583
Participants
Start Date
February 28, 2015
Primary Completion Date
May 31, 2015
Study Completion Date
May 31, 2015
Investigational BD FACSPresto System
Blood samples will be tested on the BD FACSPresto system for CD4 absolute count (CD4Abs), %CD4, and Hb concentration.
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.
Sysmex hematology analyzer KX-21
Blood samples will be tested for hemoglobic concentration on the predicate, currently marketed Sysmex hematology analyzer KX-21
Siriraj Hospital, Bangkok
Children's Hospital Los Angeles, Los Angeles
San Francisco General Hospital and Trauma Center, San Francisco
Becton Dickinson MedLab, San Jose
National AIDS Research Institute, Pune
KEMR/CDC Research and Public Health Collaboration, Kisumu
Lead Sponsor
Becton, Dickinson and Company
INDUSTRY