四种HIV抗体确证试剂性能比对  

Performance comparison of four HIV antibody confirmatory reagents

作　　者：朱丹 李姗珊 张燕琳[1] 郭悦 ZHU Dan;LI Shanshan;ZHANG Yanlin;GUO Yue(Chengdu Center for Disease Control and Prevention,Chengdu 610041,Sichuan Province,China)

机构地区：[1]成都市疾病预防控制中心,成都610041

出　　处：《预防医学情报杂志》2023年第3期324-329,共6页Journal of Preventive Medicine Information

摘　　要：目的通过检测HIV抗体筛查阳性样本,比对四种抗体确证试剂的性能。方法选取成都市各筛查实验室送至本实验室进行确证试验的360份HIV抗体筛查阳性样本作为研究对象,用A、B、C、D4种不同的HIV抗体确证试剂进行检测并判定结果,比较4种试剂的阳性符合率和阴性符合率,应用SPSS 19.0软件进行分析,率的比较采用χ^(2)检验,检验水准α=0.05。结果经A、B、C、D4种试剂平行试验检测360份HIV抗体筛查阳性样本,阳性率分别为81.944%、81.111%、81.667%和82.222%,差异无统计学意义(χ^(2)=0.163,P=0.983);有69份样本确证结果不一致。根据69份样本条带分析,4种试剂之间的阳性样本数差异无统计学意义(χ^(2)=3.485,P=0.323),阴性样本数差异有统计学意义(χ^(2)=79.454,P<0.001),不确定样本数的差异也有统计学意义(χ^(2)=73.354,P<0.001)。根据这69份样本4种确证试剂结果结合病毒载量结果分析,可以看出C的阴性符合率最高,但阳性符合率较低;D的阳性符合率最高,但阴性符合率较低;A的阳性符合率和阴性符合率都较高,但B的阳性符合率最低,且阴性符合率也较低。结论4种试剂的敏感性差别不大,但是在特异性方面存在较大差异,相比之下,A的敏感性和特异性都较高,可能更适合常规实验室选择。Objective To compare the performance of the four antibody confirmatory reagents by detecting positive samples of HIV antibody screening.Methods A total of 360 HIV antibody screening positive samples sent to our laboratory for confirmatory test were selected.Four different HIV antibody confirmatory reagents were used for testing.The positive coincidence rate and negative coincidence rate of the four reagents were compared by using SPSS 19.0 software.The rate was compared by usingχ^(2) tests,and the significance level was set asα=0.05.Results A total of 360 HIV antibody screening positive samples were detected by four parallel tests of A、B、C、D four reagents.The positive rates were 81.944%,81.111%,81.667%and 82.222%,respectively;there was no statistical significance observed(χ^(2)=0.163,P=0.983).There were 69 samples with inconsistent confirmatory results.According to the band analysis of 69 samples,there was no significant difference in the number of positive samples among the four reagents(χ^(2)=3.485,P=0.323);however,the difference of negative samples(χ^(2)=79.454,P<0.001)and uncertain samples(χ^(2)=73.354,P<0.001)was statistically significant.Based on the results of four confirmatory reagents of these 69 samples and the analysis of virus load,the negative coincidence rate of C is the highest,but the positive coincidence rate is low;the positive coincidence rate of D was the highest,but the negative coincidence rate was low;the positive coincidence rate and negative coincidence rate of A are high,but the positive coincidence rate of B is the lowest and the negative coincidence rate is also low.Conclusions There is little difference in the sensitivity of the four reagents,but there are great differences in specificity.In contrast,reagent A has higher sensitivity and specificity,which may be more suitable for routine laboratory selection.

关 键 词：HIV抗体 确证试剂 性能比对 

分 类 号：R512.91[医药卫生—内科学] R373.9[医药卫生—临床医学]