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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
Sponsor:
Information provided by (Responsible Party):
Becton, Dickinson and Company

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.


Condition or disease Intervention/treatment
Acquired Immunodeficiency Syndrome Device: Investigational BD FACSPresto System Device: BD FACSCalibur flow cytometer Device: Sysmex hematology analyzer KX-21

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Study Type : Observational
Actual Enrollment : 583 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
All subjects
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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
Study Population
The study will enroll specimens from children 0-12 years and adolescent or adult patients 13 years of age or greater. Enrolment of children in the study is expected to satisfy the binning (stratification) requirements since relative lymphocytosis and higher CD4+ lymphocyte counts are normal in children less than 5 years of age.
Criteria

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

Information from the National Library of Medicine

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


Locations
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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
India
National AIDS Research Institute
Pune, Maharashtra, India, 411 026
Kenya
KEMR/CDC Research and Public Health Collaboration
Kisumu, Kenya
Thailand
Siriraj Hospital
Bangkok, Siriraj, Thailand, 10700
Sponsors and Collaborators
Becton, Dickinson and Company
Investigators
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Study Chair: Kevin Judge, MD Becton, Dickinson

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Becton, Dickinson and Company
ClinicalTrials.gov Identifier: NCT02396355     History of Changes
Other Study ID Numbers: CAS-PCACC1
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

Keywords provided by Becton, Dickinson and Company:
flow cytometry

Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases