TY - JOUR
T1 - Clinical evaluation of roche sd biosensor rapid antigen test for sars-cov-2 in municipal health service testing site, the netherlands
AU - Iglòi, Zsòfia
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
N1 - Funding Information:
This work was partly supported by H2020 project
Publisher Copyright:
© 2021 Centers for Disease Control and Prevention (CDC). All rights reserved.
PY - 2021/5
Y1 - 2021/5
N2 - 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 specifi city 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 SARSCoV- 2 infections in the early phase of disease, thereby identifying the most infectious persons.
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 specifi city 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 SARSCoV- 2 infections in the early phase of disease, thereby identifying the most infectious persons.
UR - http://www.scopus.com/inward/record.url?scp=85105274072&partnerID=8YFLogxK
U2 - 10.3201/eid2705.204688
DO - 10.3201/eid2705.204688
M3 - Article
C2 - 33724916
AN - SCOPUS:85105274072
SN - 1080-6040
VL - 27
SP - 1323
EP - 1329
JO - Emerging Infectious Diseases
JF - Emerging Infectious Diseases
IS - 5
ER -
