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

HCV Clinical Trial

— HCV-EU-10-18  

Official title:

Evaluation of the Beckman Coulter Access Anti-HCV Assay as an Aid in the Diagnosis of HCV Infection: EU Clinical Trial Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04971330
• Other study ID #: DC-TR18-0406
• Status: Completed
• Start date: November 4, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: July 2021
• Source: Beckman Coulter, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The study involved a multicenter, prospective and retrospective collection of samples, and testing of samples with the investigational Access anti-HCV assay. Subject sample enrollment was targeted to be approximately 8,000 specimens including approximately 6,000 blood donors and 1,500 hospitalized individuals for the specificity populations and 500 confirmed HCV Ab positive patients for the sensitivity population, required by European Union's Common Technical Specification for clinical validation of in vitro diagnostic medical devices and marketing needs to align with competitor submissions. Retrospective collection included HCV Ab positive genotyped samples from existing vendor collections meeting all inclusion/exclusion criteria.

All samples collected were anonymized, leftover, remnant samples and therefore member state or Institutional Review Board/Independent Ethics Committee approval was not required. Diagnostic sensitivity and specificity were evaluated for sample antibody status determined by a CE-marked anti-HCV assay (Abbott ARCHITECT anti-HCV assay for hospitalized patient and positive samples or Abbott PRISM HCV assay for blood donor samples) and Immunoblot testing with FUJIREBIO INNO-LIA HCV Score, if necessary. HCV RNA Polymerase Chain Reaction (PCR) or genotyping was requested or was available on all Immunoblot positive samples for further characterization, but these results were not used to determine final antibody status.

A portion of hospitalized patient samples (target 700/1500) and the majority of positive HCV Ab samples were collected and stored frozen prior to testing. A targeted portion of 800 hospitalized patient samples, 30 known positive samples and all blood donor samples were collected and tested fresh. Fresh blood donor and fresh hospitalized patient samples were used to determine false Initial Reactive Rate (IRR).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7901
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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)

Exclusion Criteria:

• Samples from subjects already included in the study

Related Conditions & MeSH terms

• HCV

Intervention

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

Locations

Country	Name	City	State
France	Etablissement Français du Sang (EFS) Hauts-de-France - Normandie	Bois-Guillaume
France	Eurofins Biomnis	Ivry-sur-Seine
France	Cerba Xpert	Saint-Ouen-l'Aumône

Sponsors (1)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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