Clinical trial NCT04862065: Alinity s Anti-HCV II - Clinical Evaluation Protocol
Official title: Alinity s Anti-HCV II - Clinical Evaluation Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Abbott Transfusion Medicine
Sponsor class: INDUSTRY
First posted: 2021-04-27
Enrollment: 16388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Evaluation of assay performance characteristics.
Primary purpose: SCREENING

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assay Specificity Results for Participants (Specimens) Tested With Alinity s Anti-HCV II Assay.
timeFrame: Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.
measure: Assay Sensitivity Results for Participants (Specimens) Characterized as Positive Tested With Alinity s Anti-HCV II Assay.
timeFrame: Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.
Secondary outcomes:
measure: Assay Sensitivity Results for Participants (Specimens) With Increased Risk for HCV Tested With Alinity s Anti-HCV II Assay.
timeFrame: Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Innovative Blood Resources
state: Minnesota
city: Knoxville
country: United States
facility: CSL Plasma Inc.
state: Tennessee
city: San Antonio
country: United States
facility: QualTex Laboratories
state: Texas
city: Renton
country: United States
facility: Bloodworks Northwest
state: Washington
Study officials:
affiliation: Bloodworks Northwest
name: Theresa A Nester, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: QualTex Laboratories
name: Thomas S Jones, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CSL Plasma Inc.
name: Toby L Simon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Innovative Blood Resources
name: Jed Gorlin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: