TRFIA法和ELISA法在HBsAg检测中的方法学评价

The Methodological Evaluation of TRFIA and ELISA method for HBsAg detection

目的：对时间分辨荧光免疫分析（TRFIA）和ELISA两种方法捡测HBsAg进行方法学评价。方法：先用TRFIA筛选出HBsAg阳性标本，再用ELISA试剂检测，并分组进行比较。结果：TRFIA法HBsAgr0．21—2．0ng／m1）标本40份中，ELISA法检测阳性24例，PEl性符合率60％，差异有统计学意义（P〈0．05）：而TRFIA法HBsAg（2．1—10．0ng／ml、10．1—50．0ng／ml、50．1—100．0ng／ml、〉100．1ng／m1）标本分别为33、47、29、47份中．ELISA法检测阳性也分别为33、47、29、47例，阳性符合率100％；TRFIA法HBsAg分为0．21—2．0ng／ml、2．1-10．0ng／ml、10．1—50．0ng／ml、50．1—100．0ng／ml、〉100．1ng／m组，ELISA法检测S／CO值±s分别为2．9571±3．1833、12．5415±6．1660、22．1553±4．6074、24．8674±4．2402、25．2192±2．9074，前两组比较有统计学意义，而后三组比较无统寸学意义。结论：采用TRFIA法定量检测HBsAg灵敏度更高，线性范围更宽，在低浓度标本检测中更具优势，

Objective ： To evaluate the TRFIA and ELISA assay for HBsAg dection.Methods ： The positive results of 197 samples were detected by TRFIA ,they should be detected by ELISA ,and compared .Results ： Of 40 samples with with HBsAg（0.21-2.0ng/m]） positive by TRFIA assay ,24 samples were positive for HBsAg by ELISA assay .The positive coincidence rate of TRFIA and ELISA was 60% .The detection rate was statistically different between two methods.The HBsAg samples（2.1-10.0ng/ ml, 10.1-50.0 ng/ml, 50.1-100.0 ng/ml, 〉100.1ng/ml）detected with TRFIA were 33,47,29,47,respectively .The positive samples were also 33,47,29,47 with ELISA .The positive coincidence rate was 100% .The concentration of HBsAg detected by TRFIA was 0.21-2.0ng/ml, 2.1-10.0ng/ml, 1{）.1-50.0 ng/ml, 50.1-100.0 ng/ml, 〉100.1 ng/ml, HBsAg S/CO detected by ELISA was 2.95 71±3.1833,12.5415±6.1660,22.1553±4.6074,24.8674±4.2402,25.2192±2.9074 .There were significant differences in the front two groups ,while there have no statistically different in the behind three groups .Conclusions ; TRFIA assay is more sensitive and has wider linear range in quantitative detection of HBsAg ,TRFIA assay has more advantage than ELISA in detection of low concentration samples .