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Disease/health condition - Anaemia
Discipline - Haematology
Haemoglobin (Hb)
Setting:
1. Non-laboratory
Tiered Testing Service:
Community/outreach Primary health care center without laboratory
Assay format
Point-of-care test
Information History
First added in 2020
Changed in 2024
Purpose type
Screening, Diagnosis, Monitoring
Purpose
To diagnose and monitor anaemia. To monitor the safety of certain drugs (e.g. zidovudine for HIV infection). To screen potential blood donors.
Specimen types
Capillary whole blood
WHO prequalified or recommended products
N/A
GMDN

32435

Haemoglobin analyser IVD, point-of-care

A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often also in the laboratory, 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

W0103010601

HAEMOGLOBIN (HB)

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
Interagency list of priority medical devices for essential interventions for reproductive, maternal, newborn and child health. (2016). https://iris.who.int/bitstream/handle/10665/205490/9789241565028_eng.pdf?sequence=1 ; 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
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