Clinical trial NCT02396355: Accuracy Evaluation of the BD FACS Presto System
Official title: Accuracy Evaluation of the BD FACS Presto System: Instrument, Software and BD CD4/%CD4/Hb Cartridge Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Immunodeficiency Syndrome
Keywords: flow cytometry
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2015-03-24
Enrollment: 583
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Method bias between BD FACSPresto System vs. Predicate in venous blood (AbsCD4 and %CD4)
timeFrame: assayed upon sample collection
Secondary outcomes:
measure: Method bias between BD FACSPresto System vs. Predicate in Capillary Blood (AbsCD4 and %CD4)
timeFrame: assayed upon sample collection
measure: Method bias between BD FACSPresto System vs. Predicate for Hemoglobin
timeFrame: assayed upon sample collection
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: San Francisco
country: United States
facility: San Francisco General Hospital and Trauma Center
state: California
city: San Jose
country: United States
facility: Becton Dickinson MedLab
state: California
city: Pune
country: India
facility: National AIDS Research Institute
state: Maharashtra
city: Kisumu
country: Kenya
facility: KEMR/CDC Research and Public Health Collaboration
city: Bangkok
country: Thailand
facility: Siriraj Hospital
state: Siriraj
Study officials:
affiliation: Becton, Dickinson
name: Kevin Judge, MD
role: STUDY_CHAIR
References:
citation: 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.