从新型冠状病毒疫情看生物安全三级实验室的应急能力及内涵建设  

Improve the agility and immediate response capacity of BSL-3 to battle COVID-19

作　　者：蔡霞[1] 韩文东[1] 孙志平[1] 钱韵 陈力[2] 谢幼华[2] 瞿涤[1,2] CAI Xia;HAN Wendong;SUN Zhiping;QIAN Yun;CHEN Li;XIE Youhua;QU Di(Biosafety Level 3 Laboratory&Shanghai Medical College Fudan University,Shanghai 200032,China;Key Laboratory of Medical Molecular Virology(MOE/NHC/CAMS),School of Basic Medical Sciences,Fudan University,Shanghai 200032,China)

机构地区：[1]复旦大学生物安全三级实验室,上海200032 [2]复旦大学上海医学院基础医学院教育部、卫健委、医科院医学分子病毒学重点实验室,上海200032

出　　处：《微生物与感染》2020年第4期233-240,共8页Journal of Microbes and Infections

基　　金：“十三五”国家科技重大专项(2018ZX10734401、2019ZX09721001)。

摘　　要：面对突发疫情,生物安全三级(biosafety level 3,BSL-3)实验室是否能及时启动并稳定、安全运行,为科研攻关提供安全、可靠的技术平台,是对实验室应急能力的考验。针对2019冠状病毒病疫情,复旦大学BSL-3实验室紧急启动开展冠状病毒实验的申请流程。经国家合格评定认可委员会(China National Accreditation Service for Conformity Assessment,CNAS)和国家卫生健康委员会批准,实验室在开展实验1周内即从来自上海患者标本中分离到新型冠状病毒毒株,体现了平时实验室内涵建设的重要性。BSL-3实验室的内涵建设包括实验室风险评估及管理、不同人员针对性培训、设施和设备管理等生物安全管理体系的建设。本文介绍复旦大学BSL-3实验室在应急能力及内涵建设方面的经验和体会,期望对BSL-3实验室的建设和管理提供参考。Biosafety level 3(BSL-3)is the core facility to battle diseases caused by virulent and contagious pathogens,such as COVID-19.Outbreaks demand quick,efficient and immediate response from BSL-3 to generate the information for clinical response and public health control.This paper reviewed the management and research efforts of Fudan University BSL-3 laboratory.After receiving the mission,BSL-3 laboratory of Fudan University immediately started the application process for new coronavirus experiment activities in the lab,following the regulations of China.After obtained the approval from the National Accreditation Service for Conformity Assessment and the National Health Commission,new coronavirus strains were isolated from a sample of a COVID-19 patient in Shanghai within one week.The case demonstrated the importance of laboratory’s connotation construction in peacetime.The BSL-3 laboratory’s connotation construction includes the biosafety management systems such as risk assessment and management of laboratory,personnel training,and management of facilities and equipment,etc.In this article,we shall introduce the experience and comprehension gained from management of the Fudan University BSL-3 laboratory.

关 键 词：新型冠状病毒 生物安全三级实验室 应急能力 内涵建设 实验室管理 

分 类 号：R197[医药卫生—卫生事业管理] R-33[医药卫生—公共卫生与预防医学]