中塞友好生物安全实验室埃博拉病毒核酸检测质量控制体系的建立  

Establishment of Quality Control System of Nucleic Acid Detection for Ebola Virus in Sierra Leone-China Friendship Biological Safety Laboratory

作　　者：王芹[1,2] 张勇[1,2] 聂凯 王环宇[1,2] 杜海军[1,2] 宋敬东[1,2] 肖康[1,2] 雷雯雯[1,2] 郭建强[1,2] 隗合江[1,2] 蔡琨[1,2] 王衍海[1,2] 吴江[1,2] Gerald Bangura[2] Idrissa Laybohr Kamara 梁米芳 武桂珍[1] 董小平[1,2] 

机构地区：[1]中国疾病预防控制中心病毒病预防控制所卫生部医学病毒和病毒病重点实验室,北京102206 [2]中塞友好生物安全实验室

出　　处：《病毒学报》2016年第2期210-214,共5页Chinese Journal of Virology

基　　金：公益性行业科研项目:新时期我国实验室生物安全重要问题及其对策研究(201302006)

摘　　要：详细地阐述了中塞友好生物安全实验室实施埃博拉病毒核酸检测整个质量控制的过程,全面地展示固定P3实验室第一批检测队在埃博拉病毒病实验室检测中表现出的科学、严谨、准确与高效,为实验室检测工作提供参考和依据。首先描述了质控体系要点,包括了组织和人员管理、质量管理文件体系、仪器设备、检测试剂和耗材、审核、实验室空间和功能、实验室维护与安全保障等各个方面的质控要点。其次,从埃博拉病毒核酸检测前、检测中到检测后过程,分述了质控在埃博拉病毒检测整个流程的各个环节中的应用。技术精良的专业检测队伍和实行人性化管理是援非抗埃成功的基石;做好生物安全防护是有效质控和完成检测任务的前提;配备专业的后勤保障确实非常必要;中塞友好生物安全实验室的建立对于中塞友谊具有划时代的意义,该实验室将成为塞拉利昂今后最为重要的埃博拉病毒实验室检测基地。The quality control process throughout the Ebola virus nucleic acid detection in Sierra Leone-China Friendship Biological Safety Laboratory（SLE-CHN Biosafety Lab）was described in detail,in order to comprehensively display the scientific,rigorous,accurate and efficient practice in detection of Ebola virus of first batch detection team in SLE-CHN Biosafety Lab.Firstly,the key points of laboratory quality control system was described,including the managements and organizing,quality control documents and information management,instrument,reagents and supplies,assessment,facilities design and space allocation,laboratory maintenance and biosecurity.Secondly,the application of quality control methods in the whole process of the Ebola virus detection,including before the test,during the test and after the test,was analyzed.The excellent and professional laboratory staffs,the implementation of humanized management are the cornerstone of the success;High-level biological safety protection is the premise for effective quality control and completion of Ebola virus detection tasks.And professional logistics is prerequisite for launching the laboratory diagnosis of Ebola virus.The establishment and running of SLE-CHN Biosafety Lab has landmark significance for the friendship between Sierra Leone and China,and the lab becomes the most important base for Ebola virus laboratory testing in Sierra Leone.

关 键 词：埃博拉病毒 核酸检测 质量控制 生物安全 

分 类 号：R373.9[医药卫生—病原生物学]