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Clinical Evaluation of Roche SD Biosensor Rapid Antigen Test for SARS-CoV-2 in Municipal Health Service Testing Site, the Netherlands
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March 16 2021
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Source: Emerg Infect Dis. 27(5):1323-1329
[PDF-3.90 MB]
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Alternative Title:Emerg Infect Dis
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Description:Rapid detection of infection is essential for stopping the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The Roche SD Biosensor rapid antigen test for SARS-CoV-2 was evaluated in a nonhospitalized symptomatic population. We rapid-tested a sample onsite and compared results with those from reverse transcription PCR and virus culture. We analyzed date of onset and symptoms using data from a clinical questionnaire. Overall test sensitivity was 84.9% (95% CI 79.1-89.4) and specificity was 99.5% (95% CI 98.7-99.8). Sensitivity increased to 95.8% (95% CI 90.5-98.2) for persons who sought care within 7 days of symptom onset. Test band intensity and time to result correlated strongly with viral load; thus, strong positive results could be read before the recommended time. Approximately 98% of all viable specimens with cycle threshold <30 were detected. Rapid antigen tests can detect symptomatic SARS-CoV-2 infections in the early phase of disease, thereby identifying the most infectious persons.
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Pubmed ID:33724916
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Pubmed Central ID:PMC8084500
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Volume:27
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Issue:5
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