ASCENSIA Contour next EZ, Руководство пользователя

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TECHNICAL,
SER
VICE & CARE
TECHNICAL,
SER
VICE & CARE
®
Technical Information
Mean,
mmol/L
Pooled
Standard
Deviation
95% Confidence
Interval of Standard
Deviation, mmol/L
Coefficient of
Variation, %
2.6 0.04 0.04 – 0.05 1.7
4.7 0.06 0.06 – 0.07 1.3
7.7 0.12 0.11 – 0.13 1.5
11.2 0.15 0.13 – 0.16 1.3
18.1 0.28 0.26 – 0.30 1.5
Intermediate precision (which includes variability
across multiple days) was evaluated using 3 control
solutions. With each of 3 lots of C
ontour
n
ext
test strips, each control was tested once on each
of 10 instruments on 10 separate days for a total of
300 readings.
Table 5 – System intermediate precision results
for C
ontour
n
ext
EZ meter using C
ontour
n
ext
test strips
Control
Level
Mean,
mmol/L
Standard
Deviation,
mmol/L
95% Confidence
Interval of Standard
Deviation, mmol/L
Coefficient
of Variation,
%
Low 2.37 0.03 0.031 – 0.036 1.4
Normal 7.12 0.09 0.080 – 0.095 1.2
High 20.89 0.36 0.331 – 0.392 1.7
Technical Information
Technical Information
Technical Information
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.
Table 3 – System accuracy results for glucose
concentrations between 1.0 mmol/L and
25.6 mmol/L
Within ± 0.83 mmol/L or ±15% 600 of 600 (100%)
A repeatability study was conducted with the
C
ontour
®
n
ext
EZ blood glucose monitoring system
using 5 venous whole blood specimens with glucose
levels from 2.6 to 18.8 mmol/L. Multiple replicates
(n=300) were tested using multiple C
ontour
n
ext
EZ
blood glucose meters and 3 lots of C
ontour
®
n
ext
blood glucose test strips. The following precision
results were obtained.
Table 4 – System repeatability results for
C
ontour
®
n
ext
eZ meter using C
ontour
®
n
ext
test strips
User Accuracy
Precision
A study evaluating glucose values from fingertip
capillary blood samples obtained by 115 lay
persons showed the following results: 100% within
± 0.83 mmol/L of the medical laboratory values at
glucose concentrations below 5.55 mmol/L and
98.8% within ± 15% of the medical laboratory glucose
concentrations at or above 5.55 mmol/L.