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Accuracy
1.Bayer Accuracy Evaluation:
To assess the accuracy of the Ascensia
®
BREEZE™ System,
102 fresh fingerstick specimens from people with diabetes
were tested with the Ascensia
®
BREEZE™ (2 readings per
fingerstick) and the YSI 2300 STAT Plus Glucose Analyzer.
The glucose concentration of the samples ranged from 2.3
to 30.1 mmol/L with an average of 9.9 mmol/L. The range
of hematocrits was 29% to 55% with an average of 40%.
33
Total Total
Strip No. of Mean SD CV
Lot Operator Assays (mmol/L) (mmol/L) (%)
A Lay User (n=50) 100 8.394 0.400 4.8
B Lay User (n=50) 100 8.317 0.356 4.3
Total Total
Strip No. of Mean SD CV
Lot Operator Assays (mmol/L) (mmol/L) (%)
A Lay User (n=50) 100 18.706 0.961 5.1
B Lay User (n=50) 100 18.867 0.800 4.2