52
Clinical accuracy
The 2in1. SMART is calibrated to yield
results equivalent to plasma glucose
concentrations and is traceable to a
NIST standard. The accuracy of the 2in1.
SMART System was assessed by com-
paring blood glucose results obtained
by patients with those obtained using a
YSI 2300 Glucose Analyzer.
System accuracy result for glucose concentrations
< 75 mg/dL (4.2 mmol/L)
System accuracy result for glucose concentrations
≥
75 mg/dL(4.2 mmol/L)
within ±5 mg/dL
(0.28 mmol/L)
87% (26/30)
within ±10 mg/dL
(0.56 mmol/L)
100% (30/30)
within ±15 mg/dL
(0.83 mmol/L)
100.0% (30/30)
within ±5%
62% (106/170)
within ±10%
95% (161/170)
within ±15%
99% (168/170)
within ±20%
100% (170/170)
Performance Characteristics