Status:
COMPLETED
Alinity s Anti-HCV II - Clinical Evaluation Protocol
Lead Sponsor:
Abbott Transfusion Medicine
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
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 as...
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 qu...
Eligibility Criteria
Inclusion
- Serum or ethylenediaminetetraacetic acid (EDTA) plasma from a blood donor or a plasma from a plasmapheresis donor.
Exclusion
- 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.
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2021
Estimated Enrollment :
16388 Patients enrolled
Trial Details
Trial ID
NCT04862065
Start Date
April 19 2021
End Date
August 5 2021
Last Update
October 14 2022
Active Locations (4)
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1
Innovative Blood Resources
Saint Paul, Minnesota, United States, 55114
2
CSL Plasma Inc.
Knoxville, Tennessee, United States, 37932
3
QualTex Laboratories
San Antonio, Texas, United States, 78201
4
Bloodworks Northwest
Renton, Washington, United States, 98057