Acquired Immunodeficiency Syndrome Clinical Trial
Official title:
Accuracy Evaluation of the BD FACS Presto System: Instrument, Software and BD CD4/%CD4/Hb Cartridge Assay
Verified date | February 2017 |
Source | Becton, Dickinson and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Becton, Dickinson and Company |
United States, India, Kenya, Thailand,
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 |
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