User guide

Technical

Information

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Technical Information

Technical Information:

Accuracy: The accuracy of the

ONTOUR blood glucose monitoring

system has been assessed in a correlation study conducted by health-

care professionals. In this study, 108 fresh capillary blood specimens

were tested with the

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.

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

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

Precision: A study was conducted with the

ONTOUR blood glucose

monitoring system with five heparinized whole blood specimens with

glucose levels from 40 to 325 mg/dL. Multiple replicates (n=100)

were tested using multiple

ONTOUR blood glucose meters and one

lot of

ONTOUR blood glucose test strips. The following precision

results were obtained:

Plasma/Serum:

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%

Your CONTOUR blood glucose meter is specific for glucose and has

been referenced to plasma/serum values. Methods calibrated to

plasma/serum can be 9 to 15% higher than the results of whole blood

glucose assay methods.