Technical Information - Bayer HealthCare CONTOUR NEXT LINK User Manual

Technical Information

Accuracy
The C ® N LINK blood glucose monitoring system
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was tested in 100 capillary blood samples using 600
C ® N test strips. Two replicates were tested with
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each of 3 lots of C N
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readings. Results were compared to the YSI
which is traceable to the CDC hexokinase method.
below compare the performance of the two methods.
Table 1 — System accuracy results for C
meter using C N test strips at glucose concentration
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< 4.2 mmol/L
Within Within
± 0.28 mmol/L ± 0.56 mmol/L
63 / 78 78 / 78
(80.8%) (100%)
Table 2 — System accuracy results for C
meter using C N test strips at glucose concentration
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≥ 4.2 mmol/L
Within Within
± 5% ± 10%
402 / 522 518 / 522
(77.0%) (99.2%)
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 +/- 0.83 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.
®
60
test strips for a total of 600
® glucose analyzer,
7 The tables
N LINK
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Within
± 0.83 mmol/L
78 / 78
(100%)
N LINK
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Within Within
± 15% ± 20%
522 / 522 522 / 522
(100%) (100%)
Precision
A repeatability study was conducted with the
C ® N LINK blood glucose monitoring system using
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five venous whole blood specimens with glucose levels from
2.4 to 18.2 mmol/L. Multiple replicates (n=100 per lot) were
tested using multiple C N
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meters and 3 lots of C ® N
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precision results were obtained.
System repeatability results for C
using C N test strips
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Standard
Mean Glucose
Deviation,
Level, mmol/L
mmol/L
2.41 0.05
4.50 0.11
6.78 0.08
11.46 0.14
18.34 0.35
Principles of the Procedure
The C N LINK blood glucose test is based on
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measurement of electrical current caused by the reaction of
the glucose with the reagents on the electrode of the strip.
The blood sample is drawn into the tip of the test strip through
capillary action. Glucose in the sample reacts with FAD glucose
dehydrogenase (FAD-GDH) and a phenothiazine derivative as
a mediator. Electrons are generated, producing a current that
is proportional to the glucose in the sample. After the reaction
time, the glucose concentration in the sample is displayed. No
calculation is required.
LINK blood glucose
EXT
test strips. The following
EXT
N LINK meter
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Coefficient of
Variation
(%)
2.1%
2.4%
1.2%
1.2%
1.9%
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