乙型肝炎病毒血清标志物GICA检测性能的比对分析  

Comparative analysis on the performance of GICA for the determination of HBV serological markers

作　　者：简敏华 张健 陈慧英 蒋玲丽 陆银华 肖艳群 邵维杰 徐翀 

机构地区：[1]上海市临床检验中心,上海200126

出　　处：《检验医学》2013年第11期1040-1043,共4页Laboratory Medicine

基　　金：上海市卫生局科研计划课题资助项目(2010053)

摘　　要：目的评估乙型肝炎病毒血清标志物（HBV—M）胶体金免疫层析法（GICA）的分析性能。方法收集雅培i1000免疫检测系统检测的HBV—M阳性标本653例、阴性标本103例和HBV—M标准品，以化学发光免疫测定法（CLIA）检测结果为标准，分别用酶联免疫吸附试验（ELISA）试剂和5种GICA试剂检测，统计分析检测结果。结果检测HBV—M敏感性：ELISA和GICA检测HBV—M的最低检测限分别为乙型肝炎表面抗原（HBsAg）0．5IU／mL和4～8IU／mL、乙型肝炎表面抗体（抗HBs）10mlU／mL和15～30mlU／mL、乙型肝炎e抗原（HBeAg）1NCU／mL和2～4NCU／mL、乙型肝炎e抗体（抗HBe）2NCU／mL和64～256NCU／mL、乙型肝炎核心抗体（抗HBc）2IU／mL．和32—256IU／mL。检测标本HBV—M的符合率：ELISA分别为87．4％、99．0％、87．7％、96．6％、100．0％，GICA分别为69．6％～71．7％、69．0％～72．0％、70．5％～73．9％、42．2％～49．1％、50．0％～60．0％。检测HBV—M特异性：除GICA柃测抗HBs的特异性略差外，其余各HBV—M的检测特异性均是可接受。，结论GICA检测HBV—M低浓度的标本，漏检率很高，只能用于GICA检测线性范围里HBsAg的筛查，不能作为临床诊断乙型肝炎和疗效考核的依据。Objective To evaluate the performance of colloidal gold immunochromatography assay （ GICA ） for the determination of the serological markers of hepatitis B virus （HBV-M）. Methods Abbott il000 immunoassay system detected 653 cases ff HBV-M positive samples, and the results of 103 cases of HBV-M negative samples ad HBV-M standard materials by chemiluminescence immunoassay （CLIA） were as the standard. Enzyme-linked immunosorbent assay （ELISA） reagent and 5 GICA reagents were used for the detection, and the results were analyzed statistically. Results The sensitivity for the determination of HBV-M was analyzed. ELISA and G1CA detection limits for HBV-M showed that hepatitis B surface antigen （HBsAg） 0.5 IU/mL and 4-8 IU/mL, anti-hepatitis B surface antigen antibody （auti-HBs） 10 mIU/mL and 15-30 mIU/mL, hepatitis B e antigen （HBeAg） 1 NCU/mL and 2-4 NCU/mL, anti- hepatitis B e antigen antibody （anti-HBe） 2 NCU/mL and 64-256 IU/mL, anti-hepatitis B core antigen antibody （ anti- HBc） 2 IU/mL and 32-256 NCU/mL. The coincidence rates of HBV-M were 87.4% , 99.0% , 87.7% , 96.6% and 100.0% by EIISA and were 69.6% -71.7% , 69.0% -72.0% , 70.5% -73.9% , 42.2% -49.1% and 50.0% -60.0% by GICA. Except the specificity for the determination of anti-HBs by GICA was slightly bad, the specifieities of other HBV-M were acceptable. Conclusions GICA for the determination of HBV-M with low concentration has high missing rate. GICA can only be used ibr the screening HBsAg with linear range, and its results cannot be used for the clinical diagnosis and efficacy assessment of hepatitis B.

关 键 词：乙型肝炎病毒血清标志物 胶体金免疫层析法 化学发光免疫测定法 酶联免疫吸附试验 

分 类 号：R446.61[医药卫生—诊断学]