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10.1016/j.ijid.2021.07.010

http://scihub22266oqcxt.onion/10.1016/j.ijid.2021.07.010
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suck abstract from ncbi


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pmid34242764      Int+J+Infect+Dis 2021 ; 109 (ä): 118-122
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  • Diagnostic accuracy of a SARS-CoV-2 rapid antigen test in real-life clinical settings #MMPMID34242764
  • Jegerlehner S; Suter-Riniker F; Jent P; Bittel P; Nagler M
  • Int J Infect Dis 2021[Aug]; 109 (ä): 118-122 PMID34242764show ga
  • BACKGROUND: 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: The aim of this study was to assess the accuracy of a rapid antigen test in diagnosing SARS-CoV-2 infection in a primary/secondary care testing facility. METHODS: Consecutive individuals presenting at a COVID-19 testing facility affiliated to a Swiss University Hospital were recruited (n = 1465%). Nasopharyngeal swabs were obtained, and the Roche/SD Biosensor rapid antigen test was conducted in parallel with two real-time PCR tests (reference standard). RESULTS: Among the 1465 patients recruited, RT-PCR was positive in 141 individuals, corresponding to a prevalence of 9.6%. The Roche/SD Biosensor rapid antigen test was positive in 94 patients (6.4%), and negative in 1368 individuals (93.4%; insufficient sample material in 3 patients). 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 accuracy of the SARS-CoV-2 Roche/SD Biosensor rapid antigen test in diagnosing SARS-CoV-2 infections in a primary/secondary care testing facility was considerably lower compared with the manufacturer's data. Widespread application in such a setting might lead to a considerable number of individuals falsely classified as SARS-CoV-2 negative.
  • |*COVID-19[MESH]
  • |*SARS-CoV-2[MESH]
  • |Antigens, Viral[MESH]
  • |COVID-19 Testing[MESH]
  • |Humans[MESH]
  • |Pandemics[MESH]


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