NCT04904835Completed
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
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 21210 (actual)
- First submitted
- 18 May 2021
- Start date
- 15 Oct 2019
- Primary completion date
- 9 Dec 2025
- Lead sponsor
- Beckman Coulter, Inc.
- Diseases
- Hepatitis B
- NCT number
- NCT04904835
What you commit to
- Study type: Observational
- Participants enrolled: 21210
- From 15 Oct 2019 to the primary completion date, 9 Dec 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de Ressources Biologiques Biobanque de Picardie CHU Amiens-Picardie Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| Etablissement Français du Sang (EFS) Hauts-de-France - Normandie Coordinator of this site? Confirm its status | Bois-Guillaume | France | Unknown status |
| Cerba Xpert Coordinator of this site? Confirm its status | Frépillon | France | Unknown status |
| Eurofins Biomnis Coordinator of this site? Confirm its status | Ivry-sur-Seine | France | Unknown status |
| Laboratoire de Virologie, Laboratoire associé au CNR du VIH Institut de Biologie Clinique ; hôpital C : Nicolle, CHU Rouen Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.