安徽省艾滋病筛查实验室质量考评结果分析

Quality evaluation of HIV antibody screening laboratories in Anhui province

目的了解2015年安徽省艾滋病筛查实验室血清学检测能力和检测现状,分析检测过程和检测结果可能存在的问题并及时改进。方法对全省369家艾滋病筛查实验室发放5份盲样考核血清,要求在规定的时间内上报HIV抗体筛查结果及其原始记录,汇总分析各实验室的结果。结果 369家实验室参评,其中优秀占60.2%(222/369),良好占37.7%(139/369),合格占2.2%(8/369),无不合格实验室;5份盲样定性试验结果均正确无误,采用不同检测方法或不同试剂检测S/CO比值之间差异均有统计学意义,即使同一种试剂(万泰)和相同方法(酶联法)下酶标仪与全自动酶免对强阳性盲样也有统计学差异;疾控系统实验室在报告单、复检化验单和收样单等记录规范性上总体优于其他机构实验室,血液系统实验室在检测流程规范性和结果判定与计算的准确性上总体好于其他机构实验室。结论安徽省艾滋病筛查实验室筛查结果准确,盲样考核应以定性结果为依据,采用不同方法、试剂或设备的室间质评结果不宜直接进行定量比较。

Objective To understand the serological detection ability and detection status of HIV antibody screen- ing laboratory in Anhui province in 2015 ,analyze the laboratory testing process and possible problems of test results and improve the ability of laboratory testing in time. Methods Five blind samples were issued to the network screen- ing laboratory for the evaluation,and the results of HIV antibody screening and their original records were required to be reported in the prescribed time. The results of these laboratories were summarized and the factors influencing the results were analyzed. Results A total of 369 laboratories were evaluated,of which 60.2~ （222/369） were ex- cellent, 37.7 ~ （139/369） were good, 2.2 ~ （8/369） were qualified,and the results of 5 blind qualitative tests were correct. There were significant differences in S/CO values between different methods or different reagents. Even though using the same reagent （Wan Tai） and the same method （ enzyme linked method）, there were significant differences in high positive blind samples between the enzyme labeled instrument and the automatic enzyme immuno- assay analyzer. The CDC laboratories were generally superior to other institutional laboratories in the standardization of records such as report forms, re--examination test sheets and sample receipts. The blood system laboratory was generally better than other laboratories in the standardization of testing process and the accuracy of judging and cal- culating results. Conclusions The results of laboratory screening for AIDS in Anhui province were accurate,and the blind sample assessment should be based on qualitative results. The results of inteilat quality assessment with differ- ent methods,reagents or equipment should not be directly compared.