1. Clinical Evaluation of Roche SD Biosensor Rapid Antigen Test for SARS-CoV-2 in Municipal Health Service Testing Site, the Netherlands.
- Author
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Iglὁi, Zsὁfia, Velzing, Jans, van Beek, Janko, van de Vijver, David, Aron, Georgina, Ensing, Roel, Benschop, Kimberley, Han, Wanda, Boelsums, Timo, Koopmans, Marion, Geurtsvankessel, Corine, Molenkamp, Richard, and Igloi, Zsὁfia
- Subjects
SARS-CoV-2 ,MUNICIPAL services ,MEDICAL care ,BIOSENSORS ,ANTIGENS - Abstract
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. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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