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Open AccessArticle

The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro

1
Institute for Medical Virology, University Hospital, Goethe University Frankfurt, 60596 Frankfurt, Germany
2
Institut fuer Qualitaetssicherung in der Virusdiagnostik-IQVD der GmbH, 14129 Berlin, Germany
3
INSTAND Gesellschaft zur Foerderung der Qualitaetssicherung in Medizinischen Laboratorien e.V., 40223 Duesseldorf, Germany
4
German Centre for Infection Research, External Partner Site, 60323 Frankfurt, Germany
5
Fraunhofer Institute for Molecular Biology and Applied Ecology (IME), Branch Translational Medicine and Pharmacology, 60596 Frankfurt, Germany
*
Authors to whom correspondence should be addressed.
These authors contributed equally to this work.
These authors contributed equally to this work.
J. Clin. Med. 2021, 10(2), 328; https://doi.org/10.3390/jcm10020328
Received: 21 December 2020 / Revised: 8 January 2021 / Accepted: 12 January 2021 / Published: 17 January 2021
(This article belongs to the Section Infectious Diseases)
Due to globally rising numbers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, resources for real-time reverse-transcription polymerase chain reaction (rRT-PCR)-based testing have been exhausted. In order to meet the demands of testing and reduce transmission, SARS-CoV-2 antigen-detecting rapid diagnostic tests (Ag-RDTs) are being considered. These tests are fast, inexpensive, and simple to use, but whether they detect potentially infectious cases has not been well studied. We evaluated three lateral flow assays (RIDA®QUICK SARS-CoV-2 Antigen (R-Biopharm), SARS-CoV-2 Rapid Antigen Test (Roche)), and NADAL® COVID-19 Ag Test (Nal von Minden GmbH, Regensburg, Germany) and one microfluidic immunofluorescence assay (SARS-CoV-2 Ag Test (LumiraDx GmbH, Cologne, Germany)) using 100 clinical samples. Diagnostic rRT-PCR and cell culture testing as a marker for infectivity were performed in parallel. The overall Ag-RDT sensitivity for rRT-PCR-positive samples ranged from 24.3% to 50%. However, for samples with a viral load of more than 6 log10 RNA copies/mL (22/100), typically seen in infectious individuals, Ag-RDT positivity was between 81.8% and 100%. Only 51.6% (33/64) of the rRT-PCR-positive samples were infectious in cell culture. In contrast, three Ag-RDTs demonstrated a more significant correlation with cell culture infectivity (61.8–82.4%). Our findings suggest that large-scale SARS-CoV-2 Ag-RDT-based testing can be considered for detecting potentially infective individuals and reducing the virus spread. View Full-Text
Keywords: SARS-CoV-2; Ag-RDT; POCT; PCR; cell culture; infectivity SARS-CoV-2; Ag-RDT; POCT; PCR; cell culture; infectivity
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MDPI and ACS Style

Kohmer, N.; Toptan, T.; Pallas, C.; Karaca, O.; Pfeiffer, A.; Westhaus, S.; Widera, M.; Berger, A.; Hoehl, S.; Kammel, M.; Ciesek, S.; Rabenau, H.F. The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro. J. Clin. Med. 2021, 10, 328. https://doi.org/10.3390/jcm10020328

AMA Style

Kohmer N, Toptan T, Pallas C, Karaca O, Pfeiffer A, Westhaus S, Widera M, Berger A, Hoehl S, Kammel M, Ciesek S, Rabenau HF. The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro. Journal of Clinical Medicine. 2021; 10(2):328. https://doi.org/10.3390/jcm10020328

Chicago/Turabian Style

Kohmer, Niko; Toptan, Tuna; Pallas, Christiane; Karaca, Onur; Pfeiffer, Annika; Westhaus, Sandra; Widera, Marek; Berger, Annemarie; Hoehl, Sebastian; Kammel, Martin; Ciesek, Sandra; Rabenau, Holger F. 2021. "The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro" J. Clin. Med. 10, no. 2: 328. https://doi.org/10.3390/jcm10020328

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