摘要目的 探讨酶联免疫吸附试验( ELISA)法、时间分辨免疫荧光分析(TRFIA)法及胶体金免疫层析(GICA)法检测乙型肝炎血清标志物(乙型肝炎两对半)的临床应用价值.方法 145例疑似乙型肝炎患者分别采用ELISA法、TRFIA法及GICA法进行乙型肝炎两对半检测,对结果进行对比分析.结果 以TRFIA法测定结果为金标准,ELISA法和GICA法乙型肝炎表面抗原(HBsAg)、乙型肝炎e抗体(HBeAb)、乙型肝炎核心杭体(HBcAb)阳性符合率分别为71％(57/80)、45％(36/80),乙型肝炎表面抗体(HBsAb)、HBeAb、HBcAb阳性符合率分别为33％( 1/3)、0(0/3),两者比较差异有统计学意义(P＜0.05)；其余两项或者多项联合检测阳性符合率比较差异无统计学意义(P＞0.05).ELISA法和GICA法敏感度在HBsAg差异有统计学意义(P＜0.05),在HBsAb、乙型肝炎e抗原(HBeAg)、HBeAb、HBcAb差异无统计学意义(P＞0.05)；特异度在HBsAg、HBsAb、HBeAg、HBeAb、HBcAb差异均无统计学意义(P＞0.05).三种方法检测HBsAg的结果比较差异有统计学意义(P＜0.05),ELISA法与TRFIA法比较差异无统计学意义(P＞0.05),GICA法与TRFIA法比较差异有统计学意义(P＜0.05)；三种方法检测HBsAb、HBeAg、HBeAb、HBcAb的结果比较差异无统计学意义(P＞0.05)；三种方法检测HBsAb、HBeAb阳性的结果比较差异有统计学意义(P＜0.05),且ELISA法、GICA法与TRFIA法比较差异均有统计学意义(P＜0.05).结论 TRFIA法测量范围敏感度、特异度最高,但价格高；ELISA法准确率处于三种方法的中间水平,价格便宜,与TRFIA法同样适合于批量检测；GICA法准确率低,但快速简单,适合于前两种方法的补充.

abstractsObjective To investigate the clinical application value of enzyme-linked immunosorbent assay (ELISA) and time-resolved fluorescence analysis(TRFIA) and latex immune chromatography (GICA) in detecting hepatitis B serum markers.Methods One hundred and forty-five suspected patients of hepatitis B were detected serum markers of hepatitis B by ELISA,TRFIA and GICA method,and the results were compared and analyzed.Results When TRFIA method was as gold standard,the positive coincidence rate of ELISA and GICA method in HBsAg,HBeAb,HBcAb was 71％ (57/80),45％ (36/80),and in HBsAb,HBeAb,HBcAb was 33％( 1/3),0 (0/3),and there were significant differences between two methods (P＜0.05 ) ; the others were no significant differences (P ＞ 0.05 ).There was significant difference in the sensitivity of HBsAg between ELISA method and GICA method (P ＜ 0.05 ),but there was no significant difference in HBsAb,HBeAg,HBeAb,HBcAb(P ＞ 0.05 ).There was no significant difference in the specificity of HBsAg,HBsAb,HBsAg,HBeAb and HBcAb between ELISA method and GICA method (P ＞0.05).There was significant difference in HBsAg among three methods (P ＜0.05),but there was no significant difference between ELISA method and TRFIA method (P＞0.05),and there was significant difference between GICA method and TRFIA method (P＜0.05).There was no significant difference in HBsAb,HBeAg,HBeAb and HBcAb among three methods (P ＞ 0.05 ); there was significant difference in both HBsAb and HBeAb positive among three methods (P ＜ 0.05),and there was significant difference between ELISA method,GICA method and TRFIA method (P＜ 0.05).Conclusion TRFIA method has supreme measuring range,sensitivity and specificity supreme,but the price is higher;ELISA method is in the intermediate level of three methods and price is cheap,and it as well as TRFIA is suitable for the batch detection; GICA accuracy is low,but quick and simple,it is more suitable for the complement of the first two methods.