Global standardization of glycated hemoglobin measurement: the position of the IFCC Working Group

1, Andrea Mosca, Ian Goodall

  • 1Centre for Metrological Traceability in Laboratory Medicine (CIRME), Dept. Science and Biomedical Technology, University of Milano, Italy.

Insights

International standardization of glycated hemoglobin (HbA1c) measurement is crucial for diabetes monitoring. The IFCC established a reference system, including procedures, calibrators, and a lab network, to ensure accurate and traceable HbA1c results globally.

Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Endocrinology

Background:

  • Glycated hemoglobin (HbA1c) measurement is vital for diabetes glycemic control monitoring.
  • Numerous laboratory assays exist, leading to variability in results.
  • International standardization efforts were initiated to address this variability.

Purpose of the Study:

  • To establish an international standard for HbA1c measurement.
  • To ensure accurate and comparable HbA1c results across different laboratories worldwide.
  • To implement traceability to a common reference system.

Main Methods:

  • Development of a reference measurement procedure using purified primary calibrators.
  • Establishment of a global network of reference laboratories.
  • Initiation of traceability implementation to the IFCC reference system.

Main Results:

  • A reference measurement procedure for HbA1c has been successfully established.
  • A worldwide network of reference laboratories is operational.
  • Progress has been made in implementing traceability to the IFCC reference system.

Conclusions:

  • The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on HbA1c has made significant progress in standardizing HbA1c measurement.
  • The analyte is now defined as betaN1-deoxyfructosyl-hemoglobin with units of mmol/mol.
  • The name HbA1c is recommended for continued use in clinical practice for clarity.