Accuracy Evaluation of the BD FACS Presto System

Completed

Interventions: Device: Investigational BD FACSPresto System
Device: BD FACSCalibur flow cytometer
Device: Sysmex hematology analyzer KX-21

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Subject has been infected with HIV and willing to provide informed consent to draw venous and capillary blood
Specimen: Venous blood must be collected in blood collection tube with EDTA anticoagulant and stored at room temperature (20-25 °C) according to tube manufacturer's instructions
Specimen: post enrolment staining within 24 hours
venous blood of acceptable quality for flow cytometry, e.g. no hemolysis or clots and acceptable pre analytical handling)
venous blood sample > 1 mL for sample preparation
capillary blood applied to the investigational CD4/%CD4/Hb cartridge

Exclusion Criteria

Subject unwilling to disclose medical information regarding previous CD4 test results
Subject unwilling to discuss medical information regarding co-morbid conditions and current medications

Arm && Interventions

Group	Intervention	Description
All subjects	Investigational BD FACSPresto System	This is a single arm study. Samples from each subject will be tested with the Investigational BD FACSPresto System, the BD FACSCalibur flow cytometer, and the Sysmex hematology analyzer KX-21.
All subjects	BD FACSCalibur flow cytometer	This is a single arm study. Samples from each subject will be tested with the Investigational BD FACSPresto System, the BD FACSCalibur flow cytometer, and the Sysmex hematology analyzer KX-21.
All subjects	Sysmex hematology analyzer KX-21	This is a single arm study. Samples from each subject will be tested with the Investigational BD FACSPresto System, the BD FACSCalibur flow cytometer, and the Sysmex hematology analyzer KX-21.

Primary Outcome Measures

Name	Time	Method
Method bias between BD FACSPresto System vs. Predicate in venous blood (AbsCD4 and %CD4)	assayed upon sample collection	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.

Secondary Outcome Measures

Name	Time	Method
Method bias between BD FACSPresto System vs. Predicate in Capillary Blood (AbsCD4 and %CD4)	assayed upon sample collection	The bias (expected difference) between the investigational vs. predicate system measured as absolute CD4 lymphocyte count and %CD4 in capillary blood from a minimum of 400 specimens with valid results tested will be determined at three or more external sites.
Method bias between BD FACSPresto System vs. Predicate for Hemoglobin	assayed upon sample collection	The bias (expected difference) between the investigational BD FACSPresto system vs. predicate (Sysmex KX-21 hematology analyzer) will be determined for hemoglobin concentration using venous blood and capillary blood.

Locations (6): Becton Dickinson MedLab
🇺🇸
San Jose, California, United States
San Francisco General Hospital and Trauma Center
🇺🇸
San Francisco, California, United States
KEMR/CDC Research and Public Health Collaboration
🇰🇪
Kisumu, Kenya
Siriraj Hospital
🇹🇭
Bangkok, Siriraj, Thailand
National AIDS Research Institute
🇮🇳
Pune, Maharashtra, India
Children's Hospital Los Angeles
🇺🇸
Los Angeles, California, United States