\">The COVID Consultants<\/a> (Colorado)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.triumvirate.com\/coronavirus\" target=\"_blank\">Triumverate Environmental<\/a> (Massachusetts)<\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-MifflinSetting03-1\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-MifflinSetting03_1-0\">1.0<\/a><\/sup> <sup><a href=\"#cite_ref-MifflinSetting03_1-1\">1.1<\/a><\/sup> <sup><a href=\"#cite_ref-MifflinSetting03_1-2\">1.2<\/a><\/sup> <sup><a href=\"#cite_ref-MifflinSetting03_1-3\">1.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Mifflin, T.E. (2003). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.biosupplynet.com\/pdf\/01_pcr_primer_p.5_14.pdf\" target=\"_blank\">\"Chapter 1: Setting Up a PCR Laboratory\"<\/a>. In Dieffenbach, C.; Dveksler, G. (PDF). <i>PCR Primer<\/i> (2nd ed.). Cold Spring Harbor Laboratory Press. pp. 5\u201314. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9780879696542<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.biosupplynet.com\/pdf\/01_pcr_primer_p.5_14.pdf\" target=\"_blank\">http:\/\/www.biosupplynet.com\/pdf\/01_pcr_primer_p.5_14.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 13 August 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+1%3A+Setting+Up+a+PCR+Laboratory&rft.atitle=PCR+Primer&rft.aulast=Mifflin%2C+T.E.&rft.au=Mifflin%2C+T.E.&rft.date=2003&rft.pages=pp.%26nbsp%3B5%E2%80%9314&rft.edition=2nd&rft.pub=Cold+Spring+Harbor+Laboratory+Press&rft.isbn=9780879696542&rft_id=http%3A%2F%2Fwww.biosupplynet.com%2Fpdf%2F01_pcr_primer_p.5_14.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RochePCR06-2\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-RochePCR06_2-0\">2.0<\/a><\/sup> <sup><a href=\"#cite_ref-RochePCR06_2-1\">2.1<\/a><\/sup> <sup><a href=\"#cite_ref-RochePCR06_2-2\">2.2<\/a><\/sup> <sup><a href=\"#cite_ref-RochePCR06_2-3\">2.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Degen, H.-J.; Deufel, A.; Eisel, D. et al., ed. (2006). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gene-quantification.de\/ras-pcr-application-manual-3rd-ed.pdf\" target=\"_blank\">\"Chapter 2: General Guidelines\"<\/a> (PDF). <i>PCR Applications Manual<\/i> (3rd ed.). Roche Diagnostics GmbH. pp. 19\u201338<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.gene-quantification.de\/ras-pcr-application-manual-3rd-ed.pdf\" target=\"_blank\">https:\/\/www.gene-quantification.de\/ras-pcr-application-manual-3rd-ed.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 13 August 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+2%3A+General+Guidelines&rft.atitle=PCR+Applications+Manual&rft.date=2006&rft.pages=pp.%26nbsp%3B19%E2%80%9338&rft.edition=3rd&rft.pub=Roche+Diagnostics+GmbH&rft_id=https%3A%2F%2Fwww.gene-quantification.de%2Fras-pcr-application-manual-3rd-ed.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AhmedSetting14-3\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-AhmedSetting14_3-0\">3.0<\/a><\/sup> <sup><a href=\"#cite_ref-AhmedSetting14_3-1\">3.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Ahmed, S. (2014). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/grcpk.com\/wp-content\/uploads\/2014\/10\/12.-Setting-up-PCR-Lab.pdf\" target=\"_blank\">\"Chapter 12: Setting-up a PCR Lab\"<\/a> (PDF). <i>Manual of PCR<\/i>. Genetics Resource Centre<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/grcpk.com\/wp-content\/uploads\/2014\/10\/12.-Setting-up-PCR-Lab.pdf\" target=\"_blank\">http:\/\/grcpk.com\/wp-content\/uploads\/2014\/10\/12.-Setting-up-PCR-Lab.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 13 August 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+12%3A+Setting-up+a+PCR+Lab&rft.atitle=Manual+of+PCR&rft.aulast=Ahmed%2C+S.&rft.au=Ahmed%2C+S.&rft.date=2014&rft.pub=Genetics+Resource+Centre&rft_id=http%3A%2F%2Fgrcpk.com%2Fwp-content%2Fuploads%2F2014%2F10%2F12.-Setting-up-PCR-Lab.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RedigTheDevil14-4\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-RedigTheDevil14_4-0\">4.0<\/a><\/sup> <sup><a href=\"#cite_ref-RedigTheDevil14_4-1\">4.1<\/a><\/sup> <sup><a href=\"#cite_ref-RedigTheDevil14_4-2\">4.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Redig, J. (1 August 2014). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/bitesizebio.com\/19880\/the-devil-is-in-the-details-how-to-setup-a-pcr-laboratory\/\" target=\"_blank\">\"The Devil is in the Details: How to Setup a PCR Laboratory\"<\/a>. <i>BiteSizeBio<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/bitesizebio.com\/19880\/the-devil-is-in-the-details-how-to-setup-a-pcr-laboratory\/\" target=\"_blank\">https:\/\/bitesizebio.com\/19880\/the-devil-is-in-the-details-how-to-setup-a-pcr-laboratory\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 13 August 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+Devil+is+in+the+Details%3A+How+to+Setup+a+PCR+Laboratory&rft.atitle=BiteSizeBio&rft.aulast=Redig%2C+J.&rft.au=Redig%2C+J.&rft.date=1+August+2014&rft_id=https%3A%2F%2Fbitesizebio.com%2F19880%2Fthe-devil-is-in-the-details-how-to-setup-a-pcr-laboratory%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BioChekTheBasics18-5\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-BioChekTheBasics18_5-0\">5.0<\/a><\/sup> <sup><a href=\"#cite_ref-BioChekTheBasics18_5-1\">5.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.biochek.com\/wp-content\/uploads\/2018\/05\/BioChek-E-book-The-basics-of-PCR.pdf\" target=\"_blank\">\"The basics of PCR: Detecting viruses and bacteria red-handed\"<\/a> (PDF). BioChek BV. May 2018<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.biochek.com\/wp-content\/uploads\/2018\/05\/BioChek-E-book-The-basics-of-PCR.pdf\" target=\"_blank\">https:\/\/www.biochek.com\/wp-content\/uploads\/2018\/05\/BioChek-E-book-The-basics-of-PCR.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 13 August 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+basics+of+PCR%3A+Detecting+viruses+and+bacteria+red-handed&rft.atitle=&rft.date=May+2018&rft.pub=BioChek+BV&rft_id=https%3A%2F%2Fwww.biochek.com%2Fwp-content%2Fuploads%2F2018%2F05%2FBioChek-E-book-The-basics-of-PCR.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DasMitig18-6\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-DasMitig18_6-0\">6.0<\/a><\/sup> <sup><a href=\"#cite_ref-DasMitig18_6-1\">6.1<\/a><\/sup> <sup><a href=\"#cite_ref-DasMitig18_6-2\">6.2<\/a><\/sup> <sup><a href=\"#cite_ref-DasMitig18_6-3\">6.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Das, P.K.; Ganguly, S.B.; Mandal, B. (2018). \"Mitigating PCR \/Amplicon Contamination in a High Risk High Burden Mycobacterial Reference Laboratory in a Resource Limited Setting\". <i>Mycobacterial Diseases<\/i> <b>8<\/b> (2): 261. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.4172%2F2161-1068.1000261\" target=\"_blank\">10.4172\/2161-1068.1000261<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Mitigating+PCR+%2FAmplicon+Contamination+in+a+High+Risk+High+Burden+Mycobacterial+Reference+Laboratory+in+a+Resource+Limited+Setting&rft.jtitle=Mycobacterial+Diseases&rft.aulast=Das%2C+P.K.%3B+Ganguly%2C+S.B.%3B+Mandal%2C+B.&rft.au=Das%2C+P.K.%3B+Ganguly%2C+S.B.%3B+Mandal%2C+B.&rft.date=2018&rft.volume=8&rft.issue=2&rft.pages=261&rft_id=info:doi\/10.4172%2F2161-1068.1000261&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WHODos18-7\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-WHODos18_7-0\">7.0<\/a><\/sup> <sup><a href=\"#cite_ref-WHODos18_7-1\">7.1<\/a><\/sup> <sup><a href=\"#cite_ref-WHODos18_7-2\">7.2<\/a><\/sup> <sup><a href=\"#cite_ref-WHODos18_7-3\">7.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">World Health Organization (31 January 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/teams\/global-malaria-programme\/case-management\/diagnosis\/nucleic-acid-amplification-based-diagnostics\/dos-and-don-ts-for-molecular-testing\" target=\"_blank\">\"Dos and Don'ts for molecular testing\"<\/a>. World Health Organization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.who.int\/teams\/global-malaria-programme\/case-management\/diagnosis\/nucleic-acid-amplification-based-diagnostics\/dos-and-don-ts-for-molecular-testing\" target=\"_blank\">https:\/\/www.who.int\/teams\/global-malaria-programme\/case-management\/diagnosis\/nucleic-acid-amplification-based-diagnostics\/dos-and-don-ts-for-molecular-testing<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 08 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Dos+and+Don%27ts+for+molecular+testing&rft.atitle=&rft.aulast=World+Health+Organization&rft.au=World+Health+Organization&rft.date=31+January+2018&rft.pub=World+Health+Organization&rft_id=https%3A%2F%2Fwww.who.int%2Fteams%2Fglobal-malaria-programme%2Fcase-management%2Fdiagnosis%2Fnucleic-acid-amplification-based-diagnostics%2Fdos-and-don-ts-for-molecular-testing&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DiegoProgress19-8\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-DiegoProgress19_8-0\">8.0<\/a><\/sup> <sup><a href=\"#cite_ref-DiegoProgress19_8-1\">8.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Diego, J. G.-B.; Fern\u00e1ndez-Soto, P.; Crego-Vicente, B. et al. (2019). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6791938\" target=\"_blank\">\"Progress in loop-mediated isothermal amplification assay for detection of Schistosoma mansoni DNA: Towards a ready-to-use test\"<\/a>. <i>Scientific Reports<\/i> <b>9<\/b>: 14744. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1038%2Fs41598-019-51342-2\" target=\"_blank\">10.1038\/s41598-019-51342-2<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6791938\/\" target=\"_blank\">PMC6791938<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/31611563\" target=\"_blank\">31611563<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6791938\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6791938<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Progress+in+loop-mediated+isothermal+amplification+assay+for+detection+of+Schistosoma+mansoni+DNA%3A+Towards+a+ready-to-use+test&rft.jtitle=Scientific+Reports&rft.aulast=Diego%2C+J.+G.-B.%3B+Fern%C3%A1ndez-Soto%2C+P.%3B+Crego-Vicente%2C+B.+et+al.&rft.au=Diego%2C+J.+G.-B.%3B+Fern%C3%A1ndez-Soto%2C+P.%3B+Crego-Vicente%2C+B.+et+al.&rft.date=2019&rft.volume=9&rft.pages=14744&rft_id=info:doi\/10.1038%2Fs41598-019-51342-2&rft_id=info:pmc\/PMC6791938&rft_id=info:pmid\/31611563&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC6791938&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MartzyChall19-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MartzyChall19_9-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Martzy, R.; Kolm, C.; Krska, R. et al. (2019). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6453865\" target=\"_blank\">\"Challenges and perspectives in the application of isothermal DNA amplification methods for food and water analysis\"<\/a>. <i>Analytical and Bioanalytical Chemistry<\/i> <b>411<\/b>: 1695\u20131702. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2Fs00216-018-1553-1\" target=\"_blank\">10.1007\/s00216-018-1553-1<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6453865\/\" target=\"_blank\">PMC6453865<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/30617408\" target=\"_blank\">30617408<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6453865\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6453865<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Challenges+and+perspectives+in+the+application+of+isothermal+DNA+amplification+methods+for+food+and+water+analysis&rft.jtitle=Analytical+and+Bioanalytical+Chemistry&rft.aulast=Martzy%2C+R.%3B+Kolm%2C+C.%3B+Krska%2C+R.+et+al.&rft.au=Martzy%2C+R.%3B+Kolm%2C+C.%3B+Krska%2C+R.+et+al.&rft.date=2019&rft.volume=411&rft.pages=1695%E2%80%931702&rft_id=info:doi\/10.1007%2Fs00216-018-1553-1&rft_id=info:pmc\/PMC6453865&rft_id=info:pmid\/30617408&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC6453865&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ZanoliIsotherm13-10\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ZanoliIsotherm13_10-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Zanoli, L.M.; Spoto, G. (2013). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4263587\" target=\"_blank\">\"Isothermal Amplification Methods for the Detection of Nucleic Acids in Microfluidic Devices\"<\/a>. <i>Biosensors<\/i> <b>3<\/b> (1): 18\u201343. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.3390%2Fbios3010018\" target=\"_blank\">10.3390\/bios3010018<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4263587\/\" target=\"_blank\">PMC4263587<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/25587397\" target=\"_blank\">25587397<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4263587\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4263587<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Isothermal+Amplification+Methods+for+the+Detection+of+Nucleic+Acids+in+Microfluidic+Devices&rft.jtitle=Biosensors&rft.aulast=Zanoli%2C+L.M.%3B+Spoto%2C+G.&rft.au=Zanoli%2C+L.M.%3B+Spoto%2C+G.&rft.date=2013&rft.volume=3&rft.issue=1&rft.pages=18%E2%80%9343&rft_id=info:doi\/10.3390%2Fbios3010018&rft_id=info:pmc\/PMC4263587&rft_id=info:pmid\/25587397&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC4263587&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RoskosSimple13-11\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RoskosSimple13_11-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Roskos, K.; Hickerson, A.I.; Lu, H.-W. et al. 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Retrieved 14 August 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Loop-mediated+Isothermal+Amplification+%28LAMP%29&rft.atitle=&rft.date=17+June+2014&rft.pub=New+England+BioLabs&rft_id=https%3A%2F%2Fwww.neb.com%2Fprotocols%2F2014%2F06%2F17%2Floop-mediated-isothermal-amplification-lamp&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Fern.C3.A1ndez-SotoDevelop14-15\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Fern.C3.A1ndez-SotoDevelop14_15-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Fern\u00e1ndez-Soto, P.; Mvoulouga, P.O.; Akue, J.P. et al. 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(2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7383535\" target=\"_blank\">\"Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test\"<\/a>. <i>Journal of Clinical Microbiology<\/i> <b>58<\/b> (8): e00926-20. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1128%2FJCM.00926-20\" target=\"_blank\">10.1128\/JCM.00926-20<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7383535\/\" target=\"_blank\">PMC7383535<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32366669\" target=\"_blank\">32366669<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7383535\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7383535<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Multicenter+Evaluation+of+the+Cepheid+Xpert+Xpress+SARS-CoV-2+Test&rft.jtitle=Journal+of+Clinical+Microbiology&rft.aulast=Loeffelholz%2C+M.J.%3B+Alland%2C+D.%3B+Butler-Wu%2C+S.M.+et+al.&rft.au=Loeffelholz%2C+M.J.%3B+Alland%2C+D.%3B+Butler-Wu%2C+S.M.+et+al.&rft.date=2020&rft.volume=58&rft.issue=8&rft.pages=e00926-20&rft_id=info:doi\/10.1128%2FJCM.00926-20&rft_id=info:pmc\/PMC7383535&rft_id=info:pmid\/32366669&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7383535&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GoldenbergerBrief20-26\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GoldenbergerBrief20_26-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Goldenberger, D.; Leusinger, K.; Sogaard, K.K. et al. (2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7351036\" target=\"_blank\">\"Brief validation of the novel GeneXpert Xpress SARS-CoV-2 PCR assay\"<\/a>. <i>Journal of Virological Methods<\/i> <b>284<\/b>: 113925. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2Fj.jviromet.2020.113925\" target=\"_blank\">10.1016\/j.jviromet.2020.113925<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7351036\/\" target=\"_blank\">PMC7351036<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32659240\" target=\"_blank\">32659240<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7351036\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7351036<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Brief+validation+of+the+novel+GeneXpert+Xpress+SARS-CoV-2+PCR+assay&rft.jtitle=Journal+of+Virological+Methods&rft.aulast=Goldenberger%2C+D.%3B+Leusinger%2C+K.%3B+Sogaard%2C+K.K.+et+al.&rft.au=Goldenberger%2C+D.%3B+Leusinger%2C+K.%3B+Sogaard%2C+K.K.+et+al.&rft.date=2020&rft.volume=284&rft.pages=113925&rft_id=info:doi\/10.1016%2Fj.jviromet.2020.113925&rft_id=info:pmc\/PMC7351036&rft_id=info:pmid\/32659240&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7351036&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HoganComp20-27\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HoganComp20_27-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Hogan, C.A.; Garamani, N.; Lee, A.S. et al. (2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7383558\" target=\"_blank\">\"Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens\"<\/a>. <i>Journal of Clinical Microbiology<\/i> <b>58<\/b> (8): e01072-20. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1128%2FJCM.01072-20\" target=\"_blank\">10.1128\/JCM.01072-20<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7383558\/\" target=\"_blank\">PMC7383558<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32461285\" target=\"_blank\">32461285<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7383558\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7383558<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Comparison+of+the+Accula+SARS-CoV-2+Test+with+a+Laboratory-Developed+Assay+for+Detection+of+SARS-CoV-2+RNA+in+Clinical+Nasopharyngeal+Specimens&rft.jtitle=Journal+of+Clinical+Microbiology&rft.aulast=Hogan%2C+C.A.%3B+Garamani%2C+N.%3B+Lee%2C+A.S.+et+al.&rft.au=Hogan%2C+C.A.%3B+Garamani%2C+N.%3B+Lee%2C+A.S.+et+al.&rft.date=2020&rft.volume=58&rft.issue=8&rft.pages=e01072-20&rft_id=info:doi\/10.1128%2FJCM.01072-20&rft_id=info:pmc\/PMC7383558&rft_id=info:pmid\/32461285&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7383558&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FDAMAUDE1-28\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FDAMAUDE1_28-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfMAUDE\/TextSearch.cfm\" target=\"_blank\">\"MAUDE - Manufacturer and User Facility Device Experience\"<\/a>. U.S. Food and Drug Administration<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfMAUDE\/TextSearch.cfm\" target=\"_blank\">https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfMAUDE\/TextSearch.cfm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 08 September 2021<\/span>. \"Search for \"Accula\" in Brand Name\"<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=MAUDE+-+Manufacturer+and+User+Facility+Device+Experience&rft.atitle=&rft.pub=U.S.+Food+and+Drug+Administration&rft_id=https%3A%2F%2Fwww.accessdata.fda.gov%2Fscripts%2Fcdrh%2Fcfdocs%2FcfMAUDE%2FTextSearch.cfm&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RaviDiag20-29\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RaviDiag20_29-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Ravi, N.; Cortade, D.L.; Ng, E. et al. (2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7368663\" target=\"_blank\">\"Diagnostics for SARS-CoV-2 detection: A comprehensive review of the FDA-EUA COVID-19 testing landscape\"<\/a>. <i>Biosensors and Bioelectronics<\/i> <b>165<\/b>: 112454. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2Fj.bios.2020.112454\" target=\"_blank\">10.1016\/j.bios.2020.112454<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7368663\/\" target=\"_blank\">PMC7368663<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32729549\" target=\"_blank\">32729549<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7368663\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7368663<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Diagnostics+for+SARS-CoV-2+detection%3A+A+comprehensive+review+of+the+FDA-EUA+COVID-19+testing+landscape&rft.jtitle=Biosensors+and+Bioelectronics&rft.aulast=Ravi%2C+N.%3B+Cortade%2C+D.L.%3B+Ng%2C+E.+et+al.&rft.au=Ravi%2C+N.%3B+Cortade%2C+D.L.%3B+Ng%2C+E.+et+al.&rft.date=2020&rft.volume=165&rft.pages=112454&rft_id=info:doi\/10.1016%2Fj.bios.2020.112454&rft_id=info:pmc\/PMC7368663&rft_id=info:pmid\/32729549&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7368663&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DevineCorona20-30\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DevineCorona20_30-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Devine, C. 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Retrieved 19 May 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=FDA+probes+accuracy+issue+with+Abbott%E2%80%99s+rapid+virus+test&rft.atitle=Associated+Press&rft.aulast=Perrone%2C+M.&rft.au=Perrone%2C+M.&rft.date=14+May+2020&rft_id=https%3A%2F%2Fapnews.com%2Fc8ab010e8e02dfe7beb34a5e5df11279&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BasuPerform20-32\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BasuPerform20_32-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Basu, A.; Zinger, T.; Inglima, K. et al. 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(2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7227587\" target=\"_blank\">\"Evaluation of the COVID19 ID NOW EUA assay\"<\/a>. <i>Journal of Clinical Virology<\/i> <b>128<\/b>: 104429. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2Fj.jcv.2020.104429\" target=\"_blank\">10.1016\/j.jcv.2020.104429<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7227587\/\" target=\"_blank\">PMC7227587<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32425657\" target=\"_blank\">32425657<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7227587\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7227587<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Evaluation+of+the+COVID19+ID+NOW+EUA+assay&rft.jtitle=Journal+of+Clinical+Virology&rft.aulast=Mitchell%2C+S.L.%3B+St.+George%2C+K.&rft.au=Mitchell%2C+S.L.%3B+St.+George%2C+K.&rft.date=2020&rft.volume=128&rft.pages=104429&rft_id=info:doi\/10.1016%2Fj.jcv.2020.104429&rft_id=info:pmc\/PMC7227587&rft_id=info:pmid\/32425657&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7227587&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-TaylorAbbot20-34\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-TaylorAbbot20_34-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Taylor, N.P. 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Retrieved 19 November 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=BioFire%E2%80%99s+Respiratory+Solutions%0Awith+SARS-CoV-2&rft.atitle=&rft.pub=BioFire+Diagnostics%2C+LLC&rft_id=https%3A%2F%2Fwww.biofiredx.com%2Fcovid-19%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CreagerClinical20-42\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CreagerClinical20_42-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Creager, H.M.; Cabrera, B.; Schnaubelt, A. et al. (2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7336953\" target=\"_blank\">\"Clinical evaluation of the BioFire Respiratory Panel 2.1 and detection of SARS-CoV-2\"<\/a>. <i>Journal of Clinical Virology<\/i> <b>129<\/b>: 104538. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2Fj.jcv.2020.104538\" target=\"_blank\">10.1016\/j.jcv.2020.104538<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7336953\/\" target=\"_blank\">PMC7336953<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32650276\" target=\"_blank\">32650276<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7336953\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7336953<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Clinical+evaluation+of+the+BioFire+Respiratory+Panel+2.1+and+detection+of+SARS-CoV-2&rft.jtitle=Journal+of+Clinical+Virology&rft.aulast=Creager%2C+H.M.%3B+Cabrera%2C+B.%3B+Schnaubelt%2C+A.+et+al.&rft.au=Creager%2C+H.M.%3B+Cabrera%2C+B.%3B+Schnaubelt%2C+A.+et+al.&rft.date=2020&rft.volume=129&rft.pages=104538&rft_id=info:doi\/10.1016%2Fj.jcv.2020.104538&rft_id=info:pmc\/PMC7336953&rft_id=info:pmid\/32650276&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7336953&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FDALuciraIFU20-43\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FDALuciraIFU20_43-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/media\/143809\/download\" target=\"_blank\">\"Lucira Health COVID-19 All-In-One Test Kit\"<\/a>. Lucira Health, Inc. 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.fda.gov\/media\/143809\/download\" target=\"_blank\">https:\/\/www.fda.gov\/media\/143809\/download<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 20 November 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Lucira+Health+COVID-19+All-In-One+Test+Kit&rft.atitle=&rft.date=2020&rft.pub=Lucira+Health%2C+Inc&rft_id=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F143809%2Fdownload&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CepheidXpertOmni21-44\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CepheidXpertOmni21_44-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/media\/144033\/download\" target=\"_blank\">\"Xpert Omni SARS-CoV-2\"<\/a> (PDF). 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Retrieved 08 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Xpert+Omni+SARS-CoV-2&rft.atitle=&rft.date=April+2021&rft.pub=Cepheid&rft_id=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F144033%2Fdownload&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GeneXpertOmniArch-45\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GeneXpertOmniArch_45-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20210123173157\/https:\/\/www.cepheid.com\/en_US\/systems\/GeneXpert-Family-of-Systems\/GeneXpert-Omni\" target=\"_blank\">\"Introducing the GeneXpert Omni\"<\/a>. Cepheid. Archived from <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cepheid.com\/en_US\/systems\/GeneXpert-Family-of-Systems\/GeneXpert-Omni\" target=\"_blank\">the original<\/a> on 23 January 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20210123173157\/https:\/\/www.cepheid.com\/en_US\/systems\/GeneXpert-Family-of-Systems\/GeneXpert-Omni\" target=\"_blank\">https:\/\/web.archive.org\/web\/20210123173157\/https:\/\/www.cepheid.com\/en_US\/systems\/GeneXpert-Family-of-Systems\/GeneXpert-Omni<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 08 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Introducing+the+GeneXpert+Omni&rft.atitle=&rft.pub=Cepheid&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20210123173157%2Fhttps%3A%2F%2Fwww.cepheid.com%2Fen_US%2Fsystems%2FGeneXpert-Family-of-Systems%2FGeneXpert-Omni&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-VisbyMed21-46\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-VisbyMed21_46-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.visbymedical.com\/news\/press-release-visby-medical-covid-19-pcr-point-of-care-test-authorized-for-use-in-clia-waived-settings\" target=\"_blank\">\"Visby Medical\u2019s COVID-19 PCR Point of Care Test Authorized for Use in CLIA Waived Settings\"<\/a>. Visby Medical, Inc. 2 February 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.visbymedical.com\/news\/press-release-visby-medical-covid-19-pcr-point-of-care-test-authorized-for-use-in-clia-waived-settings\" target=\"_blank\">https:\/\/www.visbymedical.com\/news\/press-release-visby-medical-covid-19-pcr-point-of-care-test-authorized-for-use-in-clia-waived-settings<\/a><\/span><span class=\"reference-accessdate\">. 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Cue Health, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cuehealth.com\/products\/how-cue-detects-covid-19\/\" target=\"_blank\">https:\/\/www.cuehealth.com\/products\/how-cue-detects-covid-19\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 08 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Cue%E2%80%99s+COVID%E2%80%9119+Diagnostic+Test&rft.atitle=&rft.pub=Cue+Health%2C+Inc&rft_id=https%3A%2F%2Fwww.cuehealth.com%2Fproducts%2Fhow-cue-detects-covid-19%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RocheCobas20-48\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RocheCobas20_48-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/media\/150278\/download\" target=\"_blank\">\"cobas SARS-CoV-2\"<\/a>. 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Retrieved 08 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=cobas+SARS-CoV-2&rft.atitle=&rft.date=December+2020&rft.pub=Roche+Molecular+Systems%2C+Inc&rft_id=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F150278%2Fdownload&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-TalisOne-49\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-TalisOne_49-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/talisbio.com\/talis-one-covid-19-assay\/\" target=\"_blank\">\"Talis One Molecular Testing\"<\/a>. Talis Biomedical<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/talisbio.com\/talis-one-covid-19-assay\/\" target=\"_blank\">https:\/\/talisbio.com\/talis-one-covid-19-assay\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 08 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Talis+One+Molecular+Testing&rft.atitle=&rft.pub=Talis+Biomedical&rft_id=https%3A%2F%2Ftalisbio.com%2Ftalis-one-covid-19-assay%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-O.27ConnorDespite21-50\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-O.27ConnorDespite21_50-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">O'Connor, L. (11 August 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20210811210316\/https:\/\/www.360dx.com\/business-news\/despite-mdx-product-delays-talis-biomedical-expecting-meaningful-revenue-ramp-2022\" target=\"_blank\">\"Despite MDx Product Delays, Talis Biomedical Expecting 'Meaningful Revenue Ramp in 2022'\"<\/a>. <i>360 Dx<\/i>. Archived from <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.360dx.com\/business-news\/despite-mdx-product-delays-talis-biomedical-expecting-meaningful-revenue-ramp-2022\" target=\"_blank\">the original<\/a> on 11 August 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20210811210316\/https:\/\/www.360dx.com\/business-news\/despite-mdx-product-delays-talis-biomedical-expecting-meaningful-revenue-ramp-2022\" target=\"_blank\">https:\/\/web.archive.org\/web\/20210811210316\/https:\/\/www.360dx.com\/business-news\/despite-mdx-product-delays-talis-biomedical-expecting-meaningful-revenue-ramp-2022<\/a><\/span><span class=\"reference-accessdate\">. 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Retrieved 09 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Sofia+SARS+Antigen+FIA&rft.atitle=&rft.pub=Quidel+Corporation&rft_id=https%3A%2F%2Fwww.quidel.com%2Fimmunoassays%2Frapid-sars-tests%2Fsofia-sars-antigen-fia&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LimiraDxCOVIDAntigen-52\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LimiraDxCOVIDAntigen_52-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.lumiradx.com\/us-en\/what-we-do\/diagnostics\/test-technology\/antigen-test\" target=\"_blank\">\"COVID-19 SARS-CoV-2 Antigen Test\"<\/a>. 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National Institutes of Health. 22 October 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04557046\" target=\"_blank\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04557046<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Performance+Evaluation+of+LumiraDx+COVID-19+%28SARS-CoV-2%29+Ag+Test+%28ASPIRE%29&rft.atitle=ClinicalTrials.gov&rft.date=22+October+2020&rft.pub=National+Institutes+of+Health&rft_id=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT04557046&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AbbottBinaxNOW20-54\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AbbottBinaxNOW20_54-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/media\/141570\/download\" target=\"_blank\">\"BinaxNOW COVID-19 Ag CARD\"<\/a> (PDF). 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Retrieved 09 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=BinaxNOW+COVID-19+Ag+CARD&rft.atitle=&rft.date=December+2020&rft.pub=Abbott+Diagnostics+Scarborough%2C+Inc&rft_id=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F141570%2Fdownload&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-QuidelSofiaSARSFlu-55\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-QuidelSofiaSARSFlu_55-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.quidel.com\/immunoassays\/sofia-2-flu-sars-antigen-fia\" target=\"_blank\">\"Sofia 2 Flu + SARS Antigen FIA\"<\/a>. 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Retrieved 09 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Sofia+2+Flu+%2B+SARS+Antigen+FIA&rft.atitle=&rft.pub=Quidel+Corporation&rft_id=https%3A%2F%2Fwww.quidel.com%2Fimmunoassays%2Fsofia-2-flu-sars-antigen-fia&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AccessBioCOVID19Antigen-56\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AccessBioCOVID19Antigen_56-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/accessbiodiagnostics.net\/carestart-covid-19-antigen\/\" target=\"_blank\">\"CareStart COVID-19 Antigen\"<\/a>. 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Retrieved 09 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=CareStart+COVID-19+Antigen&rft.atitle=&rft.pub=Access+Bio%2C+Inc&rft_id=https%3A%2F%2Faccessbiodiagnostics.net%2Fcarestart-covid-19-antigen%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LuminosticsClip21-57\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LuminosticsClip21_57-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/lib.umso.co\/lib_XCpfHrGtBDMqBGId\/rphccfc1jrh5j5yz.pdf\" target=\"_blank\">\"Clip COVID Rapid Antigen Test\"<\/a> (PDF). 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Retrieved 09 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Clip+COVID+Rapid+Antigen+Test&rft.atitle=&rft.date=2021&rft.pub=Luminostics%2C+Inc&rft_id=https%3A%2F%2Flib.umso.co%2Flib_XCpfHrGtBDMqBGId%2Frphccfc1jrh5j5yz.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-EllumeCOVIDHome-58\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-EllumeCOVIDHome_58-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/media\/144592\/download\" target=\"_blank\">\"Ellume COVID-19 Home Test\"<\/a> (PDF). 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Retrieved 09 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=QuickVue+SARS+Antigen+Test&rft.atitle=&rft.pub=Quidel+Corporation&rft_id=https%3A%2F%2Fwww.quidel.com%2Fimmunoassays%2Fquickvue-sars-antigen-test&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PrincetonStatus-61\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PrincetonStatus_61-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pbmc.com\/products\/covid.shtm\" target=\"_blank\">\"Status COVID-19\/Flu A&B - Rapid SARS-CoV-2\/Influenza A+B Antigen Panel Test\"<\/a>. 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Retrieved 09 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Status+COVID-19%2FFlu+A%26B+-+Rapid+SARS-CoV-2%2FInfluenza+A%2BB+Antigen+Panel+Test&rft.atitle=&rft.pub=Princeton+BioMeditech+Corp&rft_id=http%3A%2F%2Fwww.pbmc.com%2Fproducts%2Fcovid.shtm&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-QuidelQuickVueAtHome21-62\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-QuidelQuickVueAtHome21_62-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/media\/146312\/download\" target=\"_blank\">\"QuickVue At-Home COVID-19 Test\"<\/a> (PDF). 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Retrieved 09 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=QuickVue+At-Home+OTC+COVID-19+Test&rft.atitle=&rft.date=May+2021&rft.pub=Quidel+Corporation&rft_id=https%3A%2F%2Fquickvueathome.com%2Fwp-content%2Fuploads%2F2021%2F08%2FEF1500200EN00.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AbbottBinaxNOWHomeTwo21-64\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AbbottBinaxNOWHomeTwo21_64-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/media\/147259\/download\" target=\"_blank\">\"BinaxNOW COVID-19 Ag Card 2 Home Test\"<\/a> (PDF). 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Retrieved 09 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=SCoV-2+Ag+Detect+Rapid+Test&rft.atitle=&rft.pub=InBios+International%2C+Inc&rft_id=https%3A%2F%2Finbios.com%2Fscov-2-ag-detecttm-rapid-test%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SalofaSiennaClarity-67\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SalofaSiennaClarity_67-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/media\/149055\/download\" target=\"_blank\">\"Sienna-Clarity COVID-19 Antigen Rapid Test Cassette\"<\/a> (PDF). 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Retrieved 09 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Sienna-Clarity+COVID-19+Antigen+Rapid+Test+Cassette&rft.atitle=&rft.pub=Salofa+Oy&rft_id=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F149055%2Fdownload&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-OraSureInteliSwabRapid-68\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-OraSureInteliSwabRapid_68-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/media\/149911\/download\" target=\"_blank\">\"InteliSwab COVID-19 Rapid Test\"<\/a> (PDF). 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Retrieved 09 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=InteliSwab+COVID-19+Rapid+Test&rft.atitle=&rft.pub=OraSure+Technologies%2C+Inc&rft_id=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F149911%2Fdownload&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-OraSureInteliSwabRapidRx-69\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-OraSureInteliSwabRapidRx_69-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/media\/149906\/download\" target=\"_blank\">\"InteliSwab COVID-19 Rapid Test Pro Rx\"<\/a> (PDF). 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Retrieved 16 August 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Isothermal+Reaction+Guide&rft.atitle=&rft.pub=OptiGene+Limited&rft_id=http%3A%2F%2Fwww.optigene.co.uk%2Fisothermal-reaction-guide%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-KashirLoop20-82\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-KashirLoop20_82-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Kashir, J.; Yaqinuddin, A. (2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7182526\" target=\"_blank\">\"Loop mediated isothermal amplification (LAMP) assays as a rapid diagnostic for COVID-19\"<\/a>. <i>Medical Hypotheses<\/i> <b>141<\/b>: 109786. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2Fj.mehy.2020.109786\" target=\"_blank\">10.1016\/j.mehy.2020.109786<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7182526\/\" target=\"_blank\">PMC7182526<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32361529\" target=\"_blank\">32361529<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7182526\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7182526<\/a><\/span>. \"Reagent-wise, the costs would be similar to that of real time RT-PCR ...\"<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Loop+mediated+isothermal+amplification+%28LAMP%29+assays+as+a+rapid+diagnostic+for+COVID-19&rft.jtitle=Medical+Hypotheses&rft.aulast=Kashir%2C+J.%3B+Yaqinuddin%2C+A.&rft.au=Kashir%2C+J.%3B+Yaqinuddin%2C+A.&rft.date=2020&rft.volume=141&rft.pages=109786&rft_id=info:doi\/10.1016%2Fj.mehy.2020.109786&rft_id=info:pmc\/PMC7182526&rft_id=info:pmid\/32361529&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7182526&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MBAccula20-83\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MBAccula20_83-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/media\/136355\/download\" target=\"_blank\">\"Accula Test\"<\/a> (PDF). 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(2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7197526\" target=\"_blank\">\"Laboratory information system requirements to manage the COVID-19 pandemic: A report from the Belgian national reference testing center\"<\/a>. <i>JAMIA<\/i>: ocaa081. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1093%2Fjamia%2Focaa081\" target=\"_blank\">10.1093\/jamia\/ocaa081<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7197526\/\" target=\"_blank\">PMC7197526<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32348469\" target=\"_blank\">32348469<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7197526\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7197526<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Laboratory+information+system+requirements+to+manage+the+COVID-19+pandemic%3A+A+report+from+the+Belgian+national+reference+testing+center&rft.jtitle=JAMIA&rft.aulast=Weemaes%2C+M.%3B+Martens%2C+S.%3B+Cuypers%2C+L.+et+al.&rft.au=Weemaes%2C+M.%3B+Martens%2C+S.%3B+Cuypers%2C+L.+et+al.&rft.date=2020&rft.pages=ocaa081&rft_id=info:doi\/10.1093%2Fjamia%2Focaa081&rft_id=info:pmc\/PMC7197526&rft_id=info:pmid\/32348469&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7197526&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-APHLLIMS20-86\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-APHLLIMS20_86-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Association of Public Health Laboratories (2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/INFO-2020-LIMS.pdf\" target=\"_blank\">\"LIMS (Laboratory Information Management System)\"<\/a> (PDF). Association of Public Health Laboratories<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/INFO-2020-LIMS.pdf\" target=\"_blank\">https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/INFO-2020-LIMS.pdf<\/a><\/span><span class=\"reference-accessdate\">. 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(23 July 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ehrintelligence.com\/news\/ehr-optimization-health-it-projects-needed-after-covid-19-surge\" target=\"_blank\">\"EHR Optimization, Health IT Projects Needed After COVID-19 Surge\"<\/a>. <i>EHR Intelligence<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/ehrintelligence.com\/news\/ehr-optimization-health-it-projects-needed-after-covid-19-surge\" target=\"_blank\">https:\/\/ehrintelligence.com\/news\/ehr-optimization-health-it-projects-needed-after-covid-19-surge<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 August 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=EHR+Optimization%2C+Health+IT+Projects+Needed+After+COVID-19+Surge&rft.atitle=EHR+Intelligence&rft.aulast=Jason%2C+C.&rft.au=Jason%2C+C.&rft.date=23+July+2020&rft_id=https%3A%2F%2Fehrintelligence.com%2Fnews%2Fehr-optimization-health-it-projects-needed-after-covid-19-surge&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ReevesTheClin21-92\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ReevesTheClin21_92-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Reeves, J.J.; Pageler, N.M.; Wick, E.C. et al. (2021). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8416224\" target=\"_blank\">\"The Clinical Information Systems Response to the COVID-19 Pandemic\"<\/a>. <i>Yearbook of Medical Informatics<\/i> <b>30<\/b> (1): 105\u201325. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1055%2Fs-0041-1726513\" target=\"_blank\">10.1055\/s-0041-1726513<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8416224\/\" target=\"_blank\">PMC8416224<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/34479384\" target=\"_blank\">34479384<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8416224\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8416224<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Clinical+Information+Systems+Response+to+the+COVID-19+Pandemic&rft.jtitle=Yearbook+of+Medical+Informatics&rft.aulast=Reeves%2C+J.J.%3B+Pageler%2C+N.M.%3B+Wick%2C+E.C.+et+al.&rft.au=Reeves%2C+J.J.%3B+Pageler%2C+N.M.%3B+Wick%2C+E.C.+et+al.&rft.date=2021&rft.volume=30&rft.issue=1&rft.pages=105%E2%80%9325&rft_id=info:doi\/10.1055%2Fs-0041-1726513&rft_id=info:pmc\/PMC8416224&rft_id=info:pmid\/34479384&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC8416224&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20210919172325\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.721 seconds\nReal time usage: 0.808 seconds\nPreprocessor visited node count: 63076\/1000000\nPost\u2010expand include size: 573792\/2097152 bytes\nTemplate argument size: 164891\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 169140\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 628.053 1 -total\n 90.73% 569.857 1 Template:Reflist\n 76.12% 478.102 92 Template:Citation\/core\n 53.22% 334.252 65 Template:Cite_web\n 22.82% 143.318 24 Template:Cite_journal\n 9.24% 58.010 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need?\n 8.94% 56.149 41 Template:Date\n 5.12% 32.139 3 Template:Cite_book\n 4.58% 28.759 60 Template:Citation\/identifier\n 4.23% 26.587 113 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12143-0!canonical and timestamp 20210919172324 and revision id 40211. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","5c08823bef2028cb17c7a3612075ff8e_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/a\/a5\/Eppendorf_Mastercycler_Pro_S.jpg"],"5c08823bef2028cb17c7a3612075ff8e_timestamp":1632073385,"e0edecb7b45ad188bb3834725c23d19b_type":"article","e0edecb7b45ad188bb3834725c23d19b_title":"3.1 What methodologies will you use?","e0edecb7b45ad188bb3834725c23d19b_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F","e0edecb7b45ad188bb3834725c23d19b_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Adding COVID-19 and other virus testing to your laboratory\/What methodologies will you use?From LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 3. Adding COVID-19 and other virus testing to your laboratory \n\n1.1 3.1 What methodologies will you use? \n\n1.1.1 3.1.1 PCR \n1.1.2 3.1.2 Pooled testing \n1.1.3 3.1.3 Rapid antigen testing \n1.1.4 3.1.4 LAMP and CRISPR \n1.1.5 3.1.5 Point-of-care and other alternative testing \n1.1.6 3.1.6 Multiplex testing \n1.1.7 3.1.7 Variant testing \n\n\n\n\n2 References \n\n\n\n3. Adding COVID-19 and other virus testing to your laboratory \nMaybe you've been running an environmental health laboratory and want to expand into clinical health testing. Perhaps you're in charge of an academic research lab but want to expand to the clinical diagnostic side. Or maybe you're running a physician office laboratory (POL) and are wondering if it's even possible to expand your waived testing efforts to COVID-19. Where the previous chapter discussed the \"what\" of COVID-19 and viral testing, this chapter aims to help you with the \"how\" of adding it to your laboratory offerings.\nNaturally, many questions come with the \"how\":\n\nDoes using one method make the most sense, or will your lab turn to multiple methods for virus testing? This may be determined by current equipment, space considerations, and budget.\nWhat type of lab are you running? A POL is going to have fewer options available than a CLIA moderate- or high-complexity lab.\nHow interoperable are you existing laboratory and clinical informatics solutions? Research laboratories face more challenges in integrating their systems with EHRs and other clinical systems.\nWhat vendors and consultants are out there to help get equipped? Some vendors have very specific solutions, whereas others may have a broader range of offerings.\nThese questions and more are addressed in this chapter.\n\n 3.1 What methodologies will you use? \n3.1.1 PCR \n SARS-CoV-2 PCR screening test by nasal swab in Strasbourg on August 21, 2020.In the previous chapter, the most common testing methodologies for COVID-19 and other coronaviruses were discussed in detail. The prevailing method (often called the \"gold standard\") among them all is real-time reverse-transcription polymerase chain reaction (rRT-PCR) assays for testing. Broadly speaking, PCR is useful in pharmaceutical, biotechnology, and genetic engineering endeavors, as well as clinical diagnostics. As such, labs in those industries that already have PCR infrastructure in place have a theoretical step-up over labs that do not.\nPCR technology has advanced to the point where it is more efficient and user-friendly than prior, yet \"the high cost of the instruments, servicing contracts, and reagents pose major challenges for the market, especially to the price-sensitive academics.\"[1] Writing about the thirty-fifth anniversary of PCR in 2018, science writer Alan Dove not only highlighted these cost issues but also the size and energy requirements for running the equipment. \"As a result, one of the defining techniques of modern molecular biology has remained stubbornly inaccessible to educators and unusable in many remote locations.\"[2] Various efforts have been made over the years to bring costs down by modifying how heating and temperature control are performed[3][4][5][6], but many of those system aren't typically optimal during a pandemic when turnaround time is critical.\nAmidst the pandemic, additional challenges also exist to those wanting to conduct PCR testing for COVID-19 and other viruses. As was discussed at the end of the previous chapter, supplies of reagents and consumables are not particularly robust mid-pandemic, with various shortages being reported off and on since the start of the pandemic.[7][8][9][10][11][12][13][14][15][16][17][18] Some of these shortages have gradually worked themselves out over time, but they highlight the need for other varying methods that don't necessarily depend on the same reagents and consumables that are in short supply.\nFor those labs wishing to adopt PCR testing of viruses\u2014particularly COVID-19\u2014into their workflow while providing reasonable turnaround times, all is not lost. However, careful planning is required. For example, you'll want to keep in mind that some PCR machines require vendor-specific reagents. If you're going to acquire a particular instrument, you'll want to do due diligence by verifying not only the supported reagents but also those reagents' overall availability (real and projected). You'll also want to consider factors such as anticipated workload (tests per day), what your workflow will look like, and how to balance overall investment with the need for reasonable turnaround times. \nAn increasing body of research is being produced suggesting ways to improve turnaround times with PCR testing for COVID-19, with many research efforts focusing on cutting out RNA extraction steps entirely. Alcoba-Florez et al. propose direct heating of the sample-containing nasopharyngeal swab at 70 \u00b0C for 10 minutes in place of RNA extraction.[19] Adams et al. have proposed an \"adaptive PCR\" method using a non-standard reagent mix that skips RNA extraction and can act \"as a contingency for resource\u2010limited settings around the globe.\"[20][21] Wee et al. skip RNA extraction and nucleic acid purification by using a single-tube homogeneous reaction method run on a lightweight, portable thermocycler.[22][23] Other innovations include tweaking reagents and enzymes to work with one step, skipping the reverse transcription step,[24] and using saliva-based molecular testing that skips RNA extraction.[25][26]\nSaliva as a specimen\nThe saliva molecular tests in particular are intriguing. Talk of the potential utility of using saliva as a specimen for COVID-19 was occurring as early as April 2020[27][28], and the first saliva-based COVID-19 test, produced by Spectrum Solutions in cooperation with RUCDR Infinite Biologics Laboratory[29] and Vault Health[30], was given an FDA EUA in April 2020. On August 15, 2020, Yale School of Public Health was given an EUA for it SalivaDirect molecular test. Although still PCR-based (and a CLIA high-complexity test), SalivaDirect is being touted as a means to improve specimen collection safety, consume fewer reagents, prove compatible with high-throughput workflow, and cut overall turnaround time. Not only is saliva easier to collect and safer for healthcare staff, the test is essentially \"open sourced,\" not requiring proprietary equipment from Yale, making the test more flexible by being validated to reliably function with a wider array of reagents and instruments.[31][32] When compared to using a nasopharyngeal swab specimen using the ThermoFisher Scientific TaqPath COVID-19 combo kit, results were comparable 94.1% of the time.[26] While sensitivity and specificity may be slightly less comparable to other PCR options[33], the overall advantages during reagent shortages and a definitive need for broader testing likely outweigh the slightly lesser sensitivity and specificity. In November 2020, public health agencies in Arizona and Minnesota reportedly began running trials of free saliva-based molecular testing.[34][35] \nAs the pandemic has progressed into 2021, saliva testing has become even more attractive, in particular for at-home over-the-counter testing.[36][37] In August 2021, Spectrum Solutions received an EUA for its Spectrum Solutions SDNA-1000 saliva collection system, specifically designed \"to avoid user collection errors\" and eliminate \"the requirement for any bio-sample temperature-controlled storage or transport,\"[38] arguably upping the game for new saliva-based test kits going forward. Additionally, as variants of COVID-19 continue to crop up, additional saliva-based at-home tests are coming into development. For example, researchers at the Wyss Institute, the Massachusetts Institute of Technology, and Boston-area hospitals have been working on a laboratory-developed test called Minimally Instrumented SHERLOCK (miSHERLOCK) based on CRISPR (clustered regularly interspaced short palindromic repeats) technology. The researchers claim that the test, able to be used with typical off-the-shelf components, \"works as well as the gold standard PCR tests and could cost as little as $3 per test.\"[39][40]\n\n3.1.2 Pooled testing \nAnother method some labs are taking to speed up turnaround time is using pooled testing. The general concept involves placing two or more test specimens together and testing the pool as one specimen. The most obvious advantage to this is that the process saves on reagents and other supplies, particularly when supply chains are disrupted, and it reduces the amount of time required to analyze large quantities of specimens.[41] This methodology is best used \"in situations where disease prevalence is low, since each negative pool test eliminates the need to individually test those specimens and maximizes the number of individuals who can be tested over a given amount of time.\"[42] However, it's best left to situations where expectations are that less than 10 percent of the population being tested is affected by what's being tested for.[42][43][44] \nThe downside of pooled testing comes with the issues of dilution, contamination, and populations with 10 or more percent infected. A target-positive specimen that commingles with other target-free specimens is itself diluted and in some cases may cause issues with the limit of detection for the assay. Additionally, if the pool tests positive, target-free specimens may become contaminated by a target-positive specimen. This may cause issues with any individual specimen assays that get ran. And the workflows involving pooling must be precise, as a technician working with multiple specimens at the same time increases the chance of lab errors.[42][43][44] Finally, at least in the U.S., a Food and Drug Administration (FDA) emergency use authorization (EUA) for a validated pooled testing method is required.[42] (Validation of pooled methods may differ in other countries.[43]) The U.S. Centers for Disease Control and Prevention (CDC) has published interim guidance on pooled testing strategies for SARS-CoV-2.\nOn April 20, 2021, the FDA updated its policies to allow for pooled testing to be added to the use case scenarios for several existing test kits. \"This means that tests with EUAs that are amended by this authorization may be used with pooled anterior nasal specimens from individuals without known or suspected COVID-19 when such individuals are tested as part of a testing program that includes testing at regular intervals, at least once per week.\"[45] However, affected kits can only be used in high-complexity CLIA labs, though \"tests authorized for use in specific named or designated high-complexity laboratories can only be used in such laboratories.\"[45] As of September 2021, four PCR test kit EUAs were amended to allow for pooled testing[45]:\n\nBiomeme SARS-CoV-2 Real-Time RT-PCR Test\nClinical Enterprise SARS-SoV-2-RT-PCR Assay\nCRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3)\nViracor SARS-CoV-2 assay\n3.1.3 Rapid antigen testing \nAs mentioned in the previous chapter, the benefits of antigen testing For COVID-19 and other viral infections are 1. specimen collection can typically be done with a simple nasal swab rather than a more invasive nasopharyngeal swab, 2. testing is more rapid and convenient, and 3. it takes some pressure off the PCR supply chain. However, antigen testing only tests what's there, rather than amplifying the amount, resulting in generally lower sensitivities.[46][47] As such, the real utility of antigen testing, despite its lower sensitivity, appears to be surveillance situations where a large group of individuals who are at risk can be screened at regularly scheduled intervals of two to four days. If your lab is able to support this sort of testing, then this type of testing may be an option. As of September 2021, thirty-four FDA EUAs for antigen tests have been issues; 28 of those 34 include allowances for CLIA-waived testing, and 10 were authorized for home use.[48] Review the FDA list to further examine your options.\nThe CDC emphasizes that molecular testing remains the \"gold standard\" for detecting SARS-CoV-2 in a sample, and it \"may be necessary to confirm an antigen test result with a laboratory-based NAAT, especially if the result of the antigen test is inconsistent with the clinical context.\" However, some molecular tests designed for point-of-care testing may not be sufficiently designed for confirmatory testing; consult the instructions for use for any confirmatory test.[49] The CDC makes available two antigen testing algorithms for determining when confirmatory testing is actually recommended.[49]\n\n3.1.4 LAMP and CRISPR \nEarly on in the pandemic, while PCR was getting most of the attention, reverse transcription loop-mediated isothermal amplification (RT-LAMP), an isothermal nucleic acid amplification technique that allows for RNA amplification, was also quietly being discussed[50][51], and it has since gained more attention.[52][53][54][55][56][57] In July 2020, the University of Oxford was in the process of getting a rapid, affordable, clinically-validated RT-LAMP test approved for the European market. Oxford also notes that \"[a]n advantage of using LAMP technology is that it uses different reagents to most laboratory-based PCR tests.\"[57] Thi et al. have tested a two-color RT-LAMP assay with an N gene primer set and diagnostic validation using LAMP-sequencing, concluding that the pairing of the two \"could offer scalable testing that would be difficult to achieve with conventional qRT-PCR based tests.\"[55] And California-based Color Genomics set up their own proprietary RT-LAMP system in the summer of 2020, capable of handling up to 10,000 tests per day.[58]\nIn most cases, LAMP-based testing is much simpler than PCR, lacking the requirement of specialized instruments. Despite LAMP generally being thought of as less sensitive than PCR[58][47][59], the explosion of research into RT-LAMP methods for testing for the presence of SARS-CoV-2 continues to indicate that \"under optimized conditions,\" RT-LAMP methods may actually be able to rival the sensitivity and specificity of many RT-PCR COVID-19 tests.[56] Esbin et al. add[56]:\n\nThese methods allow for faster amplification, less specialized equipment, and easy readout. LAMP methods also benefit from the ability to multiplex targets in a single reaction and can be combined with other isothermal methods, like [recombinase polymerase amplification] in the RAMP technique, to increase test accuracy even more. These techniques may be particularly useful for rapid, point-of-care diagnoses or for remote clinical testing without the need for laboratory equipment.\nCRISPR methods are also being used in conjunction with RT-LAMP.[47][56][60] RT-LAMP creates complementary double-stranded DNA (cDNA) from specimen RNA and then copies (amplifies) it. Then CRISPR methods are used to detect a predefined coronavirus sequence (from a cleaved molecular marker) in the resulting amplified specimen. Though as of September 2021 approved assays using CRISPR-based detection of SARS-CoV-2 are limited to a handful of companies[45][47][61], the technology has some promise as an alternative testing method. CRISPR has the additional advantage of being readily coupled with lateral flow assay technology to be deployed in the point-of-care (POC) setting[56][61], though it's worth noting the currently EUAed RT-LAMP-based CRISPR kits are only approved for high-complexity CLIA labs. (The current molecular diagnostic test kits running CRISPR technology are Sherlock BioSciences' Sherlock CRISPR SARS-CoV-2 Kit and Mammoth Biosciences' SARS-CoV-2 DETECTR Reagent Kit, both high-complexity.[45])\n\n3.1.5 Point-of-care and other alternative testing \n Example of a microfluidic chip used in point-of-care medical devicesOn September 28, 2020, the WHO published its blueprint for what they call Target Product Profiles (TPP), which \"describe the desirable and minimally acceptable profiles\" for four different COVID-19 test categories.[62] Addressing POC testing, the WHO recommends that such assays[62][63]:\nhave a sensitivity (true positive rate) of at least 80 percent, with 90 percent or better being desirable;\nhave a specificity (true negative rate) of at least 97 percent, with greater than 99 percent being desirable;\nprovide results in less than 40 minutes, with less 20 minutes or less being desirable;\nhave \"a cost that allows broad use, including in low- and middle-income countries\";\nbe simple enough that only a half day to, optimally, a few hours of training are required to run the test; and\noperate reliably outside a clean laboratory environment.\nThough at the time of the announcement few of the available test systems could likely meet all these requirements, it's clear this and other urgencies have put pressure on manufacturers to expand COVID-19 testing to the point of care setting.[63][64][65][66] Additional incentives were offered by the U.S. National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) funding program, which sought to speed up innovation in COVID-19 testing and promote \"truly nontraditional approaches for testing that have a slightly longer horizon.\"[67] In August 2020, RADx had chosen to fund seven biomedical diagnostic companies making new lab-based and POC tests that could significantly ramp up overall testing in the U.S. into September 2020. Four of those offerings were lab-based (from Ginkgo Bioworks, Helix OpCo, Fluidigm, and Mammoth Biosciences) and three were POC tests (from Mesa Biotech, Quidel, and Talis Biomedical), all using varying technologies and methods such as next-generation sequencing, CRISPR, microfluidic chips, nucleic acid testing, antigen testing, and saliva testing.[68] On October 28, 2020, RADx added an additional 15 biomedical diagnostics projects for funding, for a total of 22.[69] As of September 2021, some of those 22 programs have come to fruition, garnering FDA EUAs, including Mesa Biotech's rapid cartridge-based RT-PCR Accula System, Quidel's rapid Sofia SARS Antigen FIA test, Mammoth Bioscience's SARS-CoV-2 DETECTR Reagent Kit, and Visby Medical's COVID-19 Point of Care Test.[45]\nOutside the RADx program, enterprising researchers in other parts of the world are also attempting non-traditional approaches to improving COVID-19 testing options. Examples include[56][66][70][71]:\n\na method of DNA nanoswitch detection of virus particles;\na dual biomarker-based finger-stick test for acute respiratory infections;\na rapid breath test to detect volatile organic chemicals from the lungs;\nan affordable, hand-held spectral imaging device to detect virus in blood or saliva in seconds;\nan ultrahigh frequency spectroscopic scanning device to see virus particles resonating;\na method that combines optical devices and magnetic particles to detect virus RNA;\nan RNA extraction protocol that uses magnetic bead-based kits;\na nanotube-based electrochemical biosensor for detecting biomarkers in a sample in less than a minute;\nthe additional use of an artificial intelligence (AI) application to better scrutinize test results; and\nthe miniaturization of PCR technology to make it more portable and user-friendly.\nOf course, most of these are largely experimental technologies, and realistically getting them into the lab may be far out. But they represent out-of-the-box ideas that have some kind of chance at playing a greater role in the clinical laboratory or in point-of-care settings in the future.\n\n3.1.6 Multiplex testing \nAs the pandemic has progressed and test manufacturers have become more experienced with SARS-CoV-2 test development, multiplex testing has become an option. The multiplex assay\u2014an immunoassay test able to measure multiple analytes in a single test\u2014is certainly not new in itself. In 1989, R. Ekins developed the ambient analyte theory, which stated that miniaturizing an immunoassay can lead to an improved limit of detection (LOD). That work influenced the future development of microarray multiplex technology principles.[72] By 2013, development of multiplex protein immunoassays was becoming increasingly prominent.[72]\nAs of September 2021, eighteen \"multi-analyte\" in vitro molecular diagnostic tests are shown as receiving EUAs by the FDA, four of them even authorized for CLIA waived testing.[45] Common additional targets for analysis among the various kits include influenza A, influenza B, and respiratory syncytial virus (RSV).[45] However, several multiplex test kits cover an even broader array of respiratory-affecting organism types and subtypes such as adenovirus and a few other coronavirus types, to name a few. Kits include the ePlex Respiratory Pathogen Panel 2[73], the NxTAG Respiratory Pathogen Panel + SARS-CoV-2[74], the QIAstat-Dx Respiratory SARS-CoV-2 Panel[75], and the BioFire Respiratory Panel 2.1-EZ.[76] (Of the four, the BioFire panel is approved for CLIA waived testing.[45]) Adding multiplex testing of SARS-CoV-2 plus other organisms to your laboratory will largely revolve around your lab's CLIA status and assessment of the available options.\nMultiplexing provides a variety of benefits for laboratories and patients. In their 2015 paper on ELISA and multiplex technologies, Tighe et al find that multiplexed immunoassays have the potential to decrease diagnosis times and reduce assay costs. \"At the same time, such multiplexing offers more comprehensive analysis whether for research purposes, differential diagnoses, or monitoring of therapeutic interventions.\"[72] They also note the potential for improved health surveillance of patients, catching early-onset diseases by looking for informative biomarkers.[72] From the perspective of diagnosing infections of SARS-CoV-2 or influenza, the CDC adds that multiplexing helps preserve testing supplies that may be in short supply, conduct more tests in a given time period, and paint a clearer picture of both viruses and their prevalence in a given population.[77]\n\n3.1.7 Variant testing \nAs the pandemic has progressed, you may have heard talk of a \"delta\" variant of SARS-CoV-2, which is reportedly more contagious and virulent than the initial strain that kicked off the pandemic.[78] One or more variants of a virus are expected as time progresses, and some of those variants can cause significantly more problems than the source virus. As such, analytical testing of the virus over time is vital to public health.\nThe purpose of variant testing can be described in two ways, one for public health reasons and another for clinical care reasons. On the public health side, analysis of SARS-CoV-2 variants provides an unbiased, population-level view \"of the specific viral strains in circulation and monitors changes in the viral genome over time.\"[79] With enough public health laboratories conducting this type of analysis\u2014typically whole-genome sequencing (WGS) using next-generation sequencing (NGS) techniques\u2014a clearer picture of how an outbreak spreads is gained, as well as what variants are taking hold and further threatening human populations (even those that are vaccinated). This information is typically shared through the public health system for surveillance and reporting purposes, though the affected patients themselves may never see the data.[79]\nOn the clinical care side, analysis of SARS-CoV-2 variants provides further insights into improving COVID-19 patient outcomes. Buchan et al. identify three potential insights that clinicians may gain, noting that variant testing allows the clinician[79]:\n\nto distinguish between an existing, persistent infection caused by one viral strain vs. re-infection by a different viral strain;\nto determine whether a patient not responding to a treatment is affected by a specific viral spike protein (S) gene mutation that is \"potentially resistant or less susceptible to neutralizing antibodies or monoclonal antibodies\"; and\nto detect in the serum or plasma of a patient post-vaccination \"viral S gene substitutions in specific variants that are potentially resistant or less susceptible\" to the antibodies the vaccine generates.\nIf, for example, a patient is diagnosed with a variant that is tied to heightened disease severity, the clinician can opt for additional treatments early on to counteract the variant's effects on the patient. This testing is done in a hospital or reference lab by WGS or by targeting a portion of the genome (e.g., a spike protein) or a specific mutation (using RT-PCR). However, according to Buchan et al., the contributions a mutation makes to a \"variant's attributes is not entirely understood, and there is no definitive evidence that directly links a given mutation to poor outcomes, significantly reduced efficacy of SARS-CoV-2 therapies, or vaccine coverage.\"[79]\nThat said, and leaving the public health element to the side, if you are a laboratory conducting clinical analyses of SARS-CoV-2 specimens, the likelihood of including viral sequencing and sequence analysis for variant testing may be low for your facility. Such testing is a multi-step process requiring a non-trivial set of resources, often available to large commercial diagnostic laboratories.[79][80] The CDC represents one possible workflow for genomic sequencing as such[81]:\n\nA specimen containing the SARS-CoV-2 virus is received by the lab and promptly entered into the laboratory information system (LIS).\nThe RNA of the SARS-CoV-2 virus is extracted from the sample and then converted to complimentary DNA. It is then enriched and loaded into the appropriate NGS instrument.\nThe instrument runs the sequencing and raw data is collected, with the lab maintaining quality control steps. The raw data is turned into actionable sequence data.\nThe sequence data is verified for suitability, with a resequencing occurring if found to be inadequate. Otherwise, the data is then analyzed and interpreted.\nThe final approved sequencing results are reported to the appropriate state, local, tribal, or territorial public health department.[82]\nIf your diagnostic lab has or is planning on adding sequencing tools to supplement clinical diagnostics, it may make sense to consider adding variant testing to your available options. But in reality, this sort of testing may largely be left to large institutions, such as the University of Rochester Vaccine Treatment Evaluation Unit or the Yale School of Public Health.[83]\n\nReferences \n\n\n\u2191 Kenneth Research (23 June 2020). \"Polymerase Chain Reaction Market Sector Analysis Report, Regional Outlook & Competitive Share & Forecast - 2023\". MarketWatch. 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Retrieved 11 August 2020 .   \n \n\n\u2191 University of Nevada, Reno (14 October 2020). \"COVID-19 rapid test has successful lab results, research moves to next stages: Engineers and virologists team up for novel approach\". ScienceDaily. https:\/\/www.sciencedaily.com\/releases\/2020\/10\/201014141032.htm . Retrieved 19 November 2020 .   \n \n\n\u2191 72.0 72.1 72.2 72.3 Tighe, Patrick J.; Ryder, Richard R.; Todd, Ian; Fairclough, Lucy C. (1 April 2015). \"ELISA in the multiplex era: Potentials and pitfalls\" (in en). PROTEOMICS \u2013 Clinical Applications 9 (3-4): 406\u2013422. doi:10.1002\/prca.201400130. ISSN 1862-8346. PMC PMC6680274. PMID 25644123. https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/prca.201400130 .   \n \n\n\u2191 Hinton, D.M. (7 October 2020). \"ePlex Respiratory Pathogen Panel 2 (ePlex RP2 Panel)\" (PDF). U.S. Food and Drug Administration. https:\/\/www.fda.gov\/media\/142902\/download . Retrieved 19 September 2021 .   \n \n\n\u2191 Hinton, D.M. (3 March 2021). \"NxTAG Respiratory Pathogen Panel + SARS-CoV-2\" (PDF). U.S. Food and Drug Administration. https:\/\/www.fda.gov\/media\/146492\/download . Retrieved 19 September 2021 .   \n \n\n\u2191 Hinton, D.M. (29 July 2021). \"QIAstat-Dx Respiratory SARS-CoV-2 Panel\" (PDF). U.S. Food and Drug Administration. https:\/\/www.fda.gov\/media\/136569\/download . Retrieved 19 September 2021 .   \n \n\n\u2191 Hinton, D.M. (30 August 2021). \"BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ)\" (PDF). U.S. Food and Drug Administration. https:\/\/www.fda.gov\/media\/142693\/download . Retrieved 19 September 2021 .   \n \n\n\u2191 Centers for Disease Control and Prevention (13 July 2021). \"CDC\u2019s Influenza SARS-CoV-2 Multiplex Assay and Required Supplies\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/multiplex.html . Retrieved 19 September 2021 .   \n \n\n\u2191 Centers for Disease Control and Prevention (26 August 2021). \"Delta Variant: What We Know About the Science\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/variants\/delta-variant.html . Retrieved 18 September 2021 .   \n \n\n\u2191 79.0 79.1 79.2 79.3 79.4 Buchan, B.W.; Wolk, D.M.; Yao, J.D. (28 April 2021). \"SARS-CoV-2 Variant Testing\" (PDF). Rapid Communication. Association for Molecular Pathology. https:\/\/www.amp.org\/AMP\/assets\/File\/clinical-practice\/COVID\/AMP_RC_VariantTestingforSARSCOV2_4_28_21.pdf . Retrieved 18 September 2021 .   \n \n\n\u2191 Williams, R.W. (19 February 2021). \"Enhancing Public Health Surveillance for Variant SARSCoV-2 Viruses in Missouri\" (PDF). Missouri Department of Health & Senior Services. https:\/\/health.mo.gov\/emergencies\/ert\/alertsadvisories\/pdf\/update21921.pdf . Retrieved 18 September 2021 .   \n \n\n\u2191 Centers for Disease Control and Prevention (8 September 2021). \"CDC\u2019s Role in Tracking Variants\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/variants\/cdc-role-surveillance.html . Retrieved 18 September 2021 .   \n \n\n\u2191 Centers for Disease Control and Prevention (23 June 2021). \"Guidance for Reporting SARS-CoV-2 Sequencing Result\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/resources\/reporting-sequencing-guidance.html . Retrieved 19 September 2021 .   \n \n\n\u2191 Dupuy, B. (28 July 2021). \"COVID-19 variants tested through genome sequencing\". Reuters Fact-Checking. https:\/\/apnews.com\/article\/fact-checking-549965482111 . Retrieved 18 September 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 23 August 2020, at 19:28.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 300 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","e0edecb7b45ad188bb3834725c23d19b_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Adding_COVID-19_and_other_virus_testing_to_your_laboratory_What_methodologies_will_you_use rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Adding_COVID-19_and_other_virus_testing_to_your_laboratory_What_methodologies_will_you_use skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Adding COVID-19 and other virus testing to your laboratory\/What methodologies will you use?<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Introduction\" title=\"Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Introduction\" class=\"wiki-link\" data-key=\"d0faaf5a86a3ccb5b12357c8bd4fefe4\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h2><span class=\"mw-headline\" id=\"3._Adding_COVID-19_and_other_virus_testing_to_your_laboratory\">3. Adding COVID-19 and other virus testing to your laboratory<\/span><\/h2>\n<p>Maybe you've been running an environmental health laboratory and want to expand into clinical health testing. Perhaps you're in charge of an academic research lab but want to expand to the clinical diagnostic side. Or maybe you're running a <a href=\"https:\/\/www.limswiki.org\/index.php\/Physician_office_laboratory\" title=\"Physician office laboratory\" class=\"wiki-link\" data-key=\"0655647b0091e0dd168f162b621a6cef\">physician office laboratory<\/a> (POL) and are wondering if it's even possible to expand your waived testing efforts to COVID-19. Where the previous chapter discussed the \"what\" of COVID-19 and viral testing, this chapter aims to help you with the \"how\" of adding it to your laboratory offerings.\n<\/p><p>Naturally, many questions come with the \"how\":\n<\/p>\n<ul><li>Does using one method make the most sense, or will your lab turn to multiple methods for virus testing? This may be determined by current equipment, space considerations, and budget.<\/li>\n<li>What type of lab are you running? A POL is going to have fewer options available than a CLIA moderate- or high-complexity lab.<\/li>\n<li>How interoperable are you existing laboratory and clinical informatics solutions? Research laboratories face more challenges in integrating their systems with EHRs and other clinical systems.<\/li>\n<li>What vendors and consultants are out there to help get equipped? Some vendors have very specific solutions, whereas others may have a broader range of offerings.<\/li><\/ul>\n<p>These questions and more are addressed in this chapter.\n<\/p>\n<h3><span id=\"rdp-ebb-3.1_What_methodologies_will_you_use?\"><\/span><span class=\"mw-headline\" id=\"3.1_What_methodologies_will_you_use.3F\">3.1 What methodologies will you use?<\/span><\/h3>\n<h4><span class=\"mw-headline\" id=\"3.1.1_PCR\">3.1.1 PCR<\/span><\/h4>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:402px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Test_PCR_d%C3%A9pistage_SARS-CoV-2_pr%C3%A9l%C3%A8vement_nasal_Strasbourg_21_ao%C3%BBt_2020.jpg\" class=\"image wiki-link\" data-key=\"c44e0dee3201f85e0b3cf4e530a3d297\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/6\/6a\/Test_PCR_d%C3%A9pistage_SARS-CoV-2_pr%C3%A9l%C3%A8vement_nasal_Strasbourg_21_ao%C3%BBt_2020.jpg\" decoding=\"async\" class=\"thumbimage\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Test_PCR_d%C3%A9pistage_SARS-CoV-2_pr%C3%A9l%C3%A8vement_nasal_Strasbourg_21_ao%C3%BBt_2020.jpg\" class=\"internal wiki-link\" title=\"Enlarge\" data-key=\"c44e0dee3201f85e0b3cf4e530a3d297\"><\/a><\/div>SARS-CoV-2 PCR screening test by nasal swab in Strasbourg on August 21, 2020.<\/div><\/div><\/div><p>In the previous chapter, the most common testing methodologies for <a href=\"https:\/\/www.limswiki.org\/index.php\/COVID-19\" class=\"mw-redirect wiki-link\" title=\"COVID-19\" data-key=\"da9bd20c492b2a17074ad66c2fe25652\">COVID-19<\/a> and other <a href=\"https:\/\/www.limswiki.org\/index.php\/Coronavirus\" title=\"Coronavirus\" class=\"wiki-link\" data-key=\"86c887aaa85c1b2b96fd478c10703204\">coronaviruses<\/a> were discussed in detail. The prevailing method (often called the \"gold standard\") among them all is real-time reverse-transcription <a href=\"https:\/\/www.limswiki.org\/index.php\/Polymerase_chain_reaction\" title=\"Polymerase chain reaction\" class=\"wiki-link\" data-key=\"f6569fb01ef396379f9f4efa4527e715\">polymerase chain reaction<\/a> (rRT-PCR) assays for testing. Broadly speaking, PCR is useful in pharmaceutical, biotechnology, and genetic engineering endeavors, as well as clinical diagnostics. As such, labs in those industries that already have PCR infrastructure in place have a theoretical step-up over labs that do not.\n<\/p><p>PCR technology has advanced to the point where it is more efficient and user-friendly than prior, yet \"the high cost of the instruments, servicing contracts, and reagents pose major challenges for the market, especially to the price-sensitive academics.\"<sup id=\"rdp-ebb-cite_ref-MWPoly20_1-0\" class=\"reference\"><a href=\"#cite_note-MWPoly20-1\">[1]<\/a><\/sup> Writing about the thirty-fifth anniversary of PCR in 2018, science writer Alan Dove not only highlighted these cost issues but also the size and energy requirements for running the equipment. \"As a result, one of the defining techniques of modern molecular biology has remained stubbornly inaccessible to educators and unusable in many remote locations.\"<sup id=\"rdp-ebb-cite_ref-DovePCR18_2-0\" class=\"reference\"><a href=\"#cite_note-DovePCR18-2\">[2]<\/a><\/sup> Various efforts have been made over the years to bring costs down by modifying how heating and temperature control are performed<sup id=\"rdp-ebb-cite_ref-WongARapid15_3-0\" class=\"reference\"><a href=\"#cite_note-WongARapid15-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KuznetsovDIYbio15_4-0\" class=\"reference\"><a href=\"#cite_note-KuznetsovDIYbio15-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-NortonPhila16_5-0\" class=\"reference\"><a href=\"#cite_note-NortonPhila16-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AnLow20_6-0\" class=\"reference\"><a href=\"#cite_note-AnLow20-6\">[6]<\/a><\/sup>, but many of those system aren't typically optimal during a pandemic when turnaround time is critical.\n<\/p><p>Amidst the pandemic, additional challenges also exist to those wanting to conduct PCR testing for COVID-19 and other viruses. As was discussed at the end of the previous chapter, supplies of reagents and consumables are not particularly robust mid-pandemic, with various shortages being reported off and on since the start of the pandemic.<sup id=\"rdp-ebb-cite_ref-HerperShortage20_7-0\" class=\"reference\"><a href=\"#cite_note-HerperShortage20-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HaleQiagen20_8-0\" class=\"reference\"><a href=\"#cite_note-HaleQiagen20-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MehtaMystery20_9-0\" class=\"reference\"><a href=\"#cite_note-MehtaMystery20-9\">[9]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RocheIrish20_10-0\" class=\"reference\"><a href=\"#cite_note-RocheIrish20-10\">[10]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PadmaEfforts20_11-0\" class=\"reference\"><a href=\"#cite_note-PadmaEfforts20-11\">[11]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DavidSurvey20_12-0\" class=\"reference\"><a href=\"#cite_note-DavidSurvey20-12\">[12]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-JohnsonNCLabs20_13-0\" class=\"reference\"><a href=\"#cite_note-JohnsonNCLabs20-13\">[13]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MervoshItsLike20_14-0\" class=\"reference\"><a href=\"#cite_note-MervoshItsLike20-14\">[14]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CourageCovid20_15-0\" class=\"reference\"><a href=\"#cite_note-CourageCovid20-15\">[15]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ASMSupply20_16-0\" class=\"reference\"><a href=\"#cite_note-ASMSupply20-16\">[16]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AbbottCovid20_17-0\" class=\"reference\"><a href=\"#cite_note-AbbottCovid20-17\">[17]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WilliamsSupply21_18-0\" class=\"reference\"><a href=\"#cite_note-WilliamsSupply21-18\">[18]<\/a><\/sup> Some of these shortages have gradually worked themselves out over time, but they highlight the need for other varying methods that don't necessarily depend on the same reagents and consumables that are in short supply.\n<\/p><p>For those labs wishing to adopt PCR testing of viruses\u2014particularly COVID-19\u2014into their workflow while providing reasonable turnaround times, all is not lost. However, careful planning is required. For example, you'll want to keep in mind that some PCR machines require vendor-specific reagents. If you're going to acquire a particular instrument, you'll want to do due diligence by verifying not only the supported reagents but also those reagents' overall availability (real and projected). You'll also want to consider factors such as anticipated workload (tests per day), what your workflow will look like, and how to balance overall investment with the need for reasonable turnaround times. \n<\/p><p>An increasing body of research is being produced suggesting ways to improve turnaround times with PCR testing for COVID-19, with many research efforts focusing on cutting out RNA extraction steps entirely. Alcoba-Florez <i>et al.<\/i> <a href=\"https:\/\/www.limswiki.org\/index.php\/Journal:Fast_SARS-CoV-2_detection_by_RT-qPCR_in_preheated_nasopharyngeal_swab_samples\" title=\"Journal:Fast SARS-CoV-2 detection by RT-qPCR in preheated nasopharyngeal swab samples\" class=\"wiki-link\" data-key=\"f0e8ac6619d17d8dc75ae4e14d64b053\">propose<\/a> direct heating of the sample-containing nasopharyngeal swab at 70 \u00b0C for 10 minutes in place of RNA extraction.<sup id=\"rdp-ebb-cite_ref-Alcoba-FlorezFast20_19-0\" class=\"reference\"><a href=\"#cite_note-Alcoba-FlorezFast20-19\">[19]<\/a><\/sup> Adams <i>et al.<\/i> have proposed an \"adaptive PCR\" method using a non-standard reagent mix that skips RNA extraction and can act \"as a contingency for resource\u2010limited settings around the globe.\"<sup id=\"rdp-ebb-cite_ref-ShapiroStream20_20-0\" class=\"reference\"><a href=\"#cite_note-ShapiroStream20-20\">[20]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AdamsCOVID20_21-0\" class=\"reference\"><a href=\"#cite_note-AdamsCOVID20-21\">[21]<\/a><\/sup> Wee <i>et al.<\/i> skip RNA extraction and nucleic acid purification by using a single-tube homogeneous reaction method run on a lightweight, portable thermocycler.<sup id=\"rdp-ebb-cite_ref-MeharImproving20_22-0\" class=\"reference\"><a href=\"#cite_note-MeharImproving20-22\">[22]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WeeRapid20_23-0\" class=\"reference\"><a href=\"#cite_note-WeeRapid20-23\">[23]<\/a><\/sup> Other innovations include tweaking reagents and enzymes to work with one step, skipping the reverse transcription step,<sup id=\"rdp-ebb-cite_ref-CSIRFaster20_24-0\" class=\"reference\"><a href=\"#cite_note-CSIRFaster20-24\">[24]<\/a><\/sup> and using saliva-based molecular testing that skips RNA extraction.<sup id=\"rdp-ebb-cite_ref-RanoaSaliva20_25-0\" class=\"reference\"><a href=\"#cite_note-RanoaSaliva20-25\">[25]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ThomasFast20_26-0\" class=\"reference\"><a href=\"#cite_note-ThomasFast20-26\">[26]<\/a><\/sup>\n<\/p><p><b>Saliva as a specimen<\/b>\n<\/p><p>The saliva molecular tests in particular are intriguing. Talk of the potential utility of using saliva as a specimen for COVID-19 was occurring as early as April 2020<sup id=\"rdp-ebb-cite_ref-XuSaliva20_27-0\" class=\"reference\"><a href=\"#cite_note-XuSaliva20-27\">[27]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GreenwoodSaliva20_28-0\" class=\"reference\"><a href=\"#cite_note-GreenwoodSaliva20-28\">[28]<\/a><\/sup>, and the first saliva-based COVID-19 test, produced by Spectrum Solutions in cooperation with RUCDR Infinite Biologics Laboratory<sup id=\"rdp-ebb-cite_ref-SSFirst20_29-0\" class=\"reference\"><a href=\"#cite_note-SSFirst20-29\">[29]<\/a><\/sup> and Vault Health<sup id=\"rdp-ebb-cite_ref-VHVault20_30-0\" class=\"reference\"><a href=\"#cite_note-VHVault20-30\">[30]<\/a><\/sup>, was given an FDA EUA in April 2020. On August 15, 2020, Yale School of Public Health was given an EUA for it SalivaDirect molecular test. Although still PCR-based (and a CLIA high-complexity test), SalivaDirect is being touted as a means to improve specimen collection safety, consume fewer reagents, prove compatible with high-throughput workflow, and cut overall turnaround time. Not only is saliva easier to collect and safer for healthcare staff, the test is essentially \"open sourced,\" not requiring proprietary equipment from Yale, making the test more flexible by being validated to reliably function with a wider array of reagents and instruments.<sup id=\"rdp-ebb-cite_ref-GallagherFDA20_31-0\" class=\"reference\"><a href=\"#cite_note-GallagherFDA20-31\">[31]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ZillgittFDA20_32-0\" class=\"reference\"><a href=\"#cite_note-ZillgittFDA20-32\">[32]<\/a><\/sup> When compared to using a nasopharyngeal swab specimen using the ThermoFisher Scientific TaqPath COVID-19 combo kit, results were comparable 94.1% of the time.<sup id=\"rdp-ebb-cite_ref-ThomasFast20_26-1\" class=\"reference\"><a href=\"#cite_note-ThomasFast20-26\">[26]<\/a><\/sup> While sensitivity and specificity may be slightly less comparable to other PCR options<sup id=\"rdp-ebb-cite_ref-WeisslederCOVID20_33-0\" class=\"reference\"><a href=\"#cite_note-WeisslederCOVID20-33\">[33]<\/a><\/sup>, the overall advantages during reagent shortages and a definitive need for broader testing likely outweigh the slightly lesser sensitivity and specificity. In November 2020, public health agencies in Arizona and Minnesota reportedly began running trials of free saliva-based molecular testing.<sup id=\"rdp-ebb-cite_ref-ParsonsPlaces20_34-0\" class=\"reference\"><a href=\"#cite_note-ParsonsPlaces20-34\">[34]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MDoHState20_35-0\" class=\"reference\"><a href=\"#cite_note-MDoHState20-35\">[35]<\/a><\/sup> \n<\/p><p>As the pandemic has progressed into 2021, saliva testing has become even more attractive, in particular for at-home over-the-counter testing.<sup id=\"rdp-ebb-cite_ref-PugleNininv21_36-0\" class=\"reference\"><a href=\"#cite_note-PugleNininv21-36\">[36]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KarkusDiff21_37-0\" class=\"reference\"><a href=\"#cite_note-KarkusDiff21-37\">[37]<\/a><\/sup> In August 2021, Spectrum Solutions received an EUA for its Spectrum Solutions SDNA-1000 saliva collection system, specifically designed \"to avoid user collection errors\" and eliminate \"the requirement for any bio-sample temperature-controlled storage or transport,\"<sup id=\"rdp-ebb-cite_ref-NSMedStaffSpect21_38-0\" class=\"reference\"><a href=\"#cite_note-NSMedStaffSpect21-38\">[38]<\/a><\/sup> arguably upping the game for new saliva-based test kits going forward. Additionally, as variants of COVID-19 continue to crop up, additional saliva-based at-home tests are coming into development. For example, researchers at the Wyss Institute, the Massachusetts Institute of Technology, and Boston-area hospitals have been working on a laboratory-developed test called Minimally Instrumented SHERLOCK (miSHERLOCK) based on CRISPR (clustered regularly interspaced short palindromic repeats) technology. The researchers claim that the test, able to be used with typical off-the-shelf components, \"works as well as the gold standard PCR tests and could cost as little as $3 per test.\"<sup id=\"rdp-ebb-cite_ref-HealthDayAtHome21_39-0\" class=\"reference\"><a href=\"#cite_note-HealthDayAtHome21-39\">[39]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DePuigMinim21_40-0\" class=\"reference\"><a href=\"#cite_note-DePuigMinim21-40\">[40]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"3.1.2_Pooled_testing\">3.1.2 Pooled testing<\/span><\/h4>\n<p>Another method some labs are taking to speed up turnaround time is using pooled testing. The general concept involves placing two or more test specimens together and testing the pool as one specimen. The most obvious advantage to this is that the process saves on reagents and other supplies, particularly when supply chains are disrupted, and it reduces the amount of time required to analyze large quantities of specimens.<sup id=\"rdp-ebb-cite_ref-CDCInterimPool21_41-0\" class=\"reference\"><a href=\"#cite_note-CDCInterimPool21-41\">[41]<\/a><\/sup> This methodology is best used \"in situations where disease prevalence is low, since each negative pool test eliminates the need to individually test those specimens and maximizes the number of individuals who can be tested over a given amount of time.\"<sup id=\"rdp-ebb-cite_ref-RohdeCOVID20_42-0\" class=\"reference\"><a href=\"#cite_note-RohdeCOVID20-42\">[42]<\/a><\/sup> However, it's best left to situations where expectations are that less than 10 percent of the population being tested is affected by what's being tested for.<sup id=\"rdp-ebb-cite_ref-RohdeCOVID20_42-1\" class=\"reference\"><a href=\"#cite_note-RohdeCOVID20-42\">[42]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MashaPooled20_43-0\" class=\"reference\"><a href=\"#cite_note-MashaPooled20-43\">[43]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CitronerHowPool20_44-0\" class=\"reference\"><a href=\"#cite_note-CitronerHowPool20-44\">[44]<\/a><\/sup> \n<\/p><p>The downside of pooled testing comes with the issues of dilution, contamination, and populations with 10 or more percent infected. A target-positive specimen that commingles with other target-free specimens is itself diluted and in some cases may cause issues with the limit of detection for the assay. Additionally, if the pool tests positive, target-free specimens may become contaminated by a target-positive specimen. This may cause issues with any individual specimen assays that get ran. And the workflows involving pooling must be precise, as a technician working with multiple specimens at the same time increases the chance of lab errors.<sup id=\"rdp-ebb-cite_ref-RohdeCOVID20_42-2\" class=\"reference\"><a href=\"#cite_note-RohdeCOVID20-42\">[42]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MashaPooled20_43-1\" class=\"reference\"><a href=\"#cite_note-MashaPooled20-43\">[43]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CitronerHowPool20_44-1\" class=\"reference\"><a href=\"#cite_note-CitronerHowPool20-44\">[44]<\/a><\/sup> Finally, at least in the U.S., a Food and Drug Administration (FDA) emergency use authorization (EUA) for a validated pooled testing method is required.<sup id=\"rdp-ebb-cite_ref-RohdeCOVID20_42-3\" class=\"reference\"><a href=\"#cite_note-RohdeCOVID20-42\">[42]<\/a><\/sup> (Validation of pooled methods may differ in other countries.<sup id=\"rdp-ebb-cite_ref-MashaPooled20_43-2\" class=\"reference\"><a href=\"#cite_note-MashaPooled20-43\">[43]<\/a><\/sup>) The U.S. Centers for Disease Control and Prevention (CDC) has published <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/pooling-procedures.html\" target=\"_blank\">interim guidance<\/a> on pooled testing strategies for <a href=\"https:\/\/www.limswiki.org\/index.php\/SARS-CoV-2\" class=\"mw-redirect wiki-link\" title=\"SARS-CoV-2\" data-key=\"6c6b78479de2c640028696ed32948526\">SARS-CoV-2<\/a>.\n<\/p><p>On April 20, 2021, the FDA updated its policies to allow for pooled testing to be added to the use case scenarios for several existing test kits. \"This means that tests with EUAs that are amended by this authorization may be used with pooled anterior nasal specimens from individuals without known or suspected COVID-19 when such individuals are tested as part of a testing program that includes testing at regular intervals, at least once per week.\"<sup id=\"rdp-ebb-cite_ref-FDAInVitroEUAs21_45-0\" class=\"reference\"><a href=\"#cite_note-FDAInVitroEUAs21-45\">[45]<\/a><\/sup> However, affected kits can only be used in high-complexity CLIA labs, though \"tests authorized for use in specific named or designated high-complexity laboratories can only be used in such laboratories.\"<sup id=\"rdp-ebb-cite_ref-FDAInVitroEUAs21_45-1\" class=\"reference\"><a href=\"#cite_note-FDAInVitroEUAs21-45\">[45]<\/a><\/sup> As of September 2021, four PCR test kit EUAs were amended to allow for pooled testing<sup id=\"rdp-ebb-cite_ref-FDAInVitroEUAs21_45-2\" class=\"reference\"><a href=\"#cite_note-FDAInVitroEUAs21-45\">[45]<\/a><\/sup>:\n<\/p>\n<ul><li>Biomeme SARS-CoV-2 Real-Time RT-PCR Test<\/li>\n<li>Clinical Enterprise SARS-SoV-2-RT-PCR Assay<\/li>\n<li>CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3)<\/li>\n<li>Viracor SARS-CoV-2 assay<\/li><\/ul>\n<h4><span class=\"mw-headline\" id=\"3.1.3_Rapid_antigen_testing\">3.1.3 Rapid antigen testing<\/span><\/h4>\n<p>As mentioned in the previous chapter, the benefits of antigen testing For COVID-19 and other viral infections are 1. specimen collection can typically be done with a simple nasal swab rather than a more invasive <a href=\"https:\/\/www.limswiki.org\/index.php\/Nasopharyngeal_swab\" title=\"Nasopharyngeal swab\" class=\"wiki-link\" data-key=\"18d5d4e09d1fc5ddb05a22b36ace9daf\">nasopharyngeal swab<\/a>, 2. testing is more rapid and convenient, and 3. it takes some pressure off the PCR supply chain. However, antigen testing only tests what's there, rather than amplifying the amount, resulting in generally lower sensitivities.<sup id=\"rdp-ebb-cite_ref-ServiceRadical2020_46-0\" class=\"reference\"><a href=\"#cite_note-ServiceRadical2020-46\">[46]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GuglielmiTheExp20_47-0\" class=\"reference\"><a href=\"#cite_note-GuglielmiTheExp20-47\">[47]<\/a><\/sup> As such, the real utility of antigen testing, despite its lower sensitivity, appears to be surveillance situations where a large group of individuals who are at risk can be screened at regularly scheduled intervals of two to four days. If your lab is able to support this sort of testing, then this type of testing may be an option. As of September 2021, thirty-four FDA EUAs for antigen tests have been issues; 28 of those 34 include allowances for CLIA-waived testing, and 10 were authorized for home use.<sup id=\"rdp-ebb-cite_ref-FDAInVitroAntigen21_48-0\" class=\"reference\"><a href=\"#cite_note-FDAInVitroAntigen21-48\">[48]<\/a><\/sup> Review <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/medical-devices\/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2\" target=\"_blank\">the FDA list<\/a> to further examine your options.\n<\/p><p>The CDC emphasizes that molecular testing remains the \"gold standard\" for detecting SARS-CoV-2 in a sample, and it \"may be necessary to confirm an antigen test result with a laboratory-based NAAT, especially if the result of the antigen test is inconsistent with the clinical context.\" However, some molecular tests designed for point-of-care testing may not be sufficiently designed for confirmatory testing; consult the instructions for use for any confirmatory test.<sup id=\"rdp-ebb-cite_ref-CDCInterim21_49-0\" class=\"reference\"><a href=\"#cite_note-CDCInterim21-49\">[49]<\/a><\/sup> The CDC <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/resources\/antigen-tests-guidelines.html#anchor_1631295114633\" target=\"_blank\">makes available<\/a> two antigen testing algorithms for determining when confirmatory testing is actually recommended.<sup id=\"rdp-ebb-cite_ref-CDCInterim21_49-1\" class=\"reference\"><a href=\"#cite_note-CDCInterim21-49\">[49]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"3.1.4_LAMP_and_CRISPR\">3.1.4 LAMP and CRISPR<\/span><\/h4>\n<p>Early on in the pandemic, while PCR was getting most of the attention, reverse transcription loop-mediated isothermal amplification (RT-LAMP), an isothermal <a href=\"https:\/\/www.limswiki.org\/index.php\/Nucleic_acid_test\" title=\"Nucleic acid test\" class=\"wiki-link\" data-key=\"9b850e87cf2257909a3cde1f7ea4dd94\">nucleic acid amplification<\/a> technique that allows for RNA amplification, was also quietly being discussed<sup id=\"rdp-ebb-cite_ref-LambRapid20_50-0\" class=\"reference\"><a href=\"#cite_note-LambRapid20-50\">[50]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Schmid-BurgkLAMP20_51-0\" class=\"reference\"><a href=\"#cite_note-Schmid-BurgkLAMP20-51\">[51]<\/a><\/sup>, and it has since gained more attention.<sup id=\"rdp-ebb-cite_ref-YuRapid20_52-0\" class=\"reference\"><a href=\"#cite_note-YuRapid20-52\">[52]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ParkDevelop20_53-0\" class=\"reference\"><a href=\"#cite_note-ParkDevelop20-53\">[53]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KellnerARapid20_54-0\" class=\"reference\"><a href=\"#cite_note-KellnerARapid20-54\">[54]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ThiAColor20_55-0\" class=\"reference\"><a href=\"#cite_note-ThiAColor20-55\">[55]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-EsbinOver20_56-0\" class=\"reference\"><a href=\"#cite_note-EsbinOver20-56\">[56]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HaleOxford20_57-0\" class=\"reference\"><a href=\"#cite_note-HaleOxford20-57\">[57]<\/a><\/sup> In July 2020, the University of Oxford was in the process of getting a rapid, affordable, clinically-validated RT-LAMP test approved for the European market. Oxford also notes that \"[a]n advantage of using LAMP technology is that it uses different reagents to most laboratory-based PCR tests.\"<sup id=\"rdp-ebb-cite_ref-HaleOxford20_57-1\" class=\"reference\"><a href=\"#cite_note-HaleOxford20-57\">[57]<\/a><\/sup> Thi <i>et al.<\/i> have tested a two-color RT-LAMP assay with an N gene primer set and diagnostic validation using LAMP-sequencing, concluding that the pairing of the two \"could offer scalable testing that would be difficult to achieve with conventional qRT-PCR based tests.\"<sup id=\"rdp-ebb-cite_ref-ThiAColor20_55-1\" class=\"reference\"><a href=\"#cite_note-ThiAColor20-55\">[55]<\/a><\/sup> And California-based Color Genomics set up their own proprietary RT-LAMP system in the summer of 2020, capable of handling up to 10,000 tests per day.<sup id=\"rdp-ebb-cite_ref-SheridanThisCal20_58-0\" class=\"reference\"><a href=\"#cite_note-SheridanThisCal20-58\">[58]<\/a><\/sup>\n<\/p><p>In most cases, LAMP-based testing is much simpler than PCR, lacking the requirement of specialized instruments. Despite LAMP generally being thought of as less sensitive than PCR<sup id=\"rdp-ebb-cite_ref-SheridanThisCal20_58-1\" class=\"reference\"><a href=\"#cite_note-SheridanThisCal20-58\">[58]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GuglielmiTheExp20_47-1\" class=\"reference\"><a href=\"#cite_note-GuglielmiTheExp20-47\">[47]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HeidtSaliva20_59-0\" class=\"reference\"><a href=\"#cite_note-HeidtSaliva20-59\">[59]<\/a><\/sup>, the explosion of research into RT-LAMP methods for testing for the presence of SARS-CoV-2 continues to indicate that \"under optimized conditions,\" RT-LAMP methods may actually be able to rival the sensitivity and specificity of many RT-PCR COVID-19 tests.<sup id=\"rdp-ebb-cite_ref-EsbinOver20_56-1\" class=\"reference\"><a href=\"#cite_note-EsbinOver20-56\">[56]<\/a><\/sup> Esbin <i>et al.<\/i> add<sup id=\"rdp-ebb-cite_ref-EsbinOver20_56-2\" class=\"reference\"><a href=\"#cite_note-EsbinOver20-56\">[56]<\/a><\/sup>:\n<\/p>\n<blockquote><p>These methods allow for faster amplification, less specialized equipment, and easy readout. LAMP methods also benefit from the ability to multiplex targets in a single reaction and can be combined with other isothermal methods, like [<a href=\"https:\/\/www.limswiki.org\/index.php\/Recombinase_polymerase_amplification\" title=\"Recombinase polymerase amplification\" class=\"wiki-link\" data-key=\"716ff4ec91f1ddf64cc1458900b6a678\">recombinase polymerase amplification<\/a>] in the RAMP technique, to increase test accuracy even more. These techniques may be particularly useful for rapid, point-of-care diagnoses or for remote clinical testing without the need for laboratory equipment.<\/p><\/blockquote>\n<p>CRISPR methods are also being used in conjunction with RT-LAMP.<sup id=\"rdp-ebb-cite_ref-GuglielmiTheExp20_47-2\" class=\"reference\"><a href=\"#cite_note-GuglielmiTheExp20-47\">[47]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-EsbinOver20_56-3\" class=\"reference\"><a href=\"#cite_note-EsbinOver20-56\">[56]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BroughtonCRISPR20_60-0\" class=\"reference\"><a href=\"#cite_note-BroughtonCRISPR20-60\">[60]<\/a><\/sup> RT-LAMP creates complementary double-stranded DNA (cDNA) from specimen RNA and then copies (amplifies) it. Then CRISPR methods are used to detect a predefined coronavirus sequence (from a cleaved molecular marker) in the resulting amplified specimen. Though as of September 2021 approved assays using CRISPR-based detection of SARS-CoV-2 are limited to a handful of companies<sup id=\"rdp-ebb-cite_ref-FDAInVitroEUAs21_45-3\" class=\"reference\"><a href=\"#cite_note-FDAInVitroEUAs21-45\">[45]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GuglielmiTheExp20_47-3\" class=\"reference\"><a href=\"#cite_note-GuglielmiTheExp20-47\">[47]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GDHCRISPR20_61-0\" class=\"reference\"><a href=\"#cite_note-GDHCRISPR20-61\">[61]<\/a><\/sup>, the technology has some promise as an alternative testing method. CRISPR has the additional advantage of being readily coupled with lateral flow assay technology to be deployed in the point-of-care (POC) setting<sup id=\"rdp-ebb-cite_ref-EsbinOver20_56-4\" class=\"reference\"><a href=\"#cite_note-EsbinOver20-56\">[56]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GDHCRISPR20_61-1\" class=\"reference\"><a href=\"#cite_note-GDHCRISPR20-61\">[61]<\/a><\/sup>, though it's worth noting the currently EUAed RT-LAMP-based CRISPR kits are only approved for high-complexity CLIA labs. (The current molecular diagnostic test kits running CRISPR technology are Sherlock BioSciences' Sherlock CRISPR SARS-CoV-2 Kit and Mammoth Biosciences' SARS-CoV-2 DETECTR Reagent Kit, both high-complexity.<sup id=\"rdp-ebb-cite_ref-FDAInVitroEUAs21_45-4\" class=\"reference\"><a href=\"#cite_note-FDAInVitroEUAs21-45\">[45]<\/a><\/sup>)\n<\/p>\n<h4><span class=\"mw-headline\" id=\"3.1.5_Point-of-care_and_other_alternative_testing\">3.1.5 Point-of-care and other alternative testing<\/span><\/h4>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:402px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Microfluidic_chip_for_point-of-care_medical_devices.jpg\" class=\"image wiki-link\" data-key=\"0b86749e7b641a389208de8a6345e787\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/4\/47\/Microfluidic_chip_for_point-of-care_medical_devices.jpg\" decoding=\"async\" class=\"thumbimage\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Microfluidic_chip_for_point-of-care_medical_devices.jpg\" class=\"internal wiki-link\" title=\"Enlarge\" data-key=\"0b86749e7b641a389208de8a6345e787\"><\/a><\/div>Example of a microfluidic chip used in point-of-care medical devices<\/div><\/div><\/div><p>On September 28, 2020, the WHO published its blueprint for what they call Target Product Profiles (TPP), which \"describe the desirable and minimally acceptable profiles\" for four different COVID-19 test categories.<sup id=\"rdp-ebb-cite_ref-WHOCOVIDTarget20_62-0\" class=\"reference\"><a href=\"#cite_note-WHOCOVIDTarget20-62\">[62]<\/a><\/sup> Addressing POC testing, the WHO recommends that such assays<sup id=\"rdp-ebb-cite_ref-WHOCOVIDTarget20_62-1\" class=\"reference\"><a href=\"#cite_note-WHOCOVIDTarget20-62\">[62]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PeplowRapid20_63-0\" class=\"reference\"><a href=\"#cite_note-PeplowRapid20-63\">[63]<\/a><\/sup>:\n<\/p><ul><li>have a sensitivity (true positive rate) of at least 80 percent, with 90 percent or better being desirable;<\/li>\n<li>have a specificity (true negative rate) of at least 97 percent, with greater than 99 percent being desirable;<\/li>\n<li>provide results in less than 40 minutes, with less 20 minutes or less being desirable;<\/li>\n<li>have \"a cost that allows broad use, including in low- and middle-income countries\";<\/li>\n<li>be simple enough that only a half day to, optimally, a few hours of training are required to run the test; and<\/li>\n<li>operate reliably outside a clean laboratory environment.<\/li><\/ul>\n<p>Though at the time of the announcement few of the available test systems could likely meet all these requirements, it's clear this and other urgencies have put pressure on manufacturers to expand COVID-19 testing to the point of care setting.<sup id=\"rdp-ebb-cite_ref-PeplowRapid20_63-1\" class=\"reference\"><a href=\"#cite_note-PeplowRapid20-63\">[63]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KriegerCorona20_64-0\" class=\"reference\"><a href=\"#cite_note-KriegerCorona20-64\">[64]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BrownPoint20_65-0\" class=\"reference\"><a href=\"#cite_note-BrownPoint20-65\">[65]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WissonCOVID20_66-0\" class=\"reference\"><a href=\"#cite_note-WissonCOVID20-66\">[66]<\/a><\/sup> Additional incentives were offered by the U.S. National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) funding program, which sought to speed up innovation in COVID-19 testing and promote \"truly nontraditional approaches for testing that have a slightly longer horizon.\"<sup id=\"rdp-ebb-cite_ref-TrombergRapid20_67-0\" class=\"reference\"><a href=\"#cite_note-TrombergRapid20-67\">[67]<\/a><\/sup> In August 2020, RADx had chosen to fund seven biomedical diagnostic companies making new lab-based and POC tests that could significantly ramp up overall testing in the U.S. into September 2020. Four of those offerings were lab-based (from Ginkgo Bioworks, Helix OpCo, Fluidigm, and Mammoth Biosciences) and three were POC tests (from Mesa Biotech, Quidel, and Talis Biomedical), all using varying technologies and methods such as next-generation sequencing, CRISPR, microfluidic chips, nucleic acid testing, antigen testing, and saliva testing.<sup id=\"rdp-ebb-cite_ref-NIHDelivering20_68-0\" class=\"reference\"><a href=\"#cite_note-NIHDelivering20-68\">[68]<\/a><\/sup> On October 28, 2020, RADx added an additional 15 biomedical diagnostics projects for funding, for a total of 22.<sup id=\"rdp-ebb-cite_ref-NIHRADxTech20_69-0\" class=\"reference\"><a href=\"#cite_note-NIHRADxTech20-69\">[69]<\/a><\/sup> As of September 2021, some of those 22 programs have come to fruition, garnering FDA EUAs, including Mesa Biotech's rapid cartridge-based RT-PCR Accula System, Quidel's rapid Sofia SARS Antigen FIA test, Mammoth Bioscience's SARS-CoV-2 DETECTR Reagent Kit, and Visby Medical's COVID-19 Point of Care Test.<sup id=\"rdp-ebb-cite_ref-FDAInVitroEUAs21_45-5\" class=\"reference\"><a href=\"#cite_note-FDAInVitroEUAs21-45\">[45]<\/a><\/sup>\n<\/p><p>Outside the RADx program, enterprising researchers in other parts of the world are also attempting non-traditional approaches to improving COVID-19 testing options. Examples include<sup id=\"rdp-ebb-cite_ref-EsbinOver20_56-5\" class=\"reference\"><a href=\"#cite_note-EsbinOver20-56\">[56]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WissonCOVID20_66-1\" class=\"reference\"><a href=\"#cite_note-WissonCOVID20-66\">[66]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Leichman10Ways20_70-0\" class=\"reference\"><a href=\"#cite_note-Leichman10Ways20-70\">[70]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-UNRCOVID20_71-0\" class=\"reference\"><a href=\"#cite_note-UNRCOVID20-71\">[71]<\/a><\/sup>:\n<\/p>\n<ul><li>a method of DNA nanoswitch detection of virus particles;<\/li>\n<li>a dual biomarker-based finger-stick test for acute respiratory infections;<\/li>\n<li>a rapid breath test to detect volatile organic chemicals from the lungs;<\/li>\n<li>an affordable, hand-held spectral imaging device to detect virus in blood or saliva in seconds;<\/li>\n<li>an ultrahigh frequency spectroscopic scanning device to see virus particles resonating;<\/li>\n<li>a method that combines optical devices and magnetic particles to detect virus RNA;<\/li>\n<li>an RNA extraction protocol that uses magnetic bead-based kits;<\/li>\n<li>a nanotube-based electrochemical biosensor for detecting biomarkers in a sample in less than a minute;<\/li>\n<li>the additional use of an <a href=\"https:\/\/www.limswiki.org\/index.php\/Artificial_intelligence\" title=\"Artificial intelligence\" class=\"wiki-link\" data-key=\"0c45a597361ca47e1cd8112af676276e\">artificial intelligence<\/a> (AI) application to better scrutinize test results; and<\/li>\n<li>the miniaturization of PCR technology to make it more portable and user-friendly.<\/li><\/ul>\n<p>Of course, most of these are largely experimental technologies, and realistically getting them into the lab may be far out. But they represent out-of-the-box ideas that have some kind of chance at playing a greater role in the clinical laboratory or in point-of-care settings in the future.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"3.1.6_Multiplex_testing\">3.1.6 Multiplex testing<\/span><\/h4>\n<p>As the pandemic has progressed and test manufacturers have become more experienced with SARS-CoV-2 test development, multiplex testing has become an option. The multiplex assay\u2014an immunoassay test able to measure multiple analytes in a single test\u2014is certainly not new in itself. In 1989, R. Ekins developed the ambient analyte theory, which stated that miniaturizing an immunoassay can lead to an improved limit of detection (LOD). That work influenced the future development of microarray multiplex technology principles.<sup id=\"rdp-ebb-cite_ref-TigheELISA15_72-0\" class=\"reference\"><a href=\"#cite_note-TigheELISA15-72\">[72]<\/a><\/sup> By 2013, development of multiplex protein immunoassays was becoming increasingly prominent.<sup id=\"rdp-ebb-cite_ref-TigheELISA15_72-1\" class=\"reference\"><a href=\"#cite_note-TigheELISA15-72\">[72]<\/a><\/sup>\n<\/p><p>As of September 2021, eighteen \"multi-analyte\" <i>in vitro<\/i> molecular diagnostic tests are shown as receiving EUAs by the FDA, four of them even authorized for CLIA waived testing.<sup id=\"rdp-ebb-cite_ref-FDAInVitroEUAs21_45-6\" class=\"reference\"><a href=\"#cite_note-FDAInVitroEUAs21-45\">[45]<\/a><\/sup> Common additional targets for analysis among the various kits include influenza A, influenza B, and respiratory syncytial virus (RSV).<sup id=\"rdp-ebb-cite_ref-FDAInVitroEUAs21_45-7\" class=\"reference\"><a href=\"#cite_note-FDAInVitroEUAs21-45\">[45]<\/a><\/sup> However, several multiplex test kits cover an even broader array of respiratory-affecting organism types and subtypes such as adenovirus and a few other coronavirus types, to name a few. Kits include the ePlex Respiratory Pathogen Panel 2<sup id=\"rdp-ebb-cite_ref-HintonePlex20_73-0\" class=\"reference\"><a href=\"#cite_note-HintonePlex20-73\">[73]<\/a><\/sup>, the NxTAG Respiratory Pathogen Panel + SARS-CoV-2<sup id=\"rdp-ebb-cite_ref-HintonNxTAG21_74-0\" class=\"reference\"><a href=\"#cite_note-HintonNxTAG21-74\">[74]<\/a><\/sup>, the QIAstat-Dx Respiratory SARS-CoV-2 Panel<sup id=\"rdp-ebb-cite_ref-HintonQIAstat21_75-0\" class=\"reference\"><a href=\"#cite_note-HintonQIAstat21-75\">[75]<\/a><\/sup>, and the BioFire Respiratory Panel 2.1-EZ.<sup id=\"rdp-ebb-cite_ref-HintonBioFireRes21_76-0\" class=\"reference\"><a href=\"#cite_note-HintonBioFireRes21-76\">[76]<\/a><\/sup> (Of the four, the BioFire panel is approved for CLIA waived testing.<sup id=\"rdp-ebb-cite_ref-FDAInVitroEUAs21_45-8\" class=\"reference\"><a href=\"#cite_note-FDAInVitroEUAs21-45\">[45]<\/a><\/sup>) Adding multiplex testing of SARS-CoV-2 plus other organisms to your laboratory will largely revolve around your lab's CLIA status and assessment of the available options.\n<\/p><p>Multiplexing provides a variety of benefits for laboratories and patients. In their 2015 paper on ELISA and multiplex technologies, Tighe <i>et al<\/i> find that multiplexed immunoassays have the potential to decrease diagnosis times and reduce assay costs. \"At the same time, such multiplexing offers more comprehensive analysis whether for research purposes, differential diagnoses, or monitoring of therapeutic interventions.\"<sup id=\"rdp-ebb-cite_ref-TigheELISA15_72-2\" class=\"reference\"><a href=\"#cite_note-TigheELISA15-72\">[72]<\/a><\/sup> They also note the potential for improved health surveillance of patients, catching early-onset diseases by looking for informative biomarkers.<sup id=\"rdp-ebb-cite_ref-TigheELISA15_72-3\" class=\"reference\"><a href=\"#cite_note-TigheELISA15-72\">[72]<\/a><\/sup> From the perspective of diagnosing infections of SARS-CoV-2 or influenza, the CDC adds that multiplexing helps preserve testing supplies that may be in short supply, conduct more tests in a given time period, and paint a clearer picture of both viruses and their prevalence in a given population.<sup id=\"rdp-ebb-cite_ref-CDCInflu21_77-0\" class=\"reference\"><a href=\"#cite_note-CDCInflu21-77\">[77]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"3.1.7_Variant_testing\">3.1.7 Variant testing<\/span><\/h4>\n<p>As the pandemic has progressed, you may have heard talk of a \"delta\" variant of SARS-CoV-2, which is reportedly more contagious and virulent than the initial strain that kicked off the pandemic.<sup id=\"rdp-ebb-cite_ref-CDCDelta21_78-0\" class=\"reference\"><a href=\"#cite_note-CDCDelta21-78\">[78]<\/a><\/sup> One or more variants of a virus are expected as time progresses, and some of those variants can cause significantly more problems than the source virus. As such, analytical testing of the virus over time is vital to public health.\n<\/p><p>The purpose of variant testing can be described in two ways, one for public health reasons and another for clinical care reasons. On the public health side, analysis of SARS-CoV-2 variants provides an unbiased, population-level view \"of the specific viral strains in circulation and monitors changes in the viral genome over time.\"<sup id=\"rdp-ebb-cite_ref-BuchanSARS21_79-0\" class=\"reference\"><a href=\"#cite_note-BuchanSARS21-79\">[79]<\/a><\/sup> With enough public health laboratories conducting this type of analysis\u2014typically whole-genome sequencing (WGS) using <a href=\"https:\/\/www.limswiki.org\/index.php\/Next-generation_sequencing\" class=\"mw-redirect wiki-link\" title=\"Next-generation sequencing\" data-key=\"c9d965c11eed1543f2a7e5f1abed4bb7\">next-generation sequencing<\/a> (NGS) techniques\u2014a clearer picture of how an outbreak spreads is gained, as well as what variants are taking hold and further threatening human populations (even those that are vaccinated). This information is typically shared through the public health system for surveillance and reporting purposes, though the affected patients themselves may never see the data.<sup id=\"rdp-ebb-cite_ref-BuchanSARS21_79-1\" class=\"reference\"><a href=\"#cite_note-BuchanSARS21-79\">[79]<\/a><\/sup>\n<\/p><p>On the clinical care side, analysis of SARS-CoV-2 variants provides further insights into improving COVID-19 patient outcomes. Buchan <i>et al.<\/i> identify three potential insights that clinicians may gain, noting that variant testing allows the clinician<sup id=\"rdp-ebb-cite_ref-BuchanSARS21_79-2\" class=\"reference\"><a href=\"#cite_note-BuchanSARS21-79\">[79]<\/a><\/sup>:\n<\/p>\n<ul><li>to distinguish between an existing, persistent infection caused by one viral strain vs. re-infection by a different viral strain;<\/li>\n<li>to determine whether a patient not responding to a treatment is affected by a specific viral spike protein (S) gene mutation that is \"potentially resistant or less susceptible to neutralizing antibodies or monoclonal antibodies\"; and<\/li>\n<li>to detect in the serum or plasma of a patient post-vaccination \"viral S gene substitutions in specific variants that are potentially resistant or less susceptible\" to the antibodies the vaccine generates.<\/li><\/ul>\n<p>If, for example, a patient is diagnosed with a variant that is tied to heightened disease severity, the clinician can opt for additional treatments early on to counteract the variant's effects on the patient. This testing is done in a hospital or reference lab by WGS or by targeting a portion of the genome (e.g., a spike protein) or a specific mutation (using RT-PCR). However, according to Buchan <i>et al.<\/i>, the contributions a mutation makes to a \"variant's attributes is not entirely understood, and there is no definitive evidence that directly links a given mutation to poor outcomes, significantly reduced efficacy of SARS-CoV-2 therapies, or vaccine coverage.\"<sup id=\"rdp-ebb-cite_ref-BuchanSARS21_79-3\" class=\"reference\"><a href=\"#cite_note-BuchanSARS21-79\">[79]<\/a><\/sup>\n<\/p><p>That said, and leaving the public health element to the side, if you are a laboratory conducting clinical analyses of SARS-CoV-2 specimens, the likelihood of including viral sequencing and sequence analysis for variant testing may be low for your facility. Such testing is a multi-step process requiring a non-trivial set of resources, often available to large commercial diagnostic laboratories.<sup id=\"rdp-ebb-cite_ref-BuchanSARS21_79-4\" class=\"reference\"><a href=\"#cite_note-BuchanSARS21-79\">[79]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WilliamsEnhanc21_80-0\" class=\"reference\"><a href=\"#cite_note-WilliamsEnhanc21-80\">[80]<\/a><\/sup> The CDC represents one possible workflow for genomic sequencing as such<sup id=\"rdp-ebb-cite_ref-CDCRole21_81-0\" class=\"reference\"><a href=\"#cite_note-CDCRole21-81\">[81]<\/a><\/sup>:\n<\/p>\n<ol><li>A specimen containing the SARS-CoV-2 virus is received by the lab and promptly entered into the <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_system\" title=\"Laboratory information system\" class=\"wiki-link\" data-key=\"37add65b4d1c678b382a7d4817a9cf64\">laboratory information system<\/a> (LIS).<\/li>\n<li>The RNA of the SARS-CoV-2 virus is extracted from the sample and then converted to complimentary DNA. It is then enriched and loaded into the appropriate NGS instrument.<\/li>\n<li>The instrument runs the sequencing and raw data is collected, with the lab maintaining quality control steps. The raw data is turned into actionable sequence data.<\/li>\n<li>The sequence data is verified for suitability, with a resequencing occurring if found to be inadequate. Otherwise, the data is then analyzed and interpreted.<\/li>\n<li>The final approved sequencing results are reported to the appropriate state, local, tribal, or territorial public health department.<sup id=\"rdp-ebb-cite_ref-CDCGuidanceSeq21_82-0\" class=\"reference\"><a href=\"#cite_note-CDCGuidanceSeq21-82\">[82]<\/a><\/sup><\/li><\/ol>\n<p>If your diagnostic lab has or is planning on adding sequencing tools to supplement clinical diagnostics, it may make sense to consider adding variant testing to your available options. But in reality, this sort of testing may largely be left to large institutions, such as the University of Rochester Vaccine Treatment Evaluation Unit or the Yale School of Public Health.<sup id=\"rdp-ebb-cite_ref-DupuyCOVID21_83-0\" class=\"reference\"><a href=\"#cite_note-DupuyCOVID21-83\">[83]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-MWPoly20-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MWPoly20_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Kenneth Research (23 June 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20200809215548\/https:\/\/www.marketwatch.com\/press-release\/polymerase-chain-reaction-market-sector-analysis-report-regional-outlook-competitive-share-forecast---2023-2020-06-23\" target=\"_blank\">\"Polymerase Chain Reaction Market Sector Analysis Report, Regional Outlook & Competitive Share & Forecast - 2023\"<\/a>. <i>MarketWatch<\/i>. 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(3 April 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.chemistryworld.com\/news\/mystery-surrounds-uk-claim-of-covid-19-test-reagent-shortage\/4011457.article\" target=\"_blank\">\"Mystery surrounds UK claim of Covid-19 test reagent \u2018shortage\u2019\"<\/a>. <i>Chemistry World<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.chemistryworld.com\/news\/mystery-surrounds-uk-claim-of-covid-19-test-reagent-shortage\/4011457.article\" target=\"_blank\">https:\/\/www.chemistryworld.com\/news\/mystery-surrounds-uk-claim-of-covid-19-test-reagent-shortage\/4011457.article<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Mystery+surrounds+UK+claim+of+Covid-19+test+reagent+%E2%80%98shortage%E2%80%99&rft.atitle=Chemistry+World&rft.aulast=Mehta%2C+A.&rft.au=Mehta%2C+A.&rft.date=3+April+2020&rft_id=https%3A%2F%2Fwww.chemistryworld.com%2Fnews%2Fmystery-surrounds-uk-claim-of-covid-19-test-reagent-shortage%2F4011457.article&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RocheIrish20-10\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RocheIrish20_10-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Roche, B. (8 April 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.irishtimes.com\/news\/science\/irish-scientists-develop-reagent-in-effort-to-ease-covid-19-testing-delays-1.4223897\" target=\"_blank\">\"Irish scientists develop reagent in effort to ease Covid-19 testing delays\"<\/a>. <i>The Irish Times<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.irishtimes.com\/news\/science\/irish-scientists-develop-reagent-in-effort-to-ease-covid-19-testing-delays-1.4223897\" target=\"_blank\">https:\/\/www.irishtimes.com\/news\/science\/irish-scientists-develop-reagent-in-effort-to-ease-covid-19-testing-delays-1.4223897<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 10 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Irish+scientists+develop+reagent+in+effort+to+ease+Covid-19+testing+delays&rft.atitle=The+Irish+Times&rft.aulast=Roche%2C+B.&rft.au=Roche%2C+B.&rft.date=8+April+2020&rft_id=https%3A%2F%2Fwww.irishtimes.com%2Fnews%2Fscience%2Firish-scientists-develop-reagent-in-effort-to-ease-covid-19-testing-delays-1.4223897&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PadmaEfforts20-11\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PadmaEfforts20_11-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Padma, T.V. 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Retrieved 19 May 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Efforts+to+combat+Covid-19+in+India+hit+by+imported+reagent+shortages&rft.atitle=Chemistry+World&rft.aulast=Padma%2C+T.V.&rft.au=Padma%2C+T.V.&rft.date=13+May+2020&rft_id=https%3A%2F%2Fwww.chemistryworld.com%2Fnews%2Fefforts-to-combat-covid-19-in-india-hit-by-imported-reagent-shortages%2F4011718.article%23%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DavidSurvey20-12\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DavidSurvey20_12-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">David, E.; Farber, S.E. 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Retrieved 07 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=In+Vitro+Diagnostics+EUAs+-+Antigen+Diagnostic+Tests+for+SARS-CoV-2&rft.atitle=&rft.date=7+September+2021&rft.pub=U.S.+Food+and+Drug+Administration&rft_id=https%3A%2F%2Fwww.fda.gov%2Fmedical-devices%2Fcoronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices%2Fin-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCInterim21-49\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CDCInterim21_49-0\">49.0<\/a><\/sup> <sup><a href=\"#cite_ref-CDCInterim21_49-1\">49.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Disease Control and Prevention (9 September 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/resources\/antigen-tests-guidelines.html\" target=\"_blank\">\"Interim Guidance for Antigen Testing for SARS-CoV-2\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/resources\/antigen-tests-guidelines.html\" target=\"_blank\">https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/resources\/antigen-tests-guidelines.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Interim+Guidance+for+Antigen+Testing+for+SARS-CoV-2&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=9+September+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Flab%2Fresources%2Fantigen-tests-guidelines.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LambRapid20-50\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LambRapid20_50-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Lamb, L.E.; Barolone, S.N.; Ward, E. et al. (2020). \"Rapid Detection of Novel Coronavirus (COVID-19) by Reverse Transcription-Loop-Mediated Isothermal Amplification\". <i>medRxiv<\/i>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1101%2F2020.02.19.20025155\" target=\"_blank\">10.1101\/2020.02.19.20025155<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Rapid+Detection+of+Novel+Coronavirus+%28COVID-19%29+by+Reverse+Transcription-Loop-Mediated+Isothermal+Amplification&rft.jtitle=medRxiv&rft.aulast=Lamb%2C+L.E.%3B+Barolone%2C+S.N.%3B+Ward%2C+E.+et+al.&rft.au=Lamb%2C+L.E.%3B+Barolone%2C+S.N.%3B+Ward%2C+E.+et+al.&rft.date=2020&rft_id=info:doi\/10.1101%2F2020.02.19.20025155&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Schmid-BurgkLAMP20-51\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Schmid-BurgkLAMP20_51-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Schmid-Burgk, J.L.; Li, D.; Feldman, D. et al. (2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.biorxiv.org\/content\/10.1101\/2020.04.06.025635v2.article-info\" target=\"_blank\">\"LAMP-Seq: Population-Scale COVID-19 Diagnostics Using Combinatorial Barcoding\"<\/a>. <i>bioRxiv<\/i>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1101%2F2020.04.06.025635\" target=\"_blank\">10.1101\/2020.04.06.025635<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.biorxiv.org\/content\/10.1101\/2020.04.06.025635v2.article-info\" target=\"_blank\">https:\/\/www.biorxiv.org\/content\/10.1101\/2020.04.06.025635v2.article-info<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=LAMP-Seq%3A+Population-Scale+COVID-19+Diagnostics+Using+Combinatorial+Barcoding&rft.jtitle=bioRxiv&rft.aulast=Schmid-Burgk%2C+J.L.%3B+Li%2C+D.%3B+Feldman%2C+D.+et+al.&rft.au=Schmid-Burgk%2C+J.L.%3B+Li%2C+D.%3B+Feldman%2C+D.+et+al.&rft.date=2020&rft_id=info:doi\/10.1101%2F2020.04.06.025635&rft_id=https%3A%2F%2Fwww.biorxiv.org%2Fcontent%2F10.1101%2F2020.04.06.025635v2.article-info&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-YuRapid20-52\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-YuRapid20_52-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Yu, L.; Wu, S.; Hao, X. et al. (2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7188121\" target=\"_blank\">\"Rapid Detection of COVID-19 Coronavirus Using a Reverse Transcriptional Loop-Mediated Isothermal Amplification (RT-LAMP) Diagnostic Platform\"<\/a>. <i>Clinical Chemistry<\/i> <b>66<\/b> (7): 975\u201377. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1093%2Fclinchem%2Fhvaa102\" target=\"_blank\">10.1093\/clinchem\/hvaa102<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7188121\/\" target=\"_blank\">PMC7188121<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32315390\" target=\"_blank\">32315390<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7188121\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7188121<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Rapid+Detection+of+COVID-19+Coronavirus+Using+a+Reverse+Transcriptional+Loop-Mediated+Isothermal+Amplification+%28RT-LAMP%29+Diagnostic+Platform&rft.jtitle=Clinical+Chemistry&rft.aulast=Yu%2C+L.%3B+Wu%2C+S.%3B+Hao%2C+X.+et+al.&rft.au=Yu%2C+L.%3B+Wu%2C+S.%3B+Hao%2C+X.+et+al.&rft.date=2020&rft.volume=66&rft.issue=7&rft.pages=975%E2%80%9377&rft_id=info:doi\/10.1093%2Fclinchem%2Fhvaa102&rft_id=info:pmc\/PMC7188121&rft_id=info:pmid\/32315390&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7188121&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ParkDevelop20-53\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ParkDevelop20_53-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Park, G.-S.; Ku, K.; Baek, S.-H. et al. (2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7144851\" target=\"_blank\">\"Development of Reverse Transcription Loop-Mediated Isothermal Amplification Assays Targeting Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)\"<\/a>. <i>Journal of Molecular Diagnostics<\/i> <b>22<\/b> (6): 729\u201335. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2Fj.jmoldx.2020.03.006\" target=\"_blank\">10.1016\/j.jmoldx.2020.03.006<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7144851\/\" target=\"_blank\">PMC7144851<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32276051\" target=\"_blank\">32276051<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7144851\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7144851<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Development+of+Reverse+Transcription+Loop-Mediated+Isothermal+Amplification+Assays+Targeting+Severe+Acute+Respiratory+Syndrome+Coronavirus+2+%28SARS-CoV-2%29&rft.jtitle=Journal+of+Molecular+Diagnostics&rft.aulast=Park%2C+G.-S.%3B+Ku%2C+K.%3B+Baek%2C+S.-H.+et+al.&rft.au=Park%2C+G.-S.%3B+Ku%2C+K.%3B+Baek%2C+S.-H.+et+al.&rft.date=2020&rft.volume=22&rft.issue=6&rft.pages=729%E2%80%9335&rft_id=info:doi\/10.1016%2Fj.jmoldx.2020.03.006&rft_id=info:pmc\/PMC7144851&rft_id=info:pmid\/32276051&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7144851&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-KellnerARapid20-54\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-KellnerARapid20_54-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Kellner, M.J.; Ross, J.J.; Schnabl, J. et al. (2020). \"A rapid, highly sensitive and open-access SARS-CoV-2 detection assay for laboratory and home testing\". <i>bioRxiv<\/i>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1101%2F2020.06.23.166397\" target=\"_blank\">10.1101\/2020.06.23.166397<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=A+rapid%2C+highly+sensitive+and+open-access+SARS-CoV-2+detection+assay+for+laboratory+and+home+testing&rft.jtitle=bioRxiv&rft.aulast=Kellner%2C+M.J.%3B+Ross%2C+J.J.%3B+Schnabl%2C+J.+et+al.&rft.au=Kellner%2C+M.J.%3B+Ross%2C+J.J.%3B+Schnabl%2C+J.+et+al.&rft.date=2020&rft_id=info:doi\/10.1101%2F2020.06.23.166397&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ThiAColor20-55\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-ThiAColor20_55-0\">55.0<\/a><\/sup> <sup><a href=\"#cite_ref-ThiAColor20_55-1\">55.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Thi, V.L.D.; Herbst, K.; Boerner, K. et al. 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(2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7297120\" target=\"_blank\">\"Overcoming the bottleneck to widespread testing: a rapid review of nucleic acid testing approaches for COVID-19 detection\"<\/a>. <i>RNA<\/i> <b>26<\/b> (7): 771\u201383. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1261%2Frna.076232.120\" target=\"_blank\">10.1261\/rna.076232.120<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7297120\/\" target=\"_blank\">PMC7297120<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32358057\" target=\"_blank\">32358057<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7297120\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7297120<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Overcoming+the+bottleneck+to+widespread+testing%3A+a+rapid+review+of+nucleic+acid+testing+approaches+for+COVID-19+detection&rft.jtitle=RNA&rft.aulast=Esbin%2C+M.N.%3B+Whitney%2C+O.N.%3B+Chong%2C+S.+et+al.&rft.au=Esbin%2C+M.N.%3B+Whitney%2C+O.N.%3B+Chong%2C+S.+et+al.&rft.date=2020&rft.volume=26&rft.issue=7&rft.pages=771%E2%80%9383&rft_id=info:doi\/10.1261%2Frna.076232.120&rft_id=info:pmc\/PMC7297120&rft_id=info:pmid\/32358057&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7297120&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HaleOxford20-57\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HaleOxford20_57-0\">57.0<\/a><\/sup> <sup><a href=\"#cite_ref-HaleOxford20_57-1\">57.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Hale, C. (9 July 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fiercebiotech.com\/medtech\/oxford-researchers-develop-portable-covid-19-test-costing-less-than-25\" target=\"_blank\">\"Oxford researchers develop portable COVID-19 test costing less than $25\"<\/a>. <i>Fierce Biotech<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.fiercebiotech.com\/medtech\/oxford-researchers-develop-portable-covid-19-test-costing-less-than-25\" target=\"_blank\">https:\/\/www.fiercebiotech.com\/medtech\/oxford-researchers-develop-portable-covid-19-test-costing-less-than-25<\/a><\/span><span class=\"reference-accessdate\">. 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(6 August 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.statnews.com\/2020\/08\/06\/better-simpler-faster-covid-19-test\/\" target=\"_blank\">\"This California company has a better version of a simpler, faster Covid-19 test\"<\/a>. <i>STAT<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.statnews.com\/2020\/08\/06\/better-simpler-faster-covid-19-test\/\" target=\"_blank\">https:\/\/www.statnews.com\/2020\/08\/06\/better-simpler-faster-covid-19-test\/<\/a><\/span><span class=\"reference-accessdate\">. 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(9 July 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.the-scientist.com\/news-opinion\/saliva-tests-how-they-work-and-what-they-bring-to-covid-19-67720\" target=\"_blank\">\"Saliva Tests: How They Work and What They Bring to COVID-19\"<\/a>. <i>The Scientist<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.the-scientist.com\/news-opinion\/saliva-tests-how-they-work-and-what-they-bring-to-covid-19-67720\" target=\"_blank\">https:\/\/www.the-scientist.com\/news-opinion\/saliva-tests-how-they-work-and-what-they-bring-to-covid-19-67720<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 08 August 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Saliva+Tests%3A+How+They+Work+and+What+They+Bring+to+COVID-19&rft.atitle=The+Scientist&rft.aulast=Heidt%2C+A.&rft.au=Heidt%2C+A.&rft.date=9+July+2020&rft_id=https%3A%2F%2Fwww.the-scientist.com%2Fnews-opinion%2Fsaliva-tests-how-they-work-and-what-they-bring-to-covid-19-67720&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BroughtonCRISPR20-60\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BroughtonCRISPR20_60-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Broughton, J.P.; Deng, X.; Yu, G. et al. 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World Health Organization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.who.int\/publications\/m\/item\/covid-19-target-product-profiles-for-priority-diagnostics-to-support-response-to-the-covid-19-pandemic-v.0.1\" target=\"_blank\">https:\/\/www.who.int\/publications\/m\/item\/covid-19-target-product-profiles-for-priority-diagnostics-to-support-response-to-the-covid-19-pandemic-v.0.1<\/a><\/span><span class=\"reference-accessdate\">. 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(10 August 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cen.acs.org\/analytical-chemistry\/diagnostics\/Rapid-COVID-19-testing-breaks\/98\/web\/2020\/08\" target=\"_blank\">\"Rapid COVID-19 testing breaks free from the lab\"<\/a>. <i>Chemical & Engineering News<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/cen.acs.org\/analytical-chemistry\/diagnostics\/Rapid-COVID-19-testing-breaks\/98\/web\/2020\/08\" target=\"_blank\">https:\/\/cen.acs.org\/analytical-chemistry\/diagnostics\/Rapid-COVID-19-testing-breaks\/98\/web\/2020\/08<\/a><\/span><span class=\"reference-accessdate\">. 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Retrieved 19 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=CDC%E2%80%99s+Influenza+SARS-CoV-2+Multiplex+Assay+and+Required+Supplies&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=13+July+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Flab%2Fmultiplex.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCDelta21-78\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCDelta21_78-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Disease Control and Prevention (26 August 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/variants\/delta-variant.html\" target=\"_blank\">\"Delta Variant: What We Know About the Science\"<\/a>. 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Retrieved 18 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Delta+Variant%3A+What+We+Know+About+the+Science&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=26+August+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvariants%2Fdelta-variant.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BuchanSARS21-79\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-BuchanSARS21_79-0\">79.0<\/a><\/sup> <sup><a href=\"#cite_ref-BuchanSARS21_79-1\">79.1<\/a><\/sup> <sup><a href=\"#cite_ref-BuchanSARS21_79-2\">79.2<\/a><\/sup> <sup><a href=\"#cite_ref-BuchanSARS21_79-3\">79.3<\/a><\/sup> <sup><a href=\"#cite_ref-BuchanSARS21_79-4\">79.4<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Buchan, B.W.; Wolk, D.M.; Yao, J.D. (28 April 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.amp.org\/AMP\/assets\/File\/clinical-practice\/COVID\/AMP_RC_VariantTestingforSARSCOV2_4_28_21.pdf\" target=\"_blank\">\"SARS-CoV-2 Variant Testing\"<\/a> (PDF). <i>Rapid Communication<\/i>. Association for Molecular Pathology<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.amp.org\/AMP\/assets\/File\/clinical-practice\/COVID\/AMP_RC_VariantTestingforSARSCOV2_4_28_21.pdf\" target=\"_blank\">https:\/\/www.amp.org\/AMP\/assets\/File\/clinical-practice\/COVID\/AMP_RC_VariantTestingforSARSCOV2_4_28_21.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=SARS-CoV-2+Variant+Testing&rft.atitle=Rapid+Communication&rft.aulast=Buchan%2C+B.W.%3B+Wolk%2C+D.M.%3B+Yao%2C+J.D.&rft.au=Buchan%2C+B.W.%3B+Wolk%2C+D.M.%3B+Yao%2C+J.D.&rft.date=28+April+2021&rft.pub=Association+for+Molecular+Pathology&rft_id=https%3A%2F%2Fwww.amp.org%2FAMP%2Fassets%2FFile%2Fclinical-practice%2FCOVID%2FAMP_RC_VariantTestingforSARSCOV2_4_28_21.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WilliamsEnhanc21-80\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WilliamsEnhanc21_80-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Williams, R.W. (19 February 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/health.mo.gov\/emergencies\/ert\/alertsadvisories\/pdf\/update21921.pdf\" target=\"_blank\">\"Enhancing Public Health Surveillance for Variant SARSCoV-2 Viruses in Missouri\"<\/a> (PDF). Missouri Department of Health & Senior Services<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/health.mo.gov\/emergencies\/ert\/alertsadvisories\/pdf\/update21921.pdf\" target=\"_blank\">https:\/\/health.mo.gov\/emergencies\/ert\/alertsadvisories\/pdf\/update21921.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Enhancing+Public+Health+Surveillance+for+Variant+SARSCoV-2+Viruses+in+Missouri&rft.atitle=&rft.aulast=Williams%2C+R.W.&rft.au=Williams%2C+R.W.&rft.date=19+February+2021&rft.pub=Missouri+Department+of+Health+%26+Senior+Services&rft_id=https%3A%2F%2Fhealth.mo.gov%2Femergencies%2Fert%2Falertsadvisories%2Fpdf%2Fupdate21921.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCRole21-81\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCRole21_81-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Disease Control and Prevention (8 September 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/variants\/cdc-role-surveillance.html\" target=\"_blank\">\"CDC\u2019s Role in Tracking Variants\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/variants\/cdc-role-surveillance.html\" target=\"_blank\">https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/variants\/cdc-role-surveillance.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=CDC%E2%80%99s+Role+in+Tracking+Variants&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=8+September+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvariants%2Fcdc-role-surveillance.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCGuidanceSeq21-82\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCGuidanceSeq21_82-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Disease Control and Prevention (23 June 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/resources\/reporting-sequencing-guidance.html\" target=\"_blank\">\"Guidance for Reporting SARS-CoV-2 Sequencing Result\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/resources\/reporting-sequencing-guidance.html\" target=\"_blank\">https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/resources\/reporting-sequencing-guidance.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 19 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Guidance+for+Reporting+SARS-CoV-2+Sequencing+Result&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=23+June+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Flab%2Fresources%2Freporting-sequencing-guidance.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DupuyCOVID21-83\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DupuyCOVID21_83-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Dupuy, B. (28 July 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/apnews.com\/article\/fact-checking-549965482111\" target=\"_blank\">\"COVID-19 variants tested through genome sequencing\"<\/a>. <i>Reuters Fact-Checking<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/apnews.com\/article\/fact-checking-549965482111\" target=\"_blank\">https:\/\/apnews.com\/article\/fact-checking-549965482111<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=COVID-19+variants+tested+through+genome+sequencing&rft.atitle=Reuters+Fact-Checking&rft.aulast=Dupuy%2C+B.&rft.au=Dupuy%2C+B.&rft.date=28+July+2021&rft_id=https%3A%2F%2Fapnews.com%2Farticle%2Ffact-checking-549965482111&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20210919172300\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.549 seconds\nReal time usage: 0.646 seconds\nPreprocessor visited node count: 59996\/1000000\nPost\u2010expand include size: 501335\/2097152 bytes\nTemplate argument size: 180429\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 156728\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 512.857 1 -total\n 90.59% 464.584 1 Template:Reflist\n 77.27% 396.301 83 Template:Citation\/core\n 59.79% 306.616 61 Template:Cite_web\n 21.81% 111.853 22 Template:Cite_journal\n 13.73% 70.396 62 Template:Date\n 9.40% 48.197 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use?\n 4.46% 22.894 125 Template:Citation\/make_link\n 3.39% 17.366 35 Template:Citation\/identifier\n 1.17% 5.986 74 Template:Hide_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:12142-0!canonical and timestamp 20210919172259 and revision id 40210. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","e0edecb7b45ad188bb3834725c23d19b_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/6\/6a\/Test_PCR_d%C3%A9pistage_SARS-CoV-2_pr%C3%A9l%C3%A8vement_nasal_Strasbourg_21_ao%C3%BBt_2020.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/4\/47\/Microfluidic_chip_for_point-of-care_medical_devices.jpg"],"e0edecb7b45ad188bb3834725c23d19b_timestamp":1632073385,"39cacf950c52c601724e17a6099cf057_type":"article","39cacf950c52c601724e17a6099cf057_title":"2.4 Current test methods and their differences","39cacf950c52c601724e17a6099cf057_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Current_test_methods_and_their_differences","39cacf950c52c601724e17a6099cf057_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Diagnostic testing of COVID-19 and other coronaviruses\/Current test methods and their differencesFrom LIMSWikiJump to navigationJump to searchContents \n\n1 2.4 Current test methods and their differences \n\n1.1 2.4.1 Background on the laboratory testing environment \n1.2 2.4.2 PCR-based methods \n1.3 2.4.3 LFA and isothermal amplification methods \n1.4 2.4.4 Blood serum \n1.5 2.4.5 Antigen tests \n1.6 2.4.6 Testing alternatives and challenges \n\n\n2 References \n3 Citation information for this chapter \n\n\n\n2.4 Current test methods and their differences \nNOTE: Information shown here may rapidly become outdated given how quickly response to pandemic testing can change. A full attempt to keep the content relevant will be made. \n\n2.4.1 Background on the laboratory testing environment \nBefore continuing, it should be noted that many elements of the prior-mentioned COVID-19 testing guidance have governmental public health laboratories in mind. However, as the scale of the epidemic grew in 2020, and into 2021, the need for commercial laboratories and assay developers to get involved with efforts towards increasing analytical testing throughput\u2014through a more rigorous public-private partnership\u2014became abundantly clear.[1][2][3][4] At times during the pandemic, laboratory turnaround times have been slow due to a variety of factors, from lack of in-house laboratory resources to handle high test volumes and a slower-than-expected ramping up of test kit production[1][3][4], to actually getting diagnostic assays that are more rapid (yet still accurate) in their diagnosis, simpler to use, and useable at the point of care.[5][6] The good news is these rapid point-of-care molecular test kits are now becoming more readily available around the globe, including the United States, thanks in part to the U.S. Food and Drug Administration's Emergency Use Authorization (EUA) process. \nDespite at-home kits becoming more available, quick and effective laboratory-based testing remains important, particularly as the delta variant continues to put strains on some U.S. states and their testing efforts into the late summer of 2021.[7][8] As such, it remains important to compare the U.S. laboratory testing environments of public health and large commercial testing labs with those of small, in-office clinical labs. In the U.S., all but research-based laboratory testing of human specimens is regulated under CLIA, including public health laboratories. Of the more than 297,000 non-exempt CLIA-registered labs in the U.S., only 38,742 or 13.0 percent of them are certified to perform moderate- and high-complexity testing as of August 2021.[9] Your public health labs and commercial diagnostic labs fall into this category, with investments in the personnel, training, certifications, and equipment to conduct those sorts of tests. Contrast this with the small yet numerous physician office laboratories (POLs) and how they operate. As of August 2021, some 42.4 percent of non-exempt CLIA-certified laboratories in the United States are POLs.[9] Located in an ambulatory or outpatient care setting, these labs test specimens from human patients to assist with the diagnosis, treatment, or monitoring of a patient condition. Testing in the clinical lab generally depends on three common methodologies to meet those goals: comparing the current value of a tested substance to a reference value, examining a specimen with microscopy, and detecting the presence of infection-causing pathogens.[10] \nThese POL's operate in a different environment than your average public health laboratory or reference lab that receives, processes, and reports on specimens en masse. The POL is typically a smaller operation, performing simple laboratory testing that can produce useful diagnostic data cheaply and rapidly. Rather than performing advanced pathology and molecular diagnostic procedures that require specific equipment and expertise, the POL typically focuses on blood chemistry, urinalysis, and other testing domains that don't require significant resources and provide rapid results. This can be seen in Centers for Medicare and Medicaid Services statistics reported in August 2021 that show 69.3 percent of non-exempt POLs in the U.S. are certified to provide CLIA-waived tests[9], \"simple tests with a low risk for an incorrect result.\"[11]\nAs of September 2021, with 1. all but several handfuls of the current EUAed molecular in vitro diagnostic COVID-19 test kits being limited to moderate- and high-complexity CLIA labs[12] (the FDA claims that EUAed SARS-CoV-2 tests authorized for \"use at the point of care\" are considered CLIA-waived tests[13]), and 2. serology testing still being considered moderate- to high-complexity in nature[12], a significant majority of clinical laboratories are left with only a handful of CLIA-waived options for assisting with the effort to test the U.S. population for SARS-CoV-2 infection. Given the rapid rate of change at multiple levels of government and society and the continual spreading of misinformation[14][15][16], it's important to remember these fundamental differences in laboratories when trying to explain to someone why even in September 2021 they will still find it challenging to go to their primary care physician and get tested for SARS-CoV-2 in the doctor's office. Should researchers develop and the FDA provide EUAs for more CLIA-waived point-of-care assays, these differences may become less noticeable, and more people will be able to be tested.\n\n2.4.2 PCR-based methods \nAs of September 2021, the U.S. Food and Drug Administration (FDA) has issued 260 EAUs for all types of molecular in vitro diagnostic test kits. Two hundred and eight of those 260 are only authorized to be used in CLIA-certified high-complexity laboratories, and 19 are rated for both moderate- and high-complexity. When looking at the makeup of the EUAs, a huge majority of those tests use some form of RT-PCR methods, with most using real-time or qualitative versions of RT-PCR (qRT-PCR). CLIA-waived RT-PCR tests are still rare, however. Eight PCR-based kits from five manufacturers have an additional authorization for point-of-care (POC) use (and thus CLIA-waived use) when used with their authorized POC devices[12]:\n\nBioFire Diagnostics' BioFire Respiratory Panel 2.1-EZ\nCepheid's Xpert Omni SARS-CoV-2\nCepheid's Xpert Xpress SARS-CoV-2\nCepheid's Xpert Xpress SARS-CoV-2\/Flu\/RSV\nMesa Biotech's Accula SARS-Cov-2 Test\nRoche Molecular Systems' cobas SARS-CoV-2\nRoche Molecular Systems' cobas SARS-CoV-2 & Influenza A\/B\nVisby Medical's COVID-19 Point of Care Test\nOf course, there are many more test kits than those approved in the United States. The Foundation for Innovative New Diagnostics (FIND) is currently \"collating an overview of all SARS-CoV-2 tests commercially available or in development for the diagnosis of COVID-19.\"[17] As of September 2021, their site shows nearly 280 commercialized manual NAAT tests around the world (most being RT-PCR), with 30 in development. The AdVeritasDx test and controls database is also useful.[18]\n\n2.4.3 LFA and isothermal amplification methods \nLFAs are currently rare, but due to their advantages of being quick and useable at the point of care, some healthcare professionals have suggested that as a format for antigen and antibody (serology) testing, they could positively change the testing landscape.[19][20][21] As of September 2021, 25 of 88 serology tests that have received EUAs by the FDA are explicitly labeled as being LFAs, with 12 of those 25 being approved for POC\/CLIA-waived use.[22] An article by Sheridan in Nature Biotechnology highlights a handful of others developed around the world (see their Table 1).[19] FIND shows more than 400 commercialized rapid diagnostic immunoassay tests around the world, though it's not clear how many of them actually LFAs (from their list, only 14 are explicitly stated as being LFA).[17] While LFAs have increasingly been approved around the world in 2021[22][17], it remains a question whether or not we continue to see more of them, at least in the United States.[20]\nAlso of note are isothermal amplification methods. Abbott's ID NOW and Cue Health's Cue COVID-19 and Cue COVID-19 Test for Home and OTC tests (the latter being the first isothermal amplification test approved for home use) are described by the FDA as using \"isothermal nucleic acid amplification technology for the qualitative detection of SARS-CoV-2 viral nucleic acids.\"[23][24][25] Isothermal amplification tends to be an easier process to manage due to being able to keep amplification at a constant temperature.[26] In fact, Abbott has stated its EUAed ID NOW COVID-19 test can be completed within five minutes.[27] However, May 2020 findings by New York University put the test's accuracy into question. On July 1, 2020, an FDA spokesperson allegedly indicated receipt of 126 reports of \"adverse events\" concerning the test.[28] In 2020, some 393 complaints were reported to the FDA, with 1,492 complains being reported in 2021 (through July 31) according to an FDA MAUDE (Manufacturer and User Facility Device Experience) search.[29] The FDA was reportedly investigating the data and working with Abbott to have additional studies performed on the test's accuracy in 2020.[30] In October 2020, Abbott released additional study data showing overall sensitivity of 93.3% and specificity of 98.4%, emphasizing the ID NOW's best use with samples taken within seven days of symptom onset.[31] On August 27, 2021, the FDA re-issued its EUA for the ID NOW with updated in silico inclusivity analysis results (among other things)[32], but it's not clear if the FDA is continuing to work with Abbott on the test's accuracy claims.\nSpecific isothermal amplification techniques called loop-mediated isothermal amplification (LAMP) and reverse transcription LAMP (RT-LAMP) are beginning to emerge as options for COVID-19 testing. For example, Talis Biomedical is developing the Talis One COVID-19 system for point-of-care testing. It has received National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) funding[33] and, should it receive its EUA (as of August 2021, it was still awaiting FDA authorization[34]), is expected to be among the first U.S.-approved RT-LAMP tests for COVID-19.[35] In November 2020, the first LAMP-based, prescription \"collect and test\" at-home kit\u2014the Lucira COVID-19 All-In-One Test Kit\u2014was approved by the FDA for emergency use.[36] Globally, examining FIND's list of nearly 280 commercialized manual NAAT tests around the world, five of them are explicitly shown to be some form of LAMP test. Multiple preprints on medRxiv and bioRxiv, as well as published papers, suggest that RT-LAMP could provide rapid results for SARS-CoV-2 testing.[37][38][39][40][41] However, it's apparent that adoption of LAMP as a COVID-19 test technique has been slow at best overall.\n\n2.4.4 Blood serum \nBlood serum or serology assays come in three common varieties: LFA, enzyme-linked immunosorbent assay (ELISA), or neutralization assay.[42] As discussed prior, LFAs are intended to be rapid point-of-care tools for qualitatively testing body fluids for patient antibodies or viral antigen. The ELISA is, in contrast, a more lab-bound method which produces results that are qualitative or quantitative. In the context of COVID-19 testing, ELISA tests for the presence of patient antibodies in a given specimen based upon whether or not an interaction is observed with the viral proteins present on the test plate. However, even if antibodies are present, ELISA isn't able to tell a clinician if those antibodies are able to protect against future infection. Neutralization assays are the lengthiest to complete, taking from three upwards to five days.[42] This is largely due to the fact that the assay depends on culturing cells that encourage growth of the target virus. Afterwards, introduced patient antibodies, if present, will fight to prevent viral infection of cells. This process is performed in decreasing concentrations, giving the clinician an opportunity to \"visualize and quantify how many antibodies in the patient serum are able to block virus replication.\"[42] In contrast to ELISA, a neutralization assay is able to determine if a patient's antibodies are actively fighting against the target virus, even after recovering from the infection. In November 2020, the FDA granted an EUA to the first ELISA-based serology test to detect nuetralizing antibodies from recent or prior SARS-CoV-2 infection.[43]\nJohns Hopkins' Center for Health Security appears to be tracking serology-based COVID-19 tests that are in development or have been approved in various parts of the globe. However, for the most up-to-date list of serology tests that have received EUAs in the United States, the FDA's EUA list appears to be the best source. As of September 2021, the FDA shows 88 serology assays approved for diagnostic use in the U.S. Of those 88, sixteen are explicitly listed as being ELISA-based.\nA review of Johns Hopkins' tracking list showed more LFA-based tests among those approved in other parts of the world. Among their list of those still in development, an LFA stands out for integrating CRISPR detection.[44] CRISPR (clustered regularly interspaced short palindromic repeats) represents bacterial and archaeal DNA sequences derived from DNA fragments of previous infection. This genetic material can then be used as an activator of biomarkers when attached RNA \"guides\" find a match with target viral RNA in patient specimen.[45] This CRISPR-based LFA, called DETECTR, was further described in a paper published in October 2020, with the authors concluding it could be used \"as a complementary technically independent approach to qRT-PCR, thereby increasing the testing capacity of medical microbiological laboratories and relieving the existent PCR-platforms for routine non-SARS-CoV-2 diagnostic testing.\"[46]\n\n2.4.5 Antigen tests \nAn antigen is a substance\u2014often a protein but may also be an environmental like a virus\u2014that provokes the immune system to produce an antibody against it.[47] As such, another approach to testing for the presence of a virus in a specimen is to test for the antigen rather than the antibody. An antigen test is useful as a repeated surveillance test, but it has drawbacks as a one-time diagnostic test.[48][49][50] For COVID-19 and other viral infections, an antigen test has the advantage that specimen collection can typically be done with a simple nasal swab rather than a more invasive nasopharyngeal swab. Another advantage, on one hand, is that antigen testing is more rapid and convenient because the extraction and amplification steps of PCR are not used. On the other, antigen testing is less sensitive for the same reason: you test only what's there (rather than amplifying the amount for greater sensitivity).[49][51]\nA theory increasingly gaining traction, however, is that \"[a] higher frequency of testing makes up for poor sensitivity.\u201d[49][50][52] Several researchers have shared pre-print and published research suggesting this outcome[49]:\n\nLarremore and his colleagues have modeled the benefits of more frequent tests, even ones that are less accurate than today\u2019s. Fast tests repeated every three days, with isolation of people who test positive, prevents 88% of viral transmission compared with no tests; a more sensitive test used every two weeks reduced viral transmission by about 40%, they report in a 27 June preprint on medRxiv. Paltiel and his colleagues reached much the same conclusion when they modeled a variety of testing regimes aimed at safely reopening a 5000-student university. In a 31 July paper in JAMA Network Open, they found that, with 10 students infected at the start of the semester, a test that identified only 70% of positive cases, given to every student every two days, could limit the number of infections to 28 by the end of the semester. Screening every seven days allowed greater viral spread, with the model predicting 108 infections.\nAs such, the utility of antigen testing, despite its lower sensitivity, appears to be surveillance situations where a large group of individuals who are at risk can be screened at regularly scheduled intervals of two to four days. The end result, in theory, would be few people who are target-positive would be missed, positives could be isolated and verified with a more sensitive test, and more target-positive people would be identified and isolated before reaching peak infectivity.[49][53] To be clear, it's not a perfect solution, but as Harvard epidemiologist Michael Mina and Boston University economist Laurence Kotlikoff suggest, \"[w]e need the best means of detecting and containing the virus, not a perfect test no one can use.\"[53] In August 2020, a coalition of six U.S. state governors bought into that concept and agreed to work together with the Rockefeller Foundation, as well as the Quidel Corporation and Becton, Dickinson and Company, which had received FDA EUAs to market antigen tests for SARS-CoV-2.[52][54] As of September 2021, thirty-four FDA EUAs for antigen tests have been issues; 28 of those 34 include allowances for CLIA-waived testing, and 10 were authorized for home use.[55]\n\n2.4.6 Testing alternatives and challenges \nWe\u2019ve never faced this before, where clinical labs needed to very quickly be able to ramp up a test so fast.[56]\r\n \r\n- Jennifer Doudna, Executive Director of the Innovative Genomics Institute, University of California, Berkeley\nThough the dismantling and fund-cutting (proposed and real) of government programs designed to protect the populace from pandemics\u2014as well as shortfalls in funding overall[57]\u2014have likely hobbled local, national, and global response to COVID-19[58][59][60][61], it should be recognized that this pandemic may arguably represent a once-in-a-century type of event.[62][63] That said, even the most well-prepared governments would still face challenges in quickly learning about, controlling, and developing therapies for a novel disease agent. Shortages in supplies, workers, funding, and other resources are inevitably caused with a pandemic as people across all types of infrastructure fall ill.[57][64] This requires the additional human elements of adaptability, drive, and shared knowledge to find new and alternative solutions to fighting the challenges inherent to fighting against a novel disease.\nSee for example a non-peer-reviewed paper published on bioRxiv in early April 2020, where Schmid-Burgk et al. pointed out that though RT-PCR methods are the most common for currently testing for SARS-CoV-2, \"global capacity for testing using these approaches, however, has been limited by a combination of access and supply issues for reagents and instruments.\" They proposed \"a novel protocol that would allow for population-scale testing using massively parallel RT-LAMP by employing sample-specific barcodes.\" They claimed that a single heating step, pooled processing, and parallel sequencing with computational analysis would allow for the testing and tacking of \"tens of millions of samples.\" Though the protocol was not validated with clinical samples, and concerns about sensitivity levels of RT-LAMP (an isothermal nucleic acid amplification technique that allows for RNA amplification) have been raised, the authors' work exemplifies the immediacy and ingenuity that has gone into finding workable solutions to a once-a-century problem.[37]\nAnother example of ingenuity in the face of difficult circumstances can be found at the University of California, Berkeley. At the beginning of the pandemic, its Innovative Genomics Institute (IGI) rapidly repurposed a 2,500-square-foot scientific lab into an automated diagnostic laboratory that could initially process more than 1,000 patient samples per day, with the ability to ramp up to 3,000 per day thanks to robotics and a streamlined workflow. Partnering with dozens of people from Thermo Fisher Scientific, Salesforce, Third Wave Analytics, and Hamilton Corp., the lab focused on not only turnaround time but also accuracy of results through automation. Their continued success, of course, still relies on a steady supply of reagents and related supplies from Thermo Fisher.[56][65]\nSince the pandemic's start, others have also expressed concerns about the global supply of reagents necessary to test for SARS-CoV-2. Successful testing using RT-PCR requires two different enzymes: reverse transcriptase, for converting RNA to DNA, and polymerase, for amplifying the converted DNA. These enzymes and other reagent components may be instrument-specific, and at least one component has to be sympathetic to detection of the target virus' RNA. Little of this can be prepared without a proper sequence of the virus in question. Dr. Ronald Leonard, president and medical director of Cytocheck Laboratory and medical director of the Labette Health hospital, expressed the difficulties associated with reagent manufacturing thusly[66]:\n\nWith the instant demand for SARS-CoV-2 testing, the manufacturing process had to start from scratch for the SARS-CoV-2 specific components, and this did cause a lag time before reagents were available. The increased demand coupled with the decision to only allocate reagents to two national laboratories, some state health departments, and to \"hot spots\" has compounded the difficulty for laboratories like ours to obtain the necessary reagents to perform the testing.\nReports of COVID-19 test reagent shortages from various sources have appeared since March 2020.[67][68][69][70][71][72][73][54][53][74][75][76] Over time, those shortages even extended to supplies for non-COVID-19 tests such as those for strep throat, bronchitis, mycobacterial infections, urinary-tract infections, fungal infections, and sexually transmitted infections.[74][75][76] In the face of these supply challenges, some have taken matters into their own hands. Noting Irish laboratories' difficulties sourcing lysis buffer (for isolating molecules of interest and keeping them stable), Cork Institute of Technology's Dr. Brigid Lucey worked with several other virologists and microbiologists early in the pandemic, as well as with pharmaceutical company Eli Lilly, to produce a custom-formulated yet high-quality lysis buffer for not only Irish laboratories but also other countries can take advantage of. \"We are happy to share what we found with other countries and it\u2019s important our scientists retain their skills to make this kind of formulation because we may need to do this again in the future if we get other pandemics,\" she said.[70]\nAnother challenge lies in the accuracy of serology-based antibody tests, let alone how much they actually tell us about immunity. FierceBiotech's Conor Hale touched upon this in late April 2020[77]:\n\nCompared to molecular tests\u2014which sequence and match the RNA of the novel coronavirus to produce a result\u2014the FDA has described antibody tests that gauge the body\u2019s immune system response as a less-complicated endeavor that could proceed without review, dubbed \u201cregulatory flexibility\u201d by Commissioner Stephen Hahn. This policy shift has led to confusion, with some antibody test developers falsely claiming their tests are FDA-approved or could diagnose COVID-19 at home. Still others have sold outrightly fraudulent tests online.\nAt least in the U.S., these problems are compounded by company participation in test validation of EUAs being voluntary.[77] As a late April 2020 memorandum from Congress put it: \"FDA is unable to validate the accuracy of antibody tests that are already on the market, and companies are ignoring requests from the Department of Health and Human Services (HHS) to voluntarily submit their tests for validation ... FDA has failed to police the coronavirus serological antibody test market, has taken no public enforcement action against any company, and has not conveyed any clear policy on serological tests...\"[78] The entire memorandum is revealing in the challenges of attempting to relax social distancing measures under the pretense of the effectiveness of antibody testing. Entities such as the University of California - San Francisco[79] and the University of California - Berkeley[80] early on emphasized the importance of elements such as sensitivity, specificity, proper training, and the unknowns of the predictive ability of the test. Even assays running under trusted platforms such as PCR can reveal issues. For example, Thermo Fisher Scientific's TaqPath COVID019 Combo Kit, approved for EUA in March 2020, received scrutiny and updates to address issues with false-positive and -negative results[81][82], highlighting the difficulty of, at least early on in the pandemic, balancing the need for rapidly approving test kits for emergency use while also maintaining some semblance of oversight regarding their effectiveness and proper use. This has been further hampered by an August 2020 decision that stated the FDA could not require laboratory developed tests (LDTs) to be submitted for an EUA. As the Pew Charitable Trust's Liz Richardson argued in September 2021, reversing this decision \"would enable labs to continue bringing innovative and effective new tests to market quickly while empowering FDA to protect the public from faulty products that allow infection to spread.\"[83]\nFinally, while point-of-care testing, including at-home testing, has made strides in 2021[55], their need remains apparent. Dozens of at-home tests remained in development (many of them antigen tests) at the end of 2020, and even now a major barrier is found in making them both accurate and easy for untrained people to understand and use.[84][85] And as more at-home tests continue to receive EUAs in 2021, they are still not without concern, particularly in regards to ensuring that at-home test results get reported properly and rapidly.[84][86] One such early example at the end of 2020 was Lucira Health's LAMP-based Lucira COVID-19 All-In-One Test Kit, which was approved as a prescription-based at-home test, but with the stipulation that the prescribing healthcare provider would be responsible for reporting results.[36] Such a requirement arguably can and should be put in place for at-home antigen-based testing as well.[84]\nAs the pandemic churns through its second year, it's more important than ever for leaders across government, healthcare, and the media to continue to not spread misinformation and not make decisions based on poor scientific evidence. 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WCVB 5 ABC. https:\/\/www.wcvb.com\/article\/5-investigates-concerns-about-current-use-of-rapid-antigen-tests-for-covid-19\/33538332 . Retrieved 07 August 2020 .   \n \n\n\u2191 49.0 49.1 49.2 49.3 49.4 Service, R.F. (2020). \"Radical shift in COVID-19 testing needed to reopen schools and businesses, researchers say\". Science. doi:10.1126\/science.abe1546.   \n \n\n\u2191 50.0 50.1 Kremer, R. (7 August 2020). \"UW System Orders 350,000 COVID-19 Tests\". Urban Milwaukee. https:\/\/urbanmilwaukee.com\/2020\/08\/07\/uw-system-orders-350000-covid-19-tests\/ . Retrieved 07 August 2020 .   \n \n\n\u2191 Guglielmi, G. (2020). \"The explosion of new coronavirus tests that could help to end the pandemic\". Nature 583: 506\u201309. doi:10.1038\/d41586-020-02140-8.   \n \n\n\u2191 52.0 52.1 Clark, C. (6 August 2020). \"COVID Antigen Tests: Coming to Case Counts Near You?\". MedPage Today. https:\/\/www.medpagetoday.com\/infectiousdisease\/covid19\/87930 . Retrieved 07 August 2020 .   \n \n\n\u2191 53.0 53.1 53.2 Courage, K.H. (31 July 2020). \"Should we be testing fewer people to stop the spread of Covid-19?\". Vox. https:\/\/www.vox.com\/2020\/7\/31\/21336212\/covid-19-test-results-delays . Retrieved 05 August 2020 .   \n \n\n\u2191 54.0 54.1 Mervosh, S.; Fernandez, M. (4 August 2020). \"\u2018It\u2019s Like Having No Testing\u2019: Coronavirus Test Results Are Still Delayed\". The New York Times. https:\/\/www.nytimes.com\/2020\/08\/04\/us\/virus-testing-delays.html . Retrieved 05 August 2020 .   \n \n\n\u2191 55.0 55.1 \"In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2\". U.S. Food and Drug Administration. 7 September 2021. https:\/\/www.fda.gov\/medical-devices\/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2 . Retrieved 07 September 2021 .   \n \n\n\u2191 56.0 56.1 Terry, M. (30 March 2020). \"CRISPR Pioneer Jennifer Doudna Expects Automated COVID-19 Test Lab to Begin Testing Next Week\". BioSpace. https:\/\/www.biospace.com\/article\/crispr-discoverer-jennifer-doudna-launches-covid-19-test-lab\/ . Retrieved 10 April 2020 .   \n \n\n\u2191 57.0 57.1 Sands, P.; Mundaca-Shah, C.; Dzau, V.J. (2016). \"The Neglected Dimension of Global Security \u2014 A Framework for Countering Infectious-Disease Crises\". The New England Journal of Medicine 374 (13): 1281\u201387. doi:10.1056\/NEJMsr1600236. PMID 26761419.   \n \n\n\u2191 Morris, C. (26 February 2020). \"Trump administration budget cuts could become a major problem as coronavirus spreads\". Fortune. https:\/\/fortune.com\/2020\/02\/26\/coronavirus-covid-19-cdc-budget-cuts-us-trump\/ . Retrieved 10 April 2020 .   \n \n\n\u2191 Specter, M. (17 March 2020). \"The Coronavirus and the Gutting of America\u2019s Public-Health System\". The New Yorker. https:\/\/www.newyorker.com\/news\/daily-comment\/coronavirus-and-the-gutting-of-americas-public-health-system . Retrieved 10 April 2020 .   \n \n\n\u2191 Roos, R. (25 May 2007). \"Congress cut pandemic funds before passing spending bill\". CIDRAP - News & Perspective. https:\/\/www.cidrap.umn.edu\/news-perspective\/2007\/05\/congress-cut-pandemic-funds-passing-spending-bill . Retrieved 10 April 2020 .   \n \n\n\u2191 Schnirring, L. (20 December 2007). \"Congress slashes pandemic preparedness funding\". CIDRAP - News & Perspective. https:\/\/www.cidrap.umn.edu\/news-perspective\/2007\/12\/congress-slashes-pandemic-preparedness-funding . Retrieved 10 April 2020 .   \n \n\n\u2191 Gates, B. (2020). \"Responding to Covid-19 \u2014 A Once-in-a-Century Pandemic?\". The New England Journal of Medicine. doi:10.1056\/NEJMp2003762. PMID 32109012.   \n \n\n\u2191 Shontell, A. (10 April 2020). \"Melinda Gates: This is not a once-in-a-century pandemic. 'We will absolutely have more of these.' The billionaire philanthropist predicts a timeline for going back to normal\". Business Insider. https:\/\/www.businessinsider.com\/melinda-gates-coronavirus-interview-vaccine-timeline-2020-4 . Retrieved 10 April 2020 .   \n \n\n\u2191 Madhav, N.; Oppenheim, B.; Gallivan, M. et al. (2017). \"Chapter 17: Pandemics: Risks, Impacts, and Mitigation\". In Jamison, D.T.; Gelband, H.; Horton, S. et al.. Disease Control Priorities: Improving Health and Reducing Poverty (3rd ed.). The World Bank. ISBN 9781464805288. https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK525302\/ .   \n \n\n\u2191 Sanders, R. (30 March 2020). \"UC Berkeley scientists spin up a robotic COVID-19 testing lab\". Berkeley News. https:\/\/news.berkeley.edu\/2020\/03\/30\/uc-berkeley-scientists-spin-up-a-robotic-covid-19-testing-lab\/ . Retrieved 10 April 2020 .   \n \n\n\u2191 Nolting, R. (10 April 2020). \"Local testing delayed by lack of reagents\". Parsons Sun. https:\/\/www.parsonssun.com\/news\/coronavirus\/article_99193646-7aec-11ea-a7c5-b700f82332db.html . Retrieved 10 April 2020 .   \n \n\n\u2191 Herper, M.; Branswell, H. (10 March 2020). \"Shortage of crucial chemicals creates new obstacle to U.S. coronavirus testing\". STAT. https:\/\/www.statnews.com\/2020\/03\/10\/shortage-crucial-chemicals-us-coronavirus-testing\/ . Retrieved 10 April 2020 .   \n \n\n\u2191 Hale, C. (18 March 2020). \"Qiagen aims to more than quadruple its COVID-19 reagent production in 6 weeks\". Fierce Biotech. https:\/\/www.fiercebiotech.com\/medtech\/qiagen-aims-to-more-than-quadruple-its-covid-19-reagent-production-6-weeks . Retrieved 10 April 2020 .   \n \n\n\u2191 Mehta, A. (3 April 2020). \"Mystery surrounds UK claim of Covid-19 test reagent \u2018shortage\u2019\". Chemistry World. https:\/\/www.chemistryworld.com\/news\/mystery-surrounds-uk-claim-of-covid-19-test-reagent-shortage\/4011457.article . Retrieved 07 September 2021 .   \n \n\n\u2191 70.0 70.1 Roche, B. (8 April 2020). \"Irish scientists develop reagent in effort to ease Covid-19 testing delays\". The Irish Times. https:\/\/www.irishtimes.com\/news\/science\/irish-scientists-develop-reagent-in-effort-to-ease-covid-19-testing-delays-1.4223897 . Retrieved 10 April 2020 .   \n \n\n\u2191 Padma, T.V. (13 May 2020). \"Efforts to combat Covid-19 in India hit by imported reagent shortages\". Chemistry World. https:\/\/www.chemistryworld.com\/news\/efforts-to-combat-covid-19-in-india-hit-by-imported-reagent-shortages\/4011718.article#\/ . Retrieved 19 May 2020 .   \n \n\n\u2191 David, E.; Farber, S.E. (20 June 2020). \"Survey shows resources for COVID-19 diagnostic testing still limited months later\". ABC News. https:\/\/abcnews.go.com\/Health\/survey-shows-resources-covid-19-diagnostic-testing-limited\/story?id=71341885 . Retrieved 08 July 2020 .   \n \n\n\u2191 Johnson, K. (2 July 2020). \"NC Labs Facing Shortages In COVID-19 Testing Chemicals\". Patch. https:\/\/patch.com\/north-carolina\/charlotte\/nc-labs-facing-shortages-covid-19-testing-chemicals . Retrieved 08 July 2020 .   \n \n\n\u2191 74.0 74.1 American Society for Microbiology (9 November 2020). \"Supply Shortages Impacting COVID-19 and Non-COVID Testing\". American Society for Microbiology. https:\/\/asm.org\/Articles\/2020\/September\/Clinical-Microbiology-Supply-Shortage-Collecti-1 . Retrieved 18 November 2020 .   \n \n\n\u2191 75.0 75.1 Abbott, B.; Krouse, S. (9 November 2020). \"Covid-19 Testing Saps Supplies Needed for Other Medical Tests\". The Wall Street Journal. https:\/\/www.wsj.com\/articles\/covid-19-testing-saps-supplies-needed-for-other-medical-tests-11604926800 . Retrieved 18 November 2020 .   \n \n\n\u2191 76.0 76.1 Williams, S. (21 April 2021). \"Supply Shortages Hit Life Science Labs Hard\". The Scientist. https:\/\/www.the-scientist.com\/news-opinion\/supply-shortages-hit-life-science-labs-hard-68695 . Retrieved 07 September 2021 .   \n \n\n\u2191 77.0 77.1 Hale, C. (27 April 2020). \"Congress urges FDA to better police, evaluate COVID-19 antibody tests\". Fierce Biotech. https:\/\/www.fiercebiotech.com\/medtech\/congress-urges-fda-to-better-police-evaluate-covid-19-antibody-tests . Retrieved 01 May 2020 .   \n \n\n\u2191 Subcommittee on Economic and Consumer Policy (24 April 2020). \"Preliminary Findings of the Subcommittee\u2019s Coronavirus Antibody Testing Investigation\" (PDF). U.S. House of Representatives. https:\/\/oversight.house.gov\/sites\/democrats.oversight.house.gov\/files\/ECP%20Staff%20Report%20on%20Preliminary%20Findings%20of%20the%20Subcommittee%E2%80%99s%20Coronavirus%20Antibody%20Testing%20Investigation.pdf . Retrieved 01 May 2020 .   \n \n\n\u2191 Farley, P.; Sanders, R. (27 April 2020). \"Testing the Tests: COVID-19 Antibody Assays Scrutinized for Accuracy by UCSF, UC Berkeley Researchers\". UCSF News. https:\/\/www.ucsf.edu\/news\/2020\/04\/417276\/testing-tests-covid-19-antibody-assays-scrutinized-accuracy-ucsf-uc-berkeley . Retrieved 01 May 2020 .   \n \n\n\u2191 Sanders, R. (27 April 2020). \"What COVID-19 antibody tests can tell us, and what they can\u2019t\". Berkeley News. https:\/\/news.berkeley.edu\/2020\/04\/27\/what-covid-19-antibody-tests-can-tell-us-and-what-they-cant\/ . Retrieved 01 May 2020 .   \n \n\n\u2191 Whooley, S. (17 August 2020). \"FDA warns on false results for Thermo Fisher TaqPath COVID-19 testing kit\". + Mass Device. WTWH Media LLC. https:\/\/www.massdevice.com\/fda-warns-on-false-results-for-thermo-fisher-taqpath-covid-19-testing-kit\/ . Retrieved 23 August 2020 .   \n \n\n\u2191 Taylor, N.P. (18 August 2020). \"Thermo Fisher COVID-19 test flagged for false positive and negative results\". MedTechDive. https:\/\/www.medtechdive.com\/news\/thermo-fisher-covid-19-test-flagged-for-false-positive-false-negative-resu\/583682\/ . Retrieved 23 August 2020 .   \n \n\n\u2191 Richardson, L. (2 September 2021). \"With Delta Surging, FDA Needs Authority to Ensure Accuracy of COVID-19 Tests\". Pew Charitable Trust. https:\/\/www.pewtrusts.org\/en\/research-and-analysis\/articles\/2021\/09\/02\/with-delta-surging-fda-needs-authority-to-ensure-accuracy-of-covid19-tests . Retrieved 07 September 2021 .   \n \n\n\u2191 84.0 84.1 84.2 Wan, W. (24 October 2020). \"Home tests could help in the fight against the coronavirus. So where are they?\". The Washington Post. https:\/\/www.washingtonpost.com\/health\/2020\/10\/24\/coronavirus-home-tests\/ . Retrieved 18 November 2020 .   \n \n\n\u2191 McDermott, A. (2020). \"Inner Workings: Researchers race to develop in-home testing for COVID-19, a potential game changer\". PNAS 117 (42): 25956-25959. doi:10.1073\/pnas.2019062117. PMC PMC7584891. PMID 32999063. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7584891 .   \n \n\n\u2191 Crear-Perry, J. (5 November 2020). \"The hidden public health hazard of rapid Covid-19 tests\". STAT. https:\/\/www.statnews.com\/2020\/11\/05\/rapid-covid-19-tests-hidden-public-health-hazard\/ . Retrieved 18 November 2020 .   \n \n\n\u2191 National Institutes of Health (23 June 2020). \"Experts identify steps to expand and improve antibody tests in COVID-19 response\". News Releases. https:\/\/www.nih.gov\/news-events\/news-releases\/experts-identify-steps-expand-improve-antibody-tests-covid-19-response . Retrieved 08 July 2020 .   \n \n\n\n\r\n\n\n-----Go to the next chapter of this guide-----\nCitation information for this chapter \nChapter: 2. Diagnostic testing of COVID-19 and other coronaviruses\nEdition: Fall 2021\nTitle: COVID-19 Testing, Reporting, and Information Management in the Laboratory\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: September 2021\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Current_test_methods_and_their_differences\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Current_test_methods_and_their_differences<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 19 September 2021, at 17:24.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 590 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","39cacf950c52c601724e17a6099cf057_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Diagnostic_testing_of_COVID-19_and_other_coronaviruses_Current_test_methods_and_their_differences rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Diagnostic_testing_of_COVID-19_and_other_coronaviruses_Current_test_methods_and_their_differences skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Diagnostic testing of COVID-19 and other coronaviruses\/Current test methods and their differences<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\">\n\n<h3><span class=\"mw-headline\" id=\"2.4_Current_test_methods_and_their_differences\">2.4 Current test methods and their differences<\/span><\/h3>\n<p><i>NOTE: Information shown here may rapidly become outdated given how quickly response to pandemic testing can change. A full attempt to keep the content relevant will be made.<\/i> \n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.4.1_Background_on_the_laboratory_testing_environment\">2.4.1 Background on the laboratory testing environment<\/span><\/h4>\n<p>Before continuing, it should be noted that many elements of the prior-mentioned COVID-19 testing guidance have governmental public health laboratories in mind. However, as the scale of the epidemic grew in 2020, and into 2021, the need for commercial laboratories and assay developers to get involved with efforts towards increasing analytical testing throughput\u2014through a more rigorous public-private partnership\u2014became abundantly clear.<sup id=\"rdp-ebb-cite_ref-MadrigalPrivate20_1-0\" class=\"reference\"><a href=\"#cite_note-MadrigalPrivate20-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HaleFDAOpens20_2-0\" class=\"reference\"><a href=\"#cite_note-HaleFDAOpens20-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ApplebyWhyIt20_3-0\" class=\"reference\"><a href=\"#cite_note-ApplebyWhyIt20-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Ryan-MosleyWhySome20_4-0\" class=\"reference\"><a href=\"#cite_note-Ryan-MosleyWhySome20-4\">[4]<\/a><\/sup> At times during the pandemic, laboratory turnaround times have been slow due to a variety of factors, from lack of in-house laboratory resources to handle high test volumes and a slower-than-expected ramping up of test kit production<sup id=\"rdp-ebb-cite_ref-MadrigalPrivate20_1-1\" class=\"reference\"><a href=\"#cite_note-MadrigalPrivate20-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ApplebyWhyIt20_3-1\" class=\"reference\"><a href=\"#cite_note-ApplebyWhyIt20-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Ryan-MosleyWhySome20_4-1\" class=\"reference\"><a href=\"#cite_note-Ryan-MosleyWhySome20-4\">[4]<\/a><\/sup>, to actually getting diagnostic assays that are more rapid (yet still accurate) in their diagnosis, simpler to use, and useable at the point of care.<sup id=\"rdp-ebb-cite_ref-Nguyen2019_20_5-0\" class=\"reference\"><a href=\"#cite_note-Nguyen2019_20-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-YangPoint20_6-0\" class=\"reference\"><a href=\"#cite_note-YangPoint20-6\">[6]<\/a><\/sup> The good news is these rapid point-of-care molecular test kits are now becoming more readily available around the globe, including the United States, thanks in part to the U.S. Food and Drug Administration's Emergency Use Authorization (EUA) process. \n<\/p><p>Despite at-home kits becoming more available, quick and effective laboratory-based testing remains important, particularly as the delta variant continues to put strains on some U.S. states and their testing efforts into the late summer of 2021.<sup id=\"rdp-ebb-cite_ref-ScottWhy21_7-0\" class=\"reference\"><a href=\"#cite_note-ScottWhy21-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ZogaNBC21_8-0\" class=\"reference\"><a href=\"#cite_note-ZogaNBC21-8\">[8]<\/a><\/sup> As such, it remains important to compare the U.S. laboratory testing environments of public health and large commercial testing labs with those of small, in-office clinical labs. In the U.S., all but research-based laboratory testing of human specimens is regulated under CLIA, including public health laboratories. Of the more than 297,000 non-exempt CLIA-registered labs in the U.S., only 38,742 or 13.0 percent of them are certified to perform moderate- and high-complexity testing as of August 2021.<sup id=\"rdp-ebb-cite_ref-CMSEnroll19_9-0\" class=\"reference\"><a href=\"#cite_note-CMSEnroll19-9\">[9]<\/a><\/sup> Your public health labs and commercial diagnostic labs fall into this category, with investments in the personnel, training, certifications, and equipment to conduct those sorts of tests. Contrast this with the small yet numerous <a href=\"https:\/\/www.limswiki.org\/index.php\/Physician_office_laboratory\" title=\"Physician office laboratory\" class=\"wiki-link\" data-key=\"0655647b0091e0dd168f162b621a6cef\">physician office laboratories<\/a> (POLs) and how they operate. As of August 2021, some 42.4 percent of non-exempt <a href=\"https:\/\/www.limswiki.org\/index.php\/CLIA\" class=\"mw-redirect wiki-link\" title=\"CLIA\" data-key=\"9c0b9bbf5c8d2310833a79d137ac621e\">CLIA<\/a>-certified laboratories in the United States are POLs.<sup id=\"rdp-ebb-cite_ref-CMSEnroll19_9-1\" class=\"reference\"><a href=\"#cite_note-CMSEnroll19-9\">[9]<\/a><\/sup> Located in an ambulatory or outpatient care setting, these labs test specimens from human patients to assist with the diagnosis, treatment, or monitoring of a patient condition. Testing in the clinical lab generally depends on three common methodologies to meet those goals: comparing the current value of a tested substance to a reference value, examining a specimen with microscopy, and detecting the presence of infection-causing pathogens.<sup id=\"rdp-ebb-cite_ref-GarrelsOatis_10-0\" class=\"reference\"><a href=\"#cite_note-GarrelsOatis-10\">[10]<\/a><\/sup> \n<\/p><p>These POL's operate in a different environment than your average <a href=\"https:\/\/www.limswiki.org\/index.php\/Public_health_laboratory\" title=\"Public health laboratory\" class=\"wiki-link\" data-key=\"34ffb658cb79bf322c65efaad95996f5\">public health laboratory<\/a> or <a href=\"https:\/\/www.limswiki.org\/index.php\/Reference_lab#Referral_and_diagnostic\" class=\"mw-redirect wiki-link\" title=\"Reference lab\" data-key=\"065be6e90bd4b7d18c05243c3e8ed161\">reference lab<\/a> that receives, processes, and reports on specimens <i>en masse<\/i>. The POL is typically a smaller operation, performing simple laboratory testing that can produce useful diagnostic data cheaply and rapidly. Rather than performing advanced pathology and molecular diagnostic procedures that require specific equipment and expertise, the POL typically focuses on blood chemistry, urinalysis, and other testing domains that don't require significant resources and provide rapid results. This can be seen in <a href=\"https:\/\/www.limswiki.org\/index.php\/Centers_for_Medicare_and_Medicaid_Services\" title=\"Centers for Medicare and Medicaid Services\" class=\"wiki-link\" data-key=\"654b4449e4816e190325b420c264df1a\">Centers for Medicare and Medicaid Services<\/a> statistics reported in August 2021 that show 69.3 percent of non-exempt POLs in the U.S. are certified to provide CLIA-waived tests<sup id=\"rdp-ebb-cite_ref-CMSEnroll19_9-2\" class=\"reference\"><a href=\"#cite_note-CMSEnroll19-9\">[9]<\/a><\/sup>, \"simple tests with a low risk for an incorrect result.\"<sup id=\"rdp-ebb-cite_ref-CDCTestCom_11-0\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-11\">[11]<\/a><\/sup>\n<\/p><p>As of September 2021, with 1. all but several handfuls of the current EUAed molecular <i>in vitro<\/i> diagnostic COVID-19 test kits being limited to moderate- and high-complexity CLIA labs<sup id=\"rdp-ebb-cite_ref-FDAInVitroEUAs21_12-0\" class=\"reference\"><a href=\"#cite_note-FDAInVitroEUAs21-12\">[12]<\/a><\/sup> (the FDA claims that EUAed SARS-CoV-2 tests authorized for \"use at the point of care\" are considered CLIA-waived tests<sup id=\"rdp-ebb-cite_ref-FDA_FAQS20_13-0\" class=\"reference\"><a href=\"#cite_note-FDA_FAQS20-13\">[13]<\/a><\/sup>), and 2. serology testing still being considered moderate- to high-complexity in nature<sup id=\"rdp-ebb-cite_ref-FDAInVitroEUAs21_12-1\" class=\"reference\"><a href=\"#cite_note-FDAInVitroEUAs21-12\">[12]<\/a><\/sup>, a significant majority of clinical laboratories are left with only a handful of CLIA-waived options for assisting with the effort to test the U.S. population for SARS-CoV-2 infection. Given the rapid rate of change at multiple levels of government and society and the continual spreading of misinformation<sup id=\"rdp-ebb-cite_ref-SimoniteTheProf20_14-0\" class=\"reference\"><a href=\"#cite_note-SimoniteTheProf20-14\">[14]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SuciuDuring20_15-0\" class=\"reference\"><a href=\"#cite_note-SuciuDuring20-15\">[15]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SoucheraySurgeon21_16-0\" class=\"reference\"><a href=\"#cite_note-SoucheraySurgeon21-16\">[16]<\/a><\/sup>, it's important to remember these fundamental differences in laboratories when trying to explain to someone why even in September 2021 they will still find it challenging to go to their primary care physician and get tested for SARS-CoV-2 in the doctor's office. Should researchers develop and the FDA provide EUAs for more CLIA-waived point-of-care assays, these differences may become less noticeable, and more people will be able to be tested.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.4.2_PCR-based_methods\">2.4.2 PCR-based methods<\/span><\/h4>\n<p>As of September 2021, the U.S. Food and Drug Administration (FDA) has issued 260 EAUs for all types of molecular <i>in vitro<\/i> diagnostic test kits. Two hundred and eight of those 260 are only authorized to be used in CLIA-certified high-complexity laboratories, and 19 are rated for both moderate- and high-complexity. When looking at the makeup of the EUAs, a huge majority of those tests use some form of RT-PCR methods, with most using real-time or qualitative versions of RT-PCR (qRT-PCR). CLIA-waived RT-PCR tests are still rare, however. Eight PCR-based kits from five manufacturers have an additional authorization for point-of-care (POC) use (and thus CLIA-waived use) when used with their authorized POC devices<sup id=\"rdp-ebb-cite_ref-FDAInVitroEUAs21_12-2\" class=\"reference\"><a href=\"#cite_note-FDAInVitroEUAs21-12\">[12]<\/a><\/sup>:\n<\/p>\n<ul><li>BioFire Diagnostics' BioFire Respiratory Panel 2.1-EZ<\/li>\n<li>Cepheid's Xpert Omni SARS-CoV-2<\/li>\n<li>Cepheid's Xpert Xpress SARS-CoV-2<\/li>\n<li>Cepheid's Xpert Xpress SARS-CoV-2\/Flu\/RSV<\/li>\n<li>Mesa Biotech's Accula SARS-Cov-2 Test<\/li>\n<li>Roche Molecular Systems' cobas SARS-CoV-2<\/li>\n<li>Roche Molecular Systems' cobas SARS-CoV-2 & Influenza A\/B<\/li>\n<li>Visby Medical's COVID-19 Point of Care Test<\/li><\/ul>\n<p>Of course, there are many more test kits than those approved in the United States. The Foundation for Innovative New Diagnostics (FIND) is currently \"collating an overview of all SARS-CoV-2 tests commercially available or in development for the diagnosis of COVID-19.\"<sup id=\"rdp-ebb-cite_ref-FINDSARS20_17-0\" class=\"reference\"><a href=\"#cite_note-FINDSARS20-17\">[17]<\/a><\/sup> As of September 2021, their site shows nearly 280 commercialized manual NAAT tests around the world (most being RT-PCR), with 30 in development. The AdVeritasDx test and controls database is also useful.<sup id=\"rdp-ebb-cite_ref-AVDTheSARS_18-0\" class=\"reference\"><a href=\"#cite_note-AVDTheSARS-18\">[18]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.4.3_LFA_and_isothermal_amplification_methods\">2.4.3 LFA and isothermal amplification methods<\/span><\/h4>\n<p>LFAs are currently rare, but due to their advantages of being quick and useable at the point of care, some healthcare professionals have suggested that as a format for antigen and antibody (serology) testing, they could positively change the testing landscape.<sup id=\"rdp-ebb-cite_ref-SheridanFast20_19-0\" class=\"reference\"><a href=\"#cite_note-SheridanFast20-19\">[19]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BistriceanCOVID20_20-0\" class=\"reference\"><a href=\"#cite_note-BistriceanCOVID20-20\">[20]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DickensCorona20_21-0\" class=\"reference\"><a href=\"#cite_note-DickensCorona20-21\">[21]<\/a><\/sup> As of September 2021, 25 of 88 serology tests that have received EUAs by the FDA are explicitly labeled as being LFAs, with 12 of those 25 being approved for POC\/CLIA-waived use.<sup id=\"rdp-ebb-cite_ref-FDAInVitroEUASero21_22-0\" class=\"reference\"><a href=\"#cite_note-FDAInVitroEUASero21-22\">[22]<\/a><\/sup> An article by Sheridan in <i>Nature Biotechnology<\/i> highlights a handful of others developed around the world (see their Table 1).<sup id=\"rdp-ebb-cite_ref-SheridanFast20_19-1\" class=\"reference\"><a href=\"#cite_note-SheridanFast20-19\">[19]<\/a><\/sup> FIND shows more than 400 commercialized rapid diagnostic immunoassay tests around the world, though it's not clear how many of them actually LFAs (from their list, only 14 are explicitly stated as being LFA).<sup id=\"rdp-ebb-cite_ref-FINDSARS20_17-1\" class=\"reference\"><a href=\"#cite_note-FINDSARS20-17\">[17]<\/a><\/sup> While LFAs have increasingly been approved around the world in 2021<sup id=\"rdp-ebb-cite_ref-FDAInVitroEUASero21_22-1\" class=\"reference\"><a href=\"#cite_note-FDAInVitroEUASero21-22\">[22]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FINDSARS20_17-2\" class=\"reference\"><a href=\"#cite_note-FINDSARS20-17\">[17]<\/a><\/sup>, it remains a question whether or not we continue to see more of them, at least in the United States.<sup id=\"rdp-ebb-cite_ref-BistriceanCOVID20_20-1\" class=\"reference\"><a href=\"#cite_note-BistriceanCOVID20-20\">[20]<\/a><\/sup>\n<\/p><p>Also of note are <a href=\"https:\/\/www.limswiki.org\/index.php\/Variants_of_PCR#Isothermal_amplification_methods\" title=\"Variants of PCR\" class=\"wiki-link\" data-key=\"b1ebded834cce8945a6bb8e199de8df2\">isothermal amplification<\/a> methods. Abbott's ID NOW and Cue Health's Cue COVID-19 and Cue COVID-19 Test for Home and OTC tests (the latter being the first isothermal amplification test approved for home use) are described by the FDA as using \"isothermal nucleic acid amplification technology for the qualitative detection of SARS-CoV-2 viral nucleic acids.\"<sup id=\"rdp-ebb-cite_ref-HintonCue20_23-0\" class=\"reference\"><a href=\"#cite_note-HintonCue20-23\">[23]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HintonIDNOW20_24-0\" class=\"reference\"><a href=\"#cite_note-HintonIDNOW20-24\">[24]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HintonCueOTC21_25-0\" class=\"reference\"><a href=\"#cite_note-HintonCueOTC21-25\">[25]<\/a><\/sup> Isothermal amplification tends to be an easier process to manage due to being able to keep amplification at a constant temperature.<sup id=\"rdp-ebb-cite_ref-ZanoliIsotherm13_26-0\" class=\"reference\"><a href=\"#cite_note-ZanoliIsotherm13-26\">[26]<\/a><\/sup> In fact, Abbott has stated its EUAed ID NOW COVID-19 test can be completed within five minutes.<sup id=\"rdp-ebb-cite_ref-AbbottDetect20_27-0\" class=\"reference\"><a href=\"#cite_note-AbbottDetect20-27\">[27]<\/a><\/sup> However, May 2020 findings by New York University put the test's accuracy into question. On July 1, 2020, an FDA spokesperson allegedly indicated receipt of 126 reports of \"adverse events\" concerning the test.<sup id=\"rdp-ebb-cite_ref-DevineCorona20_28-0\" class=\"reference\"><a href=\"#cite_note-DevineCorona20-28\">[28]<\/a><\/sup> In 2020, some 393 complaints were reported to the FDA, with 1,492 complains being reported in 2021 (through July 31) according to an FDA MAUDE (Manufacturer and User Facility Device Experience) search.<sup id=\"rdp-ebb-cite_ref-FDAMAUDE_29-0\" class=\"reference\"><a href=\"#cite_note-FDAMAUDE-29\">[29]<\/a><\/sup> The FDA was reportedly investigating the data and working with Abbott to have additional studies performed on the test's accuracy in 2020.<sup id=\"rdp-ebb-cite_ref-PerroneFDA20_30-0\" class=\"reference\"><a href=\"#cite_note-PerroneFDA20-30\">[30]<\/a><\/sup> In October 2020, Abbott released additional study data showing overall sensitivity of 93.3% and specificity of 98.4%, emphasizing the ID NOW's best use with samples taken within seven days of symptom onset.<sup id=\"rdp-ebb-cite_ref-TaylorAbbot20_31-0\" class=\"reference\"><a href=\"#cite_note-TaylorAbbot20-31\">[31]<\/a><\/sup> On August 27, 2021, the FDA re-issued its EUA for the ID NOW with updated <i>in silico<\/i> inclusivity analysis results (among other things)<sup id=\"rdp-ebb-cite_ref-HintonIDNOWAug21_32-0\" class=\"reference\"><a href=\"#cite_note-HintonIDNOWAug21-32\">[32]<\/a><\/sup>, but it's not clear if the FDA is continuing to work with Abbott on the test's accuracy claims.\n<\/p><p>Specific isothermal amplification techniques called <a href=\"https:\/\/www.limswiki.org\/index.php\/Loop-mediated_isothermal_amplification\" title=\"Loop-mediated isothermal amplification\" class=\"wiki-link\" data-key=\"e71e4c1cfffeaf6781dd13b0ac1cc2a9\">loop-mediated isothermal amplification<\/a> (LAMP) and reverse transcription LAMP (RT-LAMP) are beginning to emerge as options for COVID-19 testing. For example, Talis Biomedical is developing the Talis One COVID-19 system for point-of-care testing. It has received National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) funding<sup id=\"rdp-ebb-cite_ref-NIHDelivering20_33-0\" class=\"reference\"><a href=\"#cite_note-NIHDelivering20-33\">[33]<\/a><\/sup> and, should it receive its EUA (as of August 2021, it was still awaiting FDA authorization<sup id=\"rdp-ebb-cite_ref-O.27ConnorDespite21_34-0\" class=\"reference\"><a href=\"#cite_note-O.27ConnorDespite21-34\">[34]<\/a><\/sup>), is expected to be among the first U.S.-approved RT-LAMP tests for COVID-19.<sup id=\"rdp-ebb-cite_ref-TalisOne_35-0\" class=\"reference\"><a href=\"#cite_note-TalisOne-35\">[35]<\/a><\/sup> In November 2020, the first LAMP-based, prescription \"collect and test\" at-home kit\u2014the Lucira COVID-19 All-In-One Test Kit\u2014was approved by the FDA for emergency use.<sup id=\"rdp-ebb-cite_ref-RomoFDAApproves20_36-0\" class=\"reference\"><a href=\"#cite_note-RomoFDAApproves20-36\">[36]<\/a><\/sup> Globally, examining FIND's list of nearly 280 commercialized manual NAAT tests around the world, five of them are explicitly shown to be some form of LAMP test. Multiple preprints on <i>medRxiv<\/i> and <i>bioRxiv<\/i>, as well as published papers, suggest that RT-LAMP could provide rapid results for SARS-CoV-2 testing.<sup id=\"rdp-ebb-cite_ref-Schmid-BurgkLAMP20_37-0\" class=\"reference\"><a href=\"#cite_note-Schmid-BurgkLAMP20-37\">[37]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LambRapid20_38-0\" class=\"reference\"><a href=\"#cite_note-LambRapid20-38\">[38]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KellnerARapid20_39-0\" class=\"reference\"><a href=\"#cite_note-KellnerARapid20-39\">[39]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-YuRapid20_40-0\" class=\"reference\"><a href=\"#cite_note-YuRapid20-40\">[40]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ParkDevelop20_41-0\" class=\"reference\"><a href=\"#cite_note-ParkDevelop20-41\">[41]<\/a><\/sup> However, it's apparent that adoption of LAMP as a COVID-19 test technique has been slow at best overall.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.4.4_Blood_serum\">2.4.4 Blood serum<\/span><\/h4>\n<div class=\"floatleft\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Blood_in_tubes_(9617266704).jpg\" class=\"image wiki-link\" data-key=\"bfa4da97d66b5ed2d52b381b8c5a9cfe\"><img alt=\"Blood in tubes (9617266704).jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/8\/82\/Blood_in_tubes_%289617266704%29.jpg\" decoding=\"async\" width=\"250\" height=\"188\" \/><\/a><\/div><p>Blood serum or serology assays come in three common varieties: LFA, enzyme-linked immunosorbent assay (ELISA), or neutralization assay.<sup id=\"rdp-ebb-cite_ref-JHSerology20_42-0\" class=\"reference\"><a href=\"#cite_note-JHSerology20-42\">[42]<\/a><\/sup> As discussed prior, LFAs are intended to be rapid point-of-care tools for qualitatively testing body fluids for patient antibodies or viral antigen. The ELISA is, in contrast, a more lab-bound method which produces results that are qualitative or quantitative. In the context of COVID-19 testing, ELISA tests for the presence of patient antibodies in a given specimen based upon whether or not an interaction is observed with the viral proteins present on the test plate. However, even if antibodies are present, ELISA isn't able to tell a clinician if those antibodies are able to protect against future infection. Neutralization assays are the lengthiest to complete, taking from three upwards to five days.<sup id=\"rdp-ebb-cite_ref-JHSerology20_42-1\" class=\"reference\"><a href=\"#cite_note-JHSerology20-42\">[42]<\/a><\/sup> This is largely due to the fact that the assay depends on culturing cells that encourage growth of the target virus. Afterwards, introduced patient antibodies, if present, will fight to prevent viral infection of cells. This process is performed in decreasing concentrations, giving the clinician an opportunity to \"visualize and quantify how many antibodies in the patient serum are able to block virus replication.\"<sup id=\"rdp-ebb-cite_ref-JHSerology20_42-2\" class=\"reference\"><a href=\"#cite_note-JHSerology20-42\">[42]<\/a><\/sup> In contrast to ELISA, a neutralization assay is able to determine if a patient's antibodies are actively fighting against the target virus, even after recovering from the infection. In November 2020, the FDA granted an EUA to the first ELISA-based serology test to detect nuetralizing antibodies from recent or prior SARS-CoV-2 infection.<sup id=\"rdp-ebb-cite_ref-FDACoronaNeut20_43-0\" class=\"reference\"><a href=\"#cite_note-FDACoronaNeut20-43\">[43]<\/a><\/sup>\n<\/p><p>Johns Hopkins' Center for Health Security <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.centerforhealthsecurity.org\/covid-19TestingToolkit\/serology\/Serology-based-tests-for-COVID-19.html\" target=\"_blank\">appears to be tracking<\/a> serology-based COVID-19 tests that are in development or have been approved in various parts of the globe. However, for the most up-to-date list of serology tests that have received EUAs in the United States, the FDA's <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/medical-devices\/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\/in-vitro-diagnostics-euas-serology-and-other-adaptive-immune-response-tests-sars-cov-2\" target=\"_blank\">EUA list<\/a> appears to be the best source. As of September 2021, the FDA shows 88 serology assays approved for diagnostic use in the U.S. Of those 88, sixteen are explicitly listed as being ELISA-based.\n<\/p><p>A review of Johns Hopkins' tracking list showed more LFA-based tests among those approved in other parts of the world. Among their list of those still in development, an LFA stands out for integrating CRISPR detection.<sup id=\"rdp-ebb-cite_ref-MBAProto20_44-0\" class=\"reference\"><a href=\"#cite_note-MBAProto20-44\">[44]<\/a><\/sup> CRISPR (clustered regularly interspaced short palindromic repeats) represents bacterial and archaeal DNA sequences derived from DNA fragments of previous infection. This genetic material can then be used as an activator of biomarkers when attached RNA \"guides\" find a match with target viral RNA in patient specimen.<sup id=\"rdp-ebb-cite_ref-NatureCRISPR18_45-0\" class=\"reference\"><a href=\"#cite_note-NatureCRISPR18-45\">[45]<\/a><\/sup> This CRISPR-based LFA, called DETECTR, was further described in a paper published in October 2020, with the authors concluding it could be used \"as a complementary technically independent approach to qRT-PCR, thereby increasing the testing capacity of medical microbiological laboratories and relieving the existent PCR-platforms for routine non-SARS-CoV-2 diagnostic testing.\"<sup id=\"rdp-ebb-cite_ref-BrandsmaRapid20_46-0\" class=\"reference\"><a href=\"#cite_note-BrandsmaRapid20-46\">[46]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.4.5_Antigen_tests\">2.4.5 Antigen tests<\/span><\/h4>\n<p>An antigen is a substance\u2014often a protein but may also be an environmental like a virus\u2014that provokes the immune system to produce an antibody against it.<sup id=\"rdp-ebb-cite_ref-MPAntigen_47-0\" class=\"reference\"><a href=\"#cite_note-MPAntigen-47\">[47]<\/a><\/sup> As such, another approach to testing for the presence of a virus in a specimen is to test for the antigen rather than the antibody. An antigen test is useful as a repeated surveillance test, but it has drawbacks as a one-time diagnostic test.<sup id=\"rdp-ebb-cite_ref-Anderson5Invest20_48-0\" class=\"reference\"><a href=\"#cite_note-Anderson5Invest20-48\">[48]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ServiceRadical2020_49-0\" class=\"reference\"><a href=\"#cite_note-ServiceRadical2020-49\">[49]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KremerUWSys20_50-0\" class=\"reference\"><a href=\"#cite_note-KremerUWSys20-50\">[50]<\/a><\/sup> For COVID-19 and other viral infections, an antigen test has the advantage that specimen collection can typically be done with a simple nasal swab rather than a more invasive <a href=\"https:\/\/www.limswiki.org\/index.php\/Nasopharyngeal_swab\" title=\"Nasopharyngeal swab\" class=\"wiki-link\" data-key=\"18d5d4e09d1fc5ddb05a22b36ace9daf\">nasopharyngeal swab<\/a>. Another advantage, on one hand, is that antigen testing is more rapid and convenient because the extraction and amplification steps of PCR are not used. On the other, antigen testing is less sensitive for the same reason: you test only what's there (rather than amplifying the amount for greater sensitivity).<sup id=\"rdp-ebb-cite_ref-ServiceRadical2020_49-1\" class=\"reference\"><a href=\"#cite_note-ServiceRadical2020-49\">[49]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GuglielmiTheExp20_51-0\" class=\"reference\"><a href=\"#cite_note-GuglielmiTheExp20-51\">[51]<\/a><\/sup>\n<\/p><p>A theory increasingly gaining traction, however, is that \"[a] higher frequency of testing makes up for poor sensitivity.\u201d<sup id=\"rdp-ebb-cite_ref-ServiceRadical2020_49-2\" class=\"reference\"><a href=\"#cite_note-ServiceRadical2020-49\">[49]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KremerUWSys20_50-1\" class=\"reference\"><a href=\"#cite_note-KremerUWSys20-50\">[50]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ClarkCOVID20_52-0\" class=\"reference\"><a href=\"#cite_note-ClarkCOVID20-52\">[52]<\/a><\/sup> Several researchers have shared pre-print and published research suggesting this outcome<sup id=\"rdp-ebb-cite_ref-ServiceRadical2020_49-3\" class=\"reference\"><a href=\"#cite_note-ServiceRadical2020-49\">[49]<\/a><\/sup>:\n<\/p>\n<blockquote><p>Larremore and his colleagues have modeled the benefits of more frequent tests, even ones that are less accurate than today\u2019s. Fast tests repeated every three days, with isolation of people who test positive, prevents 88% of viral transmission compared with no tests; a more sensitive test used every two weeks reduced viral transmission by about 40%, they report in a 27 June preprint on medRxiv. Paltiel and his colleagues reached much the same conclusion when they modeled a variety of testing regimes aimed at safely reopening a 5000-student university. In a 31 July paper in JAMA Network Open, they found that, with 10 students infected at the start of the semester, a test that identified only 70% of positive cases, given to every student every two days, could limit the number of infections to 28 by the end of the semester. Screening every seven days allowed greater viral spread, with the model predicting 108 infections.<\/p><\/blockquote>\n<p>As such, the utility of antigen testing, despite its lower sensitivity, appears to be surveillance situations where a large group of individuals who are at risk can be screened at regularly scheduled intervals of two to four days. The end result, in theory, would be few people who are target-positive would be missed, positives could be isolated and verified with a more sensitive test, and more target-positive people would be identified and isolated before reaching peak infectivity.<sup id=\"rdp-ebb-cite_ref-ServiceRadical2020_49-4\" class=\"reference\"><a href=\"#cite_note-ServiceRadical2020-49\">[49]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CourageCovid20_53-0\" class=\"reference\"><a href=\"#cite_note-CourageCovid20-53\">[53]<\/a><\/sup> To be clear, it's not a perfect solution, but as Harvard epidemiologist Michael Mina and Boston University economist Laurence Kotlikoff suggest, \"[w]e need the best means of detecting and containing the virus, not a perfect test no one can use.\"<sup id=\"rdp-ebb-cite_ref-CourageCovid20_53-1\" class=\"reference\"><a href=\"#cite_note-CourageCovid20-53\">[53]<\/a><\/sup> In August 2020, a coalition of six U.S. state governors bought into that concept and agreed to work together with the Rockefeller Foundation, as well as the Quidel Corporation and Becton, Dickinson and Company, which had received FDA EUAs to market antigen tests for SARS-CoV-2.<sup id=\"rdp-ebb-cite_ref-ClarkCOVID20_52-1\" class=\"reference\"><a href=\"#cite_note-ClarkCOVID20-52\">[52]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MervoshItsLike20_54-0\" class=\"reference\"><a href=\"#cite_note-MervoshItsLike20-54\">[54]<\/a><\/sup> As of September 2021, thirty-four FDA EUAs for antigen tests have been issues; 28 of those 34 include allowances for CLIA-waived testing, and 10 were authorized for home use.<sup id=\"rdp-ebb-cite_ref-FDAInVitroAntigen21_55-0\" class=\"reference\"><a href=\"#cite_note-FDAInVitroAntigen21-55\">[55]<\/a><\/sup>\n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.4.6_Testing_alternatives_and_challenges\">2.4.6 Testing alternatives and challenges<\/span><\/h4>\n<blockquote><p><i>We\u2019ve never faced this before, where clinical labs needed to very quickly be able to ramp up a test so fast.<\/i><sup id=\"rdp-ebb-cite_ref-TerryCRISPR20_56-0\" class=\"reference\"><a href=\"#cite_note-TerryCRISPR20-56\">[56]<\/a><\/sup><br \/> <br \/>- Jennifer Doudna, Executive Director of the Innovative Genomics Institute, University of California, Berkeley<\/p><\/blockquote>\n<p>Though the dismantling and fund-cutting (proposed and real) of government programs designed to protect the populace from pandemics\u2014as well as shortfalls in funding overall<sup id=\"rdp-ebb-cite_ref-SandsTheNeglect16_57-0\" class=\"reference\"><a href=\"#cite_note-SandsTheNeglect16-57\">[57]<\/a><\/sup>\u2014have likely hobbled local, national, and global response to COVID-19<sup id=\"rdp-ebb-cite_ref-MorrisTrump20_58-0\" class=\"reference\"><a href=\"#cite_note-MorrisTrump20-58\">[58]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SpecterTheCorona20_59-0\" class=\"reference\"><a href=\"#cite_note-SpecterTheCorona20-59\">[59]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RoosCongress07_60-0\" class=\"reference\"><a href=\"#cite_note-RoosCongress07-60\">[60]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SchnirringCongress07_61-0\" class=\"reference\"><a href=\"#cite_note-SchnirringCongress07-61\">[61]<\/a><\/sup>, it should be recognized that this pandemic may arguably represent a once-in-a-century type of event.<sup id=\"rdp-ebb-cite_ref-GatesRespond20_62-0\" class=\"reference\"><a href=\"#cite_note-GatesRespond20-62\">[62]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ShontellMelinda20_63-0\" class=\"reference\"><a href=\"#cite_note-ShontellMelinda20-63\">[63]<\/a><\/sup> That said, even the most well-prepared governments would still face challenges in quickly learning about, controlling, and developing therapies for a novel disease agent. Shortages in supplies, workers, funding, and other resources are inevitably caused with a pandemic as people across all types of infrastructure fall ill.<sup id=\"rdp-ebb-cite_ref-SandsTheNeglect16_57-1\" class=\"reference\"><a href=\"#cite_note-SandsTheNeglect16-57\">[57]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MadhavPandemics17_64-0\" class=\"reference\"><a href=\"#cite_note-MadhavPandemics17-64\">[64]<\/a><\/sup> This requires the additional human elements of adaptability, drive, and shared knowledge to find new and alternative solutions to fighting the challenges inherent to fighting against a novel disease.\n<\/p><p>See for example a non-peer-reviewed paper published on <i>bioRxiv<\/i> in early April 2020, where Schmid-Burgk <i>et al.<\/i> pointed out that though RT-PCR methods are the most common for currently testing for SARS-CoV-2, \"global capacity for testing using these approaches, however, has been limited by a combination of access and supply issues for reagents and instruments.\" They proposed \"a novel protocol that would allow for population-scale testing using massively parallel RT-LAMP by employing sample-specific barcodes.\" They claimed that a single heating step, pooled processing, and parallel sequencing with computational analysis would allow for the testing and tacking of \"tens of millions of samples.\" Though the protocol was not validated with clinical samples, and concerns about sensitivity levels of RT-LAMP (an isothermal nucleic acid amplification technique that allows for RNA amplification) have been raised, the authors' work exemplifies the immediacy and ingenuity that has gone into finding workable solutions to a once-a-century problem.<sup id=\"rdp-ebb-cite_ref-Schmid-BurgkLAMP20_37-1\" class=\"reference\"><a href=\"#cite_note-Schmid-BurgkLAMP20-37\">[37]<\/a><\/sup>\n<\/p><p>Another example of ingenuity in the face of difficult circumstances can be found at the University of California, Berkeley. At the beginning of the pandemic, its Innovative Genomics Institute (IGI) rapidly repurposed a 2,500-square-foot scientific lab into an automated diagnostic laboratory that could initially process more than 1,000 patient samples per day, with the ability to ramp up to 3,000 per day thanks to robotics and a streamlined workflow. Partnering with dozens of people from Thermo Fisher Scientific, Salesforce, Third Wave Analytics, and Hamilton Corp., the lab focused on not only turnaround time but also accuracy of results through automation. Their continued success, of course, still relies on a steady supply of reagents and related supplies from Thermo Fisher.<sup id=\"rdp-ebb-cite_ref-TerryCRISPR20_56-1\" class=\"reference\"><a href=\"#cite_note-TerryCRISPR20-56\">[56]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SandersUCBerk20_65-0\" class=\"reference\"><a href=\"#cite_note-SandersUCBerk20-65\">[65]<\/a><\/sup>\n<\/p><p>Since the pandemic's start, others have also expressed concerns about the global supply of reagents necessary to test for SARS-CoV-2. Successful testing using RT-PCR requires two different enzymes: reverse transcriptase, for converting RNA to DNA, and polymerase, for amplifying the converted DNA. These enzymes and other reagent components may be instrument-specific, and at least one component has to be sympathetic to detection of the target virus' RNA. Little of this can be prepared without a proper sequence of the virus in question. Dr. Ronald Leonard, president and medical director of Cytocheck Laboratory and medical director of the Labette Health hospital, expressed the difficulties associated with reagent manufacturing thusly<sup id=\"rdp-ebb-cite_ref-NoltingLocal20_66-0\" class=\"reference\"><a href=\"#cite_note-NoltingLocal20-66\">[66]<\/a><\/sup>:\n<\/p>\n<blockquote><p>With the instant demand for SARS-CoV-2 testing, the manufacturing process had to start from scratch for the SARS-CoV-2 specific components, and this did cause a lag time before reagents were available. The increased demand coupled with the decision to only allocate reagents to two national laboratories, some state health departments, and to \"hot spots\" has compounded the difficulty for laboratories like ours to obtain the necessary reagents to perform the testing.<\/p><\/blockquote>\n<p>Reports of COVID-19 test reagent shortages from various sources have appeared since March 2020.<sup id=\"rdp-ebb-cite_ref-HerperShortage20_67-0\" class=\"reference\"><a href=\"#cite_note-HerperShortage20-67\">[67]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HaleQiagen20_68-0\" class=\"reference\"><a href=\"#cite_note-HaleQiagen20-68\">[68]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MehtaMystery20_69-0\" class=\"reference\"><a href=\"#cite_note-MehtaMystery20-69\">[69]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RocheIrish20_70-0\" class=\"reference\"><a href=\"#cite_note-RocheIrish20-70\">[70]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PadmaEfforts20_71-0\" class=\"reference\"><a href=\"#cite_note-PadmaEfforts20-71\">[71]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DavidSurvey20_72-0\" class=\"reference\"><a href=\"#cite_note-DavidSurvey20-72\">[72]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-JohnsonNCLabs20_73-0\" class=\"reference\"><a href=\"#cite_note-JohnsonNCLabs20-73\">[73]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MervoshItsLike20_54-1\" class=\"reference\"><a href=\"#cite_note-MervoshItsLike20-54\">[54]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CourageCovid20_53-2\" class=\"reference\"><a href=\"#cite_note-CourageCovid20-53\">[53]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ASMSupply20_74-0\" class=\"reference\"><a href=\"#cite_note-ASMSupply20-74\">[74]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AbbottCovid20_75-0\" class=\"reference\"><a href=\"#cite_note-AbbottCovid20-75\">[75]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WilliamsSupply21_76-0\" class=\"reference\"><a href=\"#cite_note-WilliamsSupply21-76\">[76]<\/a><\/sup> Over time, those shortages even extended to supplies for non-COVID-19 tests such as those for strep throat, bronchitis, mycobacterial infections, urinary-tract infections, fungal infections, and sexually transmitted infections.<sup id=\"rdp-ebb-cite_ref-ASMSupply20_74-1\" class=\"reference\"><a href=\"#cite_note-ASMSupply20-74\">[74]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AbbottCovid20_75-1\" class=\"reference\"><a href=\"#cite_note-AbbottCovid20-75\">[75]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WilliamsSupply21_76-1\" class=\"reference\"><a href=\"#cite_note-WilliamsSupply21-76\">[76]<\/a><\/sup> In the face of these supply challenges, some have taken matters into their own hands. Noting Irish laboratories' difficulties sourcing lysis buffer (for isolating molecules of interest and keeping them stable), Cork Institute of Technology's Dr. Brigid Lucey worked with several other virologists and microbiologists early in the pandemic, as well as with pharmaceutical company Eli Lilly, to produce a custom-formulated yet high-quality lysis buffer for not only Irish laboratories but also other countries can take advantage of. \"We are happy to share what we found with other countries and it\u2019s important our scientists retain their skills to make this kind of formulation because we may need to do this again in the future if we get other pandemics,\" she said.<sup id=\"rdp-ebb-cite_ref-RocheIrish20_70-1\" class=\"reference\"><a href=\"#cite_note-RocheIrish20-70\">[70]<\/a><\/sup>\n<\/p><p>Another challenge lies in the accuracy of serology-based antibody tests, let alone how much they actually tell us about immunity. FierceBiotech's Conor Hale touched upon this in late April 2020<sup id=\"rdp-ebb-cite_ref-HaleCongress20_77-0\" class=\"reference\"><a href=\"#cite_note-HaleCongress20-77\">[77]<\/a><\/sup>:\n<\/p>\n<blockquote><p>Compared to molecular tests\u2014which sequence and match the RNA of the novel coronavirus to produce a result\u2014the FDA has described antibody tests that gauge the body\u2019s immune system response as a less-complicated endeavor that could proceed without review, dubbed \u201cregulatory flexibility\u201d by Commissioner Stephen Hahn. This policy shift has led to confusion, with some antibody test developers falsely claiming their tests are FDA-approved or could diagnose COVID-19 at home. Still others have sold outrightly fraudulent tests online.<\/p><\/blockquote>\n<p>At least in the U.S., these problems are compounded by company participation in test validation of EUAs being voluntary.<sup id=\"rdp-ebb-cite_ref-HaleCongress20_77-1\" class=\"reference\"><a href=\"#cite_note-HaleCongress20-77\">[77]<\/a><\/sup> As a late April 2020 memorandum from Congress put it: \"FDA is unable to validate the accuracy of antibody tests that are already on the market, and companies are ignoring requests from the Department of Health and Human Services (HHS) to voluntarily submit their tests for validation ... FDA has failed to police the coronavirus serological antibody test market, has taken no public enforcement action against any company, and has not conveyed any clear policy on serological tests...\"<sup id=\"rdp-ebb-cite_ref-SORPremim20_78-0\" class=\"reference\"><a href=\"#cite_note-SORPremim20-78\">[78]<\/a><\/sup> The entire memorandum is revealing in the challenges of attempting to relax social distancing measures under the pretense of the effectiveness of antibody testing. Entities such as the University of California - San Francisco<sup id=\"rdp-ebb-cite_ref-FarleyTesting20_79-0\" class=\"reference\"><a href=\"#cite_note-FarleyTesting20-79\">[79]<\/a><\/sup> and the University of California - Berkeley<sup id=\"rdp-ebb-cite_ref-SandersWhat20_80-0\" class=\"reference\"><a href=\"#cite_note-SandersWhat20-80\">[80]<\/a><\/sup> early on emphasized the importance of elements such as sensitivity, specificity, proper training, and the unknowns of the predictive ability of the test. Even assays running under trusted platforms such as PCR can reveal issues. For example, Thermo Fisher Scientific's TaqPath COVID019 Combo Kit, approved for EUA in March 2020, received scrutiny and updates to address issues with false-positive and -negative results<sup id=\"rdp-ebb-cite_ref-WhooleyFDA20_81-0\" class=\"reference\"><a href=\"#cite_note-WhooleyFDA20-81\">[81]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-TaylorThermo20_82-0\" class=\"reference\"><a href=\"#cite_note-TaylorThermo20-82\">[82]<\/a><\/sup>, highlighting the difficulty of, at least early on in the pandemic, balancing the need for rapidly approving test kits for emergency use while also maintaining some semblance of oversight regarding their effectiveness and proper use. This has been further hampered by an August 2020 decision that stated the FDA could not require laboratory developed tests (LDTs) to be submitted for an EUA. As the Pew Charitable Trust's Liz Richardson argued in September 2021, reversing this decision \"would enable labs to continue bringing innovative and effective new tests to market quickly while empowering FDA to protect the public from faulty products that allow infection to spread.\"<sup id=\"rdp-ebb-cite_ref-RichardsonWith21_83-0\" class=\"reference\"><a href=\"#cite_note-RichardsonWith21-83\">[83]<\/a><\/sup>\n<\/p><p>Finally, while point-of-care testing, including at-home testing, has made strides in 2021<sup id=\"rdp-ebb-cite_ref-FDAInVitroAntigen21_55-1\" class=\"reference\"><a href=\"#cite_note-FDAInVitroAntigen21-55\">[55]<\/a><\/sup>, their need remains apparent. Dozens of at-home tests remained in development (many of them antigen tests) at the end of 2020, and even now a major barrier is found in making them both accurate and easy for untrained people to understand and use.<sup id=\"rdp-ebb-cite_ref-WanHome20_84-0\" class=\"reference\"><a href=\"#cite_note-WanHome20-84\">[84]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-McDermottInner20_85-0\" class=\"reference\"><a href=\"#cite_note-McDermottInner20-85\">[85]<\/a><\/sup> And as more at-home tests continue to receive EUAs in 2021, they are still not without concern, particularly in regards to ensuring that at-home test results get reported properly and rapidly.<sup id=\"rdp-ebb-cite_ref-WanHome20_84-1\" class=\"reference\"><a href=\"#cite_note-WanHome20-84\">[84]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Crear-PerryTheHidden20_86-0\" class=\"reference\"><a href=\"#cite_note-Crear-PerryTheHidden20-86\">[86]<\/a><\/sup> One such early example at the end of 2020 was Lucira Health's LAMP-based Lucira COVID-19 All-In-One Test Kit, which was approved as a prescription-based at-home test, but with the stipulation that the prescribing healthcare provider would be responsible for reporting results.<sup id=\"rdp-ebb-cite_ref-RomoFDAApproves20_36-1\" class=\"reference\"><a href=\"#cite_note-RomoFDAApproves20-36\">[36]<\/a><\/sup> Such a requirement arguably can and should be put in place for at-home antigen-based testing as well.<sup id=\"rdp-ebb-cite_ref-WanHome20_84-2\" class=\"reference\"><a href=\"#cite_note-WanHome20-84\">[84]<\/a><\/sup>\n<\/p><p>As the pandemic churns through its second year, it's more important than ever for leaders across government, healthcare, and the media to continue to not spread misinformation and not make decisions based on poor scientific evidence. It will take organized efforts from multiple stakeholders\u2014such as that found with a June 2020 NIH workshop on expanding and improving COVID-19 antibody tests<sup id=\"rdp-ebb-cite_ref-NIHExperts20_87-0\" class=\"reference\"><a href=\"#cite_note-NIHExperts20-87\">[87]<\/a><\/sup>\u2014to continue to find responsible solutions to the challenges we still face with this pandemic.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-MadrigalPrivate20-1\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-MadrigalPrivate20_1-0\">1.0<\/a><\/sup> <sup><a href=\"#cite_ref-MadrigalPrivate20_1-1\">1.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Madrigal, A.C.; Meyer, R. 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(2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7665660\" target=\"_blank\">\"Rapid, sensitive and specific SARS coronavirus-2 detection: A multi-center comparison between standard qRT-PCR and CRISPR based DETECTR\"<\/a>. <i>The Journal of Infectious Diseases<\/i> <b>In Print<\/b>: jiaa641. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1093%2Finfdis%2Fjiaa641\" target=\"_blank\">10.1093\/infdis\/jiaa641<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7665660\/\" target=\"_blank\">PMC7665660<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/33038252\" target=\"_blank\">33038252<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7665660\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7665660<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Rapid%2C+sensitive+and+specific+SARS+coronavirus-2+detection%3A+A+multi-center+comparison+between+standard+qRT-PCR+and+CRISPR+based+DETECTR&rft.jtitle=The+Journal+of+Infectious+Diseases&rft.aulast=Brandsma%2C+E.%3B+Verhagen%2C+H.J.M.P.%3B+van+de+Laar%2C+T.J.W.+et+al.&rft.au=Brandsma%2C+E.%3B+Verhagen%2C+H.J.M.P.%3B+van+de+Laar%2C+T.J.W.+et+al.&rft.date=2020&rft.volume=In+Print&rft.pages=jiaa641&rft_id=info:doi\/10.1093%2Finfdis%2Fjiaa641&rft_id=info:pmc\/PMC7665660&rft_id=info:pmid\/33038252&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7665660&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Current_test_methods_and_their_differences\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MPAntigen-47\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MPAntigen_47-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/medlineplus.gov\/ency\/article\/002224.htm\" target=\"_blank\">\"Antigen\"<\/a>. <i>MedlinePlus<\/i>. 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(2016). \"The Neglected Dimension of Global Security \u2014 A Framework for Countering Infectious-Disease Crises\". <i>The New England Journal of Medicine<\/i> <b>374<\/b> (13): 1281\u201387. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1056%2FNEJMsr1600236\" target=\"_blank\">10.1056\/NEJMsr1600236<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/26761419\" target=\"_blank\">26761419<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Neglected+Dimension+of+Global+Security+%E2%80%94+A+Framework+for+Countering+Infectious-Disease+Crises&rft.jtitle=The+New+England+Journal+of+Medicine&rft.aulast=Sands%2C+P.%3B+Mundaca-Shah%2C+C.%3B+Dzau%2C+V.J.&rft.au=Sands%2C+P.%3B+Mundaca-Shah%2C+C.%3B+Dzau%2C+V.J.&rft.date=2016&rft.volume=374&rft.issue=13&rft.pages=1281%E2%80%9387&rft_id=info:doi\/10.1056%2FNEJMsr1600236&rft_id=info:pmid\/26761419&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Current_test_methods_and_their_differences\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MorrisTrump20-58\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MorrisTrump20_58-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Morris, C. 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(2017). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK525302\/\" target=\"_blank\">\"Chapter 17: Pandemics: Risks, Impacts, and Mitigation\"<\/a>. In Jamison, D.T.; Gelband, H.; Horton, S. et al.. <i>Disease Control Priorities: Improving Health and Reducing Poverty<\/i> (3rd ed.). 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Retrieved 01 May 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Congress+urges+FDA+to+better+police%2C+evaluate+COVID-19+antibody+tests&rft.atitle=Fierce+Biotech&rft.aulast=Hale%2C+C.&rft.au=Hale%2C+C.&rft.date=27+April+2020&rft_id=https%3A%2F%2Fwww.fiercebiotech.com%2Fmedtech%2Fcongress-urges-fda-to-better-police-evaluate-covid-19-antibody-tests&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Current_test_methods_and_their_differences\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SORPremim20-78\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SORPremim20_78-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Subcommittee on Economic and Consumer Policy (24 April 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/oversight.house.gov\/sites\/democrats.oversight.house.gov\/files\/ECP%20Staff%20Report%20on%20Preliminary%20Findings%20of%20the%20Subcommittee%E2%80%99s%20Coronavirus%20Antibody%20Testing%20Investigation.pdf\" target=\"_blank\">\"Preliminary Findings of the Subcommittee\u2019s Coronavirus Antibody Testing Investigation\"<\/a> (PDF). U.S. House of Representatives<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/oversight.house.gov\/sites\/democrats.oversight.house.gov\/files\/ECP%20Staff%20Report%20on%20Preliminary%20Findings%20of%20the%20Subcommittee%E2%80%99s%20Coronavirus%20Antibody%20Testing%20Investigation.pdf\" target=\"_blank\">https:\/\/oversight.house.gov\/sites\/democrats.oversight.house.gov\/files\/ECP%20Staff%20Report%20on%20Preliminary%20Findings%20of%20the%20Subcommittee%E2%80%99s%20Coronavirus%20Antibody%20Testing%20Investigation.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 01 May 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Preliminary+Findings+of+the+Subcommittee%E2%80%99s+Coronavirus+Antibody+Testing+Investigation&rft.atitle=&rft.aulast=Subcommittee+on+Economic+and+Consumer+Policy&rft.au=Subcommittee+on+Economic+and+Consumer+Policy&rft.date=24+April+2020&rft.pub=U.S.+House+of+Representatives&rft_id=https%3A%2F%2Foversight.house.gov%2Fsites%2Fdemocrats.oversight.house.gov%2Ffiles%2FECP%2520Staff%2520Report%2520on%2520Preliminary%2520Findings%2520of%2520the%2520Subcommittee%25E2%2580%2599s%2520Coronavirus%2520Antibody%2520Testing%2520Investigation.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Current_test_methods_and_their_differences\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FarleyTesting20-79\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FarleyTesting20_79-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Farley, P.; Sanders, R. 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Retrieved 08 July 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Experts+identify+steps+to+expand+and+improve+antibody+tests+in+COVID-19+response&rft.atitle=News+Releases&rft.aulast=National+Institutes+of+Health&rft.au=National+Institutes+of+Health&rft.date=23+June+2020&rft_id=https%3A%2F%2Fwww.nih.gov%2Fnews-events%2Fnews-releases%2Fexperts-identify-steps-expand-improve-antibody-tests-covid-19-response&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Current_test_methods_and_their_differences\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<p><br \/>\n<\/p>\n<div align=\"center\">-----Go to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_workflow_management\" title=\"Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Workflow and information management for COVID-19 (and other respiratory diseases)\/Laboratory informatics and workflow management\" class=\"wiki-link\" data-key=\"ca4c291ccc7893b51eae4a43ed892dc8\">the next chapter<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"Citation_information_for_this_chapter\">Citation information for this chapter<\/span><\/h2>\n<p><b>Chapter<\/b>: 2. Diagnostic testing of COVID-19 and other coronaviruses\n<\/p><p><b>Edition<\/b>: Fall 2021\n<\/p><p><b>Title<\/b>: <i>COVID-19 Testing, Reporting, and Information Management in the Laboratory<\/i>\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: September 2021\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20210919172450\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.572 seconds\nReal time usage: 0.652 seconds\nPreprocessor visited node count: 62537\/1000000\nPost\u2010expand include size: 521245\/2097152 bytes\nTemplate argument size: 189389\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 163057\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 536.281 1 -total\n 91.01% 488.046 1 Template:Reflist\n 77.15% 413.749 87 Template:Citation\/core\n 66.22% 355.145 71 Template:Cite_web\n 15.13% 81.126 68 Template:Date\n 13.48% 72.306 14 Template:Cite_journal\n 8.98% 48.134 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Current_test_methods_and_their_differences\n 4.68% 25.094 139 Template:Citation\/make_link\n 2.78% 14.919 30 Template:Citation\/identifier\n 2.24% 12.022 2 Template:Cite_book\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11914-0!canonical and timestamp 20210919172451 and revision id 44135. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Current_test_methods_and_their_differences\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Current_test_methods_and_their_differences<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","39cacf950c52c601724e17a6099cf057_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/8\/82\/Blood_in_tubes_%289617266704%29.jpg"],"39cacf950c52c601724e17a6099cf057_timestamp":1632073385,"9618f22c10f370a964cc84bac6d8f3a5_type":"article","9618f22c10f370a964cc84bac6d8f3a5_title":"2.3 Organizational and agency guidance on COVID-19 testing","9618f22c10f370a964cc84bac6d8f3a5_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing","9618f22c10f370a964cc84bac6d8f3a5_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Diagnostic testing of COVID-19 and other coronaviruses\/Organizational and agency guidance on COVID-19 testingFrom LIMSWikiJump to navigationJump to search2.3 Organizational and agency guidance on COVID-19 testing \nNOTE: Information shown here may rapidly become outdated given how quickly response to pandemic testing can change. A full attempt to keep the content relevant will be made. \n\n CDC 2019-nCoV Real-time RT-PCR Panel (Research Use Only)Early in the COVID-19 pandemic, laboratory guidance for testing for SARS-CoV-2 was relatively quick to evolve. The timely development and organized use of accurate assays and meaningful screening protocols, however, has been inconsistent but improving worldwide, with some countries more urgently and agilely responding than others.[1][2][3] With any novel virus, clinicians and public health experts are dealing with unknown factors. However, public health organizations and agencies have had a base to work from when creating laboratory testing guidance for a novel coronavirus, with more than 40 years of experience with coronavirus biology, pathogenesis, and diagnosis.[4] And while there are fundamental differences between SARS-CoV-2 and its predecessor SARS-CoV, they still share approximately 70 to 80 percent of their genetic code.[5][6] In fact, the WHO had draft guidance for laboratory testing out as early as January 10, 2020, before gene sequencing was even completed.[7] This guidance and similar draft guidance from national public health organizations and agencies have received steady revisions since as understanding of the virus has grown.\nSimilar to its predecessors SARS-CoV and MERS-CoV, RT-PCR has largely been the predominant diagnostic method used in guidance for detecting SARS-CoV-2's RNA in specimens and thus laboratory confirmation of COVID-19 cases. Other diagnostic methods such as isothermal amplification (e.g., LAMP) and antigen testing have also emerged as the pandemic has progressed. Serology has its place in testing as well, though with similar lessons from SARS and MERS that it's best used to test for past infection (typically after 14 days of suspected contact with a carrier, or mild symptoms) and thus potential short-term immunity due to the presence of antibodies in blood. It also has other uses; in its September 2020 guidance, the WHO said: \"If negative NAAT results are obtained from a patient in whom SARS-CoV-2 infection is strongly suspected, a paired serum specimen could be collected.\"[8] On April 3, the U.S. Food and Drug Administration (FDA) approved the country's first COVID-19 serology test, created by Cellex, though Mayo Clinic was also on the verge of rolling out its own in-house serology test as well[9] As of September 2021, the U.S. FDA has granted emergency use authorizations (EUA) for 88 serology\/antibody tests.[10] (Note: Johns Hopkins also appears to be maintaining a page tracking approved serology tests around the world.) \nPrimary testing guidance\nThe following sample collection and test procedures have evolved from the COVID-19 pandemic (note that this is only a summary; consult the cited literature directly for full details)[8][11][12][13][14]:\n\nDetermine that the patient is indicating clinical and\/or epidemiological evidence of COVID-19 (meets case definitions). Early on in the pandemic, case definitions and testing criteria were initially strict due to lack of test kits[15][16][17], but test kit availability has ramped up since, allowing for testing a wider group of symptomatic patients, as well as asymptomatic patients. However, clinicians are still encouraged to consider other causes for respiratory illness.[11]\nCollect at a minimum an upper respiratory tract (URT) specimen. Some guidance like that found in the U.K. also suggests collecting lower respiratory tract (LRT) specimens, whenever possible.[13] Broadly, it appears lower respiratory tract specimens such as sputum and bronchoalveolar lavage fluid are a more reliable specimen type for RT-PCR applications, as they have been shown to contain the highest viral load, in comparison to upper respiratory tract specimens.[18][19] In most cases, a URT will be sufficient; however, an LRT is especially useful when a patient tests negative with a URT but is still high suspicious of having COVID-19. Yet, as Wang et al. point out, \"testing of specimens from multiple sites may improve the sensitivity and reduce false-negative test results,\"[18] which is largely reflected in WHO, CDC, Public Health England (PHE), and Public Health Laboratory Network (PHLN; Australia) testing guidance.\nSlight differences in upper respiratory tract specimen collection procedures can be found between the WHO\/CDC and PHE\/PHLN. Both the WHO and CDC offer nasopharyngeal and oropharyngeal swabs as options. The WHO doesn't appear to give a preference, whereas the CDC has a preference for nasopharyngeal swabs but maintains oropharyngeal as still remaining \"an acceptable specimen type.\"[12] In comparison, the latest PHE and PHLN guidance prefer the approach of collecting from both pharynx locations\u2014even with the same swab\u2014\"to optimize the chances of virus detection.\"[14] Nasopharyngeal aspiration is also an acceptable sample collection method for the upper respiratory tract according to all mentioned entities except the PHLN, which appears to have removed mention of nasopharyngeal aspirate from its guidance sometime in 2021.[14]\nRegarding serum specimens, statements differ slightly. The WHO notes serology to be useful for retrospective case definition, using paired specimens from the acute and convalescent phases of the disease. The CDC doesn't make reference to serum or serology in their clinical specimen guidance. The PHE used to suggest hospital patients have \"a sample for acute serology\" taken, but that appears to have been removed from 2021 guidance.[13] The PHLN initially provided similar advice as the WHO, but in late April they expanded their guidance to discuss the value of serology.[14] They have also added collection recommendations for serology, in separate guidance, indicating that \"serological testing before two weeks from the onset of symptoms may result in false negative results.\"[20]\nFinally, and more recently, potential evidence of saliva having diagnostic value for detecting SARS-CoV-2 has arisen. Xu et al. noted in published April 2020 research that the \"diagnostic value of saliva specimens for ... nucleic acid examination remains limited but promising.\"[21] Another paper published in September 2020 provided similar thoughts, though was generally more optimistic than the paper published by Xu et al., suggesting saliva from the opening of the mouth (in contrast to Xu et al. and their finding of better results from saliva in the throat) may be viable specimen.[22] In fact, an April 2020 EUA by the FDA had been made for the first saliva-based COVID-19 test, produced by Vault Health, Inc.[23]\nAs these and similar studies have been peer reviewed and methods validated, saliva has increasingly looked like a viable sample type. The CDC updated their guidance in October 2020 regarding saliva as a testing substrate. The CDC now notes: \"Collect 1-5 ml of saliva in a sterile, leak-proof screw cap container. No preservative is required.\"[12] This is presumably in conjunction with tests approved for the use of saliva. Australia's PHLN updated their guidance in 2021 to include a full section on saliva testing and how to approach it, though cautioning it \"does not advise routine use of saliva for diagnostic testing except in specific situations.\"[14]\nConduct testing. NAAT methods like qRT-PCR have been the primary tools for diagnosing SARS-CoV-2 infection due to their high sensitivity. The PHLN provides the most background about PCR in their guidance, noting that \"RT-PCR or TMA are the methods of choice to detect SARS-CoV-2 during the acute illness.\"[14] Viral cultures are little mentioned, though the PHLN underscores the idea that viral cultures for routine diagnoses are \"of limited utility\" and, if attempted, should only be performed in Biosafety Level 3 (BSL-3) laboratories.[14] As of August 2020, only the PHLN has made any specific recommendations for how serological testing should be conducted for testing past cases of COVID-19.[14] The current set of approved serology tests from around the world appear to use lateral flow immunoassay, ELISA, or neutralization methods.[17] Also note that at least in the U.S., the FDA in October 2020 discontinued review and approval of laboratory developed tests (LDTs), in favor of tests that would be more likely to increase access to testing or overall test capacity.[24]\nConfirm the results. The WHO notes that optimally a positive result should come from a NAAT method \"with at least two independent targets on the SARS-CoV-2 genome.\" However, they recognize that \"in areas with widespread transmission of SARS-CoV-2, a simple algorithm might be adopted with one single discriminatory target,\" though monitoring of potential mutations is recommended.[8] Most guidance notes that if testing produces one or more negative results, that doesn't necessarily rule out SARS-CoV-2 infection. If suspicion of infection remains high, particularly if only upper respiratory tract specimens were collected, additional specimens from the lower respiratory tract should be collected and analyzed. They also emphasize that both external and internal controls should be applied to NAAT runs to limit the chance of incorrect results.\nReport using state and, if applicable, national reporting requirements. (See the next chapter for more on reporting.) Regardless of result, the final positive or negative laboratory confirmation should also be reported to state and national authorities. In the U.S., for example, this means reporting to the local or state health department using the CDC's COVID-19 Worksheet. In Canada, reports are sent to the Public Health Agency of Canada (PHAC) via their Coronavirus Diseases (COVID-19) Case Report Form.\nAdditional considerations for point-of-care testing and self-collection\nOne of the long-term goals of healthcare professionals, governments, and test kit manufacturers has been to develop and increase access to point-of-care (POC) testing solutions for COVID-19. This has come with many challenges, but it is largely being realized. The CDC continues to update its Guidance for SARS-CoV-2 Point-of-Care and Rapid Testing[25], and, after the first \"collect and test\" at-home kit\u2014the Lucira COVID-19 All-In-One Test Kit\u2014was approved by the FDA in November 2020[26], many more were eventually approved for emergency use.[27] However, while these easy-use or quick-result tests are promising and welcome, a few additional testing considerations come with them. For example, the CDC has indicated that though FDA-authorized POC tests are approved for symptomatic individuals, \"CLIA will temporarily allow CLIA-certified laboratories and other testing sites to use SARS-CoV-2 point-of-care and rapid antigen tests on asymptomatic people for the duration of the COVID-19 public health emergency.\"[25] Other recommendations include not reusing test devices or components, changing gloves at strategic points, and limiting opening of test materials until ready to begin testing.[25] \nIn some cases, such as drive-through testing sites, patient self-collection of a sample may be required. In these cases, it's vital that the patient is given clear and concise instructions on how to collect the sample before they begin the process. The American Association for Clinical Chemistry (AACC) notes that false-negative results are more likely with poor instruction and recommends healthcare providers provide patients with written or video instructions, along with any verbal instructions. Less invasive nasal swabs are typically being used in this case. During self-collection, the patient inserts the entire swab tip in one nasal cavity, makes four to five sweeping circles along the nasal wall for about 10 to 15 seconds, and then repeats the process in the opposite nostril.[28]\nIn the case of at-home test kits, instructions for sample collection and system use should be followed carefully. For example, the Lucira All-In-One Test Kit can be used in a CLIA-certified lab or \"for prescription home use,\" meaning a healthcare provide must approve a prescription in order for the patient can use the test at home. Additionally, the healthcare provider will still be held responsible for reporting the test results they receive from the patient using the kit at home.[29]\nMitigating risk associated with false negatives\nBefore moving on, words of caution should be issued in regard to any COVID-19 testing conducted: false-negative results can be problematic.[30][31] One of the primary reasons they are problematic is that it may leave an otherwise asymptomatic individual to continue to unknowingly spread the virus further. Those individuals may relax physical distancing measures and become lax with their mask wearing, affecting others outside the clinical setting. Inside a clinical setting, a patient with a false negative \"may be sent to the frontlines of care and inadvertently transmit the virus to patients and colleagues, further straining the already precarious ability of the health care system to respond to the pandemic.\"[31]\nIn a perspective piece published in Mayo Clinic Proceedings, West et al. of the Mayo Clinic offer four critical recommendations for society as we attempt to mitigate the risk associated with false negatives when performing clinical testing for COVID-19. Those recommendations are[31]:\n\n1. Continue protective and preventative measures inside and outside the testing facility. This includes efforts such as physical distancing, regular hand-washing, regular disinfection of surfaces, and adequate personal protective equipment (PPE) for clinical staff (as well as the encouragement of proper mask wearing by others).\n2. Develop and improve PCR and serological assays to be more sensitive and specific. The development and improvement process must include methodologically rigorous studies designed to limit the risk of biased results, as well as clearly reported test performance characteristics.\n3. Assess patients carefully for their potential risk level for being infected. Confidence in negative test results may need to be lowered for health care workers and individuals in other high-risk groups. In general, given the uncertainty around viral load, asymptomatic transmission, and other disease characteristics, caution should be used with negative results in general.\n4. Establish risk-based protocols for managing negative COVID-19 results. Truly low-risk individuals may not be a major concern when results come back negative. However, individuals in higher-risk categories may require more judicious protocols, e.g., delaying a return to a workplace (for self-isolation) despite receiving a negative and having no symptoms. (This may require a more sensitive follow-up test or at least a second negative in a repeat test, particularly among clinical workers.)\n2.3.1 Regulatory considerations: HIPAA and CLIA \n\n\r\n\nHIPAA\nThe Health Insurance Portability and Accountability Act (HIPAA) is a set of U.S. federal regulatory requirements that attempts to modernize the flow of healthcare information, stipulate how personally identifiable information (PII) (often referred to as \"protected health information\" or \"PHI\") maintained by healthcare providers and insurers should be protected from fraud and theft, and address limitations on healthcare insurance coverage in the U.S. HIPAA spans five sections or \"titles,\" mandating health care information access, portability, privacy, and security, as well as stipulations on medical savings accounts, group health insurance requirements, and other tax- and legal-status-related issues.\nNormally, HIPAA regulations would put strict requirements on how and when PII can be managed, used, shared, and stored. However, the COVID-19 pandemic has seen a relaxation of some of those requirements by the U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR). The HHS is currently maintaining a list of announcements, notifications, guidance documents, bulletins, and other resources as they relate to HIPAA and the public health emergency. Important notes pulled from that information reveal[32]:\n\nFamily, friends, and others identified by the patient as being involved in their care may receive PHI from a covered health care provider, particularly when they deem that sharing in the patient's best interest. Additionally, \"[a] covered entity also may share information about a patient as necessary to identify, locate, and notify family members, guardians, or anyone else responsible for the patient\u2019s care, of the patient\u2019s location, general condition, or death.\"\n\"Covered health care providers will not be subject to penalties for violations of the HIPAA Privacy, Security, and Breach Notification Rules that occur in the good faith provision of telehealth during the COVID-19 nationwide public health emergency. This Notification does not affect the application of the HIPAA Rules to other areas of health care outside of telehealth during the emergency.\" This exercising of enforcement discretion will last until OCR provides a notice otherwise. Telehealth should optimally be performed in a private setting, whenever possible, using non-public facing communication technologies. Providers should opt to use the most secure services possible, \"but will not be penalized for using less secure products in their effort to provide the most timely and accessible care possible to patients during the public health emergency.\"\nThe OCR extended its enforcement discretion to include business associates of covered health care providers, allowing them to share PHI data \"without risk of a HIPAA penalty.\" The OCR adds that \"[s]ome HIPAA business associates have been unable to timely participate in these efforts [to ensure the health and safety of the public] because their BAAs do not expressly permit them to make such uses and disclosures of PHI.\" Like the enforcement discretion of telehealth provision by covered health care providers, the business associate must still make a good-faith effort in the \"use or disclosure of the covered entity\u2019s PHI\" for public health and health oversight activities. Similarly, this exercising of enforcement discretion will last until OCR provides a notice otherwise.\nThe OCR also extended its enforcement discretion to include covered health care providers and business associates operating community-based COVID-19 testing sites (CBTS)\u2014\"which includes mobile, drive-through, or walk-up sites that only provide COVID-19 specimen collection or testing services to the public\"\u2014during the public health emergency. This enforcement discretion, however, \"does not apply to covered health care providers or their business associates when such entities are performing non-CBTS related activities, including the handling of PHI outside of the operation of a CBTS.\"\nAdditionally, the OCR extended its enforcement discretion to \"covered health care providers or their business associates in connection with the good faith use of online or web-based scheduling applications ... for the scheduling of individual appointments for COVID-19 vaccinations during the COVID-19 nationwide public health emergency.\"\n\"[T]he HIPAA Privacy Rule permits a covered entity to disclose the protected health information (PHI) of an individual who has been infected with, or exposed to, COVID-19, with law enforcement, paramedics, other first responders, and public health authorities1 without the individual\u2019s HIPAA authorization, in certain circumstances.\" OCR provides numerous examples, including: \"when the disclosure is needed to provide treatment,\" \"when such notification is required by law,\" when a public health authority must be notified \"to prevent or control spread of disease,\" \"when first responders may be at risk of infection,\" when preventing or lessening \"a serious and imminent threat to the health and safety of a person or the public,\" and when responding to a law enforcement inquiring concerning a lawfully detained inmate or other individual.\n\"The HIPAA Privacy Rule permits HIPAA covered entities (or their business associates on the covered entities\u2019 behalf) to use or disclose PHI for treatment, payment, and health care operations, among other purposes, without an individual\u2019s authorization.\" ICR provides more details in its guidance, noting however that reasonable effort must still be made to protect PHI, and that this does not apply to activities that constitute marketing.\nSimilarly, the HIPAA Privacy Rule \"permits covered entities or their business associates to disclose PHI to [a health information exchange (HIE)] for the HIE to report PHI to a [public health authority (PHA)] conducting public health activities\" in a variety of circumstances. For more on those circumstances, see the December 2020 guidance].\nThe public health emergency does not change restrictions on disclosing PHI to the media. This includes the prohibition of media crews in, for example, emergency departments where COVID-19 patients are being treated, as PHI is found everywhere in that setting. Only when every patient who is or will be in a potentially filmed area has signed a HIPAA authorization form can this be done.\n\r\n\nCLIA\nThe Clinical Laboratory Improvement Amendments (CLIA) are a set of U.S. federal regulatory requirements applied to all non-research-based clinical laboratory testing performed on humans. These requirements are intended to further ensure a higher standard of quality in clinical laboratory testing, focusing in on improving the accuracy, reliability, and timeliness of tests. (The implications of these requirements on U.S. clinical labs and their ability to test for COVID-19 are discussed later, in the next section.)\nCLIA uses seven different criteria to gauge and assign one of three complexity levels to laboratory devices and assays: high, moderate, and waived.[33][34] Additionally, CLIA mandates clinical laboratories handling specimens originating from the U.S. and its territories to apply for a CLIA certificate that is appropriate for the type of testing it performs. Labs using complex devices and assays would have to apply for a high complexity certificate, and so on. Waived tests are recognized as simple to perform with a low risk of erroneous results and include among others urinalysis for pregnancy and drugs of abuse, blood glucose and cholesterol tests, and fertility analysis.\nAnything but waived testing requires meeting \"the CLIA quality system standards, such as those for proficiency testing, quality control and assessment, and personnel requirements. The standards for moderate and high complexity testing differ only in the personnel requirements.\"[33] As the Centers for Medicare and Medicaid Services (CMS) points out in a frequently asked questions (FAQ) document\u2014and as can be verified on the FDA's EUA page[10]\u2014a huge majority of COVID-19 tests are only authorized for moderate or high complexity testing, and thus labs certified to do that sort of testing.[35] As of September 2021, only 14 of 260 FDA EUAed molecular diagnostic tests are approved to be performed in a CLIA-waived laboratory setting.[10]\nCMS' FAQ, as well as their March 2020 guidance document, provides additional insight in regards CLIA and COVID-19[35][36]:\n\nCLIA regulations remain firmly in effect during the U.S.-declared public health emergency; a Section 1135 waiver, under the Social Security Act, that modifies or suspends CLIA requirements is not within the authorizing jurisdiction of the CLIA program. Additionally, CMS in general does not have the authority \"to grant waivers or exceptions that are not established in statute or regulation.\"\nLaboratories choosing to use temporary testing sites for remotely (from home or another temporary location) viewing and reporting on cytology slides and images may do so if certain defined conditions are met. (Consult the memo for those defined conditions.)\nProficiency testing (PT) is still required if a CLIA-certified lab is still performing testing and issuing patient results. However, should a PT provider need to postpone, suspend, or cancel a proficiency testing event, \"[l]aboratories will not be penalized for lack of PT results ... so long as the cancelation is documented (including the notification from the PT program), and PT is conducted in a timely manner after the public health emergency ends. However, labs should consider performing their own self-assessment to ensure reliable testing.\"\nAlternate specimen collection devices (e.g., viral transport media, flocked nasopharyngeal swabs) used outside the manufacturer's instructions still require the establishment of performance specifications and assay validation prior to patient use. The FDA provides additional guidance on this topic.\nLaboratories performing laboratory developed tests (LDTs) are still required to be CLIA-certified and meet the requirements for high complexity testing. However, if the state government of such a laboratory has opted to take responsibility for authorizing an LDT (in order to expedite COVID-19 testing), then engagement with the FDA is not required.\n\"CMS will temporarily exercise enforcement discretion under CLIA for the duration of the COVID-19 public health emergency for the use of authorized SARS-CoV-2 molecular and antigen POC tests on asymptomatic individuals outside of the test\u2019s authorization.\"[37]\nAs of May 2021[38], a CLIA specialty or subspecialty has not yet been assigned to COVID-19 testing authorized under the EUA pathway. Testing may be performed by laboratories based on intended use and by CMS specialty and subspecialty assigned to similar FDA-cleared or -approved tests with similar characteristics to the EUA being used.\nReferences \n\n\n\u2191 Subbaraman, N.; Callaway, E. (23 March 2020). \"Coronavirus tests: Researchers chase new diagnostics to fight the pandemic\". Nature - News Explainer. doi:10.1038\/d41586-020-00827-6. https:\/\/www.nature.com\/articles\/d41586-020-00827-6 . Retrieved 05 April 2020 .   \n \n\n\u2191 Apuzzo, M.; Gebrekidan, S. (20 March 2020). \"Can\u2019t Get Tested? Maybe You\u2019re in the Wrong Country\". The New York Times. https:\/\/www.nytimes.com\/2020\/03\/20\/world\/europe\/coronavirus-testing-world-countries-cities-states.html . Retrieved 05 April 2020 .   \n \n\n\u2191 Hindsley, G. (28 March 2020). \"The Lost Month: How a Failure to Test Blinded the U.S. to COVID-19\". The New York Times. https:\/\/www.nytimes.com\/2020\/03\/28\/us\/testing-coronavirus-pandemic.html . Retrieved 05 April 2020 .   \n \n\n\u2191 Denison, M.R. (2004). \"Coronavirus Research: Keys to Diagnosis, Treatment, and Prevention of SARS\". Learning from SARS: Preparing for the Next Disease Outbreak. Institute of Medicine. pp. 137\u201372. doi:10.17226\/10915. ISBN 9780309182157. https:\/\/www.nap.edu\/read\/10915\/chapter\/5 .   \n \n\n\u2191 Ceccarelli, M.; Berretta, M.; Venanzi Rullo, E. et al. (2020). \"Differences and similarities between Severe Acute Respiratory Syndrome (SARS)-CoronaVirus (CoV) and SARS-CoV-2. Would a rose by another name smell as sweet?\". European Review for Medical and Pharmacological Sciences 24 (5): 2781-2783. doi:10.26355\/eurrev_202003_20551. PMID 32196628.   \n \n\n\u2191 Wilder-Smith, A.; Chiew, C.J.; Lee, V.J. (2020). \"Can we contain the COVID-19 outbreak with the same measures as for SARS?\". The Lancet Infectious Diseases. doi:10.1016\/S1473-3099(20)30129-8. PMC PMC7102636. PMID 32145768. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7102636 .   \n \n\n\u2191 World Health Organization (10 January 2020). \"Laboratory testing of human suspected cases of novel coronavirus (nCoV) infection: Interim guidance 10 January 2020\". WHO\/2019-nCoV\/laboratory\/2020.1. World Health Organization. https:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/330374\/WHO-2019-nCoV-laboratory-2020.1-eng.pdf . Retrieved 05 April 2020 .   \n \n\n\u2191 8.0 8.1 8.2 World Health Organization, et al. (11 September 2020). \"Diagnostic testing for SARS-CoV-2\". WHO\/2019-nCoV\/laboratory\/2020.6. World Health Organization. https:\/\/apps.who.int\/iris\/handle\/10665\/334254 . Retrieved 18 November 2020 .   \n \n\n\u2191 Terry, M. (3 April 2020). \"Cellex and Mayo Clinic Launch Tests to Determine COVID-19 Immunity from Previous Exposure\". BioSpace. https:\/\/www.biospace.com\/article\/fda-approves-1st-covid-19-antibody-test\/ . Retrieved 05 April 2020 .   \n \n\n\u2191 10.0 10.1 10.2 \"In Vitro Diagnostics EUAs\". U.S. Food and Drug Administration. 20 August 2020. https:\/\/www.fda.gov\/medical-devices\/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\/vitro-diagnostics-euas#individual-serological . Retrieved 23 August 2020 .   \n \n\n\u2191 11.0 11.1 Centers for Disease Control and Prevention (2 August 2021). \"Overview of Testing for SARS-CoV-2\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/hcp\/testing-overview.html . Retrieved 06 September 2021 .   \n \n\n\u2191 12.0 12.1 12.2 Centers for Disease Control and Prevention (26 February 2021). \"Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-nCoV\/lab\/guidelines-clinical-specimens.html . Retrieved 06 September 2021 .   \n \n\n\u2191 13.0 13.1 13.2 Public Health England (29 March 2021). \"COVID-19: Guidance for sampling and for diagnostic laboratories\". U.K Government. https:\/\/www.gov.uk\/government\/publications\/wuhan-novel-coronavirus-guidance-for-clinical-diagnostic-laboratories . Retrieved 06 September 2021 .   \n \n\n\u2191 14.0 14.1 14.2 14.3 14.4 14.5 14.6 14.7 Public Health Laboratory Network (22 June 2021). \"PHLN guidance on laboratory testing for SARS-CoV-2 (the virus that causes COVID-19)\". Department of Health, Australian Government. https:\/\/www.health.gov.au\/resources\/publications\/phln-guidance-on-laboratory-testing-for-sars-cov-2-the-virus-that-causes-covid-19 . Retrieved 06 September 2021 .   \n \n\n\u2191 Centers for Disease Control and Prevention (27 April 2020). \"Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19)\". Centers for Disease Control and Prevention. Archived from the original on 01 May 2020. https:\/\/web.archive.org\/web\/20200501002841\/https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/hcp\/clinical-criteria.html . Retrieved 08 July 2020 .   \n \n\n\u2191 Branswell, H. (4 April 2020). \"CDC launches studies to get more precise count of undetected Covid-19 cases\". STAT. https:\/\/www.statnews.com\/2020\/04\/04\/cdc-launches-studies-to-get-more-precise-count-of-undetected-covid-19-cases\/ . Retrieved 05 April 2020 .   \n \n\n\u2191 17.0 17.1 Center for Health Security (26 August 2021). \"Serology tests for COVID-19\". Johns Hopkins University. https:\/\/www.centerforhealthsecurity.org\/covid-19TestingToolkit\/serology\/Serology-based-tests-for-COVID-19.html . Retrieved 06 September 2021 .   \n \n\n\u2191 18.0 18.1 Wang, W.; Xu, Y.; Gao, R. et al. (2020). \"Detection of SARS-CoV-2 in Different Types of Clinical Specimens\". JAMA. doi:10.1001\/jama.2020.3786. PMC PMC7066521. PMID 32159775. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7066521 .   \n \n\n\u2191 Yu, F.; Yan, L.; Wang, N. et al. (2020). \"Quantitative Detection and Viral Load Analysis of SARS-CoV-2 in Infected Patients\". Clinical Infectious Diseases: ciaa345. doi:10.1093\/cid\/ciaa345. PMID 32221523.   \n \n\n\u2191 Public Health Laboratory Network (3 September 2020). \"PHLN guidance for serological testing in COVID-19\" (Word). Department of Health, Australian Government. https:\/\/www.health.gov.au\/sites\/default\/files\/documents\/2020\/09\/phln-guidance-for-serological-testing-in-covid-19-phln-guidance-on-serological-testing-in-covid-19.docx . Retrieved 06 September 2021 .   \n \n\n\u2191 Xu, R.; Cui, B.; Duan, X. et al. (2020). \"Saliva: Potential diagnostic value and transmission of 2019-nCoV\". International Journal of Oral Science 12: 11. doi:10.1038\/s41368-020-0080-z.   \n \n\n\u2191 Wyllie, A.L.; Fournier, J.; Casanovas-Massana, A. et al. (2020). \"Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2\". New England Journal of Medicine 383: 1283\u20136. doi:10.1056\/NEJMc2016359. PMC PMC7484747. PMID 32857487. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7484747 .   \n \n\n\u2191 Vault Health (14 April 2020). \"Vault Health Launches First-of-its-Kind Saliva-based FDA EUA Approved Test for COVID-19\". PR Newswire. https:\/\/www.prnewswire.com\/news-releases\/vault-health-launches-first-of-its-kind-saliva-based-fda-eua-approved-test-for-covid-19-301039633.html . Retrieved 01 May 2020 .   \n \n\n\u2191 Fox, A. (12 October 2020). \"EUAs for Laboratory Developed COVID-19 Tests Will No Longer Be Reviewed by the FDA\". JDSupra. https:\/\/www.jdsupra.com\/legalnews\/euas-for-laboratory-developed-covid-19-91593\/ . Retrieved 18 November 2020 .   \n \n\n\u2191 25.0 25.1 25.2 Centers for Disease Control and Prevention (13 November 2020). \"Guidance for SARS-CoV-2 Point-of-Care Testing\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/point-of-care-testing.html . Retrieved 07 September 2021 .   \n \n\n\u2191 Romo, V. (17 November 2020). \"FDA Approves 1st At-Home Coronavirus Test\". NPR. https:\/\/www.npr.org\/sections\/coronavirus-live-updates\/2020\/11\/17\/936055284\/fda-approves-first-at-home-coronavirus-test . Retrieved 18 November 2020 .   \n \n\n\u2191 \"In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2\". U.S. Food and Drug Administration. 7 September 2021. https:\/\/www.fda.gov\/medical-devices\/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2 . Retrieved 07 September 2021 .   \n \n\n\u2191 American Association for Clinical Chemistry (12 November 2020). \"Proper Self-collection of Nasal Swabs Critical for Accurate COVID-19 Testing\". Lab Tests Online. American Association for Clinical Chemistry. https:\/\/labtestsonline.org\/news\/proper-self-collection-nasal-swabs-critical-accurate-covid-19-testing . Retrieved 18 November 2020 .   \n \n\n\u2191 \"Lucira COVID-19 All-In-One Test Kit - Instruction for Use\" (PDF). Lucira Health. 2020. https:\/\/www.fda.gov\/media\/143808\/download . Retrieved 18 November 2020 .   \n \n\n\u2191 Beale, S. (29 June 2020). \"Multiple Studies Raise Questions About Reliability of Clinical Laboratory COVID-19 Diagnostic Tests\". Dark Daily. https:\/\/www.darkdaily.com\/2020\/06\/29\/multiple-studies-raise-questions-about-reliability-of-clinical-laboratory-covid-19-diagnostic-tests\/ . Retrieved 07 September 2021 .   \n \n\n\u2191 31.0 31.1 31.2 West, C.P.; Montori, V.M.; Sampathkumar, P. (2020). \"COVID-19 Testing: The Threat of False-Negative Results\". Mayo Clinic Proceedings 95 (6): 1127\u201329. doi:10.1016\/j.mayocp.2020.04.004. PMC PMC7151274. PMID 32376102. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7151274 .   \n \n\n\u2191 \"HIPAA and COVID-19\". Department of Health and Human Services. 11 May 2020. https:\/\/www.hhs.gov\/hipaa\/for-professionals\/special-topics\/hipaa-covid19\/index.html . Retrieved 18 May 2020 .   \n \n\n\u2191 33.0 33.1 Centers for Disease Control and Prevention (6 August 2018). \"Clinical Laboratory Improvement Amendments (CLIA): Test complexities\". https:\/\/www.cdc.gov\/clia\/test-complexities.html . Retrieved 09 April 2020 .   \n \n\n\u2191 \"CLIA Categorizations\". U.S. Food and Drug Administration. 25 February 2020. https:\/\/www.fda.gov\/medical-devices\/ivd-regulatory-assistance\/clia-categorizations . Retrieved 09 April 2020 .   \n \n\n\u2191 35.0 35.1 Centers for Medicare and Medicaid Services (17 December 2020). \"Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency\" (PDF). https:\/\/www.cms.gov\/files\/document\/frequently-asked-questions-faqs-clia-guidance-during-covid-19-emergency-updated-12-17-2020.pdf . Retrieved 07 September 2021 .   \n \n\n\u2191 Wright, D.R. (26 March 2020). \"Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During COVID-19 Public Health Emergency\" (PDF). Centers for Medicare and Medicaid Services. https:\/\/www.cms.gov\/files\/document\/qso-20-21-clia.pdf-0 . Retrieved 18 May 2020 .   \n \n\n\u2191 \"Updated CLIA SARS-CoV-2 Molecular and Antigen Point of Care Test Enforcement Discretion\" (PDF). Centers for Medicare and Medicaid Services. 7 December 2020. https:\/\/www.cms.gov\/files\/document\/clia-sars-cov-2-point-care-test-enforcement-discretion.pdf . Retrieved 07 September 2021 .   \n \n\n\u2191 \"CAP Responds to Your COVID-19 Questions\". College of American Pathologists. 2021. https:\/\/www.cap.org\/laboratory-improvement\/news-and-updates\/cap-responds-to-your-covid-19-questions . Retrieved 07 September 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 3 May 2020, at 19:39.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 265 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","9618f22c10f370a964cc84bac6d8f3a5_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Diagnostic_testing_of_COVID-19_and_other_coronaviruses_Organizational_and_agency_guidance_on_COVID-19_testing rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Diagnostic_testing_of_COVID-19_and_other_coronaviruses_Organizational_and_agency_guidance_on_COVID-19_testing skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Diagnostic testing of COVID-19 and other coronaviruses\/Organizational and agency guidance on COVID-19 testing<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><h3><span class=\"mw-headline\" id=\"2.3_Organizational_and_agency_guidance_on_COVID-19_testing\">2.3 Organizational and agency guidance on COVID-19 testing<\/span><\/h3>\n<p><i>NOTE: Information shown here may rapidly become outdated given how quickly response to pandemic testing can change. A full attempt to keep the content relevant will be made.<\/i> \n<\/p>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:432px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:CDC_COVID-19_test_kit.jpg\" class=\"image wiki-link\" data-key=\"6654af4c2c1084f9b8236e42ab541b9b\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/b\/b1\/CDC_COVID-19_test_kit.jpg\" decoding=\"async\" class=\"thumbimage\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:CDC_COVID-19_test_kit.jpg\" class=\"internal wiki-link\" title=\"Enlarge\" data-key=\"6654af4c2c1084f9b8236e42ab541b9b\"><\/a><\/div>CDC 2019-nCoV Real-time RT-PCR Panel (Research Use Only)<\/div><\/div><\/div><p>Early in the COVID-19 pandemic, laboratory guidance for testing for SARS-CoV-2 was relatively quick to evolve. The timely development and organized use of accurate assays and meaningful screening protocols, however, has been inconsistent but improving worldwide, with some countries more urgently and agilely responding than others.<sup id=\"rdp-ebb-cite_ref-SubbaramanCorona20_1-0\" class=\"reference\"><a href=\"#cite_note-SubbaramanCorona20-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ApuzzoCant20_2-0\" class=\"reference\"><a href=\"#cite_note-ApuzzoCant20-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HindsleyTheLost20_3-0\" class=\"reference\"><a href=\"#cite_note-HindsleyTheLost20-3\">[3]<\/a><\/sup> With any novel virus, clinicians and public health experts are dealing with unknown factors. However, public health organizations and agencies have had a base to work from when creating laboratory testing guidance for a novel coronavirus, with more than 40 years of experience with coronavirus biology, pathogenesis, and diagnosis.<sup id=\"rdp-ebb-cite_ref-DenisonCorona04_4-0\" class=\"reference\"><a href=\"#cite_note-DenisonCorona04-4\">[4]<\/a><\/sup> And while there are fundamental differences between SARS-CoV-2 and its predecessor SARS-CoV, they still share approximately 70 to 80 percent of their genetic code.<sup id=\"rdp-ebb-cite_ref-CeccarelliDiff20.22_5-0\" class=\"reference\"><a href=\"#cite_note-CeccarelliDiff20.22-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Wilder.3DSmithCanWe20.22_6-0\" class=\"reference\"><a href=\"#cite_note-Wilder.3DSmithCanWe20.22-6\">[6]<\/a><\/sup> In fact, the WHO had draft guidance for laboratory testing out as early as January 10, 2020, before gene sequencing was even completed.<sup id=\"rdp-ebb-cite_ref-WHOLabJan20_7-0\" class=\"reference\"><a href=\"#cite_note-WHOLabJan20-7\">[7]<\/a><\/sup> This guidance and similar draft guidance from national public health organizations and agencies have received steady revisions since as understanding of the virus has grown.\n<\/p><p>Similar to its predecessors SARS-CoV and MERS-CoV, RT-PCR has largely been the predominant diagnostic method used in guidance for detecting SARS-CoV-2's RNA in specimens and thus laboratory confirmation of COVID-19 cases. Other diagnostic methods such as isothermal amplification (e.g., ) and antigen testing have also emerged as the pandemic has progressed. Serology has its place in testing as well, though with similar lessons from SARS and MERS that it's best used to test for past infection (typically after 14 days of suspected contact with a carrier, or mild symptoms) and thus potential short-term immunity due to the presence of antibodies in blood. It also has other uses; in its September 2020 guidance, the WHO said: \"If negative NAAT results are obtained from a patient in whom SARS-CoV-2 infection is strongly suspected, a paired serum specimen could be collected.\"<sup id=\"rdp-ebb-cite_ref-WHOLabMar20_8-0\" class=\"reference\"><a href=\"#cite_note-WHOLabMar20-8\">[8]<\/a><\/sup> On April 3, the U.S. Food and Drug Administration (FDA) approved the country's first COVID-19 serology test, created by Cellex, though Mayo Clinic was also on the verge of rolling out its own in-house serology test as well<sup id=\"rdp-ebb-cite_ref-TerryCellex20_9-0\" class=\"reference\"><a href=\"#cite_note-TerryCellex20-9\">[9]<\/a><\/sup> As of September 2021, the U.S. FDA has granted emergency use authorizations (EUA) for 88 serology\/antibody tests.<sup id=\"rdp-ebb-cite_ref-FDAEmerg20_10-0\" class=\"reference\"><a href=\"#cite_note-FDAEmerg20-10\">[10]<\/a><\/sup> (Note: Johns Hopkins also appears to be maintaining <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.centerforhealthsecurity.org\/covid-19TestingToolkit\/serology\/Serology-based-tests-for-COVID-19.html\" target=\"_blank\">a page<\/a> tracking approved serology tests around the world.) \n<\/p><p><b>Primary testing guidance<\/b>\n<\/p><p>The following sample collection and test procedures have evolved from the COVID-19 pandemic (note that this is only a summary; consult the cited literature directly for full details)<sup id=\"rdp-ebb-cite_ref-WHOLabMar20_8-1\" class=\"reference\"><a href=\"#cite_note-WHOLabMar20-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CDCEvalTest20_11-0\" class=\"reference\"><a href=\"#cite_note-CDCEvalTest20-11\">[11]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CDCInterimGuidC19_20_12-0\" class=\"reference\"><a href=\"#cite_note-CDCInterimGuidC19_20-12\">[12]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-UKGovCOVID20_13-0\" class=\"reference\"><a href=\"#cite_note-UKGovCOVID20-13\">[13]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AusGovPHLN20_14-0\" class=\"reference\"><a href=\"#cite_note-AusGovPHLN20-14\">[14]<\/a><\/sup>:\n<\/p>\n<ul><li>Determine that the patient is indicating clinical and\/or epidemiological evidence of COVID-19 (meets case definitions). Early on in the pandemic, case definitions and testing criteria were initially strict due to lack of test kits<sup id=\"rdp-ebb-cite_ref-CDCClinical20_15-0\" class=\"reference\"><a href=\"#cite_note-CDCClinical20-15\">[15]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BranswellCDC20_16-0\" class=\"reference\"><a href=\"#cite_note-BranswellCDC20-16\">[16]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-JHSerology20_17-0\" class=\"reference\"><a href=\"#cite_note-JHSerology20-17\">[17]<\/a><\/sup>, but test kit availability has ramped up since, allowing for testing a wider group of symptomatic patients, as well as asymptomatic patients. However, clinicians are still encouraged to consider other causes for respiratory illness.<sup id=\"rdp-ebb-cite_ref-CDCEvalTest20_11-1\" class=\"reference\"><a href=\"#cite_note-CDCEvalTest20-11\">[11]<\/a><\/sup><\/li><\/ul>\n<ul><li>Collect at a minimum an upper respiratory tract (URT) specimen. Some guidance like that found in the U.K. also suggests collecting lower respiratory tract (LRT) specimens, whenever possible.<sup id=\"rdp-ebb-cite_ref-UKGovCOVID20_13-1\" class=\"reference\"><a href=\"#cite_note-UKGovCOVID20-13\">[13]<\/a><\/sup> Broadly, it appears lower respiratory tract specimens such as sputum and bronchoalveolar lavage fluid are a more reliable specimen type for RT-PCR applications, as they have been shown to contain the highest viral load, in comparison to upper respiratory tract specimens.<sup id=\"rdp-ebb-cite_ref-WangDetect20_18-0\" class=\"reference\"><a href=\"#cite_note-WangDetect20-18\">[18]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-YuQuant20_19-0\" class=\"reference\"><a href=\"#cite_note-YuQuant20-19\">[19]<\/a><\/sup> In most cases, a URT will be sufficient; however, an LRT is especially useful when a patient tests negative with a URT but is still high suspicious of having COVID-19. Yet, as Wang <i>et al.<\/i> point out, \"testing of specimens from multiple sites may improve the sensitivity and reduce false-negative test results,\"<sup id=\"rdp-ebb-cite_ref-WangDetect20_18-1\" class=\"reference\"><a href=\"#cite_note-WangDetect20-18\">[18]<\/a><\/sup> which is largely reflected in WHO, CDC, Public Health England (PHE), and Public Health Laboratory Network (PHLN; Australia) testing guidance.<\/li><\/ul>\n<dl><dd>Slight differences in upper respiratory tract specimen collection procedures can be found between the WHO\/CDC and PHE\/PHLN. Both the WHO and CDC offer nasopharyngeal and oropharyngeal swabs as options. The WHO doesn't appear to give a preference, whereas the CDC has a preference for nasopharyngeal swabs but maintains oropharyngeal as still remaining \"an acceptable specimen type.\"<sup id=\"rdp-ebb-cite_ref-CDCInterimGuidC19_20_12-1\" class=\"reference\"><a href=\"#cite_note-CDCInterimGuidC19_20-12\">[12]<\/a><\/sup> In comparison, the latest PHE and PHLN guidance prefer the approach of collecting from both pharynx locations\u2014even with the same swab\u2014\"to optimize the chances of virus detection.\"<sup id=\"rdp-ebb-cite_ref-AusGovPHLN20_14-1\" class=\"reference\"><a href=\"#cite_note-AusGovPHLN20-14\">[14]<\/a><\/sup> Nasopharyngeal aspiration is also an acceptable sample collection method for the upper respiratory tract according to all mentioned entities except the PHLN, which appears to have removed mention of nasopharyngeal aspirate from its guidance sometime in 2021.<sup id=\"rdp-ebb-cite_ref-AusGovPHLN20_14-2\" class=\"reference\"><a href=\"#cite_note-AusGovPHLN20-14\">[14]<\/a><\/sup><\/dd><\/dl>\n<dl><dd>Regarding serum specimens, statements differ slightly. The WHO notes serology to be useful for retrospective case definition, using paired specimens from the acute and convalescent phases of the disease. The CDC doesn't make reference to serum or serology in their clinical specimen guidance. The PHE used to suggest hospital patients have \"a sample for acute serology\" taken, but that appears to have been removed from 2021 guidance.<sup id=\"rdp-ebb-cite_ref-UKGovCOVID20_13-2\" class=\"reference\"><a href=\"#cite_note-UKGovCOVID20-13\">[13]<\/a><\/sup> The PHLN initially provided similar advice as the WHO, but in late April they expanded their guidance to discuss the value of serology.<sup id=\"rdp-ebb-cite_ref-AusGovPHLN20_14-3\" class=\"reference\"><a href=\"#cite_note-AusGovPHLN20-14\">[14]<\/a><\/sup> They have also added collection recommendations for serology, in separate guidance, indicating that \"serological testing before two weeks from the onset of symptoms may result in false negative results.\"<sup id=\"rdp-ebb-cite_ref-AusGovPHLN-Serology20_20-0\" class=\"reference\"><a href=\"#cite_note-AusGovPHLN-Serology20-20\">[20]<\/a><\/sup><\/dd><\/dl>\n<dl><dd>Finally, and more recently, potential evidence of saliva having diagnostic value for detecting SARS-CoV-2 has arisen. Xu <i>et al.<\/i> noted in published April 2020 research that the \"diagnostic value of saliva specimens for ... nucleic acid examination remains limited but promising.\"<sup id=\"rdp-ebb-cite_ref-XuSaliva20_21-0\" class=\"reference\"><a href=\"#cite_note-XuSaliva20-21\">[21]<\/a><\/sup> Another paper published in September 2020 provided similar thoughts, though was generally more optimistic than the paper published by Xu <i>et al.<\/i>, suggesting saliva from the opening of the mouth (in contrast to Xu <i>et al.<\/i> and their finding of better results from saliva in the throat) may be viable specimen.<sup id=\"rdp-ebb-cite_ref-WyllieSaliva20_22-0\" class=\"reference\"><a href=\"#cite_note-WyllieSaliva20-22\">[22]<\/a><\/sup> In fact, an April 2020 EUA by the FDA had been made for the first saliva-based COVID-19 test, produced by Vault Health, Inc.<sup id=\"rdp-ebb-cite_ref-VHVault20_23-0\" class=\"reference\"><a href=\"#cite_note-VHVault20-23\">[23]<\/a><\/sup><\/dd><\/dl>\n<dl><dd>As these and similar studies have been peer reviewed and methods validated, saliva has increasingly looked like a viable sample type. The CDC updated their guidance in October 2020 regarding saliva as a testing substrate. The CDC now notes: \"Collect 1-5 ml of saliva in a sterile, leak-proof screw cap container. No preservative is required.\"<sup id=\"rdp-ebb-cite_ref-CDCInterimGuidC19_20_12-2\" class=\"reference\"><a href=\"#cite_note-CDCInterimGuidC19_20-12\">[12]<\/a><\/sup> This is presumably in conjunction with tests approved for the use of saliva. Australia's PHLN updated their guidance in 2021 to include a full section on saliva testing and how to approach it, though cautioning it \"does not advise routine use of saliva for diagnostic testing except in specific situations.\"<sup id=\"rdp-ebb-cite_ref-AusGovPHLN20_14-4\" class=\"reference\"><a href=\"#cite_note-AusGovPHLN20-14\">[14]<\/a><\/sup><\/dd><\/dl>\n<ul><li>Conduct testing. NAAT methods like qRT-PCR have been the primary tools for diagnosing SARS-CoV-2 infection due to their high sensitivity. The PHLN provides the most background about PCR in their guidance, noting that \"RT-PCR or TMA are the methods of choice to detect SARS-CoV-2 during the acute illness.\"<sup id=\"rdp-ebb-cite_ref-AusGovPHLN20_14-5\" class=\"reference\"><a href=\"#cite_note-AusGovPHLN20-14\">[14]<\/a><\/sup> Viral cultures are little mentioned, though the PHLN underscores the idea that viral cultures for routine diagnoses are \"of limited utility\" and, if attempted, should only be performed in Biosafety Level 3 (BSL-3) laboratories.<sup id=\"rdp-ebb-cite_ref-AusGovPHLN20_14-6\" class=\"reference\"><a href=\"#cite_note-AusGovPHLN20-14\">[14]<\/a><\/sup> As of August 2020, only the PHLN has made any specific recommendations for how serological testing should be conducted for testing <i>past cases<\/i> of COVID-19.<sup id=\"rdp-ebb-cite_ref-AusGovPHLN20_14-7\" class=\"reference\"><a href=\"#cite_note-AusGovPHLN20-14\">[14]<\/a><\/sup> The current set of approved serology tests from around the world appear to use lateral flow immunoassay, ELISA, or <a href=\"https:\/\/www.limswiki.org\/index.php\/Neutralisation_(immunology)\" title=\"Neutralisation (immunology)\" class=\"wiki-link\" data-key=\"d1792d8486f8f102f633d759ffe50cdb\">neutralization<\/a> methods.<sup id=\"rdp-ebb-cite_ref-JHSerology20_17-1\" class=\"reference\"><a href=\"#cite_note-JHSerology20-17\">[17]<\/a><\/sup> Also note that at least in the U.S., the FDA in October 2020 discontinued review and approval of laboratory developed tests (LDTs), in favor of tests that would be more likely to increase access to testing or overall test capacity.<sup id=\"rdp-ebb-cite_ref-FoxEUAs20_24-0\" class=\"reference\"><a href=\"#cite_note-FoxEUAs20-24\">[24]<\/a><\/sup><\/li><\/ul>\n<ul><li>Confirm the results. The WHO notes that optimally a positive result should come from a NAAT method \"with at least two independent targets on the SARS-CoV-2 genome.\" However, they recognize that \"in areas with widespread transmission of SARS-CoV-2, a simple algorithm might be adopted with one single discriminatory target,\" though monitoring of potential mutations is recommended.<sup id=\"rdp-ebb-cite_ref-WHOLabMar20_8-2\" class=\"reference\"><a href=\"#cite_note-WHOLabMar20-8\">[8]<\/a><\/sup> Most guidance notes that if testing produces one or more negative results, that doesn't necessarily rule out SARS-CoV-2 infection. If suspicion of infection remains high, particularly if only upper respiratory tract specimens were collected, additional specimens from the lower respiratory tract should be collected and analyzed. They also emphasize that both external and internal controls should be applied to NAAT runs to limit the chance of incorrect results.<\/li><\/ul>\n<ul><li>Report using state and, if applicable, national reporting requirements. (See the next chapter for more on reporting.) Regardless of result, the final positive or negative laboratory confirmation should also be reported to state and national authorities. In the U.S., for example, this means reporting to the local or state health department using the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/php\/reporting-pui.html\" target=\"_blank\">CDC's COVID-19 Worksheet<\/a>. In Canada, reports are sent to the Public Health Agency of Canada (PHAC) via their <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.canada.ca\/en\/public-health\/services\/diseases\/2019-novel-coronavirus-infection\/health-professionals\/interim-guidance-surveillance-human-infection.html\" target=\"_blank\">Coronavirus Diseases (COVID-19) Case Report Form<\/a>.<\/li><\/ul>\n<p><b>Additional considerations for point-of-care testing and self-collection<\/b>\n<\/p><p>One of the long-term goals of healthcare professionals, governments, and test kit manufacturers has been to develop and increase access to point-of-care (POC) testing solutions for COVID-19. This has come with many challenges, but it is largely being realized. The CDC continues to update its <i>Guidance for SARS-CoV-2 Point-of-Care and Rapid Testing<\/i><sup id=\"rdp-ebb-cite_ref-CDCGuidancePOC20_25-0\" class=\"reference\"><a href=\"#cite_note-CDCGuidancePOC20-25\">[25]<\/a><\/sup>, and, after the first \"collect and test\" at-home kit\u2014the Lucira COVID-19 All-In-One Test Kit\u2014was approved by the FDA in November 2020<sup id=\"rdp-ebb-cite_ref-RomoFDAApproves20_26-0\" class=\"reference\"><a href=\"#cite_note-RomoFDAApproves20-26\">[26]<\/a><\/sup>, many more were eventually approved for emergency use.<sup id=\"rdp-ebb-cite_ref-FDAInVitAntigen21_27-0\" class=\"reference\"><a href=\"#cite_note-FDAInVitAntigen21-27\">[27]<\/a><\/sup> However, while these easy-use or quick-result tests are promising and welcome, a few additional testing considerations come with them. For example, the CDC has indicated that though FDA-authorized POC tests are approved for symptomatic individuals, \"CLIA will temporarily allow CLIA-certified laboratories and other testing sites to use SARS-CoV-2 point-of-care and rapid antigen tests on asymptomatic people for the duration of the COVID-19 public health emergency.\"<sup id=\"rdp-ebb-cite_ref-CDCGuidancePOC20_25-1\" class=\"reference\"><a href=\"#cite_note-CDCGuidancePOC20-25\">[25]<\/a><\/sup> Other recommendations include not reusing test devices or components, changing gloves at strategic points, and limiting opening of test materials until ready to begin testing.<sup id=\"rdp-ebb-cite_ref-CDCGuidancePOC20_25-2\" class=\"reference\"><a href=\"#cite_note-CDCGuidancePOC20-25\">[25]<\/a><\/sup> \n<\/p><p>In some cases, such as drive-through testing sites, patient self-collection of a sample may be required. In these cases, it's vital that the patient is given clear and concise instructions on how to collect the sample before they begin the process. The American Association for Clinical Chemistry (AACC) notes that false-negative results are more likely with poor instruction and recommends healthcare providers provide patients with written or video instructions, along with any verbal instructions. Less invasive nasal swabs are typically being used in this case. During self-collection, the patient inserts the entire swab tip in one nasal cavity, makes four to five sweeping circles along the nasal wall for about 10 to 15 seconds, and then repeats the process in the opposite nostril.<sup id=\"rdp-ebb-cite_ref-AACCProperSelf20_28-0\" class=\"reference\"><a href=\"#cite_note-AACCProperSelf20-28\">[28]<\/a><\/sup>\n<\/p><p>In the case of at-home test kits, instructions for sample collection and system use should be followed carefully. For example, the Lucira All-In-One Test Kit can be used in a CLIA-certified lab or \"for prescription home use,\" meaning a healthcare provide must approve a prescription in order for the patient can use the test at home. Additionally, the healthcare provider will still be held responsible for reporting the test results they receive from the patient using the kit at home.<sup id=\"rdp-ebb-cite_ref-LuciraCOVIDInst20_29-0\" class=\"reference\"><a href=\"#cite_note-LuciraCOVIDInst20-29\">[29]<\/a><\/sup>\n<\/p><p><b>Mitigating risk associated with false negatives<\/b>\n<\/p><p>Before moving on, words of caution should be issued in regard to any COVID-19 testing conducted: false-negative results can be problematic.<sup id=\"rdp-ebb-cite_ref-BealeMultiple20_30-0\" class=\"reference\"><a href=\"#cite_note-BealeMultiple20-30\">[30]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WestCOVID20_31-0\" class=\"reference\"><a href=\"#cite_note-WestCOVID20-31\">[31]<\/a><\/sup> One of the primary reasons they are problematic is that it may leave an otherwise asymptomatic individual to continue to unknowingly spread the virus further. Those individuals may relax physical distancing measures and become lax with their mask wearing, affecting others outside the clinical setting. Inside a clinical setting, a patient with a false negative \"may be sent to the frontlines of care and inadvertently transmit the virus to patients and colleagues, further straining the already precarious ability of the health care system to respond to the pandemic.\"<sup id=\"rdp-ebb-cite_ref-WestCOVID20_31-1\" class=\"reference\"><a href=\"#cite_note-WestCOVID20-31\">[31]<\/a><\/sup>\n<\/p><p>In a perspective piece published in <i>Mayo Clinic Proceedings<\/i>, West <i>et al.<\/i> of the Mayo Clinic offer four critical recommendations for society as we attempt to mitigate the risk associated with false negatives when performing clinical testing for COVID-19. Those recommendations are<sup id=\"rdp-ebb-cite_ref-WestCOVID20_31-2\" class=\"reference\"><a href=\"#cite_note-WestCOVID20-31\">[31]<\/a><\/sup>:\n<\/p>\n<dl><dd>1. Continue protective and preventative measures inside and outside the testing facility. This includes efforts such as physical distancing, regular hand-washing, regular disinfection of surfaces, and adequate personal protective equipment (PPE) for clinical staff (as well as the encouragement of proper mask wearing by others).<\/dd><\/dl>\n<dl><dd>2. Develop and improve PCR and serological assays to be more sensitive and specific. The development and improvement process must include methodologically rigorous studies designed to limit the risk of biased results, as well as clearly reported test performance characteristics.<\/dd><\/dl>\n<dl><dd>3. Assess patients carefully for their potential risk level for being infected. Confidence in negative test results may need to be lowered for health care workers and individuals in other high-risk groups. In general, given the uncertainty around viral load, asymptomatic transmission, and other disease characteristics, caution should be used with negative results in general.<\/dd><\/dl>\n<dl><dd>4. Establish risk-based protocols for managing negative COVID-19 results. Truly low-risk individuals may not be a major concern when results come back negative. However, individuals in higher-risk categories may require more judicious protocols, e.g., delaying a return to a workplace (for self-isolation) despite receiving a negative and having no symptoms. (This may require a more sensitive follow-up test or at least a second negative in a repeat test, particularly among clinical workers.)<\/dd><\/dl>\n<h4><span class=\"mw-headline\" id=\"2.3.1_Regulatory_considerations:_HIPAA_and_CLIA\">2.3.1 Regulatory considerations: HIPAA and CLIA<\/span><\/h4>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:HIPAA_Screenshot.png\" class=\"image wiki-link\" data-key=\"f43d76e7dcca207ca031bdff3314d856\"><img alt=\"HIPAA Screenshot.png\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/6\/66\/HIPAA_Screenshot.png\" decoding=\"async\" width=\"350\" height=\"180\" \/><\/a><\/div>\n<p><br \/>\n<b>HIPAA<\/b>\n<\/p><p>The <a href=\"https:\/\/www.limswiki.org\/index.php\/Health_Insurance_Portability_and_Accountability_Act\" title=\"Health Insurance Portability and Accountability Act\" class=\"wiki-link\" data-key=\"b70673a0117c21576016cb7498867153\">Health Insurance Portability and Accountability Act<\/a> (HIPAA) is a set of U.S. federal regulatory requirements that attempts to modernize the flow of healthcare information, stipulate how personally identifiable information (PII) (often referred to as \"protected health information\" or \"PHI\") maintained by healthcare providers and insurers should be protected from fraud and theft, and address limitations on healthcare insurance coverage in the U.S. HIPAA spans five sections or \"titles,\" mandating health care information access, portability, privacy, and security, as well as stipulations on medical savings accounts, group health insurance requirements, and other tax- and legal-status-related issues.\n<\/p><p>Normally, HIPAA regulations would put strict requirements on how and when PII can be managed, used, shared, and stored. However, the COVID-19 pandemic has seen a relaxation of some of those requirements by the U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR). The HHS is currently maintaining a list of announcements, notifications, guidance documents, bulletins, and other resources as they relate to HIPAA and the public health emergency. Important notes pulled from that information reveal<sup id=\"rdp-ebb-cite_ref-HHS_HIPAA20_32-0\" class=\"reference\"><a href=\"#cite_note-HHS_HIPAA20-32\">[32]<\/a><\/sup>:\n<\/p>\n<ul><li>Family, friends, and others identified by the patient as being involved in their care may receive PHI from a covered health care provider, particularly when they deem that sharing in the patient's best interest. Additionally, \"[a] covered entity also may share information about a patient as necessary to identify, locate, and notify family members, guardians, or anyone else responsible for the patient\u2019s care, of the patient\u2019s location, general condition, or death.\"<\/li><\/ul>\n<ul><li>\"Covered health care providers will not be subject to penalties for violations of the HIPAA Privacy, Security, and Breach Notification Rules that occur in the good faith provision of telehealth during the COVID-19 nationwide public health emergency. This Notification does not affect the application of the HIPAA Rules to other areas of health care outside of telehealth during the emergency.\" This exercising of enforcement discretion will last until OCR provides a notice otherwise. Telehealth should optimally be performed in a private setting, whenever possible, using non-public facing communication technologies. Providers should opt to use the most secure services possible, \"but will not be penalized for using less secure products in their effort to provide the most timely and accessible care possible to patients during the public health emergency.\"<\/li><\/ul>\n<ul><li>The OCR extended its enforcement discretion to include business associates of covered health care providers, allowing them to share PHI data \"without risk of a HIPAA penalty.\" The OCR adds that \"[s]ome HIPAA business associates have been unable to timely participate in these efforts [to ensure the health and safety of the public] because their BAAs do not expressly permit them to make such uses and disclosures of PHI.\" Like the enforcement discretion of telehealth provision by covered health care providers, the business associate must still make a good-faith effort in the \"use or disclosure of the covered entity\u2019s PHI\" for public health and health oversight activities. Similarly, this exercising of enforcement discretion will last until OCR provides a notice otherwise.<\/li><\/ul>\n<ul><li>The OCR also extended its enforcement discretion to include covered health care providers and business associates operating community-based COVID-19 testing sites (CBTS)\u2014\"which includes mobile, drive-through, or walk-up sites that only provide COVID-19 specimen collection or testing services to the public\"\u2014during the public health emergency. This enforcement discretion, however, \"does not apply to covered health care providers or their business associates when such entities are performing non-CBTS related activities, including the handling of PHI outside of the operation of a CBTS.\"<\/li><\/ul>\n<ul><li>Additionally, the OCR <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hhs.gov\/about\/news\/2021\/01\/19\/ocr-announces-notification-enforcement-discretion-use-online-web-based-scheduling-applications-scheduling-covid-19-vaccination-appointments.html\" target=\"_blank\">extended its enforcement discretion<\/a> to \"covered health care providers or their business associates in connection with the good faith use of online or web-based scheduling applications ... for the scheduling of individual appointments for COVID-19 vaccinations during the COVID-19 nationwide public health emergency.\"<\/li><\/ul>\n<ul><li>\"[T]he HIPAA Privacy Rule permits a covered entity to disclose the protected health information (PHI) of an individual who has been infected with, or exposed to, COVID-19, with law enforcement, paramedics, other first responders, and public health authorities1 without the individual\u2019s HIPAA authorization, in certain circumstances.\" OCR provides <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hhs.gov\/sites\/default\/files\/covid-19-hipaa-and-first-responders-508.pdf\" target=\"_blank\">numerous examples<\/a>, including: \"when the disclosure is needed to provide treatment,\" \"when such notification is required by law,\" when a public health authority must be notified \"to prevent or control spread of disease,\" \"when first responders may be at risk of infection,\" when preventing or lessening \"a serious and imminent threat to the health and safety of a person or the public,\" and when responding to a law enforcement inquiring concerning a lawfully detained inmate or other individual.<\/li><\/ul>\n<ul><li>\"The HIPAA Privacy Rule permits HIPAA covered entities (or their business associates on the covered entities\u2019 behalf) to use or disclose PHI for treatment, payment, and health care operations, among other purposes, without an individual\u2019s authorization.\" ICR provides <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hhs.gov\/sites\/default\/files\/guidance-on-hipaa-and-contacting-former-covid-19-patients-about-blood-and-plasma-donation.pdf\" target=\"_blank\">more details<\/a> in its guidance, noting however that reasonable effort must still be made to protect PHI, and that this does not apply to activities that constitute marketing.<\/li><\/ul>\n<ul><li>Similarly, the HIPAA Privacy Rule \"permits covered entities or their business associates to disclose PHI to [a health information exchange (HIE)] for the HIE to report PHI to a [public health authority (PHA)] conducting public health activities\" in a variety of circumstances. For more on those circumstances, see the <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hhs.gov\/sites\/default\/files\/hie-faqs.pdf\" target=\"_blank\">December 2020 guidance<\/a>].<\/li><\/ul>\n<ul><li>The public health emergency does not change restrictions on disclosing PHI to the media. This includes the prohibition of media crews in, for example, emergency departments where COVID-19 patients are being treated, as PHI is found everywhere in that setting. Only when every patient who is or will be in a potentially filmed area has signed a HIPAA authorization form can this be done.<\/li><\/ul>\n<p><br \/>\n<b>CLIA<\/b>\n<\/p><p>The <a href=\"https:\/\/www.limswiki.org\/index.php\/Clinical_Laboratory_Improvement_Amendments\" title=\"Clinical Laboratory Improvement Amendments\" class=\"wiki-link\" data-key=\"64bdae1dc17c40c28e0c560396a6ae35\">Clinical Laboratory Improvement Amendments<\/a> (CLIA) are a set of U.S. federal regulatory requirements applied to all non-research-based clinical laboratory testing performed on humans. These requirements are intended to further ensure a higher standard of quality in clinical laboratory testing, focusing in on improving the accuracy, reliability, and timeliness of tests. (The implications of these requirements on U.S. clinical labs and their ability to test for COVID-19 are discussed later, in the next section.)\n<\/p><p>CLIA uses seven different criteria to gauge and assign one of three complexity levels to laboratory devices and <a href=\"https:\/\/www.limswiki.org\/index.php\/Assay\" title=\"Assay\" class=\"wiki-link\" data-key=\"ea17cf4415e898e1838538495235ef71\">assays<\/a>: high, moderate, and waived.<sup id=\"rdp-ebb-cite_ref-CDCTestCom_33-0\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-33\">[33]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FDAIVDReg_34-0\" class=\"reference\"><a href=\"#cite_note-FDAIVDReg-34\">[34]<\/a><\/sup> Additionally, CLIA mandates clinical laboratories handling specimens originating from the U.S. and its territories to apply for a CLIA certificate that is appropriate for the type of testing it performs. Labs using complex devices and assays would have to apply for a high complexity certificate, and so on. Waived tests are recognized as simple to perform with a low risk of erroneous results and include among others urinalysis for pregnancy and drugs of abuse, blood glucose and cholesterol tests, and fertility analysis.\n<\/p><p>Anything but waived testing requires meeting \"the CLIA quality system standards, such as those for proficiency testing, quality control and assessment, and personnel requirements. The standards for moderate and high complexity testing differ only in the personnel requirements.\"<sup id=\"rdp-ebb-cite_ref-CDCTestCom_33-1\" class=\"reference\"><a href=\"#cite_note-CDCTestCom-33\">[33]<\/a><\/sup> As the Centers for Medicare and Medicaid Services (CMS) points out in a frequently asked questions (FAQ) document\u2014and as can be verified on the FDA's EUA page<sup id=\"rdp-ebb-cite_ref-FDAEmerg20_10-1\" class=\"reference\"><a href=\"#cite_note-FDAEmerg20-10\">[10]<\/a><\/sup>\u2014a huge majority of COVID-19 tests are only authorized for moderate or high complexity testing, and thus labs certified to do that sort of testing.<sup id=\"rdp-ebb-cite_ref-CMSFAQ_35-0\" class=\"reference\"><a href=\"#cite_note-CMSFAQ-35\">[35]<\/a><\/sup> As of September 2021, only 14 of 260 FDA EUAed molecular diagnostic tests are approved to be performed in a CLIA-waived laboratory setting.<sup id=\"rdp-ebb-cite_ref-FDAEmerg20_10-2\" class=\"reference\"><a href=\"#cite_note-FDAEmerg20-10\">[10]<\/a><\/sup>\n<\/p><p>CMS' FAQ, as well as their March 2020 guidance document, provides additional insight in regards CLIA and COVID-19<sup id=\"rdp-ebb-cite_ref-CMSFAQ_35-1\" class=\"reference\"><a href=\"#cite_note-CMSFAQ-35\">[35]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WrightClinical20_36-0\" class=\"reference\"><a href=\"#cite_note-WrightClinical20-36\">[36]<\/a><\/sup>:\n<\/p>\n<ul><li>CLIA regulations remain firmly in effect during the U.S.-declared public health emergency; a Section 1135 waiver, under the Social Security Act, that modifies or suspends CLIA requirements is not within the authorizing jurisdiction of the CLIA program. Additionally, CMS in general does not have the authority \"to grant waivers or exceptions that are not established in statute or regulation.\"<\/li><\/ul>\n<ul><li>Laboratories choosing to use temporary testing sites for remotely (from home or another temporary location) viewing and reporting on cytology slides and images may do so if certain defined conditions are met. (Consult <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memos-states-and\/clinical-laboratory-improvement-amendments-clia-laboratory-guidance-during-covid-19-public-health\" target=\"_blank\">the memo<\/a> for those defined conditions.)<\/li><\/ul>\n<ul><li>Proficiency testing (PT) is still required if a CLIA-certified lab is still performing testing and issuing patient results. However, should a PT provider need to postpone, suspend, or cancel a proficiency testing event, \"[l]aboratories will not be penalized for lack of PT results ... so long as the cancelation is documented (including the notification from the PT program), and PT is conducted in a timely manner after the public health emergency ends. However, labs should consider performing their own self-assessment to ensure reliable testing.\"<\/li><\/ul>\n<ul><li>Alternate specimen collection devices (e.g., viral transport media, flocked nasopharyngeal swabs) used outside the manufacturer's instructions still require the establishment of performance specifications and assay validation prior to patient use. The FDA provides <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/medical-devices\/emergency-situations-medical-devices\/faqs-testing-sars-cov-2\" target=\"_blank\">additional guidance<\/a> on this topic.<\/li><\/ul>\n<ul><li>Laboratories performing laboratory developed tests (LDTs) are still required to be CLIA-certified and meet the requirements for high complexity testing. However, if the state government of such a laboratory has opted to take responsibility for authorizing an LDT (in order to expedite COVID-19 testing), then engagement with the FDA is not required.<\/li><\/ul>\n<ul><li>\"CMS will temporarily exercise enforcement discretion under CLIA for the duration of the COVID-19 public health emergency for the use of authorized SARS-CoV-2 molecular and antigen POC tests on asymptomatic individuals outside of the test\u2019s authorization.\"<sup id=\"rdp-ebb-cite_ref-CMSPOCAgTest20_37-0\" class=\"reference\"><a href=\"#cite_note-CMSPOCAgTest20-37\">[37]<\/a><\/sup><\/li><\/ul>\n<ul><li>As of May 2021<sup id=\"rdp-ebb-cite_ref-CAPResponds21_38-0\" class=\"reference\"><a href=\"#cite_note-CAPResponds21-38\">[38]<\/a><\/sup>, a CLIA specialty or subspecialty has not yet been assigned to COVID-19 testing authorized under the EUA pathway. Testing may be performed by laboratories based on intended use and by CMS specialty and subspecialty assigned to similar FDA-cleared or -approved tests with similar characteristics to the EUA being used.<\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-SubbaramanCorona20-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SubbaramanCorona20_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Subbaraman, N.; Callaway, E. (23 March 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nature.com\/articles\/d41586-020-00827-6\" target=\"_blank\">\"Coronavirus tests: Researchers chase new diagnostics to fight the pandemic\"<\/a>. <i>Nature - News Explainer<\/i>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1038%2Fd41586-020-00827-6\" target=\"_blank\">10.1038\/d41586-020-00827-6<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.nature.com\/articles\/d41586-020-00827-6\" target=\"_blank\">https:\/\/www.nature.com\/articles\/d41586-020-00827-6<\/a><\/span><span class=\"reference-accessdate\">. 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Retrieved 06 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Overview+of+Testing+for+SARS-CoV-2&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=2+August+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fhcp%2Ftesting-overview.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCInterimGuidC19_20-12\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CDCInterimGuidC19_20_12-0\">12.0<\/a><\/sup> <sup><a href=\"#cite_ref-CDCInterimGuidC19_20_12-1\">12.1<\/a><\/sup> <sup><a href=\"#cite_ref-CDCInterimGuidC19_20_12-2\">12.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Disease Control and Prevention (26 February 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-nCoV\/lab\/guidelines-clinical-specimens.html\" target=\"_blank\">\"Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-nCoV\/lab\/guidelines-clinical-specimens.html\" target=\"_blank\">https:\/\/www.cdc.gov\/coronavirus\/2019-nCoV\/lab\/guidelines-clinical-specimens.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Interim+Guidelines+for+Collecting+and+Handling+of+Clinical+Specimens+for+COVID-19+Testing&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=26+February+2021&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-nCoV%2Flab%2Fguidelines-clinical-specimens.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-UKGovCOVID20-13\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-UKGovCOVID20_13-0\">13.0<\/a><\/sup> <sup><a href=\"#cite_ref-UKGovCOVID20_13-1\">13.1<\/a><\/sup> <sup><a href=\"#cite_ref-UKGovCOVID20_13-2\">13.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Public Health England (29 March 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gov.uk\/government\/publications\/wuhan-novel-coronavirus-guidance-for-clinical-diagnostic-laboratories\" target=\"_blank\">\"COVID-19: Guidance for sampling and for diagnostic laboratories\"<\/a>. U.K Government<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.gov.uk\/government\/publications\/wuhan-novel-coronavirus-guidance-for-clinical-diagnostic-laboratories\" target=\"_blank\">https:\/\/www.gov.uk\/government\/publications\/wuhan-novel-coronavirus-guidance-for-clinical-diagnostic-laboratories<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=COVID-19%3A+Guidance+for+sampling+and+for+diagnostic+laboratories&rft.atitle=&rft.aulast=Public+Health+England&rft.au=Public+Health+England&rft.date=29+March+2021&rft.pub=U.K+Government&rft_id=https%3A%2F%2Fwww.gov.uk%2Fgovernment%2Fpublications%2Fwuhan-novel-coronavirus-guidance-for-clinical-diagnostic-laboratories&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-AusGovPHLN20-14\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-AusGovPHLN20_14-0\">14.0<\/a><\/sup> <sup><a href=\"#cite_ref-AusGovPHLN20_14-1\">14.1<\/a><\/sup> <sup><a href=\"#cite_ref-AusGovPHLN20_14-2\">14.2<\/a><\/sup> <sup><a href=\"#cite_ref-AusGovPHLN20_14-3\">14.3<\/a><\/sup> <sup><a href=\"#cite_ref-AusGovPHLN20_14-4\">14.4<\/a><\/sup> <sup><a href=\"#cite_ref-AusGovPHLN20_14-5\">14.5<\/a><\/sup> <sup><a href=\"#cite_ref-AusGovPHLN20_14-6\">14.6<\/a><\/sup> <sup><a href=\"#cite_ref-AusGovPHLN20_14-7\">14.7<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Public Health Laboratory Network (22 June 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.health.gov.au\/resources\/publications\/phln-guidance-on-laboratory-testing-for-sars-cov-2-the-virus-that-causes-covid-19\" target=\"_blank\">\"PHLN guidance on laboratory testing for SARS-CoV-2 (the virus that causes COVID-19)\"<\/a>. Department of Health, Australian Government<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.health.gov.au\/resources\/publications\/phln-guidance-on-laboratory-testing-for-sars-cov-2-the-virus-that-causes-covid-19\" target=\"_blank\">https:\/\/www.health.gov.au\/resources\/publications\/phln-guidance-on-laboratory-testing-for-sars-cov-2-the-virus-that-causes-covid-19<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=PHLN+guidance+on+laboratory+testing+for+SARS-CoV-2+%28the+virus+that+causes+COVID-19%29&rft.atitle=&rft.aulast=Public+Health+Laboratory+Network&rft.au=Public+Health+Laboratory+Network&rft.date=22+June+2021&rft.pub=Department+of+Health%2C+Australian+Government&rft_id=https%3A%2F%2Fwww.health.gov.au%2Fresources%2Fpublications%2Fphln-guidance-on-laboratory-testing-for-sars-cov-2-the-virus-that-causes-covid-19&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCClinical20-15\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCClinical20_15-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Disease Control and Prevention (27 April 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20200501002841\/https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/hcp\/clinical-criteria.html\" target=\"_blank\">\"Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19)\"<\/a>. Centers for Disease Control and Prevention. Archived from <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/hcp\/clinical-criteria.html\" target=\"_blank\">the original<\/a> on 01 May 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20200501002841\/https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/hcp\/clinical-criteria.html\" target=\"_blank\">https:\/\/web.archive.org\/web\/20200501002841\/https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/hcp\/clinical-criteria.html<\/a><\/span><span class=\"reference-accessdate\">. 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(4 April 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.statnews.com\/2020\/04\/04\/cdc-launches-studies-to-get-more-precise-count-of-undetected-covid-19-cases\/\" target=\"_blank\">\"CDC launches studies to get more precise count of undetected Covid-19 cases\"<\/a>. <i>STAT<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.statnews.com\/2020\/04\/04\/cdc-launches-studies-to-get-more-precise-count-of-undetected-covid-19-cases\/\" target=\"_blank\">https:\/\/www.statnews.com\/2020\/04\/04\/cdc-launches-studies-to-get-more-precise-count-of-undetected-covid-19-cases\/<\/a><\/span><span class=\"reference-accessdate\">. 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(2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7151274\" target=\"_blank\">\"COVID-19 Testing: The Threat of False-Negative Results\"<\/a>. <i>Mayo Clinic Proceedings<\/i> <b>95<\/b> (6): 1127\u201329. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2Fj.mayocp.2020.04.004\" target=\"_blank\">10.1016\/j.mayocp.2020.04.004<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7151274\/\" target=\"_blank\">PMC7151274<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32376102\" target=\"_blank\">32376102<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7151274\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7151274<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=COVID-19+Testing%3A+The+Threat+of+False-Negative+Results&rft.jtitle=Mayo+Clinic+Proceedings&rft.aulast=West%2C+C.P.%3B+Montori%2C+V.M.%3B+Sampathkumar%2C+P.&rft.au=West%2C+C.P.%3B+Montori%2C+V.M.%3B+Sampathkumar%2C+P.&rft.date=2020&rft.volume=95&rft.issue=6&rft.pages=1127%E2%80%9329&rft_id=info:doi\/10.1016%2Fj.mayocp.2020.04.004&rft_id=info:pmc\/PMC7151274&rft_id=info:pmid\/32376102&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7151274&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HHS_HIPAA20-32\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HHS_HIPAA20_32-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.hhs.gov\/hipaa\/for-professionals\/special-topics\/hipaa-covid19\/index.html\" target=\"_blank\">\"HIPAA and COVID-19\"<\/a>. Department of Health and Human Services. 11 May 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.hhs.gov\/hipaa\/for-professionals\/special-topics\/hipaa-covid19\/index.html\" target=\"_blank\">https:\/\/www.hhs.gov\/hipaa\/for-professionals\/special-topics\/hipaa-covid19\/index.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 May 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=HIPAA+and+COVID-19&rft.atitle=&rft.date=11+May+2020&rft.pub=Department+of+Health+and+Human+Services&rft_id=https%3A%2F%2Fwww.hhs.gov%2Fhipaa%2Ffor-professionals%2Fspecial-topics%2Fhipaa-covid19%2Findex.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCTestCom-33\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CDCTestCom_33-0\">33.0<\/a><\/sup> <sup><a href=\"#cite_ref-CDCTestCom_33-1\">33.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Disease Control and Prevention (6 August 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/clia\/test-complexities.html\" target=\"_blank\">\"Clinical Laboratory Improvement Amendments (CLIA): Test complexities\"<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/clia\/test-complexities.html\" target=\"_blank\">https:\/\/www.cdc.gov\/clia\/test-complexities.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 09 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Clinical+Laboratory+Improvement+Amendments+%28CLIA%29%3A+Test+complexities&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=6+August+2018&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fclia%2Ftest-complexities.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FDAIVDReg-34\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FDAIVDReg_34-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/medical-devices\/ivd-regulatory-assistance\/clia-categorizations\" target=\"_blank\">\"CLIA Categorizations\"<\/a>. U.S. Food and Drug Administration. 25 February 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.fda.gov\/medical-devices\/ivd-regulatory-assistance\/clia-categorizations\" target=\"_blank\">https:\/\/www.fda.gov\/medical-devices\/ivd-regulatory-assistance\/clia-categorizations<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 09 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=CLIA+Categorizations&rft.atitle=&rft.date=25+February+2020&rft.pub=U.S.+Food+and+Drug+Administration&rft_id=https%3A%2F%2Fwww.fda.gov%2Fmedical-devices%2Fivd-regulatory-assistance%2Fclia-categorizations&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CMSFAQ-35\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CMSFAQ_35-0\">35.0<\/a><\/sup> <sup><a href=\"#cite_ref-CMSFAQ_35-1\">35.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Medicare and Medicaid Services (17 December 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/files\/document\/frequently-asked-questions-faqs-clia-guidance-during-covid-19-emergency-updated-12-17-2020.pdf\" target=\"_blank\">\"Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency\"<\/a> (PDF)<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cms.gov\/files\/document\/frequently-asked-questions-faqs-clia-guidance-during-covid-19-emergency-updated-12-17-2020.pdf\" target=\"_blank\">https:\/\/www.cms.gov\/files\/document\/frequently-asked-questions-faqs-clia-guidance-during-covid-19-emergency-updated-12-17-2020.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Frequently+Asked+Questions+%28FAQs%29%2C+CLIA+Guidance+During+the+COVID-19+Emergency&rft.atitle=&rft.aulast=Centers+for+Medicare+and+Medicaid+Services&rft.au=Centers+for+Medicare+and+Medicaid+Services&rft.date=17+December+2020&rft_id=https%3A%2F%2Fwww.cms.gov%2Ffiles%2Fdocument%2Ffrequently-asked-questions-faqs-clia-guidance-during-covid-19-emergency-updated-12-17-2020.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WrightClinical20-36\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WrightClinical20_36-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Wright, D.R. (26 March 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/files\/document\/qso-20-21-clia.pdf-0\" target=\"_blank\">\"Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During COVID-19 Public Health Emergency\"<\/a> (PDF). Centers for Medicare and Medicaid Services<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cms.gov\/files\/document\/qso-20-21-clia.pdf-0\" target=\"_blank\">https:\/\/www.cms.gov\/files\/document\/qso-20-21-clia.pdf-0<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 May 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Clinical+Laboratory+Improvement+Amendments+%28CLIA%29+Laboratory+Guidance+During+COVID-19+Public+Health+Emergency&rft.atitle=&rft.aulast=Wright%2C+D.R.&rft.au=Wright%2C+D.R.&rft.date=26+March+2020&rft.pub=Centers+for+Medicare+and+Medicaid+Services&rft_id=https%3A%2F%2Fwww.cms.gov%2Ffiles%2Fdocument%2Fqso-20-21-clia.pdf-0&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CMSPOCAgTest20-37\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CMSPOCAgTest20_37-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cms.gov\/files\/document\/clia-sars-cov-2-point-care-test-enforcement-discretion.pdf\" target=\"_blank\">\"Updated CLIA SARS-CoV-2 Molecular and Antigen Point of Care Test Enforcement Discretion\"<\/a> (PDF). Centers for Medicare and Medicaid Services. 7 December 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cms.gov\/files\/document\/clia-sars-cov-2-point-care-test-enforcement-discretion.pdf\" target=\"_blank\">https:\/\/www.cms.gov\/files\/document\/clia-sars-cov-2-point-care-test-enforcement-discretion.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Updated+CLIA+SARS-CoV-2+Molecular+and+Antigen+Point+of+Care+Test+Enforcement+Discretion&rft.atitle=&rft.date=7+December+2020&rft.pub=Centers+for+Medicare+and+Medicaid+Services&rft_id=https%3A%2F%2Fwww.cms.gov%2Ffiles%2Fdocument%2Fclia-sars-cov-2-point-care-test-enforcement-discretion.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CAPResponds21-38\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CAPResponds21_38-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cap.org\/laboratory-improvement\/news-and-updates\/cap-responds-to-your-covid-19-questions\" target=\"_blank\">\"CAP Responds to Your COVID-19 Questions\"<\/a>. College of American Pathologists. 2021<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cap.org\/laboratory-improvement\/news-and-updates\/cap-responds-to-your-covid-19-questions\" target=\"_blank\">https:\/\/www.cap.org\/laboratory-improvement\/news-and-updates\/cap-responds-to-your-covid-19-questions<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=CAP+Responds+to+Your+COVID-19+Questions&rft.atitle=&rft.date=2021&rft.pub=College+of+American+Pathologists&rft_id=https%3A%2F%2Fwww.cap.org%2Flaboratory-improvement%2Fnews-and-updates%2Fcap-responds-to-your-covid-19-questions&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20210919173027\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.271 seconds\nReal time usage: 0.289 seconds\nPreprocessor visited node count: 27467\/1000000\nPost\u2010expand include size: 256396\/2097152 bytes\nTemplate argument size: 86838\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 76381\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 253.838 1 -total\n 90.29% 229.200 1 Template:Reflist\n 73.39% 186.279 38 Template:Citation\/core\n 61.83% 156.957 30 Template:Cite_web\n 14.46% 36.702 7 Template:Cite_journal\n 13.92% 35.340 30 Template:Date\n 9.68% 24.562 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing\n 4.48% 11.372 20 Template:Citation\/identifier\n 4.15% 10.533 52 Template:Citation\/make_link\n 2.90% 7.370 1 Template:Cite_book\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11912-0!canonical and timestamp 20210919173026 and revision id 39238. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","9618f22c10f370a964cc84bac6d8f3a5_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/b\/b1\/CDC_COVID-19_test_kit.jpg","https:\/\/upload.wikimedia.org\/wikipedia\/commons\/6\/66\/HIPAA_Screenshot.png"],"9618f22c10f370a964cc84bac6d8f3a5_timestamp":1632073384,"37226828a801fdd6cfb84d2a90e4ea36_type":"article","37226828a801fdd6cfb84d2a90e4ea36_title":"2.2 Testing conducted on previous coronaviruses","37226828a801fdd6cfb84d2a90e4ea36_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses","37226828a801fdd6cfb84d2a90e4ea36_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Diagnostic testing of COVID-19 and other coronaviruses\/Testing conducted on previous coronavirusesFrom LIMSWikiJump to navigationJump to searchContents \n\n1 2.2 Testing conducted on previous coronaviruses \n\n1.1 2.2.1 Severe acute respiratory syndrome (SARS) \n1.2 2.2.2 Middle East respiratory syndrome (MERS) \n1.3 2.2.3 The common cold \n\n\n2 References \n\n\n\n2.2 Testing conducted on previous coronaviruses \n 2.2.1 Severe acute respiratory syndrome (SARS) \nSevere acute respiratory syndrome, otherwise known as SARS, arose in South China in late 2002. Caused by the SARS coronavirus (SARS-CoV) and believed to have originated from horseshoe bats[1], SARS eventually was contained in the summer of 2003. The last known infection was in April 2004, due to a laboratory accident.[2] During that time, the following sample collection and test procedures evolved from the related outbreaks (note that this is only a summary; consult the cited literature directly for full details)[3][4][5][6][7]:\n\nDetermine that the patient is indicating clinical and\/or epidemiological evidence of SARS (meets case definitions). As Knobler et al. put it: \"SARS-CoV testing should be considered if no alternative diagnosis is identified 72 hours after initiation of the clinical evaluation and the patient is thought to be at high risk for SARS-CoV disease (e.g., is part of a cluster of unexplained pneumonia cases).\"[5]\nCollect multiple specimen types at different time points of the patient's illness. Respiratory and plasma or serum specimens should be collected early into the first week of illness. Respiratory samples should be from nasopharyngeal aspirates and swabs of the upper respiratory tract or, in some cases, fluids from the lower respiratory tract using bronchoalveolar lavage, tracheal aspiration, or a pleural tap. (Sputum can also be collected.) Whole blood (5 to 10 ml) is collected into either a serum separator tube for blood serum or EDTA tube for blood plasma. Stool samples are also of import early on for virus isolation or detection and are useful in at least the first and second weeks of the illness. Blood serum is useful in weeks two and three for detecting a rising titre. Additionally, the literature also makes reference to methods of collecting specimens postmortem.\nConduct testing. At the time, the two primary test types used were enzyme immunoassay (EIA; today more commonly known as ELISA[8]) for detection of serum antibody and reverse transcription polymerase chain reaction (RT-PCR) for detection of the virus' RNA. The U.S. Centers for Disease Control and Prevention (CDC) had this to say about these tests in May 2004[4]:\nBoth the EIA and the RT-PCR tests are sensitive and highly specific for SARS-CoV. The ability to diagnose SARS-CoV infection in a patient is often limited, however, by either the low concentration of virus in most clinical specimens (RT-PCR assays) or the time it takes a person to mount a measurable antibody response to SARS-CoV (serologic assays). The likelihood of detecting infection is increased if multiple specimens (e.g., stool, serum, respiratory tract specimens) are collected at several times during the course of illness.\nThe literature also makes reference to an immunofluorescence assay (IFA) for detecting antibody, with the CDC calling its results \"essentially identical to those for the EIA for SARS antibody.\"[4] Tangentially, isolation of SARS-CoV in cell culture from a clinical specimen is also referenced, though such activity is reserved for Biosafety Level 3 (BSL-3) laboratories.\nConfirm the results. Laboratory confirmation is based on one of 1. initial local lab detection and subsequent national reference lab confirmation of a validated serology-based test detection; 2. isolation of SARS-CoV in cell culture with subsequent confirmation from a validated test; or 3. initial local lab detection and subsequent national reference lab confirmation of SARS-CoV RNA from a validated RT-PCR test which used either two clinical specimens from different sources or two same-source clinical specimens from two different days.\nAdditionally, in the case of serology, one of the following must be true:\nSARS-CoV serum antibodies are detected in a single serum specimen; or,\na \"four-fold or greater increase in SARS-CoV antibody titer between acute- and convalescent-phase serum specimens tested in parallel\"[4] is detected; or,\na \"negative SARS-CoV antibody test result on acute-phase serum and positive SARS-CoV antibody test result on convalescent-phase serum tested in parallel\"[4] is detected.\nOf note is the World Health Organization's (WHO) January 2004 cautionary message about serological diagnostics in not only SARS-CoV but other types of coronaviruses. At that time, they showed a level of unsurety in regards to how coronaviruses elicited serological cross-reactions and generated antigenic recall. They also preached caution in interpreting serological results in non-epidemic periods and when no viral sequence data are available. Finally, they also mentioned the added difficulties of rate cases when coinfection with a related human coronavirus occurs, \"although the use of expressed proteins in Western blots may help to sort this out.\"[6] More than 15 years later, Loeffelholz and Tang put this concept into clearer terms, indicating that while \"serological assays are not routinely used for diagnosis of [human coronavirus] infections due to the lack of commercial reagents,\" they still have important value \"for understanding the epidemiology of emerging [human cornaviruses], including the burden and role of asymptomatic infections,\" as well as for antibody detection of novel and emerging coronaviruses.[9]\nArrange for confirmatory testing to be performed by an appropriate test site in the case of a positive RT-PCR test.\nReport to state or local health departments details of patients radiographically confirmed with pneumonia with at least one SARS-CoV risk factor for exposure, clusters of healthcare workers with unexplained pneumonia, and any positive SARS-CoV test results. Additional international reporting of SARS by WHO Member States in regards to probable and laboratory-confirmed cases is also requested.\nSend off for an additional verification by an external member of the WHO's SARS Reference and Verification Laboratory Network before internationally announcing results as a laboratory-confirmed case.\n 2.2.2 Middle East respiratory syndrome (MERS) \n Colorized transmission electron micrograph showing particles of the Middle East respiratory syndrome coronavirus that emerged in 2012Unlike SARS, Middle East respiratory syndrome, or MERS, continues to appear in the human population. Since its appearance in 2012, several thousand laboratory-confirmed cases of MERS have been reported to the WHO.[10] The virus MERS-CoV is believed to have originated from bats, which at some unknown point spread to Dromedary camels. Approximately 55 percent of MERS-CoV infections have come from direct contact with such camels, though it's not entirely clear how the rest of known cases have been caused[11] (Alshukairi et al. suggest asymptomatic or mildly symptomatic camel workers may serve as a possible transmission source[12]). The following sample collection and test procedures have evolved from working with the MERS-CoV virus (note that this is only a summary; consult the cited literature directly for full details)[13][14][15][16][17]:\nDetermine that the patient is indicating clinical and\/or epidemiological evidence of MERS (meets case definitions). \"Testing for other respiratory pathogens using routinely available laboratory procedures, as recommended in local management guidelines for community-acquired pneumonia, should also be performed but should not delay testing for MERS-CoV.\"[15]\nCollect at a minimum both lower respiratory and upper respiratory tract samples. Lower respiratory tract specimens are typically the most revealing, as they have been shown to contain the highest viral load (due to the expression of the virus's cellular receptor DPP4 in the lower respiratory system). Bronchoalveolar lavage, tracheal aspiration, or a pleural tap can be used to collect specimens from the lower respiratory tract. (Sputum can also be collected.) Upper respiratory tract specimens (in this case, both a nasopharyngeal and an oropharyngeal swab are recommended) are also valuable in diagnosis, though extra care should be taken to ensure nasopharyngeal swabs gather secretions from the nasopharynx and not just the nostril. Nasopharyngeal aspiration is also an acceptable sample collection method for the upper respiratory tract.\nRegarding serum specimens, slight differences in guidance appear between WHO guidance and CDC guidance. The WHO appears to differentiate between symptomatic and asymptomatic patient testing, whereas the U.S. CDC seems to only indirectly differentiate the two. The WHO suggests if testing symptomatic patients, stick with lower and upper respiratory tract specimens, which will be tested using nucleic acid amplification (molecular) testing (NAAT). Serological testing of serum specimens should be used for symptomatic patients \"only if NAAT is not available.\"[15] If this is the case, the WHO recommends paired samples, one collected within the first week of illness and the second about three to four weeks later. For asymptomatic patients in high-contact outbreak scenarios, the WHO recommends all three sample types (with respiratory samples taken preferably within 14 days of last documented contact).\nThe current CDC guidance differentiates between molecular testing for active infections and serology for previous infections. The CDC adds that \"MERS-CoV serology tests are for surveillance or investigational purposes and not for diagnostic purposes.\"[13] Whether or not to collect a serum specimen in MERS diagnostics may depend on the assay used, however. For example, the CDC, in its Version 2.1 guidance, indicates that testing using the CDC MERS rRT-PCR assay requires collection of serum in addition to upper and lower respiratory tract specimens. For that specific assay, the CDC differentiates between patients who've had symptom onset less than 14 days prior and those who've had it 14 days or later: if prior, serology is for the rRT-PCR test, and if later, serology is for antibody testing. In either case, 200 \u00b5L of serum is required.\nConduct testing. NAAT methods like real-time reverse-transcription polymerase chain reaction (rRT-PCR) assays have been the most common tool for diagnosing MERS-CoV infection due to their high sensitivity. According to late 2018 research by Kelly-Cirino et al., at least 11 commercial single assay and five commercial multiplex assay kits are available (see Table S1, a PDF file, from their highly relevant paper), perhaps more as of April 2020. Serological antibody detection is performed using ELISA, indirect immunofluorescence (IIF), and microneutralization.\nConfirm the results. Laboratory confirmation of MERS-CoV infection is the same for both the WHO and the CDC: one of either a validated NAAT test providing a positive result for at least two different genomic targets, or a validated NAAT test providing a positive result for a specific genomic target along with sequencing confirmation of a separate genomic target. Persons under investigation who receive one negative NAAT result on a recommended specimen are considered to be negative for active MERS-CoV infection. The laboratory should consider testing additional specimens after the first negative. The CDC considers known MERS patients to be negative for active MERS-CoV infection after two consecutive negative NAAT tests on all specimens. The WHO adds: \"A patient with a positive NAAT result for a single specific target without further testing but with a history of potential exposure and consistent clinical signs is considered a probable case.\"[15] The WHO also has additional guidance on using serology for confirming MERS-CoV infection for purposes of reporting under the International Health Regulations.\nReport using national reporting requirements. More broadly, state or local health departments should receive details about received specimens to be tested for MERS-CoV, even before testing begins. Regardless of result, the final positive or negative laboratory confirmation should also be reported to national authorities. If the infection becomes widespread, updates for each new confirmed case or suspected positive should also be made.\n2.2.3 The common cold \nApproximately 10 to 15 percent of cases of what we call the \"common cold\" are associated with an endemic coronavirus, of which are two distinct groups: HCoV-229E and HCoV-OC43.[18] Disease symptoms associated with these coronaviruses\u2014typically in the form of respiratory infection and the symptoms that come with it\u2014by themselves are typically mild[9], and laboratory testing isn't necessarily indicated for those immunocompetent individuals capable of self-limiting.[19] However, symptom overlap with pharyngitis and bronchitis, as well as the complication of pharyngitis and sinusitis also potentially having bacterial origin, can complicate clinical diagnosis. Additionally, as more antivirals that target a specific virus are created, and as concerns of unnecessarily using antibiotics to treat viral diseases grows[20][21], laboratory methods of respiratory virus diagnosis\u2014particularly for those who are immunocompromised\u2014have value.[18][19] \nRT-PCR, a molecular method, has been used for well over a decade for detecting coronaviruses.[18][22] However, as molecular methods of analysis have expanded over the years, more rapid solutions for testing have been developed. For example, the GenMark ePlex rapid multiplex molecular diagnostics instrument and the ePlex Respiratory Pathogen Panel were evaluated in a multicenter trial by Babady et al. in 2017.[19] The panel is capable of testing for the presence of 15 viral types\u2014including the -229E, -OC43, and two other coronaviruses\u2014and two bacterial types in nasopharyngeal swab specimens, with results in typically less than two hours.[19] The cost associated with these sorts of tests, compared to their benefits, likely limits ubiquitous use at the first sign of a cold[19], but as molecular diagnostic technologies become more compact and easy-to-use, testing for infection by endemic human coronaviruses may become slightly more commonplace. However, as the authors point out, with no treatment for these endemic coronaviruses, any additional utility beyond diagnosing an illness as viral rather than bacterial would primarily be found in epidemiological studies of the associated genotyping data.[19]\n\nReferences \n\n\n\u2191 McKie, R. (9 December 2017). \"Scientists trace 2002 Sars virus to colony of cave-dwelling bats in China\". The Guardian. https:\/\/www.theguardian.com\/world\/2017\/dec\/10\/sars-virus-bats-china-severe-acute-respiratory-syndrome . Retrieved 03 April 2020 .   \n \n\n\u2191 Normile, D. (2004). \"Mounting Lab Accidents Raise SARS Fears\". Science (5671): 659\u201361. doi:10.1126\/science.304.5671.659. PMID 15118129.   \n \n\n\u2191 New York State Department of Health (February 2004). \"Laboratory Testing for SARS\". State of New York. https:\/\/www.health.ny.gov\/diseases\/communicable\/sars\/sars_reporting\/attachment_6_dear_doctor_lab.htm . Retrieved 03 April 2020 .   \n \n\n\u2191 4.0 4.1 4.2 4.3 4.4 Centers for Disease Control and Prevention (21 May 2004). \"Public Health Guidance for Community-Level Preparedness and Response to Severe Acute Respiratory Syndrome (SARS), Version 2 - Supplement F: Laboratory Guidance\" (PDF). Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/sars\/guidance\/f-lab\/downloads\/F-lab-full.pdf . Retrieved 03 April 2020 .   \n \n\n\u2191 5.0 5.1 Knobler, S.; Mahmoud, A.; Lemon, S. et al., ed. (2004). \"Appendix C: In the absence of SARS-CoV transmission worldwide: Guidance for surveillance, clinical and laboratory evaluation, and reporting\". Learning from SARS: Preparing for the Next Disease Outbreak. National Academies Press. pp. 292\u2013302. doi:10.17226\/10915. ISBN 9780309182157.   \n \n\n\u2191 6.0 6.1 World Health Organization (23 January 2004). \"WHO SARS International Reference and Verification Laboratory Network: Policy and Procedures in the Inter-Epidemic Period\". World Health Organization. http:\/\/www.who.int\/csr\/resources\/publications\/en\/SARSReferenceLab.pdf . Retrieved 03 April 2020 .   \n \n\n\u2191 Liang, G.; Chen, Q.; Xu, J. et al. (2004). \"Laboratory Diagnosis of Four Recent Sporadic Cases of Community-acquired SARS, Guangdong Province, China\". Emerging Infectious Diseases 10 (10): 1774\u201381. doi:10.3201\/eid1010.040445. PMC PMC3323270. PMID 15504263. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC3323270 .   \n \n\n\u2191 Lequin, R.M. (2005). \"Enzyme Immunoassay (EIA)\/Enzyme-Linked Immunosorbent Assay (ELISA)\". Clinical Chemistry 51 (12): 2415\u201318. doi:10.1373\/clinchem.2005.051532. PMID 16179424.   \n \n\n\u2191 9.0 9.1 Loeffelholz, M.J.; Tang, T.-W. (2020). \"Laboratory diagnosis of emerging human coronavirus infections \u2013 The state of the art\". Emerging Microbes & Infections 9 (1): 747\u201356. doi:10.1080\/22221751.2020.1745095. PMID 32196430.   \n \n\n\u2191 Bernard-Stoecklin, S.; Nikolay, B.; Assiri, A. et al. (2019). \"Comparative Analysis of Eleven Healthcare-Associated Outbreaks of Middle East Respiratory Syndrome Coronavirus (Mers-Cov) from 2015 to 2017\". Scientific Reports 9: 7385. doi:10.1038\/s41598-019-43586-9. PMC PMC6517387. PMID 31089148. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6517387 .   \n \n\n\u2191 Banerjee, A.; Kulcsar, K.; Misra, V. et al. (2019). \"Bats and Coronaviruses\". Viruses 11 (1): E41. doi:10.3390\/v11010041. PMC PMC6356540. PMID 30634396. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6356540 .   \n \n\n\u2191 Alshukairi, A.N.; Zheng, J.; Zhao, J. et al. (2018). \"High Prevalence of MERS-CoV Infection in Camel Workers in Saudi Arabia\". mBio 9 (5): e01985-18. doi:10.1128\/mBio.01985-18. PMC PMC6212820. PMID 30377284. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6212820 .   \n \n\n\u2191 13.0 13.1 Centers for Disease Control and Prevention (2 August 2019). \"CDC Laboratory Testing for Middle East Respiratory Syndrome Coronavirus (MERS-CoV)\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/mers\/lab\/lab-testing.html . Retrieved 04 April 2020 .   \n \n\n\u2191 Centers for Disease Control and Prevention (2 August 2019). \"Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) \u2013 Version 2.1\". Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/coronavirus\/mers\/guidelines-clinical-specimens.html . Retrieved 04 April 2020 .   \n \n\n\u2191 15.0 15.1 15.2 15.3 World Health Organization (January 2018). \"Laboratory testing for Middle East Respiratory Syndrome Coronavirus: Interim guidance\". WHO\/MERS\/LAB\/15.1\/Rev1\/2018. World Health Organization. https:\/\/www.who.int\/csr\/disease\/coronavirus_infections\/mers-laboratory-testing\/en\/ . Retrieved 04 April 2020 .   \n \n\n\u2191 Al-Abdely, H.M.; Midgley, C.M.; Alkhamis, A.M. et al. (2019). \"Middle East Respiratory Syndrome Coronavirus Infection Dynamics and Antibody Responses among Clinically Diverse Patients, Saudi Arabia\". Emerging Infectious Diseases 25 (4): 753-766. doi:10.3201\/eid2504.181595.   \n \n\n\u2191 Kelly-Cirino, C.; Mazzola, L.T.; Chua, A. et al. (2019). \"An updated roadmap for MERS-CoV research and product development: focus on diagnostics\". BMJ Global Health 4 (Suppl. 2): e001105. doi:10.1136\/bmjgh-2018-001105. PMC PMC6361340. PMID 30815285. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6361340 .   \n \n\n\u2191 18.0 18.1 18.2 Wat, D. (2004). \"The common cold: A review of the literature\". European Journal of Internal Medicine 15 (2): 79\u201388. doi:10.1016\/j.ejim.2004.01.006. PMID 15172021.   \n \n\n\u2191 19.0 19.1 19.2 19.3 19.4 19.5 Babady, N.E.; England, M.R.; Jurcic Smith, K.L. et al. (2018). \"Multicenter Evaluation of the ePlex Respiratory Pathogen Panel for the Detection of Viral and Bacterial Respiratory Tract Pathogens in Nasopharyngeal Swabs\". Journal of Clinical Microbiology 56 (2): e01658-17. doi:10.1128\/JCM.01658-17. PMC PMC5786739. PMID 29212701. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC5786739 .   \n \n\n\u2191 Jenison, R. (30 November 2016). \"Rapid lab tests can help reduce antibiotic resistance\". STAT. https:\/\/www.statnews.com\/2016\/11\/30\/antibiotic-resistance-molecular-diagnostics\/ . Retrieved 03 April 2020 .   \n \n\n\u2191 Roy, K. (26 September 2018). \"Rapid test for viral infections reduces unnecessary antibiotic prescribing\". Healio. https:\/\/www.healio.com\/news\/infectious-disease\/20180926\/rapid-test-for-viral-infections-reduces-unnecessary-antibiotic-prescribing . Retrieved 06 September 2021 .   \n \n\n\u2191 Mahoney, J.B. (2008). \"Detection of Respiratory Viruses by Molecular Methods\". Clinical Microbiology Reviews 21 (4): 716\u201347. doi:10.1128\/CMR.00037-07. PMC PMC2570148. PMID 18854489. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC2570148 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 3 May 2020, at 19:36.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 259 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","37226828a801fdd6cfb84d2a90e4ea36_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Diagnostic_testing_of_COVID-19_and_other_coronaviruses_Testing_conducted_on_previous_coronaviruses rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Diagnostic_testing_of_COVID-19_and_other_coronaviruses_Testing_conducted_on_previous_coronaviruses skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Diagnostic testing of COVID-19 and other coronaviruses\/Testing conducted on previous coronaviruses<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\">\n\n<h3><span class=\"mw-headline\" id=\"2.2_Testing_conducted_on_previous_coronaviruses\">2.2 Testing conducted on previous coronaviruses<\/span><\/h3>\n<h4><span id=\"rdp-ebb-2.2.1_Severe_acute_respiratory_syndrome_(SARS)\"><\/span><span class=\"mw-headline\" id=\"2.2.1_Severe_acute_respiratory_syndrome_.28SARS.29\">2.2.1 Severe acute respiratory syndrome (SARS)<\/span><\/h4>\n<p><a href=\"https:\/\/www.limswiki.org\/index.php\/Severe_acute_respiratory_syndrome\" title=\"Severe acute respiratory syndrome\" class=\"wiki-link\" data-key=\"11abe2043ece64ad43ee0052402c5cec\">Severe acute respiratory syndrome<\/a>, otherwise known as SARS, arose in South China in late 2002. Caused by the SARS coronavirus (SARS-CoV) and believed to have originated from horseshoe bats<sup id=\"rdp-ebb-cite_ref-McKieScientists17_1-0\" class=\"reference\"><a href=\"#cite_note-McKieScientists17-1\">[1]<\/a><\/sup>, SARS eventually was contained in the summer of 2003. The last known infection was in April 2004, due to a laboratory accident.<sup id=\"rdp-ebb-cite_ref-NormileMounting04_2-0\" class=\"reference\"><a href=\"#cite_note-NormileMounting04-2\">[2]<\/a><\/sup> During that time, the following sample collection and test procedures evolved from the related outbreaks (note that this is only a summary; consult the cited literature directly for full details)<sup id=\"rdp-ebb-cite_ref-NYSDHLab04_3-0\" class=\"reference\"><a href=\"#cite_note-NYSDHLab04-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CDCSevere04_4-0\" class=\"reference\"><a href=\"#cite_note-CDCSevere04-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KnoblerLearning04_5-0\" class=\"reference\"><a href=\"#cite_note-KnoblerLearning04-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WHO_SARSInt04_6-0\" class=\"reference\"><a href=\"#cite_note-WHO_SARSInt04-6\">[6]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LiangLab04_7-0\" class=\"reference\"><a href=\"#cite_note-LiangLab04-7\">[7]<\/a><\/sup>:\n<\/p>\n<ul><li>Determine that the patient is indicating clinical and\/or epidemiological evidence of SARS (meets case definitions). As Knobler <i>et al.<\/i> put it: \"SARS-CoV testing should be considered if no alternative diagnosis is identified 72 hours after initiation of the clinical evaluation and the patient is thought to be at high risk for SARS-CoV disease (e.g., is part of a cluster of unexplained pneumonia cases).\"<sup id=\"rdp-ebb-cite_ref-KnoblerLearning04_5-1\" class=\"reference\"><a href=\"#cite_note-KnoblerLearning04-5\">[5]<\/a><\/sup><\/li><\/ul>\n<ul><li>Collect multiple specimen types at different time points of the patient's illness. Respiratory and plasma or serum specimens should be collected early into the first week of illness. Respiratory samples should be from <a href=\"https:\/\/www.limswiki.org\/index.php\/Nasopharyngeal_swab\" title=\"Nasopharyngeal swab\" class=\"wiki-link\" data-key=\"18d5d4e09d1fc5ddb05a22b36ace9daf\">nasopharyngeal aspirates and swabs<\/a> of the upper respiratory tract or, in some cases, fluids from the lower respiratory tract using <a href=\"https:\/\/www.limswiki.org\/index.php\/Bronchoalveolar_lavage\" title=\"Bronchoalveolar lavage\" class=\"wiki-link\" data-key=\"500aa79d30c49b81ed6c58bc319231dc\">bronchoalveolar lavage<\/a>, tracheal aspiration, or a pleural tap. (Sputum can also be collected.) Whole blood (5 to 10 ml) is collected into either a serum separator tube for blood serum or EDTA tube for blood plasma. Stool samples are also of import early on for virus isolation or detection and are useful in at least the first and second weeks of the illness. Blood serum is useful in weeks two and three for detecting a rising titre. Additionally, the literature also makes reference to methods of collecting specimens <i>postmortem<\/i>.<\/li><\/ul>\n<ul><li>Conduct testing. At the time, the two primary test types used were enzyme immunoassay (EIA; today more commonly known as <a href=\"https:\/\/www.limswiki.org\/index.php\/ELISA\" title=\"ELISA\" class=\"wiki-link\" data-key=\"f48f479ea5841a7362147598ac925bd6\">ELISA<\/a><sup id=\"rdp-ebb-cite_ref-LequinEnzyme05_8-0\" class=\"reference\"><a href=\"#cite_note-LequinEnzyme05-8\">[8]<\/a><\/sup>) for detection of serum antibody and reverse transcription polymerase chain reaction (RT-PCR) for detection of the virus' RNA. The U.S. <a href=\"https:\/\/www.limswiki.org\/index.php\/Centers_for_Disease_Control_and_Prevention\" title=\"Centers for Disease Control and Prevention\" class=\"wiki-link\" data-key=\"176aa9c9513251c328d864d1e724e814\">Centers for Disease Control and Prevention<\/a> (CDC) had this to say about these tests in May 2004<sup id=\"rdp-ebb-cite_ref-CDCSevere04_4-1\" class=\"reference\"><a href=\"#cite_note-CDCSevere04-4\">[4]<\/a><\/sup>:<\/li><\/ul>\n<blockquote><p>Both the EIA and the RT-PCR tests are sensitive and highly specific for SARS-CoV. The ability to diagnose SARS-CoV infection in a patient is often limited, however, by either the low concentration of virus in most clinical specimens (RT-PCR assays) or the time it takes a person to mount a measurable antibody response to SARS-CoV (serologic assays). The likelihood of detecting infection is increased if multiple specimens (e.g., stool, serum, respiratory tract specimens) are collected at several times during the course of illness.<\/p><\/blockquote>\n<dl><dd>The literature also makes reference to an <a href=\"https:\/\/www.limswiki.org\/index.php\/Immunofluorescence\" title=\"Immunofluorescence\" class=\"wiki-link\" data-key=\"c55d45a8ab77d3257b745272419e865c\">immunofluorescence assay<\/a> (IFA) for detecting antibody, with the CDC calling its results \"essentially identical to those for the EIA for SARS antibody.\"<sup id=\"rdp-ebb-cite_ref-CDCSevere04_4-2\" class=\"reference\"><a href=\"#cite_note-CDCSevere04-4\">[4]<\/a><\/sup> Tangentially, isolation of SARS-CoV in cell culture from a clinical specimen is also referenced, though such activity is reserved for <a href=\"https:\/\/www.limswiki.org\/index.php\/Biosafety_level\" title=\"Biosafety level\" class=\"wiki-link\" data-key=\"df3da482bc6a095d4f125bcf7fccfc76\">Biosafety Level 3<\/a> (BSL-3) laboratories.<\/dd><\/dl>\n<ul><li>Confirm the results. Laboratory confirmation is based on one of 1. initial local lab detection and subsequent national reference lab confirmation of a validated serology-based test detection; 2. isolation of SARS-CoV in cell culture with subsequent confirmation from a validated test; or 3. initial local lab detection and subsequent national reference lab confirmation of SARS-CoV RNA from a validated RT-PCR test which used either two clinical specimens from different sources or two same-source clinical specimens from two different days.<\/li><\/ul>\n<dl><dd>Additionally, in the case of serology, one of the following must be true:<\/dd><\/dl>\n<ol><li>SARS-CoV serum antibodies are detected in a single serum specimen; or,<\/li>\n<li>a \"four-fold or greater increase in SARS-CoV antibody titer between acute- and convalescent-phase serum specimens tested in parallel\"<sup id=\"rdp-ebb-cite_ref-CDCSevere04_4-3\" class=\"reference\"><a href=\"#cite_note-CDCSevere04-4\">[4]<\/a><\/sup> is detected; or,<\/li>\n<li>a \"negative SARS-CoV antibody test result on acute-phase serum and positive SARS-CoV antibody test result on convalescent-phase serum tested in parallel\"<sup id=\"rdp-ebb-cite_ref-CDCSevere04_4-4\" class=\"reference\"><a href=\"#cite_note-CDCSevere04-4\">[4]<\/a><\/sup> is detected.<\/li><\/ol>\n<dl><dd>Of note is the <a href=\"https:\/\/www.limswiki.org\/index.php\/World_Health_Organization\" title=\"World Health Organization\" class=\"wiki-link\" data-key=\"2a49f1470638d5f579e3f6419e239b03\">World Health Organization<\/a>'s (WHO) January 2004 cautionary message about serological diagnostics in not only SARS-CoV but other types of coronaviruses. At that time, they showed a level of unsurety in regards to how coronaviruses elicited serological cross-reactions and generated antigenic recall. They also preached caution in interpreting serological results in non-epidemic periods and when no viral sequence data are available. Finally, they also mentioned the added difficulties of rate cases when coinfection with a related human coronavirus occurs, \"although the use of expressed proteins in Western blots may help to sort this out.\"<sup id=\"rdp-ebb-cite_ref-WHO_SARSInt04_6-1\" class=\"reference\"><a href=\"#cite_note-WHO_SARSInt04-6\">[6]<\/a><\/sup> More than 15 years later, Loeffelholz and Tang put this concept into clearer terms, indicating that while \"serological assays are not routinely used for diagnosis of [human coronavirus] infections due to the lack of commercial reagents,\" they still have important value \"for understanding the epidemiology of emerging [human cornaviruses], including the burden and role of asymptomatic infections,\" as well as for antibody detection of novel and emerging coronaviruses.<sup id=\"rdp-ebb-cite_ref-LoeffelholzLab20_9-0\" class=\"reference\"><a href=\"#cite_note-LoeffelholzLab20-9\">[9]<\/a><\/sup><\/dd><\/dl>\n<ul><li>Arrange for confirmatory testing to be performed by an appropriate test site in the case of a positive RT-PCR test.<\/li><\/ul>\n<ul><li>Report to state or local health departments details of patients radiographically confirmed with pneumonia with at least one SARS-CoV risk factor for exposure, clusters of healthcare workers with unexplained pneumonia, and any positive SARS-CoV test results. Additional international reporting of SARS by WHO Member States in regards to probable and laboratory-confirmed cases is also requested.<\/li><\/ul>\n<ul><li>Send off for an additional verification by an external member of the WHO's SARS Reference and Verification Laboratory Network before internationally announcing results as a laboratory-confirmed case.<\/li><\/ul>\n<h4><span id=\"rdp-ebb-2.2.2_Middle_East_respiratory_syndrome_(MERS)\"><\/span><span class=\"mw-headline\" id=\"2.2.2_Middle_East_respiratory_syndrome_.28MERS.29\">2.2.2 Middle East respiratory syndrome (MERS)<\/span><\/h4>\n<div class=\"thumb tleft\"><div class=\"thumbinner\" style=\"width:302px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:MERS-CoV_Particles_(8414774264).jpg\" class=\"image wiki-link\" data-key=\"19452b37ce3ed860f29d857efa8edccf\"><img alt=\"\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/4\/4b\/MERS-CoV_Particles_%288414774264%29.jpg\" decoding=\"async\" width=\"300\" height=\"390\" class=\"thumbimage\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:MERS-CoV_Particles_(8414774264).jpg\" class=\"internal wiki-link\" title=\"Enlarge\" data-key=\"19452b37ce3ed860f29d857efa8edccf\"><\/a><\/div>Colorized transmission electron micrograph showing particles of the Middle East respiratory syndrome coronavirus that emerged in 2012<\/div><\/div><\/div><p>Unlike SARS, Middle East respiratory syndrome, or MERS, continues to appear in the human population. Since its appearance in 2012, several thousand laboratory-confirmed cases of MERS have been reported to the WHO.<sup id=\"rdp-ebb-cite_ref-Bernard-StoecklinCompar19_10-0\" class=\"reference\"><a href=\"#cite_note-Bernard-StoecklinCompar19-10\">[10]<\/a><\/sup> The virus MERS-CoV is believed to have originated from bats, which at some unknown point spread to Dromedary camels. Approximately 55 percent of MERS-CoV infections have come from direct contact with such camels, though it's not entirely clear how the rest of known cases have been caused<sup id=\"rdp-ebb-cite_ref-BanerjeeBats19_11-0\" class=\"reference\"><a href=\"#cite_note-BanerjeeBats19-11\">[11]<\/a><\/sup> (Alshukairi <i>et al.<\/i> suggest asymptomatic or mildly symptomatic camel workers may serve as a possible transmission source<sup id=\"rdp-ebb-cite_ref-AlshukairiHigh18_12-0\" class=\"reference\"><a href=\"#cite_note-AlshukairiHigh18-12\">[12]<\/a><\/sup>). The following sample collection and test procedures have evolved from working with the MERS-CoV virus (note that this is only a summary; consult the cited literature directly for full details)<sup id=\"rdp-ebb-cite_ref-CDCLabTestMERS19_13-0\" class=\"reference\"><a href=\"#cite_note-CDCLabTestMERS19-13\">[13]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CDCInterimMERS19_14-0\" class=\"reference\"><a href=\"#cite_note-CDCInterimMERS19-14\">[14]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WHOLabMERS18_15-0\" class=\"reference\"><a href=\"#cite_note-WHOLabMERS18-15\">[15]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Al-AbdelyMiddle19_16-0\" class=\"reference\"><a href=\"#cite_note-Al-AbdelyMiddle19-16\">[16]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Kelly-CirinoAnUpdated19_17-0\" class=\"reference\"><a href=\"#cite_note-Kelly-CirinoAnUpdated19-17\">[17]<\/a><\/sup>:\n<\/p><ul><li>Determine that the patient is indicating clinical and\/or epidemiological evidence of MERS (meets case definitions). \"Testing for other respiratory pathogens using routinely available laboratory procedures, as recommended in local management guidelines for community-acquired pneumonia, should also be performed but should not delay testing for MERS-CoV.\"<sup id=\"rdp-ebb-cite_ref-WHOLabMERS18_15-1\" class=\"reference\"><a href=\"#cite_note-WHOLabMERS18-15\">[15]<\/a><\/sup><\/li><\/ul>\n<ul><li>Collect at a minimum both lower respiratory and upper respiratory tract samples. Lower respiratory tract specimens are typically the most revealing, as they have been shown to contain the highest viral load (due to the expression of the virus's cellular receptor DPP4 in the lower respiratory system). Bronchoalveolar lavage, tracheal aspiration, or a pleural tap can be used to collect specimens from the lower respiratory tract. (Sputum can also be collected.) Upper respiratory tract specimens (in this case, both a nasopharyngeal and an oropharyngeal swab are recommended) are also valuable in diagnosis, though extra care should be taken to ensure nasopharyngeal swabs gather secretions from the <a href=\"https:\/\/www.limswiki.org\/index.php\/Pharynx#Nasopharynx\" title=\"Pharynx\" class=\"wiki-link\" data-key=\"4ac1cfa358d8a1be59a60ff22c944721\">nasopharynx<\/a> and not just the nostril. Nasopharyngeal aspiration is also an acceptable sample collection method for the upper respiratory tract.<\/li><\/ul>\n<dl><dd>Regarding serum specimens, slight differences in guidance appear between WHO guidance and CDC guidance. The WHO appears to differentiate between symptomatic and asymptomatic patient testing, whereas the U.S. CDC seems to only indirectly differentiate the two. The WHO suggests if testing symptomatic patients, stick with lower and upper respiratory tract specimens, which will be tested using nucleic acid amplification (molecular) testing (NAAT). Serological testing of serum specimens should be used for symptomatic patients \"only if NAAT is not available.\"<sup id=\"rdp-ebb-cite_ref-WHOLabMERS18_15-2\" class=\"reference\"><a href=\"#cite_note-WHOLabMERS18-15\">[15]<\/a><\/sup> If this is the case, the WHO recommends paired samples, one collected within the first week of illness and the second about three to four weeks later. For asymptomatic patients in high-contact outbreak scenarios, the WHO recommends all three sample types (with respiratory samples taken preferably within 14 days of last documented contact).<\/dd><\/dl>\n<dl><dd>The current CDC guidance differentiates between molecular testing for active infections and serology for previous infections. The CDC adds that \"MERS-CoV serology tests are for surveillance or investigational purposes and not for diagnostic purposes.\"<sup id=\"rdp-ebb-cite_ref-CDCLabTestMERS19_13-1\" class=\"reference\"><a href=\"#cite_note-CDCLabTestMERS19-13\">[13]<\/a><\/sup> Whether or not to collect a serum specimen in MERS diagnostics may depend on the assay used, however. For example, the CDC, in its Version 2.1 guidance, indicates that testing using the CDC MERS rRT-PCR assay requires collection of serum in addition to upper and lower respiratory tract specimens. For that specific assay, the CDC differentiates between patients who've had symptom onset less than 14 days prior and those who've had it 14 days or later: if prior, serology is for the rRT-PCR test, and if later, serology is for antibody testing. In either case, 200 \u00b5L of serum is required.<\/dd><\/dl>\n<ul><li>Conduct testing. NAAT methods like real-time reverse-transcription polymerase chain reaction (rRT-PCR) assays have been the most common tool for diagnosing MERS-CoV infection due to their high sensitivity. According to late 2018 research by Kelly-Cirino <i>et al.<\/i>, at least 11 commercial single assay and five commercial multiplex assay kits are available (see <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/gh.bmj.com\/content\/bmjgh\/4\/Suppl_2\/e001105\/DC1\/embed\/inline-supplementary-material-1.pdf\" target=\"_blank\">Table S1<\/a>, a PDF file, from their highly relevant paper), perhaps more as of April 2020. Serological antibody detection is performed using ELISA, <a href=\"https:\/\/www.limswiki.org\/index.php\/Immunofluorescence#Secondary_.28indirect.29\" title=\"Immunofluorescence\" class=\"wiki-link\" data-key=\"cd9ba67908563e501dce7f4e64008d1d\">indirect immunofluorescence<\/a> (IIF), and <a href=\"https:\/\/www.limswiki.org\/index.php\/Neutralisation_(immunology)\" title=\"Neutralisation (immunology)\" class=\"wiki-link\" data-key=\"d1792d8486f8f102f633d759ffe50cdb\">microneutralization<\/a>.<\/li><\/ul>\n<ul><li>Confirm the results. Laboratory confirmation of MERS-CoV infection is the same for both the WHO and the CDC: one of either a validated NAAT test providing a positive result for at least two different genomic targets, or a validated NAAT test providing a positive result for a specific genomic target along with sequencing confirmation of a separate genomic target. Persons under investigation who receive one negative NAAT result on a recommended specimen are considered to be negative for active MERS-CoV infection. The laboratory should consider testing additional specimens after the first negative. The CDC considers known MERS patients to be negative for active MERS-CoV infection after two consecutive negative NAAT tests on all specimens. The WHO adds: \"A patient with a positive NAAT result for a single specific target without further testing but with a history of potential exposure and consistent clinical signs is considered a probable case.\"<sup id=\"rdp-ebb-cite_ref-WHOLabMERS18_15-3\" class=\"reference\"><a href=\"#cite_note-WHOLabMERS18-15\">[15]<\/a><\/sup> The WHO also has additional guidance on using serology for confirming MERS-CoV infection for purposes of reporting under the International Health Regulations.<\/li><\/ul>\n<ul><li>Report using national reporting requirements. More broadly, state or local health departments should receive details about received specimens to be tested for MERS-CoV, even before testing begins. Regardless of result, the final positive or negative laboratory confirmation should also be reported to national authorities. If the infection becomes widespread, updates for each new confirmed case or suspected positive should also be made.<\/li><\/ul>\n<h4><span class=\"mw-headline\" id=\"2.2.3_The_common_cold\">2.2.3 The common cold<\/span><\/h4>\n<p>Approximately 10 to 15 percent of cases of what we call the \"common cold\" are associated with an endemic coronavirus, of which are two distinct groups: HCoV-229E and HCoV-OC43.<sup id=\"rdp-ebb-cite_ref-WatTheCommon04_18-0\" class=\"reference\"><a href=\"#cite_note-WatTheCommon04-18\">[18]<\/a><\/sup> Disease symptoms associated with these coronaviruses\u2014typically in the form of respiratory infection and the symptoms that come with it\u2014by themselves are typically mild<sup id=\"rdp-ebb-cite_ref-LoeffelholzLab20_9-1\" class=\"reference\"><a href=\"#cite_note-LoeffelholzLab20-9\">[9]<\/a><\/sup>, and laboratory testing isn't necessarily indicated for those immunocompetent individuals capable of self-limiting.<sup id=\"rdp-ebb-cite_ref-BabadyMulti18_19-0\" class=\"reference\"><a href=\"#cite_note-BabadyMulti18-19\">[19]<\/a><\/sup> However, symptom overlap with pharyngitis and bronchitis, as well as the complication of pharyngitis and sinusitis also potentially having bacterial origin, can complicate clinical diagnosis. Additionally, as more antivirals that target a specific virus are created, and as concerns of unnecessarily using antibiotics to treat viral diseases grows<sup id=\"rdp-ebb-cite_ref-JenisonRapid16_20-0\" class=\"reference\"><a href=\"#cite_note-JenisonRapid16-20\">[20]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RoyRapid18_21-0\" class=\"reference\"><a href=\"#cite_note-RoyRapid18-21\">[21]<\/a><\/sup>, laboratory methods of respiratory virus diagnosis\u2014particularly for those who are immunocompromised\u2014have value.<sup id=\"rdp-ebb-cite_ref-WatTheCommon04_18-1\" class=\"reference\"><a href=\"#cite_note-WatTheCommon04-18\">[18]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BabadyMulti18_19-1\" class=\"reference\"><a href=\"#cite_note-BabadyMulti18-19\">[19]<\/a><\/sup> \n<\/p><p>RT-PCR, a molecular method, has been used for well over a decade for detecting coronaviruses.<sup id=\"rdp-ebb-cite_ref-WatTheCommon04_18-2\" class=\"reference\"><a href=\"#cite_note-WatTheCommon04-18\">[18]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MahonyDetect08_22-0\" class=\"reference\"><a href=\"#cite_note-MahonyDetect08-22\">[22]<\/a><\/sup> However, as molecular methods of analysis have expanded over the years, more rapid solutions for testing have been developed. For example, the GenMark ePlex rapid multiplex molecular diagnostics instrument and the ePlex Respiratory Pathogen Panel were evaluated in a multicenter trial by Babady <i>et al.<\/i> in 2017.<sup id=\"rdp-ebb-cite_ref-BabadyMulti18_19-2\" class=\"reference\"><a href=\"#cite_note-BabadyMulti18-19\">[19]<\/a><\/sup> The panel is capable of testing for the presence of 15 viral types\u2014including the -229E, -OC43, and two other coronaviruses\u2014and two bacterial types in nasopharyngeal swab specimens, with results in typically less than two hours.<sup id=\"rdp-ebb-cite_ref-BabadyMulti18_19-3\" class=\"reference\"><a href=\"#cite_note-BabadyMulti18-19\">[19]<\/a><\/sup> The cost associated with these sorts of tests, compared to their benefits, likely limits ubiquitous use at the first sign of a cold<sup id=\"rdp-ebb-cite_ref-BabadyMulti18_19-4\" class=\"reference\"><a href=\"#cite_note-BabadyMulti18-19\">[19]<\/a><\/sup>, but as molecular diagnostic technologies become more compact and easy-to-use, testing for infection by endemic human coronaviruses may become slightly more commonplace. However, as the authors point out, with no treatment for these endemic coronaviruses, any additional utility beyond diagnosing an illness as viral rather than bacterial would primarily be found in epidemiological studies of the associated genotyping data.<sup id=\"rdp-ebb-cite_ref-BabadyMulti18_19-5\" class=\"reference\"><a href=\"#cite_note-BabadyMulti18-19\">[19]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-McKieScientists17-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-McKieScientists17_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">McKie, R. (9 December 2017). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.theguardian.com\/world\/2017\/dec\/10\/sars-virus-bats-china-severe-acute-respiratory-syndrome\" target=\"_blank\">\"Scientists trace 2002 Sars virus to colony of cave-dwelling bats in China\"<\/a>. <i>The Guardian<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.theguardian.com\/world\/2017\/dec\/10\/sars-virus-bats-china-severe-acute-respiratory-syndrome\" target=\"_blank\">https:\/\/www.theguardian.com\/world\/2017\/dec\/10\/sars-virus-bats-china-severe-acute-respiratory-syndrome<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 03 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Scientists+trace+2002+Sars+virus+to+colony+of+cave-dwelling+bats+in+China&rft.atitle=The+Guardian&rft.aulast=McKie%2C+R.&rft.au=McKie%2C+R.&rft.date=9+December+2017&rft_id=https%3A%2F%2Fwww.theguardian.com%2Fworld%2F2017%2Fdec%2F10%2Fsars-virus-bats-china-severe-acute-respiratory-syndrome&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NormileMounting04-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NormileMounting04_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Normile, D. (2004). \"Mounting Lab Accidents Raise SARS Fears\". <i>Science<\/i> (5671): 659\u201361. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1126%2Fscience.304.5671.659\" target=\"_blank\">10.1126\/science.304.5671.659<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/15118129\" target=\"_blank\">15118129<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Mounting+Lab+Accidents+Raise+SARS+Fears&rft.jtitle=Science&rft.aulast=Normile%2C+D.&rft.au=Normile%2C+D.&rft.date=2004&rft.issue=5671&rft.pages=659%E2%80%9361&rft_id=info:doi\/10.1126%2Fscience.304.5671.659&rft_id=info:pmid\/15118129&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NYSDHLab04-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NYSDHLab04_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">New York State Department of Health (February 2004). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.health.ny.gov\/diseases\/communicable\/sars\/sars_reporting\/attachment_6_dear_doctor_lab.htm\" target=\"_blank\">\"Laboratory Testing for SARS\"<\/a>. State of New York<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.health.ny.gov\/diseases\/communicable\/sars\/sars_reporting\/attachment_6_dear_doctor_lab.htm\" target=\"_blank\">https:\/\/www.health.ny.gov\/diseases\/communicable\/sars\/sars_reporting\/attachment_6_dear_doctor_lab.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 03 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Laboratory+Testing+for+SARS&rft.atitle=&rft.aulast=New+York+State+Department+of+Health&rft.au=New+York+State+Department+of+Health&rft.date=February+2004&rft.pub=State+of+New+York&rft_id=https%3A%2F%2Fwww.health.ny.gov%2Fdiseases%2Fcommunicable%2Fsars%2Fsars_reporting%2Fattachment_6_dear_doctor_lab.htm&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCSevere04-4\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CDCSevere04_4-0\">4.0<\/a><\/sup> <sup><a href=\"#cite_ref-CDCSevere04_4-1\">4.1<\/a><\/sup> <sup><a href=\"#cite_ref-CDCSevere04_4-2\">4.2<\/a><\/sup> <sup><a href=\"#cite_ref-CDCSevere04_4-3\">4.3<\/a><\/sup> <sup><a href=\"#cite_ref-CDCSevere04_4-4\">4.4<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Disease Control and Prevention (21 May 2004). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/sars\/guidance\/f-lab\/downloads\/F-lab-full.pdf\" target=\"_blank\">\"Public Health Guidance for Community-Level Preparedness and Response to Severe Acute Respiratory Syndrome (SARS), Version 2 - Supplement F: Laboratory Guidance\"<\/a> (PDF). Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/sars\/guidance\/f-lab\/downloads\/F-lab-full.pdf\" target=\"_blank\">https:\/\/www.cdc.gov\/sars\/guidance\/f-lab\/downloads\/F-lab-full.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 03 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Public+Health+Guidance+for+Community-Level+Preparedness+and+Response+to+Severe+Acute+Respiratory+Syndrome+%28SARS%29%2C+Version+2+-+Supplement+F%3A+Laboratory+Guidance&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=21+May+2004&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fsars%2Fguidance%2Ff-lab%2Fdownloads%2FF-lab-full.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-KnoblerLearning04-5\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-KnoblerLearning04_5-0\">5.0<\/a><\/sup> <sup><a href=\"#cite_ref-KnoblerLearning04_5-1\">5.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation book\">Knobler, S.; Mahmoud, A.; Lemon, S. et al., ed. (2004). \"Appendix C: In the absence of SARS-CoV transmission worldwide: Guidance for surveillance, clinical and laboratory evaluation, and reporting\". <i>Learning from SARS: Preparing for the Next Disease Outbreak<\/i>. National Academies Press. pp. 292\u2013302. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.17226%2F10915\" target=\"_blank\">10.17226\/10915<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9780309182157.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Appendix+C%3A+In+the+absence+of+SARS-CoV+transmission+worldwide%3A+Guidance+for+surveillance%2C+clinical+and+laboratory+evaluation%2C+and+reporting&rft.atitle=Learning+from+SARS%3A+Preparing+for+the+Next+Disease+Outbreak&rft.date=2004&rft.pages=pp.%26nbsp%3B292%E2%80%93302&rft.pub=National+Academies+Press&rft_id=info:doi\/10.17226%2F10915&rft.isbn=9780309182157&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WHO_SARSInt04-6\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-WHO_SARSInt04_6-0\">6.0<\/a><\/sup> <sup><a href=\"#cite_ref-WHO_SARSInt04_6-1\">6.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">World Health Organization (23 January 2004). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.who.int\/csr\/resources\/publications\/en\/SARSReferenceLab.pdf\" target=\"_blank\">\"WHO SARS International Reference and Verification Laboratory Network: Policy and Procedures in the Inter-Epidemic Period\"<\/a>. World Health Organization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.who.int\/csr\/resources\/publications\/en\/SARSReferenceLab.pdf\" target=\"_blank\">http:\/\/www.who.int\/csr\/resources\/publications\/en\/SARSReferenceLab.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 03 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=WHO+SARS+International+Reference+and+Verification+Laboratory+Network%3A+Policy+and+Procedures+in+the+Inter-Epidemic+Period&rft.atitle=&rft.aulast=World+Health+Organization&rft.au=World+Health+Organization&rft.date=23+January+2004&rft.pub=World+Health+Organization&rft_id=http%3A%2F%2Fwww.who.int%2Fcsr%2Fresources%2Fpublications%2Fen%2FSARSReferenceLab.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LiangLab04-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LiangLab04_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Liang, G.; Chen, Q.; Xu, J. et al. (2004). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC3323270\" target=\"_blank\">\"Laboratory Diagnosis of Four Recent Sporadic Cases of Community-acquired SARS, Guangdong Province, China\"<\/a>. <i>Emerging Infectious Diseases<\/i> <b>10<\/b> (10): 1774\u201381. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.3201%2Feid1010.040445\" target=\"_blank\">10.3201\/eid1010.040445<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3323270\/\" target=\"_blank\">PMC3323270<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/15504263\" target=\"_blank\">15504263<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC3323270\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC3323270<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Laboratory+Diagnosis+of+Four+Recent+Sporadic+Cases+of+Community-acquired+SARS%2C+Guangdong+Province%2C+China&rft.jtitle=Emerging+Infectious+Diseases&rft.aulast=Liang%2C+G.%3B+Chen%2C+Q.%3B+Xu%2C+J.+et+al.&rft.au=Liang%2C+G.%3B+Chen%2C+Q.%3B+Xu%2C+J.+et+al.&rft.date=2004&rft.volume=10&rft.issue=10&rft.pages=1774%E2%80%9381&rft_id=info:doi\/10.3201%2Feid1010.040445&rft_id=info:pmc\/PMC3323270&rft_id=info:pmid\/15504263&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC3323270&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LequinEnzyme05-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LequinEnzyme05_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Lequin, R.M. (2005). \"Enzyme Immunoassay (EIA)\/Enzyme-Linked Immunosorbent Assay (ELISA)\". <i>Clinical Chemistry<\/i> <b>51<\/b> (12): 2415\u201318. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1373%2Fclinchem.2005.051532\" target=\"_blank\">10.1373\/clinchem.2005.051532<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/16179424\" target=\"_blank\">16179424<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Enzyme+Immunoassay+%28EIA%29%2FEnzyme-Linked+Immunosorbent+Assay+%28ELISA%29&rft.jtitle=Clinical+Chemistry&rft.aulast=Lequin%2C+R.M.&rft.au=Lequin%2C+R.M.&rft.date=2005&rft.volume=51&rft.issue=12&rft.pages=2415%E2%80%9318&rft_id=info:doi\/10.1373%2Fclinchem.2005.051532&rft_id=info:pmid\/16179424&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LoeffelholzLab20-9\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-LoeffelholzLab20_9-0\">9.0<\/a><\/sup> <sup><a href=\"#cite_ref-LoeffelholzLab20_9-1\">9.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Loeffelholz, M.J.; Tang, T.-W. (2020). \"Laboratory diagnosis of emerging human coronavirus infections \u2013 The state of the art\". <i>Emerging Microbes & Infections<\/i> <b>9<\/b> (1): 747\u201356. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1080%2F22221751.2020.1745095\" target=\"_blank\">10.1080\/22221751.2020.1745095<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32196430\" target=\"_blank\">32196430<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Laboratory+diagnosis+of+emerging+human+coronavirus+infections+%E2%80%93+The+state+of+the+art&rft.jtitle=Emerging+Microbes+%26+Infections&rft.aulast=Loeffelholz%2C+M.J.%3B+Tang%2C+T.-W.&rft.au=Loeffelholz%2C+M.J.%3B+Tang%2C+T.-W.&rft.date=2020&rft.volume=9&rft.issue=1&rft.pages=747%E2%80%9356&rft_id=info:doi\/10.1080%2F22221751.2020.1745095&rft_id=info:pmid\/32196430&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Bernard-StoecklinCompar19-10\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Bernard-StoecklinCompar19_10-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Bernard-Stoecklin, S.; Nikolay, B.; Assiri, A. et al. 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(2018). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6212820\" target=\"_blank\">\"High Prevalence of MERS-CoV Infection in Camel Workers in Saudi Arabia\"<\/a>. <i>mBio<\/i> <b>9<\/b> (5): e01985-18. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1128%2FmBio.01985-18\" target=\"_blank\">10.1128\/mBio.01985-18<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6212820\/\" target=\"_blank\">PMC6212820<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/30377284\" target=\"_blank\">30377284<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6212820\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6212820<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=High+Prevalence+of+MERS-CoV+Infection+in+Camel+Workers+in+Saudi+Arabia&rft.jtitle=mBio&rft.aulast=Alshukairi%2C+A.N.%3B+Zheng%2C+J.%3B+Zhao%2C+J.+et+al.&rft.au=Alshukairi%2C+A.N.%3B+Zheng%2C+J.%3B+Zhao%2C+J.+et+al.&rft.date=2018&rft.volume=9&rft.issue=5&rft.pages=e01985-18&rft_id=info:doi\/10.1128%2FmBio.01985-18&rft_id=info:pmc\/PMC6212820&rft_id=info:pmid\/30377284&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC6212820&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCLabTestMERS19-13\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CDCLabTestMERS19_13-0\">13.0<\/a><\/sup> <sup><a href=\"#cite_ref-CDCLabTestMERS19_13-1\">13.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Disease Control and Prevention (2 August 2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/mers\/lab\/lab-testing.html\" target=\"_blank\">\"CDC Laboratory Testing for Middle East Respiratory Syndrome Coronavirus (MERS-CoV)\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/coronavirus\/mers\/lab\/lab-testing.html\" target=\"_blank\">https:\/\/www.cdc.gov\/coronavirus\/mers\/lab\/lab-testing.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 04 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=CDC+Laboratory+Testing+for+Middle+East+Respiratory+Syndrome+Coronavirus+%28MERS-CoV%29&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=2+August+2019&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2Fmers%2Flab%2Flab-testing.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCInterimMERS19-14\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCInterimMERS19_14-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Disease Control and Prevention (2 August 2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/mers\/guidelines-clinical-specimens.html\" target=\"_blank\">\"Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) \u2013 Version 2.1\"<\/a>. Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/coronavirus\/mers\/guidelines-clinical-specimens.html\" target=\"_blank\">https:\/\/www.cdc.gov\/coronavirus\/mers\/guidelines-clinical-specimens.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 04 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Interim+Guidelines+for+Collecting%2C+Handling%2C+and+Testing+Clinical+Specimens+from+Persons+Under+Investigation+%28PUIs%29+for+Middle+East+Respiratory+Syndrome+Coronavirus+%28MERS-CoV%29+%E2%80%93+Version+2.1&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Prevention&rft.au=Centers+for+Disease+Control+and+Prevention&rft.date=2+August+2019&rft.pub=Centers+for+Disease+Control+and+Prevention&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2Fmers%2Fguidelines-clinical-specimens.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WHOLabMERS18-15\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-WHOLabMERS18_15-0\">15.0<\/a><\/sup> <sup><a href=\"#cite_ref-WHOLabMERS18_15-1\">15.1<\/a><\/sup> <sup><a href=\"#cite_ref-WHOLabMERS18_15-2\">15.2<\/a><\/sup> <sup><a href=\"#cite_ref-WHOLabMERS18_15-3\">15.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">World Health Organization (January 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/csr\/disease\/coronavirus_infections\/mers-laboratory-testing\/en\/\" target=\"_blank\">\"Laboratory testing for Middle East Respiratory Syndrome Coronavirus: Interim guidance\"<\/a>. <i>WHO\/MERS\/LAB\/15.1\/Rev1\/2018<\/i>. World Health Organization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.who.int\/csr\/disease\/coronavirus_infections\/mers-laboratory-testing\/en\/\" target=\"_blank\">https:\/\/www.who.int\/csr\/disease\/coronavirus_infections\/mers-laboratory-testing\/en\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 04 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Laboratory+testing+for+Middle+East+Respiratory+Syndrome+Coronavirus%3A+Interim+guidance&rft.atitle=WHO%2FMERS%2FLAB%2F15.1%2FRev1%2F2018&rft.aulast=World+Health+Organization&rft.au=World+Health+Organization&rft.date=January+2018&rft.pub=World+Health+Organization&rft_id=https%3A%2F%2Fwww.who.int%2Fcsr%2Fdisease%2Fcoronavirus_infections%2Fmers-laboratory-testing%2Fen%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Al-AbdelyMiddle19-16\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Al-AbdelyMiddle19_16-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Al-Abdely, H.M.; Midgley, C.M.; Alkhamis, A.M. et al. (2019). \"Middle East Respiratory Syndrome Coronavirus Infection Dynamics and Antibody Responses among Clinically Diverse Patients, Saudi Arabia\". <i>Emerging Infectious Diseases<\/i> <b>25<\/b> (4): 753-766. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.3201%2Feid2504.181595\" target=\"_blank\">10.3201\/eid2504.181595<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Middle+East+Respiratory+Syndrome+Coronavirus+Infection+Dynamics+and+Antibody+Responses+among+Clinically+Diverse+Patients%2C+Saudi+Arabia&rft.jtitle=Emerging+Infectious+Diseases&rft.aulast=Al-Abdely%2C+H.M.%3B+Midgley%2C+C.M.%3B+Alkhamis%2C+A.M.+et+al.&rft.au=Al-Abdely%2C+H.M.%3B+Midgley%2C+C.M.%3B+Alkhamis%2C+A.M.+et+al.&rft.date=2019&rft.volume=25&rft.issue=4&rft.pages=753-766&rft_id=info:doi\/10.3201%2Feid2504.181595&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Kelly-CirinoAnUpdated19-17\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Kelly-CirinoAnUpdated19_17-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Kelly-Cirino, C.; Mazzola, L.T.; Chua, A. et al. 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Retrieved 03 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Rapid+lab+tests+can+help+reduce+antibiotic+resistance&rft.atitle=STAT&rft.aulast=Jenison%2C+R.&rft.au=Jenison%2C+R.&rft.date=30+November+2016&rft_id=https%3A%2F%2Fwww.statnews.com%2F2016%2F11%2F30%2Fantibiotic-resistance-molecular-diagnostics%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RoyRapid18-21\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RoyRapid18_21-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Roy, K. (26 September 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.healio.com\/news\/infectious-disease\/20180926\/rapid-test-for-viral-infections-reduces-unnecessary-antibiotic-prescribing\" target=\"_blank\">\"Rapid test for viral infections reduces unnecessary antibiotic prescribing\"<\/a>. <i>Healio<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.healio.com\/news\/infectious-disease\/20180926\/rapid-test-for-viral-infections-reduces-unnecessary-antibiotic-prescribing\" target=\"_blank\">https:\/\/www.healio.com\/news\/infectious-disease\/20180926\/rapid-test-for-viral-infections-reduces-unnecessary-antibiotic-prescribing<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Rapid+test+for+viral+infections+reduces+unnecessary+antibiotic+prescribing&rft.atitle=Healio&rft.aulast=Roy%2C+K.&rft.au=Roy%2C+K.&rft.date=26+September+2018&rft_id=https%3A%2F%2Fwww.healio.com%2Fnews%2Finfectious-disease%2F20180926%2Frapid-test-for-viral-infections-reduces-unnecessary-antibiotic-prescribing&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MahonyDetect08-22\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MahonyDetect08_22-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Mahoney, J.B. (2008). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC2570148\" target=\"_blank\">\"Detection of Respiratory Viruses by Molecular Methods\"<\/a>. <i>Clinical Microbiology Reviews<\/i> <b>21<\/b> (4): 716\u201347. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1128%2FCMR.00037-07\" target=\"_blank\">10.1128\/CMR.00037-07<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2570148\/\" target=\"_blank\">PMC2570148<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/18854489\" target=\"_blank\">18854489<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC2570148\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC2570148<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Detection+of+Respiratory+Viruses+by+Molecular+Methods&rft.jtitle=Clinical+Microbiology+Reviews&rft.aulast=Mahoney%2C+J.B.&rft.au=Mahoney%2C+J.B.&rft.date=2008&rft.volume=21&rft.issue=4&rft.pages=716%E2%80%9347&rft_id=info:doi\/10.1128%2FCMR.00037-07&rft_id=info:pmc\/PMC2570148&rft_id=info:pmid\/18854489&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC2570148&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20210919173026\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.174 seconds\nReal time usage: 0.190 seconds\nPreprocessor visited node count: 16694\/1000000\nPost\u2010expand include size: 168149\/2097152 bytes\nTemplate argument size: 51080\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 50707\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 163.356 1 -total\n 89.28% 145.845 1 Template:Reflist\n 70.37% 114.950 22 Template:Citation\/core\n 40.31% 65.845 12 Template:Cite_journal\n 32.89% 53.733 9 Template:Cite_web\n 10.67% 17.438 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\n 9.31% 15.216 32 Template:Citation\/identifier\n 7.75% 12.662 9 Template:Date\n 4.44% 7.249 27 Template:Citation\/make_link\n 4.43% 7.232 1 Template:Cite_book\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11910-0!canonical and timestamp 20210919173026 and revision id 39235. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","37226828a801fdd6cfb84d2a90e4ea36_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/4\/4b\/MERS-CoV_Particles_%288414774264%29.jpg"],"37226828a801fdd6cfb84d2a90e4ea36_timestamp":1632073384,"9cee66545e86ad0648ca3d040588e9df_type":"article","9cee66545e86ad0648ca3d040588e9df_title":"2.1 Testing terminology","9cee66545e86ad0648ca3d040588e9df_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_terminology","9cee66545e86ad0648ca3d040588e9df_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Diagnostic testing of COVID-19 and other coronaviruses\/Testing terminologyFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nContents \n\n1 2. Diagnostic testing of COVID-19 and other coronaviruses \n\n1.1 2.1 Testing terminology \n\n1.1.1 2.1.1. Introduction \n1.1.2 2.1.2 Polymerase chain reaction (PCR) \n1.1.3 2.1.3 Lateral flow assay (LFA) \n\n\n\n\n2 References \n\n\n\n2. Diagnostic testing of COVID-19 and other coronaviruses \n2.1 Testing terminology \nAs you read through this chapter, you may discover terms like \"polymerase chain reaction\" (PCR) and \"lateral flow assay\" (LFA). If you're a laboratorian or have a clinical background, you're likely to be familiar with these terms. However, it seems prudent to at least briefly discuss a few of them before delving into coronavirus testing itself. \n\n2.1.1. Introduction \nLiving organisms store information in their genetic material, using DNA or RNA as the information carrier. That information, or genetic code, essentially provides instructions for organism development, function, growth, and reproduction. In the late twentieth century, researchers were laying the groundwork for molecular diagnostics, the concept of examining an organism's genetic code and its associated biological markers to diagnose and treat disease on a more personalized basis. This requires an assay, an investigative procedure for assessing the presence of, or measuring the amount or functional activity of, a target analyte. In the case of molecular diagnostics, and more broadly molecular biology, the target is biological in nature, and thus biological assays are used. These biological assays are designed to accurately detect the presence of or enable counts of biological molecules, including DNA, RNA, proteins, cells, bacteria, and virus particles (e.g., viral plaque assays).[1]\n\n 2.1.2 Polymerase chain reaction (PCR) \nPolymerase chain reaction or PCR is a molecular biology method that takes small amounts of DNA sequences and makes copies of (amplifies) them to the point of having enough material to sufficiently study or work with. The base technique can yield results in several hours and has a high level of sensitivity, with its ability to amplify the DNA to counts of millions or billions. PCR has been used in molecular diagnostics for testing prospective parents for being genetic carriers of particular diseases (i.e., expanded carrier screening)[2][3], tissue typing to ensure more effective organ transplants[4], and analyzing mutations in oncogenes to customize cancer treatments.[5] However, the method has also been applied to forensic science[6] and epidemiology.[7] \nPCR and its variations have been used to characterize and detect infectious disease organisms such as human immunodeficiency virus (HIV), pathogenic tuberculosis bacteria, and Bordetella pertussis, which causes whooping cough.[8] Additionally, a selection of viruses can have their RNA detected using PCR, though the primers (short single-strand DNA fragments) used in the process must by sympathetic to the virus' genetic structure to ensure that only target virus material is amplified.[9] As it turns out, coronaviruses are RNA viruses, having some of the longest genomes of any RNA virus, and, detrimentally, the highest known frequency of recombination (the exchange of genetic material with another organism); this broadly means high rates of virus mutation, which interferes with maintaining consistent diagnostic detection and therapy.[10][11]\nPCR comes in several variant methods. For example, while PCR monitors the amplification portion at the end of the overall process, real-time or \"quantitative\" PCR (qPCR) allows for the generation rate of the amplified product to be monitored at a particular point during each PCR cycle. Reverse transcription PCR (RT-PCR) is a combinatory process, applying reverse transcription (creating complementary double-stranded DNA [cDNA] from an RNA template) with PCR. If RT-PCR incorporates qPCR, you end up with \"real-time RT-PCR\" (rRT-PCR), sometimes referred to as \"quantitative RT-PCR\" (qRT-PCR). In the case of using PCR for detecting coronaviruses, more often than not we see some variation of RT-PCR, with or without real-time amplification monitoring. (It's important to not assume all RT-PCR processes incorporate real-time methods.) \nHow does PCR work in practice? The simplified version (see this JAMA Patient Page for a useful graphical explanation, using COVID-19 as an example) has a clinician obtaining a biological specimen from the appropriate location or source material. Then, special techniques are used to isolate viral (or in some cases, bacterial) genetic material from the specimen. (If RT-PCR is performed, the next step of reverse transcription of the isolated viral RNA into cDNA is also performed.) Once the viral genetic material is isolated, suitable primers that are sympathetic to the structure of the isolated genetic material are introduced. Those primers bind to the virus' genetic material and begin making copies of it. Fluorescent or other biomarkers that were attached to the copies during the PCR process eventually release from the copies, and an attempt is made to detect the presence of those biomarkers. The presence or absence of these markers drives the determination of a positive or negative detection for the sought-after virus.[12]\n\n (a) Sample LFA strip and (b) region of interest of an LFA strip with an analyte. The intensity and density of red color in the test line region determine the amount of analyte in the sample. (From Foysal et al. 2019)\n 2.1.3 Lateral flow assay (LFA) \nThe lateral flow assay or LFA is another molecular biology method for detecting the presence of a target analyte in specimen material. In comparison to PCR, LFA has the advantages of being more rapid, low-cost, easy-to-use, and applicable at the point of care, though the average LFA is at best semi-quantitative in its results and has slightly lower sensitivity.[13][14] The method involves a cellulose-based strip with an ordered collection of specific \"pads\" and reagents that are reactive to a target analyte in a liquid, which is placed on the strip and moves across the various reagents using capillary and electrostatic interactions.[13][15][16] LFA has been used in molecular diagnostics for testing urine, saliva, sweat, serum, plasma, and other biological fluids for the presence of specific antigens and antibodies, as well as signs of gene amplification. The method has also been effectively applied to other industries outside healthcare, including the food and beverage, chemical, and environmental industries.[13]\nIn the realm of infectious disease, the LFA has played an important role in disease diagnosis and control, particularly in resource-constrained settings where resources are limited and point-of-care testing is critical to filling the gap.[17] Testing for the presence of an infectious agent in body fluids using LFA can be performed in two ways: lateral flow immunoassay (LFI) or lateral flow nucleic acid (LFNA). The immunoassay variant looks for antibodies created as a result of the presence of an infectious agent, whereas the nucleic acid variant is built to detect an amplified nucleic acid sequence specific to a target infectious agent.[18] Speaking specifically to the SARS-CoV-2 coronavirus, the antibody-based immunoassay method of lateral flow is predominantly used, targeting one of either a monoclonal antibody directed at a viral antigen, or a viral antigen that is recognizable by a patient's developed antibodies.[19][20]\nTesting using LFI is generally as follows. A specialized adsorbent sample pad at one end of the LFI strip receives the specimen material. That material then migrates to the next conjugate release pad, where the specimen material is exposed to \"antibodies that are specific to the target analyte and are conjugated to coloured or fluorescent particles.\"[13] The material then progresses to a detection zone containing antibodies or antigens that are fixed in the zone and intended to react to a specific analyte. If the analyte is present, a test line produces a visual, qualitative response, and a control line ensures proper liquid flow across the strip. A wicking pad at the other end properly maintains the flow of liquids across the strip.[13]\n\nReferences \n\n\n\u2191 AdvaMedDx (2013). \"Introduction to Molecular Diagnostics: The Essentials of Diagnostics Series\". pp. 19. http:\/\/www.epemed.org\/online\/www\/content2\/108\/469\/3172\/listdownloads\/3175\/507\/ENG\/dxinsights.pdf . Retrieved 06 September 2021 .   \n \n\n\u2191 Gregg, A.R. (2018). \"Expanded Carrier Screening\". Obstetrics and Gynecology Clinics of North America 45 (1): 103\u2013112. doi:10.1016\/j.ogc.2017.10.005. PMID 29428278.   \n \n\n\u2191 Chokoshvili, D.; Vears, D.F.; Borry, P. (2018). \"Reproductive autonomy in expanded carrier screening: More than meets the eye?\". Expert Review of Molecular Diagnostics 18 (12): 993\u201394. doi:10.1080\/14737159.2018.1544496. PMID 30394810.   \n \n\n\u2191 Edgerly, C.H.; Weimer, E.T. (2018). \"The Past, Present, and Future of HLA Typing in Transplantation\". Methods in Molecular Biology 1802: 1\u201310. doi:10.1007\/978-1-4939-8546-3_1. PMID 29858798.   \n \n\n\u2191 Loda, M. (1994). \"Polymerase chain reaction-based methods for the detection of mutations in oncogenes and tumor suppressor genes\". Human Pathology 25 (6): 564\u201371. doi:10.1016\/0046-8177(94)90220-8. PMID 7912220.   \n \n\n\u2191 Ninfa, A.J.; Ballou, D.P.; Benore, M. (2009). Fundamental Laboratory Approaches for Biochemistry and Biotechnology. Wiley. pp. 408\u2013410. ISBN 9780470087664. https:\/\/books.google.com\/books?id=k6_XQwAACAAJ&pg=PA408 . Retrieved 08 April 2020 .   \n \n\n\u2191 Hamborsky, J.; Kroger, A.; Wolfe, C., ed. (2015). Epidemiology and Prevention of Vaccine-Preventable Diseases (13th ed.). Centers for Disease Control and Prevention. https:\/\/www.cdc.gov\/vaccines\/pubs\/pinkbook\/index.html . Retrieved 08 April 2020 .   \n \n\n\u2191 Buckingham, L. (2019). \"Chapter 11: Detection and Identification of Microorganisms\". Molecular Diagnostics: Fundamentals, Methods and Clinical Applications (3rd ed.). F.A. Davis Company. pp. 301\u2013343. ISBN 9780803699540. https:\/\/books.google.com\/books?hl=en&lr=&id=dJWNDwAAQBAJ&pg=301 .   \n \n\n\u2191 Kim, H.; Kang, N.; An, K. et al. (2017). \"MRPrimerV: A database of PCR primers for RNA virus detection\". Nucleic Acids Research 45 (D1): D475\u201381. doi:10.1093\/nar\/gkw1095. PMC PMC5210568. PMID 27899620. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC5210568 .   \n \n\n\u2191 Makin, S. (5 February 2020). \"How Coronaviruses Cause Infection\u2014from Colds to Deadly Pneumonia\". Scientific American. https:\/\/www.scientificamerican.com\/article\/how-coronaviruses-cause-infection-from-colds-to-deadly-pneumonia1\/ . Retrieved 08 April 2020 .   \n \n\n\u2191 Rohde, R. (31 January 2020). \"2019 Novel Coronavirus (2019-nCoV) Update: Uncoating the Virus\". American Society for Microbiology. https:\/\/asm.org\/Articles\/2020\/January\/2019-Novel-Coronavirus-2019-nCoV-Update-Uncoating . Retrieved 08 April 2020 .   \n \n\n\u2191 Hadaya, J.; Schumm, M.; Livingston, E.H. (2020). \"Testing Individuals for Coronavirus Disease 2019 (COVID-19)\". JAMA. doi:10.1001\/jama.2020.5388. PMID 32236503.   \n \n\n\u2191 13.0 13.1 13.2 13.3 13.4 Koczula, K.M.; Gallotta, A. (2016). \"Lateral flow assays\". Essays in Biochemistry 60 (1): 111\u201320. doi:10.1042\/EBC20150012. PMC PMC4986465. PMID 27365041. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC4986465 .   \n \n\n\u2191 Liu, Z.; Hu, J.; Qu, Z.; Xu, F. (2018). \"Chapter 8: Paper-Based Immunoassays\". In Vashist, S.K.; Luong, J.H.T.. Handbook of Immunoassay Technologies: Approaches, Performances, and Applications. Academic Press. pp. 183\u2013202. ISBN 9780128117620. https:\/\/books.google.com\/books?id=jSk0DwAAQBAJ&pg=PA183 . Retrieved 08 April 2020 .   \n \n\n\u2191 Jauset-Rubio, M.; Svobodov\u00e1, M.; Mairal, T. et al. (2016). \"Ultrasensitive, rapid and inexpensive detection of DNA using paper based lateral flow assay\". Scientific Reports 6: 37732. doi:10.1038\/srep37732. PMC PMC5123575. PMID 27886248. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC5123575 .   \n \n\n\u2191 Foysal, K.H.; Seo, S.E.; Kim, M.J. et al. (2019). \"Analyte Quantity Detection from Lateral Flow Assay Using a Smartphone\". Sensors 19 (21): 4812. doi:10.3390\/s19214812. PMC PMC6864604. PMID 31694281. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6864604 .   \n \n\n\u2191 Hanafiah, K.M.; Arifin, N.; Bustami, T. et al. (2017). \"Development of Multiplexed Infectious Disease Lateral Flow Assays: Challenges and Opportunities\". Diagnostics 7 (3): 51. doi:10.3390\/diagnostics7030051. PMC PMC5617951. PMID 28880218. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC5617951 .   \n \n\n\u2191 Ngom, B.; Guo, Y.; Wang, X.; Bi, D. (2010). \"Development and application of lateral flow test strip technology for detection of infectious agents and chemical contaminants: A review\". Analytical and Bioanalytical Chemistry 397: 1113\u20131135. doi:10.1007\/s00216-010-3661-4. PMID 20422164.   \n \n\n\u2191 Sheridan, C. (23 March 2020). \"Fast, portable tests come online to curb coronavirus pandemic\". Nature Biotechnology - News. doi:10.1038\/d41587-020-00010-2. https:\/\/www.nature.com\/articles\/d41587-020-00010-2 . Retrieved 08 April 2020 .   \n \n\n\u2191 \"Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method)\" (PDF). RayBiotech. 3 April 2020. Archived from the original on 08 April 2020. https:\/\/web.archive.org\/web\/20200408211820\/https:\/\/www.raybiotech.com\/index.php?dispatch=attachments.getfile&attachment_id=3095 . Retrieved 06 September 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_terminology\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_terminology<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 3 May 2020, at 19:34.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 298 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","9cee66545e86ad0648ca3d040588e9df_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Diagnostic_testing_of_COVID-19_and_other_coronaviruses_Testing_terminology rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Diagnostic_testing_of_COVID-19_and_other_coronaviruses_Testing_terminology skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Diagnostic testing of COVID-19 and other coronaviruses\/Testing terminology<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Introduction\" title=\"Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Introduction\" class=\"wiki-link\" data-key=\"d0faaf5a86a3ccb5b12357c8bd4fefe4\">the beginning<\/a> of this guide-----<\/div>\n\n\n<h2><span class=\"mw-headline\" id=\"2._Diagnostic_testing_of_COVID-19_and_other_coronaviruses\">2. Diagnostic testing of COVID-19 and other coronaviruses<\/span><\/h2>\n<h3><span class=\"mw-headline\" id=\"2.1_Testing_terminology\">2.1 Testing terminology<\/span><\/h3>\n<p>As you read through this chapter, you may discover terms like \"<a href=\"https:\/\/www.limswiki.org\/index.php\/Polymerase_chain_reaction\" title=\"Polymerase chain reaction\" class=\"wiki-link\" data-key=\"f6569fb01ef396379f9f4efa4527e715\">polymerase chain reaction<\/a>\" (PCR) and \"<a href=\"https:\/\/www.limswiki.org\/index.php\/Lateral_flow_test\" title=\"Lateral flow test\" class=\"wiki-link\" data-key=\"c8e204476b567850c0ec03a045f16661\">lateral flow assay<\/a>\" (LFA). If you're a laboratorian or have a clinical background, you're likely to be familiar with these terms. However, it seems prudent to at least briefly discuss a few of them before delving into coronavirus testing itself. \n<\/p>\n<h4><span class=\"mw-headline\" id=\"2.1.1._Introduction\">2.1.1. Introduction<\/span><\/h4>\n<p>Living organisms store information in their genetic material, using DNA or RNA as the information carrier. That information, or genetic code, essentially provides instructions for organism development, function, growth, and reproduction. In the late twentieth century, researchers were laying the groundwork for molecular diagnostics, the concept of examining an organism's genetic code and its associated biological markers to diagnose and treat disease on a more personalized basis. This requires an assay, an investigative procedure for assessing the presence of, or measuring the amount or functional activity of, a target analyte. In the case of molecular diagnostics, and more broadly molecular biology, the target is biological in nature, and thus biological assays are used. These biological assays are designed to accurately detect the presence of or enable counts of biological molecules, including DNA, RNA, proteins, cells, bacteria, and virus particles (e.g., viral plaque assays).<sup id=\"rdp-ebb-cite_ref-ADXIntro13_1-0\" class=\"reference\"><a href=\"#cite_note-ADXIntro13-1\">[1]<\/a><\/sup>\n<\/p>\n<h4><span id=\"rdp-ebb-2.1.2_Polymerase_chain_reaction_(PCR)\"><\/span><span class=\"mw-headline\" id=\"2.1.2_Polymerase_chain_reaction_.28PCR.29\">2.1.2 Polymerase chain reaction (PCR)<\/span><\/h4>\n<p>Polymerase chain reaction or PCR is a molecular biology method that takes small amounts of DNA sequences and makes copies of (amplifies) them to the point of having enough material to sufficiently study or work with. The base technique can yield results in several hours and has a high level of sensitivity, with its ability to amplify the DNA to counts of millions or billions. PCR has been used in molecular diagnostics for testing prospective parents for being genetic carriers of particular diseases (i.e., expanded carrier screening)<sup id=\"rdp-ebb-cite_ref-GreggExpanded18_2-0\" class=\"reference\"><a href=\"#cite_note-GreggExpanded18-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ChokoschviliRepro18_3-0\" class=\"reference\"><a href=\"#cite_note-ChokoschviliRepro18-3\">[3]<\/a><\/sup>, tissue typing to ensure more effective organ transplants<sup id=\"rdp-ebb-cite_ref-EdgerlyThePast18_4-0\" class=\"reference\"><a href=\"#cite_note-EdgerlyThePast18-4\">[4]<\/a><\/sup>, and analyzing mutations in oncogenes to customize cancer treatments.<sup id=\"rdp-ebb-cite_ref-LodaPoly94_5-0\" class=\"reference\"><a href=\"#cite_note-LodaPoly94-5\">[5]<\/a><\/sup> However, the method has also been applied to <a href=\"https:\/\/www.limswiki.org\/index.php\/Forensic_science\" title=\"Forensic science\" class=\"wiki-link\" data-key=\"415d36a7b65494677b6d2873d5febec1\">forensic science<\/a><sup id=\"rdp-ebb-cite_ref-NinfaFund09_6-0\" class=\"reference\"><a href=\"#cite_note-NinfaFund09-6\">[6]<\/a><\/sup> and <a href=\"https:\/\/www.limswiki.org\/index.php\/Epidemiology\" title=\"Epidemiology\" class=\"wiki-link\" data-key=\"123badb8bf0b37a513182dbcfc3875bc\">epidemiology<\/a>.<sup id=\"rdp-ebb-cite_ref-HamborskyEpidem15_7-0\" class=\"reference\"><a href=\"#cite_note-HamborskyEpidem15-7\">[7]<\/a><\/sup> \n<\/p><p>PCR and its variations have been used to characterize and detect infectious disease organisms such as human immunodeficiency virus (HIV), pathogenic tuberculosis bacteria, and <i>Bordetella pertussis<\/i>, which causes whooping cough.<sup id=\"rdp-ebb-cite_ref-BuckinghamMolec19_8-0\" class=\"reference\"><a href=\"#cite_note-BuckinghamMolec19-8\">[8]<\/a><\/sup> Additionally, a selection of viruses can have their RNA detected using PCR, though the primers (short single-strand DNA fragments) used in the process must by sympathetic to the virus' genetic structure to ensure that only target virus material is amplified.<sup id=\"rdp-ebb-cite_ref-KimMRPrimer17_9-0\" class=\"reference\"><a href=\"#cite_note-KimMRPrimer17-9\">[9]<\/a><\/sup> As it turns out, coronaviruses are RNA viruses, having some of the longest genomes of any RNA virus, and, detrimentally, the highest known frequency of recombination (the exchange of genetic material with another organism); this broadly means high rates of virus mutation, which interferes with maintaining consistent diagnostic detection and therapy.<sup id=\"rdp-ebb-cite_ref-MakinHowCorona20_10-0\" class=\"reference\"><a href=\"#cite_note-MakinHowCorona20-10\">[10]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Rohde2019_20_11-0\" class=\"reference\"><a href=\"#cite_note-Rohde2019_20-11\">[11]<\/a><\/sup>\n<\/p><p>PCR comes in several variant methods. For example, while PCR monitors the amplification portion at the end of the overall process, real-time or \"quantitative\" PCR (qPCR) allows for the generation rate of the amplified product to be monitored at a particular point during each PCR cycle. Reverse transcription PCR (RT-PCR) is a combinatory process, applying reverse transcription (creating complementary double-stranded DNA [cDNA] from an RNA template) with PCR. If RT-PCR incorporates qPCR, you end up with \"real-time RT-PCR\" (rRT-PCR), sometimes referred to as \"quantitative RT-PCR\" (qRT-PCR). In the case of using PCR for detecting coronaviruses, more often than not we see some variation of RT-PCR, with or without real-time amplification monitoring. (It's important to not assume all RT-PCR processes incorporate real-time methods.) \n<\/p><p>How does PCR work in practice? The simplified version (see this <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/doi.org\/10.1001\/jama.2020.5388\" target=\"_blank\">JAMA Patient Page<\/a> for a useful graphical explanation, using COVID-19 as an example) has a clinician obtaining a biological specimen from the appropriate location or source material. Then, special techniques are used to isolate viral (or in some cases, bacterial) genetic material from the specimen. (If RT-PCR is performed, the next step of reverse transcription of the isolated viral RNA into cDNA is also performed.) Once the viral genetic material is isolated, suitable primers that are sympathetic to the structure of the isolated genetic material are introduced. Those primers bind to the virus' genetic material and begin making copies of it. Fluorescent or other biomarkers that were attached to the copies during the PCR process eventually release from the copies, and an attempt is made to detect the presence of those biomarkers. The presence or absence of these markers drives the determination of a positive or negative detection for the sought-after virus.<sup id=\"rdp-ebb-cite_ref-HadayaTesting20_12-0\" class=\"reference\"><a href=\"#cite_note-HadayaTesting20-12\">[12]<\/a><\/sup>\n<\/p>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:432px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Fig2_Foysal_Sensors2019_19-21.png\" class=\"image wiki-link\" data-key=\"e41f1ee5762604c1316eb6b9f45cd7db\"><img alt=\"\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/d\/d8\/Fig2_Foysal_Sensors2019_19-21.png\" decoding=\"async\" class=\"thumbimage\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Fig2_Foysal_Sensors2019_19-21.png\" class=\"internal wiki-link\" title=\"Enlarge\" data-key=\"e41f1ee5762604c1316eb6b9f45cd7db\"><\/a><\/div>(<b>a<\/b>) Sample LFA strip and (<b>b<\/b>) region of interest of an LFA strip with an analyte. The intensity and density of red color in the test line region determine the amount of analyte in the sample. (<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/doi.org\/10.3390\/s19214812\" target=\"_blank\">From Foysal <i>et al.<\/i> 2019<\/a>)<\/div><\/div><\/div>\n<h4><span id=\"rdp-ebb-2.1.3_Lateral_flow_assay_(LFA)\"><\/span><span class=\"mw-headline\" id=\"2.1.3_Lateral_flow_assay_.28LFA.29\">2.1.3 Lateral flow assay (LFA)<\/span><\/h4>\n<p>The lateral flow assay or LFA is another molecular biology method for detecting the presence of a target analyte in specimen material. In comparison to PCR, LFA has the advantages of being more rapid, low-cost, easy-to-use, and applicable at the point of care, though the average LFA is at best semi-quantitative in its results and has slightly lower sensitivity.<sup id=\"rdp-ebb-cite_ref-KoczulaLateral16_13-0\" class=\"reference\"><a href=\"#cite_note-KoczulaLateral16-13\">[13]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LiuPaper18_14-0\" class=\"reference\"><a href=\"#cite_note-LiuPaper18-14\">[14]<\/a><\/sup> The method involves a cellulose-based strip with an ordered collection of specific \"pads\" and reagents that are reactive to a target analyte in a liquid, which is placed on the strip and moves across the various reagents using capillary and electrostatic interactions.<sup id=\"rdp-ebb-cite_ref-KoczulaLateral16_13-1\" class=\"reference\"><a href=\"#cite_note-KoczulaLateral16-13\">[13]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Jauset-RubioUltra16_15-0\" class=\"reference\"><a href=\"#cite_note-Jauset-RubioUltra16-15\">[15]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FoysalAnalyte19_16-0\" class=\"reference\"><a href=\"#cite_note-FoysalAnalyte19-16\">[16]<\/a><\/sup> LFA has been used in molecular diagnostics for testing urine, saliva, sweat, serum, plasma, and other biological fluids for the presence of specific antigens and antibodies, as well as signs of gene amplification. The method has also been effectively applied to other industries outside healthcare, including the food and beverage, chemical, and environmental industries.<sup id=\"rdp-ebb-cite_ref-KoczulaLateral16_13-2\" class=\"reference\"><a href=\"#cite_note-KoczulaLateral16-13\">[13]<\/a><\/sup>\n<\/p><p>In the realm of infectious disease, the LFA has played an important role in disease diagnosis and control, particularly in resource-constrained settings where resources are limited and point-of-care testing is critical to filling the gap.<sup id=\"rdp-ebb-cite_ref-HanafiahDevelop17_17-0\" class=\"reference\"><a href=\"#cite_note-HanafiahDevelop17-17\">[17]<\/a><\/sup> Testing for the presence of an infectious agent in body fluids using LFA can be performed in two ways: lateral flow immunoassay (LFI) or lateral flow nucleic acid (LFNA). The immunoassay variant looks for antibodies created as a result of the presence of an infectious agent, whereas the nucleic acid variant is built to detect an amplified nucleic acid sequence specific to a target infectious agent.<sup id=\"rdp-ebb-cite_ref-NgomDevelop10_18-0\" class=\"reference\"><a href=\"#cite_note-NgomDevelop10-18\">[18]<\/a><\/sup> Speaking specifically to the SARS-CoV-2 coronavirus, the antibody-based immunoassay method of lateral flow is predominantly used, targeting one of either a monoclonal antibody directed at a viral antigen, or a viral antigen that is recognizable by a patient's developed antibodies.<sup id=\"rdp-ebb-cite_ref-SheridanFast20_19-0\" class=\"reference\"><a href=\"#cite_note-SheridanFast20-19\">[19]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RBCoronavirus20_20-0\" class=\"reference\"><a href=\"#cite_note-RBCoronavirus20-20\">[20]<\/a><\/sup>\n<\/p><p>Testing using LFI is generally as follows. A specialized adsorbent sample pad at one end of the LFI strip receives the specimen material. That material then migrates to the next conjugate release pad, where the specimen material is exposed to \"antibodies that are specific to the target analyte and are conjugated to coloured or fluorescent particles.\"<sup id=\"rdp-ebb-cite_ref-KoczulaLateral16_13-3\" class=\"reference\"><a href=\"#cite_note-KoczulaLateral16-13\">[13]<\/a><\/sup> The material then progresses to a detection zone containing antibodies or antigens that are fixed in the zone and intended to react to a specific analyte. If the analyte is present, a test line produces a visual, qualitative response, and a control line ensures proper liquid flow across the strip. A wicking pad at the other end properly maintains the flow of liquids across the strip.<sup id=\"rdp-ebb-cite_ref-KoczulaLateral16_13-4\" class=\"reference\"><a href=\"#cite_note-KoczulaLateral16-13\">[13]<\/a><\/sup>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-ADXIntro13-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ADXIntro13_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">AdvaMedDx (2013). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.epemed.org\/online\/www\/content2\/108\/469\/3172\/listdownloads\/3175\/507\/ENG\/dxinsights.pdf\" target=\"_blank\">\"Introduction to Molecular Diagnostics: The Essentials of Diagnostics Series\"<\/a>. pp. 19<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.epemed.org\/online\/www\/content2\/108\/469\/3172\/listdownloads\/3175\/507\/ENG\/dxinsights.pdf\" target=\"_blank\">http:\/\/www.epemed.org\/online\/www\/content2\/108\/469\/3172\/listdownloads\/3175\/507\/ENG\/dxinsights.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Introduction+to+Molecular+Diagnostics%3A+The+Essentials+of+Diagnostics+Series&rft.atitle=&rft.aulast=AdvaMedDx&rft.au=AdvaMedDx&rft.date=2013&rft.pages=pp.+19&rft_id=http%3A%2F%2Fwww.epemed.org%2Fonline%2Fwww%2Fcontent2%2F108%2F469%2F3172%2Flistdownloads%2F3175%2F507%2FENG%2Fdxinsights.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_terminology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GreggExpanded18-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GreggExpanded18_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Gregg, A.R. (2018). \"Expanded Carrier Screening\". <i>Obstetrics and Gynecology Clinics of North America<\/i> <b>45<\/b> (1): 103\u2013112. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2Fj.ogc.2017.10.005\" target=\"_blank\">10.1016\/j.ogc.2017.10.005<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/29428278\" target=\"_blank\">29428278<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Expanded+Carrier+Screening&rft.jtitle=Obstetrics+and+Gynecology+Clinics+of+North+America&rft.aulast=Gregg%2C+A.R.&rft.au=Gregg%2C+A.R.&rft.date=2018&rft.volume=45&rft.issue=1&rft.pages=103%E2%80%93112&rft_id=info:doi\/10.1016%2Fj.ogc.2017.10.005&rft_id=info:pmid\/29428278&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_terminology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ChokoschviliRepro18-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ChokoschviliRepro18_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Chokoshvili, D.; Vears, D.F.; Borry, P. (2018). \"Reproductive autonomy in expanded carrier screening: More than meets the eye?\". <i>Expert Review of Molecular Diagnostics<\/i> <b>18<\/b> (12): 993\u201394. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1080%2F14737159.2018.1544496\" target=\"_blank\">10.1080\/14737159.2018.1544496<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/30394810\" target=\"_blank\">30394810<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Reproductive+autonomy+in+expanded+carrier+screening%3A+More+than+meets+the+eye%3F&rft.jtitle=Expert+Review+of+Molecular+Diagnostics&rft.aulast=Chokoshvili%2C+D.%3B+Vears%2C+D.F.%3B+Borry%2C+P.&rft.au=Chokoshvili%2C+D.%3B+Vears%2C+D.F.%3B+Borry%2C+P.&rft.date=2018&rft.volume=18&rft.issue=12&rft.pages=993%E2%80%9394&rft_id=info:doi\/10.1080%2F14737159.2018.1544496&rft_id=info:pmid\/30394810&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_terminology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-EdgerlyThePast18-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-EdgerlyThePast18_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Edgerly, C.H.; Weimer, E.T. (2018). \"The Past, Present, and Future of HLA Typing in Transplantation\". <i>Methods in Molecular Biology<\/i> <b>1802<\/b>: 1\u201310. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2F978-1-4939-8546-3_1\" target=\"_blank\">10.1007\/978-1-4939-8546-3_1<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/29858798\" target=\"_blank\">29858798<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+Past%2C+Present%2C+and+Future+of+HLA+Typing+in+Transplantation&rft.jtitle=Methods+in+Molecular+Biology&rft.aulast=Edgerly%2C+C.H.%3B+Weimer%2C+E.T.&rft.au=Edgerly%2C+C.H.%3B+Weimer%2C+E.T.&rft.date=2018&rft.volume=1802&rft.pages=1%E2%80%9310&rft_id=info:doi\/10.1007%2F978-1-4939-8546-3_1&rft_id=info:pmid\/29858798&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_terminology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LodaPoly94-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LodaPoly94_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Loda, M. (1994). \"Polymerase chain reaction-based methods for the detection of mutations in oncogenes and tumor suppressor genes\". <i>Human Pathology<\/i> <b>25<\/b> (6): 564\u201371. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2F0046-8177%2894%2990220-8\" target=\"_blank\">10.1016\/0046-8177(94)90220-8<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/7912220\" target=\"_blank\">7912220<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Polymerase+chain+reaction-based+methods+for+the+detection+of+mutations+in+oncogenes+and+tumor+suppressor+genes&rft.jtitle=Human+Pathology&rft.aulast=Loda%2C+M.&rft.au=Loda%2C+M.&rft.date=1994&rft.volume=25&rft.issue=6&rft.pages=564%E2%80%9371&rft_id=info:doi\/10.1016%2F0046-8177%2894%2990220-8&rft_id=info:pmid\/7912220&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_terminology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-NinfaFund09-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-NinfaFund09_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Ninfa, A.J.; Ballou, D.P.; Benore, M. (2009). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=k6_XQwAACAAJ&pg=PA408\" target=\"_blank\"><i>Fundamental Laboratory Approaches for Biochemistry and Biotechnology<\/i><\/a>. Wiley. pp. 408\u2013410. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9780470087664<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=k6_XQwAACAAJ&pg=PA408\" target=\"_blank\">https:\/\/books.google.com\/books?id=k6_XQwAACAAJ&pg=PA408<\/a><\/span><span class=\"reference-accessdate\">. 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(2015). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/vaccines\/pubs\/pinkbook\/index.html\" target=\"_blank\"><i>Epidemiology and Prevention of Vaccine-Preventable Diseases<\/i><\/a> (13th ed.). Centers for Disease Control and Prevention<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/vaccines\/pubs\/pinkbook\/index.html\" target=\"_blank\">https:\/\/www.cdc.gov\/vaccines\/pubs\/pinkbook\/index.html<\/a><\/span><span class=\"reference-accessdate\">. 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Davis Company. pp. 301\u2013343. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9780803699540<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?hl=en&lr=&id=dJWNDwAAQBAJ&pg=301\" target=\"_blank\">https:\/\/books.google.com\/books?hl=en&lr=&id=dJWNDwAAQBAJ&pg=301<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+11%3A+Detection+and+Identification+of+Microorganisms&rft.atitle=Molecular+Diagnostics%3A+Fundamentals%2C+Methods+and+Clinical+Applications&rft.aulast=Buckingham%2C+L.&rft.au=Buckingham%2C+L.&rft.date=2019&rft.pages=pp.%26nbsp%3B301%E2%80%93343&rft.edition=3rd&rft.pub=F.A.+Davis+Company&rft.isbn=9780803699540&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fhl%3Den%26lr%3D%26id%3DdJWNDwAAQBAJ%26pg%3D301&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_terminology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-KimMRPrimer17-9\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-KimMRPrimer17_9-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Kim, H.; Kang, N.; An, K. et al. 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(5 February 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.scientificamerican.com\/article\/how-coronaviruses-cause-infection-from-colds-to-deadly-pneumonia1\/\" target=\"_blank\">\"How Coronaviruses Cause Infection\u2014from Colds to Deadly Pneumonia\"<\/a>. <i>Scientific American<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.scientificamerican.com\/article\/how-coronaviruses-cause-infection-from-colds-to-deadly-pneumonia1\/\" target=\"_blank\">https:\/\/www.scientificamerican.com\/article\/how-coronaviruses-cause-infection-from-colds-to-deadly-pneumonia1\/<\/a><\/span><span class=\"reference-accessdate\">. 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(2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=jSk0DwAAQBAJ&pg=PA183\" target=\"_blank\">\"Chapter 8: Paper-Based Immunoassays\"<\/a>. In Vashist, S.K.; Luong, J.H.T.. <i>Handbook of Immunoassay Technologies: Approaches, Performances, and Applications<\/i>. Academic Press. pp. 183\u2013202. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9780128117620<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=jSk0DwAAQBAJ&pg=PA183\" target=\"_blank\">https:\/\/books.google.com\/books?id=jSk0DwAAQBAJ&pg=PA183<\/a><\/span><span class=\"reference-accessdate\">. 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(23 March 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nature.com\/articles\/d41587-020-00010-2\" target=\"_blank\">\"Fast, portable tests come online to curb coronavirus pandemic\"<\/a>. <i>Nature Biotechnology - News<\/i>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1038%2Fd41587-020-00010-2\" target=\"_blank\">10.1038\/d41587-020-00010-2<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.nature.com\/articles\/d41587-020-00010-2\" target=\"_blank\">https:\/\/www.nature.com\/articles\/d41587-020-00010-2<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 08 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Fast%2C+portable+tests+come+online+to+curb+coronavirus+pandemic&rft.atitle=Nature+Biotechnology+-+News&rft.aulast=Sheridan%2C+C.&rft.au=Sheridan%2C+C.&rft.date=23+March+2020&rft_id=info:doi\/10.1038%2Fd41587-020-00010-2&rft_id=https%3A%2F%2Fwww.nature.com%2Farticles%2Fd41587-020-00010-2&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_terminology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-RBCoronavirus20-20\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-RBCoronavirus20_20-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20200408211820\/https:\/\/www.raybiotech.com\/index.php?dispatch=attachments.getfile&attachment_id=3095\" target=\"_blank\">\"Novel Coronavirus (SARS-CoV-2) IgM Antibody Detection Kit (Colloidal Gold Method)\"<\/a> (PDF). RayBiotech. 3 April 2020. Archived from <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.raybiotech.com\/index.php?dispatch=attachments.getfile&attachment_id=3095\" target=\"_blank\">the original<\/a> on 08 April 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20200408211820\/https:\/\/www.raybiotech.com\/index.php?dispatch=attachments.getfile&attachment_id=3095\" target=\"_blank\">https:\/\/web.archive.org\/web\/20200408211820\/https:\/\/www.raybiotech.com\/index.php?dispatch=attachments.getfile&attachment_id=3095<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Novel+Coronavirus+%28SARS-CoV-2%29+IgM+Antibody+Detection+Kit+%28Colloidal+Gold+Method%29&rft.atitle=&rft.date=3+April+2020&rft.pub=RayBiotech&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20200408211820%2Fhttps%3A%2F%2Fwww.raybiotech.com%2Findex.php%3Fdispatch%3Dattachments.getfile%26attachment_id%3D3095&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_terminology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20210919173026\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.154 seconds\nReal time usage: 0.234 seconds\nPreprocessor visited node count: 15001\/1000000\nPost\u2010expand include size: 139882\/2097152 bytes\nTemplate argument size: 42206\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 42724\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 148.349 1 -total\n 89.21% 132.349 1 Template:Reflist\n 70.10% 103.992 20 Template:Citation\/core\n 41.03% 60.866 11 Template:Cite_journal\n 23.70% 35.154 5 Template:Cite_web\n 13.26% 19.675 4 Template:Cite_book\n 10.74% 15.930 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_terminology\n 10.27% 15.241 31 Template:Citation\/identifier\n 5.78% 8.576 5 Template:Date\n 4.39% 6.509 25 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11908-0!canonical and timestamp 20210919173025 and revision id 39233. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_terminology\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_terminology<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","9cee66545e86ad0648ca3d040588e9df_images":["https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/d\/d8\/Fig2_Foysal_Sensors2019_19-21.png"],"9cee66545e86ad0648ca3d040588e9df_timestamp":1632073384,"cf539edc559ed35fa7053ca6e3a7e227_type":"article","cf539edc559ed35fa7053ca6e3a7e227_title":"1.3 Challenges of managing the disease in the human population","cf539edc559ed35fa7053ca6e3a7e227_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population","cf539edc559ed35fa7053ca6e3a7e227_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Overview of COVID-19 and its challenges\/Challenges of managing the disease in the human populationFrom LIMSWikiJump to navigationJump to search1.3 Challenges of managing the disease in the human population \n The graphical abstract from Li et al. 2020, showing general features of SARS-CoV-2, current knowledge of molecular immune pathogenesis, and diagnosis methods of COVID-19 based on present understanding of SARS-CoV and MERS-CoV viral infectionsCOVID-19 has presented numerous societal challenges, from supply line interruptions and economic sagging to overwhelmed healthcare systems and civil disorder. However, these are largely the social, economic, and political ripple effects of a disease that has brought with it a set of inherent attributes that make it more difficult to manage in human populations than say the flu. \nHowever, COVID-19 is not the flu, and it is indeed worse in its effects than the flu, contrary to many people's perceptions. Yes, COVID-19 and the flu have some symptom overlap. Yes, COVID-19 and the flu have some transmission type overlap. But from there it diverges. COVID-19 and SARS-CoV-2 is different in that it is more prone to be transmitted to others during the presymptomatic phase. And the body of evidence has grown since early on in the pandemic[1] that SARS-CoV-2 is transmittable predominately via an airborne route[2][3][4][5], though transmission from contaminated surfaced or physical intimacy are also believed possible.[6][7] Hospitalization rates are higher, perhaps up to 10 times higher than the flu, and hospital stays are longer with COVID-19. People are dying more often from COVID-19 too, up to 10 times more often than people stricken with the flu.[8][9][10] And while flu vaccines are largely the norm around the world, and COVID-19 vaccines are gradually becoming more available, those who willing choose to not get the vaccine have a massively higher chance of dying from COVID-19 (as of August 2021, more than 99 percent of all deaths from COVID-19 are found with the unvaccinated[11], compared to some 80% of children who die from the flu while unvaccinated[12]).\nOther aspects of the disease that make it difficult to manage include:\n\nMedian incubation period: According to research published in Annals of Internal Medicine, the median (i.e., the central tendency, which is less skewed than average[13]) incubation period is 5.1 days (Note that as new variants arrive, incubation times my change; the delta variant is thought to have an incubation period of four days, for example.[14]), with 97.5% of symptomatic carriers showing symptoms within 11.5 days. The authors found this to be compatible with U.S. government recommendations of monitored 14-day self-quarantines if individuals were at risk of exposure.[15] However, many people continue to not take mask-wearing\u2014and vaccination\u2014seriously, and thus unmasked presymptomatic (and asymptomatic) carriers are thus largely more prone to spreading the virus.[16][17] This has become even more precarious with the highly contagious delta variant, which can be spread even by the vaccinated, highlighting that \"measures such as masks and hand hygiene which can reduce transmission are important for everyone, regardless of vaccination status.\"[18]\nPresymptomatic and asymptomatic virus shedding: As mentioned in the previous point, carriers can be contagious during the presymptomatic phase of the disease, even while remaining symptom-free.[16][17][19][20] (The latest comprehensive research, from August 2021, appears to indicate that 35.1 percent of infected people may go without any recognizable symptoms after infection occurs.[21]) This contagion is a result of what's called viral shedding, when the virus moves from cell to cell following successful reproduction. When the virus is in this state, it can be actively found in a carrier's body fluids, excrement, and other sources. Depending on the virus, the virus can then be introduced to another person via those sources. In the case of COVID-19, the core route of transmission appears to be through the air via aerosolized and other forms of water droplets, though saliva and other bodily constituents pose a transmission hazard due to shedding (see previous bulletpoint). Early in the pandemic, uncertainty about transmission routes of viral shedding, along with mixed messages early on about masks and their effectiveness for COVID-19[22][23][24], caused problems. Today we know that masks and social distancing\u2014when appropriate\u2014are an even stronger necessity to limit community transmission of the disease from presymptomatic and asymptomatic individuals, even for those who are vaccinated.[18]\nUnderstanding of high viral loads and infectious doses: Respiratory diseases such as influenza, SARS, and MERS see a correlation between the infectious dose amount and the severity of disease symptoms, meaning the higher the infectious dose, the worse the symptoms.[25] Similarly, viral load\u2014a quantification of viral genomic fragments\u2014also tends to correlate with clinical symptoms.[26] However, even with the breakthroughs in COVID research since the start of the pandemic, we are still in the investigative stages of definitively determining if that similarly holds true to COVID-19.[25][27][28] Research early on indicated, for example, there is little difference between the viral load of those with mild or no COVID-19 symptoms and those with more severe symptoms.[25] However, Pujadas et al. suggested a link between high viral load and overall mortality rate.[29] Research later in 2020 has suggested more of a positive correlation between severity of symptoms and viral load[30][31], as has a July 2021 study published in Science.[32] However, more research must be performed to better understand how the viral load infectious dose plays a role in transmission. Given the continued unknowns in this realm, wearing masks and getting vaccinate help minimize exposure and remain the best defense against the worst outcomes of the disease.[25]\nCardiovascular issues: Coronaviruses and their accompanying respiratory infections are known to complicate issues of the cardiovascular system, which in turn may \"increase the incidence and severity\" of infectious diseases such as SARS and COVID-19.[33][34][35] While the exact cardiac effect COVID-19 has on patients is still unknown, suspicion is those with \"hypertension, diabetes, and diagnosed cardiovascular disease\" may be more prone to having cardiovascular complications from the disease.[36][37] Current thinking is SARS-CoV-2 either attacks heart tissues, causing myocardial dysfunction, or inevitably causes heart failure through a \"cytokine storm,\"[33][34][36][37][38][39][40], an overproduction of signaling molecules that promote inflammation by white blood cells (leukocytes).[41][42] What's scary is that like the 1918 Spanish flu, SARS, and other epidemics, some otherwise healthy patients' immune responses are entirely overreactive, leading to acute respiratory distress syndrome (ARDS) or heart failure.[40][39][43] Additionally, as the disease has progressed, medical professionals have noted two additional cardiovascular issues. First, an atypical amount of blood clotting has shown up in some infected patients, which may be related to overreactive immune systems, autoantibodies, and underlying health conditions.[44][45] Second, what is being called pediatric multisystem inflammatory syndrome (PMIS) or multisystem inflammatory syndrome in children (MIS-C) has shown up in children after the infection has passed, characterized by inflamed blood vessels and toxic shock syndrome.[46][47][48] While research is ongoing to determine whether these seemingly hyperactive cardiovascular responses are directly linked to the virus[49] or if virus-independent immunopathology is responsible[50], these uncertainties only emphasize the level of difficulty of properly treating COVID-19.\nOther systemic and bodily issues: As the pandemic has progressed, researchers have discovered SARS-CoV-2 appears to negatively impact other organs and systems in the human body, including the renal system, digestive system, endocrine system, neurological system, and even the reproductive system.[40][51][52][53][54] Another bodily issue that appears to remain for a subset of post-recovery COVID-19 patients is fatigue. The University of Minnesota's Center for Infectious Disease Research and Policy reports on an observational study published in PLOS One' that showed more than half of people who recovered from their COVID-19 infection still dealt with the lingering effects of fatigue at a median of 10 weeks after recovery. The study reports no link between the persistent fatigue and severity of symptoms, need for hospitalization, concentration of laboratory biomarkers, and age.[55] These systemic and body issues have added further complication to an already complicated disease, making extended treatment planning difficult. The long-term affects of these and other organ system injuries remains to be fully understood.\nMental health concerns: The mental health toll of the pandemic is becoming increasingly apparent as it wears on. A June 2020 CDC survey of 5,412 U.S. adults (regardless of infection status) \"found that 40.9% of respondents reported 'at least one adverse mental or behavioral health condition,' including depression, anxiety, posttraumatic stress, and substance abuse, with rates that were three to four times the rates one year earlier.\" More than 10 percent of respondents also indicated they had seriously considered suicide in a time period thirty days prior to responding.[56] From an inability to grieve communally with loved ones, to income loss, increased anxiety, and long periods of social isolation, these increasing numbers are not surprising, particularly in light of research on previous pandemics.[56][57] Without proper treatment, these conditions may worsen into prolonged grief disorder, only exasperating a growing mental health crisis.[56] Further, at least one study suggests that those who contract COVID-19 may be at a greater risk of developing some sort of mental illness within 90 days, including anxiety, depression, and insomnia. This effect may be worse for those who already have a history of mental health illness.[58] Mitigating the effects of these mental health concerns will require further study, greater funding, expanded screening, and improved focus on community methods of dealing with tragedy and loss.[56]\nReferences \n\n\n\u2191 Achenach, J.; Johnson, C.Y. (29 April 2020). \"Studies leave question of \u2018airborne\u2019 coronavirus transmission unanswered\". The Washington Post. https:\/\/www.washingtonpost.com\/health\/2020\/04\/29\/studies-leave-question-airborne-coronavirus-transmission-unanswered\/ . Retrieved 01 May 2020 .   \n \n\n\u2191 Van Beusekom, M. (6 July 2020). \"Global experts: Ignoring airborne COVID spread risky\". Center for Infectious Disease Research and Policy. University of Minnesota. https:\/\/www.cidrap.umn.edu\/news-perspective\/2020\/07\/global-experts-ignoring-airborne-covid-spread-risky . Retrieved 07 July 2020 .   \n \n\n\u2191 Ducharme, J. (7 July 2020). \"The WHO Says Airborne Coronavirus Transmission Isn't a Big Risk. Scientists Are Pushing Back\". Time. https:\/\/time.com\/5863220\/airborne-coronavirus-transmission\/ . Retrieved 07 July 2020 .   \n \n\n\u2191 Penn Medicine (2 August 2020). \"COVID-19 Transmission: Droplet or Airborne? Penn Medicine Epidemiologists Issue Statement\". Penn Physician Blog. https:\/\/www.pennmedicine.org\/updates\/blogs\/penn-physician-blog\/2020\/august\/airborne-droplet-debate-article . Retrieved 23 August 2020 .   \n \n\n\u2191 Greenhalgh, T.; Jimenez, J.L.; Prather, K.A. et al. (2021). \"Ten scientific reasons in support of airborne transmission of SARS-CoV-2\". Lancet 397 (10285): 1603\u20135. doi:10.1016\/S0140-6736(21)00869-2. PMC PMC8049599. PMID 33865497. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8049599 .   \n \n\n\u2191 \"Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission for Indoor Community Environments\". Centers for Disease Control and Prevention. 5 April 2021. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/more\/science-and-research\/surface-transmission.html . Retrieved 06 September 2021 .   \n \n\n\u2191 Winter, E.; Datil, A. (27 May 2021). \"VERIFY: Yes, vaccinated people can transmit COVID-19 through kissing\". WUSA9 - Verify. https:\/\/www.wusa9.com\/article\/news\/verify\/yes-vaccinated-people-can-transmit-covid-through-kissing\/536-00d88093-498c-4e58-9db6-331a69618248 . Retrieved 06 September 2021 .   \n \n\n\u2191 Huang, P. (20 March 2020). \"How The Novel Coronavirus And The Flu Are Alike ... And Different\". NPR: Goats and Soda. https:\/\/www.npr.org\/sections\/goatsandsoda\/2020\/03\/20\/815408287\/how-the-novel-coronavirus-and-the-flu-are-alike-and-different . Retrieved 01 April 2020 .   \n \n\n\u2191 Resnick, B.; Animashaun, C. (18 March 2020). \"Why Covid-19 is worse than the flu, in one chart\". 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Infection Control Today. https:\/\/www.infectioncontroltoday.com\/view\/asymptomatic-carriers-covid-19-make-it-tough-target . Retrieved 06 September 2021 .   \n \n\n\u2191 Sah, P.; Fitzpatrick, M.C.; Zimmer, C.F. et al. (2021). \"Asymptomatic SARS-CoV-2 infection: A systematic review and meta-analysis\". PNAS 118 (34): e2109229118. doi:10.1073\/pnas.2109229118. PMID 34376550.   \n \n\n\u2191 Greenfieldboyce, N. (28 March 2020). \"WHO Reviews 'Current' Evidence On Coronavirus Transmission Through Air\". NPR. https:\/\/www.npr.org\/2020\/03\/28\/823292062\/who-reviews-available-evidence-on-coronavirus-transmission-through-air . Retrieved 01 April 2020 .   \n \n\n\u2191 Chicago Sun Times Editorial Board (31 March 2020). \"Ignore the mixed messages and wear that mask\". Chicago Sun Times. https:\/\/chicago.suntimes.com\/2020\/3\/31\/21200144\/coronavirus-covid-19-masks-wear-cdc-pritzker-trump-public-health-virus-face-cough-sneeze . Retrieved 01 April 2020 .   \n \n\n\u2191 Mulholland, J. (29 March 2020). \"To mask or not to mask: mixed messages in a time of crisis\". RFI. http:\/\/www.rfi.fr\/en\/international\/20200329-to-mask-or-not-to-mask-mixed-messages-in-a-time-of-coronavirus-crisis-france-covid-19-spread-droplets . Retrieved 01 April 2020 .   \n \n\n\u2191 25.0 25.1 25.2 25.3 Geddes, L. (27 March 2020). \"Does a high viral load or infectious dose make covid-19 worse?\". New Scientist. https:\/\/www.newscientist.com\/article\/2238819-does-a-high-viral-load-or-infectious-dose-make-covid-19-worse\/ . Retrieved 01 April 2020 .   \n \n\n\u2191 Hijano, D.R.; Brazelton de Cardenas, J.; Maron, G. et al. (2019). \"Clinical correlation of influenza and respiratory syncytial virus load measured by digital PCR\". PLoS One 14 (9): e0220908. doi:10.1371\/journal.pone.0220908. PMC PMC6720028. PMID 31479459. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6720028 .   \n \n\n\u2191 Liu, Y.; Yan, L.-M.; Wan, L. et al. 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PMID 33127906. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7603483 .   \n \n\n\u2191 \"SARS-Cov-2 Viral Load as an Indicator for COVID-19 Patients\u2019 Hospital Stay\". medRxiv. 2020. doi:10.1101\/2020.11.04.20226365.   \n \n\n\u2191 Jones, T.C.; Biele, G.; M\u00fchlemann, B. et al. (2021). \"Estimating infectiousness throughout SARS-CoV-2 infection course\". Science 373 (6551): abi5273. doi:10.1126\/science.abi5273. PMID 34035154.   \n \n\n\u2191 33.0 33.1 Madjid, M.; Safavi-Naeini, P.; Solomon, S.D. (2020). \"Potential Effects of Coronaviruses on the Cardiovascular System\". JAMA Cardiology. doi:10.1001\/jamacardio.2020.1286. PMID 32219363.   \n \n\n\u2191 34.0 34.1 Xiong, T.-Y.; Redwood, S.; Prendergast, B.; Chen, M. (2020). \"Coronaviruses and the cardiovascular system: acute and long-term implications\". European Heart Journal: ehaa231. doi:10.1093\/eurheartj\/ehaa231. PMID 32186331.   \n \n\n\u2191 Driggin, E.; Madhavan, M.V.; Bikdeli, B. et al. (2020). \"Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the Coronavirus Disease 2019 (COVID-19) Pandemic\". Journal of the American College of Cardiology. doi:10.1016\/j.jacc.2020.03.031. PMID 32201335.   \n \n\n\u2191 36.0 36.1 Otto, M.A. (26 March 2020). \"Cardiac symptoms can be first sign of COVID-19\". The Hospitalist. https:\/\/www.the-hospitalist.org\/hospitalist\/article\/219645\/coronavirus-updates\/cardiac-symptoms-can-be-first-sign-covid-19 . Retrieved 01 April 2020 .   \n \n\n\u2191 37.0 37.1 Clerkin, K.J.; Fried, J.A.; Raikhelkar, J. et al. (2020). \"Coronavirus Disease 2019 (COVID-19) and Cardiovascular Disease\". Circulation. doi:10.1161\/CIRCULATIONAHA.120.046941. PMID 32200663.   \n \n\n\u2191 Mehta, P.; McAuley, D.F.; Brown, M. et al. (2020). \"COVID-19: Consider cytokine storm syndromes and immunosuppression\". The Lancet 395 (10229): P1033\u201334. doi:10.1016\/S0140-6736(20)30628-0. PMID 32192578.   \n \n\n\u2191 39.0 39.1 Mandavilli, A. (1 April 2020). \"The Coronavirus Patients Betrayed by Their Own Immune Systems\". The New York Times. https:\/\/www.nytimes.com\/2020\/04\/01\/health\/coronavirus-cytokine-storm-immune-system.html . Retrieved 01 April 2020 .   \n \n\n\u2191 40.0 40.1 40.2 Weidmann, M.D.; Otori, J.; Rai, A.J. (2020). \"Laboratory Biomarkers in the Management of Patients With COVID-19\". American Journal of Clinical Pathology: aqaa205. doi:10.1093\/ajcp\/aqaa205. PMID 33107558.   \n \n\n\u2191 Tisoncik, J.R.; Korth, M.J.; Simmons, C.P. et al. (2012). \"Into the eye of the cytokine storm\". Microbiology and Molecular Biology Reviews 76 (1): 16\u201332. doi:10.1128\/MMBR.05015-11. PMC PMC3294426. PMID 22390970. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC3294426 .   \n \n\n\u2191 Yang, L.; Xie, X.; Tu, Z. et al. (2021). \"The signal pathways and treatment of cytokine storm in COVID-19\". Signal Transduction and Targeted Therapy 6: 255. doi:10.1038\/s41392-021-00679-0. PMC PMC8261820. PMID 34234112. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8261820 .   \n \n\n\u2191 Basilio, P. (26 March 2020). \"A new potential risk of COVID-19: Sudden cardiac death\". MDLinx. https:\/\/www.mdlinx.com\/article\/a-new-potential-risk-of-covid-19-sudden-cardiac-death\/3z05mHtQN0PL1EdhlWltmH . Retrieved 06 September 2021 .   \n \n\n\u2191 Rettner, R. (23 April 2020). \"Mysterious blood clots in COVID-19 patients have doctors alarmed\". LiveScience. https:\/\/www.livescience.com\/coronavirus-blood-clots.html . Retrieved 28 April 2020 .   \n \n\n\u2191 Hampton, T. (2021). \"Autoantibodies May Drive COVID-19 Blood Clots\". JAMA 325 (5): 425. doi:10.1001\/jama.2020.25699. PMID 33528515.   \n \n\n\u2191 Moyer, M.W. (19 May 2020). \"What We Know About the Covid-Related Syndrome Affecting Children\". The New York Times. https:\/\/www.nytimes.com\/2020\/05\/19\/parenting\/pmis-coronavirus-children.html . Retrieved 19 May 2020 .   \n \n\n\u2191 Fischer, K. (18 May 2020). \"What to Know About PMIS, the COVID-19-Linked Syndrome Affecting Children\". Healthline. https:\/\/www.healthline.com\/health-news\/what-to-know-pmis-syndrome-linked-to-covid-19-affects-children . Retrieved 19 May 2020 .   \n \n\n\u2191 MacMillan, C. (14 July 2021). \"Researchers Continue to Find Clues About MIS-C\". Yale Medicine. Yale University. https:\/\/www.yalemedicine.org\/news\/multisystem-inflammatory-syndrome-in-children-misc-covid-kids . Retrieved 06 September 2021 .   \n \n\n\u2191 Manne, B.K.; Denorme, F.; Middleton, E.A. et al. (2020). \"Platelet Gene Expression and Function in COVID-19 Patients\". Blood: blood.2020007214. doi:10.1182\/blood.2020007214.   \n \n\n\u2191 Dorward, D.A.; Russell, C.D.; Um, I.H. et al. (2020). \"Tissue-specific tolerance in fatal Covid-19\". medRxiv. doi:10.1101\/2020.07.02.20145003.   \n \n\n\u2191 Centers for Disease Control and Preventions (22 February 2021). \"Symptoms of Coronavirus\". Centers for Disease Control and Preventions. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/symptoms-testing\/symptoms.html . Retrieved 06 September 2021 .   \n \n\n\u2191 Mayo Clinic Staff (7 October 2020). \"COVID-19 (coronavirus): Long-term effects\". Mayo Clinic. https:\/\/www.mayoclinic.org\/diseases-conditions\/coronavirus\/in-depth\/coronavirus-long-term-effects\/art-20490351 . Retrieved 12 November 2020 .   \n \n\n\u2191 Budson, A.E. (8 October 2020). \"The hidden long-term cognitive effects of COVID-19\". Harvard Health Blog. https:\/\/www.health.harvard.edu\/blog\/the-hidden-long-term-cognitive-effects-of-covid-2020100821133 . Retrieved 12 November 2020 .   \n \n\n\u2191 Ma, C.; Cong, Y.; Zhang, H. (2020). \"COVID-19 and the Digestive System\". American Journal of Gastroenterology 115 (7): 1003\u20136. doi:10.14309\/ajg.0000000000000691. PMC PMC7273952. PMID 32618648. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7273952 .   \n \n\n\u2191 Van Beusekom, M. (11 November 2020). \"Half of recovered COVID-19 patients report lingering fatigue\". CUDRAP News & Perspective. University of Minnesota. https:\/\/www.cidrap.umn.edu\/news-perspective\/2020\/11\/half-recovered-covid-19-patients-report-lingering-fatigue . Retrieved 18 November 2020 .   \n \n\n\u2191 56.0 56.1 56.2 56.3 Simon, N.M.; Saxe, G.N.; Marmar, C.R. (2020). \"Mental Health Disorders Related to COVID-19\u2013Related Deaths\". JAMA 324 (15): 1493\u201394. doi:10.1001\/jama.2020.19632. PMID 33044510.   \n \n\n\u2191 Savage, M. (28 October 2020). \"Coronavirus: The possible long-term mental health impacts\". BBC Worklife. https:\/\/www.bbc.com\/worklife\/article\/20201021-coronavirus-the-possible-long-term-mental-health-impacts . Retrieved 18 November 2020 .   \n \n\n\u2191 Kelland, K. (9 November 2020). \"Study Shows COVID-19 Patients at Greater Risk of Mental Health Problems\". Insurance Journal. https:\/\/www.insurancejournal.com\/news\/international\/2020\/11\/09\/590113.htm . Retrieved 18 November 2020 .   \n \n\n\n\r\n\n\n-----Go to the next chapter of this guide-----\nCitation information for this chapter \nChapter: 1. Overview of COVID-19 and its challenges\nEdition: Fall 2021\nTitle: COVID-19 Testing, Reporting, and Information Management in the Laboratory\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: September 2021\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 19 September 2021, at 17:25.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 295 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","cf539edc559ed35fa7053ca6e3a7e227_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Overview_of_COVID-19_and_its_challenges_Challenges_of_managing_the_disease_in_the_human_population rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Overview_of_COVID-19_and_its_challenges_Challenges_of_managing_the_disease_in_the_human_population skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Overview of COVID-19 and its challenges\/Challenges of managing the disease in the human population<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><h3><span class=\"mw-headline\" id=\"1.3_Challenges_of_managing_the_disease_in_the_human_population\">1.3 Challenges of managing the disease in the human population<\/span><\/h3>\n<div class=\"thumb tright\"><div class=\"thumbinner\" style=\"width:652px;\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Fig1_Li_JofPharmAnal2020_10-2.jpg\" class=\"image wiki-link\" data-key=\"fbecc368ee5ad358b1cdd928e3dd5875\"><img alt=\"\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/b\/b1\/Fig1_Li_JofPharmAnal2020_10-2.jpg\" decoding=\"async\" class=\"thumbimage\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a> <div class=\"thumbcaption\"><div class=\"magnify\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Fig1_Li_JofPharmAnal2020_10-2.jpg\" class=\"internal wiki-link\" title=\"Enlarge\" data-key=\"fbecc368ee5ad358b1cdd928e3dd5875\"><\/a><\/div>The graphical abstract from <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/doi.org\/10.1016\/j.jpha.2020.03.001\" target=\"_blank\">Li <i>et al.<\/i> 2020<\/a>, showing general features of SARS-CoV-2, current knowledge of molecular immune pathogenesis, and diagnosis methods of COVID-19 based on present understanding of SARS-CoV and MERS-CoV viral infections<\/div><\/div><\/div><p>COVID-19 has presented numerous societal challenges, from supply line interruptions and economic sagging to overwhelmed healthcare systems and civil disorder. However, these are largely the social, economic, and political ripple effects of a disease that has brought with it a set of inherent attributes that make it more difficult to manage in human populations than say the flu. \n<\/p><p>However, COVID-19 is not the flu, and it is indeed worse in its effects than the flu, contrary to many people's perceptions. Yes, COVID-19 and the flu have some symptom overlap. Yes, COVID-19 and the flu have some transmission type overlap. But from there it diverges. COVID-19 and SARS-CoV-2 is different in that it is more prone to be transmitted to others during the presymptomatic phase. And the body of evidence has grown since early on in the pandemic<sup id=\"rdp-ebb-cite_ref-AchenbachStudies20_1-0\" class=\"reference\"><a href=\"#cite_note-AchenbachStudies20-1\">[1]<\/a><\/sup> that SARS-CoV-2 is transmittable predominately via an airborne route<sup id=\"rdp-ebb-cite_ref-VanBeusekomGlobal20_2-0\" class=\"reference\"><a href=\"#cite_note-VanBeusekomGlobal20-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DucharmeTheWHO20_3-0\" class=\"reference\"><a href=\"#cite_note-DucharmeTheWHO20-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PennCOVID20_4-0\" class=\"reference\"><a href=\"#cite_note-PennCOVID20-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-GreenhalghTen21_5-0\" class=\"reference\"><a href=\"#cite_note-GreenhalghTen21-5\">[5]<\/a><\/sup>, though transmission from contaminated surfaced or physical intimacy are also believed possible.<sup id=\"rdp-ebb-cite_ref-CDCScienceBrief21_6-0\" class=\"reference\"><a href=\"#cite_note-CDCScienceBrief21-6\">[6]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WinterVerifyYes21_7-0\" class=\"reference\"><a href=\"#cite_note-WinterVerifyYes21-7\">[7]<\/a><\/sup> Hospitalization rates are higher, perhaps up to 10 times higher than the flu, and hospital stays are longer with COVID-19. People are dying more often from COVID-19 too, up to 10 times more often than people stricken with the flu.<sup id=\"rdp-ebb-cite_ref-HuangHow20_8-0\" class=\"reference\"><a href=\"#cite_note-HuangHow20-8\">[8]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ResnickWhy20_9-0\" class=\"reference\"><a href=\"#cite_note-ResnickWhy20-9\">[9]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-KumarCOVID20_10-0\" class=\"reference\"><a href=\"#cite_note-KumarCOVID20-10\">[10]<\/a><\/sup> And while flu vaccines are largely the norm around the world, and COVID-19 vaccines are gradually becoming more available, those who willing choose to not get the vaccine have a massively higher chance of dying from COVID-19 (as of August 2021, more than 99 percent of all deaths from COVID-19 are found with the unvaccinated<sup id=\"rdp-ebb-cite_ref-MostMyths21_11-0\" class=\"reference\"><a href=\"#cite_note-MostMyths21-11\">[11]<\/a><\/sup>, compared to some 80% of children who die from the flu while unvaccinated<sup id=\"rdp-ebb-cite_ref-USAFacts61000_21_12-0\" class=\"reference\"><a href=\"#cite_note-USAFacts61000_21-12\">[12]<\/a><\/sup>).\n<\/p><p>Other aspects of the disease that make it difficult to manage include:\n<\/p>\n<ul><li><i>Median incubation period<\/i>: According to research published in <i>Annals of Internal Medicine<\/i>, the median (i.e., the central tendency, which is less skewed than average<sup id=\"rdp-ebb-cite_ref-NRCSMedian_13-0\" class=\"reference\"><a href=\"#cite_note-NRCSMedian-13\">[13]<\/a><\/sup>) incubation period is 5.1 days (Note that as new variants arrive, incubation times my change; the delta variant is thought to have an incubation period of four days, for example.<sup id=\"rdp-ebb-cite_ref-KochvarDelta21_14-0\" class=\"reference\"><a href=\"#cite_note-KochvarDelta21-14\">[14]<\/a><\/sup>), with 97.5% of symptomatic carriers showing symptoms within 11.5 days. The authors found this to be compatible with U.S. government recommendations of monitored 14-day self-quarantines if individuals were at risk of exposure.<sup id=\"rdp-ebb-cite_ref-LauerTheInc20_15-0\" class=\"reference\"><a href=\"#cite_note-LauerTheInc20-15\">[15]<\/a><\/sup> However, many people continue to not take mask-wearing\u2014and vaccination\u2014seriously, and thus unmasked presymptomatic (and asymptomatic) carriers are thus largely more prone to spreading the virus.<sup id=\"rdp-ebb-cite_ref-MandavilliInfected20_16-0\" class=\"reference\"><a href=\"#cite_note-MandavilliInfected20-16\">[16]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MockAsymptom20_17-0\" class=\"reference\"><a href=\"#cite_note-MockAsymptom20-17\">[17]<\/a><\/sup> This has become even more precarious with the highly contagious delta variant, which can be spread even by the vaccinated, highlighting that \"measures such as masks and hand hygiene which can reduce transmission are important for everyone, regardless of vaccination status.\"<sup id=\"rdp-ebb-cite_ref-SubbaramanHowDo21_18-0\" class=\"reference\"><a href=\"#cite_note-SubbaramanHowDo21-18\">[18]<\/a><\/sup><\/li><\/ul>\n<ul><li><i>Presymptomatic and asymptomatic virus shedding<\/i>: As mentioned in the previous point, carriers can be contagious during the presymptomatic phase of the disease, even while remaining symptom-free.<sup id=\"rdp-ebb-cite_ref-MandavilliInfected20_16-1\" class=\"reference\"><a href=\"#cite_note-MandavilliInfected20-16\">[16]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MockAsymptom20_17-1\" class=\"reference\"><a href=\"#cite_note-MockAsymptom20-17\">[17]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-YuenSARS20_19-0\" class=\"reference\"><a href=\"#cite_note-YuenSARS20-19\">[19]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DiamondAsympt20_20-0\" class=\"reference\"><a href=\"#cite_note-DiamondAsympt20-20\">[20]<\/a><\/sup> (The latest comprehensive research, from August 2021, appears to indicate that 35.1 percent of infected people may go without any recognizable symptoms after infection occurs.<sup id=\"rdp-ebb-cite_ref-SahAsymptom21_21-0\" class=\"reference\"><a href=\"#cite_note-SahAsymptom21-21\">[21]<\/a><\/sup>) This contagion is a result of what's called <a href=\"https:\/\/www.limswiki.org\/index.php\/Viral_shedding\" title=\"Viral shedding\" class=\"wiki-link\" data-key=\"9cdeb21c8f17cdbe0e75c232b40d5e6a\">viral shedding<\/a>, when the virus moves from cell to cell following successful reproduction. When the virus is in this state, it can be actively found in a carrier's body fluids, excrement, and other sources. Depending on the virus, the virus can then be introduced to another person via those sources. In the case of COVID-19, the core route of transmission appears to be through the air via aerosolized and other forms of water droplets, though saliva and other bodily constituents pose a transmission hazard due to shedding (see previous bulletpoint). Early in the pandemic, uncertainty about transmission routes of viral shedding, along with mixed messages early on about masks and their effectiveness for COVID-19<sup id=\"rdp-ebb-cite_ref-GreenfieldboyceWHO20_22-0\" class=\"reference\"><a href=\"#cite_note-GreenfieldboyceWHO20-22\">[22]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CSTEditorialIgnore31_23-0\" class=\"reference\"><a href=\"#cite_note-CSTEditorialIgnore31-23\">[23]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MulhollandToMask20_24-0\" class=\"reference\"><a href=\"#cite_note-MulhollandToMask20-24\">[24]<\/a><\/sup>, caused problems. Today we know that masks and social distancing\u2014when appropriate\u2014are an even stronger necessity to limit community transmission of the disease from presymptomatic and asymptomatic individuals, even for those who are vaccinated.<sup id=\"rdp-ebb-cite_ref-SubbaramanHowDo21_18-1\" class=\"reference\"><a href=\"#cite_note-SubbaramanHowDo21-18\">[18]<\/a><\/sup><\/li><\/ul>\n<ul><li><i>Understanding of high viral loads and infectious doses<\/i>: Respiratory diseases such as influenza, SARS, and MERS see a correlation between the infectious dose amount and the severity of disease symptoms, meaning the higher the infectious dose, the worse the symptoms.<sup id=\"rdp-ebb-cite_ref-GeddesDoesA20_25-0\" class=\"reference\"><a href=\"#cite_note-GeddesDoesA20-25\">[25]<\/a><\/sup> Similarly, viral load\u2014a quantification of viral genomic fragments\u2014also tends to correlate with clinical symptoms.<sup id=\"rdp-ebb-cite_ref-HijanoClinical19_26-0\" class=\"reference\"><a href=\"#cite_note-HijanoClinical19-26\">[26]<\/a><\/sup> However, even with the breakthroughs in COVID research since the start of the pandemic, we are still in the investigative stages of definitively determining if that similarly holds true to COVID-19.<sup id=\"rdp-ebb-cite_ref-GeddesDoesA20_25-1\" class=\"reference\"><a href=\"#cite_note-GeddesDoesA20-25\">[25]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LiuViral20_27-0\" class=\"reference\"><a href=\"#cite_note-LiuViral20-27\">[27]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-JoyntUnder20_28-0\" class=\"reference\"><a href=\"#cite_note-JoyntUnder20-28\">[28]<\/a><\/sup> Research early on indicated, for example, there is little difference between the viral load of those with mild or no COVID-19 symptoms and those with more severe symptoms.<sup id=\"rdp-ebb-cite_ref-GeddesDoesA20_25-2\" class=\"reference\"><a href=\"#cite_note-GeddesDoesA20-25\">[25]<\/a><\/sup> However, Pujadas <i>et al.<\/i> suggested a link between high viral load and overall mortality rate.<sup id=\"rdp-ebb-cite_ref-PujadasSARS20_29-0\" class=\"reference\"><a href=\"#cite_note-PujadasSARS20-29\">[29]<\/a><\/sup> Research later in 2020 has suggested more of a positive correlation between severity of symptoms and viral load<sup id=\"rdp-ebb-cite_ref-FajnzylberSARS20_30-0\" class=\"reference\"><a href=\"#cite_note-FajnzylberSARS20-30\">[30]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-AlAliSARS20_31-0\" class=\"reference\"><a href=\"#cite_note-AlAliSARS20-31\">[31]<\/a><\/sup>, as has a July 2021 study published in <i>Science<\/i>.<sup id=\"rdp-ebb-cite_ref-JonesEstim21_32-0\" class=\"reference\"><a href=\"#cite_note-JonesEstim21-32\">[32]<\/a><\/sup> However, more research must be performed to better understand how the viral load infectious dose plays a role in transmission. Given the continued unknowns in this realm, wearing masks and getting vaccinate help minimize exposure and remain the best defense against the worst outcomes of the disease.<sup id=\"rdp-ebb-cite_ref-GeddesDoesA20_25-3\" class=\"reference\"><a href=\"#cite_note-GeddesDoesA20-25\">[25]<\/a><\/sup><\/li><\/ul>\n<ul><li><i>Cardiovascular issues<\/i>: Coronaviruses and their accompanying respiratory infections are known to complicate issues of the cardiovascular system, which in turn may \"increase the incidence and severity\" of infectious diseases such as SARS and COVID-19.<sup id=\"rdp-ebb-cite_ref-MadjidPotent20_33-0\" class=\"reference\"><a href=\"#cite_note-MadjidPotent20-33\">[33]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-XiongCorona20_34-0\" class=\"reference\"><a href=\"#cite_note-XiongCorona20-34\">[34]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-DrigginCardio20_35-0\" class=\"reference\"><a href=\"#cite_note-DrigginCardio20-35\">[35]<\/a><\/sup> While the exact cardiac effect COVID-19 has on patients is still unknown, suspicion is those with \"hypertension, diabetes, and diagnosed cardiovascular disease\" may be more prone to having cardiovascular complications from the disease.<sup id=\"rdp-ebb-cite_ref-OttoCardiac20_36-0\" class=\"reference\"><a href=\"#cite_note-OttoCardiac20-36\">[36]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ClerkinCorona20_37-0\" class=\"reference\"><a href=\"#cite_note-ClerkinCorona20-37\">[37]<\/a><\/sup> Current thinking is SARS-CoV-2 either attacks heart tissues, causing myocardial dysfunction, or inevitably causes heart failure through a \"cytokine storm,\"<sup id=\"rdp-ebb-cite_ref-MadjidPotent20_33-1\" class=\"reference\"><a href=\"#cite_note-MadjidPotent20-33\">[33]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-XiongCorona20_34-1\" class=\"reference\"><a href=\"#cite_note-XiongCorona20-34\">[34]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-OttoCardiac20_36-1\" class=\"reference\"><a href=\"#cite_note-OttoCardiac20-36\">[36]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ClerkinCorona20_37-1\" class=\"reference\"><a href=\"#cite_note-ClerkinCorona20-37\">[37]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MehtaCOVID20_38-0\" class=\"reference\"><a href=\"#cite_note-MehtaCOVID20-38\">[38]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MandavilliTheCoronaCyto20_39-0\" class=\"reference\"><a href=\"#cite_note-MandavilliTheCoronaCyto20-39\">[39]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WeidmannLab20_40-0\" class=\"reference\"><a href=\"#cite_note-WeidmannLab20-40\">[40]<\/a><\/sup>, an overproduction of signaling molecules that promote inflammation by white blood cells (leukocytes).<sup id=\"rdp-ebb-cite_ref-TisoncikInto12_41-0\" class=\"reference\"><a href=\"#cite_note-TisoncikInto12-41\">[41]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-YangTheSig21_42-0\" class=\"reference\"><a href=\"#cite_note-YangTheSig21-42\">[42]<\/a><\/sup> What's scary is that like the 1918 Spanish flu, SARS, and other epidemics, some otherwise healthy patients' immune responses are entirely overreactive, leading to acute respiratory distress syndrome (ARDS) or heart failure.<sup id=\"rdp-ebb-cite_ref-WeidmannLab20_40-1\" class=\"reference\"><a href=\"#cite_note-WeidmannLab20-40\">[40]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MandavilliTheCoronaCyto20_39-1\" class=\"reference\"><a href=\"#cite_note-MandavilliTheCoronaCyto20-39\">[39]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BasilioANew20_43-0\" class=\"reference\"><a href=\"#cite_note-BasilioANew20-43\">[43]<\/a><\/sup> Additionally, as the disease has progressed, medical professionals have noted two additional cardiovascular issues. First, an atypical amount of blood clotting has shown up in some infected patients, which may be related to overreactive immune systems, autoantibodies, and underlying health conditions.<sup id=\"rdp-ebb-cite_ref-RettnerMyster20_44-0\" class=\"reference\"><a href=\"#cite_note-RettnerMyster20-44\">[44]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HamptonAuto21_45-0\" class=\"reference\"><a href=\"#cite_note-HamptonAuto21-45\">[45]<\/a><\/sup> Second, what is being called pediatric multisystem inflammatory syndrome (PMIS) or multisystem inflammatory syndrome in children (MIS-C) has shown up in children after the infection has passed, characterized by inflamed blood vessels and toxic shock syndrome.<sup id=\"rdp-ebb-cite_ref-MoyerWhatWe20_46-0\" class=\"reference\"><a href=\"#cite_note-MoyerWhatWe20-46\">[46]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-FischerWhatTo20_47-0\" class=\"reference\"><a href=\"#cite_note-FischerWhatTo20-47\">[47]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MacMillanResearch21_48-0\" class=\"reference\"><a href=\"#cite_note-MacMillanResearch21-48\">[48]<\/a><\/sup> While research is ongoing to determine whether these seemingly hyperactive cardiovascular responses are directly linked to the virus<sup id=\"rdp-ebb-cite_ref-MannePlatelet20_49-0\" class=\"reference\"><a href=\"#cite_note-MannePlatelet20-49\">[49]<\/a><\/sup> or if virus-independent immunopathology is responsible<sup id=\"rdp-ebb-cite_ref-DorwardTissue20_50-0\" class=\"reference\"><a href=\"#cite_note-DorwardTissue20-50\">[50]<\/a><\/sup>, these uncertainties only emphasize the level of difficulty of properly treating COVID-19.<\/li><\/ul>\n<ul><li><i>Other systemic and bodily issues<\/i>: As the pandemic has progressed, researchers have discovered SARS-CoV-2 appears to negatively impact other organs and systems in the human body, including the renal system, digestive system, endocrine system, neurological system, and even the reproductive system.<sup id=\"rdp-ebb-cite_ref-WeidmannLab20_40-2\" class=\"reference\"><a href=\"#cite_note-WeidmannLab20-40\">[40]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CDCSymptoms20_51-0\" class=\"reference\"><a href=\"#cite_note-CDCSymptoms20-51\">[51]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MayoCOVID20_52-0\" class=\"reference\"><a href=\"#cite_note-MayoCOVID20-52\">[52]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BudsonTheHidden20_53-0\" class=\"reference\"><a href=\"#cite_note-BudsonTheHidden20-53\">[53]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MaCOVID20_54-0\" class=\"reference\"><a href=\"#cite_note-MaCOVID20-54\">[54]<\/a><\/sup> Another bodily issue that appears to remain for a subset of post-recovery COVID-19 patients is fatigue. The University of Minnesota's Center for Infectious Disease Research and Policy reports on an observational study published in <i>PLOS One'<\/i> that showed more than half of people who recovered from their COVID-19 infection still dealt with the lingering effects of fatigue at a median of 10 weeks after recovery. The study reports no link between the persistent fatigue and severity of symptoms, need for hospitalization, concentration of laboratory biomarkers, and age.<sup id=\"rdp-ebb-cite_ref-VanBeusekomHalf20_55-0\" class=\"reference\"><a href=\"#cite_note-VanBeusekomHalf20-55\">[55]<\/a><\/sup> These systemic and body issues have added further complication to an already complicated disease, making extended treatment planning difficult. The long-term affects of these and other organ system injuries remains to be fully understood.<\/li><\/ul>\n<ul><li><i>Mental health concerns<\/i>: The mental health toll of the pandemic is becoming increasingly apparent as it wears on. A June 2020 CDC survey of 5,412 U.S. adults (regardless of infection status) \"found that 40.9% of respondents reported 'at least one adverse mental or behavioral health condition,' including depression, anxiety, posttraumatic stress, and substance abuse, with rates that were three to four times the rates one year earlier.\" More than 10 percent of respondents also indicated they had seriously considered suicide in a time period thirty days prior to responding.<sup id=\"rdp-ebb-cite_ref-SimonMental20_56-0\" class=\"reference\"><a href=\"#cite_note-SimonMental20-56\">[56]<\/a><\/sup> From an inability to grieve communally with loved ones, to income loss, increased anxiety, and long periods of social isolation, these increasing numbers are not surprising, particularly in light of research on previous pandemics.<sup id=\"rdp-ebb-cite_ref-SimonMental20_56-1\" class=\"reference\"><a href=\"#cite_note-SimonMental20-56\">[56]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SavageCorona20_57-0\" class=\"reference\"><a href=\"#cite_note-SavageCorona20-57\">[57]<\/a><\/sup> Without proper treatment, these conditions may worsen into prolonged grief disorder, only exasperating a growing mental health crisis.<sup id=\"rdp-ebb-cite_ref-SimonMental20_56-2\" class=\"reference\"><a href=\"#cite_note-SimonMental20-56\">[56]<\/a><\/sup> Further, at least one study suggests that those who contract COVID-19 may be at a greater risk of developing some sort of mental illness within 90 days, including anxiety, depression, and insomnia. This effect may be worse for those who already have a history of mental health illness.<sup id=\"rdp-ebb-cite_ref-KellandStudy20_58-0\" class=\"reference\"><a href=\"#cite_note-KellandStudy20-58\">[58]<\/a><\/sup> Mitigating the effects of these mental health concerns will require further study, greater funding, expanded screening, and improved focus on community methods of dealing with tragedy and loss.<sup id=\"rdp-ebb-cite_ref-SimonMental20_56-3\" class=\"reference\"><a href=\"#cite_note-SimonMental20-56\">[56]<\/a><\/sup><\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-AchenbachStudies20-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AchenbachStudies20_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Achenach, J.; Johnson, C.Y. (29 April 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.washingtonpost.com\/health\/2020\/04\/29\/studies-leave-question-airborne-coronavirus-transmission-unanswered\/\" target=\"_blank\">\"Studies leave question of \u2018airborne\u2019 coronavirus transmission unanswered\"<\/a>. <i>The Washington Post<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.washingtonpost.com\/health\/2020\/04\/29\/studies-leave-question-airborne-coronavirus-transmission-unanswered\/\" target=\"_blank\">https:\/\/www.washingtonpost.com\/health\/2020\/04\/29\/studies-leave-question-airborne-coronavirus-transmission-unanswered\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 01 May 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Studies+leave+question+of+%E2%80%98airborne%E2%80%99+coronavirus+transmission+unanswered&rft.atitle=The+Washington+Post&rft.aulast=Achenach%2C+J.%3B+Johnson%2C+C.Y.&rft.au=Achenach%2C+J.%3B+Johnson%2C+C.Y.&rft.date=29+April+2020&rft_id=https%3A%2F%2Fwww.washingtonpost.com%2Fhealth%2F2020%2F04%2F29%2Fstudies-leave-question-airborne-coronavirus-transmission-unanswered%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-VanBeusekomGlobal20-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-VanBeusekomGlobal20_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Van Beusekom, M. (6 July 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cidrap.umn.edu\/news-perspective\/2020\/07\/global-experts-ignoring-airborne-covid-spread-risky\" target=\"_blank\">\"Global experts: Ignoring airborne COVID spread risky\"<\/a>. <i>Center for Infectious Disease Research and Policy<\/i>. University of Minnesota<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cidrap.umn.edu\/news-perspective\/2020\/07\/global-experts-ignoring-airborne-covid-spread-risky\" target=\"_blank\">https:\/\/www.cidrap.umn.edu\/news-perspective\/2020\/07\/global-experts-ignoring-airborne-covid-spread-risky<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 July 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Global+experts%3A+Ignoring+airborne+COVID+spread+risky&rft.atitle=Center+for+Infectious+Disease+Research+and+Policy&rft.aulast=Van+Beusekom%2C+M.&rft.au=Van+Beusekom%2C+M.&rft.date=6+July+2020&rft.pub=University+of+Minnesota&rft_id=https%3A%2F%2Fwww.cidrap.umn.edu%2Fnews-perspective%2F2020%2F07%2Fglobal-experts-ignoring-airborne-covid-spread-risky&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-DucharmeTheWHO20-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-DucharmeTheWHO20_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Ducharme, J. (7 July 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/time.com\/5863220\/airborne-coronavirus-transmission\/\" target=\"_blank\">\"The WHO Says Airborne Coronavirus Transmission Isn't a Big Risk. Scientists Are Pushing Back\"<\/a>. <i>Time<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/time.com\/5863220\/airborne-coronavirus-transmission\/\" target=\"_blank\">https:\/\/time.com\/5863220\/airborne-coronavirus-transmission\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 July 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+WHO+Says+Airborne+Coronavirus+Transmission+Isn%27t+a+Big+Risk.+Scientists+Are+Pushing+Back&rft.atitle=Time&rft.aulast=Ducharme%2C+J.&rft.au=Ducharme%2C+J.&rft.date=7+July+2020&rft_id=https%3A%2F%2Ftime.com%2F5863220%2Fairborne-coronavirus-transmission%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PennCOVID20-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PennCOVID20_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Penn Medicine (2 August 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pennmedicine.org\/updates\/blogs\/penn-physician-blog\/2020\/august\/airborne-droplet-debate-article\" target=\"_blank\">\"COVID-19 Transmission: Droplet or Airborne? Penn Medicine Epidemiologists Issue Statement\"<\/a>. <i>Penn Physician Blog<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.pennmedicine.org\/updates\/blogs\/penn-physician-blog\/2020\/august\/airborne-droplet-debate-article\" target=\"_blank\">https:\/\/www.pennmedicine.org\/updates\/blogs\/penn-physician-blog\/2020\/august\/airborne-droplet-debate-article<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 23 August 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=COVID-19+Transmission%3A+Droplet+or+Airborne%3F+Penn+Medicine+Epidemiologists+Issue+Statement&rft.atitle=Penn+Physician+Blog&rft.aulast=Penn+Medicine&rft.au=Penn+Medicine&rft.date=2+August+2020&rft_id=https%3A%2F%2Fwww.pennmedicine.org%2Fupdates%2Fblogs%2Fpenn-physician-blog%2F2020%2Faugust%2Fairborne-droplet-debate-article&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GreenhalghTen21-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-GreenhalghTen21_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Greenhalgh, T.; Jimenez, J.L.; Prather, K.A. et al. (2021). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8049599\" target=\"_blank\">\"Ten scientific reasons in support of airborne transmission of SARS-CoV-2\"<\/a>. <i>Lancet<\/i> <b>397<\/b> (10285): 1603\u20135. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2FS0140-6736%2821%2900869-2\" target=\"_blank\">10.1016\/S0140-6736(21)00869-2<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8049599\/\" target=\"_blank\">PMC8049599<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/33865497\" target=\"_blank\">33865497<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8049599\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8049599<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Ten+scientific+reasons+in+support+of+airborne+transmission+of+SARS-CoV-2&rft.jtitle=Lancet&rft.aulast=Greenhalgh%2C+T.%3B+Jimenez%2C+J.L.%3B+Prather%2C+K.A.+et+al.&rft.au=Greenhalgh%2C+T.%3B+Jimenez%2C+J.L.%3B+Prather%2C+K.A.+et+al.&rft.date=2021&rft.volume=397&rft.issue=10285&rft.pages=1603%E2%80%935&rft_id=info:doi\/10.1016%2FS0140-6736%2821%2900869-2&rft_id=info:pmc\/PMC8049599&rft_id=info:pmid\/33865497&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC8049599&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCScienceBrief21-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCScienceBrief21_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/more\/science-and-research\/surface-transmission.html\" target=\"_blank\">\"Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission for Indoor Community Environments\"<\/a>. 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Retrieved 01 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Ignore+the+mixed+messages+and+wear+that+mask&rft.atitle=Chicago+Sun+Times&rft.aulast=Chicago+Sun+Times+Editorial+Board&rft.au=Chicago+Sun+Times+Editorial+Board&rft.date=31+March+2020&rft_id=https%3A%2F%2Fchicago.suntimes.com%2F2020%2F3%2F31%2F21200144%2Fcoronavirus-covid-19-masks-wear-cdc-pritzker-trump-public-health-virus-face-cough-sneeze&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MulhollandToMask20-24\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MulhollandToMask20_24-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Mulholland, J. 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Retrieved 01 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=To+mask+or+not+to+mask%3A+mixed+messages+in+a+time+of+crisis&rft.atitle=RFI&rft.aulast=Mulholland%2C+J.&rft.au=Mulholland%2C+J.&rft.date=29+March+2020&rft_id=http%3A%2F%2Fwww.rfi.fr%2Fen%2Finternational%2F20200329-to-mask-or-not-to-mask-mixed-messages-in-a-time-of-coronavirus-crisis-france-covid-19-spread-droplets&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-GeddesDoesA20-25\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-GeddesDoesA20_25-0\">25.0<\/a><\/sup> <sup><a href=\"#cite_ref-GeddesDoesA20_25-1\">25.1<\/a><\/sup> <sup><a href=\"#cite_ref-GeddesDoesA20_25-2\">25.2<\/a><\/sup> <sup><a href=\"#cite_ref-GeddesDoesA20_25-3\">25.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Geddes, L. (27 March 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.newscientist.com\/article\/2238819-does-a-high-viral-load-or-infectious-dose-make-covid-19-worse\/\" target=\"_blank\">\"Does a high viral load or infectious dose make covid-19 worse?\"<\/a>. <i>New Scientist<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.newscientist.com\/article\/2238819-does-a-high-viral-load-or-infectious-dose-make-covid-19-worse\/\" target=\"_blank\">https:\/\/www.newscientist.com\/article\/2238819-does-a-high-viral-load-or-infectious-dose-make-covid-19-worse\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 01 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Does+a+high+viral+load+or+infectious+dose+make+covid-19+worse%3F&rft.atitle=New+Scientist&rft.aulast=Geddes%2C+L.&rft.au=Geddes%2C+L.&rft.date=27+March+2020&rft_id=https%3A%2F%2Fwww.newscientist.com%2Farticle%2F2238819-does-a-high-viral-load-or-infectious-dose-make-covid-19-worse%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HijanoClinical19-26\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HijanoClinical19_26-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Hijano, D.R.; Brazelton de Cardenas, J.; Maron, G. et al. (2019). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6720028\" target=\"_blank\">\"Clinical correlation of influenza and respiratory syncytial virus load measured by digital PCR\"<\/a>. <i>PLoS One<\/i> <b>14<\/b> (9): e0220908. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1371%2Fjournal.pone.0220908\" target=\"_blank\">10.1371\/journal.pone.0220908<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6720028\/\" target=\"_blank\">PMC6720028<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/31479459\" target=\"_blank\">31479459<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6720028\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC6720028<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Clinical+correlation+of+influenza+and+respiratory+syncytial+virus+load+measured+by+digital+PCR&rft.jtitle=PLoS+One&rft.aulast=Hijano%2C+D.R.%3B+Brazelton+de+Cardenas%2C+J.%3B+Maron%2C+G.+et+al.&rft.au=Hijano%2C+D.R.%3B+Brazelton+de+Cardenas%2C+J.%3B+Maron%2C+G.+et+al.&rft.date=2019&rft.volume=14&rft.issue=9&rft.pages=e0220908&rft_id=info:doi\/10.1371%2Fjournal.pone.0220908&rft_id=info:pmc\/PMC6720028&rft_id=info:pmid\/31479459&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC6720028&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LiuViral20-27\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LiuViral20_27-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Liu, Y.; Yan, L.-M.; Wan, L. et al. (2020). \"Viral dynamics in mild and severe cases of COVID-19\". <i>The Lancet Infectious Diseases<\/i>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2FS1473-3099%2820%2930232-2\" target=\"_blank\">10.1016\/S1473-3099(20)30232-2<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32199493\" target=\"_blank\">32199493<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Viral+dynamics+in+mild+and+severe+cases+of+COVID-19&rft.jtitle=The+Lancet+Infectious+Diseases&rft.aulast=Liu%2C+Y.%3B+Yan%2C+L.-M.%3B+Wan%2C+L.+et+al.&rft.au=Liu%2C+Y.%3B+Yan%2C+L.-M.%3B+Wan%2C+L.+et+al.&rft.date=2020&rft_id=info:doi\/10.1016%2FS1473-3099%2820%2930232-2&rft_id=info:pmid\/32199493&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-JoyntUnder20-28\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-JoyntUnder20_28-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Joynt, G.M.; Wu, W.K.K. (2020). \"Understanding COVID-19: what does viral RNA load really mean?\". <i>The Lancet Infectious Diseases<\/i>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2FS1473-3099%2820%2930237-1\" target=\"_blank\">10.1016\/S1473-3099(20)30237-1<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Understanding+COVID-19%3A+what+does+viral+RNA+load+really+mean%3F&rft.jtitle=The+Lancet+Infectious+Diseases&rft.aulast=Joynt%2C+G.M.%3B+Wu%2C+W.K.K.&rft.au=Joynt%2C+G.M.%3B+Wu%2C+W.K.K.&rft.date=2020&rft_id=info:doi\/10.1016%2FS1473-3099%2820%2930237-1&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PujadasSARS20-29\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PujadasSARS20_29-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Pujadas, E.; Chaudhry, F.; McBride, R. et al. 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(2020). \"Tissue-specific tolerance in fatal Covid-19\". <i>medRxiv<\/i>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1101%2F2020.07.02.20145003\" target=\"_blank\">10.1101\/2020.07.02.20145003<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Tissue-specific+tolerance+in+fatal+Covid-19&rft.jtitle=medRxiv&rft.aulast=Dorward%2C+D.A.%3B+Russell%2C+C.D.%3B+Um%2C+I.H.+et+al.&rft.au=Dorward%2C+D.A.%3B+Russell%2C+C.D.%3B+Um%2C+I.H.+et+al.&rft.date=2020&rft_id=info:doi\/10.1101%2F2020.07.02.20145003&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CDCSymptoms20-51\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCSymptoms20_51-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Disease Control and Preventions (22 February 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/symptoms-testing\/symptoms.html\" target=\"_blank\">\"Symptoms of Coronavirus\"<\/a>. 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Retrieved 06 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Symptoms+of+Coronavirus&rft.atitle=&rft.aulast=Centers+for+Disease+Control+and+Preventions&rft.au=Centers+for+Disease+Control+and+Preventions&rft.date=22+February+2021&rft.pub=Centers+for+Disease+Control+and+Preventions&rft_id=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fsymptoms-testing%2Fsymptoms.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MayoCOVID20-52\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MayoCOVID20_52-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Mayo Clinic Staff (7 October 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mayoclinic.org\/diseases-conditions\/coronavirus\/in-depth\/coronavirus-long-term-effects\/art-20490351\" target=\"_blank\">\"COVID-19 (coronavirus): Long-term effects\"<\/a>. Mayo Clinic<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.mayoclinic.org\/diseases-conditions\/coronavirus\/in-depth\/coronavirus-long-term-effects\/art-20490351\" target=\"_blank\">https:\/\/www.mayoclinic.org\/diseases-conditions\/coronavirus\/in-depth\/coronavirus-long-term-effects\/art-20490351<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 12 November 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=COVID-19+%28coronavirus%29%3A+Long-term+effects&rft.atitle=&rft.aulast=Mayo+Clinic+Staff&rft.au=Mayo+Clinic+Staff&rft.date=7+October+2020&rft.pub=Mayo+Clinic&rft_id=https%3A%2F%2Fwww.mayoclinic.org%2Fdiseases-conditions%2Fcoronavirus%2Fin-depth%2Fcoronavirus-long-term-effects%2Fart-20490351&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BudsonTheHidden20-53\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BudsonTheHidden20_53-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Budson, A.E. (8 October 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.health.harvard.edu\/blog\/the-hidden-long-term-cognitive-effects-of-covid-2020100821133\" target=\"_blank\">\"The hidden long-term cognitive effects of COVID-19\"<\/a>. <i>Harvard Health Blog<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.health.harvard.edu\/blog\/the-hidden-long-term-cognitive-effects-of-covid-2020100821133\" target=\"_blank\">https:\/\/www.health.harvard.edu\/blog\/the-hidden-long-term-cognitive-effects-of-covid-2020100821133<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 12 November 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=The+hidden+long-term+cognitive+effects+of+COVID-19&rft.atitle=Harvard+Health+Blog&rft.aulast=Budson%2C+A.E.&rft.au=Budson%2C+A.E.&rft.date=8+October+2020&rft_id=https%3A%2F%2Fwww.health.harvard.edu%2Fblog%2Fthe-hidden-long-term-cognitive-effects-of-covid-2020100821133&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MaCOVID20-54\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MaCOVID20_54-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Ma, C.; Cong, Y.; Zhang, H. (2020). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7273952\" target=\"_blank\">\"COVID-19 and the Digestive System\"<\/a>. <i>American Journal of Gastroenterology<\/i> <b>115<\/b> (7): 1003\u20136. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.14309%2Fajg.0000000000000691\" target=\"_blank\">10.14309\/ajg.0000000000000691<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7273952\/\" target=\"_blank\">PMC7273952<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32618648\" target=\"_blank\">32618648<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7273952\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7273952<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=COVID-19+and+the+Digestive+System&rft.jtitle=American+Journal+of+Gastroenterology&rft.aulast=Ma%2C+C.%3B+Cong%2C+Y.%3B+Zhang%2C+H.&rft.au=Ma%2C+C.%3B+Cong%2C+Y.%3B+Zhang%2C+H.&rft.date=2020&rft.volume=115&rft.issue=7&rft.pages=1003%E2%80%936&rft_id=info:doi\/10.14309%2Fajg.0000000000000691&rft_id=info:pmc\/PMC7273952&rft_id=info:pmid\/32618648&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7273952&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-VanBeusekomHalf20-55\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-VanBeusekomHalf20_55-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Van Beusekom, M. (11 November 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cidrap.umn.edu\/news-perspective\/2020\/11\/half-recovered-covid-19-patients-report-lingering-fatigue\" target=\"_blank\">\"Half of recovered COVID-19 patients report lingering fatigue\"<\/a>. <i>CUDRAP News & Perspective<\/i>. University of Minnesota<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cidrap.umn.edu\/news-perspective\/2020\/11\/half-recovered-covid-19-patients-report-lingering-fatigue\" target=\"_blank\">https:\/\/www.cidrap.umn.edu\/news-perspective\/2020\/11\/half-recovered-covid-19-patients-report-lingering-fatigue<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Half+of+recovered+COVID-19+patients+report+lingering+fatigue&rft.atitle=CUDRAP+News+%26+Perspective&rft.aulast=Van+Beusekom%2C+M.&rft.au=Van+Beusekom%2C+M.&rft.date=11+November+2020&rft.pub=University+of+Minnesota&rft_id=https%3A%2F%2Fwww.cidrap.umn.edu%2Fnews-perspective%2F2020%2F11%2Fhalf-recovered-covid-19-patients-report-lingering-fatigue&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SimonMental20-56\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-SimonMental20_56-0\">56.0<\/a><\/sup> <sup><a href=\"#cite_ref-SimonMental20_56-1\">56.1<\/a><\/sup> <sup><a href=\"#cite_ref-SimonMental20_56-2\">56.2<\/a><\/sup> <sup><a href=\"#cite_ref-SimonMental20_56-3\">56.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Simon, N.M.; Saxe, G.N.; Marmar, C.R. (2020). \"Mental Health Disorders Related to COVID-19\u2013Related Deaths\". <i>JAMA<\/i> <b>324<\/b> (15): 1493\u201394. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1001%2Fjama.2020.19632\" target=\"_blank\">10.1001\/jama.2020.19632<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/33044510\" target=\"_blank\">33044510<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Mental+Health+Disorders+Related+to+COVID-19%E2%80%93Related+Deaths&rft.jtitle=JAMA&rft.aulast=Simon%2C+N.M.%3B+Saxe%2C+G.N.%3B+Marmar%2C+C.R.&rft.au=Simon%2C+N.M.%3B+Saxe%2C+G.N.%3B+Marmar%2C+C.R.&rft.date=2020&rft.volume=324&rft.issue=15&rft.pages=1493%E2%80%9394&rft_id=info:doi\/10.1001%2Fjama.2020.19632&rft_id=info:pmid\/33044510&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SavageCorona20-57\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SavageCorona20_57-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Savage, M. (28 October 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.bbc.com\/worklife\/article\/20201021-coronavirus-the-possible-long-term-mental-health-impacts\" target=\"_blank\">\"Coronavirus: The possible long-term mental health impacts\"<\/a>. <i>BBC Worklife<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.bbc.com\/worklife\/article\/20201021-coronavirus-the-possible-long-term-mental-health-impacts\" target=\"_blank\">https:\/\/www.bbc.com\/worklife\/article\/20201021-coronavirus-the-possible-long-term-mental-health-impacts<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Coronavirus%3A+The+possible+long-term+mental+health+impacts&rft.atitle=BBC+Worklife&rft.aulast=Savage%2C+M.&rft.au=Savage%2C+M.&rft.date=28+October+2020&rft_id=https%3A%2F%2Fwww.bbc.com%2Fworklife%2Farticle%2F20201021-coronavirus-the-possible-long-term-mental-health-impacts&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-KellandStudy20-58\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-KellandStudy20_58-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Kelland, K. (9 November 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.insurancejournal.com\/news\/international\/2020\/11\/09\/590113.htm\" target=\"_blank\">\"Study Shows COVID-19 Patients at Greater Risk of Mental Health Problems\"<\/a>. <i>Insurance Journal<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.insurancejournal.com\/news\/international\/2020\/11\/09\/590113.htm\" target=\"_blank\">https:\/\/www.insurancejournal.com\/news\/international\/2020\/11\/09\/590113.htm<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 18 November 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Study+Shows+COVID-19+Patients+at+Greater+Risk+of+Mental+Health+Problems&rft.atitle=Insurance+Journal&rft.aulast=Kelland%2C+K.&rft.au=Kelland%2C+K.&rft.date=9+November+2020&rft_id=https%3A%2F%2Fwww.insurancejournal.com%2Fnews%2Finternational%2F2020%2F11%2F09%2F590113.htm&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<p><br \/>\n<\/p>\n<div align=\"center\">-----Go to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_terminology\" title=\"Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Diagnostic testing of COVID-19 and other coronaviruses\/Testing terminology\" class=\"wiki-link\" data-key=\"9cee66545e86ad0648ca3d040588e9df\">the next chapter<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"Citation_information_for_this_chapter\">Citation information for this chapter<\/span><\/h2>\n<p><b>Chapter<\/b>: 1. Overview of COVID-19 and its challenges\n<\/p><p><b>Edition<\/b>: Fall 2021\n<\/p><p><b>Title<\/b>: <i>COVID-19 Testing, Reporting, and Information Management in the Laboratory<\/i>\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: September 2021\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20210919172517\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.401 seconds\nReal time usage: 0.478 seconds\nPreprocessor visited node count: 42387\/1000000\nPost\u2010expand include size: 354041\/2097152 bytes\nTemplate argument size: 119107\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 112881\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 379.732 1 -total\n 88.77% 337.084 1 Template:Reflist\n 75.26% 285.777 58 Template:Citation\/core\n 46.07% 174.927 33 Template:Cite_web\n 33.91% 128.780 25 Template:Cite_journal\n 11.21% 42.572 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\n 10.34% 39.263 32 Template:Date\n 5.92% 22.497 53 Template:Citation\/identifier\n 5.02% 19.045 85 Template:Citation\/make_link\n 2.10% 7.972 114 Template:Hide_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11906-0!canonical and timestamp 20210919172518 and revision id 44136. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","cf539edc559ed35fa7053ca6e3a7e227_images":["https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/b\/b1\/Fig1_Li_JofPharmAnal2020_10-2.jpg"],"cf539edc559ed35fa7053ca6e3a7e227_timestamp":1632073384,"90976a93da236fdb84deea9f14d59f06_type":"article","90976a93da236fdb84deea9f14d59f06_title":"1.2 COVID-19: History and impact (so far)","90976a93da236fdb84deea9f14d59f06_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)","90976a93da236fdb84deea9f14d59f06_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Overview of COVID-19 and its challenges\/COVID-19: History and impact (so far)From LIMSWikiJump to navigationJump to search 1.2 COVID-19: History and impact (so far) \nCOVID-19 is an infectious disease caused by the SARS-CoV-2 virus, typically yielding varying levels of short- and long-term symptoms, including fever, cough, shortness of breath, loss of taste or smell, headaches, fatigue, joint pain, chest pain, heart palpitations, brain fog, and mood changes.[1][2] A majority of cases yield relatively mild symptoms, but some progress to life-threatening short- and long-term situations involving pneumonia, organ failure, cardiovascular complications, renal complications, neurological complications, and psychiatric issues.[2][3][4][5][6]\nThe first known case of COVID-19 dates back to November 2019, \"according to government data seen by the South China Morning Post\"[7], though additional research has suggested an even earlier timeline. A non-peer-reviewed report released by Harvard Medical School in June 2020 suggested that circumstantial evidence of higher traffic around hospitals even a month earlier may push the Wuhan timeline back further.[8] Stories of routinely analyzed wastewater samples from locations in Brazil[9] and Italy[10] may likewise indicate that the SARS-CoV-2 virus was circulating earlier than initially gauged. And June 2021 peer-reviewed research by Roberts et al. suggests the possibility of COVID-19 beginning to spread as early as early October.[11] \nBy the middle of December, infections were at 27, and by the end of the year the number was 266.[7] By that time, Chinese health authorities had been updated that the pneumonia-like symptoms of patients in China's Hubei province may have been the symptoms of a disease caused by a novel (new) coronavirus[7], and the WHO was notified.[12] At the start of 2020, that number grew to 381 known cases[7], jumping to more than 7,700 confirmed and 12,000 suspected cases by the end of January.[13] By that time, the WHO had convened a second meeting of its Emergency Committee to discuss the declaration of a PHEIC, saying the then-called \"2019-nCoV\" constituted a health emergency of international concern.[13] This spurred the publishing of WHO technical advice to other countries, with a focus on \"reducing human infection, prevention of secondary transmission and international spread, and contributing to the international response.\"[13] However, at the same time, the virus was already beginning to spread in locations such as Australia[14], France[15], Germany[16] Italy[17], Japan[18], South Korea[19], Spain[20], the United Kingdom[21], and the United States.[22]\nAs the disease continued to spread in February 2020, naming conventions came together, with the WHO declaring the disease's name \"COVID-19,\" short for \"coronavirus disease 2019.\"[23][24] By the end of the month, the WHO warned a \"very high\" likelihood the virus's spread could turn into a full pandemic.[25] Less than two weeks later, on March 11, 2020, the WHO declared the outbreak of SARS-CoV-2 a pandemic, noting more than 118,000 confirmed cases and 4,000 deaths on all continents except Antarctica.[26] By November 2020, the pandemic had become more serious, in the U.S. in particular; hospitals became overwhelmed\u2014the most recorded COVID-19 hospitalizations since the pandemic started[27]\u2014and the pandemic became \"a humanitarian crisis.\"[28] The U.S. FDA issued its first and second Emergency Use Authorization (EUA) for a COVID-19 vaccine, the Pfizer-BioNTech COVID-19 Vaccine[29] and Moderna COVID-19 Vaccine[30], in December 2020, giving hope that a much wider vaccine roll-out would happen by late winter and early spring of 2021 in the U.S.[31] However, concerns that wealthier residents and countries would largely lead the charge while leaving poorer residents and countries behind were heavily vocalized.[31][32]\nGovernmental reaction to the pandemic around the globe has varied significantly since the pandemic's declaration in March 2020. Some of that variance can be seen when reviewing the various policies implemented by the world's governments. The International Monetary Fund's policy tracker for COVID-19 response, for example, paints a picture of the laboratory testing, social, transportation, trade, and financial situations of each country. Reviewing the policy tracker reveals a diverse set of approaches from country to country, some significant and enduring, others limited and weak. [33] Another source for examining government reaction is through the collation of data on how governments have implemented technological tracking measures in the name of slowing the epidemic. Groups like Privacy International collate such information through their collective tracking project, which links to hundreds of news stories concerning the use of mobile phone data, drones, and other surveillance mechanisms for tracking and enforcing quarantines; geolocation tracking though phones; and the implementation of facial recognition technology as part of a COVID-19 mitigation strategy.[34] Other projects such as the University of Oxford's COVID-19 Government Response Tracker also paint a broad picture of governments' responses to the pandemic using a wide variety of indicators, including school closures, travel restrictions, and vaccination policies. The University of Oxford maintains a core working paper and monthly regional reports, painting a picture of more governments decreasing policy changes as vaccination roll-out continues.[35]\nCitizen reaction to the pandemic has also varied. Local governments in China have been criticized[36][37], while the central government has, at least at times, been seen in positive light for its handling of the pandemic.[38][39][40] Some Indians have criticized their government for its police brutality during lockdowns[41], while some Italians have criticized their government for trivializing the situation for too long.[42] In the U.S.\u2014and in other parts of the world\u2014criticism has at times been significant concerning the United States government's response[43][44][45][46], though some governors have received praise for standing up for their state's citizens.[47][48][49] American's views of presidential handling of the COVID-19 crisis have varied. During President Trump's tenure, Americans increasingly expressed disapproval with the U.S. president's handling of the COVID-19 crisis, from 47.8% dissapproval on April 8 to 57.1% disasapproval by the end of his term.[50], which seemingly aligned with his attempts to downplay the existence of the COVID-19 virus.[51][52] Americans' perceptions of President Biden's handling of COVID-19 began strong, at above 60% approval, but has weakened over time to 52.9% as of September 2021, largely falling along partisan lines.[50]\nIt's difficult to truly quantitatively (or qualitatively) measure the impact of COVID-19 on the world, let alone the United States. From the start of the pandemic there have been significant job losses[53] and bankruptcies[54], to poor mental health impacts[55] and postponed cancer surgeries.[56] With time, some firmer numbers have become known, however. As of August 31, 2021, the number of global confirmed cases of COVID-19 was more than 216 million, with more than 4.5 million people dead.[57] As of July 2021, out of more than 320 vaccine candidates, 99 were still in clinical testing, 25 had reached Phase III efficacy studies, and 18 had received some form of formal approval.[58] Some 3.2 billion doses of vaccine had been administered globally as of July 2021 (with the caveat that only ~1% of people in low-income countries have received at least one dose), and nearly 11 billion doses were still needed to fully vaccinate 70% of the world's population.[59] Other statistics include:\n\n\"The global economy contracted by 3.5 percent in 2020 according to the April 2021 World Economic Outlook Report published by the IMF, a 7 percent loss relative to the 3.4 percent growth forecast back in October 2019.\"[60]\n\"At a global scale, the fiscal support [applied to COVID-19] reached nearly $16 trillion (around 15 percent of global GDP) in 2020.\"[60]\nAs of July 2021, some 10 percent of American adults have reported sometimes or often not having enough to eat in a given week, compared to 3.4 percent for the entirety of 2019.[61]\n\"An estimated 11.4 million [U.S.] adults living in rental housing\u201416 percent of adult renters\u2014were not caught up on rent\" as of the beginning of July 2021, with an additional 7.4 million estimated to not be caught up on mortgage payments.[61]\n\"Some 63 million [U.S.] adults\u201427 percent of all adults in the country\u2014reported it was somewhat or very difficult for their household to cover usual expenses in the past seven days,\" as of the beginning of July 2021.[61]\nDespite the remaining unknowns and difficulties facing societies everywhere, what has long been known and remains true, however, is that preventative measures such as wearing masks[62], getting vaccinated[58], and getting tested for exposure[63] remain vital in order to further limit the negative consequences of the pandemic.\n\nReferences \n\n\n\u2191 Centers for Disease Control and Preventions (22 February 2021). \"Symptoms of Coronavirus\". 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Columbia Journalism Review. 27 March 2020. https:\/\/www.cjr.org\/analysis\/andrew-cuomo-coronavirus-covid19-barkan.php . Retrieved 25 April 2020 .   \n \n\n\u2191 50.0 50.1 Bycoffe, A.; Groskopf, C.; Mehta, D. (11 November 2020). \"How Americans View The Coronavirus Crisis And Trump's Response\". FiveThirtyEight. https:\/\/projects.fivethirtyeight.com\/coronavirus-polls\/ . Retrieved 12 November 2020 .   \n \n\n\u2191 Collinson, S. (24 June 2020). \"Fauci warns of disturbing trend as Trump ignores viral surge\". CNN Politics. https:\/\/www.cnn.com\/2020\/06\/23\/politics\/donald-trump-coronavirus-pandemic-election-2020\/index.html . Retrieved 07 July 2020 .   \n \n\n\u2191 Hellmann, J. (6 July 2020). \"Trump downplaying sparks new criticism of COVID-19 response\". The Hill. Archived from the original on 07 July 2021. https:\/\/web.archive.org\/web\/20200707133105\/https:\/\/thehill.com\/policy\/healthcare\/506075-trump-downplaying-sparks-new-criticism-of-covid-19-response . Retrieved 06 September 2021 .   \n \n\n\u2191 Rothwell, J.; Van Drie, H. (27 April 2020). \"The effect of COVID-19 and disease suppression policies on labor markets: A preliminary analysis of the data\". Brookings. The Brookings Institute. https:\/\/www.brookings.edu\/research\/the-effect-of-covid-19-and-disease-suppression-policies-on-labor-markets-a-preliminary-analysis-of-the-data\/ . Retrieved 28 April 2020 .   \n \n\n\u2191 Rosenberg, J.M. (26 April 2020). \"A flood of business bankruptcies likely in coming months\". Associated Press. https:\/\/apnews.com\/article\/virus-outbreak-business-courts-ap-top-news-small-business-b9ae754f44d27671ec63d85542c468f8 . Retrieved 06 September 2021 .   \n \n\n\u2191 Ting, V. (26 April 2020). \"Coronavirus: suicide experts warn of pandemic\u2019s impact on mental health, with Hong Kong\u2019s jobless, poor and elderly most at risk\". South China Morning Post. https:\/\/www.scmp.com\/news\/hong-kong\/health-environment\/article\/3081582\/coronavirus-suicide-experts-warn-pandemics-impact . Retrieved 28 April 2020 .   \n \n\n\u2191 Colaianni, A. (22 April 2020). \"\u201cFor Now, We Wait\u201d: Postponing Cancer Surgery During the Coronavirus Crisis\". The New Yorker. https:\/\/www.newyorker.com\/science\/medical-dispatch\/for-now-we-wait-postponing-cancer-surgery-during-the-coronavirus-crisis . Retrieved 28 April 2020 .   \n \n\n\u2191 World Health Organization (31 August 2021). \"COVID-19 Weekly Epidemiological Update - 31 August 2021\" (PDF). World Health Organization. https:\/\/www.who.int\/docs\/default-source\/coronaviruse\/situation-reports\/20210831_weekly_epi_update_55.pdf . Retrieved 06 November 2021 .   \n \n\n\u2191 58.0 58.1 Tregoning, J.S.; Flight, K.E.; Highman, S.L. et al. (2021). \"Progress of the COVID-19 vaccine effort: viruses, vaccines and variants versus efficacy, effectiveness and escape\". Nature Reviews Immunology: 1\u201311. doi:10.1038\/s41577-021-00592-1. PMC PMC8351583. PMID 34373623. http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8351583 .   \n \n\n\u2191 Padma, T.V. (2021). \"COVID vaccines to reach poorest countries in 2023 \u2014 despite recent pledges\". Nature 595: 342\u201343. doi:10.1038\/d41586-021-01762-w. PMID 34226742.   \n \n\n\u2191 60.0 60.1 Yeyati, E.L.; Filippini, F. (8 June 2021). \"Social and economic impact of COVID-19\". Brookings. https:\/\/www.brookings.edu\/research\/social-and-economic-impact-of-covid-19\/ . Retrieved 06 September 2021 .   \n \n\n\u2191 61.0 61.1 61.2 Center on Budget and Policy Priorities (9 August 2021). \"Tracking the COVID-19 Recession\u2019s Effects on Food, Housing, and Employment Hardships\". COVID Hardship Watch. https:\/\/www.cbpp.org\/research\/poverty-and-inequality\/tracking-the-covid-19-recessions-effects-on-food-housing-and . Retrieved 06 September 2021 .   \n \n\n\u2191 Falcon, R. (7 August 2021). \"Do face masks work? Here are 49 scientific studies that explain why they do\". KXAN. https:\/\/www.kxan.com\/news\/coronavirus\/do-face-masks-work-here-are-49-scientific-studies-that-explain-why-they-do\/ . Retrieved 06 September 2021 .   \n \n\n\u2191 Scott, D. (1 September 2021). \"Why can\u2019t America fix its Covid-19 testing problems?\". Vox. https:\/\/www.vox.com\/coronavirus-covid19\/2021\/9\/1\/22642745\/us-covid-19-test-numbers-delta-variant . Retrieved 06 September 2021 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 3 May 2020, at 19:24.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 385 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","90976a93da236fdb84deea9f14d59f06_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Overview_of_COVID-19_and_its_challenges_COVID-19_History_and_impact_so_far rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Overview_of_COVID-19_and_its_challenges_COVID-19_History_and_impact_so_far skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Overview of COVID-19 and its challenges\/COVID-19: History and impact (so far)<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><h3><span id=\"rdp-ebb-1.2_COVID-19:_History_and_impact_(so_far)\"><\/span><span class=\"mw-headline\" id=\"1.2_COVID-19:_History_and_impact_.28so_far.29\">1.2 COVID-19: History and impact (so far)<\/span><\/h3>\n<p>COVID-19 is an infectious disease caused by the SARS-CoV-2 virus, typically yielding varying levels of short- and long-term symptoms, including fever, cough, shortness of breath, loss of taste or smell, headaches, fatigue, joint pain, chest pain, heart palpitations, brain fog, and mood changes.<sup id=\"rdp-ebb-cite_ref-CDCSymptoms20_1-0\" class=\"reference\"><a href=\"#cite_note-CDCSymptoms20-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CDCLong20_2-0\" class=\"reference\"><a href=\"#cite_note-CDCLong20-2\">[2]<\/a><\/sup> A majority of cases yield relatively mild symptoms, but some progress to life-threatening short- and long-term situations involving pneumonia, organ failure, cardiovascular complications, renal complications, neurological complications, and psychiatric issues.<sup id=\"rdp-ebb-cite_ref-CDCLong20_2-1\" class=\"reference\"><a href=\"#cite_note-CDCLong20-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-WadmanHowDoes20_3-0\" class=\"reference\"><a href=\"#cite_note-WadmanHowDoes20-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CCDCTheEpid20_4-0\" class=\"reference\"><a href=\"#cite_note-CCDCTheEpid20-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-ElezkurtajCauses21_5-0\" class=\"reference\"><a href=\"#cite_note-ElezkurtajCauses21-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-TaquetSixMonth21_6-0\" class=\"reference\"><a href=\"#cite_note-TaquetSixMonth21-6\">[6]<\/a><\/sup>\n<\/p><p>The first known case of COVID-19 dates back to November 2019, \"according to government data seen by the <i>South China Morning Post<\/i>\"<sup id=\"rdp-ebb-cite_ref-MaCorona20_7-0\" class=\"reference\"><a href=\"#cite_note-MaCorona20-7\">[7]<\/a><\/sup>, though additional research has suggested an even earlier timeline. A non-peer-reviewed report released by Harvard Medical School in June 2020 suggested that circumstantial evidence of higher traffic around hospitals even a month earlier may push the Wuhan timeline back further.<sup id=\"rdp-ebb-cite_ref-FolmerSat20_8-0\" class=\"reference\"><a href=\"#cite_note-FolmerSat20-8\">[8]<\/a><\/sup> Stories of routinely analyzed wastewater samples from locations in Brazil<sup id=\"rdp-ebb-cite_ref-ChenEarlier20_9-0\" class=\"reference\"><a href=\"#cite_note-ChenEarlier20-9\">[9]<\/a><\/sup> and Italy<sup id=\"rdp-ebb-cite_ref-KellandItaly20_10-0\" class=\"reference\"><a href=\"#cite_note-KellandItaly20-10\">[10]<\/a><\/sup> may likewise indicate that the SARS-CoV-2 virus was circulating earlier than initially gauged. And June 2021 peer-reviewed research by Roberts <i>et al.<\/i> suggests the possibility of COVID-19 beginning to spread as early as early October.<sup id=\"rdp-ebb-cite_ref-RobertsDating21_11-0\" class=\"reference\"><a href=\"#cite_note-RobertsDating21-11\">[11]<\/a><\/sup> \n<\/p><p>By the middle of December, infections were at 27, and by the end of the year the number was 266.<sup id=\"rdp-ebb-cite_ref-MaCorona20_7-1\" class=\"reference\"><a href=\"#cite_note-MaCorona20-7\">[7]<\/a><\/sup> By that time, Chinese health authorities had been updated that the pneumonia-like symptoms of patients in China's Hubei province may have been the symptoms of a disease caused by a novel (new) coronavirus<sup id=\"rdp-ebb-cite_ref-MaCorona20_7-2\" class=\"reference\"><a href=\"#cite_note-MaCorona20-7\">[7]<\/a><\/sup>, and the WHO was notified.<sup id=\"rdp-ebb-cite_ref-HuiTheCont20_12-0\" class=\"reference\"><a href=\"#cite_note-HuiTheCont20-12\">[12]<\/a><\/sup> At the start of 2020, that number grew to 381 known cases<sup id=\"rdp-ebb-cite_ref-MaCorona20_7-3\" class=\"reference\"><a href=\"#cite_note-MaCorona20-7\">[7]<\/a><\/sup>, jumping to more than 7,700 confirmed and 12,000 suspected cases by the end of January.<sup id=\"rdp-ebb-cite_ref-WHOStatement20_13-0\" class=\"reference\"><a href=\"#cite_note-WHOStatement20-13\">[13]<\/a><\/sup> By that time, the WHO had convened a second meeting of its Emergency Committee to discuss the declaration of a PHEIC, saying the then-called \"2019-nCoV\" constituted a health emergency of international concern.<sup id=\"rdp-ebb-cite_ref-WHOStatement20_13-1\" class=\"reference\"><a href=\"#cite_note-WHOStatement20-13\">[13]<\/a><\/sup> This spurred the publishing of WHO technical advice to other countries, with a focus on \"reducing human infection, prevention of secondary transmission and international spread, and contributing to the international response.\"<sup id=\"rdp-ebb-cite_ref-WHOStatement20_13-2\" class=\"reference\"><a href=\"#cite_note-WHOStatement20-13\">[13]<\/a><\/sup> However, at the same time, the virus was already beginning to spread in locations such as Australia<sup id=\"rdp-ebb-cite_ref-HuntFirst20_14-0\" class=\"reference\"><a href=\"#cite_note-HuntFirst20-14\">[14]<\/a><\/sup>, France<sup id=\"rdp-ebb-cite_ref-JacobCorona20_15-0\" class=\"reference\"><a href=\"#cite_note-JacobCorona20-15\">[15]<\/a><\/sup>, Germany<sup id=\"rdp-ebb-cite_ref-SPIEGELBayer20_16-0\" class=\"reference\"><a href=\"#cite_note-SPIEGELBayer20-16\">[16]<\/a><\/sup> Italy<sup id=\"rdp-ebb-cite_ref-SevergniniCorona20_17-0\" class=\"reference\"><a href=\"#cite_note-SevergniniCorona20-17\">[17]<\/a><\/sup>, Japan<sup id=\"rdp-ebb-cite_ref-SimJapan20_18-0\" class=\"reference\"><a href=\"#cite_note-SimJapan20-18\">[18]<\/a><\/sup>, South Korea<sup id=\"rdp-ebb-cite_ref-Jin-wooConfirmation20_19-0\" class=\"reference\"><a href=\"#cite_note-Jin-wooConfirmation20-19\">[19]<\/a><\/sup>, Spain<sup id=\"rdp-ebb-cite_ref-LindeSanidad20_20-0\" class=\"reference\"><a href=\"#cite_note-LindeSanidad20-20\">[20]<\/a><\/sup>, the United Kingdom<sup id=\"rdp-ebb-cite_ref-BallHunt20_21-0\" class=\"reference\"><a href=\"#cite_note-BallHunt20-21\">[21]<\/a><\/sup>, and the United States.<sup id=\"rdp-ebb-cite_ref-HolshueFirst20_22-0\" class=\"reference\"><a href=\"#cite_note-HolshueFirst20-22\">[22]<\/a><\/sup>\n<\/p><p>As the disease continued to spread in February 2020, naming conventions came together, with the WHO declaring the disease's name \"COVID-19,\" short for \"coronavirus disease 2019.\"<sup id=\"rdp-ebb-cite_ref-EnserinkUpdate20_23-0\" class=\"reference\"><a href=\"#cite_note-EnserinkUpdate20-23\">[23]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-JiangADistinct20_24-0\" class=\"reference\"><a href=\"#cite_note-JiangADistinct20-24\">[24]<\/a><\/sup> By the end of the month, the WHO warned a \"very high\" likelihood the virus's spread could turn into a full <a href=\"https:\/\/www.limswiki.org\/index.php\/Pandemic\" title=\"Pandemic\" class=\"wiki-link\" data-key=\"bd9a48e6c6e41b6d603ee703836b01f1\">pandemic<\/a>.<sup id=\"rdp-ebb-cite_ref-MulierWHO20_25-0\" class=\"reference\"><a href=\"#cite_note-MulierWHO20-25\">[25]<\/a><\/sup> Less than two weeks later, on March 11, 2020, the WHO declared the outbreak of SARS-CoV-2 a pandemic, noting more than 118,000 confirmed cases and 4,000 deaths on all continents except Antarctica.<sup id=\"rdp-ebb-cite_ref-GumbrechtWho20_26-0\" class=\"reference\"><a href=\"#cite_note-GumbrechtWho20-26\">[26]<\/a><\/sup> By November 2020, the pandemic had become more serious, in the U.S. in particular; hospitals became overwhelmed\u2014the most recorded COVID-19 hospitalizations since the pandemic started<sup id=\"rdp-ebb-cite_ref-DallUSHits20_27-0\" class=\"reference\"><a href=\"#cite_note-DallUSHits20-27\">[27]<\/a><\/sup>\u2014and the pandemic became \"a humanitarian crisis.\"<sup id=\"rdp-ebb-cite_ref-MaxourisAsTheHoli20_28-0\" class=\"reference\"><a href=\"#cite_note-MaxourisAsTheHoli20-28\">[28]<\/a><\/sup> The U.S. FDA issued its first and second Emergency Use Authorization (EUA) for a COVID-19 vaccine, the Pfizer-BioNTech COVID-19 Vaccine<sup id=\"rdp-ebb-cite_ref-FDATakesKey20_29-0\" class=\"reference\"><a href=\"#cite_note-FDATakesKey20-29\">[29]<\/a><\/sup> and Moderna COVID-19 Vaccine<sup id=\"rdp-ebb-cite_ref-FDATakesAdd20_30-0\" class=\"reference\"><a href=\"#cite_note-FDATakesAdd20-30\">[30]<\/a><\/sup>, in December 2020, giving hope that a much wider vaccine roll-out would happen by late winter and early spring of 2021 in the U.S.<sup id=\"rdp-ebb-cite_ref-ThomasVacc21_31-0\" class=\"reference\"><a href=\"#cite_note-ThomasVacc21-31\">[31]<\/a><\/sup> However, concerns that wealthier residents and countries would largely lead the charge while leaving poorer residents and countries behind were heavily vocalized.<sup id=\"rdp-ebb-cite_ref-ThomasVacc21_31-1\" class=\"reference\"><a href=\"#cite_note-ThomasVacc21-31\">[31]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BaharRich21_32-0\" class=\"reference\"><a href=\"#cite_note-BaharRich21-32\">[32]<\/a><\/sup>\n<\/p><p>Governmental reaction to the pandemic around the globe has varied significantly since the pandemic's declaration in March 2020. Some of that variance can be seen when reviewing the various policies implemented by the world's governments. The International Monetary Fund's policy tracker for COVID-19 response, for example, paints a picture of the laboratory testing, social, transportation, trade, and financial situations of each country. Reviewing the policy tracker reveals a diverse set of approaches from country to country, some significant and enduring, others limited and weak. <sup id=\"rdp-ebb-cite_ref-IMFPolicy20_33-0\" class=\"reference\"><a href=\"#cite_note-IMFPolicy20-33\">[33]<\/a><\/sup> Another source for examining government reaction is through the collation of data on how governments have implemented technological tracking measures in the name of slowing the epidemic. Groups like Privacy International collate such information through their collective tracking project, which links to hundreds of news stories concerning the use of mobile phone data, drones, and other surveillance mechanisms for tracking and enforcing quarantines; geolocation tracking though phones; and the implementation of facial recognition technology as part of a COVID-19 mitigation strategy.<sup id=\"rdp-ebb-cite_ref-PITracking20_34-0\" class=\"reference\"><a href=\"#cite_note-PITracking20-34\">[34]<\/a><\/sup> Other projects such as the University of Oxford's COVID-19 Government Response Tracker also paint a broad picture of governments' responses to the pandemic using a wide variety of indicators, including school closures, travel restrictions, and vaccination policies. The University of Oxford maintains a core working paper and monthly regional reports, painting a picture of more governments decreasing policy changes as vaccination roll-out continues.<sup id=\"rdp-ebb-cite_ref-OxfordCOVID21_35-0\" class=\"reference\"><a href=\"#cite_note-OxfordCOVID21-35\">[35]<\/a><\/sup>\n<\/p><p>Citizen reaction to the pandemic has also varied. Local governments in China have been criticized<sup id=\"rdp-ebb-cite_ref-WuChinese20_36-0\" class=\"reference\"><a href=\"#cite_note-WuChinese20-36\">[36]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BJNewsJan21She_37-0\" class=\"reference\"><a href=\"#cite_note-BJNewsJan21She-37\">[37]<\/a><\/sup>, while the central government has, at least at times, been seen in positive light for its handling of the pandemic.<sup id=\"rdp-ebb-cite_ref-JohnsonChina20_38-0\" class=\"reference\"><a href=\"#cite_note-JohnsonChina20-38\">[38]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RichieDon.27t20_39-0\" class=\"reference\"><a href=\"#cite_note-RichieDon.27t20-39\">[39]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BowmanBill20_40-0\" class=\"reference\"><a href=\"#cite_note-BowmanBill20-40\">[40]<\/a><\/sup> Some Indians have criticized their government for its police brutality during lockdowns<sup id=\"rdp-ebb-cite_ref-PTICorona20_41-0\" class=\"reference\"><a href=\"#cite_note-PTICorona20-41\">[41]<\/a><\/sup>, while some Italians have criticized their government for trivializing the situation for too long.<sup id=\"rdp-ebb-cite_ref-HorowitzItaly20_42-0\" class=\"reference\"><a href=\"#cite_note-HorowitzItaly20-42\">[42]<\/a><\/sup> In the U.S.\u2014and in other parts of the world\u2014criticism has at times been significant concerning the United States government's response<sup id=\"rdp-ebb-cite_ref-SNSTheUnited20_43-0\" class=\"reference\"><a href=\"#cite_note-SNSTheUnited20-43\">[43]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LuscombeTrump20_44-0\" class=\"reference\"><a href=\"#cite_note-LuscombeTrump20-44\">[44]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PerryFact20_45-0\" class=\"reference\"><a href=\"#cite_note-PerryFact20-45\">[45]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MeltonCritic20_46-0\" class=\"reference\"><a href=\"#cite_note-MeltonCritic20-46\">[46]<\/a><\/sup>, though some governors have received praise for standing up for their state's citizens.<sup id=\"rdp-ebb-cite_ref-ClayBBC20_47-0\" class=\"reference\"><a href=\"#cite_note-ClayBBC20-47\">[47]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-RenbaumGlendening20_48-0\" class=\"reference\"><a href=\"#cite_note-RenbaumGlendening20-48\">[48]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BarkanGlowing20_49-0\" class=\"reference\"><a href=\"#cite_note-BarkanGlowing20-49\">[49]<\/a><\/sup> American's views of presidential handling of the COVID-19 crisis have varied. During President Trump's tenure, Americans increasingly expressed disapproval with the U.S. president's handling of the COVID-19 crisis, from 47.8% dissapproval on April 8 to 57.1% disasapproval by the end of his term.<sup id=\"rdp-ebb-cite_ref-BycoffeHowAmer20_50-0\" class=\"reference\"><a href=\"#cite_note-BycoffeHowAmer20-50\">[50]<\/a><\/sup>, which seemingly aligned with his attempts to downplay the existence of the COVID-19 virus.<sup id=\"rdp-ebb-cite_ref-CollinsonFauci20_51-0\" class=\"reference\"><a href=\"#cite_note-CollinsonFauci20-51\">[51]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-HellmannTrump20_52-0\" class=\"reference\"><a href=\"#cite_note-HellmannTrump20-52\">[52]<\/a><\/sup> Americans' perceptions of President Biden's handling of COVID-19 began strong, at above 60% approval, but has weakened over time to 52.9% as of September 2021, largely falling along partisan lines.<sup id=\"rdp-ebb-cite_ref-BycoffeHowAmer20_50-1\" class=\"reference\"><a href=\"#cite_note-BycoffeHowAmer20-50\">[50]<\/a><\/sup>\n<\/p><p>It's difficult to truly quantitatively (or qualitatively) measure the impact of COVID-19 on the world, let alone the United States. From the start of the pandemic there have been significant job losses<sup id=\"rdp-ebb-cite_ref-RothwellTheEffect20_53-0\" class=\"reference\"><a href=\"#cite_note-RothwellTheEffect20-53\">[53]<\/a><\/sup> and bankruptcies<sup id=\"rdp-ebb-cite_ref-RosenbergAFlood20_54-0\" class=\"reference\"><a href=\"#cite_note-RosenbergAFlood20-54\">[54]<\/a><\/sup>, to poor mental health impacts<sup id=\"rdp-ebb-cite_ref-TingCorona20_55-0\" class=\"reference\"><a href=\"#cite_note-TingCorona20-55\">[55]<\/a><\/sup> and postponed cancer surgeries.<sup id=\"rdp-ebb-cite_ref-ColaianniForNow20_56-0\" class=\"reference\"><a href=\"#cite_note-ColaianniForNow20-56\">[56]<\/a><\/sup> With time, some firmer numbers have become known, however. As of August 31, 2021, the number of global confirmed cases of COVID-19 was more than 216 million, with more than 4.5 million people dead.<sup id=\"rdp-ebb-cite_ref-.E2.80.9DWHOSitRep120_20.E2.80.9D_57-0\" class=\"reference\"><a href=\"#cite_note-.E2.80.9DWHOSitRep120_20.E2.80.9D-57\">[57]<\/a><\/sup> As of July 2021, out of more than 320 vaccine candidates, 99 were still in clinical testing, 25 had reached Phase III efficacy studies, and 18 had received some form of formal approval.<sup id=\"rdp-ebb-cite_ref-TregoningProgress21_58-0\" class=\"reference\"><a href=\"#cite_note-TregoningProgress21-58\">[58]<\/a><\/sup> Some 3.2 billion doses of vaccine had been administered globally as of July 2021 (with the caveat that only ~1% of people in low-income countries have received at least one dose), and nearly 11 billion doses were still needed to fully vaccinate 70% of the world's population.<sup id=\"rdp-ebb-cite_ref-PadmaCOVID21_59-0\" class=\"reference\"><a href=\"#cite_note-PadmaCOVID21-59\">[59]<\/a><\/sup> Other statistics include:\n<\/p>\n<ul><li>\"The global economy contracted by 3.5 percent in 2020 according to the April 2021 World Economic Outlook Report published by the IMF, a 7 percent loss relative to the 3.4 percent growth forecast back in October 2019.\"<sup id=\"rdp-ebb-cite_ref-YeyatiSocial21_60-0\" class=\"reference\"><a href=\"#cite_note-YeyatiSocial21-60\">[60]<\/a><\/sup><\/li>\n<li>\"At a global scale, the fiscal support [applied to COVID-19] reached nearly $16 trillion (around 15 percent of global GDP) in 2020.\"<sup id=\"rdp-ebb-cite_ref-YeyatiSocial21_60-1\" class=\"reference\"><a href=\"#cite_note-YeyatiSocial21-60\">[60]<\/a><\/sup><\/li>\n<li>As of July 2021, some 10 percent of American adults have reported sometimes or often not having enough to eat in a given week, compared to 3.4 percent for the entirety of 2019.<sup id=\"rdp-ebb-cite_ref-CBPPTracking21_61-0\" class=\"reference\"><a href=\"#cite_note-CBPPTracking21-61\">[61]<\/a><\/sup><\/li>\n<li>\"An estimated 11.4 million [U.S.] adults living in rental housing\u201416 percent of adult renters\u2014were not caught up on rent\" as of the beginning of July 2021, with an additional 7.4 million estimated to not be caught up on mortgage payments.<sup id=\"rdp-ebb-cite_ref-CBPPTracking21_61-1\" class=\"reference\"><a href=\"#cite_note-CBPPTracking21-61\">[61]<\/a><\/sup><\/li>\n<li>\"Some 63 million [U.S.] adults\u201427 percent of all adults in the country\u2014reported it was somewhat or very difficult for their household to cover usual expenses in the past seven days,\" as of the beginning of July 2021.<sup id=\"rdp-ebb-cite_ref-CBPPTracking21_61-2\" class=\"reference\"><a href=\"#cite_note-CBPPTracking21-61\">[61]<\/a><\/sup><\/li><\/ul>\n<p>Despite the remaining unknowns and difficulties facing societies everywhere, what has long been known and remains true, however, is that preventative measures such as wearing masks<sup id=\"rdp-ebb-cite_ref-FalconDoFace21_62-0\" class=\"reference\"><a href=\"#cite_note-FalconDoFace21-62\">[62]<\/a><\/sup>, getting vaccinated<sup id=\"rdp-ebb-cite_ref-TregoningProgress21_58-1\" class=\"reference\"><a href=\"#cite_note-TregoningProgress21-58\">[58]<\/a><\/sup>, and getting tested for exposure<sup id=\"rdp-ebb-cite_ref-ScottWhyCant21_63-0\" class=\"reference\"><a href=\"#cite_note-ScottWhyCant21-63\">[63]<\/a><\/sup> remain vital in order to further limit the negative consequences of the pandemic.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap mw-references-columns\"><ol class=\"references\">\n<li id=\"cite_note-CDCSymptoms20-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CDCSymptoms20_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Centers for Disease Control and Preventions (22 February 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/symptoms-testing\/symptoms.html\" target=\"_blank\">\"Symptoms of Coronavirus\"<\/a>. 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Centers for Disease Control and Preventions<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/long-term-effects.html\" target=\"_blank\">https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/long-term-effects.html<\/a><\/span><span class=\"reference-accessdate\">. 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(17 April 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.science.org\/news\/2020\/04\/how-does-coronavirus-kill-clinicians-trace-ferocious-rampage-through-body-brain-toes\" target=\"_blank\">\"How does coronavirus kill? Clinicians trace a ferocious rampage through the body, from brain to toes\"<\/a>. <i>Science<\/i>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1126%2Fscience.abc3208\" target=\"_blank\">10.1126\/science.abc3208<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.science.org\/news\/2020\/04\/how-does-coronavirus-kill-clinicians-trace-ferocious-rampage-through-body-brain-toes\" target=\"_blank\">https:\/\/www.science.org\/news\/2020\/04\/how-does-coronavirus-kill-clinicians-trace-ferocious-rampage-through-body-brain-toes<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+does+coronavirus+kill%3F+Clinicians+trace+a+ferocious+rampage+through+the+body%2C+from+brain+to+toes&rft.atitle=Science&rft.aulast=Wadman%2C+M.%3B+Couzin-Frankel%2C+J.%3B+Kaiser%2C+J.+et+al.&rft.au=Wadman%2C+M.%3B+Couzin-Frankel%2C+J.%3B+Kaiser%2C+J.+et+al.&rft.date=17+April+2020&rft_id=info:doi\/10.1126%2Fscience.abc3208&rft_id=https%3A%2F%2Fwww.science.org%2Fnews%2F2020%2F04%2Fhow-does-coronavirus-kill-clinicians-trace-ferocious-rampage-through-body-brain-toes&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CCDCTheEpid20-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CCDCTheEpid20_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Chinese Center for Disease Control and Prevention (2020). \"The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China\". <i>Chinese Journal of Epidemiology<\/i> <b>41<\/b> (2): 145\u201351. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.3760%2Fcma.j.issn.0254-6450.2020.02.003\" target=\"_blank\">10.3760\/cma.j.issn.0254-6450.2020.02.003<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32064853\" target=\"_blank\">32064853<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+epidemiological+characteristics+of+an+outbreak+of+2019+novel+coronavirus+diseases+%28COVID-19%29+in+China&rft.jtitle=Chinese+Journal+of+Epidemiology&rft.aulast=Chinese+Center+for+Disease+Control+and+Prevention&rft.au=Chinese+Center+for+Disease+Control+and+Prevention&rft.date=2020&rft.volume=41&rft.issue=2&rft.pages=145%E2%80%9351&rft_id=info:doi\/10.3760%2Fcma.j.issn.0254-6450.2020.02.003&rft_id=info:pmid\/32064853&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ElezkurtajCauses21-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ElezkurtajCauses21_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Elezkurtaj, S.; Greuel, S.; Ihlow, J. et al. (2021). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7895917\" target=\"_blank\">\"Causes of death and comorbidities in hospitalized patients with COVID-19\"<\/a>. <i>Scientific Reports<\/i> <b>11<\/b>: 4263. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1038%2Fs41598-021-82862-5\" target=\"_blank\">10.1038\/s41598-021-82862-5<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7895917\/\" target=\"_blank\">PMC7895917<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/33608563\" target=\"_blank\">33608563<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7895917\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC7895917<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Causes+of+death+and+comorbidities+in+hospitalized+patients+with+COVID-19&rft.jtitle=Scientific+Reports&rft.aulast=Elezkurtaj%2C+S.%3B+Greuel%2C+S.%3B+Ihlow%2C+J.+et+al.&rft.au=Elezkurtaj%2C+S.%3B+Greuel%2C+S.%3B+Ihlow%2C+J.+et+al.&rft.date=2021&rft.volume=11&rft.pages=4263&rft_id=info:doi\/10.1038%2Fs41598-021-82862-5&rft_id=info:pmc\/PMC7895917&rft_id=info:pmid\/33608563&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC7895917&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-TaquetSixMonth21-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-TaquetSixMonth21_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Taquet, M.; Geddes, J.R.; Husain, M. et al. (2021). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8023694\" target=\"_blank\">\"6-month neurological and psychiatric outcomes in 236\u2009379 survivors of COVID-19: A retrospective cohort study using electronic health records\"<\/a>. <i>The Lancet Psychiatry<\/i> <b>8<\/b> (5): 416\u201327. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2FS2215-0366%2821%2900084-5\" target=\"_blank\">10.1016\/S2215-0366(21)00084-5<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8023694\/\" target=\"_blank\">PMC8023694<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/33836148\" target=\"_blank\">33836148<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8023694\" target=\"_blank\">http:\/\/www.pubmedcentral.nih.gov\/articlerender.fcgi?tool=pmcentrez&artid=PMC8023694<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=6-month+neurological+and+psychiatric+outcomes+in+236%E2%80%89379+survivors+of+COVID-19%3A+A+retrospective+cohort+study+using+electronic+health+records&rft.jtitle=The+Lancet+Psychiatry&rft.aulast=Taquet%2C+M.%3B+Geddes%2C+J.R.%3B+Husain%2C+M.+et+al.&rft.au=Taquet%2C+M.%3B+Geddes%2C+J.R.%3B+Husain%2C+M.+et+al.&rft.date=2021&rft.volume=8&rft.issue=5&rft.pages=416%E2%80%9327&rft_id=info:doi\/10.1016%2FS2215-0366%2821%2900084-5&rft_id=info:pmc\/PMC8023694&rft_id=info:pmid\/33836148&rft_id=http%3A%2F%2Fwww.pubmedcentral.nih.gov%2Farticlerender.fcgi%3Ftool%3Dpmcentrez%26artid%3DPMC8023694&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MaCorona20-7\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-MaCorona20_7-0\">7.0<\/a><\/sup> <sup><a href=\"#cite_ref-MaCorona20_7-1\">7.1<\/a><\/sup> <sup><a href=\"#cite_ref-MaCorona20_7-2\">7.2<\/a><\/sup> <sup><a href=\"#cite_ref-MaCorona20_7-3\">7.3<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Ma, J. (13 March 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.scmp.com\/news\/china\/society\/article\/3074991\/coronavirus-chinas-first-confirmed-covid-19-case-traced-back\" target=\"_blank\">\"Coronavirus: China\u2019s first confirmed Covid-19 case traced back to November 17\"<\/a>. <i>South China Morning Post<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.scmp.com\/news\/china\/society\/article\/3074991\/coronavirus-chinas-first-confirmed-covid-19-case-traced-back\" target=\"_blank\">https:\/\/www.scmp.com\/news\/china\/society\/article\/3074991\/coronavirus-chinas-first-confirmed-covid-19-case-traced-back<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 31 March 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Coronavirus%3A+China%E2%80%99s+first+confirmed+Covid-19+case+traced+back+to+November+17&rft.atitle=South+China+Morning+Post&rft.aulast=Ma%2C+J.&rft.au=Ma%2C+J.&rft.date=13+March+2020&rft_id=https%3A%2F%2Fwww.scmp.com%2Fnews%2Fchina%2Fsociety%2Farticle%2F3074991%2Fcoronavirus-chinas-first-confirmed-covid-19-case-traced-back&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FolmerSat20-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FolmerSat20_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Folmer, K.; Margolin. J. 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(19 June 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.reuters.com\/article\/us-health-coronavirus-italy-sewage\/italy-sewage-study-suggests-covid-19-was-there-in-december-2019-idUSKBN23Q1J9\" target=\"_blank\">\"Italy sewage study suggests COVID-19 was there in December 2019\"<\/a>. <i>Reuters<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.reuters.com\/article\/us-health-coronavirus-italy-sewage\/italy-sewage-study-suggests-covid-19-was-there-in-december-2019-idUSKBN23Q1J9\" target=\"_blank\">https:\/\/www.reuters.com\/article\/us-health-coronavirus-italy-sewage\/italy-sewage-study-suggests-covid-19-was-there-in-december-2019-idUSKBN23Q1J9<\/a><\/span><span class=\"reference-accessdate\">. 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Retrieved 12 November 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=As+the+holidays+get+closer%2C+Covid-19+hospitalizations+and+deaths+are+happening+at+a+faster+rate&rft.atitle=CNN+Health&rft.aulast=Maxouris%2C+C.&rft.au=Maxouris%2C+C.&rft.date=12+November+2020&rft_id=https%3A%2F%2Fwww.cnn.com%2F2020%2F11%2F12%2Fhealth%2Fus-coronavirus-thursday%2Findex.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FDATakesKey20-29\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FDATakesKey20_29-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19\" target=\"_blank\">\"FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine\"<\/a>. U.S. Food and Drug Administration. 11 December 2020<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19\" target=\"_blank\">https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=FDA+Takes+Key+Action+in+Fight+Against+COVID-19+By+Issuing+Emergency+Use+Authorization+for+First+COVID-19+Vaccine&rft.atitle=&rft.date=11+December+2020&rft.pub=U.S.+Food+and+Drug+Administration&rft_id=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FDATakesAdd20-30\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FDATakesAdd20_30-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid\" target=\"_blank\">\"FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine\"<\/a>. 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(28 March 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wacotrib.com\/opinion\/columns\/guest_columns\/rodney-richie-don-t-be-quick-to-blame-chinese-for-obscuring-viral-contagion\/article_91f410f5-07a9-549a-9f8c-8b785bfc1207.html\" target=\"_blank\">\"Rodney Richie: Don\u2019t be quick to blame Chinese for obscuring viral contagion\"<\/a>. <i>Waco Tribune-Herald<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.wacotrib.com\/opinion\/columns\/guest_columns\/rodney-richie-don-t-be-quick-to-blame-chinese-for-obscuring-viral-contagion\/article_91f410f5-07a9-549a-9f8c-8b785bfc1207.html\" target=\"_blank\">https:\/\/www.wacotrib.com\/opinion\/columns\/guest_columns\/rodney-richie-don-t-be-quick-to-blame-chinese-for-obscuring-viral-contagion\/article_91f410f5-07a9-549a-9f8c-8b785bfc1207.html<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 25 April 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Rodney+Richie%3A+Don%E2%80%99t+be+quick+to+blame+Chinese+for+obscuring+viral+contagion&rft.atitle=Waco+Tribune-Herald&rft.aulast=Richie%2C+R.&rft.au=Richie%2C+R.&rft.date=28+March+2020&rft_id=https%3A%2F%2Fwww.wacotrib.com%2Fopinion%2Fcolumns%2Fguest_columns%2Frodney-richie-don-t-be-quick-to-blame-chinese-for-obscuring-viral-contagion%2Farticle_91f410f5-07a9-549a-9f8c-8b785bfc1207.html&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BowmanBill20-40\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BowmanBill20_40-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Bowman, N. 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(2021). \"COVID vaccines to reach poorest countries in 2023 \u2014 despite recent pledges\". <i>Nature<\/i> <b>595<\/b>: 342\u201343. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1038%2Fd41586-021-01762-w\" target=\"_blank\">10.1038\/d41586-021-01762-w<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/34226742\" target=\"_blank\">34226742<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=COVID+vaccines+to+reach+poorest+countries+in+2023+%E2%80%94+despite+recent+pledges&rft.jtitle=Nature&rft.aulast=Padma%2C+T.V.&rft.au=Padma%2C+T.V.&rft.date=2021&rft.volume=595&rft.pages=342%E2%80%9343&rft_id=info:doi\/10.1038%2Fd41586-021-01762-w&rft_id=info:pmid\/34226742&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-YeyatiSocial21-60\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-YeyatiSocial21_60-0\">60.0<\/a><\/sup> <sup><a href=\"#cite_ref-YeyatiSocial21_60-1\">60.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Yeyati, E.L.; Filippini, F. (8 June 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.brookings.edu\/research\/social-and-economic-impact-of-covid-19\/\" target=\"_blank\">\"Social and economic impact of COVID-19\"<\/a>. <i>Brookings<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.brookings.edu\/research\/social-and-economic-impact-of-covid-19\/\" target=\"_blank\">https:\/\/www.brookings.edu\/research\/social-and-economic-impact-of-covid-19\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Social+and+economic+impact+of+COVID-19&rft.atitle=Brookings&rft.aulast=Yeyati%2C+E.L.%3B+Filippini%2C+F.&rft.au=Yeyati%2C+E.L.%3B+Filippini%2C+F.&rft.date=8+June+2021&rft_id=https%3A%2F%2Fwww.brookings.edu%2Fresearch%2Fsocial-and-economic-impact-of-covid-19%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CBPPTracking21-61\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-CBPPTracking21_61-0\">61.0<\/a><\/sup> <sup><a href=\"#cite_ref-CBPPTracking21_61-1\">61.1<\/a><\/sup> <sup><a href=\"#cite_ref-CBPPTracking21_61-2\">61.2<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Center on Budget and Policy Priorities (9 August 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cbpp.org\/research\/poverty-and-inequality\/tracking-the-covid-19-recessions-effects-on-food-housing-and\" target=\"_blank\">\"Tracking the COVID-19 Recession\u2019s Effects on Food, Housing, and Employment Hardships\"<\/a>. <i>COVID Hardship Watch<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cbpp.org\/research\/poverty-and-inequality\/tracking-the-covid-19-recessions-effects-on-food-housing-and\" target=\"_blank\">https:\/\/www.cbpp.org\/research\/poverty-and-inequality\/tracking-the-covid-19-recessions-effects-on-food-housing-and<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Tracking+the+COVID-19+Recession%E2%80%99s+Effects+on+Food%2C+Housing%2C+and+Employment+Hardships&rft.atitle=COVID+Hardship+Watch&rft.aulast=Center+on+Budget+and+Policy+Priorities&rft.au=Center+on+Budget+and+Policy+Priorities&rft.date=9+August+2021&rft_id=https%3A%2F%2Fwww.cbpp.org%2Fresearch%2Fpoverty-and-inequality%2Ftracking-the-covid-19-recessions-effects-on-food-housing-and&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-FalconDoFace21-62\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-FalconDoFace21_62-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Falcon, R. (7 August 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.kxan.com\/news\/coronavirus\/do-face-masks-work-here-are-49-scientific-studies-that-explain-why-they-do\/\" target=\"_blank\">\"Do face masks work? Here are 49 scientific studies that explain why they do\"<\/a>. <i>KXAN<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.kxan.com\/news\/coronavirus\/do-face-masks-work-here-are-49-scientific-studies-that-explain-why-they-do\/\" target=\"_blank\">https:\/\/www.kxan.com\/news\/coronavirus\/do-face-masks-work-here-are-49-scientific-studies-that-explain-why-they-do\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Do+face+masks+work%3F+Here+are+49+scientific+studies+that+explain+why+they+do&rft.atitle=KXAN&rft.aulast=Falcon%2C+R.&rft.au=Falcon%2C+R.&rft.date=7+August+2021&rft_id=https%3A%2F%2Fwww.kxan.com%2Fnews%2Fcoronavirus%2Fdo-face-masks-work-here-are-49-scientific-studies-that-explain-why-they-do%2F&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-ScottWhyCant21-63\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-ScottWhyCant21_63-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Scott, D. (1 September 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.vox.com\/coronavirus-covid19\/2021\/9\/1\/22642745\/us-covid-19-test-numbers-delta-variant\" target=\"_blank\">\"Why can\u2019t America fix its Covid-19 testing problems?\"<\/a>. <i>Vox<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.vox.com\/coronavirus-covid19\/2021\/9\/1\/22642745\/us-covid-19-test-numbers-delta-variant\" target=\"_blank\">https:\/\/www.vox.com\/coronavirus-covid19\/2021\/9\/1\/22642745\/us-covid-19-test-numbers-delta-variant<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Why+can%E2%80%99t+America+fix+its+Covid-19+testing+problems%3F&rft.atitle=Vox&rft.aulast=Scott%2C+D.&rft.au=Scott%2C+D.&rft.date=1+September+2021&rft_id=https%3A%2F%2Fwww.vox.com%2Fcoronavirus-covid19%2F2021%2F9%2F1%2F22642745%2Fus-covid-19-test-numbers-delta-variant&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20210918194601\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.405 seconds\nReal time usage: 0.467 seconds\nPreprocessor visited node count: 46058\/1000000\nPost\u2010expand include size: 388747\/2097152 bytes\nTemplate argument size: 152356\/2097152 bytes\nHighest expansion depth: 20\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 119564\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 435.598 1 -total\n 82.28% 358.421 1 Template:Reflist\n 70.49% 307.035 63 Template:Citation\/core\n 63.61% 277.084 54 Template:Cite_web\n 17.70% 77.097 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)\n 14.17% 61.723 54 Template:Date\n 10.77% 46.896 9 Template:Cite_journal\n 4.48% 19.526 108 Template:Citation\/make_link\n 2.86% 12.452 23 Template:Citation\/identifier\n 0.95% 4.123 50 Template:Hide_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11904-0!canonical and timestamp 20210918194600 and revision id 39228. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","90976a93da236fdb84deea9f14d59f06_images":[],"90976a93da236fdb84deea9f14d59f06_timestamp":1632073384,"8dcc5ee06ab45aab603ce9ff68ed83ad_type":"article","8dcc5ee06ab45aab603ce9ff68ed83ad_title":"1.1 COVID-19: The terminology","8dcc5ee06ab45aab603ce9ff68ed83ad_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_The_terminology","8dcc5ee06ab45aab603ce9ff68ed83ad_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Overview of COVID-19 and its challenges\/COVID-19: The terminologyFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n1. Overview of COVID-19 and its challenges \nPlease note: Information during a pandemic changes, sometime rapidly, in regards to test methods, reported figures, and social situations. Efforts will be made to keep this guide up-to-date as best as possible given time constraints and resources.\n\n1.1 COVID-19: The terminology \nA pneumonia-like outbreak was fully in process in Wuhan\u2014located in the Hubei province of China\u2014by December 2019. The World Health Organization (WHO) was notified by the end of the month that the cause could be a novel threat to the larger populace.[1] By the end of January 2020, the WHO had declared the growing viral threat a Public Health Emergency of International Concern (PHEIC), an act which includes with it a need \"to implement a comprehensive risk communication strategy.\"[2] As the disease progressed beyond its Chinese origins, public confusion slowly grew regarding the terminology surrounding the disease. Leaders at the WHO and the Coronavirus Study Group (CSG) of the International Committee on Taxonomy of Viruses came to different naming conclusions, differing in their naming conventions while adding to the confusion.[3][4] In the end, \"COVID-19\" has ended up as the common disease name, caused by the SARS-CoV-2 virus, which is a member of the coronavirus family. Today, however, some still refer to the disease simply as \"coronavirus,\" which is in error. \nThis isn't the first time a disease has had a different name from its associated virus. One should look back to 1982, when the U.S. Centers for Disease Control and Prevention (CDC) gave the name \"acquired immune deficiency syndrome\" or \"AIDS\" to the disease associated with the human immunodeficiency virus (HIV) (a member of the retrovirus family).[5] It took time for the layman to get used to the terminology, and even then some still ended up mistakenly referring to the disease as \"HIV.\"\nConsistent terminology is vital to communicating technical material to a global audience.[6][7] With that in mind, it's beneficial to ensure everyone is clear on the terms used. For purposes of this guide:\n\nCoronavirus disease 2019 (otherwise known as COVID-19) is the respiratory disease being discussed in this guide.\nSARS-CoV-2 is the virus responsible for COVID-19.\nCoronavirus (or Coronaviridae) is a family of related viruses, of which SARS-CoV-2 is a member.\nSevere acute respiratory syndrome (otherwise known as SARS) is a different respiratory disease, which surfaced in the early 2000s, caused by a related but different type of coronavirus (SARS-CoV or SARS-CoV-1).\nMiddle East respiratory syndrome (otherwise known as MERS) is a different respiratory disease, which surfaced in 2012, caused by a related but different type of coronavirus (MERS-CoV).\nReferences \n\n\n\u2191 Hui, D.S.; Azhar, E.I.; Madani, T.A. et al. (2020). \"The continuing 2019-nCoV epidemic threat of novel coronaviruses to global health\u2014The latest 2019 novel coronavirus outbreak in Wuhan, China\". International Journal of Infectious Diseases 91: 264\u201366. doi:10.1016\/j.ijid.2020.01.009. PMID 31953166.   \n \n\n\u2191 World Health Organization (30 January 2020). \"Statement on the second meeting of the International Health Regulations (2005) Emergency Committee regarding the outbreak of novel coronavirus (2019-nCoV)\". World Health Organization. https:\/\/www.who.int\/news\/item\/30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-outbreak-of-novel-coronavirus-(2019-ncov) . Retrieved 06 September 2021 .   \n \n\n\u2191 Enserink, M. (12 February 2020). \"Update: \u2018A bit chaotic.\u2019 Christening of new coronavirus and its disease name create confusion\". Science. https:\/\/www.science.org\/news\/2020\/02\/bit-chaotic-christening-new-coronavirus-and-its-disease-name-create-confusion . Retrieved 06 September 2021 .   \n \n\n\u2191 Jiang, S.; Shi, Z.; Shu, Y. et al. (2020). \"A distinct name is needed for the new coronavirus\". The Lancet 395 (10228): 949. doi:10.1016\/S0140-6736(20)30419-0. PMID 32087125.   \n \n\n\u2191 Oppenheimer, G.M. (1992). \"Chapter 2: Causes, Cases, and Cohorts: The Role of Epidemiology in the Historical Construction of AIDS\". In Fee, E.; Fox, D.M.. AIDS: The Making of a Chronic Disease. University of California Press. pp. 49\u201383. ISBN 0520077784. https:\/\/books.google.com\/books?id=CmME6xfdEFAC&pg=PA49 . Retrieved 31 March 2020 .   \n \n\n\u2191 Kohl, J.R. (2008). The Global English Style Guide: Writing Clear, Trnaslatable Documentation for a Global Market. SAS Institute. ISBN 9781599946573.   \n \n\n\u2191 Megathlin, B.A.; Langford, R.S. (1991). \"Controlling the Unruly: Terminology\". 1991 Proceedings 38th International Technical Communication Conference: WE22\u2013WE24.   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_The_terminology\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_The_terminology<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 3 May 2020, at 19:18.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 326 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","8dcc5ee06ab45aab603ce9ff68ed83ad_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Overview_of_COVID-19_and_its_challenges_COVID-19_The_terminology rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Overview_of_COVID-19_and_its_challenges_COVID-19_The_terminology skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Overview of COVID-19 and its challenges\/COVID-19: The terminology<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Introduction\" title=\"Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Introduction\" class=\"wiki-link\" data-key=\"d0faaf5a86a3ccb5b12357c8bd4fefe4\">the beginning<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"1._Overview_of_COVID-19_and_its_challenges\">1. Overview of COVID-19 and its challenges<\/span><\/h2>\n<p><i>Please note<\/i>: Information during a pandemic changes, sometime rapidly, in regards to test methods, reported figures, and social situations. Efforts will be made to keep this guide up-to-date as best as possible given time constraints and resources.\n<\/p>\n<h3><span class=\"mw-headline\" id=\"1.1_COVID-19:_The_terminology\">1.1 COVID-19: The terminology<\/span><\/h3>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Novel_Coronavirus_SARS-CoV-2_(49640655213).jpg\" class=\"image wiki-link\" data-key=\"477c418bc16017f87cd50320ccf7d9c4\"><img alt=\"Novel Coronavirus SARS-CoV-2 (49640655213).jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/9\/95\/Novel_Coronavirus_SARS-CoV-2_%2849640655213%29.jpg\" decoding=\"async\" width=\"260\" height=\"260\" \/><\/a><\/div><p>A pneumonia-like outbreak was fully in process in Wuhan\u2014located in the Hubei province of China\u2014by December 2019. The <a href=\"https:\/\/www.limswiki.org\/index.php\/World_Health_Organization\" title=\"World Health Organization\" class=\"wiki-link\" data-key=\"2a49f1470638d5f579e3f6419e239b03\">World Health Organization<\/a> (WHO) was notified by the end of the month that the cause could be a novel threat to the larger populace.<sup id=\"rdp-ebb-cite_ref-HuiTheCont20_1-0\" class=\"reference\"><a href=\"#cite_note-HuiTheCont20-1\">[1]<\/a><\/sup> By the end of January 2020, the WHO had declared the growing viral threat a Public Health Emergency of International Concern (PHEIC), an act which includes with it a need \"to implement a comprehensive risk communication strategy.\"<sup id=\"rdp-ebb-cite_ref-WHOStatement20_2-0\" class=\"reference\"><a href=\"#cite_note-WHOStatement20-2\">[2]<\/a><\/sup> As the disease progressed beyond its Chinese origins, public confusion slowly grew regarding the terminology surrounding the disease. Leaders at the WHO and the Coronavirus Study Group (CSG) of the International Committee on Taxonomy of Viruses came to different naming conclusions, differing in their naming conventions while adding to the confusion.<sup id=\"rdp-ebb-cite_ref-EnserinkUpdate20_3-0\" class=\"reference\"><a href=\"#cite_note-EnserinkUpdate20-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-JiangADistinct20_4-0\" class=\"reference\"><a href=\"#cite_note-JiangADistinct20-4\">[4]<\/a><\/sup> In the end, \"<a href=\"https:\/\/www.limswiki.org\/index.php\/COVID-19\" class=\"mw-redirect wiki-link\" title=\"COVID-19\" data-key=\"da9bd20c492b2a17074ad66c2fe25652\">COVID-19<\/a>\" has ended up as the common disease name, caused by the <a href=\"https:\/\/www.limswiki.org\/index.php\/SARS-CoV-2\" class=\"mw-redirect wiki-link\" title=\"SARS-CoV-2\" data-key=\"6c6b78479de2c640028696ed32948526\">SARS-CoV-2<\/a> virus, which is a member of the <a href=\"https:\/\/www.limswiki.org\/index.php\/Coronavirus\" title=\"Coronavirus\" class=\"wiki-link\" data-key=\"86c887aaa85c1b2b96fd478c10703204\">coronavirus<\/a> family. Today, however, some still refer to the disease simply as \"coronavirus,\" which is in error. \n<\/p><p>This isn't the first time a disease has had a different name from its associated virus. One should look back to 1982, when the U.S. <a href=\"https:\/\/www.limswiki.org\/index.php\/Centers_for_Disease_Control_and_Prevention\" title=\"Centers for Disease Control and Prevention\" class=\"wiki-link\" data-key=\"176aa9c9513251c328d864d1e724e814\">Centers for Disease Control and Prevention<\/a> (CDC) gave the name \"acquired immune deficiency syndrome\" or \"AIDS\" to the disease associated with the human immunodeficiency virus (HIV) (a member of the retrovirus family).<sup id=\"rdp-ebb-cite_ref-OppenheimerCauses92_5-0\" class=\"reference\"><a href=\"#cite_note-OppenheimerCauses92-5\">[5]<\/a><\/sup> It took time for the layman to get used to the terminology, and even then some still ended up mistakenly referring to the disease as \"HIV.\"\n<\/p><p>Consistent terminology is vital to communicating technical material to a global audience.<sup id=\"rdp-ebb-cite_ref-KohlTheGlobal_6-0\" class=\"reference\"><a href=\"#cite_note-KohlTheGlobal-6\">[6]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-MagathlinControl91_7-0\" class=\"reference\"><a href=\"#cite_note-MagathlinControl91-7\">[7]<\/a><\/sup> With that in mind, it's beneficial to ensure everyone is clear on the terms used. For purposes of this guide:\n<\/p>\n<ul><li><b>Coronavirus disease 2019<\/b> (otherwise known as <b>COVID-19<\/b>) is the respiratory disease being discussed in this guide.<\/li>\n<li><b>SARS-CoV-2<\/b> is the virus responsible for COVID-19.<\/li>\n<li><b>Coronavirus<\/b> (or <i>Coronaviridae<\/i>) is a family of related viruses, of which SARS-CoV-2 is a member.<\/li>\n<li><b><a href=\"https:\/\/www.limswiki.org\/index.php\/Severe_acute_respiratory_syndrome\" title=\"Severe acute respiratory syndrome\" class=\"wiki-link\" data-key=\"11abe2043ece64ad43ee0052402c5cec\">Severe acute respiratory syndrome<\/a><\/b> (otherwise known as <b>SARS<\/b>) is a different respiratory disease, which surfaced in the early 2000s, caused by a related but different type of coronavirus (SARS-CoV or SARS-CoV-1).<\/li>\n<li><b><a href=\"https:\/\/www.limswiki.org\/index.php\/Middle_East_respiratory_syndrome\" title=\"Middle East respiratory syndrome\" class=\"wiki-link\" data-key=\"6a290adf3ac17e4b8a75ef1ce0b28afd\">Middle East respiratory syndrome<\/a><\/b> (otherwise known as <b>MERS<\/b>) is a different respiratory disease, which surfaced in 2012, caused by a related but different type of coronavirus (MERS-CoV).<\/li><\/ul>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-HuiTheCont20-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HuiTheCont20_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Hui, D.S.; Azhar, E.I.; Madani, T.A. et al. (2020). \"The continuing 2019-nCoV epidemic threat of novel coronaviruses to global health\u2014The latest 2019 novel coronavirus outbreak in Wuhan, China\". <i>International Journal of Infectious Diseases<\/i> <b>91<\/b>: 264\u201366. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2Fj.ijid.2020.01.009\" target=\"_blank\">10.1016\/j.ijid.2020.01.009<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/31953166\" target=\"_blank\">31953166<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=The+continuing+2019-nCoV+epidemic+threat+of+novel+coronaviruses+to+global+health%E2%80%94The+latest+2019+novel+coronavirus+outbreak+in+Wuhan%2C+China&rft.jtitle=International+Journal+of+Infectious+Diseases&rft.aulast=Hui%2C+D.S.%3B+Azhar%2C+E.I.%3B+Madani%2C+T.A.+et+al.&rft.au=Hui%2C+D.S.%3B+Azhar%2C+E.I.%3B+Madani%2C+T.A.+et+al.&rft.date=2020&rft.volume=91&rft.pages=264%E2%80%9366&rft_id=info:doi\/10.1016%2Fj.ijid.2020.01.009&rft_id=info:pmid\/31953166&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_The_terminology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-WHOStatement20-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-WHOStatement20_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">World Health Organization (30 January 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/news\/item\/30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-outbreak-of-novel-coronavirus-(2019-ncov)\" target=\"_blank\">\"Statement on the second meeting of the International Health Regulations (2005) Emergency Committee regarding the outbreak of novel coronavirus (2019-nCoV)\"<\/a>. World Health Organization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.who.int\/news\/item\/30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-outbreak-of-novel-coronavirus-(2019-ncov)\" target=\"_blank\">https:\/\/www.who.int\/news\/item\/30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-outbreak-of-novel-coronavirus-(2019-ncov)<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Statement+on+the+second+meeting+of+the+International+Health+Regulations+%282005%29+Emergency+Committee+regarding+the+outbreak+of+novel+coronavirus+%282019-nCoV%29&rft.atitle=&rft.aulast=World+Health+Organization&rft.au=World+Health+Organization&rft.date=30+January+2020&rft.pub=World+Health+Organization&rft_id=https%3A%2F%2Fwww.who.int%2Fnews%2Fitem%2F30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-%282005%29-emergency-committee-regarding-the-outbreak-of-novel-coronavirus-%282019-ncov%29&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_The_terminology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-EnserinkUpdate20-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-EnserinkUpdate20_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Enserink, M. (12 February 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.science.org\/news\/2020\/02\/bit-chaotic-christening-new-coronavirus-and-its-disease-name-create-confusion\" target=\"_blank\">\"Update: \u2018A bit chaotic.\u2019 Christening of new coronavirus and its disease name create confusion\"<\/a>. <i>Science<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.science.org\/news\/2020\/02\/bit-chaotic-christening-new-coronavirus-and-its-disease-name-create-confusion\" target=\"_blank\">https:\/\/www.science.org\/news\/2020\/02\/bit-chaotic-christening-new-coronavirus-and-its-disease-name-create-confusion<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 06 September 2021<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Update%3A+%E2%80%98A+bit+chaotic.%E2%80%99+Christening+of+new+coronavirus+and+its+disease+name+create+confusion&rft.atitle=Science&rft.aulast=Enserink%2C+M.&rft.au=Enserink%2C+M.&rft.date=12+February+2020&rft_id=https%3A%2F%2Fwww.science.org%2Fnews%2F2020%2F02%2Fbit-chaotic-christening-new-coronavirus-and-its-disease-name-create-confusion&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_The_terminology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-JiangADistinct20-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-JiangADistinct20_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Jiang, S.; Shi, Z.; Shu, Y. et al. (2020). \"A distinct name is needed for the new coronavirus\". <i>The Lancet<\/i> <b>395<\/b> (10228): 949. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1016%2FS0140-6736%2820%2930419-0\" target=\"_blank\">10.1016\/S0140-6736(20)30419-0<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/32087125\" target=\"_blank\">32087125<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=A+distinct+name+is+needed+for+the+new+coronavirus&rft.jtitle=The+Lancet&rft.aulast=Jiang%2C+S.%3B+Shi%2C+Z.%3B+Shu%2C+Y.+et+al.&rft.au=Jiang%2C+S.%3B+Shi%2C+Z.%3B+Shu%2C+Y.+et+al.&rft.date=2020&rft.volume=395&rft.issue=10228&rft.pages=949&rft_id=info:doi\/10.1016%2FS0140-6736%2820%2930419-0&rft_id=info:pmid\/32087125&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_The_terminology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-OppenheimerCauses92-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-OppenheimerCauses92_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Oppenheimer, G.M. (1992). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/books.google.com\/books?id=CmME6xfdEFAC&pg=PA49\" target=\"_blank\">\"Chapter 2: Causes, Cases, and Cohorts: The Role of Epidemiology in the Historical Construction of AIDS\"<\/a>. In Fee, E.; Fox, D.M.. <i>AIDS: The Making of a Chronic Disease<\/i>. University of California Press. pp. 49\u201383. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 0520077784<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/books.google.com\/books?id=CmME6xfdEFAC&pg=PA49\" target=\"_blank\">https:\/\/books.google.com\/books?id=CmME6xfdEFAC&pg=PA49<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 31 March 2020<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Chapter+2%3A+Causes%2C+Cases%2C+and+Cohorts%3A+The+Role+of+Epidemiology+in+the+Historical+Construction+of+AIDS&rft.atitle=AIDS%3A+The+Making+of+a+Chronic+Disease&rft.aulast=Oppenheimer%2C+G.M.&rft.au=Oppenheimer%2C+G.M.&rft.date=1992&rft.pages=pp.%26nbsp%3B49%E2%80%9383&rft.pub=University+of+California+Press&rft.isbn=0520077784&rft_id=https%3A%2F%2Fbooks.google.com%2Fbooks%3Fid%3DCmME6xfdEFAC%26pg%3DPA49&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_The_terminology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-KohlTheGlobal-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-KohlTheGlobal_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation book\">Kohl, J.R. (2008). <i>The Global English Style Guide: Writing Clear, Trnaslatable Documentation for a Global Market<\/i>. SAS Institute. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9781599946573.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=The+Global+English+Style+Guide%3A+Writing+Clear%2C+Trnaslatable+Documentation+for+a+Global+Market&rft.aulast=Kohl%2C+J.R.&rft.au=Kohl%2C+J.R.&rft.date=2008&rft.pub=SAS+Institute&rft.isbn=9781599946573&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_The_terminology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MagathlinControl91-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MagathlinControl91_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Megathlin, B.A.; Langford, R.S. (1991). \"Controlling the Unruly: Terminology\". <i>1991 Proceedings 38th International Technical Communication Conference<\/i>: WE22\u2013WE24.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Controlling+the+Unruly%3A+Terminology&rft.jtitle=1991+Proceedings+38th+International+Technical+Communication+Conference&rft.aulast=Megathlin%2C+B.A.%3B+Langford%2C+R.S.&rft.au=Megathlin%2C+B.A.%3B+Langford%2C+R.S.&rft.date=1991&rft.pages=WE22%E2%80%93WE24&rfr_id=info:sid\/en.wikipedia.org:Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_The_terminology\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20210918204001\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.079 seconds\nReal time usage: 0.162 seconds\nPreprocessor visited node count: 4993\/1000000\nPost\u2010expand include size: 43749\/2097152 bytes\nTemplate argument size: 15160\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 12981\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 79.637 1 -total\n 85.89% 68.402 1 Template:Reflist\n 60.76% 48.390 7 Template:Citation\/core\n 36.93% 29.413 3 Template:Cite_journal\n 21.67% 17.256 2 Template:Cite_web\n 14.73% 11.729 2 Template:Cite_book\n 14.01% 11.155 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_The_terminology\n 9.09% 7.241 6 Template:Citation\/identifier\n 7.31% 5.822 2 Template:Date\n 4.09% 3.256 9 Template:Citation\/make_link\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11902-0!canonical and timestamp 20210918204000 and revision id 39226. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_The_terminology\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_The_terminology<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","8dcc5ee06ab45aab603ce9ff68ed83ad_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/9\/95\/Novel_Coronavirus_SARS-CoV-2_%2849640655213%29.jpg"],"8dcc5ee06ab45aab603ce9ff68ed83ad_timestamp":1632073384,"d0faaf5a86a3ccb5b12357c8bd4fefe4_type":"article","d0faaf5a86a3ccb5b12357c8bd4fefe4_title":"Introduction","d0faaf5a86a3ccb5b12357c8bd4fefe4_url":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Introduction","d0faaf5a86a3ccb5b12357c8bd4fefe4_plaintext":"\n\nBook:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/IntroductionFrom LIMSWikiJump to navigationJump to search\nTitle: COVID-19 Testing, Reporting, and Information Management in the Laboratory\nEdition: Fall 2021\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: September 2021\n\r\n\nThis guide discusses the evolving status of laboratory testing, reporting, and information management for the COVID-19 disease and pandemic. The focus is primarily on testing and reporting in the United States, but other parts of the world are also addressed. It also examines the disease's history, what makes it difficult to combat, and what diagnostic testing methods are currently available. Additionally, the guide examines what testing workflow for COVID-19 is like, along with the equipment, software, and reporting required by testing labs, as well as additional benefits and challenges of laboratory informatics in disease testing and public health. This guide closes with final remarks, as well as a listing of associated resources, including guidance documents, web portals, and key reading. \nThis guide is published in a time when information about COVID-19 and the SARS-CoV-2 virus is still changing rapidly. An attempt to make small, incremental updates to the guide will be made as the state of reasearch and testing continues to shift. November's Fall 2020 edition brought with it a number of small additions and updates, including updates on statistics, long-term health issues, testing guidance, available test kits, coding and reporting issues, interoperability, and contact tracing, among other topics. The latest Fall 2021 edition significantly adds to the history and impact section, updates some of the challenges to disease management, heavily revises testing methods and their implementation in the lab, and broadly updates statistics, reporting requirements, and other historical data. It also adds section 3.1.6 Multiplex testing and 3.1.7 Variant testing.\nThe table of contents for COVID-19 Testing, Reporting, and Information Management in the Laboratory is as follows: \n\r\n\n1. Overview of COVID-19 and its challenges\n\n1.1 COVID-19: The terminology\n1.2 COVID-19: History and impact (so far)\n1.3 Challenges of managing the disease in the human population\n2. Diagnostic testing of COVID-19 and other coronaviruses\n\n2.1 Testing terminology\n2.1.1 Introduction\n2.1.2 Polymerase chain reaction (PCR)\n2.1.3 Lateral flow assay (LFA)<\/dd>\n2.2 Testing conducted on previous coronaviruses\n2.2.1 Severe acute respiratory syndrome (SARS)\n2.2.2 Middle East respiratory syndrome (MERS)\n2.2.3 The common cold<\/dd>\n2.3 Organizational and agency guidance on COVID-19 testing\n2.3.1 Regulatory considerations: HIPAA and CLIA<\/dd>\n2.4 Current test methods and their differences\n2.4.1 Background on the laboratory testing environment\n2.4.2 PCR-based methods\n2.4.3 LFA and isothermal amplification methods\n2.4.4 Blood serum\n2.4.5 Antigen tests\n2.4.6 Testing alternatives and challenges<\/dd>\n3. Adding COVID-19 and other virus testing to your laboratory\n\n3.1 What methodologies will you use?\n3.1.1 PCR\n3.1.2 Pooled testing\n3.1.3 Rapid antigen testing\n3.1.4 LAMP and CRISPR\n3.1.5 Point-of-care and other alternative testing\n3.1.6 Multiplex testing\n3.1.7 Variant testing<\/dd>\n3.2 What kind of space, equipment, and supplies will you need?\n3.2.1 Laboratory space arrangements\n3.2.2 Instruments and assays\n3.2.3 Reagents\n3.2.4 Consumables\n3.2.5 Software and services\n3.2.6 Major vendors and consultants<\/dd>\n3.3 What other considerations should be made?\n3.3.1 U.S. regulatory compliance\n3.3.2 Reporting\n3.3.3 Billing, Medicare, and Medicaid\n3.3.4 Biosafety<\/dd>\n4. Workflow and information management for COVID-19 (and other respiratory diseases)\n\n4.1 Laboratory informatics and workflow management\n4.1.1 Does the system provide a flexible provider portal?\n4.1.2 Does the system allow for the flexible addition of users, providers, and patients?\n4.1.3 Does the system allow for laboratory workflows sympathetic to COVID-19 and other types of respiratory illness testing?\n4.1.4 Does the system allow for interfacing with most instruments currently used for testing for COVID-19?\n4.1.5 Does the system allow for versatile viewing and reporting of COVID-19 results?<\/dd>\n4.2 Laboratory informatics and reporting requirements\n4.2.1 ICD, CPT, and HCPCS coding\n4.2.2 Reporting to local and regional health departments<\/dd>\n4.3 Additional benefits and challenges of informatics in disease testing and public health\n4.3.1 System interoperability\n4.3.2 Contact tracing<\/dd>\n5. Final thoughts and additional resources\n\n5.1 Final thoughts\n5.2 Key guidance documents\n5.3 Web portals\n5.4 Key journal articles\n5.5 Public health lab directory\n5.6 Test kit and other resources\n5.7 Public health laboratory informatics vendors\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Introduction\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Introduction<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationSponsors \r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\n\t\r\n\n\t\r\n\n \n\t\n\t\r\n\n\t\r\n\n\t\n\t\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 3 May 2020, at 19:10.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 314 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","d0faaf5a86a3ccb5b12357c8bd4fefe4_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Introduction rootpage-Book_COVID-19_Testing_Reporting_and_Information_Management_in_the_Laboratory_Introduction skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Introduction<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:SARS-CoV-2_without_background.png\" class=\"image wiki-link\" data-key=\"e88de8c3246e31eccefb12f9f3e26d35\"><img alt=\"SARS-CoV-2 without background.png\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/8\/82\/SARS-CoV-2_without_background.png\" decoding=\"async\" width=\"300\" height=\"301\" \/><\/a><\/div>\n<p><b>Title<\/b>: <i>COVID-19 Testing, Reporting, and Information Management in the Laboratory<\/i>\n<\/p><p><b>Edition<\/b>: Fall 2021\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: September 2021\n<\/p><p><br \/>\nThis guide discusses the evolving status of <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a> testing, reporting, and <a href=\"https:\/\/www.limswiki.org\/index.php\/Information_management\" title=\"Information management\" class=\"wiki-link\" data-key=\"f8672d270c0750a858ed940158ca0a73\">information management<\/a> for the <a href=\"https:\/\/www.limswiki.org\/index.php\/COVID-19\" class=\"mw-redirect wiki-link\" title=\"COVID-19\" data-key=\"da9bd20c492b2a17074ad66c2fe25652\">COVID-19<\/a> disease and pandemic. The focus is primarily on testing and reporting in the United States, but other parts of the world are also addressed. It also examines the disease's history, what makes it difficult to combat, and what diagnostic testing methods are currently available. Additionally, the guide examines what testing workflow for COVID-19 is like, along with the equipment, software, and reporting required by testing labs, as well as additional benefits and challenges of <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> in disease testing and public health. This guide closes with final remarks, as well as a listing of associated resources, including guidance documents, web portals, and key reading. \n<\/p><p>This guide is published in a time when information about COVID-19 and the SARS-CoV-2 virus is still changing rapidly. An attempt to make small, incremental updates to the guide will be made as the state of reasearch and testing continues to shift. November's Fall 2020 edition brought with it a number of small additions and updates, including updates on statistics, long-term health issues, testing guidance, available test kits, coding and reporting issues, interoperability, and contact tracing, among other topics. The latest Fall 2021 edition significantly adds to the history and impact section, updates some of the challenges to disease management, heavily revises testing methods and their implementation in the lab, and broadly updates statistics, reporting requirements, and other historical data. It also adds section 3.1.6 Multiplex testing and 3.1.7 Variant testing.\n<\/p><p>The table of contents for <i>COVID-19 Testing, Reporting, and Information Management in the Laboratory<\/i> is as follows: \n<\/p><p><br \/>\n1. <a href=\"https:\/\/www.limswiki.org\/index.php\/LII:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\" title=\"LII:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Overview of COVID-19 and its challenges\" class=\"wiki-link\" data-key=\"4bbbc0390bc27b074b5efc5545121df0\">Overview of COVID-19 and its challenges<\/a>\n<\/p>\n<dl><dd>1.1 COVID-19: The terminology<\/dd>\n<dd>1.2 COVID-19: History and impact (so far)<\/dd>\n<dd>1.3 Challenges of managing the disease in the human population<\/dd><\/dl>\n<p>2. <a href=\"https:\/\/www.limswiki.org\/index.php\/LII:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\" title=\"LII:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Diagnostic testing of COVID-19 and other coronaviruses\" class=\"wiki-link\" data-key=\"90e252aacaa7df3a5a201c93ebecbe80\">Diagnostic testing of COVID-19 and other coronaviruses<\/a>\n<\/p>\n<dl><dd>2.1 Testing terminology\n<dl><dd>2.1.1 Introduction<\/dd>\n<dd>2.1.2 Polymerase chain reaction (PCR)<\/dd>\n<dd>2.1.3 Lateral flow assay (LFA)<\/dd><\/dl><\/dd>\n<dd>2.2 Testing conducted on previous coronaviruses\n<dl><dd>2.2.1 Severe acute respiratory syndrome (SARS)<\/dd>\n<dd>2.2.2 Middle East respiratory syndrome (MERS)<\/dd>\n<dd>2.2.3 The common cold<\/dd><\/dl><\/dd>\n<dd>2.3 Organizational and agency guidance on COVID-19 testing\n<dl><dd>2.3.1 Regulatory considerations: HIPAA and CLIA<\/dd><\/dl><\/dd>\n<dd>2.4 Current test methods and their differences\n<dl><dd>2.4.1 Background on the laboratory testing environment<\/dd>\n<dd>2.4.2 PCR-based methods<\/dd>\n<dd>2.4.3 LFA and isothermal amplification methods<\/dd>\n<dd>2.4.4 Blood serum<\/dd>\n<dd>2.4.5 Antigen tests<\/dd>\n<dd>2.4.6 Testing alternatives and challenges<\/dd><\/dl><\/dd><\/dl>\n<p>3. <a href=\"https:\/\/www.limswiki.org\/index.php\/LII:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\" title=\"LII:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Adding COVID-19 and other virus testing to your laboratory\" class=\"wiki-link\" data-key=\"54fab629d7b0b92adcbd1986e0edde2c\">Adding COVID-19 and other virus testing to your laboratory<\/a>\n<\/p>\n<dl><dd>3.1 What methodologies will you use?\n<dl><dd>3.1.1 PCR<\/dd>\n<dd>3.1.2 Pooled testing<\/dd>\n<dd>3.1.3 Rapid antigen testing<\/dd>\n<dd>3.1.4 LAMP and CRISPR<\/dd>\n<dd>3.1.5 Point-of-care and other alternative testing<\/dd>\n<dd>3.1.6 Multiplex testing<\/dd>\n<dd>3.1.7 Variant testing<\/dd><\/dl><\/dd>\n<dd>3.2 What kind of space, equipment, and supplies will you need?\n<dl><dd>3.2.1 Laboratory space arrangements<\/dd>\n<dd>3.2.2 Instruments and assays<\/dd>\n<dd>3.2.3 Reagents<\/dd>\n<dd>3.2.4 Consumables<\/dd>\n<dd>3.2.5 Software and services<\/dd>\n<dd>3.2.6 Major vendors and consultants<\/dd><\/dl><\/dd>\n<dd>3.3 What other considerations should be made?\n<dl><dd>3.3.1 U.S. regulatory compliance<\/dd>\n<dd>3.3.2 Reporting<\/dd>\n<dd>3.3.3 Billing, Medicare, and Medicaid<\/dd>\n<dd>3.3.4 Biosafety<\/dd><\/dl><\/dd><\/dl>\n<p>4. <a href=\"https:\/\/www.limswiki.org\/index.php\/LII:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\" title=\"LII:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Workflow and information management for COVID-19 (and other respiratory diseases)\" class=\"wiki-link\" data-key=\"8a6653e6518317400489361cdb29c1d8\">Workflow and information management for COVID-19 (and other respiratory diseases)<\/a>\n<\/p>\n<dl><dd>4.1 Laboratory informatics and workflow management\n<dl><dd>4.1.1 Does the system provide a flexible provider portal?<\/dd>\n<dd>4.1.2 Does the system allow for the flexible addition of users, providers, and patients?<\/dd>\n<dd>4.1.3 Does the system allow for laboratory workflows sympathetic to COVID-19 and other types of respiratory illness testing?<\/dd>\n<dd>4.1.4 Does the system allow for interfacing with most instruments currently used for testing for COVID-19?<\/dd>\n<dd>4.1.5 Does the system allow for versatile viewing and reporting of COVID-19 results?<\/dd><\/dl><\/dd>\n<dd>4.2 Laboratory informatics and reporting requirements\n<dl><dd>4.2.1 ICD, CPT, and HCPCS coding<\/dd>\n<dd>4.2.2 Reporting to local and regional health departments<\/dd><\/dl><\/dd>\n<dd>4.3 Additional benefits and challenges of informatics in disease testing and public health\n<dl><dd>4.3.1 System interoperability<\/dd>\n<dd>4.3.2 Contact tracing<\/dd><\/dl><\/dd><\/dl>\n<p>5. <a href=\"https:\/\/www.limswiki.org\/index.php\/LII:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Final_thoughts_and_additional_resources\" title=\"LII:COVID-19 Testing, Reporting, and Information Management in the Laboratory\/Final thoughts and additional resources\" class=\"wiki-link\" data-key=\"0da8735a9e13a797caefbf61cb07b4e6\">Final thoughts and additional resources<\/a>\n<\/p>\n<dl><dd>5.1 Final thoughts<\/dd>\n<dd>5.2 Key guidance documents<\/dd>\n<dd>5.3 Web portals<\/dd>\n<dd>5.4 Key journal articles<\/dd>\n<dd>5.5 Public health lab directory<\/dd>\n<dd>5.6 Test kit and other resources<\/dd>\n<dd>5.7 Public health laboratory informatics vendors<\/dd><\/dl>\n<p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20210919174303\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.016 seconds\nReal time usage: 0.094 seconds\nPreprocessor visited node count: 3\/1000000\nPost\u2010expand include size: 5666\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 2\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 2.611 1 Template:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Introduction\n100.00% 2.611 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:11900-0!canonical and timestamp 20210919174303 and revision id 39223. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Introduction\">https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Introduction<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","d0faaf5a86a3ccb5b12357c8bd4fefe4_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/8\/82\/SARS-CoV-2_without_background.png"],"d0faaf5a86a3ccb5b12357c8bd4fefe4_timestamp":1632073383,"816bc5ee048c8669f9d42b30425606b4":{"type":"chapter","title":"About this book","key":"816bc5ee048c8669f9d42b30425606b4"}},"link":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory","price_currency":"","price_amount":"","book_size":"","download_url":"https:\/\/www.limsforum.com?ebb_action=book_download&book_id=90584","language":"","cta_button_content":"","toc":[{"type":"chapter","name":"About this book","id":"816bc5ee048c8669f9d42b30425606b4","children":[{"type":"article","name":"Introduction","id":"d0faaf5a86a3ccb5b12357c8bd4fefe4","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Introduction"}]},{"type":"chapter","name":"1. Overview of COVID-19 and its challenges","id":"4bd7f9fec34a1122d0b66865b643a877","children":[{"type":"article","name":"1.1 COVID-19: The terminology","id":"8dcc5ee06ab45aab603ce9ff68ed83ad","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_The_terminology"},{"type":"article","name":"1.2 COVID-19: History and impact (so far)","id":"90976a93da236fdb84deea9f14d59f06","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/COVID-19:_History_and_impact_(so_far)"},{"type":"article","name":"1.3 Challenges of managing the disease in the human population","id":"cf539edc559ed35fa7053ca6e3a7e227","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Overview_of_COVID-19_and_its_challenges\/Challenges_of_managing_the_disease_in_the_human_population"}]},{"type":"chapter","name":"2. Diagnostic testing of COVID-19 and other coronaviruses","id":"1e7790d3d0aec3ca8cb9516fa27b7e14","children":[{"type":"article","name":"2.1 Testing terminology","id":"9cee66545e86ad0648ca3d040588e9df","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_terminology"},{"type":"article","name":"2.2 Testing conducted on previous coronaviruses","id":"37226828a801fdd6cfb84d2a90e4ea36","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Testing_conducted_on_previous_coronaviruses"},{"type":"article","name":"2.3 Organizational and agency guidance on COVID-19 testing","id":"9618f22c10f370a964cc84bac6d8f3a5","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Organizational_and_agency_guidance_on_COVID-19_testing"},{"type":"article","name":"2.4 Current test methods and their differences","id":"39cacf950c52c601724e17a6099cf057","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Diagnostic_testing_of_COVID-19_and_other_coronaviruses\/Current_test_methods_and_their_differences"}]},{"type":"chapter","name":"3. Adding COVID-19 and other virus testing to your laboratory","id":"66098daaeabbe5683a196ef395a21ff0","children":[{"type":"article","name":"3.1 What methodologies will you use?","id":"e0edecb7b45ad188bb3834725c23d19b","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_methodologies_will_you_use%3F"},{"type":"article","name":"3.2 What kind of space, equipment, and supplies will you need?","id":"5c08823bef2028cb17c7a3612075ff8e","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_kind_of_space,_equipment,_and_supplies_will_you_need%3F"},{"type":"article","name":"3.3 What other considerations should be made?","id":"34c3276514d9f10cb02cbbef9c7fc276","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Adding_COVID-19_and_other_virus_testing_to_your_laboratory\/What_other_considerations_should_be_made%3F"}]},{"type":"chapter","name":"4. Workflow and information management for COVID-19 (and other respiratory diseases)","id":"c00a0b84c33b043835f9e520556f37de","children":[{"type":"article","name":"4.1 Laboratory informatics and workflow management","id":"ca4c291ccc7893b51eae4a43ed892dc8","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_workflow_management"},{"type":"article","name":"4.2 Laboratory informatics and reporting requirements","id":"500f43f0e2f5122484d8d18d8e4145c4","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Laboratory_informatics_and_reporting_requirements"},{"type":"article","name":"4.3 Additional benefits and challenges of informatics in disease testing and public health","id":"38734314415297e7ef1e374a32ba8612","pageUrl":"https:\/\/www.limswiki.org\/index.php\/Book:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory\/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases)\/Additional_benefits_and_challenges_of_informatics_in_disease_testing_and_public_health"}]},{"type":"chapter","name":"5. 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COVID-19 Testing, Reporting, and Information Management in the Laboratory
Fall 2021 Edition
Editor: Shawn Douglas
Publisher: LabLynx Press
Copyright LabLynx Inc. All rights reserved.