| [objective]1.To understand the clinical significance of serum HBeAg,HBsAg level by means of TRFIA in Chronic Hepatitis B patients,and the relationship between the level of HBsAg,HBeAg and the HBV-DNA load.2.Through comparing the HBsAg quantitative analysis result of MEIA methods with TRFIA methods,to evaluate the TRFIA clinical practical value and significance.[Methods]In this study,chronic HBV infection in all serum samples(203 cases), ELISA method,according to the qualitative detection of HBeAg were divided into e+ CHB group and e-CHB group;then quantitative PCR detection system based on quantitative detection of HBV-DNA results are for the 3 groups(according to the number of HBV-DNA on the results is divided into 3＞1gHBV-DNA group,3≤1gHBV-DNA＜5 group,5≤1gHBV-DNA group).TRFIA method measured on HBsAg, HBeAg results exceeded the scope of testing of serum samples,further dilution experiments to do the specific quantitative results.All serum samples(203 cases) were confirmed by a third party inspection agency(Guangzhou Golden Mile Medical laboratory) the gold standard quantitative detection of HBsAg MEIA method.This study and MEIA TRFIA of two methods of HBsAg,HBeAg and HBV-DNA quantitative results are converted into the corresponding pairs of values were compared.[results]1.e + CHB group of 109 specimens,HBeAg levels of HBV-DNA in different groups there is a difference overall(F=5.286,P value=0.006＜0.05).By 22 more:3≤1gHBV-DNA＜5 group and 5≤1gHBV-DNA group HBeAg levels were significantly different(X1=0.75±0.60;X2=1.11±0.38;P value=0.02＜0.05),5≤ 1gHBV HBeAg-DNA group was higher than 3≤1gHBV-DNA＜5 group.Pearson correlation analysis between the two levels of HBeAg and HBV-DNA levels and between the correlation was a positive correlation(r=0.339,P value=0.003＜0.05).2.e + CHB group of 109 specimens,TRFIA quantification of HBsAg levels in different groups of HBV-DNA there is a difference in the overall(F=3.494,P value = 0.034＜0.05).Through pairwise comparison:3＞1gHBV-DNA group and 3≤1gHBV-DNA＜5 group HBsAg levels was significant difference(X1=3.95±0.61; X2=3.29±0.99;P value=0.049＜0.05),3＞1gHBV-DNA group HBsAg level higher than 3≤1gHBV-DNA＜5;3≤1gHBV-DNA＜5 group and 5≤1gHBV-DNA group HBsAg levels were significantly different(X1 =3.29±0.99;X2=3.82±1.20;P value=0.019＜0.05),5≥1gHBV-DNA group of HBsAg was higher than 3≥1gHBV-DNA＜5 group.HBsAg MEIA method measured the level of HBV-DNA in different groups in general was not significantly different(F=0.721,P value= 0.489＞0.05).e-CHB groups of 94 samples,TRFIA quantification of the level of HBsAg of HBV-DNA in different groups there is a difference overall(F=22.439,P value＜0.001).By 22 more:3＞1gHBV-DNA group and 3≤1gHBV-DNA＜5 group HBsAg levels was significant difference(X1=1.49±0.69;X2=2.81±1.03;P value＜0.001), 3≤1gHBV-DNA＜5 group HBsAg level higher than 3＞1gHBV-DNA group;3＞1gHBV-DNA group and 5≤1gHBV-DNA group HBsAg levels were significantly different(X1=1.49±0.69;X2=3.91±0.89;P value＜0.001),5≤1gHBV-DNA group of HBsAg was higher than 3＞1gHBV-DNA group.Quantitative detection of HBsAg MEIA levels in different groups of HBV-DNA is the whole difference(F= 14.038,P value＜0.001).By 22 more:3＞1gHBV-DNA group and 3≤1gHBV-DNA＜5 group HBsAg levels was significant difference(X1=2.01±0.82;X2=3.09±0.97;P value＜0.001),3≤1gHBV- DNA＜5 group HBsAg level higher than 3＞1gHBV-DNA group;3＞1gHBV-DNA group and 5≤1gHBV-DNA group HBsAg levels were significantly different(X1=2.01±0.82;X2=3.32±0.88;P value＜0.001),5≤1gHBV-DNA group of HBsAg was higher than 3＞1gHBV-DNA group.e + CHB group and e-CHB group TRFIA and MEIA detection method of quantitative detection of two HBsAg and HBV-DNA Pearson correlation analysis between the two results:e-CHB group TRFIA method measured the level of HBsAg and HBV-DNA correlation between the level(P=0.031＜0.05),the other groups HBsAg and HBV-DNA level had no correlation between levels(P values were＞0.05).3.e + CHB group of 109 cases of samples,HBeAg TRFIA and MEIA with two methods for quantitative detection of HBsAg Pearson correlation analysis results: HBeAg levels and for both methods no correlation between the level of HBsAg(P values were＞0.05).4.in e + CHB group and in e-CHB group and two groups of the two methods and TRFIA and quantitative detection of HBsAg MEIA Pearson correlation analysis were as follows:in the 3 groups for both methods were between the levels of HBsAg correlation(P values were＜0.001).5.HBV-DNA level,TRFIA method and MEIA method HBsAg levels were measured in e + CHB,and e-CHB results between the two groups:HBV-DNA levels in e+ CHB,and e-CHB was no statistical difference between groups significance(t=0.891, P value=0.374＞0.05);TRFIA law HBsAg measured in e + CHB group and e-CHB significantly between groups(t=6.308,P value＜0.001),TRFIA method HBsAg levels measured in e + CHB group of HBsAg was higher than that e-CHB group; MEIA method measured the level of HBsAg in e + CHB group and e-CHB significantly between groups(t=4.663,P value＜0.001),MEIA method to measure the level of e + CHB were HBsAg HBsAg group was higher than that e-CHB group.[conclusion]1.The experiments e + CHB group,HBeAg levels in certain HBV-DNA(1g3～1g5) within a certain correlation between the two,but can not be good representatives of HBeAg HBV-DNA levels,HBeAg to do quantitative analysis indicators for traditional test has its limitations.Clinically,the level of HBeAg alone to determine the level of HBV-DNA replication is not completely reliable,requires a combination of integrated HBV-DNA quantitative results to judge condition.2.The experiments e + CHB group,TRFIA and MEIA measured two ways to detect HBsAg and HBV-DNA level was no clear correlation between,can not serve as clinical indicators for monitoring the level of HBV replication,e-CHB group,HBsAg and HBV-DNA level of correlation between the need to further research.3.The experiments e + CHB group,TRFIA with MEIA measured two ways to detect HBsAg and HBeAg level was no correlation between the level.4.TRFIA used in this study and MEIA method measured by two different methods a correlation between the level of HBsAg,and were positively correlated.Between the two detection methods a high degree of consistency.TRFIA in the clinical application of quantitative detection of HBsAg has its value.5.e + CHB group,HBsAg was higher than the level of e-CHB group of HBsAg.In the e-CHB group,HBV-DNA＜1g3和1g5＞HBV-DNA＞1g3 TRFIA can be used within the one-step quantitative clinical testing HBsAg,e + CHB group,two steps need to use TRFIA dilution assay for quantification of HBsAg.
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