Accuracy Evaluation of the BD FACS Presto System

NCT02396355 | Completed

• 1 other identifier: CAS-PCACC1
• Study Type: observational
• Target: 583
• Locations: 4 countries
• Sites: 6

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.

Conditions

Acquired Immunodeficiency Syndrome

Keywords

flow cytometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Method bias between BD FACSPresto System vs. Predicate in Capillary Blood (AbsCD4 and %CD4)

  assayed upon sample collection

• Method bias between BD FACSPresto System vs. Predicate for Hemoglobin

  assayed upon sample collection

Study Arms (1)

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; Device: BD FACSCalibur flow cytometer; Device: Sysmex hematology analyzer KX-21

Interventions

Investigational BD FACSPresto System DEVICE

Blood samples will be tested on the BD FACSPresto system for CD4 absolute count (CD4Abs), %CD4, and Hb concentration.

All subjects

BD FACSCalibur flow cytometer DEVICE

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.

All subjects

Sysmex hematology analyzer KX-21 DEVICE

Blood samples will be tested for hemoglobic concentration on the predicate, currently marketed Sysmex hematology analyzer KX-21

All subjects

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

You may qualify if:

• 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

You may not qualify if:

• Subject unwilling to disclose medical information regarding previous CD4 test results
• Subject unwilling to discuss medical information regarding co-morbid conditions and current medications

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (6)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

San Francisco General Hospital and Trauma Center

San Francisco, California, 94111, United States

Location

Becton Dickinson MedLab

San Jose, California, 95131, United States

Location

National AIDS Research Institute

Pune, Maharashtra, 411 026, India

Location

KEMR/CDC Research and Public Health Collaboration

Kisumu, Kenya

Location

Siriraj Hospital

Bangkok, Siriraj, 10700, Thailand

Location

Related Publications (1)

• Angira F, Akoth B, Omolo P, Opollo V, Bornheimer S, Judge K, Tilahun H, Lu B, Omana-Zapata I, Zeh C. Clinical Evaluation of the BD FACSPresto Near-Patient CD4 Counter in Kenya. PLoS One. 2016 Aug 2;11(8):e0157939. doi: 10.1371/journal.pone.0157939. eCollection 2016.

  PMID: 27483008 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Kevin Judge, MD

  Becton, Dickinson

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 24, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1); US (3); IN (1); KE (1)