不同检测方法对低水平乙型肝炎表面抗原的测定及其临床评估  

Evaluation of different methods in determination of low level HBsAg

作　　者：费春荣[1] 叶爱青[1] 张钧[1] 

机构地区：[1]浙江大学医学院附属邵逸夫医院检验科,浙江杭州310016

出　　处：《浙江大学学报（医学版）》2011年第4期436-439,共4页Journal of Zhejiang University(Medical Sciences)

摘　　要：目的:探讨免疫发光、电化学免疫发光、ELISA三种方法对检测低水平乙型肝炎表面抗原的价值。方法:以免疫发光测试系统Architect i2000检测结果为参考,把70例<50 IU/ml的标本分成三个级别:<1 ng/ml、1~5 ng/ml、≥5 ng/ml三组,用电化学免疫发光MODULAR〈E〉170、ELISA检测,对三种方法测定的结果进行比较。结果:免疫发光Architect i2000与电化学免疫发光MODULAR〈E〉170比较,<1 ng/ml组符合率79.2%(P(0.05),1~5 ng/ml组符合率100%,≥5ng/ml组符合率100%。免疫发光Architect i2000与ELISA比较,<1 ng/ml组符合率0%,1~5 ng/ml组符合率45.5%(P<0.05),≥5 ng/ml组符合率100%。结论:免疫发光Architect i2000与电化学免疫发光MODULAR〈E〉170对低水平HBsAg的检测效能基本一致,结果相对可靠,常规ELISA法对≥5 ng/ml的HBsAg检测结果可靠,但对低水平HBsAg漏检率高,特别是<1 ng/ml HBsAg很难检出。Objective:To evaluate chemiluminescent immunoassay(CLIA),electrochemiluminescent immunoassay(ECLIA) and ELISA in determination of low level HBsAg.Methods:According to the standard of CLIA Architect i2000,70 samples were divided into three groups by HBsAg concentration :﹤1 ng/ml,1-5 ng/ml and ≥5 ng/ml.The samples were also determined by ECLIA MODULARE170 and ELISA,and the results were compared with those measured by CLIA Architect i2000.Results:The concordance rates of ECLIA MODULARE170 with Architect i2000 was 79.2% for﹤1 ng/ml group,100% for 1-5 ng/ml group,100% for ≥5 ng/ml group.And the concordance rates of ELISA with Architect i2000 was 0% for﹤1 ng/ml group,45.5% for 1-5 ng/ml group and 100% for ≥5 ng/ml group.Conclusion:For determination of low level HBsAg,CLIA Architect i2000 and ECLIA MODULARE170 have high credibility.ELISA is also credible when HBsAg ≥5 ng/ml,but not for low level HBsAg,especially for HBsAg﹤1 ng/ml.

关 键 词：肝炎表面抗原 乙型/分析 酶联免疫吸附测定/方法 乙型肝炎表面抗原 免疫发光测定 电化学免疫发光测定 ELISA 

分 类 号：R446.6[医药卫生—诊断学]