Comparison between a rapid glycohaemoglobin (HbA1c) immunoassay and other indices of glycaemic control

Acta Diabetol. 1996 Sep;33(3):232-5. doi: 10.1007/BF02048549.

Abstract

The aims of the study were to compare glycohaemoglobin (HbA1c) values measured by DCA (a benchtop analyzer primarily designed for within-clinic rapid HbA1c determination) to a reference HbA1c method and home blood glucose monitoring, and to explore the possibility of an uniform expression of data. A total of 103 blood samples and the corresponding mean capillary glucose values (4.4 +/- 1.2 tests/day) of the preceding 2 months were collected from 34 insulin-dependent diabetic adults. We measured the correlations and agreements using the residual plots method and regression equations between HbA1c measured by DCA and high-pressure liquid chromatography (HPLC), and between DCA and capillary glucose values. A highly significant correlation (r2 = 0.85, P < 0.001) and an acceptable agreement (97% of values within 2 SD of the mean difference of 0.9% +/- 0.4%) was found between DCA and HPLC values. The regression equation calculated on the first half of the cases was: DCA (%) = 0.72 HPLC (%) +1.38. Of DCA values expressed in HPLC terms using this equation 87% fell within a clinically acceptable confidence interval when compared with measured HPLC data. A significant correlation (r2 = 0.40, P < 0.01) was found between DCA and capillary glucose values, and the regression equation was: DCA (%) = 0.34 capillary glucose (mM) +4.44. Of glycaemic levels calculated from DCA values using this formula 82% fell within a clinically acceptable error range when compared with measured glycaemic values. We conclude that the three methods of assessment of diabetes control are well correlated and that it is possible, with a degree of precision acceptable for the clinical setting, to express all data in uniform units, e.g. mM of capillary glucose or percentage of HPLC-HbA1c, though a simple correspondence table based on our transfer equations may be clinically sufficient and more handy.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Agglutination Tests / methods
  • Biomarkers / blood
  • Blood Glucose / analysis*
  • Blood Glucose Self-Monitoring
  • Chromatography, High Pressure Liquid / methods
  • Diabetes Mellitus, Type 1 / blood*
  • Glycated Hemoglobin / analysis*
  • Humans
  • Immunoassay / methods
  • Regression Analysis
  • Reproducibility of Results

Substances

  • Biomarkers
  • Blood Glucose
  • Glycated Hemoglobin A