HIV抗体诊断试剂的临床质量评估

目的掌握国内市售艾滋病病毒（HIV）抗体诊断试剂的实际质量情况,为选用质量优良的HIV抗体诊断试剂提供依据。方法用5种酶联免疫吸附试验（ELISA）（双抗原夹心法）（A、B、C、D、E）试剂和3种快速试剂（胶体金法、乳胶层析法）（F、G、H）,分别对各自的血清盘（包括：阳性样品、阴性样品和现场样品）检测抗体,并对各参评试剂的性能指标进行分析。结果国家参考品评估结果：ELISA试剂的功效率为89.58%～100.00%,试剂D的敏感性只有85.71%,试剂E的功效率为100.00%。快速试剂的功效率为93.33%～95.56%。自备样品评估结果：ELISA试剂的功效率为98.19%～99.55%,其中试剂D敏感性和功效率最低,分别为96.83%和98.19%。快速试剂的功效率为92.44%～97.33%。结论除了试剂E没出现假阴性、试剂H没出现假阳性结果外,其他试剂均不同程度地出现了假阳性和假阴性共同存在的现象。试剂质量参差不齐,假阳性或假阴性会导致资源浪费或HIV的传播,国产试剂质量有待进一步提高。

Evaluation of screening reagents for detecting antibodies of human immunodeficiency virus

Objective To understand the quality of the screening reagents used for detecting human immunodeficiency virus（HIV） antibody in Hebei Province,so as to provide evidence for the selection of qualified HIV screening reagents.Methods Five enzyme-linked immuneosorbent assay（ELISA） reagents（A,B,C,D,E） and 3 rapid screening reagents（F,G,H） were used to detect the samples including positive and negative samples and the samples taken on the spot.The indices of sensitivities,specificities,efficiency,NPV and PPV of all the screening reagents were analyzed.Results The total consistence rates of the quality control samples bought from the National Reference Center were 89.58%-100.00% for the ELISA reagents,while the sensitivity of the reagent D was only 85.71% and the total consistence rate of the reagent E was 100.00%.The total consistence rate of the rapid reagents was 93.33%-95.56%.The total consistence rates of the samples prepared by the laboratory was 98.19%-99.55% for ELISA reagents,and the sensitivities and the total consistence rate of the reagent D were the lowest,only 96.83% and 98.19%,respectively.The total consistence rate of the rapid reagents was 92.44%-97.33%.Conclusion There are co-existence of false positive and false negative results in tested reagents except for reagent E in which no false negativity is found and for reagent H in which no false positivity is found.The quality of the screening reagents is rather different.The false negativity or the false positivity would result in resource waste or HIV transmission.The quality of reagents produced domestically should be further improved.