Study Compares Analytical Performance of Quantitative Hepatitis B Surface Antigen Assays

 Quantitative measurement of hepatitis B surface antigen (qHBsAg) has become an important tool for evaluating disease status and informing treatment strategies. Researchers now report an analytical comparison of three commercial quantitative HBsAg assays, highlighting performance differences and the need for harmonization as no HBsAg assays are currently authorized by the U.S. Food and Drug Administration.

The evaluation compared three quantitative hepatitis B surface antigen (qHBsAg) assays: Architect HBsAg (Abbott) qualitative assay, which was adapted for quantitative use; Elecsys HBsAg II quant II (Roche), and LIAISON XL Murex HBsAg Quant (DiaSorin). These assays quantify circulating hepatitis B surface antigen to monitor infection status and response to antiviral therapy, often serving as primary endpoints in hepatitis B virus trials.

Analytical performance was assessed for precision, accuracy, sensitivity, linearity, and lot-to-lot variability using World Health Organization (WHO) International Standards 12/226 and 03/262 in accordance with Clinical and Laboratory Standards Institute (CLSI) guidelines. Clinical accuracy was further examined using 72 HBsAg‑positive clinical specimens.

The lower limits of quantification were 0.02 IU/mL for Architect, 0.07 IU/mL for Elecsys, and 1.02 IU/mL for LIAISON. While all three assays demonstrated acceptable overall precision and accuracy, the LIAISON showed reduced linearity, greater variability at high antigen concentrations, and notable lot-to-lot variability. As a result, the LIAISON assay required recalibration using the WHO International Standard 03/262 to achieve comparable performance.

The authors concluded that Architect and Elecsys exhibited sufficient analytical performance for clinical use, whereas LIAISON performance was constrained by linearity, lower limit of quantification, and lot variability. They emphasized that standardization is essential to ensure consistent and accurate HBsAg quantification for clinical monitoring and treatment goal setting. The study, conducted by investigators from the University of Washington, Chosun University, and Fred Hutchinson Cancer Research Center, was published in Clinical Chemistry on January 16, 2026.