Chapter 9. Performance Evaluations
The performance evaluation is determined in both clinical and laboratory settings.
Accuracy
Accuracy describes how well the readings from a testing system (meter and test strips)
agree with the readings from an internationally accepted reference system (laboratory
glucose analyzer) and are performed according to an internationally recognized
standard. The accuracy of the GlucoSure
®
Plus Blood Glucose Monitoring System is
referenced to the YSI 2300 Glucose Analyzer and the evaluation studies were performed
according to ISO/ DIS 15197 guidelines.
A total of 127 fresh capillary blood specimens from different subjects were collected and
tested with the GlucoSure
®
Plus Blood Glucose Monitoring System. The specimens
ranged from 39 mg/dL to 496 mg/dL, as measured by the YSI 2300 comparative method.
Linear regression data showed that the GlucoSure
®
Plus Blood Glucose Monitoring
System correlates well with the YSI 2300 Glucose Analyzer.
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USER'S GUIDE
Chapter 9.
Performance Evaluations
