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NCT02396355 · ClinicalTrials.gov registry record
Accuracy Evaluation of the BD FACS Presto System
A clinical trial, sponsored by Becton, Dickinson and Company.
- Completed
- Registry status
- 583
- Enrollment target
NCT02396355: Completed study, sponsored by Becton, Dickinson and Company.
NCT02396355 is a clinical trial that has completed, run by Becton, Dickinson and Company. The registered enrollment target is 583 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02396355 has completed, sponsored by Becton, Dickinson and Company.
- COMPLETED
- Registry status
- 583 participants
- Enrollment target
Study Summary
The enumeration of T lymphocytes positive for the CD4 antigen is used to determine the immune status of patients with, or suspected of developing, immune deficiencies such as AIDS. The BD FACS Presto™ is an investigational automated system for in vitro diagnostic use in performing the direct enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and hemoglobin (Hb) concentration in human whole blood. This is a prospective study to determine the relative bias between the investigational BD FACS Presto system and the predicate BD FACS Calibur with BD Tritest system in their determination of absolute CD4, % CD4, and Hb concentrations.
Primary Outcome
The primary endpoint is the bias (expected difference) between the investigational vs. predicate system measured as absolute CD4 lymphocyte count and %CD4 in peripheral venous blood from a minimum of 400 specimens with valid results tested at three or more external sites.
Interventions
- DEVICE Investigational BD FACSPresto System
- DEVICE BD FACSCalibur flow cytometer
- DEVICE Sysmex hematology analyzer KX-21
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 583 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-05 |
What the finished NCT02396355 record still lists
NCT02396355 is an observational study that tracks outcomes without assigning an intervention. The registered 583 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which Investigational BD FACSPresto System is the first listed.
NCT02396355 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02396355 about?
NCT02396355 is a clinical study titled "Accuracy Evaluation of the BD FACS Presto System". The enumeration of T lymphocytes positive for the CD4 antigen is used to determine the immune status of patients with, or suspected of developing, immune deficiencies such as AIDS. The BD FACS Presto™ is an investigational automated system for in vitro diagnostic use in performing the direct enumera...
What is the current status of trial NCT02396355?
This trial is currently completed. The enrollment target is 583 participants. The study started on 2015-02. Estimated completion is 2015-05.
What interventions are being tested in trial NCT02396355?
The interventions under investigation include: Investigational BD FACSPresto System (DEVICE), BD FACSCalibur flow cytometer (DEVICE), Sysmex hematology analyzer KX-21 (DEVICE).
Who is sponsoring clinical trial NCT02396355?
This trial is sponsored by Becton, Dickinson and Company, which has 33 total clinical trials registered on ClinicalTrials.gov.
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