The new, disappointing glucose meter guideline – CLSI POCT12-A3

March 27, 2013

disappointment

I and my sometimes coauthor (George Cembrowski) have written about the use of error grids to improve specifications – particularly glucose specifications:

  1. Jan S. Krouwer and George S. Cembrowski. Towards more complete specifications for acceptable analytical performance – a plea for error grid analysis. Clinical Chemistry and Laboratory Medicine, 2011;49:1127-1130.
  2. Jan S. Krouwer and George S. Cembrowski A review of standards and statistics used to describe blood glucose monitor performance. Journal of Diabetes Science and Technology, Journal of Diabetes Science and Technology, 2010;4:75-83.

 I have also critiqued existing glucose meter specifications:

  1.  Wrong thinking about glucose standards. Clin Chem, 2010;56:874-875.

 and recommended how evaluations could be improved:

  1. Jan S. Krouwer: Analysis of the Performance of the OneTouch SelectSimple Blood Glucose Monitoring System: Why Ease of Use Studies Need to Be Part of Accuracy Studies. Journal of Diabetes Science and Technology, 2011;5:610-611.
  2. Jan S. Krouwer: Evaluation of the Analytical Performance of the Coulometry-Based Optium Omega Blood Glucose Meter: What Do Such Evaluations Show? Journal of Diabetes Science and Technology, 2011;5:618-620.
  3. Jan S. Krouwer: Interference Testing: Why Following Standards Is Not Always the Right Thing to Do. Journal of Diabetes Science and Technology, 2012;6:1182–1184.

Yet in spite of all of this, I was chagrined to see the new CLSI glucose meter guideline – POCT12-A3 – neither incorporate any of these recommendations nor even cite any of the above publications.

Undeterred, a new publication critiquing POCT12-A3, including recommendations on how to improve it, will appear in the September issue of the Journal of Diabetes Science and Technology

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Bad news – good news and unnecessary confusion

March 12, 2013

confusion

The new version of EP09-A3 is being readied for publication. The bad news is that my suggestion to use “average bias” in the title rather than “bias” has been dropped. The title mentions only “bias”. The good news is that in the beginning text, the document says is it is about estimating average bias.

It would have been better to keep average bias in the title. Speaking of confusion, the title also says “measurement procedure comparison” instead of “method comparison.” Here are the results of a Google search for these two terms:

“measurement procedure comparison” 292 hits

“method comparison” 213,000 hits

Is method comparison better than measurement procedure comparison? You can bet your measurand it is.