NCT02396355

Accuracy Evaluation of the BD FACS Presto System

Accuracy Evaluation of the BD FACS Presto System: Instrument, Software and BD CD4/%CD4/Hb Cartridge Assay

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 583 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Acquired Immunodeficiency Syndrome

Interventions

Type	Name	Description
DEVICE	Investigational BD FACSPresto System	Blood samples will be tested on the BD FACSPresto system for CD4 absolute count (CD4Abs), %CD4, and Hb concentration.
DEVICE	BD FACSCalibur flow cytometer	Blood samples will be tested on the predicate, currently marketed device. For CD4Abs and %CD4 measurement, the BD FACSCalibur flow cytometer will be used with BD Multiset software version 1.1 or later and BD Tritest CD3/CD4/CD45 reagent with Trucount tubes.
DEVICE	Sysmex hematology analyzer KX-21	Blood samples will be tested for hemoglobic concentration on the predicate, currently marketed Sysmex hematology analyzer KX-21

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-03-24
• Last updated: 2017-02-09

Locations

6 sites across 4 countries: United States, India, Kenya, Thailand