Comparison of novel DiaRD-HBV DNA qPCR kit with the artus HBV QS-RGQ kit for quantification of HBV DNA in clinical samples.

Abstract

Background/aim: Hepatitis B virus (HBV) leads to widespread chronic infections that may result in long-term complications such as cirrhosis and hepatocellular carcinoma. The use of sensitive molecular methods for HBV DNA quantitation has provided significant contributions for diagnosis and monitoring of disease. The current study aimed to evaluate the diagnostic performances of a novel DiaRD HBV qPCR kit (novel kit) in comparison with the artus HBV QS-RGQ kit (comparator kit).

Materials and methods: A total of 288 plasma samples-105 HBV DNA-positive and 183 HBV DNA-negative-were tested using both kits. The diagnostic and quantitative results of the novel kit were compared to those of the comparator kit.

Results: The novel kit had very high sensitivity, specificity, and accuracy with rates of >99.9%. Comparative analyses conducted on 105 HBV DNA-positive samples showed no significant differences of ≥ 1 log₁₀ between the novel kit and comparator kit. The median viral load detected by the novel kit was 6.21 × 10⁷ IU/mL (range: 0.9 × 10¹ to 2.98 × 10⁹) as compared to the comparator kit where it was 5.43 × 10⁷ IU/mL (range: 1.00 × 10¹ to 2.87 × 10⁹). The correlation plot demonstrated a strong linear relationship (R² value of 0.9655) between the two kits. Reproducibility testing performed on three different HVB DNA loads showed the overall coefficient of variations <5%. The mean difference between the quantitative results of two kits was -0.03 log IU/mL by Bland-Altman analysis.

Conclusion: The result of the current study indicates that this novel DiaRD HBV qPCR kit can be used in routine diagnosis and monitoring of HBV infections.