献血者HIV筛查反应性标本电化学发光检测和确证结果分析  

ECLIA and confirmation results of HIV reactive samples in blood screening

作　　者：王全慧 于洋 李浩龙[1] 潘彤 刘军 樊晶[1] WANG Quanhui;YU Yang;LI Haolong;PAN Tong;LIU Jun;FAN Jing(Tianjin Blood Center,Tianjin 300110,China)

机构地区：[1]天津市血液中心,天津300110

出　　处：《中国输血杂志》2022年第1期25-28,共4页Chinese Journal of Blood Transfusion

摘　　要：目的对HIV筛查反应性标本进行ECLIA和WB确证试验,比较分析ELISA(酶联免疫法)、ECLIA检测结果与确证感染的关系,为化学发光检测在血液筛查领域的应用提供数据支持。方法收集2019年2~10月本实验室检测的HIV筛查反应性标本177份,ELISA单试剂反应性137份;双试剂反应性39份;窗口期标本1份;所有项目均为阴性标本10份,总计187份进行ECLIA检测;HIV筛查反应性标本送CDC(疾病预防控制中心)进行确证试验,并对检测结果分析比较。结果177份标本中ECLIA反应性66份,阴性111份,10份阴性标本全部检测为阴性。检测指标比较分析:ECLIA检测的灵敏度97.1%,特异度81.1%,阳性预期值55%,阴性预期值99.1%,总符合率84.2%。除灵敏度相同外均大于2种ELSIA试剂。阳性预期值、特异度分别进行χ;检验,ECLIA与试剂2比较有差异(P<0.05)。ECLIA与确证结果显著相关,Kappa检验2者一致性良好。检测准确度分析:3种试剂ECLIA准确度最高、Youden指数最大。结论ECLIA具有较高的检测灵敏度,能提高早期感染标本的检出能力,缩短HIV检测的窗口期;准确度、特异性均优于ELISA试剂。ECLIA可在血液筛查中加以推广充分发挥其优势。Objective To perform electrochemiluminescence immunoassay(ECLIA)and Western blotting(WB)confirmation tests for HIV reactive samples in blood screening,and analyze the correlation between ELISA(enzyme-linked immunosorbent assay),ECLIA results and confirmed infection,so as to provide data support for the application of ECLIA in blood screening.Methods 177 HIV reactive samples in blood screening testing detected by our laboratory from February to October 2019 were collected,of which 137 were reactiv to isolated ELISA reagent e,39 to dual ELISA reagent,and 1 in window period.Ten maker-negative samples were randomly selected to undergo ECLIA with the above 177 samples.HIV reactive samples were sent to Centers for Disease Control and Prevention(CDC)for confirmation tests,and the results were analyzed and compared.Results Among the 177 HIV reactive samples,66 were ECLIA reactive,111 negative,and the 10 maker-negative samples remained negative.The sensitivity,specificity,positive predictive value,negative predictive value and total concordance rate of ECLIA were 97.1%,81.1%,55%,99.1%and 84.2%,respectively,showing better performance than that of two ELISA reagents(P<0.05)with exception of sensitivity(P>0.05).The positive predictive value and specificity were tested by chi-square test,and the difference between ECLIA and reagent 2 was statistically significant(P<0.05).The ECLIA results showed significant correlation with the confirmation results with good consistency(examed by Kappa test).Among the three reagents,ECLIA presented highest accuracy and largest Youden index.Conclusion ECLIA presents high detection sensitivity,which can improve the detection ability of early HIV infection and shorten the window period of HIV detection,therefore should be popularized in blood screening.

关 键 词：电化学发光免疫分析试验(ECLIA) 血液筛查 确证结果 窗口期 

分 类 号：R457.1[医药卫生—治疗学] R446[医药卫生—临床医学]