From Dr. Carmen Ricos, on behalf o the SEQC-Analytical Quality Commission:
Sten Westgard, MSIs it time for a tighter quality requirement for glucose meters?Fresh on the heels of Dr. George Klee's review of setting performance specifications, as well as the recent FDA public meeting on glucose meter quality, Dr. Klee and Dr. Brad Karon of the Mayo Clinic and Dr. James C. Boyd of the University of Virginia recently published a study that used simulation modeling to determine performance criteria for glucose meters:"Glucose Meter Performance Criteria for Tight Glycemic Control Estimated by Simulation Modeling", Brad S Karon, James C. Boy, and George G. Klee, Clinical Chemistry 56:7; 1091-1097 (2010)
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Posted by Sten Westgard, MSAttending the AACC/ASCLS convention predictably results in one frustration. Walking through the poster sections, you find that many of the method validation abstracts are only performing within-run precision studies.What's so bad about that?Repeat after me: it's not about the repeatability...
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