Multicenter evaluation of the Elecsys hepatitis B surface antigen quantitative assay

Area of Science:

• Clinical Chemistry
• Immunology
• Hepatology

Background:

• Hepatitis B virus (HBV) infection remains a global health concern.
• Accurate quantification of hepatitis B surface antigen (HBsAg) is crucial for managing chronic hepatitis B (CHB).
• Existing assays may require manual dilutions, increasing complexity and potential for error.

Purpose of the Study:

• To evaluate the performance of the novel Elecsys hepatitis B surface antigen (HBsAg) II quantitative assay.
• To assess the assay's accuracy, precision, and reliability in routine clinical samples.
• To determine the effectiveness of its onboard dilution and algorithm for HBsAg quantification.

Main Methods:

• Performance evaluation of the Elecsys HBsAg II assay using 611 routine serum samples from HBsAg carriers and CHB patients across five international centers.
• Assessment of serial dilutions (1:100 to 1:1,000,000) to evaluate the onboard dilution algorithm and assay linearity.
• Determination of assay precision and assessment for high-dose hook effect.

Main Results:

• 70.0% to 85.6% of samples yielded results within the linear range on the first test using onboard dilution.
• No high-dose hook effect was observed up to 870,000 IU/ml.
• High assay precision was demonstrated across different analyzers (CV: 1.4%–9.6%) for HBsAg concentrations ranging from 0.1 to 37,300 IU/ml.
• Reliable HBsAg quantification was achieved across various HBV genotypes, infection phases, and disease stages.

Conclusions:

• The Elecsys HBsAg II quantitative assay provides accurate and reliable HBsAg measurement in routine clinical settings.
• The integrated onboard dilution and simple algorithm enhance efficiency by minimizing retesting and potential errors.
• This assay is suitable for diverse patient populations with chronic hepatitis B.