胶体金免疫层析法检测乙型肝炎表面抗原应用评价

Evaluation for the Application of Gold Immunochromatograpy for HbsAg Detection

目的对胶体金免疫层析法检测乙肝表面抗原(Hepatitis B surface antigens,HBsAg)的敏感性、特异性进行分析和初步评价。方法采用胶体金免疫层析(Gold Immunochromatography Assay,GICA)法,酶联免疫吸附(Enzyme-linked immunosorbent Assay,ELISA)法,对HBsAg定值血清和200份待测血清标本同时测定,对GICA法的测定结果进行分析评价。结果 GICA法的最小检出量≥1.0ng/ml,ELISA法的最小检出量≥0.5ng/ml,GICA法的敏感性低于ELISA法。与ELISA法相比,GICA法敏感度为91.1%,特异性为99.4%。结论 GICA法适用于HbsAg的急诊和初筛检查。

Objective To analyze and preliminarily evaluate the sensitivity and specificity of Gold Immunochromatography Assay （GICA） for the detection of Hepatitis B surface antigens （HbsAg）. Methods Test quite some quantitative HBsAg sera samples and 200 unknown sera samples with GICA and Enzyme-linked immunosorbent Assay （ELISA）. Analyze and evaluate the results of GICA trips. Re- sults The minimal detection limits of GICA was ≥1.0ng/ml, the minimal detection limits of ELISA was≥0.5 ng/ml. The sensitivity of GI- CA was lower than ELISA. Compared with ELISA, the sensitivity of GICA was 91.1%, with specificity of 99.4%. Conclusion GICA is ap- plicable to emergency of HBsAg and preliminary screening detection.