IFCC-afstemningen i 2007 om IFCC’s rekommandation for navn og enhed for HbA1c

1. IFCC-afstemningen i 2007 om IFCC’s rekommandation for navn og enhed for HbA1c DSKB medlemsmøde 6.3.2008

2. 23.5.2006 Dear Colleagues, The Working Group Standardization of HbA1c (WG-HbA1c), on behalf of the Scientific Division of IFCC, decided to establish a global reference system for the measurement of glycated hemoglobin (HbA1c) comprising the following elements: - Reference Measurement Procedure This has been developed on the basis of a specific proteolytic procedure measuring the amount of b-chains of hemoglobin that have a stable hexose adduct bound to the N-terminal valines.

3. - Network of Reference Laboratories A group of reference laboratories (including manufacturers’ laboratories) were selected to provide the necessary skill and equipment for performing measurements following the SOPs on a high metrological level. • Reference Materials Specific reference materials are going to be certified by the network of reference laboratories in co-operation between IFCC and IRMM.

4. In order to achieve global standardization of glycated hemoglobin on the basis of the IFCC reference system, it is important to find a way of avoiding confusion in expressing the results of the measurements performed by IFCC-standardized assays, respect to the other current ways. To this regard the IFCC Committee on Nomenclature, Properties and Units (C-NPU) has addressed the problem of finding proper name and measurement units for HbA1c, which are now described in the attached recommendation.

5. The Executive Board of the IFCC, the Scientific Division, the IFCC WG-Hb1c and the C-NPU recommend the approval of the document, attached to this letter, as official IFCC recommendation. • With this mail ballot the Executive Board asks the members of IFCC for their consent by August 31st, 2006. President of IFCC Prof. Jocelyn MB Hicks Chairman of IFCC SD Prof. Mauro Panteghini Chairman of C-NPU Dr. Françoise Pontet

6. International Federation of ClinicalChemistry and Laboratory Medicine (IFCC) IFCC Scientific Division Committee on Nomenclature, Properties and Units (C-NPU) Recommendation for Term and Measurement Unit for ‘HbA1c’ Prepared for publication by Gunnar Nordin1 and René Dybkær2 on behalf of the IFCC-IUPAC C-NPU

7.  Recommendation for Term and Measurement Unit for ‘HbA1c’ by Gunnar Nordin and René Dybkær YES  NO  ABSTENTION  Please, indicate the vote of your Society by X Name of Full Member Society:

8. 21.1.2007 • The deadline for voting re.IFCC RECOMMENDATION FOR NAME AND UNIT FOR HbA1c is drawing close. • Our national society in Denmark is not certain on the consequences of voting yes or no and we therefore request some clarification. • If we agree to recommend name and unit - but find that certain important issues have to be dealt with before implementation - how should we then vote?

9. 31.1.2007 • With reference to your question, Prof. Panteghini, Chair of the IFCC Scientific Division, would like to inform you that, as IFCC has proposed a recommendation for name and unit for HbA1c, we would like to receive a positive vote from National Societies.

10. In the meantime, IFCC wishes to assure you and your Colleagues that a plan for the correct implementation of the new aspects is in preparation to avoid problems with final users, i.e. clinicians and diabetic patients. I remain at your disposal for any further information you may need. P.B, IFCC Office

11. Resultatet af afstemningen The final result of the mail ballot for HbA1c was as follows: out of 73 Countries, 24 voted (32%): results as follows: • 3 abstensions • 2 negative • 19 in favour