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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Zsὁfia Iglὁi, Jans Velzing, Janko van Beek, David van de Vijver, Georgina Aron, Roel Ensing, Kimberley Benschop, Wanda Han, Timo Boelsums, Marion Koopmans, Corine Geurtsvankessel, and Richard Molenkamp
- Subjects
COVID-19 ,coronavirus disease ,SARS-CoV-2 ,severe acute respiratory syndrome coronavirus 2 ,viruses ,respiratory infections ,Medicine ,Infectious and parasitic diseases ,RC109-216 - 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
- Published
- 2021
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