Determining the Reliability of Rapid SARS-CoV-2 Antigen Detection in Fully Vaccinated Individuals

23 Pages Posted: 4 Jan 2022

See all articles by Nareshkumar Poopalasingam

Nareshkumar Poopalasingam

University of Cologne - Institute of Virology

Michael Korenkov

University of Cologne - Institute of Virology

Artem Ashurov

University of Cologne - Institute of Virology

Janina Strobel

University of Cologne - University Hospital of Cologne

Irina Fish

University of Cologne - Institute of Virology

Martin Hellmich

University of Cologne - Institute of Medical Statistics

Henning Gruell

University of Cologne - Institute of Virology

Clara Lehmann

German Center for Infection Research (DZIF)

Eva Heger

University of Cologne - Institute of Virology

Florian Klein

Charité - Universitätsmedizin Berlin - Department of Infectious Diseases and Respiratory Medicine

Abstract

Rapid antigen detection tests (RADT) are commonly used as SARS-CoV-2 diagnostic tests both by medical professionals and laypeople. However, the performance of RADT in vaccinated individuals has not been fully investigated. Here, RT-qPCR and rapid antigen detection testing were performed in an outpatient clinic to evaluate the performance of the Standard Q COVID-19 Ag Test in detecting SARS-CoV-2 breakthrough infections in vaccinated individuals. A total of 696 samples were tested with both RT-qPCR and RADT that included 692 (99.4%) samples from vaccinated individuals. Of these, 76 (11.0%) samples were detected SARS-CoV-2 positive by RT-qPCR and 45 (6.5%) samples by the Standard Q COVID-19 Ag test. Stratified by Ct values, sensitivity of the RADT was 100.0%, 94.4% and 81.1% for Ct ≤ 20 (n=18), Ct ≤ 25 (n=36) and Ct ≤ 30 (n=53), respectively. Samples with Ct values ≥ 30 (n=23) were not detected. Overall RADT specificity was 99.7% and symptom status did not affect RADT performance. Notably, RADT detected 4 out of 4 samples of probable Omicron variant infection based on single nucleotide polymorphism analysis. Our results show that RADT testing remains a valuable tool in detecting breakthrough infections with high RNA loads.

Note:
Funding: Bundesministerium für Bildung und Forschung grant 01KX2021 („B- FAST“, „NaFoUniMedCovid19“)

Declaration of Interests: The authors declare no competing interests.

Ethics Approval Statement: The Institutional Review Board of the University of Cologne acknowledged and approved the study under application number 21-1039.

Keywords: SARS-CoV-2, antigen test, RT-qPCR, vaccination, Omicron

Suggested Citation

Poopalasingam, Nareshkumar and Korenkov, Michael and Ashurov, Artem and Strobel, Janina and Fish, Irina and Hellmich, Martin and Gruell, Henning and Lehmann, Clara and Heger, Eva and Klein, Florian, Determining the Reliability of Rapid SARS-CoV-2 Antigen Detection in Fully Vaccinated Individuals. Available at SSRN: https://ssrn.com/abstract=4000128 or http://dx.doi.org/10.2139/ssrn.4000128

Nareshkumar Poopalasingam

University of Cologne - Institute of Virology ( email )

Germany

Michael Korenkov

University of Cologne - Institute of Virology ( email )

Germany

Artem Ashurov

University of Cologne - Institute of Virology ( email )

Germany

Janina Strobel

University of Cologne - University Hospital of Cologne ( email )

Building 47, 9th floor Kerpener Str.
Herderstrasse 52
Cologne, 50931
Germany

Irina Fish

University of Cologne - Institute of Virology ( email )

Germany

Martin Hellmich

University of Cologne - Institute of Medical Statistics ( email )

Cologne, 50931
Germany

Henning Gruell

University of Cologne - Institute of Virology ( email )

Germany

Clara Lehmann

German Center for Infection Research (DZIF) ( email )

Inhoffenstraße 7
Braunschweig, 738124
Germany

Eva Heger

University of Cologne - Institute of Virology ( email )

Germany

Florian Klein (Contact Author)

Charité - Universitätsmedizin Berlin - Department of Infectious Diseases and Respiratory Medicine ( email )

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