Indication - Diabetes mellitus
Facility level:
Assay formats
Glucose meter
Status history
First added in 2019
Changed in 2020
Purpose type
Diagnosis, Monitoring, Screening
To diagnose and monitor type 1 and type 2 diabetes mellitus; To diagnose impaired fasting glucose/impaired glucose tolerance; To screen for type 2 diabetes mellitus and impaired fasting glucose/impaired glucose tolerance
Specimen types
Capillary whole blood
WHO prequalified or recommended products
WHO supporting documents
ICD11 code: 5A14

Summary of SAGE IVD recommendation

General In vitro diagnostics tests are the general core and routine laboratory tests for clinical chemistry, haematology, blood transfusion, microbiology (virology, bacteriology, parasitology and mycology) and histopathology. These tests were selected on the basis of the scientific validity of an analyte, i.e. the association between an analyte and a clinical condition or physiological state; and clinical utility. Many of these tests are required for effective management of patients and have already been described in WHO publications.

Details of submission from 2020

The inclusion of this entry was based on WHO guidelines and technical reports that include recommendations for the appropriate IVDs.