Performance Characteristics - i-SENS KetoSens Manual Del Usuario

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 BKM 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 sample
Range tested
System accuracy results for capillary blood ketone
Within ± 0.15 mmol/L Within ± 0.225 mmol/L
183/185(98.9%) 185/185(100%)
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0.994
-0.007
0.970
185
0.017–1.054 mmol/L
Within ± 0.3 mmol/L
185/185(100%)
Precision: Precision studies were performed in a laboratory using
the KetoSens Brand of BKM Systems.
Within Run Precision
Blood avg. 0.4 mmol/L
Blood avg. 1.1 mmol/L
Blood avg. 3.4 mmol/L
Blood avg. 5.2 mmol/L
Blood avg. 6.9 mmol/L
Between Run Precision
Control avg. 0.6 mmol/L
Control avg. 2.2 mmol/L
Control avg. 4.0 mmol/L
This study shows that there could be a variation of up to 4.3%.
Reference:
1. A. Rewers, Current Controversies in Treatment and Prevention of
Diabetic Ketoacidosis, Advances in Pediatrics 57 (2010) 247–267.
2. CLSI EP5-A3 (Evaluation of Precision Performance of Quantitative
Measurement Methods; Approved Guideline-Third Edition)
3. CLSI EP6-A (Evaluation of the Linearity of Quantitative Measurement
Procedures: A Statistical A Approach; Approved)
4. CLSI EP9-A3 (Measurement Procedure Comparison and Bias
Estimation Using Patient Samples; Approved Guideline-Third Edition)
5. CLSI EP30-A (Characterization and Qualification of Commutable
Reference Materials for Laboratory Medicine; Approved Guideline)
6. CLSI EP7-A2, 2005 (Interference Testing in Clinical Chemistry;
Approved Guideline – Second Edition)
SD = 0.027 mmol/L
SD = 0.056 mmol/L
CV = 3.7%
CV = 3.5%
CV = 3.6%
SD = 0.049 mmol/L
CV = 3.8%
CV = 4.3%
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