Evaluation Of ECLIA And Application In Hepatitis B.

Objective:ElectroChemiLuminescenceImmunoAssay(ECLIA)and Enzyme Immune Assay(EIA)were used to detect Hepatitis B(HB)virus markers respectively. We aim to assess the sensitivity,specificity and duplicability of HBsAg,HBeAg and anti-HBe detection with ECLIA and EIA,and compare the two methods in methodology and practical application,as well as study the application of ECLIA in clinical blocking of hepatitis B vertical dissemination.Methods:Hepatitis B virus markers in serum and latex samples were detected by ECLIA and EIA on Roche Elecsys 2010.Results:1.The maximum intra-batch and inter-day variations by ECLIA are≤8.30%,≤15.33%respectively.Sensitivity of HBsAg detection by ECLIA is 0.05ng/ml, whereas the sensitivity of HBeAg by ECLIA is 0.03 NCU/ml.The linear range of HBsAg is 0.05～6250 ng/ml.The maximum intra-batch and inter-day variations by ELISA are≤8.23%,≤16.69%respectively.The sensitivity of HBsAg detection by ECLIA is 1.0ng/ml,and linear range of HBsAg is 6.1～390.0 ng/ml.2.In newborns delivered by HBsAg positive mothers,the gender ratio of male to female is 158:100,and the HBeAg infection percentages are 50.60%,49.24% respectively.No statistical significance was found between both infection percentages. The infection percentages of HBsAg fall down to 0.60%and 1.05%separately when the children are half a year old.Conclusions:The ECLIA has a higher sensitivity,better duplicability and wider detection range than EIA for HBsAg assay,possibly a much higher sensitivity for HBeAg assay.ECLIA can detect the hepatitis B markers quantitatively,which not only avoids the shortcoming of missed diagnosis by EIA when hepatitis B markers were in a low concentration during the early stage,but also makes it possible to discover the disease early and monitor the conditions at a "real-time" mode. Moreover,it can block the vertical dissemination of hepatitis B effectively,and succeed in blocking the maternal infant transmission finally.