TECHNICAL
INFORMA
TION
61
T
echnical Information - Pr
ecision
A repeatability study was conducted with the C
ONTOUR
®
N
EXT
blood glucose monitoring system using 5 venous
whole blood specimens with glucose levels from 2.2 to
17.9 mmol/L. Multiple replicates (n=300) were tested using
multiple C
ONTOUR
N
EXT
blood glucose meters and 3 lots
of C
ONTOUR
®
N
EXT
blood glucose test strips. The following
precision results were obtained.
Table 4 – System repeatability results for C
ONTOUR
N
EXT
meter using C
ONTOUR
N
EXT
test strips
Mean,
mmol/L
Pooled
Standard
Deviation
95% Confidence
Interval of Standard
Deviation, mmol/L
Coefficient of
Variation, %
2.2
0.05
0.043 – 0.051
2.1
4.8
0.07
0.062 – 0.073
1.4
6.8
0.09
0.082 – 0.097
1.3
11.4
0.15
0.138 – 0.164
1.3
18.2
0.26
0.238 – 0.282
1.4
Intermediate precision (which includes variability across
multiple days) was evaluated using 3 control solutions. With
each of 3 lots of C
ONTOUR
N
EXT
Test Strips, each control
was tested once on each of 10 instruments on 10 separate
days for a total of 300 readings.
Table 5 – System intermediate precision results for
C
ONTOUR
N
EXT
meter using C
ONTOUR
N
EXT
test strips
Control
Level
Mean,
mmol/L
Standard
Deviation,
mmol/L
95% Confidence
Interval of Standard
Deviation, mmol/L
Coefficient
of Variation,
%
Low
2.41
0.04
0.036 – 0.043
1.6
Normal 7.16
0.10
0.093 – 0.111
1.4
High
21.30
0.35
0.321 – 0.380
1.6
User Accuracy
Precision
A study evaluating glucose values from fingertip capillary
blood samples obtained by 221 lay persons showed
the following results: 100% within ± 0.83 mmol/L of the
medical laboratory values at glucose concentrations below
5.55 mmol/L and 98.9% within ± 15% of the medical
laboratory glucose concentrations at or above 5.55 mmol/L.
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