Analytical Performance Comparison of Three Quantitative Hepatitis B Surface Antigen Assays

Area of Science:

• Clinical Chemistry
• Virology
• Assay Development

Background:

• Quantitative hepatitis B surface antigen (qHBsAg) assays are crucial for monitoring hepatitis B virus (HBV) infection and treatment.
• No FDA-authorized qHBsAg assay currently exists in the U.S., necessitating performance evaluations of available methods.

Purpose of the Study:

• To evaluate the analytical performance of three commercial qHBsAg assays: Abbott Architect, Roche Elecsys, and DiaSorin LIAISON.
• To assess assay precision, accuracy, sensitivity, linearity, and lot-to-lot variability against WHO International Standards.

Main Methods:

• Analytical performance testing of Architect, Elecsys, and LIAISON qHBsAg assays.
• Evaluation followed CLSI guidelines using WHO International Standards (12/226, 03/262).
• Clinical accuracy assessed using 72 HBsAg-positive specimens.

Main Results:

• Lower limits of quantification: Architect (0.02 IU/mL), Elecsys (0.07 IU/mL), LIAISON (1.02 IU/mL).
• LIAISON showed limited linearity, high variability in high HBsAg samples, and significant lot-to-lot variability.
• All assays demonstrated acceptable precision and accuracy, with LIAISON requiring recalibration.

Conclusions:

• Architect and Elecsys assays possess adequate analytical performance for clinical application.
• LIAISON assay performance was constrained by linearity, quantification limits, and variability.
• Standardization of qHBsAg assays is vital for accurate HBsAg quantification and effective clinical management of HBV.