Normal Control Solution
High Control Solution
Accuracy
1. Bayer Accuracy Evaluation:
To assess the accuracy of the Ascensia
®
B
REEZE
™ System,
102 fresh fingerstick specimens from people with diabetes
were tested with the Ascensia
®
B
REEZE
™ (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
