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General Clinical Chemistry |
1 Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN.
2 Biostatistics Center, the George Washington University, Rockville, MD.
3 Departments of Pathology and Anatomical Sciences and Child Health, University of Missouri, Columbia, MO.
4 Fairview University Medical Center, Minneapolis, MN.
aAddress correspondence to this author at: University of Minnesota, Department of Laboratory Medicine and Pathology, MMC 609, 420 Delaware St. S.E., Minneapolis, MN 55454. Fax 612-273-3489; e-mail steff001{at}umn.edu.
Background: Clinical trials require assays that provide consistent results during the course of a study. The hemoglobin A1c (HbA1c) assay, a measure of chronic glycemia, is critical to the study of diabetes control and complications.
Methods: The Diabetes Control and Complications Trial (DCCT) and its follow-up study, the Epidemiology of Diabetes Interventions and Complications (EDIC), required 20 years of consistent HbA1c results, measured by three different ion-exchange HPLC procedures. To maintain and document consistent HbA1c results measured in the DCCT and EDIC Central Biochemistry Laboratory, a backup laboratory used frozen hemolysates as long-term calibrators and a HPLC method with a single lot of Bio-Rex 70 resin.
Results: Over 20 years, long-term quality-control values have remained constant. Four studies of nondiabetic ranges produced nearly identical values [mean (SD), 5.1 (0.5)%, 4.9 (0.3)%, 5.0 (0.4)%, and 5.0 (0.3)%].
Conclusion: The overall consistency of the HbA1c assays during the 20-year course of the DCCT and EDIC has been critical in establishing the benefits of intensive therapy and in understanding the relationship between long-term glycemia and the development and progression of the complications of diabetes.
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