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

Garry John1, Emma English

  • 1Department of Clinical Biochemistry, Norfolk and Norwich University Hospital, Norwich Medical School, University of East Anglia, Norwich, UK. g.john@nnuh.nhs.uk

Clinical Chemistry and Laboratory Medicine
|August 2, 2012
PubMed

Insights

International standardization of glycated hemoglobin (HbA1c) measurements is now achievable. A new reference method ensures accurate HbA1c monitoring, improving diabetes management and patient outcomes globally.

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.

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