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Turkish Journal of Medical Sciences

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.

Author ORCID Identifier

ÜLKER ÇUHACI: 0000-0002-6420-6185

HANDE TOPTAN: 0000-0001-6893-8490

BENGÜL DURMAZ: 0000-0002-9093-7440

MEHMET KÖROĞLU: 0000-0001-8101-1104

RIZA DURMAZ: 0000-0001-6561-778X

DOI

10.55730/1300-0144.6053

Keywords

artus HBV QS-RGQ kit, DiaRD-HBV qPCR kit, Hepatitis B virus, novel kit

First Page

1003

Last Page

1013

Publisher

The Scientific and Technological Research Council of Türkiye (TÜBİTAK)

Creative Commons License

Creative Commons Attribution 4.0 International License
This work is licensed under a Creative Commons Attribution 4.0 International License.

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