Accuracy Evaluation of the BD FACS Presto System
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|ClinicalTrials.gov Identifier: NCT02396355|
Recruitment Status : Completed
First Posted : March 24, 2015
Last Update Posted : February 9, 2017
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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.
|Condition or disease||Intervention/treatment|
|Acquired Immunodeficiency Syndrome||Device: Investigational BD FACSPresto System Device: BD FACSCalibur flow cytometer Device: Sysmex hematology analyzer KX-21|
|Study Type :||Observational|
|Actual Enrollment :||583 participants|
|Official Title:||Accuracy Evaluation of the BD FACS Presto System: Instrument, Software and BD CD4/%CD4/Hb Cartridge Assay|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
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
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
- Method bias between BD FACSPresto System vs. Predicate in venous blood (AbsCD4 and %CD4) [ Time Frame: 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.
- Method bias between BD FACSPresto System vs. Predicate in Capillary Blood (AbsCD4 and %CD4) [ Time Frame: 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 [ Time Frame: 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.
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Subject unwilling to disclose medical information regarding previous CD4 test results
- Subject unwilling to discuss medical information regarding co-morbid conditions and current medications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02396355
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027|
|San Francisco General Hospital and Trauma Center|
|San Francisco, California, United States, 94111|
|Becton Dickinson MedLab|
|San Jose, California, United States, 95131|
|National AIDS Research Institute|
|Pune, Maharashtra, India, 411 026|
|KEMR/CDC Research and Public Health Collaboration|
|Bangkok, Siriraj, Thailand, 10700|
|Study Chair:||Kevin Judge, MD||Becton, Dickinson|
|Responsible Party:||Becton, Dickinson and Company|
|Other Study ID Numbers:||
|First Posted:||March 24, 2015 Key Record Dates|
|Last Update Posted:||February 9, 2017|
|Last Verified:||February 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Immune System Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Slow Virus Diseases