Accuracy Evaluation of the BD FACS Presto System

Study Overview
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Brief Summary
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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.

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

Conditions
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Acquired Immunodeficiency Syndrome

Intervention / Treatment
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* Device: Investigational BD FACSPresto System
* Device: BD FACSCalibur flow cytometer
* Device: Sysmex hematology analyzer KX-21


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All subjects<br>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. | Device: Investigational BD FACSPresto System<br>* Blood samples will be tested on the BD FACSPresto system for CD4 absolute count (CD4Abs), %CD4, and Hb concentration.<br>Device: BD FACSCalibur flow cytometer<br>* 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.<br>Device: Sysmex hematology analyzer KX-21<br>* Blood samples will be tested for hemoglobic concentration on the predicate, currently marketed Sysmex hematology analyzer KX-21<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Method bias between BD FACSPresto System vs. Predicate in venous blood (AbsCD4 and %CD4) | 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. | assayed upon sample collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Method bias between BD FACSPresto System vs. Predicate in Capillary Blood (AbsCD4 and %CD4) | 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. | assayed upon sample collection | 
| Method bias between BD FACSPresto System vs. Predicate for Hemoglobin | 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. | assayed upon sample collection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flow cytometry