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Disease/health condition - Anaemia
Discipline - Haematology
Haemoglobin (Hb)
Setting:
2. Laboratory
Tiered Testing Service:
District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Automated haematology analyser
Information History
First added in 2019
Changed in 2024
Purpose type
Screening, Aid to diagnosis, Diagnosis, Montoring
Purpose
To diagnose and monitor anaemia and polycythaemia. To monitor the safety of certain drugs (e.g. zidovudine for HIV infection). To screen potential blood donors. Clinical marker for certain severe infections (e.g. malaria, viral haemorrhagic fevers).
Specimen types
Capillary whole blood, Venous whole blood
WHO prequalified or recommended products
N/A
GMDN

56693

Haemoglobin analyser IVD, laboratory

An automated or semi-automated laboratory instrument intended to be used to determine the concentration of haemoglobin in a clinical specimen, using technology which may include colorimetry, electrometry or photometry.

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

W01030102

HAEMOGLOBIN (TYPES) TESTING

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
World Health Organization. (‎2024)‎. Guideline on haemoglobin cutoffs to define anaemia in individuals and populations. World Health Organization. https://iris.who.int/handle/10665/376196 ; WHO list of priority medical devices for management of cardiovascular diseases and diabetes. (2021). https://iris.who.int/handle/10665/341967
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