Thermo Scientific BRAHMS KRYPTOR compact PLUS - Intended Use and Performance

B'R'A'H'M'S
Aktiengesellschaft
510(k)
Premarket
Notification
B'R'A'H'M'S
PCT
sensitive
KRYPTOR
®
Test
System
Section
5.0, 510(k)
Summary
Page
2 of
6
The
basis
of
the TRACE®
technology
is
a non-radiative
energy
transfer
from
a donor
[a cage-like
structure
with
a europium
ion
in the
center
(cryptate)]
to
an acceptor
(XL
665).
The
proximity
of donor
(cryptate)
and acceptor
(XL
665)
in
a
formed
immunocomplex
and
the
spectral
overlap
between
donor
emission
and
acceptor
absorption
spectra
on the
one
hand
intensifies
the
fluorescent
signal
and
on the
other
hand
extends
the
life
span
of the
acceptor
signal,
allowing
for
the measurement
of
temporally
delayed
fluorescence.
After
the
sample
to be
measured
has
been
excited
with
a nitrogen
laser
at
337
nm, the
donor
(cryptate)
emits
a long-life
fluorescent
signal
in
the milli-second
range
at 620
nm,
while
the acceptor
(XL
665) generates
a short-life
signal
in the
range
of nano-
seconds
at 665
nm.
When
both
components
are
bound
in an
immunocomplex,
both
the signal
amplification
and
the
prolonged
life
span
of the
acceptor
signal
occur
at
665
nm,
and
the life
is
in the
microsecond
range.
This
delayed
acceptor
signal
is
proportional
to the
concentration
of
the analyte
to be
measured.
The
specific
fluorescence
which
is proportional
to
the
antigen
concentration
is
obtained
through
a double
selection:
spectral
(separation
depending
on
wave-length)
and temporal
(time
resolved
measurement).
This
enables
an exclusive
measurement
of
the signal
emitted
by
the immunological
complex
and
the ratio
between
the
two
wave-lengths
(665/620)
allows
a real-time
correction
of
the variations
in
optic
transmission
from
the medium.
The
contents
of the
BR.A.H.M.S
PCT
sensitive
KRYPTOR
assay
are:
Quantity
for
50
Reagent
deemntos
Content
determinations
Cryptate
1 bottle
Cryptate
conjugate,
cryptate
labeled,
Conjugate
lyophilized
anti-PCT
antibody
(polyclonal,
sheep),
3.2
ml after
reconstitution
with
KRYPTOR®
Solution
1 and
KRYPTOR®
Solution 2
XL665
1 bottle
XL665
conjugate,
XL665
labeled,
Conjugate
lyophilized
anti-PCT
antibody
(monoclonal,
mouse),
3.95
ml after
reconstitution
with
KRYPTOR®
Solution
1
and
KRYPTOR®
Solution
2
Diluent
1 bottle
Defibrinated
human
plasma,
for
diluting
samples
above
50
ng/ml,
ready
to use
Controls,
Calibrator,
and
Consumables
are provided
separate
from
the reagent
unit.