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Performance of six rapid diagnostic tests for SARS-CoV-2 antigen detection and implications for practical use
BACKGROUND: Direct detection of SARS-CoV-2 viral proteins in nasopharyngeal swabs using lateral flow immunoassays is a simple, fast and cheap approach to diagnose the infection. AIMS AND METHODS: The performance of 6 SARS-CoV-2 antigen rapid diagnostic tests has been assessed in 634 hospitalized pat...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier B.V.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8310570/ https://www.ncbi.nlm.nih.gov/pubmed/34390929 http://dx.doi.org/10.1016/j.jcv.2021.104930 |
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author | Fourati, Slim Langendorf, Céline Audureau, Etienne Challine, Dominique Michel, Justine Soulier, Alexandre Ahnou, Nazim Désveaux, Isaac Picard, Oriane Ortonne, Valérie Gourgeon, Aurélie Mills, Clair Hémery, François Rieux, Claire Pawlotsky, Jean-Michel Malou, Nada Chevaliez, Stéphane |
author_facet | Fourati, Slim Langendorf, Céline Audureau, Etienne Challine, Dominique Michel, Justine Soulier, Alexandre Ahnou, Nazim Désveaux, Isaac Picard, Oriane Ortonne, Valérie Gourgeon, Aurélie Mills, Clair Hémery, François Rieux, Claire Pawlotsky, Jean-Michel Malou, Nada Chevaliez, Stéphane |
author_sort | Fourati, Slim |
collection | PubMed |
description | BACKGROUND: Direct detection of SARS-CoV-2 viral proteins in nasopharyngeal swabs using lateral flow immunoassays is a simple, fast and cheap approach to diagnose the infection. AIMS AND METHODS: The performance of 6 SARS-CoV-2 antigen rapid diagnostic tests has been assessed in 634 hospitalized patients or outpatients including 297 patients found to be positive for SARS-CoV-2 RNA by means of RT-PCR and 337 patients presumed to be SARS-CoV-2 RNA-negative. RESULTS: The specificity of SARS-CoV-2 RDTs was generally high (398.5%). One assay had a lower specificity of 93.2%. The overall sensitivity of the 6 RDTs was variable, from 32.3% to 61.7%. Sensitivity correlated with the delay of sampling after the onset of symptoms and the viral load estimated by the Ct value in RT-PCR. Four out of 6 RDTs tested achieved sensitivities 380% when clinical specimens were collected during the first 3 days following symptom onset or with a Ct value ≤25. CONCLUSIONS: The present study shows that SARS-CoV-2 antigen can be easily and reliably detected by RDTs. These tests are easy and rapid to perform. However, the specificity and sensitivity of COVID-19 antigen RDTs may widely vary across different tests and must therefore be carefully evaluated before releasing these assays for realworld applications. |
format | Online Article Text |
id | pubmed-8310570 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Elsevier B.V. |
record_format | MEDLINE/PubMed |
spelling | pubmed-83105702021-07-26 Performance of six rapid diagnostic tests for SARS-CoV-2 antigen detection and implications for practical use Fourati, Slim Langendorf, Céline Audureau, Etienne Challine, Dominique Michel, Justine Soulier, Alexandre Ahnou, Nazim Désveaux, Isaac Picard, Oriane Ortonne, Valérie Gourgeon, Aurélie Mills, Clair Hémery, François Rieux, Claire Pawlotsky, Jean-Michel Malou, Nada Chevaliez, Stéphane J Clin Virol Article BACKGROUND: Direct detection of SARS-CoV-2 viral proteins in nasopharyngeal swabs using lateral flow immunoassays is a simple, fast and cheap approach to diagnose the infection. AIMS AND METHODS: The performance of 6 SARS-CoV-2 antigen rapid diagnostic tests has been assessed in 634 hospitalized patients or outpatients including 297 patients found to be positive for SARS-CoV-2 RNA by means of RT-PCR and 337 patients presumed to be SARS-CoV-2 RNA-negative. RESULTS: The specificity of SARS-CoV-2 RDTs was generally high (398.5%). One assay had a lower specificity of 93.2%. The overall sensitivity of the 6 RDTs was variable, from 32.3% to 61.7%. Sensitivity correlated with the delay of sampling after the onset of symptoms and the viral load estimated by the Ct value in RT-PCR. Four out of 6 RDTs tested achieved sensitivities 380% when clinical specimens were collected during the first 3 days following symptom onset or with a Ct value ≤25. CONCLUSIONS: The present study shows that SARS-CoV-2 antigen can be easily and reliably detected by RDTs. These tests are easy and rapid to perform. However, the specificity and sensitivity of COVID-19 antigen RDTs may widely vary across different tests and must therefore be carefully evaluated before releasing these assays for realworld applications. Elsevier B.V. 2021-09 2021-07-25 /pmc/articles/PMC8310570/ /pubmed/34390929 http://dx.doi.org/10.1016/j.jcv.2021.104930 Text en © 2021 Elsevier B.V. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Article Fourati, Slim Langendorf, Céline Audureau, Etienne Challine, Dominique Michel, Justine Soulier, Alexandre Ahnou, Nazim Désveaux, Isaac Picard, Oriane Ortonne, Valérie Gourgeon, Aurélie Mills, Clair Hémery, François Rieux, Claire Pawlotsky, Jean-Michel Malou, Nada Chevaliez, Stéphane Performance of six rapid diagnostic tests for SARS-CoV-2 antigen detection and implications for practical use |
title | Performance of six rapid diagnostic tests for SARS-CoV-2 antigen detection and implications for practical use |
title_full | Performance of six rapid diagnostic tests for SARS-CoV-2 antigen detection and implications for practical use |
title_fullStr | Performance of six rapid diagnostic tests for SARS-CoV-2 antigen detection and implications for practical use |
title_full_unstemmed | Performance of six rapid diagnostic tests for SARS-CoV-2 antigen detection and implications for practical use |
title_short | Performance of six rapid diagnostic tests for SARS-CoV-2 antigen detection and implications for practical use |
title_sort | performance of six rapid diagnostic tests for sars-cov-2 antigen detection and implications for practical use |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8310570/ https://www.ncbi.nlm.nih.gov/pubmed/34390929 http://dx.doi.org/10.1016/j.jcv.2021.104930 |
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