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Accuracy Evaluation of the BD FACS Presto System

NCT02396355 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 583

Last updated 2017-02-09

No results posted yet for this study

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.

Conditions

  • Acquired Immunodeficiency Syndrome

Interventions

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

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Principal Investigators

  • Kevin Judge, MD · Becton, Dickinson

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States
  • India
  • Kenya
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02396355 on ClinicalTrials.gov