The long and winding road to optimal HbA1c measurement

Randie R Little1, Curt L Rohlfing

  • 1Department of Pathology and Anatomical Sciences, University of Missouri School of Medicine, One Hospital Dr., Columbia, MO 65212, USA. littler@health.missouri.edu

Insights

Standardizing hemoglobin A1c (HbA1c) testing has improved diabetes management since 1996. Ongoing efforts address new methods and point-of-care testing for accurate results.

Area of Science:

  • Clinical Chemistry
  • Endocrinology
  • Laboratory Medicine

Background:

  • Hemoglobin A1c (HbA1c) is crucial for monitoring diabetes mellitus and predicting complications.
  • Early trials like DCCT and UKPDS established HbA1c targets but faced comparability issues.
  • Lack of standardization hindered clinical application of HbA1c results.

Purpose of the Study:

  • To review the historical development and current status of HbA1c standardization.
  • To discuss advancements including the International Federation of Clinical Chemistry (IFCC) reference method.
  • To highlight emerging issues like point-of-care (POC) testing and diagnostic use.

Main Methods:

  • Review of landmark clinical trials (DCCT, UKPDS).
  • Analysis of the National Glycohemoglobin Standardization Program (NGSP) initiation and success.
  • Examination of the development of higher-order reference methods and POC testing.

Main Results:

  • HbA1c standardization efforts, initiated in 1996 by NGSP, have been highly successful.
  • Significant progress in aligning HbA1c results with DCCT/UKPDS values.
  • Emergence of IFCC reference methods and increased use of POC testing.

Conclusions:

  • HbA1c standardization has greatly improved diabetes care and comparability of results.
  • Continued evolution includes advanced reference methods and point-of-care technologies.
  • Understanding current limitations in HbA1c testing is vital for healthcare providers.

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