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

NCT04971330 | Completed

• 1 other identifier: DC-TR18-0406
• Study Type: observational
• Target: 7,901
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this study was the collection and testing of clinical samples to determine the clinical performance in terms of diagnostic accuracy measured by specificity and sensitivity of the Access anti-Hepatitis C Virus (anti-HCV) assay on the DxI 9000 Access Immunoassay Analyzer. The Design Input Document (DID) indicates performance requirements and minimum target enrollment numbers (based on those in the CTS) of blood donor, hospitalized patient and known HCV antibody (Ab) positive samples for novel anti-HCV assays. A secondary objective was to determine the false initial reactive rate (IRR) of the Access anti-HCV assay.

Conditions

HCV

Outcome Measures

Primary Outcomes (1)

• sensitivity and specificity

  sensitivity and specificity relative to the final patient HCV Ab status determined from reference HCV Ab assay and/or supplemental confirmation testing (HCV Ab result by immunoblot).

  Baseline

Study Arms (3)

Known HCV Ab Positive Patients

leftover samples be 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 will be Abbott Architect anti-HCV assay for positive samples.

Diagnostic Test: Access HCV

Hospitalized Patients

leftover samples be 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 will be Abbott Architect anti-HCV assay for hospitalized patient. 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

Diagnostic Test: Access HCV

Unselected Blood Donors

Leftover samples be 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. les. For blood donors, Abbott PRISM HCV will be 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.

Diagnostic Test: Access HCV

Interventions

Access HCV DIAGNOSTIC_TEST

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

Hospitalized Patients; Known HCV Ab Positive Patients; Unselected Blood Donors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The test population includes : * 513 Known HCV Ab Positive Patients * 1533 Hospitalized patients * 5855 Unselected Blood donors

You may qualify if:

• Anonymized or pseudo-anonymised leftover ethylenediaminetetraacetic acid (EDTA) plasma/serum samples from
• Males or females
• Aged ≥18 years of age
• Belonging to one of the following enrollment groups
• Unselected blood donor
• Hospitalized patient from GI, hepatology, Internal Medicine or Infectious Disease services
• Known HCV Ab positive (by Immunoblot) at different stages of disease
• with at least 1.5 mL leftover sample (without genotype or PCR on same draw) OR
• at least 0.8 mL leftover sample (with genotype or HCV PCR on same draw)

You may not qualify if:

• Samples from subjects already included in the study

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead

Study Sites (3)

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

Bois-Guillaume, 76232, France

Location

Eurofins Biomnis

Ivry-sur-Seine, 94208, France

Location

Cerba Xpert

Saint-Ouen-l'Aumône, 95310, France

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 21, 2021
• Study Start: November 4, 2019
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)