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NLw SLPS|S MAPKLP

PATHFAST PRESEPSIN
Diagnosis & early prognosis
Risk stratication
Patient monitoring
Past and quantltatlve results out of whole blood ln l7 mlnutes
Por routlne laboratory and polnt of care use
New Sepsls marker
PATHFAST Presepsin
PATHFAST Presepsin is a chemiluminescent
enzyme immunoassay for the quantitative
measurement of presepsin concentration in
whole blood or plasma. PATHFAST Presepsin
can be used as an aid in the diagnosis and
prognosis of sepsis, in the assessment of
the degree of septic severity, and in the risk
stratication of critically ill septic patients.
|ntroductlon
CDl4 ls a glycoproteln expressed on the membrane surface of
monocytes/macrophages and serves as a receptor for com-
plexes of llpopolysaccharldes (LPS) and LPS blndlng proteln
(LP8), actlvatlng the toll-llke receptor 4 (TLP4) speclc pro-
lnnammatory slgnallng cascade on contact wlth lnfectlous
agents. Slmultaneously, CDl4 ls shed from the cell membrane
lnto the clrculatlon formlng soluble CDl4 (sCDl4). How ever,
plasma protease actlvlty generates also another sCDl4 mole-
cule called sCDl4 subtype (sCDl4-ST) or presepsln.
l
The levels
of presepsln were slgnlcantly hlgher ln septlc patlents than
ln patlents wlth S|PS or appearently healthy lndlvlduals.
2

Presepsln levels were elevated earller than |L-6 and D-dlmer
along wlth occurrence of blood bacterla ln anlmal model.
The determlnatlon of the presepsln concentratlon can be
used for dlagnosls and prognosls of sepsls and also to monltor
the course of the dlsease.
3,4
Larly dlagnosls and prognosls
|n a reference range study presepsln concentratlons were de-
termlned ln LDTA plasma samples from ll9 healthy lndlvlduals
(age: 2l 69 years, 60 females and 59 males).
Arlthmetrlc mean: l60 pg/ml (95% C|: 48 l7l pg/ml),
95th percentlle: 320 pg/ml (no lnnuence of age and gender).
5
The presepsln values were determlned at presentatlon ln the
emergency department ln patlents wlth sepsls.
Quartlles of presepsln showed a strong assoclatlon wlth the
30 day mortallty:
6
Cllnlcal use of PATHPAST' Presepsln
Early diagnosis and prognosis of sepsis
Prognosis already at rst presentation
For emergency and intensive care use
Mechanism of presepsin secretion
mCDl4: membrane CDl4, sCDl4: soluble CDl4, sCDl4-ST: soluble CDl4
subtype (Presepsln), LPS: llpopolysaccharlde, L8P: llpopolysaccharlde
blndlng proteln, TLP4: toll-llke receptor 4, MD2: Co-Proteln of TLP4.
mCD14
sCD14
MD2
TLP4
L8P
LPS
Slgnal transductlon
L8P
LPS
sCD14-ST
Presepsin
Quartile 1
st
(n37)
2
nd

(n35)
3
rd

(n35)
4
th

(n33)
Presepsin
(pg/ml)
l77 5l2 524 927 950 l,8l0 l,850 l5,757
Mortality
(p<0.000l)
2.7% 8.6% l7.l% 39.4%
Prognostlc value of presepsln ln emergency patlents
uslng the new assay PATHFAST Presepsin
Magnetic particles
ALP-conjugated antibody
Chemiluminescent substrate
(CDP-Star with Sapphire II)
Sample diluent
Washing buer
Counting well
Sample well
Reagent cartridge
ROC analysis at presentation
100-Specity
S
e
n
s
i
t
i
v
i
t
y
0
20
40
60
80
100
0 20 40 60 80 100
Presepsin
0 h
24 h
72 h
AUC
0.929
0.887
0.929


100-Specity
S
e
n
s
i
t
i
v
i
t
y
0
20
40
60
80
100
0 20 40 60 80 100

Presepsin
APACHE II
Procalcitonin
AUC
0.878
0.815
0.661
p
g
/
m
L
8000
7000
6000
5000
4000
3000
2000
1000
0
At admission 24 hours 72 hours

3094
3506
4553
1203
1009
1135
p=0.0002 p<0.0001 p=0.0002
POC analysls comparlng the accuracy for the predlctlon of
30-day mortallty revealed areas under the recelver operatlng
characterlstlcs curve (AUC) for presepsln, APACHL || score and
procalcltonln of 0.878, 0.815 and 0.661, respectlvely.
5
Presepsin showed superior prognostic accuracy!
7
Dlsease monltorlng
Presepsln was measured at presentatlon, at 24 hours and at
72 hours after admlsslon. |n patlents wlth favorable outcome
wlthln 30 days after admlsslon (nl04) presepsln levels de-
creased from basellne to 72 hours. |n the patlent group who
experlenced adverse outcome (n36), presepsln levels showed
an lncreaslng tendency.
Por emergency and lntenslve care use
PATHPAST Presepsln can be measured out of whole blood and
ls due to the fast turn around tlme and hlgh prognostlc power
already at admlsslon sultable for the use ln emergency and
lntenslve care unlts.
Sample material:
antlcoagulated (LDTA/heparln) whole blood or plasma
Turn around time:
l7 mln
|nterpretatlon of results
The followlng prellmlnary cut-off values were derlved from flrst
cllnlcal study data:
Lxcluslon of sepsls or lnfectlon < 200 pg/ml
Lxcluslon of severe sepsls or septlc shock 300 pg/ml
Sepsls posslble > 300 pg/ml
Hlgh probablllty of severe sepsls or septlc shock > l000 pg/ml
Correlation of presepsin values and patient outcome
Course of mean values of presepsln (error bars 95% C|) ln patlents wlth
worse outcome (orange llne) and favourable outcome (blue llne).
100-Specity
S
e
n
s
i
t
i
v
i
t
y
0
20
40
60
80
100
0 20 40 60 80 100
Presepsin
0 h
24 h
72 h
AUC
0.929
0.887
0.929


100-Specity
S
e
n
s
i
t
i
v
i
t
y
0
20
40
60
80
100
0 20 40 60 80 100

Presepsin
APACHE II
Procalcitonin
AUC
0.878
0.815
0.661
p
g
/
m
L
8000
7000
6000
5000
4000
3000
2000
1000
0
At admission 24 hours 72 hours

3094
3506
4553
1203
1009
1135
p=0.0002 p<0.0001 p=0.0002
PATHFAST Presepsin
Larly prognosls of sepsls ls key for lmproved cllnlcal outcome
The PATHPAST' System
The PATHFAST analysis system combines the accuracy of a
full-scale lab with the exibility of a mobile solution. Best
prerequisites for fast dierential diagnosis at the point of
care. Easy to operate, install and network. Highest pre cision
make this device an adequate outpost of a full-scale lab on
intensive care or emergency ward. Parallel processing en-
ables the examination of six samples in only 17 minutes.
Slx parallel channels. Slx quantltatlve analysls slmultaneously.
Slx results ln l7 mlnutes. Thls glves PATHPAST lts unlque speed.
|ts compact deslgn and low welght make PATHPAST the
ldeal analysls system ln emergency labs, hospltals and medlcal
om ces. Applled wherever fast quantltatlve results wlth full-
scale lab quallty provlde declslve dlagnostlc advantages.
Dlrectly at the polnt of care.
PATHPAST ls a fully automatlc lmmunoassay analyzer, whlch
comblnes the progresslve chemllumlnescence technology
wlth the patented Magtratlon' technology. Small sample
volumes can be detected wlth hlgh accuracy and preclslon.
|nsert the reagent cartrldge, apply the samples and press the
Start button. PATHPAST takes care of everythlng else fully
auto matlc. A slmple 3-step method provldes results ln lab quallty.
References
l) Shozushlma T, Takahashl G, Matsumoto N, Ko[lka M, Okamura ,
Lndo S. Usefulness of presepsln (sCDl4-ST) measurements as
a marker for the dlagnosls and severlty of sepsls that satlsed
dlagnostlc crlterla of systemlc lnammatory response syndrome.
1 |nfect Chemother. 20ll May, ll(5): Lpub
2) aegashl , Shlrakawa K, Sato N, Suzukl , Ko[lka M, |mal S,
Takahashl G, Mlyata M, Purusako S, Lndo S. Lvaluatlon of a newly
ldentled soluble CDl4 subtype as a marker for sepsls. 1 |nfect
Chemother. 2005 Oct, ll(5): 234-8
3) Ko[lka M, Takahashl G, Matsumoto N, Klkkawa T, Hoshlkawa K,
Shloya N, Shlbata S, Suzukl , Aokl H, Shlrakawa K, Lndo S. Serum
levels of soluble CDl4 subtype renect the APACHL || and SOPA
Scores. Medlcal Postgraduates 20l0 1an, 48(l): 46-50
4) Takahashl G, Suzukl , Ko[lka M, Matsumoto N, Shozushlma T,
Makabe H, amada , Shloya N, Shlbata S, Shlrakawa K, Lndo S.
Lvaluatlon of responses to |v|G therapy ln patlents wlth severe
sepsls and septlc shock by soluble CDl4 subtype monltorlng.
Medlcal Postgraduates 20l0 1an, 48(l): l9-24
5) |nternal data
6) Spanuth L, wllhelm 1, Loppnow H, Lbelt H, |vandlc 8, werdan K.
Dlagnostlc and Prognostlc value of Presepsln (Soluble CDl4
Subtype) ln Lmergency Patlents wlth Larly Sepsls Uslng the
New Assay PATHPAST Presepsln. |PCC world Lab/LuroMedLab
Proceedlngs 20ll
7) Pulz-Alvarez M1 et al. Dlagnostlc em cacy and prognostlc value
of serum procalcltonln concentartlon ln patlents wlth suspected
sepsls. 1 |ntens care Med zoop, z(:6-;:
Analytlcal performance data
Analytlcal performance was evaluated on PATHPAST system
wlth whole blood and plasma.
Assay range 20 20,000 pg/mL
Correlatlon between
whole blood and
plasma on PATHPAST
y l.04 x - l0.8 , r 0.986 , n l04
(y: LDTA whole blood, x: LDTA plasma)
Total % Cv ln plasma QC-LL 4.4%, QC-L 4.0%, QC-M 3.8%,
QC-H 5.0%
PATHFAST The hlghly preclse, fast and compact
chemllumlnescence lmmunoassay analysls system
PATHPAST' Test Prlnclple
Instrument type: Desktop Immunoassay Analyzer
Throughput: Up to 6 samples or parameters per run
Measuring time: Less than 17 min for 6 samples
using PATHFAST Presepsin
Sampling material: Whole blood, plasma, serum
Measuring principle: Analysis takes place with
the help of the chemiluminescence
enzyme immunoassay
technology (CLEIA) and
Magtration technology.
Reaction temperature: 37,5 C
Sample volume: 100 l
Wavelength: 300 650 nm
Data storage: Patient data: 1000
QC data: 1800
CAL data: 300

Datatransfer: ASTM standard
Dimensions: 375 (w) x 570 (d) x 510 (h) mm
Weight: 33 kg
El. requirements: 100 - 240 V AC (50/60 Hz)
Power consumption: 360 VA
Monitor/keyboard: LCD touch-screen
Printer: Integrated
PC: Integrated
Interface: RS-22C
Calibration: Factory calibration,
2-point calibration
every 4 weeks
24-h operation (stand-by): recommended
PATHPAST' Technlcal Speclcatlons
PATHFAST The hlghly preclse, fast and compact
chemllumlnescence lmmunoassay analysls system
Mitsubishi Chemical Medience Corporation
2-8 Shlbaura 4-chome, Mlnato-ku,
Tokyo l08-8559, 1apan
Phone: +8l - 3 - 67 22 - 40 80
Pacslmlle: +8l - 3 - 67 22 - 40 8l
www.PATHFAST.eu
Mitsubishi Chemical Europe GmbH
wlllstatter Str. 30 , 40549 Dusseldorf, Germany
Phone: +49 (0) 2ll - 5 20 54 l0
Pacslmlle: +49 (0) 2ll - 59 l2 72
emall: PathfastQmc-e.de
Product List |tem number Pack slze
SYSTEM
PATHPAST'

|mmunoanalyser
Analyzer for the detection of sepsis, fertility,
cardiac and other emergency parameters
:::(-oooo : x :
CONSUMABLES AND ACCESSORIES
PATHPAST' plpette tlps :::(-:ooo x (z unlts
PATHPAST'

waste box :::(-:oo: :o unlts
REAGENT KITS FOR SEPSIS DIAGNOSTICS
PATHPAST' Presepsln :::o-(ooo 6o tests
PATHPAST'

Presepsln control set :::o-(oo: ( x : ml
REAGENT KITS FOR CRITICAL CARE DIAGNOSTICS
PATHPAST' cTn| :::o-zooo 6o tests
PATHPAST' Myoglobln :::o-zoo: 6o tests
PATHPAST' CK-M8 :::o-zooz 6o tests
PATHPAST' D-Dlmer :::o-zoo 6o tests
PATHPAST' NTpro8NP :::o-zoo( 6o tests
PATHPAST' hsCPP :::o-zoo 6o tests
PATHPAST' HCG :::o-zoop 6o tests