Jegerlehner, SabrinaSabrinaJegerlehnerSuter, Franziska MartaFranziska MartaSuterJent, PhilippPhilippJentBittel, PascalPascalBittelNagler, MichaelMichaelNagler2024-09-022024-09-022021-08https://boris-portal.unibe.ch/handle/20.500.12422/42730BACKGROUND Laboratory tests are a mainstay in managing the COVID-19 pandemic, and high hopes are placed on rapid antigen tests. However, the accuracy of rapid antigen tests in real-life clinical settings is unclear because adequately designed diagnostic accuracy studies are essentially lacking. OBJECTIVES We aimed to assess the diagnostic accuracy of a rapid antigen test to diagnose SARS-CoV-2 infection in a primary/ secondary care testing facility. METHODS Consecutive individuals presented at a COVID-19 testing facility affiliated to a Swiss University Hospital were recruited (n=1'465%). Nasopharyngeal swabs were obtained, and the Roche/ SD Biosensor rapid antigen test was conducted in-parallel with two real-time PCR (reference standard). RESULTS Among 1'465 patients recruited, RT-PCR was positive in 141 individuals, corresponding to a prevalence of prevalence 9.6%. The Roche/ SD Biosensor rapid antigen test was positive in 94 patients (6.4%), and negative in 1'368 individuals (93.4%). The overall sensitivity of the rapid antigen test was 65.3% (95% confidence interval, CI, 56.8, 73.1), the specificity was 99.9% (95%CI 99.5, 100.0). In asymptomatic individuals, the sensitivity was 44.0% (95%CI 24.4, 65.1). CONCLUSIONS The diagnostic accuracy of the SARS-CoV-2 Roche/SD Biosensor rapid antigen test to diagnose a SARS-CoV-2 infection in a primary/ secondary care testing facility was considerably lower compared to manufacturers' data. Widespread application in this setting might lead to a considerable number of individuals falsely classified as SARS-CoV-2 negative.enCOVID-19 diagnostic testing [Supplementary Concept] Infections/*epidemiology/transmission severe acute respiratory syndrome coronavirus 2 [Supplementary Concept]600 - Technology::610 - Medicine & health500 - Science::570 - Life sciences; biologyarticle10.48350/1576243424276410.1016/j.ijid.2021.07.010