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    Intended as an aid in the diagnosis of hematological disorders 

     

     

    Overview

    The BD OneFlow™ LST 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™ LST is intended for flow cytometric immunophenotyping of normal and aberrant mature lymphocyte populations of B, T and NK cell lineages in peripheral blood, bone marrow and lymph nodes, as an aid in 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).

    Learn more from the BD OneFlow™ Solution brochure.
     
    performance1

    View video describing the BD OneFlow™ Solution on the BD FACSLyric™ Flow Cytometer.

    FEATURES

    The BD OneFlow™ LST:

    • Is a preconfigured single-use, ready-to-use 8-color 12-antibodies reagent that is provided in a single-test tube format
    • Can guide the need for further analysis as a screening tube in combination with panel(s), such as the BD OneFlow™ B-CLPD-T1, specifically designed for the classification of different forms of malignancies (B, T or NK)
    • Is available in the 20 test/box size (4 pouches of 5 tubes each)
    • Allows for easy visual identification as dark blue color-coded boxes, pouches and tubes

     

     

     

     

    The BD OneFlow™ Reagents increase efficiency by simplifying instrument standardization, 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 standardize 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 standardize 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™ SOPs.3
    • The specifically designed BD® FC Beads 8-Color Kit eliminates the need for using single-vial reagents and cells for compensation 

     

    The BD OneFlow™ LST reagent composition

     

    AntibodyFluorochromeCloneTarget Populations
    CD45BD Horizon V500-C2Dl (anti-HLe-1)Mature lymphocytes, B-cell precursor

    CD19

    		PE-Cy 7SJ25-C1B-cells, and NK-cells by exclusion
    CD20BD Horizon V450L27B cells and NK cells by exclusion
    Anti-LambdaFITC 1-155-2Normal and clonally expanded B cells
    Anti-KappaPETB28-2Normal and clonally expanded B Cells
    CD38APC-H7HB7Plasma cells and B-cell precursors, Lymphoid malignancies, NK cells
    CD3APCSK7T cells, B- and NK-cells by exclusion
    CD4BD Horizon™ 450SK3 (Leu-3a)T cell subpopulations
    CD8FITCSK1 (Leu-2a)T cell subpopulations
    CD5PerCP-Cy 5.5L17F12T cell subpopulations
    Anti-TCR-1PE-Cy 711F2T cell subpopulations
    CD56PEMY31 (Leu-19)NK Cells

     

    A full description of the utility of the antibodies chosen for the BD OneFlow™ LST is provided in the publication by the EuroFlow Consortium.1  

     

     

    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.

    Periodic and daily setup

    Supporting Evidence

    The EuroFlow “LST detected aberrant B-, T-, or NK-cells immunophenotypes in 149/150 (99.4%) of B-CLPD and in 78/83 (94%) of T/NK-CLPD with an overall frequency of 97.4%."1* 

     

    Results from the clinical trial study (BD OneFlow™ LST Instructions for Use) show that the BD OneFlow™ LST in combination with the BD OneFlow™ B-CLPD T1 gave 100% (101 of 101) overall agreement in classifying patients as having CLL (54 of 54 concordant) and in identifying patients with other B cell chronic lymphoproliferative diseases (47 out of 47 concordant) when compared with the EuroFlow system. Furthermore, interpretation of the BD OneFlow™ Solution results was highly concordant to diagnostic truth.

    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

    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

    BD Flow Cytometers are Class 1 Laser Products.

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

    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.

    *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™ LST Instructions for Use).

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