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Disease/health condition - Cancer
Leukemia immunophenotyping panel
Setting:
2. Laboratory
Tiered Testing Service:
District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Flow cytometry
Information History
First added in 2019
Changed in 2024
Purpose type
Diagnosis
Purpose
For the diagnosis and differentiation of leukaemia.
Specimen types
Bone marrow aspirate, Venous whole blood, Body fluids (e.g., Cerebrospinal fluid, Pleural fluid, Peritoneal fluid), Lymph node aspirate
WHO prequalified or recommended products
N/A
GMDN

56916

Multiple CD cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations, using a fluorescent activated cell sorting/flow cytometry (FACS/Flow) method.

The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024
EMDN

W0103080699

REAGENTS FOR FLOW CYTOMETRY - OTHER

The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdn
WHO supporting publications
Haematolymphoid Tumours WHO Classification of Tumours, 5th Edition, Volume 11, 2024. https://publications.iarc.who.int/Book-And-Report-Series/Who-Classification-Of-Tumours/Haematolymphoid-Tumours-2024 ; World Health Organization. (‎2017)‎. WHO list of priority medical devices for cancer management. World Health Organization. https://iris.who.int/handle/10665/255262 ; World Health Organization. (‎2019)‎. Guide for establishing a pathology laboratory in the context of cancer control. World Health Organization. https://iris.who.int/handle/10665/330664
Technical specifications
N/A
Related Medical Devices in MeDevIS
In 2019 the SAGE IVD recommended conditional inclusion on the EDL of the proposed essential panel of antibodies for flow cytometry for differentiation of leukaemia subtypes, pending submission of additional evidence of use in LMICs that lack highly skilled laboratory staff. The Group requested submission of more evidence on clinical use of the test and use of the panel in a wider range of countries and regions. The SAGE IVD recommended conditional listing of the test as an aid in the diagnosis of acute leukaemias. In 2020 WHO proposed adding HLA DR, CD5, CD23 and CD43 markers to the flow cytometry panel, and provided evidence for the use of each marker (available at: https://iris.who.int/handle/10665/339064). The working group accepted the evidence provided and agreed that all suggested markers should be included as essential flow cytometry antibodies for the diagnosis and differentiation of leukaemia.
A diagnosis of acute leukaemia requires immunophenotyping, and this panel will simplify diagnosis in countries with minimal skilled staff and pathologists. For the diagnosis and management of acute leukaemia in LMICs, where limited treatment is available, it is essential to make the basic distinction between acute myeloid leukaemia and acute lymphoblastic leukaemia (ALL), and ALL must be further classified into B or T cell, as the management differs. Although this is a basic panel, it will be invaluable for LMICs. In 2020 WHO proposed adding HLA DR, CD5, CD23 and CD43 markers to the flow cytometry panel, and provided evidence for the use of each marker (available at: https://iris.who.int/handle/10665/339064). The working group accepted the evidence provided and agreed that all suggested markers should be included as essential flow cytometry antibodies for the diagnosis and differentiation of leukaemia.
Evidence provided on the accuracy of flow cytometry for the purposes listed (in the diagnosis of acute leukaemias and definition of prognostic and predictive features) was limited. The disease classes are the basis for choosing therapy, and it is anticipated that there are randomized clinical trials (RCT) that show the benefits of various treatments for different subtypes of disease, thus providing evidence for the usefulness of this test. In 2020 WHO proposed adding HLA DR, CD5, CD23 and CD43 markers to the flow cytometry panel, and provided evidence for the use of each marker (available at: https://iris.who.int/handle/10665/339064). The working group accepted the evidence provided and agreed that all suggested markers should be included as essential flow cytometry antibodies for the diagnosis and differentiation of leukaemia.
World Health Organization. (‎2019)‎. The selection and use of essential in vitro diagnostics: report of the second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (‎including the second WHO model list of essential in vitro diagnostics)‎. World Health Organization. https://iris.who.int/handle/10665/329527 ; World Health Organization. (‎2021)‎. The selection and use of essential in vitro diagnostics: report of the third meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2020 (‎including the third WHO model list of essential in vitro diagnostics)‎. World Health Organization. https://iris.who.int/handle/10665/339064