2014年度风疹病毒IgM抗体检测试剂盒国家监督抽验质量分析  

The Quality Analysis of National Supervising Sampling for Rubella Virus IgM Diagnostic Kits in 2014

作　　者：于婷[1] 曲守方[1] 张小燕 孙楠[1] 高尚先[1] 李海宁[1] 黄杰[1] 

机构地区：[1]中国食品药品检定研究院体外诊断试剂一室卫生部生物技术产品检定方法及其标准化重点实验室,北京市100050 [2]江苏省医疗器械检验所,南京市210022

出　　处：《中国医疗器械杂志》2015年第4期282-284,共3页Chinese Journal of Medical Instrumentation

基　　金：国家高技术研究发展计划(863计划)(2011AA02A115)

摘　　要：目的对风疹病毒Ig M抗体检测试剂盒进行国家监督抽验,评价其质量现状。方法采用法定检验结合探索性研究,对阴阳性符合率、检测限和重复性项目进行检验,结果法定检验显示16批次中15批次合格(93.8%),不合格项目为阴性符合率;探索性研究中仅11批次满足行业标准要求(68.8%),不合格项为阳性样本符合率、检测限和重复性。结论目前上市的风疹病毒Ig M抗体检测试剂盒存在一定的质量问题,建议今后在注册检验中,统一采用行业标准和国家参考盘,以促进企业改进产品质量。Objective To evaluate the quality status of rubel a virus IgM diagnostic kits by national supervising sampling. Methods Using legal inspection combining with exploratory study, the positive and negative coincidence rate, detection limit and repeatability of kits were verified. Results The results showed that 15 of 16 batches of kits were qualified using legal inspection, and the passing rate was 93.8%. The unqualified item was negative coincidence rate. In exploratory study, only 11 batches （68.8%） complied with industry standard. The unqualified items were negative coincidence rate, detection limit and repeatability. Conclusion At present, rubel a virus IgM diagnostic Kits have some quality problems in the market. It is recommended that we adopt industry standard and national reference panel in the registration inspection for the future, which wil prompt enterprises to improve quality.

关 键 词：风疹病毒IgM抗体检测试剂盒 国家监督抽验 质量分析 

分 类 号：R450[医药卫生—治疗学] TH771[医药卫生—临床医学]