For Professionals in Clinical Diagnostics
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 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™ 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 Leukaemia Orientation Tube (ALOT).
The BD OneFlow™ LST reagent composition
| Antibody | Fluorochrome | Clone | Target Populations |
|---|---|---|---|
| CD45 | BD Horizon V500-C | 2Dl (anti-HLe-1) | Mature lymphocytes, B-cell precursor |
CD19 | PE-Cy7 | SJ25-C1 | B-cells and NK-cells by exclusion |
| CD20 | BD Horizon V450 | L27 | B-cells and NK-cells by exclusion |
| Anti-Lambda | FITC | 1-155-2 | Normal and clonally expanded B cells |
| Anti-Kappa | PE | TB28-2 | Normal and clonally expanded B Cells |
| CD38 | APC-H7 | HB7 | Plasma cells and B-cell precursors, Lymphoid malignancies, NK cells |
| CD3 | APC | SK7 | T cells, B- and NK-cells by exclusion |
| CD4 | BD Horizon™ 450 | SK3 (Leu-3a) | T cell subpopulations |
| CD8 | FITC | SK1 (Leu-2a) | T cell subpopulations |
| CD5 | PerCP-Cy5.5 | L17F12 | T cell subpopulations |
| Anti-TCR-1 | PE-Cy7 | 11F2 | T cell subpopulations |
| CD56 | PE | MY31 (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
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.
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.
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.
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Instructions for Use
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Application Guides - For BD FACSLyric™ Flow Cytometer Users
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Applications Guides - For BD FACSCanto™ II Flow Cytometer Users
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Tools
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Application Note
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Application Guides - For BD FACSLyric™ Flow Cytometer Users
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Application Guides - For BD FACSCanto™ II Flow Cytometer Users
References
- 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
- 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
- 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, BDTM® FC Beads (8-Color, 7-Color, 5-Color and 2-Color Kits), BD OneFlow™ Setup Beads, BD FACSDiva™ CS&T IVD Beads and BDTM® 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 (BD OneFlow™ LST 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.
