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.

Publication date: Jul 17, 2025

Manufacturers claim high sensitivity for rapid antigen SARS-CoV-2 tests on product labels, yet systematic reviews report considerably lower sensitivity. To describe study characteristics and compare the sensitivity and specificity United States Food and Drug Administration (FDA)-approved rapid antigen SARS-CoV-2 tests in pre-versus postapproval studies. Systematic review and meta-analysis. FDA website, Medline, Embase, and Google Scholar. Diagnostic test accuracy studies according to instruction for use. Patients with symptoms of COVID-19. Rapid antigen SARS-CoV-2 tests. Reverse transcriptase polymerase chain reaction. QUADAS-2 tool. Bivariate binomial-normal restricted maximum likelihood random-effects meta-analysis and meta-regressions applying the delta method and likelihood ratio tests. We identified postapproval studies for 13 of 61 (21%) rapid antigen tests, of which nine tests had eligible studies. The analysis incorporated 13 preapproval studies (591 COVID-19 cases, 3,155 participants) and 26 postapproval studies (2,765 cases, 12,444 participants). The pooled sensitivity for pre- and postapproval studies was 86. 5% (95% CI: 83. 3-89. 1) and 84. 5% (95% CI: 81. 2-87. 3), respectively. The absolute difference was 2. 0% (95% CI: -1. 9 to 6. 2) and (0%, 95% CI: -0. 6 to 0. 6) for sensitivity and specificity, respectively. Two of the nine tests had lower sensitivity in postapproval studies. Our study found that sensitivity estimates from postapproval studies on FDA-approved rapid antigen tests are largely consistent with manufacturers’ estimates. However, for two of the nine tests, postapproval sensitivity was lower than the manufacturers’ high estimates. Differences in sensitivity observed in prior systematic reviews likely result from variations in study populations, not bias in study conduct. Given that 79% of FDA-approved rapid antigen tests lacked postapproval studies, ongoing evaluations are needed to ensure alignment with clinical expectations. The study was preregistered, and the protocol is available at https://osf. io/97cft.

Semantics

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