Evaluation of a Device for Self-Monitoring of Blood Glucose

To systematically evaluate and validate the performance, analytical precision and clinical accuracy according to the guidelines set by ISO 15197:2003, a blood glucose monitor was compared with the respective reference analyzers and methods under controlled conditions. The system performance was verified by performing parallel studies on the dependence of hematocrit (Hct), sample volume, interferences and temperature correction. Clinical accuracy was investigated by comparing the finger-stick blood glucose measurements obtained by the monitor (DS(superscript ®)) with whole blood and plasma samples calibrated by YSI 2300 STAT Plus(superscript ®) Glucose and L-lactate analyzer (YSI Incorporated, Yellow Springs, OH) and an automatic Beckman Coulter SYNCHRON LX(superscript ®) 20 system (Fullerton, CA), respectively. It was thus demonstrated that discrepancies in sample volume from 2.5 to 10μL and physiological concentrations of interfering metabolites generated bias of less than 5%. Furthermore, exogenous interferents and hematocrits of 30% to 60% yielded bias of less than 10% and 20% when presented in therapeutic and normal levels, respectively. Finally, 100% whole blood readings and over 95% of the adjusted plasma readings were in uniformity with reference methods, respectively. In conclusion, the DS(superscript ®) blood glucose monitoring system met the criteria of individual as well as hospital use.

並列關鍵字

Self-monitoring of blood glucose ； glucose oxidase ； ISO 15197:2003

國際替代計量

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