A.MENARINI GlucoMen Day METER 2K, User Manual

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English
/ 10.6
β
-Ketone: Accuracy
The accuracy of the the GlucoMen
®
Day METER 2K system was
assessed by comparing blood
β
-ketone results obtained by patients
with those obtained using a Randox Monaco, a laboratory instrument.
Slope 0.9922
Y-intercept 0.03908 mmol/L
Correlation coe cient (r) 0.994
Number of subjects 200
Range tested 0.01-7.66 mmol/L
/ 10.7
β
-Ketone: Precision
The precision studies were performed in a laboratory using GlucoMen
®
Day METER 2K system.
Within Run Precision
*Bloodav 0.5 mmol/L SD = 0.039 mmol/L
*Bloodav 1.3 mmol/L SD = 0.061 mmol/L
*Bloodav 3.5 mmol/L CV = 3.9 %
*Bloodav 5.6 mmol/L CV = 3.7 %
*Bloodav 7.3 mmol/L CV = 4.5 %
Between Run Precision
*Controlav 0.80 mmol/L SD = 0.017 mmol/L
*Controlav 2.65 mmol/L CV = 2.7 %
*Controlav 4.74 mmol/L CV = 3.2 %
This study shows that there could be variation of up to 4.5 %.