Alinity s Anti-HCV II - Clinical Evaluation Protocol

Healthy Clinical Trial

Official title:

Alinity s Anti-HCV II - Clinical Evaluation Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04862065
• Other study ID #: T3M3-02-19H04-01
• Status: Completed
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: August 5, 2021

Study information

• Verified date: September 2022
• Source: Abbott Transfusion Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16388
• Est. completion date: August 5, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Alinity s Anti-HCV II
For all donor specimens with investigational Alinity s Anti-HCV II results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.

Locations

Country	Name	City	State
United States	CSL Plasma Inc.	Knoxville	Tennessee
United States	Bloodworks Northwest	Renton	Washington
United States	Innovative Blood Resources	Saint Paul	Minnesota
United States	QualTex Laboratories	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Transfusion Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assay Specificity Results for Participants (Specimens) Tested With Alinity s Anti-HCV II Assay.	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%	Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.
Primary	Assay Sensitivity Results for Participants (Specimens) Characterized as Positive Tested With Alinity s Anti-HCV II Assay.	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%	Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.
Secondary	Assay Sensitivity Results for Participants (Specimens) With Increased Risk for HCV Tested With Alinity s Anti-HCV II Assay.	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%	Each participant (specimen) was tested on the Alinity s Anti-HCV II assay in 1 day.