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

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...

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Autores principales: 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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7830733/
https://www.ncbi.nlm.nih.gov/pubmed/33477365
http://dx.doi.org/10.3390/jcm10020328
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author 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.
author_facet 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.
author_sort Kohmer, Niko
collection PubMed
description 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 log(10) 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.
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spelling pubmed-78307332021-01-26 The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro 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. J Clin Med Article 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 log(10) 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. MDPI 2021-01-17 /pmc/articles/PMC7830733/ /pubmed/33477365 http://dx.doi.org/10.3390/jcm10020328 Text en © 2021 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
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.
The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro
title The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro
title_full The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro
title_fullStr The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro
title_full_unstemmed The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro
title_short The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro
title_sort comparative clinical performance of four sars-cov-2 rapid antigen tests and their correlation to infectivity in vitro
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7830733/
https://www.ncbi.nlm.nih.gov/pubmed/33477365
http://dx.doi.org/10.3390/jcm10020328
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