Access Anti-HCV Assay European Union (EU) Clinical Trial Protocol

CompletedOBSERVATIONAL
Enrollment

7,901

Participants

Timeline

Start Date

November 4, 2019

Primary Completion Date

March 30, 2021

Study Completion Date

March 30, 2021

Conditions
HCV
Interventions
DIAGNOSTIC_TEST

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"

Trial Locations (3)

76232

Etablissement Français du Sang (EFS) Hauts-de-France - Normandie, Bois-Guillaume

94208

Eurofins Biomnis, Ivry-sur-Seine

95310

Cerba Xpert, Saint-Ouen-l'Aumône

Sponsors
All Listed Sponsors
lead

Beckman Coulter, Inc.

INDUSTRY