Multicenter clinical evaluation of alinity m HBV assay performance

Area of Science:

• Virology
• Molecular Diagnostics
• Clinical Chemistry

Background:

• Accurate detection and quantification of hepatitis B virus (HBV) DNA are crucial for managing chronic HBV infections.
• Molecular assays guide treatment decisions, assess treatment response, and predict HBV-related complications.
• New real-time HBV DNA platforms offer rapid results (2-3 hours) with continuous loading and random access.

Purpose of the Study:

• To evaluate the clinical performance of the Alinity m HBV assay for detecting and quantifying HBV DNA.
• To assess the accuracy of the Alinity m HBV assay using patient samples with diverse HBV genotypes.
• To examine the precision and reproducibility of the Alinity m HBV assay on the Alinity m platform.

Main Methods:

• An international, multisite study was conducted.
• The Alinity m HBV assay's performance was compared against four existing clinical HBV assays.
• Clinical performance was assessed using patient samples with various HBV genotypes.

Main Results:

• The Alinity m HBV assay demonstrated linear quantitation of HBV DNA with high precision (CV 4.1%-8.8%) and reproducibility.
• Excellent correlation (r ≥0.947) was observed between the Alinity m HBV assay and comparator assays, with minimal bias (-0.07 to 0.17 Log10 IU/mL).
• 97% of quantifiable results showed less than 1 Log10 IU/mL difference compared to other assays, with consistent performance across HBV genotypes.

Conclusions:

• The Alinity m HBV assay, a real-time PCR-based method, is sensitive and reproducible.
• It accurately quantifies HBV DNA levels in HBsAg-positive patients across its dynamic range.
• This assay is a valuable tool for the clinical management of hepatitis B virus infections.