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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
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.
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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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