Analysis of two methods for detection of hepatitis C virus antibody in blood donors
-
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116 843、98 903人份,间接法抗-HCV抗体单试剂阳性标本复检阳性率0.088%(102/116 843)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%(12/98 903),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。Abstract: 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 116 844 and 98 903 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%(102/116 843) and that of anti HCV antibody single reagent of double antigen sandwich method was 0.012%(12/98 903), 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.
-
[1] 何学虎,郭雅琪,董洁,等.新型丙型肝炎病毒核酸定量试剂检测性能验证[J].中华医院感染学杂志,2019,29(6):821-826.
[2] 马淑青,宋宇,毕艳妮,等.HCV抗体血清学检测联合HCV-RNA检测的应用价值:附2例病例分析[J].实用检验医师杂志,2019,11(2):122-124.
[3] 蔡华娟,张雅丽,林永财,等.酶联免疫吸附试验试剂与核酸检测联检丙型肝炎病毒的检测模式的选择分析[J].临床合理用药杂志,2019,12(9):161-163.
[4] 谢振迪,金速速,余坚,等.乙型肝炎病毒基因分型的双通道荧光PCR检测及其在未成年乙型肝炎病毒感染者中的临床应用[J].中国卫生检验杂志,2019,29(6):662-665.
[5] 马晓军,杨文勇,李治鹏.乙型肝炎、丙型肝炎单试剂检测阳性献血者的分析[J].检验医学与临床,2019,16(08):1107-1109.
[6] 黄耀东,彭云娟,魏丽华.丙型肝炎病毒抗体检测联合核酸检测在血液筛查中的价值[J].实用检验医师杂志,2018,10(1):53-54.
[7] 武春艳.某市无偿献血者血样不合格率及乙肝、丙肝、艾滋筛查结果分析[D].济南:山东大学,2018.
[8] 汪峰,费静娴,庄小狮,等.抗-HCV ELISA试剂评价体系的建立及检测结果[J].临床血液学杂志,2015,28(3):462-464.
[9] 吴敏,陈俊梅,刘召波,等.乙型肝炎病毒核心抗体Ig M的蛋白芯片检测法研究[J].现代生物医学进展,2019,19(3):560-562,575.
计量
- 文章访问数: 340
- PDF下载数: 185
- 施引文献: 0