Access HBV Assays - European Union (EU) Clinical Trial Protocol -

Inclusion Criteria

• •Subject aged ≥ 18 years,
• •Subject who has provided consent (oral or written) or sample collected under waiver
• •With sufficient volume to perform clinical trial testing
• •And belonging to one of the following enrollment groups:
• •* Unselected blood donors
• •* Hospitalized patients
• •* Presumed HBsAg positive patients by Confirmatory testing of a CE-marked assay
• •* Patients having recovered from natural HBV infection, presumed Anti-HBs positive (i.e. Anti-HBs and Anti-HBc Total positive by CE-marked assays)
• •* Patients having received HBV vaccination, presumed Anti-HBs positive (confirmed by testing at the time of enrollment, i.e. positive for Anti-HBs and negative for Anti-HBc by CE-marked assays).
• •* Presumed Anti-HBc Total positive patients by a CE-marked assay
• •* Presumed Anti-HBc IgM positive patients by a CE-marked assay with acute/recent HBV infection 8
• •* Presumed HBeAg positive patients by a CE-marked assay
• •* Presumed Anti-HBe positive patients by a CE-marked assay
• •* Patients with chronic HBV infection