81
Performance
Characteristics
Clinical accuracy
The accuracy of the
2in1.
STEP
System was assessed by comparing
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)
Regression statistics
2in1. STEP
System
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% (30/30)
2in1. STEP
System
within ±5%
63% (107/170)
within ±10%
95% (162/170)
within ±15%
99% (169/170)
within ±20%
100% (170/170)
2in1. STEP
System
Slope
0,9955
Intercept
-1,9843 mg/dL
R
2
0,9954
No. of samples
100
Range tested
31,4~430 mg/dL
