低浓度乙型肝炎表面抗原三种检测方法的比较与分析

Comparison and analysis of three methods to detect low concentrations of hepatitis B surface antigen

目的比较金标记免疫层析法(GICA)、酶联免疫吸附试验(ELISA)和电化学发光免疫分析法(ECLIA)检测乙型肝炎表面抗原(HBsAg)的敏感度。方法对平时收集的用化学发光微粒子免疫分析法(CMIA)检测的0.05 IU/ml<HBsAg≤10.0 IU/ml的368份血清标本和200例CMIA法检测的HBsAg阴性标本分别用GICA、ELISA和ECLIA三种方法检测,以CMIA为标准,对GICA、ELISA和ECLIA的敏感度、特异度进行比较。结果 ECLIA法检测低浓度HBsAg的敏感度高于ELISA和GICA法(P<0.05)。结论 ECLIA法检测低浓度HBsAg的敏感度高于ELISA和GICA法,CMIA和ECLIA对低浓度的HBsAg有很好的检出率,GICA和ELISA在低浓度的HBsAg检测方面漏检现象严重,建议对首次进行HBsAg的标本应选择敏感度高的CMIA或ECLIA。

Objective To compare the sensitivity of gold-labeled immunochromatography assay （ GICA）, enzyme-linked immunosor- bent assay （ELISA） and electrochemilumineseence immunoassay （ECLIA） in detecting hepatitis B surface antigen （HBsAg）. Methods A total of 368 collected serum samples with HBsAg concentration between 0.05 - 10.0 IU/ml detected by chemiluminescent im- munoassay （CMIA）, as well as another 200 HBsAg negative serum samples, were detected GICA, ELISA and ECLIA, respective- ly. With CMIA acting as standard, sensitivity and specificity were compared among GICA, ELISA and ECLIA. Results The sen- sitivity of ECLIA was higher than that of ELISA and GICA in detecting low concentration of HBsAg （P 〈 0.05 ）. Conclusion The sensitivity of ECLIA is higher than that of ELISA and GICA in the detection of low concentration of HBsAg. CMIA and ECLIA are good at detecting low concentration of HBsAg. GICA and ELISA have serious missed rate. It is recommended that the first HBsAg specimens be detected by CMIA or ECLIA whose sensitivity is high.