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Real-Time Polymerase Chain Reaction-Based Detection and Quantification of Hepatitis B Virus DNA
Published on: December 15, 2023
Hepatitis B virus core and core-related antigen quantitation in Chinese patients with chronic genotype B and C
Akinori Rokuhara1, Xiaohong Sun, Eiji Tanaka
1Department of Medicine, Shinshu University School of Medicine, Matsumoto, Japan.
Insights
New Hepatitis B virus (HBV) assays measuring HBcrAg and HBcAg are clinically useful for quantifying HBV DNA in Chinese patients with chronic HBV genotypes B and C. These assays aid in analyzing infection status.
Area of Science:
- Hepatology
- Virology
- Clinical Diagnostics
Background:
- Hepatitis B virus (HBV) infection is a global health concern.
- Accurate measurement of HBV viral load is crucial for patient management.
- Existing methods for HBV quantitation have limitations.
Purpose of the Study:
- To develop and assess the clinical utility of Hepatitis B virus (HBV) core-related antigen (HBcrAg) and HBV core antigen (HBcAg) assays.
- To evaluate these assays for measuring serum HBV load in Chinese patients with chronic HBV genotypes B and C.
Main Methods:
- Serum HBcrAg and HBcAg were measured using chemiluminescence enzyme immunoassay.
- HBV DNA levels were quantified via sensitive polymerase chain reaction (PCR) assay.
- Data were analyzed for HBV genotypes B and C, including the HBcrAg/HBcAg ratio in relation to HBeAg status.
Main Results:
- Significant positive correlations were observed between HBcrAg/HBcAg concentrations and HBV DNA levels in both HBV/B and HBV/C genotypes (P < 0.001).
- Established cut-off values for positive HBcAg and HBcrAg assays were determined.
- The HBcrAg/HBcAg ratio was significantly higher in patients with hepatitis B e antigen (HBeAg) positivity.
Conclusions:
- HBcrAg and HBcAg assays demonstrate clinical utility for viral quantitation in chronic Hepatitis B genotypes B and C.
- These assays, particularly in combination, offer a valuable tool for analyzing the clinical status of HBV infection.
Background And Aims:
Hepatitis B virus (HBV) core-related antigen (HBcrAg) and HBV core antigen (HBcAg) assays were developed for the measurement of serum HBV load. The aim of this study was to assess the clinical utility of these assays in Chinese patients with chronic genotype B and C HBV infection.
Methods:
One hundred and ninety-three chronic hepatitis B patients were enrolled. Serum HBcrAg and HBcAg were measured by chemiluminescence enzyme immunoassay, and HBV-DNA was measured by using a sensitive polymerase chain reaction assay. The data were analyzed in patients with HBV genotype B (HBV/B) and genotype C (HBV/C). The HBcrAg/HBcAg ratio was calculated and compared between patients with and without hepatitis B e antigen (HBeAg).
Results:
The concentrations of HBcrAg and HBcAg showed significant positive correlation with the HBV-DNA concentration in both HBV/B (r = 0.79, P < 0.001, and r = 0.77, P < 0.001, respectively) and HBV/C (r = 0.87, P < 0.001, and r = 0.90, P < 0.001, respectively). The cut-off for a positive HBcAg corresponded to approximately 4.5 log copies/mL, and that for a positive HBcrAg result corresponded to 3-4 log copies/mL. The HBcrAg/HBcAg ratio was higher in patients with HBeAg than in those without HBeAg.
Conclusions:
The HBcrAg assay and HBcAg assay are clinically useful in viral quantitation of HBV/B and HBV/C. A combination of these assays would be a valuable tool for analyzing the clinical status of HBV infection.
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