7,901
Participants
Start Date
November 4, 2019
Primary Completion Date
March 30, 2021
Study Completion Date
March 30, 2021
Access HCV
"All samples were tested with both reference anti-HCV assay and Access anti-HCV assay according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity. Reference assay was Abbott Architect anti-HCV assay. For blood donors, Abbott PRISM HCV was used as reference.~For the specificity cohorts (blood donor and hospitalized patient samples), all HCV Ab positive results will have supplemental confirmation testing with HCV Immunoblot for final HCV Ab status"
Etablissement Français du Sang (EFS) Hauts-de-France - Normandie, Bois-Guillaume
Eurofins Biomnis, Ivry-sur-Seine
Cerba Xpert, Saint-Ouen-l'Aumône
Lead Sponsor
Beckman Coulter, Inc.
INDUSTRY