Development of a quantitative real-time detection assay for hepatitis B virus DNA and comparison with two commercial assays

A highly reproducible and sensitive real-time detection assay based on TaqM an technology was developed for the detection of hepatitis B virus (HBV) DN A and compared with two commercially available assays. The assay was valida ted with the Viral Quality Control panel, which also includes EUROHEP HBV D NA standards. This real-time PCR detection system had a dynamic range of 37 3 to 10(10) genome copies per mi and showed an excellent correlation with b oth the commercial HBV Digene Hybrid Capture II microplate assay (Digene Di agnostics) and the HBV MONITOR assay (Roche Diagnostics). To demonstrate it s clinical utility, four chronically HBV-infected patients treated with lam uvidine were monitored using the three different assays. From the results w e concluded that this assay is an excellent alternative for monitoring of H BV-infected patients in routine diagnostics and clinical practice, enabling the analysis of a large dynamic range of HBV DNA in a single, undiluted sa mple.