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基于暴露分析与关键控制点方法对医院开展严重急性呼吸综合征冠状病毒 2 型检测的可行性研究

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    1. 上海交通大学医学院附属第一人民医院检验科,上海 200080; 2. 浙江大学,浙江大学-爱丁堡大学联合研究院,浙江 海宁 314400; 3. 宾夕法尼亚大学佩雷尔曼医学院病理和检验医学系,费城 PA19104; 4. 复旦大学附属公共卫生临床中心噬菌体研究所,上海 201508; 5. 复旦大学附属妇产科医院检验科,上海 200011; 6. 上海交通大学医学院附属瑞金医院检验系,上海 200011; 7. 南昌大学附属第一人民医院检验系,江西 南昌 330006; 8. 上海交通大学医学院附属瑞金医院急诊科,上海 200025; 9. 徐州医科大学病原与免疫学系,江苏 徐州 221004; 10. 上海交通大学医学院国家热带病研究中心全球健康医学院,上海 200025; 11. 英国肯特大学梅德韦药学院,肯特 ME4 4TB; 12. 上海交通大学医学院附属第一人民医院临床药学科,上海 201620

收稿日期: 2020-11-26

  网络出版日期: 2021-02-25

基金资助

上海交通大学“科技发展研究基金-新型冠状病毒防治专项软课题”(2020PK50); 浙江大学新冠肺炎防控特别基金(2020XGZX037)

Feasibility for SARS-CoV-2 tests in the hospital: an Exposure Analysis and Critical Control Points approach

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  • 1. Department of Laboratory Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200080, China; 2. Zhejiang University-University of Edinburgh Institute (ZJU-UoE), Zhejiang University, Haining, 314400, Zhejiang Province, China; 3. Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA19104, USA; 4. Shanghai Institute of Phage, Shanghai Public Health Clinical Center, Fudan University, Shanghai, 201508, China; 5. Department of Clinical Laboratory, Obstetrics and Gynecology Hospital, Fudan University. Shanghai, 200011, China; 6. Department of Laboratory Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China; 7. Department of Clinical Laboratory, the First Affiliated Hospital, Nanchang University, Nanchang, 330006, Jiangxi Province, China; 8. Department of Emergency Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China; 9. Department of Pathogenic Biology and Immunology, Xuzhou Medical University, Xuzhou, 221004, Jiangsu Province, China; 10. Key Laboratory of Parasite and Vector Biology, Ministry of Health, China; School of Global Health, Chinese Center for Tropical Diseases Research, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China; 11. Viral Pseudotype Unit, Medway School of Pharmacy, University of Kent, Chatham, Kent, ME4 4TB, United Kingdom; 12. Department of Clinical Pharmacy, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 201620, China

Received date: 2020-11-26

  Online published: 2021-02-25

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摘要

评估2019新型冠状病毒病暴发期间在医院开展严重急性呼吸综合征冠状病毒 2 型(severe acute respiratory syndrome coronavirus 2,SARS-CoV-2)核酸检测的可行性,为最终在医院开展核酸检测提供参考。熟悉暴露分析和关键点控制(exposure analysis and critical control points,EACCP)工作框架的专业人员在基于医院现实条件下,对SARS-CoV-2检测过程中可能的感染暴露风险和途径进行梳理,建立整个检测流程,验证在配备有发热门诊的医院开展的可行性,并明确降低暴露风险的关键控制点。高风险是在发热门诊标本的采集和灭活处理,中风险是未灭活标本的储运,低风险是灭活标本的储运和检测。优化检验流程能降低检测过程中感染暴露风险,对于高风险的操作,可在生物安全二级实验室(发热门诊或移动采集点等)和相应的安全防护等级下进行操作; EACCP分析方法可用于新发感染性疾病暴发期间的管理。

本文引用格式

崔泽林1,Sebastian Leptihn2,李明月3,郭明权4,高晶5,李擎天6,曾令兵7,周与华8,韦艳霞9,郭晓奎10,Nigel Temperton1 . 基于暴露分析与关键控制点方法对医院开展严重急性呼吸综合征冠状病毒 2 型检测的可行性研究[J]. 微生物与感染, 2021 , 16(1) : 26 -36 . DOI: 10.3969/j.issn.1673-6184.2021.01.004

Abstract

This work aims to assess the feasibility of performing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA tests in hospitals and communities experiencing coronavirus disease 19 (COVID-19) outbreaks, to ultimately provide recommendations for hospitals with so-called fever clinics. In China, these specialized clinics within a hospital specifically receive outpatients with fever symptoms. A team with expertise in the Exposure Analysis and Critical Control Points (EACCP) framework identified potential infection routes during the testing for SARS-CoV-2, then constructed and tested flow diagrams, which were confirmed under actual conditions, demonstrating the feasibility to carry out in hospitals with fever clinics. The team determined critical control points to mitigate the exposure risks at each control point. The sampling and inactivation steps of clinical samples in fever clinics appeared to be associated with particularly high-risk levels of exposure to SARS-CoV-2. Moderate exposure levels were associated with storage and transportation of samples for inactivation. Low-risk levels associated with the transportation, storage, and detection steps after inactivation. To minimize infection risks for personnel, we proposed optimized processes to carry out SARS-CoV-2 RNA tests in hospitals with fever clinics in China. The high risk of SARS-CoV-2 exposure during procedures preceding testing is the sampling and biological inactivation. Simultaneously, full personal protective equipment and biosafety level-2 (BSL-2) laboratories in fever clinics or mobile BSL-2 laboratories could reduce the risk. Implementing the EACCP framework could facilitate rapid responses to outbreaks of emerging infectious diseases.
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