I and my sometimes coauthor (George Cembrowski) have written about the use of error grids to improve specifications – particularly glucose specifications:
- 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.
- 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:
- Wrong thinking about glucose standards. Clin Chem, 2010;56:874-875.
and recommended how evaluations could be improved:
- 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.
- 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.
- 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