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      For Professionals in Clinical Diagnostics

       

      Overview

      The BD OneFlow™ B-CLPD T1 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 characterisation of hematological malignancies for improved accurate diagnosis.1*

       

      The BD OneFlow™ B-CLPD T1 is intended for flow cytometric immunophenotyping of B cells in peripheral blood and bone marrow as an aid in the diagnosis of chronic lymphocytic leukaemia (CLL) and other B cell chronic lymphoproliferative diseases.

       

      Other reagents belonging to the BD OneFlow™ Solution are BD OneFlow™ Lymphoid Screening Tube (LST), 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™ B-CLPD T1:

      • Is a preconfigured single-use, ready-to-use 8-color reagent provided in a single tube
      • Is a classification tube that is used for specimens with B lineage populations needing further investigation in combination with the BD OneFlow™ Lymphoid Screening Tube (LST)
      • Is available in the 20 test/box size (4 pouches of 5 tubes each)
      • Allows for reagent visual identification with boxes, pouches and tubes color coded with a lighter blue color than the one identifying BD OneFlow™ LST. The blue color (dark and light) identifies the BD OneFlow™ B-cell Chronic Lymphoproliferative Disease Panel

      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 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
      • Specifically designed BD® FC Beads eliminate the need for using single-vial reagents and cells for compensation 

      The BD OneFlow™ B-CLPD T1 reagent composition

       

      Antibody Fluorochrome Clone Target Populations
      CD23 FITC EBVCS-5 Contributes to the classification of CLL or other B-cell chronic lymphoproliferative diseases

      CD10

      		 PE MEM-78 Contributes to the classification of CLL or other B-cell chronic lymphoproliferative diseases
      CD79b PerCP-Cy 5.5 SN8 Contributes to the classification of CLL or other B-cell chronic lymphoproliferative diseases
      CD19 PE-CY 7  SJ25-C1 Backbone marker. In common with BD OneFlow™ LST
      CD200 APC MRC 0X-104 Contributes to the classification of CLL or other B-cell chronic lymphoproliferative diseases
      CD43 APC-H7 1G10 Contributes to the classification of CLL or other B-cell chronic lymphoproliferative diseases
      CD20 BD Horizon™ V450 L27 Backbone marker. In common with BD OneFlow™ LST
      CD45 BD Horizon™ V500-C 2D1 Backbone marker. In common with BD OneFlow™ LST

       

      The EuroFlow antibody panel article1* has a full description of the utility of the antibodies chosen for the BD OneFlow™ B-CLPD T1.

       

       

      APPLICATIONS

      BD OneFlow™ B-CLPD T1 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™ B-CLPD T1 single-test reagent acquired on the BD FACSLyric™ Flow Cytometer with BD FACSuite™ Clinical Application v1.4.
      BD OneFlow™ B-CLPD T1 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™ B-CLPD T1 single-test reagent acquired on the BD FACSLyric™ Flow Cytometer with BD FACSuite™ Clinical Application v1.4.
      BD OneFlow™ Reagents can be run on both the BD FACSLyric™ and BD FACSCanto™ II Flow Cytometers with equivalent results.
      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

      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 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.

      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.

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