Performance Characteristics - i-SENS KetoSens Manual Del Usario

Performance Characteristics

The performance of KetoSens Blood β-Ketone Monitoring System
has been evaluated in laboratory and in clinical tests.
Accuracy: The accuracy of the KetoSens Blood β-Ketone
Monitoring System was assessed by comparing blood β-Ketone
results obtained by patients with those obtained using a Randox
Monaco, a laboratory instrument. The following results were
obtained by diabetic patients at clinic centers.
Capillary Blood Sample
System accuracy results for capillary blood ketone
Slope
Y-intercept
Correlation coefficient (r)
Number of Subjects
Range tested
System accuracy results for capillary blood ketone
Within ± 0.15 mmol/L
183/185 (98.9 %)
Precision: Precision studies were performed in a laboratory using
the KetoSens Brand of Blood β-Ketone Monitoring Systems.
Within Run Precision
Blood average
0.994
-0.007
0.970
185
0.017–1.054 mmol/L
Within
± 0.225 mmol/L
185/185 (100 %)
0.4 mmol/L
1.1 mmol/L
Within ± 0.3 mmol/L
185/185 (100 %)
SD = 0.027 mmol/L
SD = 0.056 mmol/L
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