Alinity s Anti-HCV II - Clinical Evaluation Protocol
- Conditions
- Healthy
- Interventions
- Device: Alinity s Anti-HCV II
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16388
- Serum or ethylenediaminetetraacetic acid (EDTA) plasma from a blood donor or a plasma from a plasmapheresis donor.
- 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
- Arm && Interventions
Group Intervention Description Screening Alinity s Anti-HCV II 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.
- 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
QualTex Laboratories
🇺🇸San Antonio, Texas, United States
Bloodworks Northwest
🇺🇸Renton, Washington, United States
CSL Plasma Inc.
🇺🇸Knoxville, Tennessee, United States