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Glycated hemoglobin standardization--National Glycohemoglobin Standardization Program (NGSP) perspective
1Department of Pathology, University of Missouri School of Medicine, Columbia, MO 65212, USA. LittleR@health.missouri.edu
Clinical Chemistry and Laboratory Medicine
|November 6, 2003
Summary
The National Glycohemoglobin Standardization Program (NGSP) improved hemoglobin A1c (HbA1c) test comparability. This standardization allows for better diabetes management and tracking of complications.
Area of Science:
- Clinical Chemistry
- Endocrinology
- Diabetes Mellitus Research
Background:
- Diabetes complications are linked to glycemic control, measured by glycated hemoglobin (GHb).
- International guidelines recommend hemoglobin A1c (HbA1c) targets based on DCCT/UKPDS studies.
- Lack of GHb test comparability hindered guideline implementation in 1993.
Purpose of the Study:
- To establish a standardized system for reporting GHb/HbA1c results traceable to DCCT/UKPDS outcomes.
- To improve the comparability of GHb test results across laboratories and methods.
Main Methods:
- Implementation of the National Glycohemoglobin Standardization Program (NGSP).
- Certification of laboratories and methods for NGSP traceability.
- Proficiency testing to assess comparability of GHb results.
Main Results:
- Significant increase in NGSP-certified methods and laboratories reporting DCCT/UKPDS-traceable results.
- Marked improvement in GHb result comparability, with 98% of labs reporting HbA1c equivalents by 2002.
- High percentage (97%) of labs used NGSP-certified methods, with low between-laboratory CVs (<5% for most).
Conclusions:
- The NGSP successfully enhanced the comparability of GHb/HbA1c testing.
- Standardization enables meaningful implementation of diabetes care guidelines based on glycemic control.
- The majority of US laboratories now report traceable HbA1c results, supporting better diabetes management.