TY - JOUR AU - Igloi, Zsὁfia AU - Velzing, Jans AU - van Beek, Janko AU - van de Vijver, David AU - Aron, Georgina AU - Ensing, Roel AU - Benschop, Kimberley AU - Han, Wanda AU - Boelsums, Timo AU - Koopmans, Marion AU - Geurtsvankessel, Corine AU - Molenkamp, Richard T1 - Clinical Evaluation of Roche SD Biosensor Rapid Antigen Test for SARS-CoV-2 in Municipal Health Service Testing Site, the Netherlands T2 - Emerging Infectious Disease journal PY - 2021 VL - 27 IS - 5 SP - 1323 SN - 1080-6059 AB - 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. KW - COVID-19 KW - coronavirus disease KW - SARS-CoV-2 KW - severe acute respiratory syndrome coronavirus 2 KW - viruses KW - respiratory infections KW - zoonoses KW - Roche KW - rapid antigen test KW - clinical evaluation KW - diagnostics KW - the Netherlands DO - 10.3201/eid2705.204688 UR - https://wwwnc.cdc.gov/eid/article/27/5/20-4688_article ER - End of Reference