Purpose:
HbA1c is used for both the diagnosis (Type 2) and monitoring of diabetes (Type 1 & 2) and as part of the NHS England Health Check for subjects that on initial screen are identified as having a risk of developing diabetes.
The diagnosis of diabetes is based on the measurement of plasma glucose or glycated haemoglobin (HbA1c), with a cut off value for HbA1c of 48 mmol/mol used as the diagnostic threshold for diabetes; however, plasma glucose remains the preferred test in people with symptoms who are suspected of having type 1. Diagnosis and management of type 2 diabetes (HEARTS-D). Geneva]: World Health Organization; 2020 (WHO/UCN/NCD/20.1).
HbA1c is commonly used to monitor glycaemic control in both Type 1 and Type 2 diabetes as it provides a measure of average plasma glucose over the preceding 8 – 12 weeks.
Scope:
The programme aim is to cover the clinically relevant ranges, encompassing the diagnostic cut-off level, of 48mmol/mol Hb for the diagnosis of diabetes. However, the analytical measuring range will also be assessed where appropriate. The programme is suitable for all Laboratory and POCT applications.
Fresh EDTA whole blood from individual diabetic patients and healthy volunteers are distributed monthly/bi-monthly. These samples reflect the wide range of HbA1c seen in healthy individuals and in Diabetic patients. Challenging samples from patients with known Hb variants are also distributed to assess current practice. Samples from volunteers and diabetic patients are distributed to ensure that the concentration range is appropriate for population health check screening, diabetes diagnosis and diabetes patient monitoring.
The HbA1c reference target values in the Weqas programme are assigned using IFCC secondary reference methods in an IFCC network laboratory. The programme allows for the assessment of the organisation’s and method’s performance, including linearity, trueness, bias, and imprecision.
![]() |
Key Features:
|
HbA1c Programme | ||
---|---|---|
Analyte | Approx. Range Covered | |
*HbA1c | 32 - 85 | mmol/mol Hb |
* IFCC and NGSP values assigned by the European Reference Laboratory for Glycohaemoglobin.
Related Documents