Accuracy Evaluation of the BD FACS Presto System

February 7, 2017 updated by: Becton, Dickinson and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

583

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Pune, Maharashtra, India, 411 026
        • National AIDS Research Institute
  • Kenya
      • Kisumu, Kenya
        • KEMR/CDC Research and Public Health Collaboration
  • Thailand
    • Siriraj
      • Bangkok, Siriraj, Thailand, 10700
        • Siriraj Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
      • San Francisco, California, United States, 94111
        • San Francisco General Hospital and Trauma Center
      • San Jose, California, United States, 95131
        • Becton Dickinson MedLab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
assayed upon sample collection
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.
assayed upon sample collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Becton, Dickinson and Company

Investigators

  • Study Chair: Kevin Judge, MD, Becton, Dickinson

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAS-PCACC1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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