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Global standardisation of HbA1c
1Gleneagles Intan Medical Centre, Kuala Lumpur, Malaysia.
The Malaysian Journal of Pathology
|March 19, 2009
Summary
Standardizing hemoglobin A1c (HbA1c) assays is crucial for accurate diabetes management and complication risk prediction. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) developed a global reference system for improved accuracy and comparability.
Area of Science:
- Clinical Chemistry
- Diabetology
- Laboratory Medicine
Background:
- Hemoglobin A1c (HbA1c) is vital for assessing glycemic control in diabetes patients.
- HbA1c levels predict the risk of diabetes-related complications, as shown by the DCCT trial.
- Standardization of HbA1c assays is essential for reliable and comparable results across laboratories.
Purpose of the Study:
- To highlight the importance of standardizing HbA1c assays.
- To introduce the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) global HbA1c reference system.
- To recommend reporting HbA1c results using both IFCC and NGSP standards, along with estimated average glucose (eAG).
Main Methods:
- Review of existing HbA1c standardization programs (NGSP, Sweden, Japan).
- Development of a global HbA1c reference system by the IFCC Working Group.
- Establishment of a relationship between IFCC-HbA1c, NGSP-HbA1c, and estimated average glucose (eAG).
Main Results:
- Existing standardization programs (NGSP, Sweden, Japan) use direct comparison methods (DCMs) and yield different results.
- The IFCC has developed a global reference system with significantly improved intra-assay and inter-assay precision.
- A strong correlation between eAG and HbA1c has been demonstrated, supporting dual reporting.
Conclusions:
- Standardized HbA1c measurements are critical for effective diabetes care and complication risk assessment.
- The IFCC global reference system offers improved accuracy and consistency for HbA1c testing.
- Reporting HbA1c in both IFCC units (mmol/mol Hb) and NGSP units (%) alongside eAG provides comprehensive glycemic information.
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