Alinity s Anti-HCV II - Clinical Evaluation Protocol
Completed · Not applicable
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT04862065
- Run by
- Abbott Transfusion Medicine
- People needed
- 16388
- Starts
- 2021-04-19
- Expected to finish
- 2021-08-05
- Last updated by the study team
- 2022-10-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Serum or ethylenediaminetetraacetic acid (EDTA) plasma from a blood donor or a plasma from a plasmapheresis donor.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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