In this communication we introduce the quantitative determination of HBV DNA in serum We used real-time PCR method performed by LightCycler (Roche Diagnostics). First aim of this work was to distinguish the concentration values between the group of patients with chronic hepatitis B in replication phase and patients with integrated HBV DNA. Second aim was to obtain the decision limit for the beginning of patients treatment. While in patients with chronic hepatitis B in replication phase we obtained HVB DNA values in interval 1,42 × 105 – 1,8 × 109 copies/ml, these values in patients with integrated HBV DNA were significantly lower and ranged in interval < 103 – 4,2 × 105 copies/ml. We used the value of 4,2 × 105 copies HBV DNA/ml as decision limit for beginning the treatment. Introduced method shows very good precision (< 10% in clinically useful area) and very broad linearity range – 103 – 108 copies HBV DNA/ml. Diagnostic accuracy of method was assessed by mean of ROC analysis. We determined AUC value 0.995, clinical sensitivity for given decision limit 100%, specificity 96% and positive likelihood ratio (LR+) 26.0. All analytical and clinical characteristics of introduced method show their usefulness for diagnosis and treatment of chronic hepatitis B.

        Key words: hepatitis B – HBV DNA quantification – real-time PCR – LightCycler – ROC analysis