i-SENS KetoSens Manual Del Usario página 50

Blood average
Between Run Precision
Control average
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
50 www.i-sens.com
3.4 mmol/L
5.2 mmol/L
6.9 mmol/L
0.6 mmol/L
2.2 mmol/L
4.0 mmol/L
CV = 3.7 %
CV = 3.5 %
CV = 3.6 %
SD = 0.049 mmol/L
CV = 3.8 %
CV = 4.3 %