Thermo Scientific BRAHMS KRYPTOR compact PLUS - Page 49

B'R'A'H'M'S
Aktiengesellschaft
510(k)
Premarket
Notification
B.R.AH'M'S
PCT
sensitive
KRYPTOR®
Test
System
Section
5.0,
510(k)
Summary
Page
4 of 6
Interference
and
Cross
Reactivity
Based
on CLSI
testing,
the
substances
evaluated
with the
B.R.A.H.M.S
PCT sensitive
KRYPTOR®
assay
were
found
not
to affect
the test
performance
at concentrations
reasonably
and
consistently
found
in
clinical
situations.
The
substances
included
the
following
* bilirubin,
* hemoglobin,
* triglycerides,
*
albumin,
•
substances
that
share amino
acid
sequences
with
procalcitonin,
*
drugs which are typically used for
septic patients in intensive care
units, and
*
drugs
which
may
be
commonly
used
in
subjects
at greater
risk
of
developing
community
acquired
pneumonia
than
the
general
population,
such
as
in asthma
and/or
COPD
patients.
Method
Comparison
Summary
The
B.R.A.H.M.S
PCT
sensitive
KRYPTOR®
and the
B.R.A.H.M.S
PCT
LIA
both
detect
procalcitonin
(PCT)
in
human
serum
or plasma.
A
correlation
study
was
performed
in
accordance
with CLSI
guideline
EP9-A,
"Method
Comparison
and
Bias
Estimation
Using
Patient
Samples"
between
the
B-R'A'H'M'S
PCT
sensitive
KRYPTOR®
assay
and
the
B.R.A.H-M-S
PCT
LIA
assay.
There
were
184
samples
from three
(3)
sites, which
had
B.R-A.H.M.S
PCT LIA
measurements
of 0.3
ng/ml
(the
functional
assay
sensitivity
of
13BR.A.H.MS
PCT
LIA)
or higher
and/or
B.R.A.H-M.S
PCT
sensitive
KRYPTOR®
measurements
of
0.06
ng/ml
(the
functional
assay
sensitivity
of B-R'A'H'M'S
PCT
sensitive
KRYPTOR®)
or higher.
Passing-Bablock
analysis
shows
a
nearly
perfect
correlation
of
the B-R-A.H.M.S
PCT
sensitive
KRYPTOR®
assay
and B.R.A-H.M.S
PCT LIA
assay,
as
demonstrated
in
the correlation
graph
below.