Indication - Diabetes mellitus
Haemoglobin A1c (HbA1c)
Facility level:
Assay formats
Status history
First added in 2018
Changed in 2020
Purpose type
Diagnosis, Monitoring
To diagnose and monitor diabetes mellitus
Specimen types
Venous whole blood
WHO prequalified or recommended products
WHO supporting documents
HEARTS-D: diagnosis and management of type 2 diabetes (2020) https://www.who.int/publications/i/item/who-ucn-ncd-20.1
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.