IFCC standardised HbA(1c): should the world be as one?

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Metrology

Background:

• The Diabetes Control and Complications Trial (DCCT) established HbA1c's importance in monitoring glycaemic control and delaying diabetic complications.
• Lack of international standardization for glycated hemoglobin (GHb) measurements led to national standardization programs.
• The need for globally consistent HbA1c measurements became a critical objective.

Purpose of the Study:

• To establish an internationally standardized reference measurement procedure for HbA1c.
• To ensure metrological traceability for HbA1c measurements.
• To define the measurand and unit of measurement for HbA1c.

Main Methods:

• Development of a reference measurement procedure using HPLC-MS or HPLC-CE.
• Anchoring the reference method to a global network of 15 approved reference laboratories.
• Defining HbA1c as a stable glucose adduct on hemoglobin (Hb) β chain N-terminus and specifying mmol/mol as the unit.

Main Results:

• Establishment of a sustainable reference measurement system with low uncertainty.
• Improved inter-method and inter-laboratory agreement for HbA1c measurements.
• Foundation laid for globally harmonized clinical goals and diagnostic guidelines.

Conclusions:

• International standardization of HbA1c is now feasible through a metrologically sound reference system.
• This standardization will enhance the reliability of diabetes monitoring worldwide.
• Global adoption of standardized HbA1c measurements will facilitate consistent diabetes care and guideline implementation across countries.