6种人类免疫缺陷病毒(HIV)抗体初筛试剂质量评估

目的]评估国内临床试剂市场中流通的部分HIV抗体初筛试剂的质量。方法]分别用5种HIV抗体ELISA检测试剂和1种HIV抗体快速诊断试剂对100份已知结果样品和100份未知结果样品的进行检测，初筛结果阳性或可疑阳性的样品用蛋白印迹法（WB）确认。根据检测结果，计算各被评估试剂的质量性能指标。结果]5种酶标试剂的综合质量性能指标（功效率）均等地或大于96.5%。部分国产试剂的质量性能指标已经接近国际先进产品的水平，但仍有个别国产试剂存在较为严重的漏检问题，假阴性率超过9.09%。HIV快速诊断试剂与ELISA试剂相比，仍存在差距。结论]本次所评估的5种ELISAHIV抗体初筛试剂在综合质量性能指标（功效率）上优于快速诊断试剂，所评估的进口试剂仍领先于国内同类产品。国产试剂的总体质量虽已有所提高，但加强对国产试剂质量管理和监督机制的建设仍不容忽视。

Quality Evaluation of Six kinds of Commercial HIV Antibodies Screening Kits

To evaluate the quality of commercial kits for HIV antibodies screening 200 serum (or plasma) samples were tested with 6 kinds of commercial HIV antibodies screening kits The positives were confirmed with Western blot According to the results, the test power, sensitivity, specificity and so on were calculated for evaluating The test power of the evaluated 5 ELISA kits equaled to or was higher than 96 5% And some indicators of the evaluated domestic made kits were closed to imported kits However, It was worth to notice that one domestic made kit still had a high false negative rate (9 09%) Conclusion] This study showed that the test power of ELISA kits was higher than the fast screening kit Among those 5 evaluated ELISA HIV screening kits,the imported one still occupied the first place Although there were improvement in quality of domestic made HIV screening kits,there still is necessary to establish a quality monitoring system, and evaluate them regularly so that problems would be identified and proper measures could be taken to minimize the possible risks