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Volume 27, Number 5—May 2021
Research

Clinical Evaluation of Roche SD Biosensor Rapid Antigen Test for SARS-CoV-2 in Municipal Health Service Testing Site, the Netherlands

Zsὁfia Iglὁi, Jans Velzing, Janko van Beek, David van de Vijver, Georgina Aron, Roel Ensing, Kimberley Benschop, Wanda Han, Timo Boelsums, Marion Koopmans, Corine Geurtsvankessel, and Richard Molenkamp

Author affiliations: Erasmus MC, Rotterdam, the Netherlands (Z. Igloi, J. Velzing, J. van Beek, D. van de Vijver, G. Aron, M. Koopmans, C. Geurtsvankessel, R. Molenkamp); Public Health Service Rotterdam-Rijnmond, Rotterdam (R. Ensing, T. Boelsums); National Public Health Institute (RIVM), Bilthoven, the Netherlands (K. Benschop, W. Han)

Main Article

Table 3

Characteristics of rapid antigen detection test compared with reverse transcription PCR stratified by days after symptom onset, the Netherlands*

0–3 d past onset
 0–7 d past onset
 All
Characteristic No. % (95% CI) No. % (95% CI) No. % (95% CI)
Clinical sensitivity 319 94.9 (86.1–98.3) 650 90.6 (84.3–94.6) 970 84.9 (79.1–89.4)
Sensitivity Ct <30 316 98.2 (90.6–99.9) 640 95.8 (90.5–98.2) 943 94.3 (89.6–0.97)
Sensitivity Ct <25
 305
 100 (92.1–100)
608
 98.8 (93.7–99.9)
897
 99.1 (95.2–100)
Clinical specificity
 319
 99.6 (97.9-100)
650
 99.6 (98.6-99.9)
970
 99.5 (98.7-99.8)
Positive predictive value NA 98.2 (90.7–99.9) NA 98.3 (94.0–99.5) NA 97.5 (93.8–99.0)
Negative predictive value NA 98.9 (96.7–99.6) NA 97.7 (96.1–98.7) NA 96.5 (95.0–97.6)

*Sensitivity and specificity of Ag RDT was calculated based on reverse transcription PCR results and days since symptoms onset. Positive and negative predictive values were calculated using 19.2% prevalence setting. Ag RDT, rapid antigen detection test; Ct, cycle threshold; NA, not applicable.

Main Article

Page created: March 16, 2021
Page updated: April 20, 2021
Page reviewed: April 20, 2021
The conclusions, findings, and opinions expressed by authors contributing to this journal do not necessarily reflect the official position of the U.S. Department of Health and Human Services, the Public Health Service, the Centers for Disease Control and Prevention, or the authors' affiliated institutions. Use of trade names is for identification only and does not imply endorsement by any of the groups named above.
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