Global Biodefense Systematic review reveals most FDA-authorized SARS-CoV-2 antigen tests maintain high accuracy after approval—though some underperform, highlighting need for continued oversight. A newly published analysis in Clinical Microbiology and Infection 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—often used to gain Emergency Use Authorization (EUA)—with postapproval studies that followed real-world use conditions according to manufacturers’ instructions.
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—on average—diagnostic 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.