MEIA法测定乙肝病毒表面抗原的评价及临床应用

The Evaluation of Determination HBsAg by Microparticle Enzyme Immunoassay and Its Application

目的 对微粒子酶免疫测定法(MEIA法)检测乙肝病毒表面抗原进行方法学评价并研究低含量乙肝表面抗原人群阳性检出率。方法 采用美国雅培公司的AXSYM型化学发光仪对乙肝病毒表面抗原卫生部质控物、高浓度乙肝病毒表面抗原标本进行稀释测定,同时与ELISA法检测乙肝表面抗原进行比较;对低浓度(HBsAg≤1μg/L)的标本进行中和确证试验与采用PCR-ELISA法定量测定HBV DNA。结果 微粒子化学发光法检测乙肝病毒表面抗原具有较高灵敏度,达0.1μg/L;有较好的重复性和特异性;低浓度(HBsAg≤1μg/L)在人群中分布率为0.53％。结论 微粒子酶免疫法对提高低含量乙肝表面抗原阳性检出率具有重要意义。

Objective To investigate the evaluation of detection HBsAg by microparticle enzyme immunoassay and reveal the distribution of the population with lower level HBsAg in serum. Methods HBsAg was detected in the higher serum samples and control serum from healthful institution and defined their dilutions with HBsAg concentration by using ELISA and Axsym MEIA system and HBV DNA was detected by PCR-ELISA and quantitative PCR in lower level HBsAg (HB-sAg≤1μg/L). Results There were higher sensitivity(lower to 0. 1 μg/L)repetition and specificity in detection of HBsAg by microparticle enzyme immunoassay and 0. 53% of population with HBsAg lower than 1 μg/L was detected by MEIA. Conclusion MEIA is important signification to improve detection percent of low level HBsAg of population in serum.