Çuhaci Ülker, Toptan Hande, Durmaz Bengül, Köroğlu Mehmet, Durmaz Rıza
Department of Medical Microbiology, Faculty of Medicine, Yüksek İhtisas University, Ankara, Turkiye.
Department of Medical Microbiology, Faculty of Medicine, Sakarya University, Sakarya, Turkiye.
Turk J Med Sci. 2025 Jul 8;55(4):1003-1013. doi: 10.55730/1300-0144.6053. eCollection 2025.
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 HBV QS-RGQ kit (comparator kit).
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.
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 log between the novel kit and comparator kit. The median viral load detected by the novel kit was 6.21 × 10 IU/mL (range: 0.9 × 10 to 2.98 × 10) as compared to the comparator kit where it was 5.43 × 10 IU/mL (range: 1.00 × 10 to 2.87 × 10). The correlation plot demonstrated a strong linear relationship (R 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.
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.
背景/目的：乙型肝炎病毒（HBV）可导致广泛的慢性感染，可能引发肝硬化和肝细胞癌等长期并发症。使用灵敏的分子方法进行HBV DNA定量检测，对疾病的诊断和监测发挥了重要作用。本研究旨在评估新型DiaRD HBV qPCR试剂盒（新型试剂盒）与HBV QS-RGQ试剂盒（对照试剂盒）相比的诊断性能。
使用这两种试剂盒对总共288份血浆样本进行检测，其中105份HBV DNA阳性样本，183份HBV DNA阴性样本。将新型试剂盒的诊断和定量结果与对照试剂盒的结果进行比较。
新型试剂盒具有非常高的灵敏度、特异性和准确性，比率均>99.9%。对105份HBV DNA阳性样本进行的比较分析显示，新型试剂盒与对照试剂盒之间差异不显著，相差≥1个对数。新型试剂盒检测到的病毒载量中位数为6.21×10 IU/mL（范围：0.9×10至2.98×10），而对照试剂盒为5.43×10 IU/mL（范围：1.00×10至2.87×10）。相关性图显示两种试剂盒之间存在很强的线性关系（R值为0.9655）。对三种不同HBV DNA载量进行的重复性测试显示总体变异系数<5%。通过Bland-Altman分析，两种试剂盒定量结果的平均差异为-0.03 log IU/mL。
本研究结果表明，这种新型DiaRD HBV qPCR试剂盒可用于HBV感染的常规诊断和监测。
