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System Accuracy Results for
Glucose Concentrations <75 mg/dL
Within
±5 mg/dL
Within
±10 mg/dL
Within
±15 mg/dL†
69% (58/84) 98.8% (83/84) 100% (84/84)
Percent (and number) of meter results that
match the laboratory test
†
ISO 15197 Minimum Acceptable Accuracy Requirements.
Percent (and number) of meter results that
match the laboratory test
System Accuracy Results for
Glucose Concentrations >75 mg/dL
Within
±5%
Within
±10%
Within
±15%
Within
±20%†
45.9%
(237/516)
86.2%
(445/516)
99.4%
(513/516)
99.6%
(514/516)
Percent (and number) of meter results that
match the laboratory test
Therefore, 99.7% of the total results obtained with the
OneTouch® SelectSimple™ System achieved the goal suggested
by the diabetes experts.
System Accuracy Results across
the entire Glucose Range
Within ±15 mg/dL or ±20%
99.7% (598/600)
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 75 mg/dL, and within
20% of a laboratory method when the glucose concentration
is 75 mg/dL or higher. Samples from 100 diabetic patients
at 1 clinical centre were tested using both the OneTouch®
SelectSimple™ System and the YSI Model 2300 Glucose
Analyser (laboratory test).