实验动物四种呼吸道病原菌实验室检测能力验证结果分析  

Result Analysis of Proficiency testing for Four Respiratory Pathogens in Laboratory Animals

作　　者：冯育芳[1] 王洪[1] 付瑞[1] 张雪青 高强 岳秉飞[1] 邢进[1] FENG Yufang;WANG Hong;FU Rui;ZHANG Xueqing;GAO Qiang;YUE Bingfei;XING Jin(National Rodent Laboratory Animal Resources Center,Institute for Laboratory Animal Resources,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院实验动物资源研究所,国家啮齿类实验动物资源库,北京102629

出　　处：《实验动物与比较医学》2022年第6期498-504,共7页Laboratory Animal and Comparative Medicine

基　　金：国家重点研发计划“基础科研条件与重大科学仪器设备研发”重点专项“实验动物新发病原检测与抗体评价关键技术体系建立”(2021YFF0703100)。

摘　　要：目的通过实施实验动物支气管鲍特杆菌、嗜肺巴斯德杆菌、多杀巴斯德杆菌和鼠棒状杆菌检测能力验证活动,达到评估实验动物检测机构的检验能力,提高实验动物质量检测水平的目的。方法2021年和2022年按照中国合格评定国家认可委员会(China National Accreditation Service for Conformity Assessment,CNAS)相关准则设立NIFDC-PT-309和NIFDC-PT-363两个项目(分别检测实验动物样品中呼吸道病原菌支气管鲍特杆菌/嗜肺巴斯德杆菌、鼠棒状杆菌/多杀巴斯德杆菌),开展能力验证活动。制备4种实验动物呼吸道病原菌和阴性对照大肠埃希菌的冷冻干燥样品;均匀性和稳定性检验合格后,随机分组编号,将样品发放给参加单位,要求在规定时限提交检验报告和原始记录。反馈的结果与样品设置一致的判定为满意结果,不一致或未按时提交的判定为不满意结果。结果2021年共有29家实验室参加了NIFDC-PT-309项目,获得满意结果的实验室为27个,满意率为93.1%。2022年共有30家实验室参加了NIFDC-PT-363项目,满意率为100%。结论国内大多数实验动物质量检测机构具备较强的呼吸道病原菌检测能力,并且通过开展能力验证活动这一检测能力正在稳步提升。Objective To assess the ability of the inspection institutions of laboratory animals and to improve their detection levels through the implementation of the proficiency testing for the detection ability of Bordetella bronchiseptica,Pasteurella pneumotropica,Pasteurella multocida and Corynebacterium kutscheri in laboratory animals.Methods According to the proficiency testing scheme approved by China National Accreditation Service for Conformity Assessment(CNAS),the two projects,NIFDC-PT-309 and NIFDC-PT-363 in 2021 and 2022 were set up,respectively.The samples of respiratory tract pathogens in laboratory animal were prepared by freeze-drying at low temperature.The samples were randomly grouped and numbered through the CNAS platform and issued to participating units after passing the homogeneity and stability tests.A work instruction was attached with each sample set.The inspection reports and original records were required to be submitted within the specified time.If the feedback results were consistent with the sample setting,the results were deemed as satisfactory,and if the feedback results were inconsistent or not submitted on time,the results were deemed as unsatisfactory.Results There were 29 laboratories joined to NIFDC-PT-309,27 laboratories(93.1%)achieved satisfactory test results.There were 30 laboratories joined to NIFDC-PT-363,the satisfaction rate is 100%.Conclusion Laboratory animal quality inspection institutions have the ability to detect respiratory pathogens,which gets steadily improved through the ability verification activities.

关 键 词：支气管鲍特杆菌 嗜肺巴斯德杆菌 多杀巴斯德杆菌 鼠棒状杆菌 能力验证 

分 类 号：Q95-33[生物学—动物学]