鼠疫耶尔森菌F1抗体检测试剂国家参考品的研制  

Development of national reference for detection reagents for Yersinia pestis F1 antibody

作　　者：张园园 孙竹林 赵爱华[1] 周亚洲 杨瑞馥 张平平 魏东[1] ZHANG Yuanyuan;SUN Zhulin;ZHAO Aihua;ZHOU Yazhou;YANG Ruifu;ZHANG Pingping;WEI Dong(NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,National Institute for Food and Drug Control,Beijing 102629,China;State Key Laboratory of Pathogens and Biosecurity,Institute of Microbiology and Epidemiology,Academy of Military Medical Sciences,Academy of Military Sciences,Beijing 100071,China)

机构地区：[1]中国食品药品检定研究院国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室,北京102629 [2]军事科学院军事医学研究院微生物流行病研究所病原微生物生物安全国家重点实验室,北京100071

出　　处：《微生物与感染》2023年第3期137-142,共6页Journal of Microbes and Infections

基　　金：国家重点研发计划(2021YFC1200201,2021YFC1200202)。

摘　　要：为研制鼠疫耶尔森菌F1抗体检测试剂国家参考品,本研究制备了6份F1抗体阳性参考品、8份F1抗体阴性参考品、1份最低检出限参考品和1份重复性参考品,组成了鼠疫耶尔森菌F1抗体检测试剂国家参考品。对参考品进行均匀性检查及稳定性评估,并组织4家实验室进行协作标定。结果显示,参考品均匀性及稳定性良好。协作标定结果显示,6份阳性参考品阳性率均为100%;8份阴性参考品阴性率均为100%;最低检出限参考品的检出水平介于1~100倍稀释度;重复性参考品检测结果一致(其中酶联免疫法及上转发光法试剂检测结果的变异系数均小于15%)。结果表明,本研究建立的鼠疫耶尔森菌F1抗体检测试剂国家参考品基本符合体外诊断试剂参考品的要求,可用于相关试剂的质量评价。The present paper aims to prepare a national reference for detection reagents for Yersinia pestis F1 antibody,which was consisted of six positive references,eight negative references,one minimum detection limit reference and one repetitive reference.The uniformity and stability of this reference met the requirements for national references.The collaborative calibration results of four laboratories showed that six positive references were 100%positive,eight negative references were 100%negative,the detection level of the minimum detection limit reference was 1-100 times dilution,and the testing results of repetitive reference were consistent(for the detection reagents based on enzyme-linked immunosorbent assay and up-converting phosphor technology,the coefficient of variation of testing results was less than 15%).So a national reference for detection reagents for Yersinia pestis F1 antibody was prepared which was suitable for the quality evaluation and control of related reagents.

关 键 词：鼠疫耶尔森菌 F1抗体 检测试剂 国家参考品 

分 类 号：R378.2[医药卫生—病原生物学]