HIV抗体ELISA试剂盒的性能验证

目的对本实验室所使用的HIV抗体ELISA试剂盒进行性能验证,判断该试剂盒是否能够满足本实验室的日常检验要求。方法分析并计算该试剂盒的最低检测下限、精密度（包括重复性和中间精密度）、阴阳符合率,与试剂盒说明书提供的性能指标进行比较,对试剂盒提供的CUTOFF值进行验证,判断其是否适用于实验室周边人群,以此评估试剂盒的性能情况。结果 HIV ELISA试剂盒的最低检测下限为0.125NCU/ml;重复性试验中检测浓度为2NCU/ml的质控血清和健康人新鲜血清的CV%分别为5.6%和6.4%;中间精密度试验的CV%为10.9%;阴阳符合率均为100%;CUTOFF值验证试验中选定标本的检测结果OD值的（x±3SD）为0.038,小于试剂盒提供的CUTOFF值,验证通过。结论本实验室所使用的HIV ELISA试剂盒基本适用于实验室进行日常的初筛检测。

The verification of the performance of the ELISA kit of HIV antibody

Objective To verify the performance of the ELISA kit of HIV antibody in order to know whether the kit is fit for screening test.Methods The minimum detection limit,the precision includes repeatability and intermediate precision,the negative and positive coincidence rate were determined.The CUTOFF value was also evaluated.Results Through the experimental study,the minimum detection limit of the kit was 0.125 NCU/ml.The CV% of variations of repeatability test of the test samples and normal people samples were 5.6% and 6.4%,respectively.The CV% of variation of intermediate precision test was 10.9% .The negative and positive coincidence rates of the kit were both 100% .In the verifying test of CUTOFF value,the （±3SD） of the OD of the detected results was 0.038,which was less than the CUTOFF value of the kit.Conclusion The ELISA kit is fit for screening test.