21,210
Participants
Start Date
October 15, 2019
Primary Completion Date
December 31, 2025
Study Completion Date
May 31, 2026
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.
RECRUITING
Laboratoire de Virologie, Laboratoire associé au CNR du VIH Institut de Biologie Clinique ; hôpital C : Nicolle, CHU Rouen, Rouen
NOT_YET_RECRUITING
Etablissement Français du Sang (EFS) Hauts-de-France - Normandie, Bois-Guillaume
RECRUITING
Centre de Ressources Biologiques Biobanque de Picardie CHU Amiens-Picardie, Amiens
RECRUITING
Eurofins Biomnis, Ivry-sur-Seine
RECRUITING
Cerba Xpert, Saint-Ouen-l'Aumône
Lead Sponsor
Beckman Coulter, Inc.
INDUSTRY