title: HBA1c: clinical and biological agreement for standardization of assay methods. Report by the experts of ALFEDIAM (Association de Langue Française pour lEtude du Diabète et des Maladies Métabolique) and SFBC (Société Française de Biologie Clinique).
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 Française de Biologie Clinique (SFBC), Association de Langue Française pour l'Etude du Diabète et des Maladies Métaboliques (ALFEDIAM) and Société Française 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.
authors.affiliation: Laboratoire Central de Biochimie, Hôpital Robert Debré, CHU de Reims. pgillery@chu-reims.fr
authors.forename: P
authors.initials: P
authors.lastname: Gillery
authors.forename: M
authors.initials: M
authors.lastname: Bordas-Fonfrède
authors.forename: J P
authors.initials: JP
authors.lastname: Chapelle
authors.forename: P
authors.initials: P
authors.lastname: Drouin
authors.forename: G
authors.initials: G
authors.lastname: Hue
authors.forename: C
authors.initials: C
authors.lastname: Lévy-Marchal
authors.forename: C
authors.initials: C
authors.lastname: Périer
authors.forename: J L
authors.initials: JL
authors.lastname: Sélam
authors.forename: G
authors.initials: G
authors.lastname: Slama
authors.forename: C
authors.initials: C
authors.lastname: Thivolet
authors.forename: B
authors.initials: B
authors.lastname: Vialettes
mesh_terms: D019411:Clinical Laboratory Techniques / Q000592:standards*; D003920:Diabetes Mellitus / Q000097:blood*; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D007753:Laboratories / Q000592:standards; D011785:Quality Assurance, Health Care
chemical_list: D006442:Glycated Hemoglobin