TECHNICAL
INFORMA
TION
60
®
T
echnical Information - Accuracy
Accuracy
Table 1 – System accuracy results for glucose
concentration < 5.55 mmol/L
Difference range in values
between YSI laboratory
reference method and
C
ONTOUR
N
EXT
meter
Within ±
0.28
mmol/L
Within ±
0.56
mmol/L
Within ±
0.83
mmol/L
Number (and percent)
of samples within
specified range
167 of 180
(92.8%)
179 of 180
(99.4%)
180 of 180
(100%)
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
meter
Within ±
5%
Within ±
10%
Within ±
15%
Number (and percent)
of samples within
specified range
319 of 420
(76.0%)
412 of 420
(98.1%)
419 of 420
(99.8%)
Acceptance criteria in ISO 15197: 2013 are that 95% of all
differences in glucose values (i.e., between reference method and
meter) should be within ±0.83 mmol/L for glucose values less than
5.55 mmol/L, and within ±15% for glucose values greater than or
equal to 5.55 mmol/L.
Technical Information
The C
ONTOUR
®
N
EXT
blood glucose monitoring system
was tested in 100 capillary blood samples using 600
C
ONTOUR
®
N
EXT
test strips. Two replicates were tested
with each of 3 lots of C
ONTOUR
N
EXT
test strips for a
total of 600 readings. Results were compared to the YSI
®
glucose analyzer, which is traceable to the CDC hexokinase
method.
The tables below compare the performance of the
2 methods.
Table 3 – System accuracy results for glucose
concentrations between 1.3 mmol/L and 30.6 mmol/L
Within ± 0.83 mmol/L or ±15%
599 of 600 (99.8%)
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