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.
Key Findings
Most FDA-Authorized Tests Showed Stable Accuracy Postapproval
The pooled sensitivity in preapproval studies was 86.5%, compared to 84.5% in postapproval studies—a small absolute difference of 2.0%, which was not statistically significant. Specificity remained unchanged at 99.6%. These findings suggest that most rapid antigen tests perform consistently when used correctly, despite earlier skepticism stemming from systematic reviews reporting lower real-world sensitivity.
Some Brands Showed Significant Postapproval Declines
Two test brands—LumiraDx and SOFIA—demonstrated statistically significant declines in sensitivity in postapproval settings (10.9% and 15.0% lower, respectively). These brands had reported the highest preapproval sensitivity (>96%), suggesting that initial studies may have overestimated their performance or that later virus variants affected detection capabilities.
Limited Postapproval Research Despite Widespread Use
Out of 61 FDA-authorized rapid antigen test brands, only 21% had postapproval studies that adhered to manufacturer instructions. Alarmingly, 79% of tests lacked such evaluations entirely, raising concerns about oversight, particularly during a public health emergency when rapid tests were deployed widely and with varying protocols.
Industry Funding Not Linked to Test Accuracy
The study found no evidence that industry sponsorship biased test performance results in postapproval studies. In fact, most postapproval studies were conducted independently and reported high methodological rigor.
Why This Matters
Rapid antigen tests played a central role in the COVID-19 pandemic response, providing quick, accessible diagnostics across clinical and community settings, including for essential workers, schools, and at-home users. Reliable diagnostic accuracy directly influences public behavior, containment policies, and health system preparedness. False negatives can lead to unchecked spread, while false positives can result in unnecessary isolation and strain on healthcare resources.
This study’s findings reinforce the necessity of transparent, continuous evaluation of medical diagnostics—especially as future public health emergencies may again require rapid development and deployment of point-of-care tests. Ensuring that real-world performance matches manufacturer claims is a critical part of safeguarding national health security and public trust.
Policy and Research Implications
- Mandatory Postapproval Surveillance: Regulatory agencies should require systematic postmarket evaluations, particularly when tests are widely used in non-clinical or asymptomatic populations.
- Transparency and Peer Review: Only 5 of the 69 preapproval studies reviewed had been published in peer-reviewed journals. Future approval processes should require public reporting of study protocols and results.
- Preparedness for Future Pandemics: Lessons from COVID-19 highlight the importance of rigorous frameworks for diagnostic test evaluation during public health emergencies. Proposed international frameworks now call for standardized processes for rapid test development and validation across outbreak settings.
The study provides reassuring evidence that most FDA-authorized COVID-19 rapid antigen tests maintain acceptable accuracy when used according to instructions. However, the observed discrepancies in select test brands and the lack of comprehensive postapproval studies for the majority of authorized tests point to systemic gaps in diagnostic oversight. As pandemic preparedness evolves, ensuring sustained, evidence-based evaluation of diagnostic tools must remain a central pillar of public health policy.
Damkjær M, Laursen DRT, Elkjær M, et al. Pre- and postapproval diagnostic test accuracy of FDA-authorized rapid antigen SARS-CoV-2 tests used according to instruction: A systematic review and meta-analysis. Clinical Microbiology and Infection. 17 July 2025