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[Diabetes mellitus and HbA1c].
1Department of Laboratory Medicine, Yamagata University School of Medicine, Yamagata 990-9585.
Rinsho Byori. the Japanese Journal of Clinical Pathology
|July 30, 2003
Summary
Japan achieved Hemoglobin A1c (HbA1c) measurement standardization through JDS calibrators since 1995. Lot 2, a deeply frozen material, currently maintains this crucial HbA1c standardization in Japan.
Area of Science:
- Clinical Chemistry
- Endocrinology
- Laboratory Medicine
Background:
- The Japan Diabetes Association (JDS) initiated Hemoglobin A1c (HbA1c) standardization in Japan in 1995 using Lot 1 calibrators.
- Standardization facilitated the adoption of HbA1c as a diagnostic and monitoring tool for diabetes mellitus.
Purpose of the Study:
- To detail the evolution of HbA1c measurement standardization in Japan.
- To highlight the transition from Lot 1 to Lot 2 calibrators for maintaining measurement accuracy.
Main Methods:
- Distribution of primary calibrators (Lot 1, then Lot 2) by the JDS to manufacturers.
- Implementation of new diagnostic criteria and clinical guidelines incorporating standardized HbA1c values.
Main Results:
- Successful standardization of HbA1c measurement across Japan since 1995.
- Identification of limitations with the freeze-dried Lot 1 calibrator.
- Adoption of the deeply frozen Lot 2 calibrator in 2001 to ensure continued standardization.
Conclusions:
- The JDS's calibration efforts have been pivotal in standardizing HbA1c measurements in Japan.
- The transition to Lot 2 reflects an ongoing commitment to accurate diabetes mellitus management.
- Standardized HbA1c measurements are essential for reliable diabetes diagnosis and treatment goal setting.