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Disease/health condition -
Anaemia, Sickle cell disease (SCD)
Discipline -
Haematology
Reticulocyte count
Assay format
Microscopic examination
Information History
First added in 2024
Purpose type
Aid to diagnosis, Montoring
Purpose
To aid in the diagnosis of anemia. To monitor the effectiveness of treatments like iron, vitamin B12, or folate supplementation. To assess bone marrow recovery after chemotherapy or transplantation.
Specimen types
Venous whole blood
WHO prequalified or recommended products
N/A
GMDN
43587
Biological stain IVD
A chemical agent(s), dye(s) and/or solution(s) intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.
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 2005-2024EMDN
W0103010399
HAEMATOLOGY STAINS FOR MICROSCOPY - 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/emdnWHO supporting publications
WHO SICKLE package of interventions for sickle-cell disease management: strategic guidance framework: Module 1. Brazzaville: WHO African Region, 2024. https://www.afro.who.int/sites/default/files/2024-06/WHO%20SICKLE_Module_3.pdf
Technical specifications
N/A
Related Medical Devices in MeDevIS
SAGE IVD recommended including this test in the EDL on the basis of the scientific validity of the analyte. It was recognized that the test is a foundational IVD test and is included in clinical guidelines.
N/A
The inclusion of this test was based on WHO guidelines and/or technical documents that include recommendations for the use of this test.
N/A