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

Evaluation of the Beckman Coulter Access Hepatitis B Virus (HBV) Serological Marker Assays as an Aid in the Diagnosis of HBV Infection: EU Clinical Trial Protocol

The objective of this protocol is the collection and testing of clinical samples to determine the clinical performance of the Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer.

The study will involve a multicenter, prospective and retrospective collection of samples, and testing of samples with the investigational Hepatitis B Virus assays as required per the European Union Common Technical Specification. All samples collected will be anonymized or pseudo-anonymised, leftover, remnant samples. Pseudo-anonymised collection of samples will require documented patient consent (oral or written).

Sensitivity to final status on presumed HBV serological marker positive subjects will be calculated. Specificity will be calculated from hospitalized patients and blood donors specimens. False Initial Reactive Rate will be calculated on fresh hospitalized patient samples for Access HBsAg assay only (Qualitative).

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

Exclusion Criteria:

• Samples from subjects already included in the study* (* Patient can be included only once per HBV marker study, but can potentially be enrolled for several separate HBV marker studies.)