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Access HBV Assays - European Union (EU) Clinical Trial Protocol -
Sponsor: Beckman Coulter, Inc.
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 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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
21210
Start Date
2019-10-15
Completion Date
2026-05
Last Updated
2024-12-04
Healthy Volunteers
No
Conditions
Interventions
Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
All samples will be tested with both CE-marked HBV serological predicate assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) and Access HBV serological assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) according to respective Instructions For Use to determine non-reactive (NR), initially reactive (IR), repeatedly reactive (RR), or confirmed or not confirmed Positive.
Locations (5)
Centre de Ressources Biologiques Biobanque de Picardie CHU Amiens-Picardie
Amiens, France
Etablissement Français du Sang (EFS) Hauts-de-France - Normandie
Bois-Guillaume, France
Eurofins Biomnis
Ivry-sur-Seine, France
Laboratoire de Virologie, Laboratoire associé au CNR du VIH Institut de Biologie Clinique ; hôpital C : Nicolle, CHU Rouen
Rouen, France
Cerba Xpert
Saint-Ouen-l'Aumône, France