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      For Professionals in Clinical Diagnostics

       

      Overview

      The BD OneFlow™ PCST 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™ PCST is intended for flow cytometric immunophenotyping of normal polyclonal and aberrant plasma cell populations in bone marrow as an aid in the diagnosis of hematological disorders.

       

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

      performance1

      FEATURES

      The BD OneFlow™ PCST:

      • Is a preconfigured single-use 8-color reagent comprising two tubes—one containing the cytoplasmic markers (C tube) and the other containing the surface markers (S tube) 

      • Is available in 10 test/box size (4 pouches of 5 tubes each: 2 pouches of S tubes and 2 pouches of C tubes) 

      • Allows for easy visual identification with dark green color-coded boxes, pouches and tubes

         

         

      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™ PCST reagent composition

       

      AntibodyFluorochromeCloneTubeTarget Populations
      CD38FITCHB7SBackbone markers. Identification of plasma cells

      CD56

      		PEMY31SIdentification of aberrant plasma cells
      β2-MicroglobulinPerCP-Cy5.5TU99SIdentification of aberrant plasma cells
      CD19PE-Cy7 SJ25-C1SBackbone markers. Identification of plasma cells. Identify and characterize mature B cells
      Anti-KappaAPCTB28-2CPlasma cells clonality
      Anti-LambdaAPC-H71-155-2CPlasma cells clonality
      CD45BD Horizon™ V4502D1SBackbone markers. Identification of plasma cells
      CD138BD Horizon™ V500-CMI15SBackbone marker.
      Identification of plasma cells

       

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

       

       

       

      APPLICATIONS

      BD OneFlow™ PCST 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 8-antibody BD OneFlow™ PCST single-test reagent acquired on the BD FACSLyric™ Flow Cytometer with BD FACSuite™ Clinical Application v1.4 for the identification of normal polyclonal and aberrant plasma cell populations.
      BD OneFlow™ PCST 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 8-antibody BD OneFlow™ PCST single-test reagent acquired on the BD FACSLyric™ Flow Cytometer with BD FACSuite™ Clinical Application v1.4 for the identification of normal polyclonal and aberrant plasma cell populations.
      BD OneFlow™ Reagents can be run on both the BD FACSLyric™ and BD FACSCanto™ II Flow Cytometers with equivalent results.
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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

      2. 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

      3. 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).

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

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

      *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 (BD OneFlow™ PCST Instructions for Use).

      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.