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

Launched by BECKMAN COULTER, INC. · May 25, 2021

Keywords

ClinConnect Summary

The Access HBV Assays clinical trial is studying new tests for detecting the Hepatitis B virus (HBV) using samples collected from various groups of people. The goal is to evaluate how well these tests work in identifying HBV infections and to ensure they meet the required standards in the European Union. The study will include both new samples and leftover samples from patients who have given consent for their use. Participants may come from different backgrounds, such as blood donors, hospitalized patients, or those with known HBV infections.

To be eligible for this trial, participants must be at least 18 years old and provide consent for their samples to be tested. They can include people who are healthy blood donors, those diagnosed with HBV, individuals who have recovered from HBV infections, or those who have been vaccinated against HBV. If you choose to participate, you will be contributing to important research that may help improve the diagnosis and management of Hepatitis B in the future. Remember, your samples will be treated confidentially and will not be linked to your identity.

Gender

ALL

Eligibility criteria

• 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.)