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NCT04862065 · ClinicalTrials.gov registry record · NA
Alinity s Anti-HCV II - Clinical Evaluation Protocol
A NA study of Healthy, sponsored by Abbott Transfusion Medicine.
- Completed
- Registry status
- NA
- Development phase
- 16,388
- Enrollment target
- 4
- Study locations
NCT04862065: Completed NA study of Healthy, sponsored by Abbott Transfusion Medicine.
NCT04862065 is a NA study of Healthy that has completed, run by Abbott Transfusion Medicine. The registered enrollment target is 16,388 participants, above the 632-participant average among 1,090 other Healthy trials with a reported enrollment target (2493% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04862065, a NA study of Healthy, has completed, sponsored by Abbott Transfusion Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 16,388 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
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 pr
Conditions Studied
Interventions
- DEVICE Alinity s Anti-HCV II
Study Locations (4)
Minnesota
- Innovative Blood Resources - Saint Paul
Tennessee
- CSL Plasma Inc. - Knoxville
Texas
- QualTex Laboratories - San Antonio
Washington
- Bloodworks Northwest - Renton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16,388 participants |
| Start Date | 2021-04-19 |
| Est. Completion | 2021-08-05 |
| Phase | NA |
What the finished NCT04862065 record still lists
NCT04862065 is an interventional study that assigns participants to a tested intervention. Its 16,388 participants enrollment target places it among the larger protocols in the corpus, above the 632-participant average among 1,090 other Healthy trials with a reported enrollment target (2493% higher).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Alinity s Anti-HCV II is the first listed.
NCT04862065 reports a single indexed study location in Minnesota, Tennessee, Texas.
Frequently Asked Questions
What is clinical trial NCT04862065 about?
NCT04862065 is a clinical study titled "Alinity s Anti-HCV II - Clinical Evaluation Protocol". 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 an...
What is the current status of trial NCT04862065?
This trial is currently completed. It is a NA study. The enrollment target is 16,388 participants. The study started on 2021-04-19. Estimated completion is 2021-08-05.
What conditions does trial NCT04862065 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT04862065?
The interventions under investigation include: Alinity s Anti-HCV II (DEVICE).
Who is sponsoring clinical trial NCT04862065?
This trial is sponsored by Abbott Transfusion Medicine, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04862065 being conducted?
This trial has 4 study locations across Minnesota, Tennessee, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04862065's enrollment target sits among peer trials
16,388 6th of 1090 higher than 1,085 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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