Status:
RECRUITING
Access HBV Assays - European Union (EU) Clinical Trial Protocol -
Lead Sponsor:
Beckman Coulter, Inc.
Conditions:
HBV
Eligibility:
All Genders
18+ years
Brief Summary
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 An...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
October 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
21210 Patients enrolled
Trial Details
Trial ID
NCT04904835
Start Date
October 15 2019
End Date
May 1 2026
Last Update
December 4 2024
Active Locations (5)
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1
Centre de Ressources Biologiques Biobanque de Picardie CHU Amiens-Picardie
Amiens, France, 80054
2
Etablissement Français du Sang (EFS) Hauts-de-France - Normandie
Bois-Guillaume, France, 76232
3
Eurofins Biomnis
Ivry-sur-Seine, France, 94208
4
Laboratoire de Virologie, Laboratoire associé au CNR du VIH Institut de Biologie Clinique ; hôpital C : Nicolle, CHU Rouen
Rouen, France, 76031