Performance Comparison of the artus HBV QS-RGQ and the CAP/CTM HBV v2.0 Assays regarding Hepatitis B Virus DNA Quantification

Abstract

Background. Over 240 million people are chronically infected with hepatitis B virus (HBV), the leading cause of liver cancer worldwide. The quantification of the HBV DNA level is critical for monitoring the efficacy of antiviral treatment of chronic HBV patients. Methods. In our study, we compared the performance of the artus HBV QS-RGQ assay to the CAP/CTM v2.0 test, as a reference method, on 142 Moroccan patients. The analytical performance of the artus HBV QS-RGQ assay, such as the limit of detection, quantification, precision, reproducibility, and linearity, was determined using dilution series from 10 to 0.1 log10 IU/mL. Results. Detection rates and viral loads quantified by the artus HBV QS-RGQ assay were significantly lower than those from the CAP/CTM v2.0 assay (73.94% vs. 82.39%; 3.34±1.94 log10 IU/mL vs. 3.91±2.45 log10 IU/mL; p<0.01). A Bland-Altman plot found a mean difference of CAP/CTM v2.0−artus HBV QS−RGQ=0.5717 log10 IU/mL, with an average range of -1.13 to 2.31 log10 IU/mL. The two methods demonstrated a high correlation (r=0.88) for 100 positive samples, a moderate correlation for samples below 2000 IU/mL (r=0.76), and a very high correlation for the samples above 2000 IU/mL (r=0.95). Linearity of the artus QS-RGQ test ranged from 1.07 to 7.51 log10 IU/mL. Conclusion. The artus HBV QS-RGQ assay showed a strong correlation, precision, and linearity in comparison with the CAP/CTM v2.0. However, viral loads determined by the artus HBV QS-RGQ assay were lower than those determined by the CAP/CTM v2.0 assay.