{"id":9940,"date":"2025-07-23T10:18:45","date_gmt":"2025-07-23T15:18:45","guid":{"rendered":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/?p=9940"},"modified":"2025-07-23T10:18:48","modified_gmt":"2025-07-23T15:18:48","slug":"fda-rapid-antigen-covid-tests-hold-up-after-approval-but-oversight-still-lacking","status":"publish","type":"post","link":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/2025\/07\/23\/fda-rapid-antigen-covid-tests-hold-up-after-approval-but-oversight-still-lacking\/","title":{"rendered":"FDA Rapid Antigen COVID Tests Hold Up After Approval\u2014But Oversight Still Lacking"},"content":{"rendered":"<div class=\"panel body-content\"><div class=\"panel__container\">\n<p><a href=\"https:\/\/globalbiodefense.com\/2025\/07\/23\/fda-covid-rapid-antigen-test-accuracy-review\/\">Global Biodefense<\/a> Systematic review reveals most FDA-authorized SARS-CoV-2 antigen tests maintain high accuracy after approval\u2014though some underperform, highlighting need for continued oversight. A newly published&nbsp;<a href=\"https:\/\/www.clinicalmicrobiologyandinfection.com\/article\/S1198-743X(25)00349-0\/fulltext\">analysis<\/a>&nbsp;in&nbsp;<em>Clinical Microbiology and Infection<\/em>&nbsp;provides critical insights into the diagnostic accuracy of FDA-authorized SARS-CoV-2 rapid antigen tests. Conducted by researchers from Cochrane Denmark and the Centre for Evidence-Based Medicine Odense (CEBMO), this study compared test performance data from preapproval studies\u2014often used to gain Emergency Use Authorization (EUA)\u2014with postapproval studies that followed real-world use conditions according to manufacturers\u2019 instructions.<\/p>\n\n\n\n<p>The study analyzed 13 preapproval and 26 postapproval studies across nine different test brands, encompassing data from over 15,500 individuals. Despite concerns about exaggerated performance claims by manufacturers, the results indicate that\u2014on average\u2014diagnostic accuracy in postapproval studies remained largely consistent with initial manufacturer-reported sensitivity and specificity. However, two widely used test brands showed significantly lower sensitivity postapproval, underscoring the importance of postmarket surveillance and validation.<\/p>\n<\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>Global Biodefense Systematic review reveals most FDA-authorized SARS-CoV-2 antigen tests maintain high accuracy after approval\u2014though some underperform, highlighting need for continued oversight. A newly published&nbsp;analysis&nbsp;in&nbsp;Clinical Microbiology and Infection&nbsp;provides critical insights into the diagnostic accuracy of FDA-authorized SARS-CoV-2 rapid antigen tests. Conducted by researchers from Cochrane Denmark and the Centre for Evidence-Based Medicine Odense (CEBMO), this [&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[14],"tags":[],"class_list":["post-9940","post","type-post","status-publish","format-standard","hentry","category-science-and-tech"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/posts\/9940","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/comments?post=9940"}],"version-history":[{"count":1,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/posts\/9940\/revisions"}],"predecessor-version":[{"id":9941,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/posts\/9940\/revisions\/9941"}],"wp:attachment":[{"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/media?parent=9940"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/categories?post=9940"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/tags?post=9940"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}