Bayer HealthCare Contour next USB User Manual page 41

Accuracy
The C ® N USB blood glucose monitoring
ONTOUR EXT
system was tested on 100 capillary blood samples using
C ® N test strips. Two replicates were tested with
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each of three lots of C
600 readings. Results were compared to the YSI
analyzer, which is traceable to the CDC hexokinase method.
The tables below compare the performance of the two
methods.
Table 1 — System accuracy results for C
meter using C
ONTOUR
concentration < 4.2 mmol/L.
Difference range in values
between YSI laboratory
reference method and
C N USB meter
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Number (and percent)
of samples within
specified range
Table 2 — System accuracy results for C
meter using C
ONTOUR
concentration ≥ 4.2 mmol/L.
Difference range in values
between YSI laboratory
reference method and
C N USB
ONTOUR EXT
meter
Number (and percent)
of samples within
specified range
Acceptance criteria in ISO 15197:2003 are that 95% of all
differences in glucose values (i.e., between reference method and
meter) should be within 0.8 mmol/L for glucose values less than
4.2 mmol/L, and within 20% for glucose values greater than or equal
to 4.2 mmol/L.
74
84318354_CntrNext_USB_UG_ENca_FpBp_v1.indd 74-75 84318354_CntrNext_USB_UG_ENca_FpBp_v1.indd 74-75
N test strips for a total of
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®
glucose
N USB
ONTOUR EXT
N test strips at glucose
EXT
Within ± Within ± Within ±
0.28 0.56 0.83
mmol/L mmol/L mmol/L
65 / 78 78 / 78 78 / 78
(83.3%) (100%) (100%)
N USB
ONTOUR EXT
N test strips at glucose
EXT
Within ± Within ± Within ± Within ±
5% 10% 15% 20%
390 / 522 512 / 522 522 / 522 522 / 522
(74.7%) (98.1%) (100%) (100%)
Precision
A repeatability study was conducted with the
C ® N USB blood glucose monitoring system using
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100 venous whole blood specimens with glucose levels from
2.6 to 18.4. Multiple replicates (n=300) were tested using
multiple C N USB blood glucose meters and
ONTOUR EXT
®
three lots of C N blood glucose test strips. The
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following precision results were obtained.
System repeatability results for C
meter using C N test strips
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Pooled Standard
Mean, mmol/L
Deviation
2.6 0.05
4.8 0.07
7.3 0.11
11.7 0.15
19.0 0.35
N USB
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Coefficient of
Variation, %
1.8
1.5
1.5
1.3
1.9
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