Technical Information - Bayer HealthCare Ascensia Contour CONTOUR Blood Glucose Meter and Ascensia CONTOURTM Test Strips User Manual

Technical Information:

Accuracy: The accuracy of the Ascensia C
Glucose Monitoring System has been assessed in a corre-
lation study conducted by healthcare professionals. In this
study, 108 fresh capillary blood specimens were tested
with the Ascensia C
System by 108 untrained people with diabetes using three
test strip lots. The reference measurement was done on
the YSI Glucose Analyzer. Ascensia C
well with the results from the YSI method.
Regression Statistics (Plasma/Serum Reference):
plasma reference glucose range: 75 to 397 mg/dL
Lot
1
2
3
Precision: A study was conducted with the Ascensia C
Blood Glucose Monitoring System with fi ve heparinized
whole blood specimens with glucose levels from 40 to
325 mg/dL. Multiple replicates (n=100) were tested using
multiple Ascensia C
one lot of Ascensia C
following precision results were obtained:
Plasma/Serum:
Mean
38 mg/dL
101 mg/dL
118 mg/dL
205 mg/dL
326 mg/dL
Blood Glucose Monitoring
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y =
1.02x – 0.12 mg/dL
1.03x – 4.34 mg/dL
0.95x – 0.41 mg/dL
Blood Glucose Meters and
ONTOUR
Blood Glucose Test Strips. The
ONTOUR
SD
1.9 mg/dL
5.1 mg/dL
4.4 mg/dL
6.8 mg/dL
11.7 mg/dL
www.BayerDiabetes.com
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data compare
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Correlation
Coeffi cient (r)
0.972
0.963
0.974
Coeffi cient
of variation
4.8%
5.1%
3.7%
3.3%
3.6%
Blood
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