64
65
C
ontour
®
n
ext
GEN blood glucose monitoring system
TECHNICAL INFORMATION
Table 2: System accuracy results for glucose concentration
≥ 5.55 mmol/L
Difference range in values
between YSI laboratory
reference method and
C
ontour
n
ext
GEN meter
Within
± 5%
Within
± 10%
Within
± 15%
Number (and percent) of samples
within specified range
262 of
408
(64.2%)
397 of
408
(97.3%)
408 of
408
(100%)
Table 3: System accuracy results for glucose concentrations from
1.9 mmol/L to 29.1 mmol/L
Within ± 0.83 mmol/L or ± 15%
600 of 600 (100%)
Acceptance criterion in ISO 15197:2013 is that 95% of the measured
glucose values shall fall within either ± 0.83 mmol/L of the average
measured values of the reference measurement procedure at
glucose concentrations < 5.55 mmol/L or within ± 15% at glucose
concentrations ≥ 5.55 mmol/L.
User Accuracy
A study evaluating glucose values from fingertip capillary blood
samples obtained by 324 lay persons showed the following results:
100% within ± 0.83 mmol/L of the medical laboratory values at glucose
concentrations < 5.55 mmol/L and 98.60% within ± 15% of the medical
laboratory glucose concentrations ≥ 5.55 mmol/L.
User Accuracy Radar Plot
1.7
mmol/L
>1.9
mmol/L
1.1
mmol/L
1.4
mmol/L
0.8
mmol/L
0.6
mmol/L
0.3
mmol/L
20.0
33
.3
0.
8
16.1
20.0
16.
1
11.
1
23.7
27
.8
YS
I
®
(m
mo
l/L
)
5.
6
23.7
11.
1
5.
6
27
.8
10%
20%
30% >35%
5%
15%
25%
+
–
All samples (n = 324)
0.8 mmol/L or 15%
0.6 mmol/L or 10%
The 324 data points represent the blood glucose monitoring system
(BGMS) results. The distance from the center represents the
magnitude of the error compared with the laboratory reference result.
