风疹病毒IgG抗体检测试剂盒国家监督抽验工作  

The National Supervision and Sampling Inspection for Rubella Virus IgG Antibody Detection Kits

作　　者：曲守方[1] 黄杰[1] 于婷[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2017年第6期642-646,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:按照国家体外诊断试剂抽验工作方案,评价风疹病毒IgG抗体检测试剂盒(酶联免疫法和化学发光法)的质量。方法:分别使用风疹病毒IgG抗体国家参考品和企业参考品对抽验的试剂盒进行准确性、特异性、检测限和重复性项目检测。结果:使用企业参考品按照产品注册标准进行检测,17批次试剂盒的抽验合格为16批。使用国家参考品检测,检验合格为10批,其中6批次试剂盒将国家阴性参考品检测为阳性,1批次试剂盒将国家检测限参考品检测为可疑。结论:使用国家参考品和企业参考品产生了抽验结果差异,建议在今后国家体外诊断试剂监督抽验工作中,继续探讨使用国家参考品作为统一的评判标准,以加强相关产品的监管工作。Objective： To evaluate the quality of Rubella virus IgG antibody detection kits （ELISA ＆ Chemiluminescence） according to the working program of national supervision and sampling inspection for in vitro diagnostic reagent （IVD）. Methods： The accuracy, specificity, limit and repeatability of the sampling kits were tested using the national and company references of Rubella virus IgG antibody. Results： The passing number of 17 different batches of the kits was 16 using the company reference according to the product registration standard. But the passing number was 10 using the national reference. The results of national negative reference were positive in 6 batches and the result of national limit reference was suspicious in one batch. Conclusion： The different results of sampling inspection using the national or company reference suggested that national reference should be used as the unified standard to strengthen the supervision of related products in the national supervision and sampling inspection for IVD in the future.

关 键 词：监督抽验 风疹病毒IgG抗体 参考品 酶联免疫法 化学发光法 准确性 特异性 检测限 

分 类 号：R392[医药卫生—免疫学] TH771[医药卫生—基础医学]