鼠疫耶尔森菌F1抗原检测试剂国家参考品的研制  

Development of national reference reagents for the detection of Yersinia pestis F1 antigen

作　　者：张园园 张平平 赵爱华[1] 周亚洲 杨瑞馥 魏东[1] ZHANG Yuan-yuan;ZHANG Ping-ping;ZHAO Ai-hua;ZHOU Ya-zhou;YANG Rui-fu;WEI Dong(NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,National Institute for Food and Drug Control,Beijing 102629,China;不详)

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：《微生物学免疫学进展》2023年第1期26-30,共5页Progress In Microbiology and Immunology

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

摘　　要：目的 研制鼠疫耶尔森菌F1抗原检测试剂国家参考品。方法 选取5株表达F1抗原的鼠疫耶尔森菌和10株非鼠疫耶尔森菌的菌种,组建了阳性参考品和阴性参考品。经分装冻干鼠疫耶尔森菌F1抗原,组建了最低检出限参考品和重复性参考品。经4家实验室共使用5种鼠疫耶尔森菌(F1)抗原检测试剂盒进行协作标定,评价参考品的均匀性和稳定性。结果 本套参考品的均匀性和稳定性良好。协作标定结果显示:①阳性参考品及阴性参考品的符合率均为100%;②最低检出限参考品的检出限在10~100 ng/mL之间;③重复性参考品检测反应结果应一致(酶联免疫法、上转发光免疫层析法等CV<15%)。结论 本套参考品基本符合国家关于体外诊断试剂的参考品设计要求,可用于评价相关试剂。Objective To develop a national reference reagents for Yersinia pestis F1 antigen detection. Methods Five strains of Yersinia pestis and 10 strains of non-Yersinia pestis were selected to form positive and negative reference articles. The minimum detection limit reference and repetitive reference were derived from the freeze-dried F1 antigen of Yersinia pestis. Five Yersinia pestis antigen detection reagents were used in four collaborative calibration laboratories to evaluate the uniformity and stability of the reference article. Results The reference set has good uniformity and stability. The collaborative calibration results showed that the accuracy rates of positive references and negative references were 100%. The limit of the minimum detection limit reference was as low as 10 ng/mL. The testing results of repetitive reference were consistent. Conclusion This set of reference products basically meet the national reference product design requirements for in vitro diagnostic reagents, and can be used to evaluate related reagents.

关 键 词：鼠疫耶尔森菌 F1抗原 检测试剂 国家参考品 协作标定 最低检出限 符合率 质量控制 

分 类 号：R516.8[医药卫生—内科学]