User guide

TECHNICAL
AND CARE
60
TECHNICAL
AND CARE
61
Within
± 5%
Within
± 10%
Within
± 15%
Within
± 20%
402 / 522
(77.0%)
518 / 522
(99.2%)
522 / 522
(100%)
522 / 522
(100%)
Precision
A repeatability study was conducted with the
CONTOUR
®
NEXTLINK blood glucose monitoring system using
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 CONTOUR NEXTLINK blood glucose
meters and 3 lots of CONTOUR
®
NEXT test strips. The following
precision results were obtained.
System repeatability results for CONTOUR NEXT LINK meter
using CONTOUR NEXT test strips
®
Accuracy
Precision
Principles of the Procedure
The CONTOUR NEXT LINK blood glucose test is based on
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.
Within
± 0.28 mmol/L
Within
± 0.56 mmol/L
Within
± 0.83 mmol/L
63 / 78
(80.8%)
78 / 78
(100%)
78 / 78
(100%)
Table 2 — System accuracy results for CONTOUR NEXTLINK
meter using CONTOUR NEXT test strips at glucose concentration
≥ 4.2 mmol/L
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.
Technical Information
Accuracy
The CONTOUR
®
NEXTLINK blood glucose monitoring system
was tested in 100 capillary blood samples using 600
CONTOUR
®
NEXT test strips. Two replicates were tested with
each of 3 lots of CONTOUR NEXT test strips for a total of 600
readings. Results were compared to the YSI
®
glucose analyzer,
which is traceable to the CDC hexokinase method.
8
The tables
below compare the performance of the two methods.
Table 1 — System accuracy results for C
ONTOUR NEXTLINK
meter using CONTOUR NEXT test strips at glucose concentration
< 4.2 mmol/L
Mean Glucose
Level, mmol/L
Standard
Deviation,
mmol/L
Coefficient of
Variation
(%)
2.41 0.05 2.1%
4.50 0.11 2.4%
6.78 0.08 1.2%
11.46 0.14 1.2%
18.34 0.35 1.9%
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