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

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