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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03285295
The ClinicalTrials.gov registry entry for NCT03285295 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 106,881 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Diagnostics Division, which has 7 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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