Lifescan OneTouch Select Plus Simple - Page 47

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DETAILED INFORMATION ABOUT YOUR SYSTEM
User Performance Accuracy
A study evaluating glucose values from fingertip capillary blood
samples obtained by 160 lay persons showed the following
results:
96.6% within ±15mg/dL of the medical laboratory values at
glucose concentrations below 100mg/dL, and 94.7% within
±15% of the medical laboratory values at glucose concentrations
at or above 100mg/dL.
95.0% of the total number of samples were within ±15mg/dL or
±15% of the medical laboratory values.
Regression Statistics
Samples were tested in duplicate on each of three test strip lots.
Results indicate that the OneTouchSelect Plus Simple
®
System
compares well with a laboratory method.
# of Subjects # of Tests Slope Intercept
(mg/dL)
100 600 1.00 -2.19
95% CI Slope 95% CI
Intercept
(mg/dL)
Std. Error (S
y.x
)
(mg/dL)
R
2
0.99 to 1.00 -3.64 to -0.73 9.19 0.99