tetano
Editor, Senior Moderator
Emerg Infect Dis
. 2021 Mar 16;27(5).
doi: 10.3201/eid2705.204688. Online ahead of print.
Clinical Evaluation of Roche SD Biosensor Rapid Antigen Test for SARS-CoV-2 in Municipal Health Service Testing Site, the Netherlands
Zs?fia Igl?i, Jans Velzing, Janko van Beek, David van de Vijver, Georgina Aron, Roel Ensing, Kimberley Benschop, Wanda Han, Timo Boelsums, Marion Koopmans, Corine Geurtsvankessel, Richard Molenkamp
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.
Keywords: COVID-19; Roche; SARS-CoV-2; clinical evaluation; coronavirus disease; diagnostics; rapid antigen test; respiratory infections; severe acute respiratory syndrome coronavirus 2; the Netherlands; viruses; zoonoses.
. 2021 Mar 16;27(5).
doi: 10.3201/eid2705.204688. Online ahead of print.
Clinical Evaluation of Roche SD Biosensor Rapid Antigen Test for SARS-CoV-2 in Municipal Health Service Testing Site, the Netherlands
Zs?fia Igl?i, Jans Velzing, Janko van Beek, David van de Vijver, Georgina Aron, Roel Ensing, Kimberley Benschop, Wanda Han, Timo Boelsums, Marion Koopmans, Corine Geurtsvankessel, Richard Molenkamp
- PMID: 33724916
- DOI: 10.3201/eid2705.204688
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.
Keywords: COVID-19; Roche; SARS-CoV-2; clinical evaluation; coronavirus disease; diagnostics; rapid antigen test; respiratory infections; severe acute respiratory syndrome coronavirus 2; the Netherlands; viruses; zoonoses.