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Performance of three polymerase chain reaction-based assays for detection of SARS-CoV-2 in different upper respiratory tract specimens

To meet the testing demands and overcome supply chain issues during the SARS-CoV-2 pandemic, many clinical laboratories validated multiple SARS-CoV-2 molecular testing platforms. Here, we compare three different molecular assays for SARS-CoV-2 that received emergency use authorization (EUA) from the...

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Autores principales: Eberly, Allison R., Germer, Jeffery J., Boerger, Aimee C., Fernholz, Emily C., Binnicker, Matthew J., Yao, Joseph D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8160280/
https://www.ncbi.nlm.nih.gov/pubmed/34186320
http://dx.doi.org/10.1016/j.diagmicrobio.2021.115441
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author Eberly, Allison R.
Germer, Jeffery J.
Boerger, Aimee C.
Fernholz, Emily C.
Binnicker, Matthew J.
Yao, Joseph D.
author_facet Eberly, Allison R.
Germer, Jeffery J.
Boerger, Aimee C.
Fernholz, Emily C.
Binnicker, Matthew J.
Yao, Joseph D.
author_sort Eberly, Allison R.
collection PubMed
description To meet the testing demands and overcome supply chain issues during the SARS-CoV-2 pandemic, many clinical laboratories validated multiple SARS-CoV-2 molecular testing platforms. Here, we compare three different molecular assays for SARS-CoV-2 that received emergency use authorization (EUA) from the U.S. Food and Drug Administration. In order to determine the agreement among Roche cobas® SARS-CoV-2 Test (Cobas), Abbott RealTime SARS-CoV-2 assay (ART), and Mayo Clinic Laboratory SARS-CoV-2 Molecular Detection Assay (Mayo LDT), 100 each of anterior nares (AN), nasopharyngeal (NP), oropharyngeal (OP), and NP+OP swabs were tested on each platform. The consensus result was defined as agreement by 2 or more methods. Furthermore, 30 positive NP swabs from each molecular platform (n = 90 total) were tested on the three platforms to determine the PPA among positive samples. ART platform called more specimens positive than the other two platforms. All three assays performed with greater than 90% agreement for NP specimens throughout the study.
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spelling pubmed-81602802021-05-28 Performance of three polymerase chain reaction-based assays for detection of SARS-CoV-2 in different upper respiratory tract specimens Eberly, Allison R. Germer, Jeffery J. Boerger, Aimee C. Fernholz, Emily C. Binnicker, Matthew J. Yao, Joseph D. Diagn Microbiol Infect Dis Article To meet the testing demands and overcome supply chain issues during the SARS-CoV-2 pandemic, many clinical laboratories validated multiple SARS-CoV-2 molecular testing platforms. Here, we compare three different molecular assays for SARS-CoV-2 that received emergency use authorization (EUA) from the U.S. Food and Drug Administration. In order to determine the agreement among Roche cobas® SARS-CoV-2 Test (Cobas), Abbott RealTime SARS-CoV-2 assay (ART), and Mayo Clinic Laboratory SARS-CoV-2 Molecular Detection Assay (Mayo LDT), 100 each of anterior nares (AN), nasopharyngeal (NP), oropharyngeal (OP), and NP+OP swabs were tested on each platform. The consensus result was defined as agreement by 2 or more methods. Furthermore, 30 positive NP swabs from each molecular platform (n = 90 total) were tested on the three platforms to determine the PPA among positive samples. ART platform called more specimens positive than the other two platforms. All three assays performed with greater than 90% agreement for NP specimens throughout the study. Elsevier Inc. 2021-10 2021-05-28 /pmc/articles/PMC8160280/ /pubmed/34186320 http://dx.doi.org/10.1016/j.diagmicrobio.2021.115441 Text en © 2021 Elsevier Inc. 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
Eberly, Allison R.
Germer, Jeffery J.
Boerger, Aimee C.
Fernholz, Emily C.
Binnicker, Matthew J.
Yao, Joseph D.
Performance of three polymerase chain reaction-based assays for detection of SARS-CoV-2 in different upper respiratory tract specimens
title Performance of three polymerase chain reaction-based assays for detection of SARS-CoV-2 in different upper respiratory tract specimens
title_full Performance of three polymerase chain reaction-based assays for detection of SARS-CoV-2 in different upper respiratory tract specimens
title_fullStr Performance of three polymerase chain reaction-based assays for detection of SARS-CoV-2 in different upper respiratory tract specimens
title_full_unstemmed Performance of three polymerase chain reaction-based assays for detection of SARS-CoV-2 in different upper respiratory tract specimens
title_short Performance of three polymerase chain reaction-based assays for detection of SARS-CoV-2 in different upper respiratory tract specimens
title_sort performance of three polymerase chain reaction-based assays for detection of sars-cov-2 in different upper respiratory tract specimens
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8160280/
https://www.ncbi.nlm.nih.gov/pubmed/34186320
http://dx.doi.org/10.1016/j.diagmicrobio.2021.115441
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