By Sten Westgard on Tuesday, 23 December 2008
Category: CLIA

Comments on "HbA1c for screening and diagnosis of diabetes?"

By Sten Westgard, MS

Dr. Westgard's recent essay on HbA1c for screening and diagnosis of diabetes and an accompanying post generated an interesting reply. Offered here in its entirety:

Jim, Sten,
 
I would like to comment on your article on HbA1c for screening and Diagnosis.  First, the comment by Sten that the tighter CAP criteria are not addressing the issue of bias.  It does indeed address both bias and imprecision because the CAP is using an accuracy base - the NGSP assigned values.  So if a method is either biased from NGSP or shows variability within or between labs, this will decrease the lab's chances of passing.  The CAP no longer uses peer group grading for HbA1c. 
 
I'm not sure what you mean by "scientific marketing" and if this should be taken as a negative comment.  Sure manufacturers would like to see HbA1c used for screening since this would increase use of the test.  But use of HbA1c for screening has been discussed for a long time and the discussion is based on very sound arguments.
 
The main reason to use HbA1c rather than fasting glucose is not for "convenience of any particular group".  It, in fact, will get people screened and diagnosed that may not otherwise be diagnosed.  There is still a large group of people who have undiagnosed diabetes.  This is why so many people (25% of those diagnosed) have complications at the time of diagnosis!  Using HbA1c will allow screening and/or diagnosis more readily e.g. at regular doctors' appointments where patients usually don't come fasting.  Furthermore, many physicians already use HbA1c but there are no specified cutoffs so it's hard to know exactly how it is being used and it may not be used appropriately. 
 
Another drawback of fasting glucose is that it has a large (much larger than HbA1c) biological variability.  And measurement of glucose isn't perfect either.
 
The screening cuoff for HbA1c of 6% is equivalent to 125 mg/dL AVERAGE GLUCOSE, not fasting glucose.  The equation (eAG =28.7*HbA1c-46.7) gives you a mean blood glucose, not fasting.   You can't easily equate a patients mean glucose with his or her fasting.
 
And I disagree that discussions of using HbA1c for diagnosis/screening are guided by market forces and not quality of care.  The main goal is to get more people with undiagnosed diabetes diagnosed.  It is not for the pockets of manufacturers or scientists. 
 
Randie
 

Randie R. Little, Ph.D.

NGSP Network Coordinator

Co-Director Diabetes Diagnostic Laboratory

Depts. Of Pathology & Anatomical Sciences and Child Health
University of Missouri School of Medicine
Columbia Missouri


Just to be clear, we meant no disrespect of the NGSP efforts in either the essay or the post. Indeed, they are doing far more to improve quality than most other organizations of a similar nature.

As they say, it's important to be able to disagree without being disagreeable. We welcome feedback, comments, and different points of view.

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