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Indication -
Diabetes mellitus
Haemoglobin A1c (HbA1c)
Assay formats
Handheld and small analysers
Status 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
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; https://www.who.int/health-topics/diabetes#tab=tab_1
Codes
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.