ELISA测定HBsAg血清样本经化学发光法定量检测与乳胶免疫层析法两对半检测结果分析  

Quantitative detection by a chemiluminescence immunoassay method of HBs Ag determination around ELISA cut- off value samples and comprehensive analysis of two half- and- half examination by latex immunochromatographic test

作　　者：李宏杰[1] 应雄江 鄢姣 王倩倩[3] 陈飞群 王瑛[1] 

机构地区：[1]杭州市西湖区第二人民医院检验科,浙江杭州310024 [2]永康市第一人民医院检验科,浙江永康321300 [3]淮南市第一人民医院检验科,安徽淮南232000

出　　处：《中国卫生检验杂志》2015年第6期856-859,共4页Chinese Journal of Health Laboratory Technology

摘　　要：目的探讨ELISA测定HBs Ag临界附近样本及其乳胶免疫层析法两对半检测结果综合分析的意义。方法ELISA测定HBs Ag阴性的血清样本并进行复检,临界附近样本以化学发光法(CLIA)定量检测进行结果比对,并进行乳胶免疫层析法两对半检测。结果 ELISA测定HBs Ag临界附近样本存在一定程度的假阴(阳)性率。乳胶免疫层析法两对半检测在HBs Ag 0.073 5≤A<1.000、0.073 5≤A<0.105一侧以Anti-HBs阳性682/1 020(66.86%)和全阴性345/1 020(33.82%)为主;而在0.105≤A<1.000一侧主要是Anti-HBe或/和Anti-HBc阳性329/333(包括36例HBe Ag阳性者)(99.80%)。结论 ELISA检测HBs Ag临界附近样本可以CLIA定量检测进行结果判断;结合乳胶免疫层析法两对半检测结果综合分析可使绝大部分临界附近样本免做复检。Objective To investigate the comprehensive analysis performances of two half- and- half detection by latex immunochromatographic assay for serum samples of HBs Ag around ELISA cuo- off value. Methods Serum HBs Ag was detected by ELISA reagents made in China. Negative samples were retested. Comparisons of HBs Ag borderline samples were carried on quantitative detection by a chemiluminescence immunoassay（ CLIA） method. And two half- and- half detections of the borderline samples were made by latex immunochromatographic assay. Results HBs Ag determination around ELISA cut- off value samples were of a certain degree of false negative（ positive） rate. Anti- HBs positive 682 /1 020（ 66. 86%） and all negative345 /1 020（ 33. 82%） in one side of 0. 073 5 ≤A 〈0. 105 were found in two half- and- half examination by latex immunochromatographic test,and in another 0. 105 ≤A 〈1. 000 side Anti- HBe or / and Anti- HBc positive 329 /333（ including 36 cases of HBe Ag positive）（ 99. 80%） were major. Conclusion HBs Ag ELISA borderline samples would be carried on quantitative detection by CLIA as a comparison. If comprehensive analysis of two half- and- half examination by latex immunochromatographic test were used,retesting of the most bordline samples would be omitted.

关 键 词：酶联免疫吸附试验 乙型肝炎病毒表面抗原 复检范围 化学发光免疫法 定量检测 乳胶免疫层析法 两对半检测 

分 类 号：R446.61[医药卫生—诊断学]