BD OneFlow™ Acute Lymphoblastic Leukemia Panel (BCP-ALL Tube 1)

As an aid in the differential diagnosis of B-cell acute lymphoblastic leukemia

Overview

The BD OneFlow™ BCP-ALL T1 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 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™ BCP-ALL T1 is intended for flow-cytometric immunophenotyping of mature and immature hematopoietic cells populations (lymphoid lineage) in bone marrow and peripheral blood. It is used as an aid in the differential diagnosis of hematologically abnormal patients, including pediatric patients, having or suspected of having, B-cell acute lymphoblastic leukemia.

Features

The BD OneFlow™ BCP-ALL T1

Is a pre-configured single-use, 8-color reagent
Is available in a 10 test/box size, two pouches, of five ready-to-use tubes each
Is specifically designed for the classification of B-cell acute lymphoblastic leukemia and can be used in combination with BD OneFlow™ ALOT orientation tube
Boxes, pouches and tubes are color coded with orange 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 BCP All T1 Increased Efficiency

BD OneFlow™ Acute B-cell Leukemia 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.
The BD OneFlow™ BCP-ALL Tube 1 simplifies this process, delivering
- Up to 81% savings in hands-on time during preliminary setup and antibody cocktailing.
- Up to 94% reduction in error-prone steps, improving consistency and reliability compared to liquid antibody preparation.

The BD OneFlow™ Acute B-cell Leukemia Panel Has a High Diagnostic Accuracy (specificity) and Sensitivity

A comparison between clinical performance of the BD OneFlow™ Acute B-cell Leukemia Panel on the BD FACSLyric™ Flow Cytometer and final clinical diagnosis demonstrated:

High specificity (through identification of BCP-ALL negative specimens) in 98.7% and 99.1% of the cases as analyzed by two independent experts*^,¤
High sensitivity (through detection of BCP-ALL positive specimens) in 94.8% and 100% 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	94.8%	85.6%, 98.9%	85.9%, 98.2%
Expert #1	Specificity	98.7%	96.2%, 99.7%	96.2%, 99.6%
Expert #2	Sensitivity	100.0%	93.8%, 100.0%	93.8%, 100.0%
Expert #2	Specificity	99.1%	96.9%, 99.9%	96.9%, 99.8%

The BD OneFlow™ BCP-ALL T1 reagent composition

Reagent	Antibody	Clone	Fluorochrome	Target Population
BD OneFlow™ BCP-ALL T1	CD58	IC3	FITC	Associated with LAP phenotype. Required for subclassification of BCP-ALL
	CD66c	B6.2	PE	Required for subclassification of BCP-ALL
	CD34	8G12	PerCP-Cy5.5	Backbone marker for the BCP-ALL panel. Identification of immature B-cells
	CD19	SJ25C1	PE-Cy7	Backbone marker for the BCP-ALL panel. Identification of immature B-cells
	CD10	HI10A	APC	B-cell lineage associated markers useful in the positive diagnosis of BCP-ALL
	CD38	HB7	APC-H7	Required for subclassification of BCP-ALL
	CD20	L27	BD Horizon™ V450	B-cell lineage associated markers useful in the positive diagnosis of BCP-ALL
	CD45	2D1	BD Horizon™ V500-C	Backbone marker for the BCP-ALL panel. Identification of immature B-cellsA full description of the utility of the antibodies chosen for the BD OneFlow™ BCP-ALL T1 is provided in the publication by the EuroFlow Consortium.¹

A full description of the utility of the antibodies chosen for the BD OneFlow™ BCP-ALL T1 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

BD OneFlow^TM BCP-ALL T1 Lab Report

Resources

Expand All Collapse All

Brochure

BD OneFlow^TM Solution

Application Guide

BD OneFlow Application Guide

Instruction for Use

BD OneFlow Acute B-Cell Leukemia Panel

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).