HIV抗原/抗体检测的电化学发光法在献血者血液筛查中的应用评估  

Evaluation for the performance of HIV Ag/Ab assay based on ECLIA in blood screening

作　　者：杨帆 马晓军 杨文勇 李治鹏 张梅 欧阳思蒙 邢颖 刘畅 杨红梅 刘招佚 YANG Fan;MA Xiaojun;YANG Wenyong;LI Zhipeng;ZHANG Mei;OUYANG Simeng;XING Ying;LIU Chang;YANG Hongmei;LIU Zhaoyi(Guangyuan Central Blood Center,Guangyuan 610000,China)

机构地区：[1]广元市中心血站,四川广元610000

出　　处：《中国输血杂志》2022年第6期605-607,共3页Chinese Journal of Blood Transfusion

摘　　要：目的评估检测HIV抗原/抗体的电化学发光免疫分析法(ECLIA)在献血者血液筛查中的应用效果。方法选取本站2016年9月~2020年9月采用ELISA法抗-HIV反应性的献血者标本128(人)份[双试剂反应性7份(其中WB确认抗-HIV阳性6份、NAT确认抗-HIV阴性1份),单试剂反应性121份(均经WB确认为阴性)]以及从本站2020年6~9月以ELISA法筛查和NAT检测均为非反应性的献血者留存标本中随机选取1360(人)份,用ECLIA法对这2类献血者标本做HIV抗原/抗体检测;比较2种方法的检测结果,包括HIV阳(阴)性符合率、敏感性与特异性。结果对于1360份ELISA和NAT检测均为非反应性的标本,用ECLIA检测亦均为非反应性。ECLIA法对于ELISA法检测和确认试验均为献血者HIV反应性标本的检测结果符合率100%(6/6);对于ELISA法抗-HIV检测反应性但确认试验阴性的122份标本的HIV抗原/抗体检测反应(性)率3.28%(4/122)、非反应(性)率96.72(118/122)ECLIA法与ELISA法的总体符合率为96.88%(124/128)。ECLIA的敏感性、特异性和假阳性率分别为100%,99.73%和0.27%;ELISA的敏感性、特异性和假阳性率分别为100%、91.77%和8.23%。结论检测HIV抗原/抗体的ECLIA法同时具有良好的敏感性和特异性,可以满足献血者血液筛查的要求,且较血站目前常规使用的ELISA法检测的HIV假阳性率更低。Objective To evaluate the performance of electrochemiluminescence immunoassay(ECLIA)in detecting HIV antigen/antibody in blood screening.Methods A total of 128 donors,reactive to anti-HIV(ELISA)testing,from September 2016 to September 2020 were enrolled,and seven samples were reactive to double anti-HIV reagents,among which 6 were confirmed by WB,1 confirmed by NAT as negative.Two group of donors,reactive to solo anti-HIV reagent but being confirmed negative by WB(n=121)vs.randomly selected donors non-reactive to ELISA+NAT(June to September 2020,n=1360),were subjected to HIV antigen/antibody testing using ECLIA to compare the testing results,including concordance rate,sensitivity and specificity.Results The ECLIA results remained non-reactive for 1360 samples initially non-reactive to both ELISA and NAT.The concordance rate of anti-HIV reactivity by ECLIA and ELISA+WB were 100%(6/6).For 122 samples,reactive to ELISA anti-HIV testing but nonreactive to confirmatory testing,4(3.28%)of them were reactive to HIV antigen/antibody testing and 118(96.72%)nonreactive,with the concordance rate of ECLIA and ELISA at 96.88%(124/128).The sensitivity,specificity and false positive rate of ECLIA and ELISA were 100%vs 100%,99.73%vs 91.77%,and 0.27%vs 8.23%,respectively.Conclusion ECLIA for HIV antigen/antibody detection has good sensitivity and specificity,which can meet the requirements of blood screening,and the false positive rate is lower than that of ELISA,adopted commonly in blood bank at present.

关 键 词：电化学发光法 HIV抗原/抗体检测 酶联免疫吸附法 抗-HIV检测 血液筛查 献血者 

分 类 号：R446.61[医药卫生—诊断学]