化学发光免疫分析法检测低水平HBsAg与其他方法的比较

Chemiluminescence Immunoassay in Detection of Low Level HBsAg

目的 比较并分析化学发光免疫分析法、ELISA法、胶体金法三种方法检测低水平HBsAg的结果.方法 以化学发光免疫分析仪Architect i2000检测结果作为参考,将100例＜50 IU/ml标本分为3组,分别为：＜1 IU/ml,1～5 IU/ml,＞5 IU/ml.采用ELISA、胶体金法对3组标本进行检测,对测定结果进行比较分析.结果 应用化学发光免疫分析仪Ar-chitect i2000与ELISA测定低水平（＜1 IU /ml） HBsAg的差异有统计学意义,在＜1 IU /ml组,两者符合率仅为3.8％（P＜0.05）,（1～5） IU/ml组和＞5 IU /ml组符合率分别为76.5％和100.0％.Architect i2000与胶体金法在测定低水平HB-sAg的差异有统计学意义（P＜0.05）,两种方法在＜1 IU/ml组符合率为0,（1～5） IU /ml组符合率为2.9％,＞5 IU /ml组符合率为100.0％.结论 化学发光免疫分析法检测低水平HBsAg （＜5IU /ml）灵敏度明显高于ELISA和胶体金法.

Objective To compare chemiluminescent immunoassay （CLIA） with ELISA and colloidal gold method for detection of low level HBsAg.Methods According to the standard of CLIA Architect i2000,100 samples were divided into three groups by HBsAg concentration （IU/ml）：〈 1,（1～ 5）,〉 5.The samples were also determined by ELISA and colloidal gold.The results were compared with those measured by CLIA Architect i2000.Results The concordance rates of ELISA with CLIA Architect i2000 was 3.8% for 〈1 IU/ml group,76.5% and 100.0% for （1～5） IU/ml group and 〉 5 IU /ml group.The concordance rates of colloidal gold with CLIA Architect i2000 was 0 for 〈1 IU/ml group,2.9% for （1～5） IU/ml group and 100.0% for〉5 IU /ml group.Conclusion The detection rate of CLIA in low level HBsAg （〈 5 IU /ml） was significantly higher than that of ELISA and colloidal gold assay.