Bayer HealthCare CONTOUR XT, Руководство пользователя

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42
T
e
c
hnical,
Service & Care
C
ONTOUR
® XT meter C
ONTOUR
® N
EXT
test strips 43
T
e
c
hnical,
Service & Care
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T
e
c
hnical Information
Technical Information Technical Information
The C
ONTOUR
®
XT blood glucose monitoring system
was tested using 100 capillary blood samples (duplicate
replicates from three C
ONTOUR
®
N
EXT
strip lots). The results
were compared to the YSI ® Glucose Analyzer laboratory
reference method, traceable to the CDC hexokinase
method. The tables below show how well the two methods
compared.
A repeatability study was conducted with the C
ONTOUR
®
XT
blood glucose monitoring system using five venous
whole blood specimens with glucose levels from 2.2 to
17.0 mmol/L. Multiple replicates (n=100) were tested using
multiple C
ONTOUR
XT blood glucose meters and one lot of
C
ONTOUR
® N
EXT
blood glucose test strips. The following
precision results were obtained.
Table 1 – System accuracy results for glucose
concentration < 4.2 mmol/L
Difference range
in values between
YSI laboratory
reference method and
C
ONTOUR
XT meter
Within ±
0.3 mmol/L
Within ±
0.6 mmol/L
Within ±
0.8 mmol/L*
Number (and percent)
of samples within
specifi ed range
48 of 54
(88.9%)
54 of 54
(100.0%)
54 of 54
(100.0%)
Table 2 - System accuracy results for glucose
concentration
≥
4.2 mmol/L
Difference range
in values between
YSI laboratory
reference method and
C
ONTOUR
XT meter
Within ±
5%
Within ±
10%
Within ±
15%
Within ±
20%*
Number (and percent)
of samples within
specifi ed range
439 of 546
(80.4%)
544 of 546
(99.6%)
546 of 546
(100.0%)
546 of 546
(100.0%)
*Acceptance criteria in ISO 15197: 2003 are that 95% of all differ-
ences 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.
T
e
c
hnical Information
System repeatability results for C
ONTOUR
XT meter using
C
ONTOUR
N
EXT
test strips
Mean, mmol/L
Pooled Standard
Deviation mmol/L
Coeffi cient of
Variation, %
2.28 0.04 1.8
4.15 0.08 1.9
6.50 0.08 1.3
10.59 0.12 1.2
17.05 0.29 1.7
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