Clinical Evaluation of Roche SD Biosensor Rapid Antigen Test for SARS-CoV-2 in Municipal Health Service Testing Site, the Netherlands
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 pers... Mehr ...
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Dokumenttyp: | Artikel |
Erscheinungsdatum: | 2021 |
Reihe/Periodikum: | Emerging Infectious Diseases, Vol 27, Iss 5, Pp 1323-1329 (2021) |
Verlag/Hrsg.: |
Centers for Disease Control and Prevention
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Schlagwörter: | COVID-19 / coronavirus disease / SARS-CoV-2 / severe acute respiratory syndrome coronavirus 2 / viruses / respiratory infections / Medicine / R / Infectious and parasitic diseases / RC109-216 |
Sprache: | Englisch |
Permalink: | https://search.fid-benelux.de/Record/base-28760862 |
Datenquelle: | BASE; Originalkatalog |
Powered By: | BASE |
Link(s) : | https://doi.org/10.3201/eid2705.204688 |
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.