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The Clinical Chemist

(dbruns{at}clinchem.aacc.org)

Position Statement

The following was communicated to the editor from the Presidents of the American Association for Clinical Chemistry (AACC), American Diabetes Association (ADA), and European Association for the Study of Diabetes (EASD):

The boards of directors of the AACC, ADA, and EASD jointly ask the IFCC to delay publication and implementation of its "Recommendation for Term and Measurement Unit for HbA1c" until completion of the "mean blood glucose study" sponsored by the ADA and EASD and International Diabetes Federation (IDF). It is our understanding that the IFCC recommendation is to be released in January 2007, following an affirmative vote of its member societies.

Background: In 2002, the IFCC published a reference method for HbA1c based on mass spectrometry. The reference method is more specific than the ion-exchange-based assays that were used in the Diabetes Complication and Controls Trial (DCCT) and in the United Kingdom Prospective Diabetes Study (UKDPS). The results of the ion-exchange-based assays used in the DCCT and UKDPS were calibrated according to the National Glycohemoglobin Standardization Program (NGSP). The values derived with the IFCC assay are lower than the NGSP values that are currently used for patient care. The IFCC method is currently being used by manufacturers to anchor all HbA1c methods with adjustment to NGSP values for reporting patients’ values.

IFCC/IUPAC Proposal: The above IFCC/IUPAC document recommends that the name for the HbA1c test be changed to N-(1-deoxyfructos-1-yl) hemoglobin beta chain and that the units of measurement be mmol/mol. For reporting purposes and everyday speech, the IFCC document recommends use of the term Deoxyfructosyl hemoglobin (beta) or DOF hemoglobin.

Response of AACC, ADA, and EASD: We agree that the recommended name is metrologically correct and that the IFCC method should be used for traceability and for anchoring of HbA1c assays, but we also agree that, for the time being, reported values should continue to be from methods calibrated according to NGSP to avoid significant confusion for clinicians and patients. Use of methods calibrated according to NGSP ensures that results are comparable to those in the major clinical trials that evaluated tight glycemic control in patients with type 1 (the DCCT) and type 2 (UKDPS) diabetes. These large trials form the basis for the target values for HbA1c used in patient management throughout the world. For further background, see the October 2006 issue of Clinical Laboratory News.

There has been considerable discussion in the international diabetes community as to the best way to resolve this dilemma without compromising patient care. A large international effort is underway to better define the relationship between HbA1c and mean blood glucose in healthy individuals and patients of varied ethnic backgrounds with types 1 and 2 diabetes. This trial is supported by the ADA, EASD, and IDF and also endorsed by the IFCC in their 2005 Annual Report. The initial findings of this study are expected to be presented this month at the IDF meeting and completed within the next year. We believe it is important that this clinical study be completed before any formal, and possibly binding, recommendations are made about how HbA1c will be reported to clinicians and patients in the future.

Of further concern to us are the changes that occurred to the IFCC/IUPAC document between when it was reviewed and approved by the IFCC Working Group on HbA1c in February 2006 and when it was submitted to IFCC member societies for vote in May 2006. AACC, ADA, and EASD members participated in reviewing and editing the IFCC document as part of the IFCC Working Group on Hemoglobin A1c. The final document that the IFCC working group approved in February 2006 (a), indicated that trivial names (e.g. HbA1c) could still be used; (b), suggested that the term " DOF-hemoglobin" was not meant for use in patient reports; and (c), contained statements about the mean blood glucose study and possible reporting of mean blood glucose in relation to testing of hemoglobin A1c. All of these statements were deleted from the final document that was sent for vote. Had the document not changed, our societies would not be asking the IFCC to delay the release of these recommendations. By waiting until all of the science is completed, we hope that clinicians, patient groups, and laboratorians can come together, study all of the data, and decide the best approach for naming and reporting results of this very important laboratory test to clinicians and patients.

AACC Announces the 2006 Election Results

President-Elect:

Larry Broussard

Treasurer:

Ann Gronowski

Board Members:

Catherine Hammett-Stabler

Daniel Farkas

Nominating Committee:

Larry Kricka, Chair Elect

David Grenache

Patricia Jones

Joseph McConnell

Call for Nominations

AACC’s Nominating Committee is accepting nominations for the 2007 association election. The president-elect, secretary, two positions on the Board of Directors, and four positions on the Nominating Committee are to be elected to serve, beginning January 1, 2008. Nominations should be sent in writing to: Andrea Ferreira-Gonzalez, PhD; Virginia Commonwealth University; 3000 Northlake Drive; Richmond, VA 23233 (fax: 804-225-4738; agonzale@hsc.vcu.edu).

You should indicate the office for which the nominee is proposed and include one or two sentences explaining the nomination. A nomination form will be available on the AACC website January 1. All nominations must be received by January 31, 2007. The Nominating Committee will obtain the candidates’ consent to run for office.

According to the association bylaws, in this election, members of the Midwest, North Carolina, Philadelphia, and Texas Sections are not eligible for election to the Nominating Committee for the term beginning January 2008.

Members of the 2007 Nominating Committee are: Andrea Ferreira-Gonzalez, PhD (Chair); David Grenache, PhD; Charles Hawker, PhD; Paul J. Jannetto, PhD; Patricia Jones, PhD; Larry Kricka, DPhil; Joseph McConnell, PhD; and Clark A. Rundell, PhD.

eLetters:

This Article Extract Full Text (PDF) Submit an electronic Letter to the Editor about this paper View responses Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Bruns, D. E. Search for Related Content PubMed Articles by Bruns, D. E.