Testing new hepatitis B virus assays in Europe
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
This study is testing new blood tests for hepatitis B to see how well they work in different groups of people, including blood donors and patients in hospitals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 21210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beckman Coulter, Inc. Industry-sponsored |
| Locations | 5 sites (Amiens and 4 other locations) |
| Trial ID | NCT04904835 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to collect and test clinical samples to evaluate the performance of Access HBV serological marker assays using the DxI 9000 Access Immunoassay Analyzer. It involves both prospective and retrospective sample collection from various groups, including blood donors and hospitalized patients. The study will assess the sensitivity and specificity of the assays, as well as the false initial reactive rate for the HBsAg assay. All samples will be anonymized or pseudo-anonymized, with patient consent required for pseudo-anonymized samples.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who belong to specific enrollment groups related to hepatitis B status.
Not a fit: Patients without any history or indication of hepatitis B virus infection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of hepatitis B virus diagnostics, leading to better patient management.
How similar studies have performed: Other studies have shown success with similar serological assays, indicating a promising approach for hepatitis B diagnostics.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Amiens and 4 other locations
- Centre de Ressources Biologiques Biobanque de Picardie CHU Amiens-Picardie — Amiens, France (Recruiting)
- Etablissement Français du Sang (EFS) Hauts-de-France - Normandie — Bois Guillaume, France (Not_yet_recruiting)
- Eurofins Biomnis — Ivry-sur-Seine, France (Recruiting)
- Laboratoire de Virologie, Laboratoire associé au CNR du VIH Institut de Biologie Clinique ; hôpital C : Nicolle, CHU Rouen — Rouen, France (Recruiting)
- Cerba Xpert — St Ouen l'Aumone, France (Recruiting)
Study contacts
- Study coordinator: Juliane HEY, Dr
- Email: jhey@beckman.com
- Phone: +33 645 23 81 74
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.