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Author Spotlight: Advancements and Challenges in Hepatitis B Virus Detection
Published on: December 15, 2023
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Measuring hepatitis B pgRNA stability using an updated automated HBV pgRNA assay with increased sensitivity
Mark Anderson1, Michael Stec1, Emily P Thi2
1Infectious Disease Research, Abbott Diagnostics, Abbott Park, Illinois, USA.
Hepatology Communications
|March 17, 2023
Summary
Enhanced Hepatitis B virus pgRNA assays improve detection of low viral levels and demonstrate excellent stability, aiding in treatment monitoring and outcomes. This advancement offers new insights for managing chronic HBV infection.
Area of Science:
- Hepatology and Viral Hepatitis Research
- Molecular Diagnostics and Biomarker Development
- Pharmacodynamics and Treatment Efficacy Studies
Background:
- Hepatitis B virus pregenomic RNA (HBV pgRNA) serves as a biomarker for viral activity and treatment response in HBV-infected individuals.
- Limited data exist on the stability of HBV pgRNA, impacting its utility in clinical settings.
- Enhanced assay sensitivity for HBV pgRNA could improve predictive value and provide insights at low viral loads.
Purpose of the Study:
- To develop and validate a highly sensitive assay for quantifying HBV pgRNA.
- To assess the stability of HBV pgRNA under various storage and handling conditions.
- To evaluate the performance of the enhanced assay in detecting low viral titers and in patients undergoing antiviral therapy.
Main Methods:
- A modified, fully automated HBV pgRNA assay (v2) was developed, achieving up to 15-fold increased sensitivity compared to the previous version (v1).
- Flexible sample input volumes were implemented, resulting in lower limits of quantitation (10-22 copies/mL).
- Assay results were standardized to WHO HBV DNA standards, with internal and external controls incorporated. Stability was tested across freeze-thaw cycles and different temperature storage durations.
Main Results:
- The v2 assay demonstrated significantly increased sensitivity, reducing the limit of quantitation from 152 copies/mL (v1) to 10-22 copies/mL.
- The enhanced assay improved detection and quantitation of HBV pgRNA in treatment-naive donors and patients receiving siRNA therapy (AB-729).
- HBV pgRNA exhibited excellent stability, with minimal degradation after 3 freeze-thaw cycles, 7 days at 25-37°C, and 30 days at 4°C.
Conclusions:
- The enhanced HBV pgRNA v2 assay offers improved sensitivity and flexible input volumes for detecting and quantifying low viral titers.
- Highly sensitive HBV pgRNA assays hold potential for refining predictive treatment outcomes.
- Demonstrated HBV pgRNA stability enhances the reliability of this biomarker in clinical applications.
