2种方法检测献血者丙型肝炎病毒抗体结果分析  

Analysis of two methods for detection of hepatitis C virus antibody in blood donors

作　　者：邓燕清[1] 王淏[1] 黄伯泉[1] DENG Yanqing;WANG Jian;HUANG Boquan(Guangzhou Key Laboratory of Blood Safety,Guangzhou Blood Center,Guangzhou,510095,China)

机构地区：[1]广州血液中心广州市血液安全重点实验室,广州510095

出　　处：《临床血液学杂志》2021年第4期268-270,共3页Journal of Clinical Hematology

基　　金：广州市医学重点学科建设项目(血液安全重点实验室)。

摘　　要：目的:为血液中心丙型肝炎病毒(HCV)抗体检测试剂由间接法更改为双抗原夹心法提供依据。方法:随机抽取2018—2020年无偿献血者标本,采用酶联免疫吸附试验(ELISA)间接法双试剂(A、B)和双抗原夹心法双试剂(A1、B1)检测抗-HCV抗体,同时进行HCV RNA核酸检测。统计分析4种抗-HCV ELISA试剂盒检测结果,单试剂阳性标本复查阳性符合率。结果:抗-HCV ELISA间接法双试剂、双抗原夹心法双试剂共检测无偿献血116843、98903人份,间接法抗-HCV抗体单试剂阳性标本复检阳性率0.088%(102/116843)与双抗原夹心法抗-HCV抗体单试剂阳性标本复检阳性率0.012%(12/98903),差异有统计学意义(P<0.05)。单试剂阳性标本均进行双试剂双孔复检,试剂A、B、A1、B1的再检阳性符合率分别为A(61.90%)>B(54.95%)>A1(50.00%)、B1(50.00%),4种试剂之间差异无统计学意义(P>0.05),单试剂阳性标本核酸RNA均为阴性。结论:本地区无偿献血者抗HCV抗体酶免双试剂阳性人群在性别、年龄分布有差异,对日后招募低危献血者人群有指导意义。抗-HCV双抗原夹心法ELISA检测特异性更高,减少假阳性率,保证临床用血安全。Objective:To provide the basis for the change of HCV antibody detection reagent from indirect method to double antigen sandwich method in our blood center.Methods:Samples of unpaid blood donors in our center from 2018 to 2020 were randomly selected to detect anti HCV antibody by enzyme-linked immunosorbent assay(ELISA)indirect double reagent(a,b)and double antigen sandwich double reagent(A1,B1),and HCV RNA and nucleic acid were detected at the same time;the detection results of four kinds of anti HCV ELISA kits and the positive coincidence rate of single reagent positive samples were statistically analyzed.Results:A total of 116844 and 98903 blood donors were detected by the double reagents of anti HCV ELISA indirect method and double antigen sandwich method.The positive rate of anti HCV antibody single reagent of indirect method was 0.088%(102/116843)and that of anti HCV antibody single reagent of double antigen sandwich method was 0.012%(12/98903),the difference was statistically significant(P<0.05).The positive coincidence rates of A,B,A1 and B1 were A(61.90%)>B(54.95)%>A1(50.00%)and B1(50.00%),respectively.There was no statistical difference between the four reagents(P>0.05).The nucleic acid RNA of single reagent positive samples was negative.Conclusion:Tere are differences in gender and age distribution of anti HCV antibody double reagent positive blood donors in this region,which has guiding significance for future recruitment of low-risk blood donors;anti HCV double antigen sandwich ELISA has higher specificity,reduces false positive rate,and ensures the safety of clinical blood use.

关 键 词：丙型肝炎病毒 阳性再检符合率 假阳性率 低危人群 

分 类 号：R512.6[医药卫生—内科学]