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Evaluation of a high volume antigen test for detection of SARS-CoV-2
Increasing transmission of SARS-CoV-2 infection in successive waves may strain the capacity of laboratories performing molecular diagnostic testing. Alternative testing approaches may offer additional diagnostic capacity. A high throughput chemiluminescent antigen assay (Ortho VITROS SARS-CoV-2 anti...
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/PMC8327635/ https://www.ncbi.nlm.nih.gov/pubmed/34380096 http://dx.doi.org/10.1016/j.jcv.2021.104938 |
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author | Levett, Paul N. Cheung, Branco Kustra, Jesse Pidduck, Tamara Mak, Annie Tsang, Frankie Petric, Martin Krajden, Mel |
author_facet | Levett, Paul N. Cheung, Branco Kustra, Jesse Pidduck, Tamara Mak, Annie Tsang, Frankie Petric, Martin Krajden, Mel |
author_sort | Levett, Paul N. |
collection | PubMed |
description | Increasing transmission of SARS-CoV-2 infection in successive waves may strain the capacity of laboratories performing molecular diagnostic testing. Alternative testing approaches may offer additional diagnostic capacity. A high throughput chemiluminescent antigen assay (Ortho VITROS SARS-CoV-2 antigen test) was evaluated using both an inactivated virus preparation and prospective clinical samples (nasopharyngeal swabs in virus transport medium). The limit of detection of the assay was approximately 0.5 TCID(50)/ml, equivalent to a Ct value of 33. The assay was linear over a wide range. When 528 clinical samples were tested with the antigen assay, the sensitivity was 84.2% and the specificity was 100% (positive predictive value 100% and negative predictive value 97.7%). High volume antigen tests might be used to supplement molecular diagnostic testing capacity. |
format | Online Article Text |
id | pubmed-8327635 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Elsevier B.V. |
record_format | MEDLINE/PubMed |
spelling | pubmed-83276352021-08-02 Evaluation of a high volume antigen test for detection of SARS-CoV-2 Levett, Paul N. Cheung, Branco Kustra, Jesse Pidduck, Tamara Mak, Annie Tsang, Frankie Petric, Martin Krajden, Mel J Clin Virol Article Increasing transmission of SARS-CoV-2 infection in successive waves may strain the capacity of laboratories performing molecular diagnostic testing. Alternative testing approaches may offer additional diagnostic capacity. A high throughput chemiluminescent antigen assay (Ortho VITROS SARS-CoV-2 antigen test) was evaluated using both an inactivated virus preparation and prospective clinical samples (nasopharyngeal swabs in virus transport medium). The limit of detection of the assay was approximately 0.5 TCID(50)/ml, equivalent to a Ct value of 33. The assay was linear over a wide range. When 528 clinical samples were tested with the antigen assay, the sensitivity was 84.2% and the specificity was 100% (positive predictive value 100% and negative predictive value 97.7%). High volume antigen tests might be used to supplement molecular diagnostic testing capacity. Elsevier B.V. 2021-09 2021-08-02 /pmc/articles/PMC8327635/ /pubmed/34380096 http://dx.doi.org/10.1016/j.jcv.2021.104938 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 Levett, Paul N. Cheung, Branco Kustra, Jesse Pidduck, Tamara Mak, Annie Tsang, Frankie Petric, Martin Krajden, Mel Evaluation of a high volume antigen test for detection of SARS-CoV-2 |
title | Evaluation of a high volume antigen test for detection of SARS-CoV-2 |
title_full | Evaluation of a high volume antigen test for detection of SARS-CoV-2 |
title_fullStr | Evaluation of a high volume antigen test for detection of SARS-CoV-2 |
title_full_unstemmed | Evaluation of a high volume antigen test for detection of SARS-CoV-2 |
title_short | Evaluation of a high volume antigen test for detection of SARS-CoV-2 |
title_sort | evaluation of a high volume antigen test for detection of sars-cov-2 |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8327635/ https://www.ncbi.nlm.nih.gov/pubmed/34380096 http://dx.doi.org/10.1016/j.jcv.2021.104938 |
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