Technical Information - Bayer HealthCare CONTOUR NEXT User Manual

Technical Information

Accuracy
The C
ONTOUR
was tested in 100 capillary blood samples using 600
®
C N
ONTOUR
with each of 3 lots of C
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 1 – System accuracy results for glucose
concentration < 5.55 mmol/L
Difference range in values
between YSI laboratory
reference method and
C N
ONTOUR EXT
Number (and percent)
of samples within
specified range
Table 2 – System accuracy results for glucose
concentration ≥ 5.55 mmol/L
Difference range in values
between YSI laboratory
reference method and
C N
ONTOUR EXT
Number (and percent)
of samples within
specified range
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%
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.
60
®
N blood glucose monitoring system
EXT
test strips. Two replicates were tested
EXT
ONTOUR
Within ±
meter
167 of 180
Within ±
meter
319 of 420
®
N test strips for a
EXT
Within ±
0.28 0.56
mmol/L mmol/L
179 of 180
(92.8%) (99.4%)
Within ±
5% 10%
412 of 420
(76.0%) (98.1%)
599 of 600 (99.8%)
®
Within ±
0.83
mmol/L
180 of 180
(100%)
Within ±
15%
419 of 420
(99.8%)