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Disease/health condition - Sickle cell disease (SCD)
Haemoglobin electrophoresis
Setting:
2. Laboratory
Tiered Testing Service:
District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Capillary electrophoresis
Information History
First added in 2019
Changed in 2024
Purpose type
Diagnosis
Purpose
To diagnose sickle cell disease (SCD).
Specimen types
Venous whole blood
WHO prequalified or recommended products
N/A
GMDN

55904

Haemoglobin S (HbS) IVD, kit, electrophoresis

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of haemoglobin subtype S (HbS), also known as sickle cell haemoglobin, in a clinical specimen using an electrophoresis 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

W0103010202

OTHER HAEMOGLOBIN (TYPES) TESTING - 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
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
SAGE IVD recommended including this test in the EDL on the basis of the scientific validity of the analyte and the availability of WHO guidelines and technical reports, including recommendations for the use of this test. The selection of disease specific tests for the EDL also took into account relevant priority diseases for WHO such as NCDs including DM, CVD and cancer, HIV infection, malaria, NTDs, STIs, tuberculosis, viral hepatitis B and C, among others.
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