Accuracy Evaluation of the BD FACS Presto System: Instrument, Software and BD CD4/%CD4/Hb Cartridge Assay
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 583
- Locations
- 6
- Primary Endpoint
- Method bias between BD FACSPresto System vs. Predicate in venous blood (AbsCD4 and %CD4)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Method bias between BD FACSPresto System vs. Predicate in venous blood (AbsCD4 and %CD4)
Time Frame: assayed upon sample collection
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.
Secondary Outcomes
- 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)