2010 Consensus Statement on the Worldwide Standardization of the Hemoglobin A1C Measurement

Abstract

Glycated hemoglobin concentrations (most commonly hemoglobin A1C; HbA1c) reflect time-averaged blood glucose during the previous 2–3 months and are used as the gold standard for long-term follow-up of glycemic control. Standardization with common calibration was first proposed in 1984 (1). It was only after the publication of the Diabetes Control and Complications Trial (DCCT) study in 1993 (2), however, that the issue of international standardization of HbA1c measurements became an important objective for scientists and clinicians. At that time, the lack of international standardization resulted in several countries developing National standardization programs; most notable of these are: A common feature of these national programs is the absence of primary and secondary reference materials. To overcome this lack of reference materials, achieve global standardization, and meet the requirements of the European Union directive on in vitro diagnostic (IVD) medical devices, the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) established a Working Group on HbA1c Standardization to develop a reference measurement system within the concept of metrological traceability. Such a system has been developed consisting of incubation with the enzyme endoproteinase Glu-C, cleavage of the NH2-terminal hexapeptide of the β-chain, and separation and …