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      For Professionals in Clinical Diagnostics

      Overview

      The BD OneFlow™ ALOT 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 analyse 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™ ALOT is intended for flow cytometric immunophenotyping of aberrant immature populations of hematopoietic cells (lymphoid and non-lymphoid lineage) in bone marrow and peripheral blood as an aid in the diagnosis of acute lymphoblastic leukaemia and non-lymphoid acute leukaemia.

       

      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), BD OneFlow™ Plasma Cell Disorders (PCD) Tube.

       

      performance1

      FEATURES

      The BD OneFlow™ ALOT:

      • Is a pre-configured single-use, 8-color reagent 

      • Comprises 2 ready-to-use tubes, one containing the cytoplasmic markers (C tube) and the other containing the surface markers (S tube) 

      • Can guide the need for further analysis as a screening tube in combination with panel(s) specifically designed for the classification of different forms of B cell, T cell and myeloid acute leukaemias 

      • 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 as dark red 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 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™ ALOT reagent composition

       

      AntibodyFluorochromeCloneTubeTarget Populations
      MP0FITCMP0-7CMyeloid lineage marker

      CD79A

      		PEHM57CB-lineage marker
      CD34PerCP-Cy5.58G12SBackbone marker (BCP-ALL and AML Panels).
      Identification of immature cells.
      CD19PE-Cy7 SJ25-C1SBackbone marker (BCP-ALL Panel).
      B-lineage marker
      CD7APCM-T701ST-lineage marker
      CD3APC-H7SK7SBackbone marker (T-ALL panel).
      CD3BD Horizon™ V450UCHT-1CBackbone marker (T-ALL panel).
      Maturity marker for T-cells.
      CD45BD Horizon™ V500-C2D1SBackbone marker.
      Identification of immature cells.

       

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

       

       

       

      APPLICATIONS

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

      Laboratory report of a normal peripheral blood specimen stained with the 8-color 8-antibody BD OneFlow™ ALOT single-test reagent acquired on the BD FACSLyric™ Flow Cytometer with BD FACSuite™ Clinical Application v1.4  for the identification of aberrant immature lymphoid and non-lymphoid populations.
      BD OneFlow™ ALOT 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™ ALOT single-test reagent acquired on the BD FACSLyric™ Flow Cytometer with BD FACSuite™ Clinical Application v1.4  for the identification of aberrant immature lymphoid and non-lymphoid populations.
      BD OneFlow™ Reagents can be run on both the BD FACSLyric™ and BD FACSCanto™ II Flow Cytometers with equivalent results.

      Supporting Evidence

      “An unprecedented orientation efficiency of 98.3% for non-ambiguous lineage cases was shown for the [EuroFlow] ALOT combination with a series of 483 newly diagnosed acute leukemia cases, tested prospectively at different centers.”1*

       

      Results from the clinical trial showed that the BD OneFlow™ ALOT gave an overall agreement of 100% (93 of 93) in orienting patients into lymphoid (44 of 44 concordant) and non-lymphoid (49 of 49 concordant) lineages when compared with the EuroFlow system. Furthermore, interpretation of clinical trial results using the BD OneFlow™ Solution was highly concordant to diagnostic truth derived from a composite of patient history and lab findings.

      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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