Report
7th report on the EASD Standardisation Subcommittee (ESSC)

R. Heine, The Netherlands

1. Standardisation of HbA1c measurement:
A consensus statement on the worldwide standardisation of the HbA1c measurement has been published (attachment). Ele Ferrannini and Robert Heine were EASD representatives on the consensus statement.
The multi-centre observational study to establish the relationship between the mean blood glucose and HbA1c as determined by the DCCT as well as by the IFCC methods is almost finished and the (pre) final results will be presented at the EASD meeting in Amsterdam.

 2. Standardisation of beta-cell function test:
This European-US Trial Net joint multi-centre study aims at comparing the reproducibility and sensitivity of the mixed meal test with the glucagon stimulated C-peptide secretion test. A subfinal joint manuscript to be submitted to DIABETES hopefully mid/end September has been elaborated and is attached. The conclusion of the study is that the mixed meal test is superior to the i.v. glucagon test by providing higher peak and AUC values, better reproducibility, less discomfort by the test procedure and less side effects, but is inferior in terms of time requirements.

3. Insulin assay standardisation:
The paper on the differences in the results of commercial insulin assays mentioned in last year’s report has now been published ‘Standardization of Insulin Immunoassays: Report of the American Diabetes Association. Clinical Chemistry 2007;53:711–716.
With financial support of ADA (and GSK via ADA) the accuracy of routine insulin methods vs. the ID-LC/tandem MS reference measurement procedure (Van Uytfanghe K, Rodríguez-Cabaleiro D, Stöckl D, Thienpont LM. New liquid chromatography/ electrospray ionisation tandem mass spectrometry measurement procedure for quantitative analysis of human insulin in serum. Rapid Commun Mass Spectrom 2007;21:819-21) is currently being compared, using a panel of 40 single donation human sera. In addition, 5 human sera pools and a recombinant insulin primary reference material will be evaluated for: 1) commutability with the native human sera panel, and 2) their effectiveness to be used to improve harmonization and calibration traceability for the routine methods. Sets have been distributed to Gent and to 12 insulin assay manufacturers. The protocol is attached. Results are expected soon, and a meeting for the fall is scheduled.

4. Subcommittee composition:
According to the standardization subcommittee statutes the term of office constitutes 4 years. Since Thomas Mandrup-Poulsen joined the subcommittee in May 2003, he will rotate off as member and chairman by the coming EASD meeting in Amsterdam. The subcommittee unanimously proposes Dr. Jaqueline M. Dekker, Ph.D., The Institute for Research in Extramural Medicine, VU University Medical Center, Amsterdam, The Netherlands, as new member. Dr. Dekker has represented the subcommittee in the International Insulin Assay Standardisation efforts. The subcommittee will constitute the new chairman among the subcommittee members