Download

Disease/health condition - Diabetes mellitus
Glycated haemoglobin (HbA1c)
Setting:
2. Laboratory
Tiered Testing Service:
District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Immunoturbidimetry
Information History
First added in 2018
Changed in 2024
Purpose type
Diagnosis, Montoring
Purpose
To diagnose and monitor diabetes mellitus.
Specimen types
Venous whole blood
WHO prequalified or recommended products
N/A
GMDN

61010

Glycated haemoglobin (HbA1c) IVD, kit, chemiluminescent immunoassay

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen using a chemiluminescent immunoassay 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

W0102060109

GLYCOSYLATED/ GLYCATED HAEMOGLOBIN (IC)

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. (‎2020)‎. HEARTS D: diagnosis and management of type 2 diabetes. World Health Organization. https://iris.who.int/handle/10665/331710 ; The Spanish version is published by PAHO: https://iris.paho.org/handle/10665.2/53007 ; The Portuguese version is published by PAHO: https://iris.paho.org/handle/10665.2/57457
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 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