N/A
N=16,388
Alinity s Anti-HCV II - Clinical Evaluation Protocol
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04862065 ↗Enrolled (actual)
16,388
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Assay Specificity Results for Participants (Specimens) Tested With Alinity s Anti-HCV II Assay. — 15,506; 6; 14 Specimen
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alinity s Anti-HCV II (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Transfusion Medicine
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assay Specificity Results for Participants (Specimens) Tested With Alinity s Anti-HCV II Assay. |
15,506; 6; 14 | — |
| PRIMARY Assay Sensitivity Results for Participants (Specimens) Characterized as Positive Tested With Alinity s Anti-HCV II Assay. |
0; 403 | — |
| SECONDARY Assay Sensitivity Results for Participants (Specimens) With Increased Risk for HCV Tested With Alinity s Anti-HCV II Assay. |
324; 0; 0; 70; 10; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04862065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.