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Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus
COVID-19 continues to circulate globally in 2021, while under the precise policy implementation of China’s public health system, the epidemic was quickly controlled, and society and the economy have recovered. During the pandemic response, nucleic acid detection of SARS-CoV-2 has played an indispens...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8548827/ https://www.ncbi.nlm.nih.gov/pubmed/34722341 http://dx.doi.org/10.3389/fcimb.2021.755508 |
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author | Mo, Xi Wang, Xueliang Zhu, Zhaoqin Yu, Yuetian Chang, Dong Zhang, Xinxin Li, Dong Sun, Fenyong Zhou, Lin Xu, Jin Zhang, Hong Gao, Chunfang Guan, Ming Xiao, Yanqun Wu, Wenjuan |
author_facet | Mo, Xi Wang, Xueliang Zhu, Zhaoqin Yu, Yuetian Chang, Dong Zhang, Xinxin Li, Dong Sun, Fenyong Zhou, Lin Xu, Jin Zhang, Hong Gao, Chunfang Guan, Ming Xiao, Yanqun Wu, Wenjuan |
author_sort | Mo, Xi |
collection | PubMed |
description | COVID-19 continues to circulate globally in 2021, while under the precise policy implementation of China’s public health system, the epidemic was quickly controlled, and society and the economy have recovered. During the pandemic response, nucleic acid detection of SARS-CoV-2 has played an indispensable role in the first line of defence. In the cases of emergency operations or patients presenting at fever clinics, nucleic acid detection is required to be performed and reported quickly. Therefore, nucleic acid point-of-care testing (POCT) technology for SARS-CoV-2 identification has emerged, and has been widely carried out at all levels of medical institutions. SARS-CoV-2 POCT has served as a complementary test to conventional polymerase chain reaction (PCR) batch tests, thus forming an experimental diagnosis platform that not only guarantees medical safety but also improves quality services. However, in view of the complexity of molecular diagnosis and the biosafety requirements involved, pathogen nucleic acid POCT is different from traditional blood-based physical and chemical index detection. No guidelines currently exist for POCT quality management, and there have been inconsistencies documented in practical operation. Therefore, Shanghai Society of Molecular Diagnostics, Shanghai Society of Laboratory Medicine, Clinical Microbiology Division of Shanghai Society of Microbiology and Shanghai Center for Clinical Laboratory have cooperated with experts in laboratory medicine to generate the present expert consensus. Based on the current spectrum of major infectious diseases in China, the whole-process operation management of pathogen POCT, including its application scenarios, biosafety management, personnel qualification, performance verification, quality control, and result reporting, are described here. This expert consensus will aid in promoting the rational application and robust development of this technology in public health defence and hospital infection management. |
format | Online Article Text |
id | pubmed-8548827 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-85488272021-10-28 Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus Mo, Xi Wang, Xueliang Zhu, Zhaoqin Yu, Yuetian Chang, Dong Zhang, Xinxin Li, Dong Sun, Fenyong Zhou, Lin Xu, Jin Zhang, Hong Gao, Chunfang Guan, Ming Xiao, Yanqun Wu, Wenjuan Front Cell Infect Microbiol Cellular and Infection Microbiology COVID-19 continues to circulate globally in 2021, while under the precise policy implementation of China’s public health system, the epidemic was quickly controlled, and society and the economy have recovered. During the pandemic response, nucleic acid detection of SARS-CoV-2 has played an indispensable role in the first line of defence. In the cases of emergency operations or patients presenting at fever clinics, nucleic acid detection is required to be performed and reported quickly. Therefore, nucleic acid point-of-care testing (POCT) technology for SARS-CoV-2 identification has emerged, and has been widely carried out at all levels of medical institutions. SARS-CoV-2 POCT has served as a complementary test to conventional polymerase chain reaction (PCR) batch tests, thus forming an experimental diagnosis platform that not only guarantees medical safety but also improves quality services. However, in view of the complexity of molecular diagnosis and the biosafety requirements involved, pathogen nucleic acid POCT is different from traditional blood-based physical and chemical index detection. No guidelines currently exist for POCT quality management, and there have been inconsistencies documented in practical operation. Therefore, Shanghai Society of Molecular Diagnostics, Shanghai Society of Laboratory Medicine, Clinical Microbiology Division of Shanghai Society of Microbiology and Shanghai Center for Clinical Laboratory have cooperated with experts in laboratory medicine to generate the present expert consensus. Based on the current spectrum of major infectious diseases in China, the whole-process operation management of pathogen POCT, including its application scenarios, biosafety management, personnel qualification, performance verification, quality control, and result reporting, are described here. This expert consensus will aid in promoting the rational application and robust development of this technology in public health defence and hospital infection management. Frontiers Media S.A. 2021-10-13 /pmc/articles/PMC8548827/ /pubmed/34722341 http://dx.doi.org/10.3389/fcimb.2021.755508 Text en Copyright © 2021 Mo, Wang, Zhu, Yu, Chang, Zhang, Li, Sun, Zhou, Xu, Zhang, Gao, Guan, Xiao and Wu https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Cellular and Infection Microbiology Mo, Xi Wang, Xueliang Zhu, Zhaoqin Yu, Yuetian Chang, Dong Zhang, Xinxin Li, Dong Sun, Fenyong Zhou, Lin Xu, Jin Zhang, Hong Gao, Chunfang Guan, Ming Xiao, Yanqun Wu, Wenjuan Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus |
title | Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus |
title_full | Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus |
title_fullStr | Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus |
title_full_unstemmed | Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus |
title_short | Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus |
title_sort | quality management for point-of-care testing of pathogen nucleic acids: chinese expert consensus |
topic | Cellular and Infection Microbiology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8548827/ https://www.ncbi.nlm.nih.gov/pubmed/34722341 http://dx.doi.org/10.3389/fcimb.2021.755508 |
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