时间分辨免疫荧光法定量检测血清HBeAg／HBeAb的可行性分析

Feasibility analysis of quantitative detection on serum HBeAg/HBeAb by time-resolved immunofluorescence assay

目的:探讨国产时间分辨免疫荧光法(time-resolved immunofluorescence assay,TRIFA)是否与全自动化学发光免疫分析法(automatic chemiluminescence immunoassay,CMIA)在定量检测HBeAg/HBeAb中具有同样的准确性和特异性。方法:157份来自中南大学湘雅医院感染病科门诊的HBV感染患者的血清标本,分别用CMIA和TRIFA两种方法进行HBeAg定量及HBeAg/HBeAb定性检测,并对结果进行对比分析。结果:两种方法定量检测HBeAg的直线回归方程为:Y=0.72779X–4.0551(r=0.712,P<0.001)。与CMIA比较,TRIFA检测HBeAg定性结果的灵敏度和特异性分别为89.89%和100%,两种方法诊断HBeAg符合率为94.27%。TRIFA检测HBeAb定性结果的灵敏度和特异性分别为100%和95.45%,两种方法诊断HBeAb的符合率为97.45%。结论:TRIFA在HBeAg/HBeAb定量检测上的准确性、灵敏度和特异性与CMIA基本相当,二者HBeAg/HBeAb诊断符合率高。

Objective： To determine whether time-resolved immunofluorescence assay （TRIFA） shares the similar accuracy and specificity with automatic chemiluminescence immunoassay （CMIA） in analyzing HBeAg levels in hepatitis B. Methods： A total of 157 serum samples were collected from outpatients with infection of HBV in Xiangya Hospital, Central South University. CMIA and TRIFA were used to analyze HBeAg quantitation and HBeAg/HBeAb qualitative detection, respectively. Results： The linear regression equation for the two methods was Y=0.72779X–4.0551 （r=0.712, P〈0.001）. Compared with the CMIA, the sensitivity and specificity in detection of HBeAg by TRIFA were 89.89% and 100%, respectively, and the coincidence rate of HBeAg was 94.27% by two assays. Similarly, the sensitivity and specificity in detection of HBeAb by TRIFA were 100% and 95.45%, respectively. The coincidence rate was 97.45% by two assays. Conclusion： TRIFA has similar accuracy, sensitivity, and specificity with CMIA in quantitative detection of HBeAg, and their coincidence rate in detection of HBeAg/HBeAb is high.