乙型肝炎表面抗体化学发光免疫分析法的建立  

Development of diagnostic reagent for hepatitis B surface antibody using chemiluminescence immunoassay

作　　者：张琼[1] 余娟平[1,2] 朱长城[2] 徐伟文[1] 

机构地区：[1]南方医科大学生物技术学院,广东广州510515 [2]中山大学达安基因股份有限公司,广东广州510670

出　　处：《热带医学杂志》2014年第5期615-618,共4页Journal of Tropical Medicine

基　　金：科技重大专项"十二五"课题(2012ZX10002005)

摘　　要：目的建立乙型肝炎表面抗体（HBsAb）化学发光免疫分析（CHA）检测试剂盒。方法采用两株乙型肝炎表面抗原（HBsAg）分别包被磁微球和标记吖啶酯（AE），建立双抗原夹心化学发光免疫检测试剂盒，优化反应体系并对试剂盒的各项性能指标进行评价。结果HBsAb—CLIA检测试剂的灵敏度为0．03mIU／ml，测量范围为0．03—960mIU／ml；分析内和分析问精密度分别为2．94％-5．14％和3．03％～6．33％；与乙型肝炎E抗体（HBeAb）、乙型肝炎核心抗体（HBcAb）等无交叉反应；673名正常人血清测试结果表明该检测试剂的正常参考范围为0～10mIU／ml；用本试剂与进口雅培同类试剂同时检测1411例临床样本，其相关方程为y=0．944x＋4．056．相关系数为0．947。结论已成功制备操作简单．成本低，各项性能指标均能达到临床检测要求的HBsAb-CLIA试剂盒，可用于临床血清样本HBsAb浓度的测定。Objective To establish HBsAb-CLIA kit for detection of HBsAb. Methods One HBs antigen was conjugated to magnetic beads and another was labeled with AE. A double antigen sandwich CLIA kit was established and evaluated for the performance indicators. Results The assay demonstrated a linear range of 0.03-960 mIU/ml, with an analytical sensitivity at 0.03 mIU/ml. The intra-assay and inter-assay coefficient of variation（CV） were 2.94%-5.14% and 3.03%-6.33%, respectively. No cross reaction of the reagent with HBeAb, HBcAb etc. Normal serums from 673 persons showed that the normal range of the assay was 0-10 mIU/ml. The correlation coefficient of simultaneous determination of 1 411 clinical samples used self made HBsAb-CLIA kit and Abbott HBsAb-CLIA kit was 0.947. Conclusion Simple operation and low cost self made HBsAb-CLIA kit has been successfully prepared. The performance index of the kit can reach clinical testing requirements for the determination of the concentration of HBsAb clinical serum samples.

关 键 词：乙型肝炎病毒 乙型肝炎表面抗体 化学发光免疫分析法 

分 类 号：R512.62[医药卫生—内科学]