Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-24 @ 10:15 PM
NCT ID:
NCT04904835
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.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04904835
Study Brief:
Protocol Section:
NCT04904835