Comparison of a novel real-time PCR method (RTA) and Artus RG for the quantification of HBV DNA and HCV RNA

Introduction: The purpose of this study was to evaluate and compare two manual isolation and real-time (RT) polymerase chain reaction (PCR) kits (RTA RT-PCR with RTA isolation kit and Artus RG RT-PCR with QIAamp isolation kit) for molecular diagnosis of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections. Methodology: The study was conducted on 121 and 54 clinical samples for the detection of HBV DNA and HCV RNA, respectively, with an additional 8 HCV RNA external quality control samples. Results: Though a high correlation was observed between the two kits for the HBV DNA (r = 0.955, p = 0.001) and HCV RNA quantifications (r = 0.828, p = 0.001), discordant results were found in nine of the HBV DNA and in six of the HCV RNA samples. The mean difference between the two systems was found to be 0.4 log IU/mL in Quality Control for Molecular Diagnostics (QCMD) HCV RNA samples by Bland-Altman analysis. Conclusions: Although there was a high correlation between HBV DNA and HCV RNA tests according to the results of the study, the RTA system requires improvement for the determination of HCV RNA.