COVID-19 Evidence Alerts
from McMaster PLUSTM

Current best evidence for clinical care (more info)

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Diagnosis Igloi Z, Velzing J, van Beek J, et al. Clinical Evaluation of Roche SD Biosensor Rapid Antigen Test for SARS-CoV-2 in Municipal Health Service Testing Site, the Netherlands. Emerg Infect Dis. 2021 May;27(5):1323-1329. doi: 10.3201/eid2705.204688. Epub 2021 Mar 16.

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.

Discipline / Specialty Area Score
Public Health
Infectious Disease
Comments from MORE raters

Public Health rater

This study on diagnostic test accuracy of Roche SD Biosensor Rapid Antigen Test for SARS-CoV-2 reveals a relative high rate of false negatives in a symptomatic population with nearly 20% prevalence of disease. Therefore, this test has a rather poor capability to rule out a COVID-19 infection in symptomatic people, which in a clinical and pandemic context is not satisfying.