Bayer HealthCare CONTOUR Blood Glucose Meter and Ascensia CONTOURTM Test Strips - Manual (Page 37)

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Accuracy: The accuracy of the Ascensia C ONTOUR Blood
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 ONTOUR Blood Glucose Monitoring
System by 108 untrained people with diabetes 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: 75 to 397 mg/dL
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 40 to
325 mg/dL. Multiple replicates (n=100) were tested using
multiple Ascensia
C ONTOUR Blood Glucose Meters and
one lot of Ascensia C
ONTOUR Blood Glucose Test Strips. The
following precision results were obtained:
Plasma/Serum:
Technical Information:
Technical Information
Lot y =
Correlation
Coeffi cient (r)
1 1.02x – 0.12 mg/dL 0.972
2 1.03x – 4.34 mg/dL 0.963
3 0.95x – 0.41 mg/dL 0.974
Mean SD
Coeffi cient
of variation
38 mg/dL 1.9 mg/dL 4.8%
101 mg/dL 5.1 mg/dL 5.1%
118 mg/dL 4.4 mg/dL 3.7%
205 mg/dL 6.8 mg/dL 3.3%
326 mg/dL 11.7 mg/dL 3.6%