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[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].

作者信息

Wang Qin, Zhang Yong, Nie Kai, Wang Huanyu, Du Haijun, Song Jingdong, Xiao Kang, Lei Wenwen, Guo Jianqiang, Wei Hejiang, Cai Kun, Wang Yanhai, Wu Jiang, Gerald Bangura, Kamara Idrissa Laybohr, Liang Mifang, Wu Guizhen, Dong Xiaoping

出版信息

Bing Du Xue Bao. 2016 Mar;32(2):210-4.

PMID:27396166
Abstract

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.

摘要

详细描述了中塞友好生物安全实验室(SLE-CHN生物安全实验室)埃博拉病毒核酸检测全过程的质量控制过程,以全面展示SLE-CHN生物安全实验室首批检测团队在埃博拉病毒检测中科学、严谨、准确、高效的实践。首先,阐述了实验室质量控制体系的要点,包括管理与组织、质量控制文件与信息管理、仪器、试剂与耗材、评估、设施设计与空间分配、实验室维护与生物安全。其次,分析了质量控制方法在埃博拉病毒检测全过程中的应用,包括检测前、检测中和检测后。优秀且专业的实验室工作人员、人性化管理的实施是成功的基石;高水平的生物安全防护是有效质量控制和完成埃博拉病毒检测任务的前提。而专业的后勤保障是开展埃博拉病毒实验室诊断的先决条件。中塞友好生物安全实验室的建立与运行对中塞友谊具有里程碑意义,该实验室成为塞拉利昂埃博拉病毒实验室检测最重要的基地。

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Virol Sin. 2018 Aug;33(4):323-334. doi: 10.1007/s12250-018-0044-z. Epub 2018 Jul 31.