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Disease/health condition - Diabetes mellitus, Meningitis
Discipline - Clinical chemistry
Glucose
Setting:
2. Laboratory
Tiered Testing Service:
District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Optical methods on semi-automated or automated clinical chemistry analysers
Information History
First added in 2018
Changed in 2024
Purpose type
Screening, Diagnosis, Monitoring, Determination of physiological status
Purpose
To detect hypoglycaemia and hyperglycaemia. To diagnose and monitor type 1 and type 2 diabetes mellitus if HbA1c is not available. To screen for type 2 diabetes mellitus and impaired fasting glucose. To diagnose impaired fasting glucose. To determine CSF glucose concentration and the CSF to blood glucose ratio.
Specimen types
Serum, Plasma, Cerebrospinal fluid
WHO prequalified or recommended products
N/A
GMDN

53301

Glucose IVD, kit, spectrophotometry

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glucose in a clinical specimen, using a spectrophotometry 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

W01010213

GLUCOSE

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 ; WHO list of priority medical devices for management of cardiovascular diseases and diabetes. (2021). https://iris.who.int/handle/10665/341967 ; World Health Organization. (‎2025)‎. WHO guidelines on meningitis diagnosis, treatment and care. World Health Organization. https://iris.who.int/handle/10665/381006
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