Understanding system accuracy for the OneTouch Verio Flex® meter including regression statistics, user performance accuracy and precision.
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OneTouch Verio Flex® meter
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System Accuracy:
Diabetes experts have suggested that glucose meters should agree within 15 mg/dL of a laboratory method when the glucose concentration is lower than 5.55 mmol/L, and within 15% of a laboratory method when the glucose concentration is 100 mg/dL or higher.
Samples from 100 patients were tested using both the OneTouch Verio Flex® System and the YSI 2300 Glucose Analyzer laboratory instrument.
System Accuracy Results for Glucose Concentrations <100 mg/dL
Percent (and number) of meter results that match the laboratory test
System Accuracy Results for Glucose Concentrations ≥100 mg/dL
Percent (and number) of meter results that match the laboratory test
System Accuracy Results for Glucose Concentrations between 38.2 mg/dL and 466.3 mg/dL Within ±15 mg/dL
NOTE:Where 38.2 mg/dL represents the lowest glucose reference value and 466.3 mg/dL represents the highest glucose reference value (YSI value).
Regression Statistics:
Samples were tested in duplicate on each of three test strip lots. Results indicate that the OneTouch Verio Flex® System compares well with a laboratory method.
User Performance Accuracy:
A study evaluating glucose values from fingertip capillary blood samples obtained by 167 lay persons showed the following results:
93.1% within ±15 mg/dL of the medical laboratory values at glucose concentrations below 100 mg/dL, and 98.6% within ±15% of the medical laboratory values at glucose concentrations at or above 100 mg/dL.
97.6% of the total number of samples were within ±15 mg/dL or ±15% of the medical laboratory values.
Precision:
Within Run Precision (300 Venous Blood Samples Tested per Glucose Level)
Data generated using the OneTouch Verio Flex® Meter.
Results show that the greatest variability observed between test strips when tested with blood is 1.72 mg/dL SD or less at glucose levels less than 100 mg/dL, or 1.98% CV or less at glucose levels at 100 mg/dL or above.
Total Precision (600 Control Solution Tests per Glucose Level)
Data generated using the OneTouch Verio Flex® Meter.
