Volta

Preapproval and postapproval diagnostic test accuracy of food and drug administration–authorized rapid antigen SARS-CoV-2 tests used according to instruction: a systematic review and meta-analysis

BACKGROUND: Manufacturers claim high sensitivity for rapid antigen SARS-CoV-2 tests on product labels, yet systematic reviews report considerably lower sensitivity. OBJECTIVES: This study aimed to describe study characteristics and compare the sensitivity and specificity of United States Food and Drug Administration (FDA)-approved rapid antigen SARS-CoV-2 tests in preapproval vs. postapproval studies. METHODS: Methods include systematic review and meta-analysis. DATA SOURCES: Data sources include FDA website, Medline, Embase, and Google Scholar. STUDY ELIGIBILITY CRITERIA: Study eligibility criteria include diagnostic test accuracy studies according to the instruction for use. PARTICIPANTS: Participants include patients with symptoms of COVID-19. TESTS: Test includes rapid antigen SARS-CoV-2 tests. REFERENCE STANDARD: Reference standard includes RT-PCR. ASSESSMENT OF RISK OF BIAS: Assessment of risk of bias was conducted …

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