Towards worldwide standardisation of HbA1c determination

Diabetologia
Kor Miedema

Abstract

Haemoglobin A(1)c (HbA(1)c) or glycohaemoglobin is one of the most important parameters in the management of patients with diabetes mellitus, but to date there is no international standard for determining HbA(1)c. Most of the routine HbA(1)c assays are standardised against one of the local standardisation schemes like the NGSP (USA) and other schemes (Japan, Sweden). Still, results of HbA(1)c tests diverge considerably, as do the accompanying clinical decision limits. The IFCC Working Group on HbA(1)c Standardisation has developed a reference method and also set up a reference system for HbA(1)c, in which the analyte is defined as beta-N-glycated haemoglobin. This reference system consists of a network of reference laboratories that uses the reference methods and certified reference materials for optimal measurement of HbA(1)c in human blood. The main task of the network is to assign values to secondary reference materials, to be used by manufacturers of routine HbA(1)c assays to calibrate their assays. The high specificity of the reference method results in lower HbA(1)c values in blood samples, since the unspecific components falsely identified as HbA(1)c in routine methods are not measured by the reference method. The refere...Continue Reading

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