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Completed

NCT Number: NCT02396355

Accuracy Evaluation of the BD FACS Presto System

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.

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Key information

Conditions

Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

National AIDS Research Institute, Pune, Maharashtra, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Investigational BD FACSPresto System

Device

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

BD FACSCalibur flow cytometer

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

Device

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

Primary outcomes

  1. 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

  1. Method bias between BD FACSPresto System vs. Predicate in Capillary Blood (AbsCD4 and %CD4)

    Time frame: assayed upon sample collection

    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.

  2. Method bias between BD FACSPresto System vs. Predicate for Hemoglobin

    Time frame: assayed upon sample collection

    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.

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 24, 2015
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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