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NCT04320485 · ClinicalTrials.gov registry record
Evaluation of the Clinical Specificity of the Active Anthrax Detect™ Plus (AAD Plus) Lateral Flow Immunoassay (LFI)
A clinical trial, sponsored by InBios International.
- Completed
- Registry status
- 450
- Enrollment target
NCT04320485: Completed study, sponsored by InBios International.
NCT04320485 is a clinical trial that has completed, run by InBios International. The registered enrollment target is 450 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04320485 has completed, sponsored by InBios International.
- COMPLETED
- Registry status
- 450 participants
- Enrollment target
Study Summary
The primary objective of the study is to determine the estimated clinical specificity of the AAD Plus. A secondary objective is to determine the estimated sensitivity of the AAD Plus as 10% of the study subject samples will be contrived to be positive.
Primary Outcome
For the estimated specificity, the negative percent agreement (NPA) will be calculated from testing unspiked specimens from 400 subjects (with presumed negative samples).
Interventions
- DIAGNOSTIC_TEST Active Anthrax Detect™ Plus (AAD Plus)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2020-03-25 |
| Est. Completion | 2020-12-17 |
What the finished NCT04320485 record still lists
NCT04320485 is an observational study that tracks outcomes without assigning an intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Active Anthrax Detect™ Plus (AAD Plus) is the first listed.
NCT04320485 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04320485 about?
NCT04320485 is a clinical study titled "Evaluation of the Clinical Specificity of the Active Anthrax Detect™ Plus (AAD Plus) Lateral Flow Immunoassay (LFI)". The primary objective of the study is to determine the estimated clinical specificity of the AAD Plus. A secondary objective is to determine the estimated sensitivity of the AAD Plus as 10% of the study subject samples will be contrived to be positive.
What is the current status of trial NCT04320485?
This trial is currently completed. The enrollment target is 450 participants. The study started on 2020-03-25. Estimated completion is 2020-12-17.
What interventions are being tested in trial NCT04320485?
The interventions under investigation include: Active Anthrax Detect™ Plus (AAD Plus) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04320485?
This trial is sponsored by InBios International, which has 5 total clinical trials registered on ClinicalTrials.gov.
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