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HBA1c: clinical and biological agreement for standardization of assay methods. Report by the experts of ALFEDIAM (Association de Langue Fran?aise pour lEtude du Diabète et des Maladies Métabolique) and SFBC (Société Fran?aise de Biologie Clinique)]
Authors:P Gillery  M Bordas-Fonfrède  J P Chapelle  P Drouin  G Hue  C Lévy-Marchal  C Périer  J L Sélam  G Slama  C Thivolet  B Vialettes
Institution:Laboratoire Central de Biochimie, H?pital Robert Debré, CHU de Reims. pgillery@chu-reims.fr
Abstract:Glycohaemoglobin, and particularly haemoglobin A1c(HbA1c), assays have been used for many years to retrospectively evaluate the glycaemic control of diabetic patients. Cut-off values have been established for deciding treatment modifications. The techniques used in the laboratories however exhibit varying quality, and all of them are not yet standardized. The consequence is an under-utilization of this test, especially in non-hospital practice. In this context, working groups of Société Fran?aise de Biologie Clinique (SFBC), Association de Langue Fran?aise pour l'Etude du Diabète et des Maladies Métaboliques (ALFEDIAM) and Société Fran?aise d'Endocrinologie (SFE) have met together, in order to analyze the national status, and to propose practical recommendations for implementing a standardization process on the basis of international experiences. It is recommended to exclusively express results as HbA1c percentage, using methods standardized and certified by comparison to reference methods such as those using Diabetes Control and Complications Trial (DCCT) values. Simultaneously, contacts have been established with manufacturers, and the realisation of periodic quality control surveys was encouraged.
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