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For Professionals in Clinical Diagnostics

 

Overview

The BD OneFlow™ PCD Tube is part of the innovative BD OneFlow™ Solution, a comprehensive set of reagents, setup beads, protocols and assay templates to reproducibly set up the flow cytometer and stain, acquire and analyze patient specimens for immunophenotyping of normal and aberrant cell populations. It is built on the research and validation work of the EuroFlow™ Consortium on the characterization of hematological malignancies for improved accurate diagnosis.1* 

 

The BD OneFlow™ PCD Tube, when run in parallel with the BD OneFlow™ Plasma Cell Screening Tube (PCST), is intended for flow cytometric immunophenotyping of normal and aberrant plasma cells in bone marrow as an aid in the diagnosis of multiple myeloma or other plasma cell disorders.

 

Other reagents belonging to the BD OneFlow™ Solution are BD OneFlow™ Lymphoid Screening Tube (LST), BD OneFlow™ B-cell Chronic Lymphoproliferative Diseases Tube 1 (B-CLPD T1), BD OneFlow™ Plasma Cell Screening Tube (PCST) and BD OneFlow™ Acute Leukaemia Orientation Tube (ALOT).

performance1

FEATURES

The BD OneFlow™ PCD Tube:

  • Is a preconfigured single-use, ready-to-use 8-color reagent
  • Is a classification tube that can be used for specimens with plasma cell populations needing further investigation as determined by the BD OneFlow™ PCST
  • Is available in the 10 test/box size (4 pouches of 5 tubes each)
  • Allows for easy visual identification with boxes, pouches and tubes color coded with a lighter green color than the one identifying the BD OneFlow™ PCST

The BD OneFlow™ Reagents increase efficiency by simplifying instrument standardisation, reducing the time to prepare the instrument as well as the technical burden and training needs.2

For BD FACSLyric™ Flow Cytometer users:

  • BD® CS&T IVD Beads standardise setup and monitoring for consistent performance and ensure reproducibility through Universal Setup
  • BD® FC Beads (7-Color, 5-Color and 2-Color Kits) support consistency of results, eliminating the need for using cells for compensation
  • BD® CS&T Beads and BD® FC Beads kits necessary for instrument setup and compensation can be used for other BD CE-IVD assays on the BD FACSLyric™ Flow Cytometer

For BD FACSCanto™ II Flow Cytometer users:

  • BD FACSDiva™ CS&T IVD Beads standardise setup and monitoring for consistent performance and ensure reproducibility with Application Settings
  • BD OneFlow™ Setup Beads ensure data accuracy and reproducibility by providing assay-specific target values, as per EuroFlow™ SOPs3
  • The specifically designed BD® FC Beads 8-Color Kit eliminates the need for using single-vial reagents and cells for compensation 

The BD OneFlow™ PCD Tube reagent composition

 

AntibodyFluorochromeCloneTarget Populations
CD38FITCHB7Backbone marker. Identification of plasma cells

CD28

PEL293Identification of aberrant plasma cell populations
CD27PerCP-Cy 5.5L128Identificaiton of aberrant plasma cell populations
CD19PE-Cy 7SJ25-C1Backbone markers. Identification of plasma cells. Identify and characterize mature B cells
CD117APC104D2Identificaiton of aberrant plasma cell populations
CD81APC-H7JS81Identificaiton of aberrant plasma cell populations
CD45BD Horizon V4502D1Backbone marker. Identification of plasma cells
CD138BD Horizon™ 500-CMI15Backbone marker. Identification of plasma cells

 

A full description of the utility of the antibodies chosen for the BD OneFlow™ PCD is provided in the publication by the EuroFlow Consortium1  

 

 

APPLICATIONS

BD OneFlow™ LST Lab Report (normal specimens) when used with the BD FACSLyric™ Flow Cytometer

Laboratory report of a normal bone marrow specimen stained with the 8-color 12-antibody BD OneFlow™ LST single-test reagent acquired on the BD FACSLyric™ Flow Cytometer with BD FACSuite™ Clinical Application v1.4 for the identification of normal and aberrant mature lymphocyte populations of B, T and NK cell lineages.
BD OneFlow™ LST Lab Report (abnormal specimens) when used with the BD FACSLyric™ Flow Cytometer

Laboratory report of an abnormal bone marrow specimen stained with the 8-color 12-antibody BD OneFlow™ LST single-test reagent acquired on the BD FACSLyric™ Flow Cytometer with BD FACSuite™ Clinical Application v1.4 for the identification of normal and aberrant mature lymphocyte populations of B, T and NK cell lineages.
BD OneFlow™ Reagents can be run on both the BD FACSLyric™ and BD FACSCanto™ II Flow Cytometers with equivalent results.

Supporting Evidence

The EuroFlow “PCD panel was able to detect and fully characterize the immunophenotype of aberrant plasma cells or their normal/reactive counterparts in all the samples tested (100), as also assessed by routine diagnostic protocols performed in parallel.”1*

RESOURCES
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References

  1. van Dongen JJM, Lhermitte L, Böttcher S, et al. on behalf of the EuroFlow Consortium (EU-FP6, LSHB-CT-2006-018708). EuroFlow antibody panels for standardized n-dimensional flow cytometric immunophenotyping of normal, reactive and malignant leukocytes. Leukemia. 2012;26(9): 1908-1975. doi: 10.1038/leu.2012.120

  3. Moloney E, Watson H, Barge D, et al. Efficiency and health economic evaluations of BD OneFlow™ Flow Cytometry Reagents for diagnosing chronic lymphoid leukemia. Cytometry B Clin Cytom. 2019;96(6):514-520. doi: 10.1002/cyto.b.21779

  5. Kalina T, Flores-Montero J, van der Velden VHJ, et al. EuroFlow standardization of flow cytometer instrument settings and immunophenotyping protocols. Leukemia. 2012;26(9):1986-2010. doi: 10.1038/leu.2012.122

The BD FACSLyric™ and BD FACSCanto™ II Flow Cytometers are Class 1 Laser Products.

BD OneFlow™ Reagents,  BD FACSLyric™ Flow Cytometer with the BD FACSuite™ Clinical and BD FACSuite™ Applications, BD FACSCanto™ II Flow Cytometer, BD™® FC Beads (8-Color, 7-Color, 5-Color and 2-Color Kits), BD OneFlow™ Setup Beads, BD FACSDiva™ CS&T IVD Beads and BD™® CS&T Beads are CE marked in compliance with the European In Vitro Diagnostic Medical Device Directive 98/79/EC.

The EuroFlow trademark is the property of the EuroFlow Consortium and cannot be reproduced or published without prior written permission from the EuroFlow coordinator (www.euroflow.org).

The BD OneFlow™ Solution is intended for professional use only.

Cy is a trademark of Global Life Sciences Solutions Germany GmbH or an affiliate doing business as Cytiva.

*This publication refers to EuroFlow and is relevant to the BD OneFlow™ Solution as the BD OneFlow™ Solution demonstrated equivalent results to EuroFlow through a clinical trial.

Refer to manufacturer's instructions for use and related User Manuals and Technical Data Sheets before using this product as described.

Comparisons, where applicable, are made against older BD technology, manual methods or are general performance claims. Comparisons are not made against non-BD technologies, unless otherwise noted.