i-SENS KetoSens, Руководство пользователя

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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 0.994
Y-intercept -0.007
Correlation coefficient (r) 0.970
Number of sample
185
Range tested 0.017–1.054 mmol/L
183/185 (98.9 %)
System accuracy results for capillary blood ketone
185/185 (100 %) 185/185 (100 %)
Within ± 0.225 mmol/L Within ± 0.15 mmol/L Within ± 0.3 mmol/L
Within Run Precision
Blood avg. 0.4 mmol/L SD = 0.027 mmol/L
Blood avg. 1.1 mmol/L SD = 0.056 mmol/L
Blood avg. 3.4 mmol/L CV = 3.7 %
Blood avg. 5.2 mmol/L CV = 3.5 %
Blood avg. 6.9 mmol/L CV = 3.6 %
Precision: Precision studies were performed in a laboratory
using the KetoSens Brand of BKM Systems.
Between Run Precision
Control avg. 0.6 mmol/L SD = 0.049 mmol/L
Control avg. 2.2 mmol/L CV = 3.8 %
Control avg. 4.0 mmol/L CV = 4.3 %
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