35
Performance Characteristics
5
Precision:
Precision describes the variation between results. There
are two types of precision results measured, repeatability (using
blood) and intermediate precision (using control solution).
Repeatability:
N=100
Mean
(mmol/L)
2.6 4.9 7.3 11.4
18.4
Mean
(mg/dL)
47 88 131
206
331
SD
(mmol/L)
0.09 0.12 0.19 0.33 0.61
SD
(mg/dL)
1.6 2.2 3.5 6.0 10.9
%CV
3.4 2.5 2.7 2.9 3.3
Intermediate Precision:
N=100
Mean (mmol/L) 2.7
7.3
18.2
Mean (mg/dL) 49
131
328
SD (mmol/L)
0.06
0.14
0.76
SD (mg/dL)
1.1
2.5
13.7
%CV 2.3
1.9
4.2
System Accuracy:
Diabetes experts have suggested that glucose
meters should agree 0.83 mmol/L (15 mg/dL) of the
medical laboratory values at glucose concentrations below
5.55 mmol/L (100 mg/dL) and 15% of the medical
laboratory values at glucose concentrations at or above
5.55 mmol/L (100 mg/dL). The tables below show how often
healthcare professionals (HCP) and users achieve these goals using
capillary fingertip and forearm blood samples when glucose results
are not fluctuating. The laboratory reference instrument is the
Yellow Springs Instrument (YSI) Model 2300.