Method Comparison Studies for glucose

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Hi, 
Just curious. When doing comparison studies with your glucometer and chemistry analyzer, what total allowable error percent are you using?  With the new strict criteria, are you all having issues with comparison studies even within meter to meter? 

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Is your glucometer waived? Because if so, you don't have to perform method comparison....

ETA: we have glucose testing on our blood gas instruments. We use 6% for tEA between them and chem analyzers.

Hello,
I do not perform method comparison for our glucometer to Chemistry analyzer as well, for the above reason. I do have another question along these lines since it was brought up. Does anyone have a total allowable error written in their policy regarding comparison criteria for glucometer to glucometer, and/or in their policy a total allowable error for how accurate your patient's results should be within the chemistry analyzer? An example: your patient's glucose should be within 10% if glucose is >= to 70mg/dl or +/- 7 mg/dl for glucose values <70mg/dl?

Yes, our glucometer is waived.  I guess I was also asking for our other POC instrument that measures glucose also.  That 6% is awfully tight.  Are you having issues?  We will find out in the next couple of months. I just didn't know if others were having issues or having concerns about the new criteria. 

Hi
 We are a CAP accredited facility and do not normally run twice yearly comparisons with main chemistry (COM.04250) as our glucometers perform waived testing.  Currently, using CAP whole blood quality cross check to perform analyzer to analyzer comparisons and haven't had a significant failure. (Nova Stat Strip Meters)

If comparing fingerstick results to lab values - critical high result: ±15% or 15 mg/dL whichever is greater and time between fingerstick and lab draw is 15 minutes or less - same assessment for repeat fingerstick within 5 minutes of collection.  All critical values are reviewed as a quality initiative for the POC section of the lab as a means of evaluating POC.03700 Error Detection

CAPs Whole blood quality cross check evaluation limits are ± 12.5% or 12 mg/dL whichever is greater. CAP surveys this year showed both the old and new criteria and clearly stated on the participant summary if changes were occurring.  There was none on the Whole Blood Quality Cross Check.

I am under the impression this is for analyzer -based \(moderately complex) NOT for waived glucometer testing:
NEW Criteria: Glucose (excluding FDA home use) | TV ± 6 mg/dL or ± 8% (greater)
OLD Criteria: TV ± 6 mg/dL or ± 10% (greater)
 I would be curious to see if other collogues are under the same impression??





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