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Discipline -
Urinalysis
Haemoglobin (Hb)
Assay format
Dipstick
Information History
First added in 2020
Purpose type
Aid to diagnosis
Purpose
Clinical marker for certain severe infections (e.g. malaria, viral haemorrhagic fevers). To aid in the diagnosis of intravascular haemolysis, renal conditions, rhabdomyolysis (myoglobinuria).
Specimen types
Urine
WHO prequalified or recommended products
N/A
GMDN
64807
Urine haemoglobin IVD, kit, rapid colorimetric, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for haemoglobin within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
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
W01010602
URINE TESTING (CC) - RT & POC
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 list of priority medical devices for management of cardiovascular diseases and diabetes. (2021). https://iris.who.int/handle/10665/341967
Technical specifications
N/A
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