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Publisher Summary Advances have been made with regard to the development of antiviral therapies against hepatitis B virus (HBV). The three commercially available assays evaluated in this chapter utilize different technologies to detect and quantify HBV DNA. A comparative analysis of three commercially available HBV viral load assays: the Quantiplex™ HBV DNA Assay (Chiron) from Chiron Corporation, the Digene® HBV Test Hybrid Capture® II from Digene Corporation, and the Amplicor HBV MonitorTM Test from Roche Molecular Systems to determine the dynamic range, precision, and clinical utility of each assay is presented in the chapter. In the study described in the chapter, serum samples from HBV-infected patients enrolled in a clinical trial were collected and analyzed using each assay. Viral load results were compared and a statistical analysis evaluating the correlation and the concordance of the three assays was performed. The results generated using Digene correlated more closely with the results obtained using Chiron than with Roche. The version of the Chiron method used was less sensitive than the other two methods. Digene showed an acceptable dynamic range but failed to quantify HBV DNA levels in patients with very low viral loads. |
