Thermo Scientific BRAHMS KRYPTOR compact PLUS - Results Interpretation and Handling

B'R'A'H'M'S
Aktiengesellschafi
510(k)
Premarket
Notification
B'R.A-H'M'S
PCT sensitive
KRYPTOR®
Test System
Section
5.0,
510(k)
Summary
Page
5 of 6
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B.RAoH. M.$
PCT LIA
Interpretation
of
Results
The
B.R.A.H-M.S
PCT
sensitive
KRYPTOR
®
is
intended
to
aid in
the risk
assessment
of
critically
ill
patients
on
their first
day
of
ICU admission
for
progression
to severe
sepsis
and
septic
shock.
SIRS,
Sepsis,
Severe
Sepsis,
and Septic
Shock
were
categorized
according
to
the
criteria
of the
consensus
conference
of the
American
College
of
Chest
Physicians/Society
of Critical
Care
Medicine.
PCT
should
always
be
interpreted
in
the clinical
context
of
the patient.
Therefore,
clinicians
should
use the
PCT results
in
conjunction
with
other
laboratory
findings
and
clinical
signs of
the patient.
Data
support
the following
interpretative
risk assessment
criteria:
PCT
> 2 ng/ml
PCT
levels
above
2.0
ng/ml
on the
first day
of ICU
admission
represent
a high
risk
for progression
to severe
sepsis
and/or
septic
shock.
PCT
< 0.5 ng/ml
PCT
levels
below
0.5 ng/ml
on the:
first
day of
ICU admission
represent
a
low
risk for
progression
to
severe sepsis
and/or
septic
shock.