Accuracy Evaluation of the BD FACS Presto System

Acquired Immunodeficiency Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396355
• Other study ID #: CAS-PCACC1
• Status: Completed
• Phase: N/A
• First received: March 18, 2015
• Last updated: February 7, 2017
• Start date: February 2015
• Est. completion date: May 2015

Study information

• Verified date: February 2017
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 583
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Device:
• Investigational BD FACSPresto System
Blood samples will be tested on the BD FACSPresto system for CD4 absolute count (CD4Abs), %CD4, and Hb concentration.
• 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.
• Sysmex hematology analyzer KX-21
Blood samples will be tested for hemoglobic concentration on the predicate, currently marketed Sysmex hematology analyzer KX-21

Locations

Country	Name	City	State
India	National AIDS Research Institute	Pune	Maharashtra
Kenya	KEMR/CDC Research and Public Health Collaboration	Kisumu
Thailand	Siriraj Hospital	Bangkok	Siriraj
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	San Francisco General Hospital and Trauma Center	San Francisco	California
United States	Becton Dickinson MedLab	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Countries where clinical trial is conducted

United States,  India,  Kenya,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Method bias between BD FACSPresto System vs. Predicate in Capillary Blood (AbsCD4 and %CD4)	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
Secondary	Method bias between BD FACSPresto System vs. Predicate for Hemoglobin	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