病原微生物菌(毒)种国家标准株评价技术程序探讨  

Discuss on the technical procedures for the evaluation of national standard strains of pathogenic microorganism

作　　者：卢晓贤 孙家玉 赵元元 黎薇[2] 柯昌文[2] 魏强[3] 邓小玲[2] Lu Xiaoxian;Sun Jiayu;Zhao Yuanyuan;Li Wei;Ke Changwen;Wei Qiang;Deng Xiaoling(School of Public Health,Sun Yatsen University,Guangzhou 510080,Guangdong,China;Guangdong Provincial Center for Disease Control and Prevention/Guangdong Provincial Key Laboratory of Pathogen Detection for Emerging Infectious Disease Response,Guangzhou 511430,Guangdong,China;National Pathogen Resource Center,Chinese Center for Disease Control and Prevention,Beijing 102206,China)

机构地区：[1]中山大学公共卫生学院,广东广州510080 [2]广东省疾病预防控制中心,广东省新发传染病应急检测技术研究与应用重点实验室,广东广州511430 [3]中国疾病预防控制中心,国家病原微生物保藏中心/国家病原微生物资源库,北京102206

出　　处：《疾病监测》2023年第12期1509-1512,共4页Disease Surveillance

基　　金：广东省重点领域研发计划项目(No.2022B1111020003);国家科技资源共享服务平台项目(国家病原微生物资源库-NPRC32)。

摘　　要：2022年11月,国家卫生健康委员会发布了《病原微生物菌(毒)种国家标准株评价技术标准》(WS/T 812—2022),明确了病原微生物菌(毒)种国家标准株的定义,对国家标准株的评价指标作出统一技术要求,并制定了国家标准株评价技术程序的基本框架。为进一步开展国家标准株的评价工作,推动国家标准株支撑实际工作需要,有必要制定《病原微生物菌(毒)种国家标准株评价工作指导书》等技术程序,阐述国家标准株的评价操作流程,确定提交国家标准株申请后菌(毒)株复核鉴定、评价组组建、资料审查、会议评价、评价结果报告等要求。评价技术程序将成为国家病原微生物资源保藏标准体系的重要补充和拓展,有助于推动国家标准株应用落地,提高我国病原微生物资源整体保藏质量。In November 2022,the National Health Commission issued the Technical Requirements for Evaluation of National Standard Strains of Pathogenic Microorganisms(WS/T 812—2022),which clarified the definition of national standard strains of pathogenic microorganisms,and made unified technical requirements for the evaluation indexes of national standard strains of pathogenic microorganisms.The basic framework of the evaluation procedure for national standard strains of pathogenic microorganisms was established.To carry out the evaluation of national standard strains of pathogenic microorganisms and promote them to support actual work needs,it is necessary to develop technical procedures such as work instructions to elaborate the operation process of the evaluation on the strains,which enables people to understand the requirements for the strains certification including bacterial(virus)strains review and identification,evaluation team formation,data file review,meeting evaluation,and evaluation report.The evaluation technical procedure will become an important supplement and expansion of our national standard system of pathogenic microorganism resource preservation,which will promote the application of national standard strains and improve the overall quality of our pathogenic microorganism resource.

关 键 词：病原微生物 菌(毒)种 国家标准株 评价程序 

分 类 号：R211[医药卫生—中医学] R37[生物学—微生物学] Q939.99