NIPRO Diagnostics True Metrix Pro Manual page 18

The TRUE METRIX PRO System was also tested by
®
healthcare professionals at a research center. The data
was compared to parallel results obtained on a Yellow
Springs Instrument (YSI). The table below shows how
often TRUE METRIX PRO Blood Glucose System venous
®
values obtained by healthcare professionals achieve the
accuracy goals.
Venous samples drawn into sodium heparin anticoagu-
lant tubes.
Venous Blood < 75 mg/dL
Within ±5 mg/dL 5/6 = 83.3%
Within ±10 mg/dL 6/6 = 100%
Within ±15 mg/dL 6/6 = 100%
Venous Blood ≥ 75 mg/dL
Within ±5% 20/106 = 18.9%
Within ±10% 60/106 = 56.6%
Within ±15% 101/106 = 95.3%
Within ± 20% 106/106 = 100%
TRUE METRIX PRO System Comprehensive Resource Guide (GDH-FAD Enzyme)
®
Performance Characteristics
for Healthcare Professionals
Precision (Repeatability):
Precision describes the variation between results.
Precision results were performed in a laboratory.
Blood (Within Lot): N=100
Mean (mg/dL)
SD (mg/dL)
CV%
Control Solution: N=100
Mean (mg/dL)
SD (mg/dL)
CV%
44 89 150 199
1.8 3.6 4.9 7.3
4.1 4.0 3.3 3.7
33 105 306
1.6 3.8 10.3
4.8 3.6 3.4
Performance Characteristics 13
4
cont.
329
9.6
2.9