2012-2019年南昌地区无偿献血者HIV初筛和确证结果分析

Analysis of HIV screening and confirmatory results among voluntary blood donors in Nanchang from 2012 to 2019

目的了解无偿献血者血液标本艾滋病病毒(HIV)初筛阳性反应与确证结果的符合情况,评估酶联免疫吸附试验(ELISA)和核酸检测(NAT)方法及试剂,分析HIV-1抗体阳性、HIV抗体不确定标本蛋白印迹试验(WB)带型,为南昌地区制定适宜的HIV血液筛查策略提供依据。方法收集2012-2019年南昌地区献血人群HIV检测资料。依照血清学与核酸顺序检测模式,采用ELISA双试剂和NAT试剂对献血者血液标本进行初筛,抗-HIV/HIV-1 p24抗原/艾滋病病毒核糖核酸(HIV RNA)阳性标本进行WB确证。结果518635人份无偿献血标本中检出308例HIV初筛阳性标本(0.59‰),其中ELISA双试剂阳性108例,新创(XC)试剂单阳129例,万泰(WT)试剂单阳69例,NAT阳性2例;经WB检测,HIV-1抗体阳性80例(确证阳性率0.15‰),不确定50例,阴性178例;WB确证阳性标本均为ELISA双阳;XC、WT试剂真阳性率(33.76%、45.20%)差异有统计学意义(χ^(2)=5.59,P<0.05);ELISA标本吸光度值与临界值之比(S/CO值)在0.8~10.0区间,WB无阳性结果;当XC、WT试剂标本S/CO值≥20.0,与WB确证结果阳性符合率达97.37%、98.72%;HIV-1抗体阳性标本gp160、gp120、p24条带阳性检出率均为100.00%,以全条带比例最高(23.75%);不确定标本以出现p24单条带比例最高(56.00%)。结论HIV初筛存在一定的假阳性;ELISA双阳与WB确证阳性符合度较高;ELISA强阳性反应、S/CO值较高的标本,确证阳性的可能性较大;应联合运用血清学与核酸检测方法,合理选择试剂,最大限度防止HIV漏检,减少假阳性。

Objective To understand the coincidence between HIV initial screening positive and confirmatory results,evaluate ELISA and NAT methods and reagents,and analyze WB banding patterns of HIV-1 antibody positive and HIV antibody uncertain samples,so as to provide basis for formulating appropriate HIV blood screening strategies in Nanchang.Methods HIV testing data of blood donors were collected in Nanchang from 2012 to 2019.According to the serology and nucleic acid detection mode,dual-ELISA-reagents and NAT reagents were used to screen the blood samples of blood donors.Anti-HIV/HIV-1 p24/HIV RNA positive samples were tested afterward by WB.Results 308 HIV screening positive samples(0.59‰)were detected from 518635 blood donation samples,including 108 dual-ELISA-reagents positive,129 XC reagent positive,69 WT reagent positive and 2 NAT positive samples.There were 80 HIV-1 confirmed positive samples(0.15‰),50 uncertain and 178 negative samples by WB test.The whole WB confirmed positive samples were dual-ELISA-reagents positive.There were statistical differences(χ^(2)=5.59,P<0.05)of the true positive rates between XC and WT reagents(33.76%and 45.20%).When the S/CO ratio of ELISA samples were in the range of 0.8-10.0,WB results were not positive.When the S/CO ratio of XC and WT reagents for the samples were≥20.0,the positive coincidence rates with WB were 97.37%and 98.72%.The positive detection rates of gp160,gp120 and p24 bands in HIV-1 antibody positive samples were 100.00%,with the highest proportion of all bands(23.75%).The proportion of p24 single band(56.00%)was the highest in uncertain samples.Conclusion There are some false positives in HIV screening of blood donors.There is a high coincidence between dual-ELISA-reagents positive and WB confirmed positive.Regarding the samples with strong ELISA positive reaction and high S/CO ratio,WB is more likely to confirm positive results.We should combine serology and nucleic acid testing methods,select reagents reasonably to prevent HIV from being missed and reduce false positives.