The guarantee for the OneTouch Verio Reflect® meter.
Product Guide
Global
OneTouch Verio Reflect® 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 Reflect® System and the YSI 2900 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 1.9 mmol/L and 25.0 mmol/L
NOTE: Where 1.9 mmol/L represents the lowest glucose reference value and 25.0 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 Reflect® System compares well with a laboratory method.
User performance accuracy:
A study evaluating glucose values from fingertip capillary blood samples obtained by 313 lay persons showed the following results:
97.1% within ±0.83 mmol/L of the medical laboratory values at glucose concentrations below 5.55 mmol/L, and 96.4% within ±15% of the medical laboratory values at glucose concentrations at or above 5.55 mmol/L.
96.5% 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 Reflect® Meter.
Results show that the greatest variability observed between test strips when tested with blood is 0.13 mmol/L SD or less at glucose levels less than 5.55 mmol/L, or 2.98% 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 Reflect® Meter.
