Understanding system accuracy for the OneTouch Verio Flex® meter including lay user accuracy, fingertip results for glucose concentrations, regression statistics and precision.
Product Guide
Global
OneTouch Verio Flex® meter
English
0.0
Article Details
System Accuracy:
Diabetes experts have suggested that 95% of glucose meter results should agree within 0.83 mmol/L 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 5.55 mmol/L 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 <5.55 mmol/L
Percent (and number) of meter results that match the laboratory test
System Accuracy Results for Glucose Concentrations ≥5.55 mmol/L
Percent (and number) of meter results that match the laboratory test
System Accuracy Results for Glucose Concentrations between 2.1 mmol/L and 25.9 mmol/L
NOTE:Where 2.1 mmol/L represents the lowest glucose reference value and 25.9 mmol/L 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 ±0.83 mmol/L of the medical laboratory values at glucose concentrations below 5.55 mmol/L, and 98.6% within ±15% of the medical laboratory values at glucose concentrations at or above 5.55 mmol/L.
97.6% of the total number of samples were within ±0.83 mmol/L 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 0.10 mmol/L SD or less at glucose levels less than 5.55 mmol/L, or 1.98% CV or less at glucose levels at 5.55 mmol/L or above.
Total Precision (600 Control Solution Tests per Glucose Level)
Data generated using the OneTouch Verio Flex® Meter.
