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Table3.
System
accuracy
results
for
glucose
between
0.5
mmol/L
(9
mg/dL)
and
33.3
mmol/L
(600
mg/dL)
This
study
shows
that
the
system
compares
well
with
a
laboratory
the
minimum
acceptable
performance
criteria
Precision:
The
repeatability
evaluation
performed
with
venous
whole
blood
and
the
intermediate
precision
evaluation
performed
with
control
materials.
Intermediate
Precision
Repeatability
To
maximize
your
chances
of
an
accurate
comparison
between
meter
and
laboratory
results,
follow
a
few
basic
guidelines:
Before
going
to
the
lab
·Perform
a
control
solution
test
to
make
sure
the
meter
is
working
·Do
Not
eat
for
at
least
eight
hours
before
you
test
your
blood.
Take
your
meter
with
you
to
the
lab.
·
While
at
the
lab
Conduct
your
meter
test
within
15
minutes
of
the
lab
test.
·
Use
fresh
capillary
blood
obtained
from
the
fingertip,
venous
blood,
·
Follow
all
instructions
in
this
Owners
Booklet
for
performing
a
·
blood
glucose
test
with
your
meter.
Performance
Characteristics
Within
±0.83mmol/L
or
±15%
(Within
±15mg/dL
or
±15%)
596/600(99.3%)
Control
Solution
Control
Solution
Control
Solution
Control
Solution
Control
Solution
Blood
2.6mmol/L
SD=0.11mmol/L
Blood
av
4.7mmol/L
SD=0.2mmol/L
Blood
av
7.4mmol/L
CV=2.3%
Blood
av
20.5mmol/L
CV=1.6%
Blood
av
20.8mmol/L
CV=2.4%
av
defined
in
EN
ISO
15197
:
2015.
2.2mmol/L
SD=0.08mmol/L
av
4.9mmol/L
SD=0.14mmol/L
7.2mmol/L
CV=2.0%
av
av
11.0mmol/L
CV=1.8%
av
18.1mmol/L
CV=1.4%
av
method
and
meets
properly.
neonatal
blood.
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