Multicenter performance evaluation of the Atellica IM HBcT2 immunoassay for risk or symptom-driven hepatitis B core antibody testing

Abstract

Background

Hepatitis B virus (HBV) causes major liver disease and despite widespread vaccination, HBV infection, often asymptomatic, remains a global health issue. Serological detection of HBV biomarkers, including total antibodies (IgM and IgG) to hepatitis B core antigen (HBc) is recommended as a first step for diagnosis and infection status assessment. The aim of our study was to evaluate the performance characteristics of the improved automated Atellica IM HBcT2 assay designed to detect total anti-HBc responses without a retest zone.

Methods

Reproducibility, clinical performance, and seroconversion studies were performed at three U.S. sites. Clinical performance testing included: 1751 prospective (pediatric, adult) specimens, representing U.S. populations across the lifespan at risk or symptomatic of HBV disease. Positive percent agreement (PPA) and negative percent agreement (NPA) for the Atellica IM HBcT2 assay were assessed against the reference Abbott ARCHITECT CORE assay. Analytical correlation was evaluated by regression analysis.

Results

The assay demonstrated robust reproducibility with %CV ≤10 % for samples ≥0.80 Index. Qualitative agreement between methods was excellent in the population overall as well as most HBV status categories (overall PPA=98 %, NPA=99 %). A high quantitative agreement was observed (slope, 0.89; Pearson’s r, 0.914). Seroconversion results showed that changes in anti-HBc total concentration of Atellica IM HBcT2 closely matched those of ARCHITECT CORE.

Conclusion

The Atellica IM HBcT2 assay on the Atellica IM analyzer demonstrated reliable clinical performance for detecting total anti-HBc antibodies, supporting its suitability for risk or symptom-driven testing in the diagnosis of HBV infection.