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NCT03285295 · ClinicalTrials.gov registry record · NA
Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol
A NA study, sponsored by Abbott Diagnostics Division.
- Completed
- Registry status
- NA
- Development phase
- 106,881
- Enrollment target
NCT03285295: Completed NA study, sponsored by Abbott Diagnostics Division.
NCT03285295 is a NA study that has completed, run by Abbott Diagnostics Division. The registered enrollment target is 106,881 participants, above the 1,402-participant average among 58,714 other NA trials with a reported enrollment target (7523% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03285295, a NA study, has completed, sponsored by Abbott Diagnostics Division.
- COMPLETED
- Registry status
- NA
- Development phase
- 106,881 participants
- Enrollment target
Study Summary
The objective of this study is to demonstrate the performance and intended use of each of the Alinity s investigational assays in a donor screening environment using clinical specimens to evaluate assay performance characteristics. A comparison of assay performance will be done versus the Food and Drug Administration (FDA) licensed assays. The data will be used to support regulatory submissions and/or publications.
Primary Outcome
Total of 16993 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HBsAg Assay. Repeatedly reactive specimens were further tested with Alinity s HBsAg Confirmatory and supplemental assays, if required.
Interventions
- DEVICE Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay
- DEVICE Alinity s HTLV I/II Assay
- DEVICE Alinity s Anti-HCV Assay
- DEVICE Alinity s HIV Ag/Ab Combo Assay
- DEVICE Alinity s Anti-HBc Assay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106,881 participants |
| Start Date | 2017-09-15 |
| Est. Completion | 2018-06-21 |
| Phase | NA |
What the finished NCT03285295 record still lists
NCT03285295 is an interventional study that assigns participants to a tested intervention. Its 106,881 participants enrollment target places it among the larger protocols in the corpus, above the 1,402-participant average among 58,714 other NA trials with a reported enrollment target (7523% higher).
The record links to 0 conditions, and to 5 interventions - of which Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay is the first listed.
NCT03285295 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03285295 about?
NCT03285295 is a clinical study titled "Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol". The objective of this study is to demonstrate the performance and intended use of each of the Alinity s investigational assays in a donor screening environment using clinical specimens to evaluate assay performance characteristics. A comparison of assay performance will be done versus the Food and D...
What is the current status of trial NCT03285295?
This trial is currently completed. It is a NA study. The enrollment target is 106,881 participants. The study started on 2017-09-15. Estimated completion is 2018-06-21.
What interventions are being tested in trial NCT03285295?
The interventions under investigation include: Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay (DEVICE), Alinity s HTLV I/II Assay (DEVICE), Alinity s Anti-HCV Assay (DEVICE), Alinity s HIV Ag/Ab Combo Assay (DEVICE), Alinity s Anti-HBc Assay (DEVICE).
Who is sponsoring clinical trial NCT03285295?
This trial is sponsored by Abbott Diagnostics Division, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03285295's enrollment target sits among peer trials
106,881 2nd of 2000 the highest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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