ELISA检测HIV抗原抗体的回顾性分析

HIV Ag-Abdetection by ELISA: a retrospective analysis

目的对本站ELISA检测HIV Ag-Ab作回顾性分析,达到持续改进的目的。方法对本站所用2种试剂的检测不合格率、双试剂不合格率、复检率、单试剂不合格率、复检符合率、试剂使用率进行统计,同时利用室间质评得分和z比分数分析质评成绩。结果 HIV检测不合格率为0.15%(188/123 458),双试剂不合格率为0.02%(21/123 458),2种试剂复检率分别为0.09%(116/123 458)、0.08%(79/123 458),单试剂不合格率为0.07%(88/123 458)、0.06%(79/123 458),复检符合率为75.86%(88/116)、78.21%(79/101),试剂使用率为114.54%、113.92%;CITIC室间质评得分100%,7个阴性标本及1个阳性标本z比分数<2,2个阳性标本z比分数>3。结论利用实验室质量监测指标和室间质量评价可以有效监控实验室运行状况。

Objective To conduct a retrospective analysis of HIV Ag-Ab detection by ELISA in our blood center, so as to provide reference for continuous improvement. Methods The reactive rate of HIV by each reagent, reactive rate of both reagents, re-test rate, concordance rate of initial-repeat test, and reagent utilization rate were counted, and the external quality assessment results were analyzed by PT score and z-ratio. Results The total reactive rate of HIV was 0.15%. The reactive rate by both reagents was 0.02%. The re-test rates, reactive rates, concordance rates and reagent utilization rates of the two reagents were 0.09% vs 0.08%, 0.07% vs 0.06%, 75.86% vs 78.21%, and 114.54% vs 113.92%, respectively. PT score was 100%, and z-ratio of 7 negative samples and 1 positive sample was less than 2, and of 2 positive samples was more than 3. Conclusion The laboratory quality monitoring indicators and external quality assessment can effectively monitor the operation of blood testing laboratory.