Accuracy Evaluation of the BD FACS Presto System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

583 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

BD Prevue(TM) II Peripheral Vascular Access System With Cue(TM) Needle Tracking Technology Clinical Study

NCT06632496

BD Prevue II for Peripheral Intravenous Catheter Placement

COMPLETED

An Observational Trial to Assess the Performance of the TEG® 6s Diagnostic System With the Citrated K, KH, RTH, FFH Cartridge

NCT06352125

Surgery

COMPLETED

Study of Accuracy of New Diagnostic Technology to Guide Rapid Antibiotic Treatment for Serious Infections

NCT02796716

INFECTIONS Skin and Subcutaneous Tissue Bacterial Infections Healthcare-associated Infection +1 more

COMPLETED

Direct Oral Anticoagulant Assay Detection & Classification Study for the TEG 6S System

NCT02798328

DOAC Eligible Subjects

COMPLETED

COVID-19 Immunity Assessment

NCT05080231

COVID-19

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acquired Immunodeficiency Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Investigational BD FACSPresto System

Intervention Type DEVICE

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

BD FACSCalibur flow cytometer

Intervention Type 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.

Sysmex hematology analyzer KX-21

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Investigational BD FACSPresto System

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

Intervention Type DEVICE

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.

Intervention Type DEVICE

Sysmex hematology analyzer KX-21

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No