Alinity s Anti-HCV II - Clinical Evaluation Protocol

Abbott

Status: Completed

Conditions: Healthy

Treatments: Device: Alinity s Anti-HCV II

Study type: Interventional

Funder types: Industry

Identifiers

NCT04862065

T3M3-02-19H04-01

Details and patient eligibility

About

The objective of this study is to demonstrate the performance and intended use of the Alinity s Anti-HCV II investigational assay in a donor screening environment using clinical samples to evaluate assay performance. The Alinity s Anti-HCV II assay performance will be evaluated utilizing the Food and Drug Administration (FDA) licensed Alinity s Anti-HCV assay as the comparator method. The data will be used to support regulatory submissions and/or publications.

Full description

This study evaluates the Alinity s Anti-HCV II investigational assay using the Alinity s System.

The Alinity s Anti-HCV II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma specimens on the Alinity s System. The Alinity s Anti-HCV II assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HCV.

The performance of the Alinity s Anti-HCV II assay will be evaluated by performing specificity, and sensitivity testing of the Alinity s Anti-HCV II assay.

To evaluate specificity, approximately 15,000 random unique donor specimens will be collected.

To evaluate sensitivity, Abbott will provide a minimum of 400 frozen samples from U.S. individuals characterized as HCV positive and a minimum of 400 frozen specimens from U.S. individuals at increased risk for HCV infection.

Enrollment: 16,388 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Serum or ethylenediaminetetraacetic acid (EDTA) plasma from a blood donor or a plasma from a plasmapheresis donor.

Exclusion criteria

• Previous participation in this study. Each subject must be represented only once in the study.

Note: Frozen samples (sensitivity) provided by Abbott (403 specimens characterized as positive for HCV and 404 specimens with Increased risk of HCV infection) have no specific inclusion/exclusion criteria that the clinical sites need to verify prior to testing. Inclusion and exclusion criteria only apply to specificity specimens.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16,388 participants in 1 patient group

Screening

Other group

Description:

Alinity s Anti-HCV and Alinity s Anti-HCV II. A follow-up visit may be needed if investigational Alinity s Anti-HCV II result is discordant after supplemental testing.

Treatment:

Device: Alinity s Anti-HCV II