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.
Highlights
Rapid detection of infection is essential for stopping the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Characteristics of Study Population During the study period of October 9–15, 2020, a total of 970 (26.8%) of 3,615 persons visiting the testing site were included in the study; inclusion was put on hold occasionally during the day when testing posts became crowded
We describe the results of a large clinical evaluation study using an antigen rapid test in a medium-high prevalence setting in a symptomatic, nonhospitalized population to detect SARS-CoV-2 infections
Summary
Rapid detection of infection is essential for stopping the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The sensitivity of the tests is lower than that of RT-PCR, but in patients in the early phase of illness who have high viral load, performance meets World Health Organization–set criteria of >80% sensitivity and >97% specificity compared with nucleic acid detection methods (8). All samples positive by Ag RDT and PCR were cultured to correlate results with infectivity.
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