Analytical performance evaluation of MAGLUMI HBeAg and anti-HBe chemiluminescence immunoassays and comparison with the Abbott assays.

BACKGROUND

Hepatitis B e antigen (HBeAg) and its corresponding antibody (anti-HBe) serve as critical serological markers in the evaluation and therapeutic management of Hepatitis B virus (HBV) infection.

STUDY

DESIGN

This retrospective study was designed to evaluate the performance of the newly CE-marked MAGLUMI HBeAg (CLIA) and MAGLUMI Anti-HBe (CLIA) assays by comparing with Abbott Architect HBeAg and Abbott Architect Anti-HBe assays, respectively. Analytical performance was verified in compliance with the guidelines issued by the Clinical and Laboratory Standards Institute (CLSI). Negative and positive specimens were collected to determine negative percent agreement (NPA) and positive percent agreement (PPA) respectively. Analytical specificity was assessed using negative samples containing potentially cross-reacting substances. Additionally, analytical sensitivity was evaluated using 1st WHO International Standard.

RESULTS

The claimed performance specifications for LoB, LoD, linearity, and precision were successfully verified. Both MAGLUMI HBeAg (CLIA) and MAGLUMI Anti-HBe (CLIA) assays exhibited satisfactory NPA and PPA (≥98%). No significant cross-reactivity or interference was observed. Furthermore, all tested plasma matrices demonstrated equivalence to serum in both assays.

CONCLUSIONS

The MAGLUMI HBeAg (CLIA) and MAGLUMI Anti-HBe (CLIA) met the CLIS verification criteria with favorable analytical performance, and achieved high NPA and PPA relative to the Abbott Architect comparative assays. Besides, future concordance assessments based on a large intended cohort, together with independent clinical validation, are required to fully confirm their suitability for routine clinical application and management of HBV infection.