Publicité
42
The
performance
of
the
system
has
been
evaluated
both
in
laboratory
and
in
clinical
tests.
Range:
The
display
range
of
the
meter
is
0.5mmol/L
to
33.3
mmol/L
(9mg/dL
to
600
mg/dL).
"HI"
and
"Lo"
messages
indicate
results
outside
of
this
range.
•
Accuracy:
The
accuracy
of
the
system
was
assessed
by
comparing
blood
glucose
results
from
fresh
capillary
whole
blood
obtained
by
patients
with
those
obtained
using
a
YSI
Glucose
Analyzer,
a
laboratory
instrument.
Table1.
System
accuracy
results
for
glucose
concentration
<5.55
mmol/L
(100
mg/dL)
Within
±0.28mmol/L
(Within
±5mg/dL)
118/150
When
the
blood
glucose
is
below
5.55mmol/L(100mg/dL),
100%
of
measured
glucose
results
should
fall
wi
of
the
laboratory
result.
Table2.
System
accuracy
results
for
glucose
concentration
≥5.55mmol/L
(100
mg/dL)
277/450(61.6%)
the
blood
glucose
is
equal
to
or
above
5.55mmol/L
When
measured
glucose
results
should
fall
within
±15
%
of
the
laboratory
result.
Performance
Characteristics
(78.7%
)
Within
±5%
Within
±0.56mmol/L
(Within
±10mg/dL)
150/150
(100%
)
thin
±0.83mmol/L
(±15
mg/dL)
Within
±10%
400/450(88.9%)
Within
±0.83mmol/L
(Within
±15mg/dL)
150/150
(100%
Within
±15%
446/450(99.1%)
(1
00mg/dL),
99.1%
of
)
Publicité
