四种HIV抗体确证试剂盒用于HIV感染检测性能的比较研究

A comparative study on the performance of four commercial kits for anti-HIV confirmatory assay in detection of HIV infection

目的比较4种HIV抗体确证试剂盒的检测性能,为临床使用试剂提供参考。方法使用2种免疫印迹法(Western blot, WB)试剂、2种重组/线性免疫印迹法(recombinant immunoblot assay/line immune assay,RIBA/LIA)试剂平行检测185份样本,采用McNermar检验分析试剂检测结果与HIV感染状态的一致性,以最常用MP公司的WB试剂检测结果为参照进行优势比(OR)计算。结果 4种试剂检测结果与HIV感染结果一致率为83.24%~92.43%,Kappa值为0.558~0.831。英旻泰公司的WB试剂检测57份HIV未感染样本的OR值为0.932(95%CI:0.446~1.946,P=0.851),RIBA试剂的OR值为2.348(95%CI:1.069~5.158,P=0.034),LIA试剂的OR值为23.064(95%CI:5.125~103.789,P<0.001);LIA试剂检测128份HIV感染样本的OR值为0.153(95%CI:0.034~0.700,P=0.016)。对95份HIV抗体筛查阳性样本检测,LIA试剂有反应的比例最低,与其他3种试剂有反应的比例差异有统计学意义(P值均<0.05),其他3种试剂差异无统计学意义(P值均>0.05)。出现非特异反应时条带数均≤4条,显色较浅的条带比例占52.1%(37/71),出现条带主要为gp160(81.3%)、p24(71.9%)和p17(28.1%)。结论两种WB试剂检测结果无显著性差异,RIBA/LIA试剂可减少不确定结果的产生,但LIA试剂对于弱反应性样本存在假阴性风险。

Objective To compare the performance of four commercial kits for anti-HIV confirmatory assay and to provide a reference for clinical application.Methods Two western blot(WB)kits and two recombinant immunoblot assay/line immune assay kits were used to detect 185 samples in parallel,McNermar test was used to analyze the consistency between the testing results and HIV infection status.Compared to the testing result of the most used MP company’s WB kit,the odds ratio(OR)was calculated.Results The consistency of the testing results with the status of HIV infection by the four kits was 83.24%-92.43%,and the Kappa value was 0.558-0.831.The OR value of IMT company’s WB kit obtained from 57 HIV-uninfected samples was 0.932(95%CI:0.446-1.946,P=0.851),and the OR values of WT company’s recombinant immunoblot assay(RIBA)and MK company’s line immune assay(LIA)were 2.348(95%CI:1.069-5.158,P=0.034)and 23.064(95%CI:5.125-103.789,P<0.001),respectively.The OR value of LIA obtained from 128 HIV-infected samples was 0.153(95%CI:0.034-0.700,P=0.016).LIA showed fewest reactions by testing 95 HIV positive screening samples,which was significantly different from any other kit(P<0.05).There was no significant difference among the other three kits.In the case of non-specific reactions,the numbers of bands were all≤4,and the proportion of light-colored bands accounted for 52.1%(37/71).The main bands were gp160(81.3%),p24(71.9%),and p17(28.1%).Conclusions There was no significant difference between the two WB kits.The RIBA/LIA detection kits could reduce the generation of indeterminate result,but the LIA kit has the risk of false negative for weakly reactive samples.