Alinity s Anti-HCV II - Clinical Evaluation Protocol

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT04862065
• Lead Sponsor: Abbott Transfusion Medicine

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.

Study Timeline

• Study Start: 2021-04-19
• Study First Submitted: 2021-04-23
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-27
• Primary Completion: 2021-06-21
• Study Completion: 2021-08-05
• Results First Submitted: 2022-07-22
• Results First Submitted QC: 2022-08-17
• Status Verified: 2022-09
• Results First Posted: 2022-09-16
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16388

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Assay Specificity Results for Participants (Specimens) Tested With Alinity s Anti-HCV II Assay.	Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.	A total of 15,526 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with the investigational Alinity s Anti-HCV II assay. Repeatedly reactive specimens were tested further with supplemental assays, if required, to determine final status.; Anti-HCV II Repeatedly Reactive, Final Status Indeterminate = B; Anti-HCV II Repeatedly Reactive, Final Status Negative = C; Anti-HCV II Nonreactive, Final Status Negative = F; Specificity is calculated as the proportion of nonreactive specimens from specimens with negative status: F / (C+F) × 100%; Specificity can be also calculated as the proportion of nonreactive specimens with negative status from specimens with negative status and repeatedly reactive specimens with indeterminate status: F / (C + B + F) × 100%
Assay Sensitivity Results for Participants (Specimens) Characterized as Positive Tested With Alinity s Anti-HCV II Assay.	Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.	A total of 403 specimens characterized as positive for HCV were obtained from specimen vendors and tested with the investigational Alinity s Anti-HCV II assay.; Anti-HCV II Repeatedly Reactive, Final Status Positive = A; Anti-HCV II Nonreactive, Final Status Positive = D; Anti-HCV II Nonreactive, Final Status Indeterminate = E; Sensitivity is calculated as the proportion of repeatedly reactive specimens from specimens with positive final status: A / (A+D) × 100%; Sensitivity can also be calculated as the proportion of repeatedly reactive specimens with positive status from specimens with positive status and nonreactive specimens with indeterminate status: A / (A + D + E) × 100%

Secondary Outcome Measures

Name	Time	Method
Assay Sensitivity Results for Participants (Specimens) With Increased Risk for HCV Tested With Alinity s Anti-HCV II Assay.	Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.	404 specimens from subjects at increased risk for HCV infection were obtained from specimen vendors and tested with investigational Alinity s Anti-HCV II assay. Repeatedly reactive specimens were tested further with supplemental assays, if required, to determine final status.; Anti-HCV II Repeatedly Reactive, Final Status Positive = A; Anti-HCV II Nonreactive, Final Status Positive = D; Anti-HCV II Nonreactive, Final Status Indeterminate = E; Sensitivity is calculated as the proportion of repeatedly reactive specimens from specimens with positive final status: A / (A+D) × 100%; Sensitivity can also be calculated as the proportion of repeatedly reactive specimens with positive status from specimens with positive status and nonreactive specimens with indeterminate status: A / (A + D + E) × 100%

Trial Locations

Locations (4)

Innovative Blood Resources; 🇺🇸 Saint Paul, Minnesota, United States

CSL Plasma Inc.; 🇺🇸 Knoxville, Tennessee, United States

QualTex Laboratories; 🇺🇸 San Antonio, Texas, United States

Bloodworks Northwest; 🇺🇸 Renton, Washington, United States