BD OneFlow™ Acute Myeloid Leukemia/Myelodysplatic Syndrome Panel

As an aid in the differential diagnosis of acute myeloid leukemia, acute leukemia of ambiguous lineage, mixed phenotype acute leukemia, myelodysplastic syndrome, or myelodysplastic/myeloproliferative neoplasms

Overview

The BD OneFlow™ Acute Myeloid Leukemia/Myelodysplatic Syndrome Panel is part of the standardized 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 the 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™ AML/MDS Panel is intended for qualitative flow-cytometric immunophenotyping of mature and immature hematopoietic cells populations (lymphoid and myeloid lineages) in bone marrow and peripheral blood. It is used as an aid in the differential diagnosis of hematologically abnormal patients, having or suspected of having, acute myeloid leukemia, acute leukemia of ambiguous lineage, mixed phenotype acute leukemia, myelodysplastic syndrome, or myelodysplastic/myeloproliferative neoplasms.

Features

The BD OneFlow™ AML/MDS Panel

Consists of four different pre-configured single-use, 8-color reagents (AML T1, AML T2, AML T3, AML T4)
Available in 10 test/box size, each box contains 2 pouches of five ready-to-use tubes (AML T1, AML T2, AML T3), or 4 pouches of five ready-to-use tubes (AML T4), where 2 pouches contain tubes with the cytoplasmic markers (C tube) and 2 pouches contain tubes with the surface markers (S tube)
Used in combination with BD OneFlow™ ALOT, it is designed for the classification of different forms of acute myeloid leukemias
Boxes, pouches and tubes are color coded with dark red bands for easy identification.

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:

Instrument set-up hands-on time is less than 30 minutes annually and daily setup time for operator is less than 10 minutes
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

BD OneFlow™ AML/MDS Panel increases efficiency by reducing time for preliminary set-up and antibody cocktailing

In a comparative study between traditional liquid antibodies and BD OneFlow™, the setup for liquid reagents involved multiple manual steps—including assembling materials, preparing specimens, labeling vials, and pipetting pre-titered volumes of each antibody to create cocktails.
BD OneFlow™ AML/MDS panel consisting of four tubes, AML T1-T4 simplifies this process, delivering
- Up to 90% savings in hands-on time during preliminary setup and antibody cocktailing.
- Up to 93% reduction in error-prone steps, improving consistency and reliability compared to liquid antibody preparation.

The BD OneFlow™ AML/MDS Panel Has a High Diagnostic Accuracy (specificity) and Sensitivity

A comparison between clinical performance of the BD OneFlow™ AML/MDS Panel on the BD FACSLyric™ Flow Cytometer and final clinical diagnosis demonstrated:

High specificity (through identification of AML negative specimens) in 99.6% of the cases as analyzed by two independent experts*¤
High sensitivity (through detection of AML positive specimens) in 81.8% of cases as analyzed by two independent experts *¤

* A clinical performance evaluation between the BD OneFlow™ system on the BD FACSLyric™ Flow Cytometer and the final clinical diagnosis was performed at seven clinical sites. The results were analyzed by two independent experts in leukemia and lymphoma immunophenotyping who did not know the final clinical diagnosis. The final clinical diagnosis was performed according to World Health Organization (WHO) guidelines. The clinical history, complete blood count, morphological assessment, flow cytometry, histopathology, molecular genetic findings, and other laboratory data were taken into consideration

¤Based on exploratory analysis

Expert	Metrics	Value	Clopper-Pearson 95% CI	Wilson Score 95% CI
Expert #1	Sensitivity	81.8%	69.1%, 90.9%	69.7%, 89.8%
Expert #1	Specificity	99.6%	97.6%, 100.0%	97.6%, 99.9%
Expert #2	Sensitivity	81.8%	69.1%, 90.9%	69.7%, 89.8%
Expert #2	Specificity	99.6%	97.6%, 100.0%	97.6%, 99.9%

The BD OneFlow™ AML T1-T4 Reagent Composition

BD OneFlow™ AML T1

Antibodies were chosen for their ability to assess neutrophilic maturation

Reagent	Antibody	Clone	Fluorochrome	Target Population
BD OneFlow™ AML T1	CD16	CLB-Fcgran/1	FITC	Expressed on neutrophils in a maturation-stage specific manner
	CD13	L138.1	PE	Expressed on neutrophils in a maturation-stage specific manner
	CD34	8G12	PerCP-Cy5.5	Backbone marker for the AML panel. Identification of immature cells
	CD117	104D2	PE-Cy7	Backbone marker for the AML panel. Identification of immature cells
	CD11b	D12	APC	Expressed on neutrophils in a maturation-stage specific manner
	CD10	HI10A	APC-H7	Expressed on neutrophils in a maturation-stage specific manner
	HLA-DR	L243	BD Horizon™ V450	Backbone marker for the AML panel. Identification of immature cells
	CD45	2D1	BD Horizon™ V500-C	Backbone marker for the AML panel. Identification of immature cells

BD OneFlow™ AML T2

Antibodies were chosen for their ability to assess monocytic maturation

Reagent	Antibody	Clone	Fluorochrome	Target Population
BD OneFlow™ AML T2	CD35	E11	FITC	Expressed on monocytes during various stages of maturation
	CD64	10.1	PE	Expressed on monocytes during various stages of maturation
	CD34	8G12	PerCP-Cy5.5	Backbone marker for the AML panel. Identification of immature cells
	CD117	104D2	PE-Cy7	Backbone marker for the AML panel. Identification of immature cells
	CD300e (IREM-2)	UP-H2	APC	Expressed on monocytes during various stages of maturation
	CD14	MΦP9	APC-H7	Expressed on monocytes during various stages of maturation
	HLA-DR	L243	BD Horizon™ V450	Backbone marker for the AML panel. Identification of immature cells
	CD45	2D1	BD Horizon™ V500-C	Backbone marker for the AML panel. Identification of immature cells

BD OneFlow™ AML T3

Antibodies were chosen for their ability to assess erythrocytic maturation

Reagent	Antibody	Clone	Fluorochrome	Target Population
BD OneFlow™ AML T3	CD36	CLB-IVC7	FITC	Evaluates erythroid differentiation
	CD105	266	PE	Evaluates erythroid differentiation
	CD34	8G12	PerCP-Cy5.5	Backbone marker for the AML panel. Identification of immature cells
	CD117	104D2	PE-Cy7	Backbone marker for the AML panel. Identification of immature cells
	CD33	P67.6	APC	Evaluates erythroid differentiation
	CD71	M-A712	APC-H7	Evaluates erythroid differentiation
	HLA-DR	L243	BD Horizon™ V450	Backbone marker for the AML panel. Identification of immature cells
	CD45	2D1	BD Horizon™ V500-C	Backbone marker for the AML panel. Identification of immature cells

BD OneFlow™ AML T4 Tube(s)

Antibodies were chosen for their ability to assess aberrant expression of lymphoid markers

Reagent	Antibody	Clone	Fluorochrome	Target Population
BD OneFlow™ AML T4 Tube (S)	CD56	MY31	PE	Detection of aberrant expression of lymphoid markers on myeloid cells
	CD34	8G12	PerCP-Cy5.5	Backbone marker for the AML panel. Identification of immature cells
	CD117	104D2	PE-Cy7	Backbone marker for the AML panel. Identification of immature cells
	CD7	M-T701	APC	Detection of aberrant expression of lymphoid markers on myeloid cells
	CD19	SJ25C1	APC-H7	Detection of aberrant expression of lymphoid markers on myeloid cells
	HLA-DR	L243	BD Horizon™ V450	Backbone marker for the AML panel. Identification of immature cells
	CD45	2D1	BD Horizon™ V500-C	Backbone marker for the AML panel. Identification of immature cells
BD OneFlow™ AML T4 Tube (C)	NuTdT	HT-6	FITC	Detection of aberrant expression of lymphoid markers on myeloid cells

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

Acquisition and analysis in BD FACSuite™ Clinical Application

Standardised acquisition and analysis in BD FACSuite™ Clinical Application with predefined templates for consistency of results
Supplemental analysis reports for flexibility in examining additional cell populations
Reports available in 25 languages

Download BD OneFlow™ AML T1 Lab Report>

Download BD OneFlow^™ AML T2 Lab Report >

Download BD OneFlow™ AML T3 Lab Report >

Download BD OneFlow™ AML T4 Lab Report >

Resources

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Brochure

BD OneFlow^TM Solution

Application Guide

BD OneFlow Application Guide

Instruction for Use

BD OneFlow Acute Myeloid Leukemia/MDS

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

The BD FACSLyric™ Flow Cytometer with the BD FACSuite™ Clinical and BD FACSuite™ Applications are an in vitro diagnostic medical device bearing a CE mark.

The BD OneFlow™ LST , BD OneFlow™ B-CLPD T1, BD OneFlow™ PCST, BD OneFlow™ PCD, BD OneFlow™ ALOT, BD OneFlow™ AML T1, BD OneFlow™ AML T2, BD OneFlow™ AML T3, BD OneFlow™ AML T4, BD OneFlow™ BCP-ALL T1 are in vitro diagnostic medical device bearing a CE mark and are CE certified by BSI Group the Netherlands B.V.

(Notified Body Number = 2797).
BD Flow Cytometers are Class 1 Laser Products.

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).