《Table 1 Characteristics of the analytical methods for hemoglobin A1c measurement》

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《Update on biomarkers of glycemic control》

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DCCT:Diabetes Control and Complications Trial；HbF:Fetal hemoglobin；GHb:Total glycated hemoglobin.

Various analytical methods for HbA1c determination commonly utilize either of the two principles（Table 1）:（1）HbA1c separation from other hemoglobin fractions that is based on charge differences using either chromatography or electrophoresis；or（2）the direct measurement of HbA1c by specific binding（immunochemistry or affinity）or enzymatic cleavage[22].Due to differences between these analytical methods in their use of different principles and a lack of standardization，HbA1c testing inherently suffers from a significant between-method variability which has seriously affected its clinical accuracy in the longitudinal monitoring of average glycemia with different methods and comparing the results of the DCCT-and UKPDS-derived targets.Heterogeneity of molecular entities that were measured by different methods significantly contributed to the analytical variability，as the glycation reaction involved not onlyβ-N-terminal valine but also other accessible amino groups within theαandβ-globin chains，and these results depended on the type of analyte that was captured by a particular method[12].Thus，the standardization of the HbA1c measurement and reporting that included a uniform definition of the analyte was shortly identified as one of the most important issues in diabetes care[23，24].