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External Quality Assessment for Molecular Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Clinical Laboratories
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) poses a huge threat to public health. Viral nucleic acid testing is the diagnostic gold standard and can play an important role in the prevention and control of this infection. In this study, bacteriophage MS2 virus-like particles encapsul...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Association for Molecular Pathology and American Society for Investigative Pathology. Published by Elsevier Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7587075/ https://www.ncbi.nlm.nih.gov/pubmed/33122140 http://dx.doi.org/10.1016/j.jmoldx.2020.10.008 |
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author | Wang, Zhe Chen, Yuqing Yang, Jing Han, Yanxi Shi, Jiping Zhan, Shaohua Peng, Rongxue Li, Rui Zhang, Runling Li, Jinming Zhang, Rui |
author_facet | Wang, Zhe Chen, Yuqing Yang, Jing Han, Yanxi Shi, Jiping Zhan, Shaohua Peng, Rongxue Li, Rui Zhang, Runling Li, Jinming Zhang, Rui |
author_sort | Wang, Zhe |
collection | PubMed |
description | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) poses a huge threat to public health. Viral nucleic acid testing is the diagnostic gold standard and can play an important role in the prevention and control of this infection. In this study, bacteriophage MS2 virus-like particles encapsulating specific RNA sequences of SARS-CoV-2 and other coronaviruses were prepared by genetic engineering. The assessment panel, consisting of four positive samples with concentrations of 2.8, 3.5, 4.2, and 4.9 log(10) copies/mL and five negative samples with other human coronaviruses, was prepared and distributed to evaluate the accuracy of routine viral RNA detection. Results of 931 panels from 844 laboratories were collected. The overall percentage agreement, positive percentage agreement (PPA), and negative percentage agreement, defined as the percentage of agreement between the correct results and total results submitted for all, positive, and negative samples were 96.8% (8109/8379), 93.9% (3497/3724), and 99.1% (4612/4655), respectively. For samples with concentrations of 4.9 and 4.2 log(10) copies/mL, the PPAs were >95%. However, for 3.5 and 2.8 log(10) copies/mL, the PPAs were 94.6% (881/931) and 84.9% (790/931), respectively. For all negative samples, the negative percentage agreement values were >95%. Thus, most laboratories can reliably detect SARS-CoV-2. However, further improvement and optimization are required to ensure the accuracy of detection in panel members with lower concentrations of viral RNA. |
format | Online Article Text |
id | pubmed-7587075 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Association for Molecular Pathology and American Society for Investigative Pathology. Published by Elsevier Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-75870752020-10-27 External Quality Assessment for Molecular Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Clinical Laboratories Wang, Zhe Chen, Yuqing Yang, Jing Han, Yanxi Shi, Jiping Zhan, Shaohua Peng, Rongxue Li, Rui Zhang, Runling Li, Jinming Zhang, Rui J Mol Diagn Regular Article Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) poses a huge threat to public health. Viral nucleic acid testing is the diagnostic gold standard and can play an important role in the prevention and control of this infection. In this study, bacteriophage MS2 virus-like particles encapsulating specific RNA sequences of SARS-CoV-2 and other coronaviruses were prepared by genetic engineering. The assessment panel, consisting of four positive samples with concentrations of 2.8, 3.5, 4.2, and 4.9 log(10) copies/mL and five negative samples with other human coronaviruses, was prepared and distributed to evaluate the accuracy of routine viral RNA detection. Results of 931 panels from 844 laboratories were collected. The overall percentage agreement, positive percentage agreement (PPA), and negative percentage agreement, defined as the percentage of agreement between the correct results and total results submitted for all, positive, and negative samples were 96.8% (8109/8379), 93.9% (3497/3724), and 99.1% (4612/4655), respectively. For samples with concentrations of 4.9 and 4.2 log(10) copies/mL, the PPAs were >95%. However, for 3.5 and 2.8 log(10) copies/mL, the PPAs were 94.6% (881/931) and 84.9% (790/931), respectively. For all negative samples, the negative percentage agreement values were >95%. Thus, most laboratories can reliably detect SARS-CoV-2. However, further improvement and optimization are required to ensure the accuracy of detection in panel members with lower concentrations of viral RNA. Association for Molecular Pathology and American Society for Investigative Pathology. Published by Elsevier Inc. 2021-01 2020-10-26 /pmc/articles/PMC7587075/ /pubmed/33122140 http://dx.doi.org/10.1016/j.jmoldx.2020.10.008 Text en © 2021 Association for Molecular Pathology and American Society for Investigative Pathology. Published by 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 | Regular Article Wang, Zhe Chen, Yuqing Yang, Jing Han, Yanxi Shi, Jiping Zhan, Shaohua Peng, Rongxue Li, Rui Zhang, Runling Li, Jinming Zhang, Rui External Quality Assessment for Molecular Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Clinical Laboratories |
title | External Quality Assessment for Molecular Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Clinical Laboratories |
title_full | External Quality Assessment for Molecular Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Clinical Laboratories |
title_fullStr | External Quality Assessment for Molecular Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Clinical Laboratories |
title_full_unstemmed | External Quality Assessment for Molecular Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Clinical Laboratories |
title_short | External Quality Assessment for Molecular Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Clinical Laboratories |
title_sort | external quality assessment for molecular detection of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in clinical laboratories |
topic | Regular Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7587075/ https://www.ncbi.nlm.nih.gov/pubmed/33122140 http://dx.doi.org/10.1016/j.jmoldx.2020.10.008 |
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