Conformity of cleia and clia HBsAg quantitative assay with qPCR gold standard in hepatitis B patients

Abstract

Quantitative HBsAg assay is an alternative marker of potential viremia and monitoring response to antiviral treatment. Various methods have been developed to assess HBsAg quantification. This cross-sectional observational research aims to understand the performance of quantitative HBsAg assay with CLEIA (Chemiluminescence Enzyme Immunoassay) and CLIA (Chemiluminescence Immunoassay) methods and their compliance with qPCR. Serum samples were obtained from 69 Hepatitis B patients at the Outpatient Clinic. Quantitative HBsAg assay was performed with Sysmex HISCL-5000 and Mindray CL-900i, HBV DNA by using GeneXpert® HBV Viral Load. The results showed that the HBsAg value of the CLEIA method ranged from 9.77 to >2,500 IU/mL, while the CLIA method ranged from 19.97 to >50,000 IU/mL. Analysis of the CLEIA and CLIA methods showed agreement ((LoA: -5014.01 – 1815.33) with the relationship between the two methods showed a positive correlation (p <0.05). There is a positive correlation between HBsAg results using CLEIA method and HBV DNA (p <0.05) and also between the HBsAg CLIA method and HBV DNA (p <0.05).