Bayer HealthCare Ascensia Contour Blood Glucose Meter - Manual (Page 37)

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Accuracy
The accuracy of the Ascensia C
ONTOUR Blood Glucose Monitor-
ing System has been assessed in a correlation study conducted
by healthcare professionals. In this study, 108 fresh capillary
blood specimens were tested with the Ascensia C
ONTOUR Blood
Glucose Monitoring System by 108 untrained people with dia-
betes using three test strip lots. The reference measurement
was done on the YSI Glucose Analyzer. Ascensia C
ONTOUR data
compare well with the results from the YSI method.
Regression Statistics (Plasma/Serum Reference):
plasma reference glucose range: 4.2 to 22.0 mmol/L
Precision
A study was conducted with the Ascensia C
ONTOUR Blood
Glucose Monitoring System with fi ve heparinized whole
blood specimens with glucose levels from 2.2 to 18.0
mmol/L. Multiple replicates (n=100) were tested using mul-
tiple Ascensia C
ONTOUR Blood Glucose Meters and one lot
of Ascensia M
ICROFILL Blood Glucose Test Strips. The fol-
lowing precision results were obtained:
Plasma/Serum:
Technical Information:
Technical Information
Lot y =
Correlation
Coeffi cient
(r)
1 1.02x – 0.01 mmol/L 0.972
2 1.03x – 0.24 mmol/L 0.963
3 0.95x – 0.02 mmol/L 0.974
Mean SD
Coeffi cient
of
variation
2.1 mmol/L 0.10 mmol/L 4.8%
5.6 mmol/L 0.28 mmol/L 5.1%
6.5 mmol/L 0.24 mmol/L 3.7%
11.4 mmol/L 0.38 mmol/L 3.3%
18.1 mmol/L 0.65 mmol/L 3.6%