Clinical Performance Evaluation of DxN HBV Assay

Clinical Utility of the DxN HBV Assay as an Aid in the Management of HBV-Infected Individuals Undergoing Antiviral Therapy

The DxN Hepatitis B Virus (HBV) Assay is an in vitro diagnostic assay intended as an aid in the management of HBV-infected individuals undergoing antiviral therapy. The purpose of the study is to establish the clinical performance of the DxN HBV Assay for plasma samples in the intended use population.

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Inclusion Criteria:

• Subject is 18 years of age or older
• Subject has serological evidence of chronic HBV infection, and measurable HBV-DNA and ALT at baseline
• Subject will undergo treatment with tenofovir or entecavir for a minimum of 48 weeks

Exclusion Criteria:

• Co-infection with HIV or HCV at enrollment
• Subject has decompensated liver disease or liver cancer
• Prior participation in study
• Current or planned participation in an investigational drug or device study