i-SENS CARESENS DUAL, User Manual

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Influence Quantities
Glucose
Packed Cell Volume (Hematocrit)
Packed cell volume evaluation was conducted in various
hematocrit levels. The range of hematocrit levels within the
acceptance criteria is 15–65 %.
Precision: Precision studies were performed in a laboratory using
the CareSens Dual Blood β -Ketone Monitoring Systems.
This study shows that there could be a variation of up to 4.4 %.
Slope 1.012
Y-intercept -0.0223 mmol/L
Correlation coefficient (r) 0.996
Number of subjects 100
Range tested 0.015–7.2 mmol/L
Within Run Precision
Blood average
0.5 mmol/L SD = 0.04 mmol/L
1.4 mmol/L SD = 0.05 mmol/L
3.2 mmol/L CV = 2.9 %
5.5 mmol/L CV = 3.1 %
7.2 mmol/L CV = 3.8 %
Between Run Precision
Control average
0.7 mmol/L SD = 0.05 mmol/L
2.4 mmol/L CV = 4.0 %
4.7 mmol/L CV = 4.4 %