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Article

Diagnostic Performance of SARS-CoV-2 Rapid Antigen Test in a Large, German Cohort

1
Center for Child and Adolescent Medicine, Center for Clinical and Translational Research (CCTR), Helios University Hospital Wuppertal, Witten/Herdecke University, 42283 Wuppertal, Germany
2
Institute for Medical Laboratory Diagnostics, Center for Clinical and Translational Research (CCTR), Helios University Hospital Wuppertal, Witten/Herdecke University, 42283 Wuppertal, Germany
3
Laboratory of Experimental Pediatric Pneumology and Allergology, Center for Biomedical Education and Research, School of Life Sciences (ZBAF), Faculty of Health, Witten/Herdecke University, 58448 Witten, Germany
*
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Academic Editor: Anna Nilsson
Received: 12 July 2021 / Revised: 1 August 2021 / Accepted: 5 August 2021 / Published: 8 August 2021
(This article belongs to the Special Issue Advances in Pediatric Infection and Immunity)
We assessed the performance of a rapid antigen test (RAT) in everyday clinical practice. Between 1 November 2020 until 1 April 2021 all in-patients at the Helios University Hospital Wuppertal, Germany, as well as the accompanying relatives at the Children’s Hospital received a SARS-CoV-2 RAT and a SARS-CoV-2 RT-PCR prior to admission. Out of 3686 patients, 22 (0.6%) subjects were tested positive by RT-PCR and RAT, and 3591 (97.4%) were negative by both methods, showing discordant results: RT-PCR+/RAT− in 58 (1.6%) and RT-PCR−/RAT+ in 15 patients (0.4%). Overall sensitivity and specificity of RAT was 27.5% (95%CI 18.1–38.6%) and 99.6% (95%CI 99.3–99.8%), respectively. The sensitivity was slightly higher in adults (30.4%, 95%CI 18.8–90.9%) than in pediatric subjects (20.8%, 95%CI 7.1–42.2%). False negative RAT had a statistically higher Ct-value (p < 0.001) compared to true positive values, and overall sensitivity increased to 80% [59.3–93.2%] with Ct value < 30. While the sensitivity of the RAT was poor compared with the RT-PCR, the specificity was excellent. However, the sensitivity increased with lower Ct value, and with the right anamnesis the RAT can be a quick and easy approach to distinguish people who are infectious with SARS-CoV-2 from noninfectious people, enabling appropriate triage in clinical practice while waiting for the RT-PCR result. View Full-Text
Keywords: COVID-19; SARS-CoV-2 early diagnosis; rapid antigen detection test; primary healthcare center COVID-19; SARS-CoV-2 early diagnosis; rapid antigen detection test; primary healthcare center
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MDPI and ACS Style

Mboma, O.; Rieke, E.; Ahmad-Nejad, P.; Wirth, S.; Aydin, M. Diagnostic Performance of SARS-CoV-2 Rapid Antigen Test in a Large, German Cohort. Children 2021, 8, 682. https://0-doi-org.brum.beds.ac.uk/10.3390/children8080682

AMA Style

Mboma O, Rieke E, Ahmad-Nejad P, Wirth S, Aydin M. Diagnostic Performance of SARS-CoV-2 Rapid Antigen Test in a Large, German Cohort. Children. 2021; 8(8):682. https://0-doi-org.brum.beds.ac.uk/10.3390/children8080682

Chicago/Turabian Style

Mboma, Olivier, Elmar Rieke, Parviz Ahmad-Nejad, Stefan Wirth, and Malik Aydin. 2021. "Diagnostic Performance of SARS-CoV-2 Rapid Antigen Test in a Large, German Cohort" Children 8, no. 8: 682. https://0-doi-org.brum.beds.ac.uk/10.3390/children8080682

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