Thermo Scientific BRAHMS KRYPTOR compact PLUS - Page 51

B.R.A'H'M'S
Aktiengesellschaft
5 10(k)
Premarket
Notification
B.R.A.H'M'S
PCT
sensitive
KRYPTOR®
Test
System
Section
5.0, 510(k)
Summary
Page
6 of
6
Note:
PCT
levels
below
0.5 ng/ml
do
not
exclude
an
infection,
because
localized
infections
(without
systemic
signs)
may
also be
associated
with
such
low levels.
If
the PCT
measurement
is done
very
early
after
the
systemic
infection
process
has
started
(usually
< 6
hours),
these
values
may
still
be low.
As
various
non-infectious
conditions
are known
to
induce
PCT
as
well,
PCT levels
between
0.5
ng/ml
and
2.0 ng/ml
should
be reviewed
carefully
to take
into
account
the
specific
clinical
background
and
condition(s)
of the
individual
patient.
Expected
Values
In
normal
subjects,
PCT
concentrations
are
< 0.1
ng/ml.
In a
population
of 151
subjects,
146
had a
PCT value
< 0.1
ng/ml.
Specimen
Collection
and Handling
Serum
or plasma
may be
used.
B-R-A.HM.S
recommends
the use
of
only one
matrix,
i.e., use
the
same material
(either
serum
or plasma
[EDTA
or heparin])
throughout
the patient's
clinical
course.
It is recommended
that
citrate
plasma
not
be
used,
since
concentrations
were
underestimated
with
citrate
plasma.
CLSI
guidelines
should
be
followed
for
collecting,
transporting,
and
processing
patient
samples.
The
sample
volume
needed
for an
assay
is
50
PI.
Testing
demonstrated
that
there
is no
difference
between
the
use of
glass
and
plastic
collecting
tube
types
and
that filling
volume
has
no impact
on
the
result.
In any
case,
the
results
of
the
BR.A.H.M.S
PCT
sensitive
KRYPTOR®
assay
should
be evaluated
in
context
of all
laboratory
findings
and
the total
clinical
status
of the
patient.
In
cases
where
the
laboratory
results
do
not agree
with
the
clinical
picture
or
history,
additional
tests should
be
performed.
Samples
may
be stored
up to
5 days
at :2 -
8
0
C. Samples
may be
frozen
(-20
0
C) and
thawed
four times.
Conclusions
The
BR.A.H.M.S
PCT
sensitive
KRYPTOR®
Test
System
is substantially
equivalent
to legally
marketed
Inflammatory
Response
Markers.