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Disease/health condition - Diabetes mellitus
Glycated haemoglobin (HbA1c)
Setting:
1. Non-laboratory
Tiered Testing Service:
Primary health care center without laboratory District hospital with laboratory
Assay format
Point-of-care test
Information History
First added in 2020
Purpose type
Diagnosis, Montoring
Purpose
To diagnose and monitor diabetes mellitus.
Specimen types
Capillary whole blood
WHO prequalified or recommended products
N/A
GMDN

62206

Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care

A collection of devices including a portable, electrically-powered, semi-automated or automated instrument (meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glycated haemoglobin (HbA1c) in a whole blood clinical specimen. The measurement is typically based on an immunological method (e.g., immunoassay) and/or spectrophotometry, and is used to evaluate the long-term control of blood glucose concentration, primarily in persons with diabetes mellitus.

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

W0102160102

GLYCOSYLATED/ GLYCATED HAEMOGLOBIN (IC) 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/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