NIPRO Diagnostics True Metrix Pro, Руководство пользователя

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Performance Characteristics
4
for Healthcare Professionals
TRUE METRIX
®
PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Performance Characteristics 12
Fingertip Capillary Blood
≥
75 mg/dL (HCP finger vs. YSI)
100% of TRUE METRIX
®
PRO forearm values fell within
15 mg/dL of the YSI results at glucose levels <75 mg/dL
and within 20% at glucose levels
≥
75 mg/dL
Forearm Capillary Blood < 75 mg/dL
(HCP forearm vs. HCP finger)
Forearm Capillary Blood
≥
75 mg/dL
(HCP forearm vs. HCP finger)
Introduction
The International Organization for Standardization (ISO)
develops standards in response to an identified need
in the community that will eventually be suitable for
implementation on as broad a basis as possible. ISO
developed the standard for blood glucose monitoring
performance – 15197:2003 – based on a consensus of
professionals around the world.
3
It is recognized as the
standard in many countries.
Clinical data obtained by healthcare professionals on
the TRUE METRIX
®
PRO Blood Glucose Monitoring
System exceeded the minimum accuracy criteria for
ISO 15197:2003.
Accuracy:
TRUE METRIX
®
PRO accuracy was assessed against the
Yellow Springs Instrument. Studies were conducted at 3
clinical sites by healthcare professionals;
100% of healthcare professionals (HCP) TRUE METRIX
®
PRO fingertip values fell within 15 mg/dL of the YSI
results at glucose level <75 mg/dL and within 20% at
glucose levels
≥
75 mg/dL.
Fingertip Capillary Blood < 75 mg/dL (HCP finger vs. YSI)
±5 mg/dL 26/34 = 76.5%
±10 mg/dL 32/34 = 94.1%
±15 mg/dL 34/34 = 100%
±5% 122 / 266 = 45.9%
±10% 220 / 266 = 82.7%
±15% 260 / 266 = 97.7%
±20% 266 / 266 = 100%
±5 mg/dL 2/4 = 50%
±10 mg/dL 3/4 = 75%
±15 mg/dL 4/4 = 100%
±5% 24/96 = 25%
±10% 58/96 = 60.4%
±15% 88/96 = 91.7%
±20% 96/96 = 100%
Standard Reference Results ISO Bias Limit Criteria for Accuracy
Less than 75 mg/dL
± 15 mg/dL from laboratory
reference result
95% of all results
Greater than or equal to 75 mg/dL
± 20% from laboratory
reference result