结核抗体检测试剂国家参考品的建立  

Establishment of national reference panel for Mycobacterium tuberculosis antibody detection kits

作　　者：石大伟[1] 王威 杨晓[3] 于丽 黄嘉维 张春涛[1] 许四宏[1] Shi Dawei;Wang Wei;Yang Xiao;Yu Li;Huang Jiawei;Zhang Chuntao;Xu Sihong(Division II of In Vitro Diagnostics for Infectious Diseases,National Institutes for Food and Drug Control,Beijing 100050,China;Department of Clinical Laboratory and Disease Control,Foshan Fourth People’s Hospital,Foshan 528000,China;Center of TB Systems Biology and Translational Medicine,the Foshan Branch,Institute of Biophysics,Chinese Academy of Sciences,Foshan 528000,China;School of Chemical Engineering and Technology,Tianjin University,Tianjin 300072,China)

机构地区：[1]中国食品药品检定研究院传染病诊断试剂二室,北京100050 [2]广东省佛山市第四人民医院结核病参比实验室,佛山528000 [3]中国科学院生物物理研究所佛山分所结核病系统生物学与转化医学中心,佛山528000 [4]天津大学化工学院,天津300072

出　　处：《中国防痨杂志》2023年第3期285-291,共7页Chinese Journal of Antituberculosis

基　　金：“十三五”国家科技重大专项(2018ZX10732-401;2018ZX10102-001)。

摘　　要：目的:制备结核抗体检测试剂的国家参考品。方法:利用9家公司的胶体金和酶联免疫法结核抗体检测试剂对参考品原料进行筛选和复核,分装后由9家公司协作标定,最终确定国家参考品的组成和质量标准,同时,对参考品的均匀性和稳定性进行了考察。结果:协作标定样本中预期为阳性的部分,不同试剂间检出的差异较大。根据协作标定结果和适当督促的原则,确定了参考品由10份阴性参考品、10份阳性参考品、5份最低检出限参考品和1份精密度参考品组成。参考品的质量标准确定为:阴性参考品符合率应为10/10;阳性参考品符合率应≥9/10;最低检出限参考品S1~S5中S1和S2应均为阳性,S3~S5可为阳性或阴性;精密度参考品R平行检测10次,结果应均为阳性,且检测结果的变异系数(CV值)应≤15%。本参考品的均匀性为各分装样品间差异不超出30%,且稳定性条件处理组与-20℃对照组无差异。结论:本研究首次建立了一套适用于酶联免疫法和固相蛋白芯片法结核抗体检测试剂的国家参考品,可用于该类试剂的质量评价。Objective:To prepare a national reference panel for Mycobacterium tuberculosis antibody detection.Methods:The reference materials were screened and rechecked using colloidal gold and ELISA tuberculosis antibody detection reagents from 9 companies.After subpackage,9 companies cooperated to calibrate,and finally determined the composition and quality standard of the national reference panel.At the same time,the homogeneity and stability of the reference panel was investigated.Results:The result of positive references varies from different companies and test kits.According to the cooperative calibration results and the principle of proper supervision,the reference panel was determined to be composed of 10 negative samples,10 positive samples,5 Limit of Detection(LoD)samples and 1 precision sample.The quality standard requirement of the reference panel was determined as follows:the agreement rate of the negative samples should be 10/10;the agreement rate of positive samples should≥9/10;in the LoD samples S1-S5,S1 and S2 should be positive,while S3-S5 could be positive or negative.Precision reference sample R should be tested 10 times in parallel,and the results should be all positive,and the coefficient of variation value(CV value)of the test results shall be≤15%.The homogeneity was that the difference among the sub-packaged samples was not more than 30%,and there was no difference between the stability condition group and the-20℃control group.Conclusion:A set of national reference panel applicable to ELISA and solid-phase protein microarray for Mycobacterium tuberculosis antibody has been established for the first time,which could be used to evaluate the quality of the reagents.

关 键 词：分枝杆菌 结核 抗体 细菌 试剂盒 诊断 参考标准 

分 类 号：R446.6[医药卫生—诊断学] R52[医药卫生—临床医学] R8