Caution – Investigational Device, Limited by Federal (or US) Law to Investigational Use. Not available for Sale in the United States.
IAI INTRA-ABDOMINALINFECTIONAPPLICATION
2 3
CONTeNT
Caution – Investigational Device, Limited by Federal (or US) Law to Investigational Use. Not available for Sale in the United States.
UNYVERO IAI APPLICATION
The Unyvero IAI Application is a high-quality
tool to detect pathogens (bacteria and fungi),
toxins, and antibiotic resistance markers in
severe intra-abdominal infections. The Unyvero
IAI Cartridge analyzes simultaneously in one
patient sample over 100 DNA targets. In a few
hours, specific analytes for resistance markers,
pathogens, toxins and also a Universal Bacteria
primer are assayed. Intra-abdominal infections
are associated with unmet medical needs. The
Unyvero approach helps to make informed
treatment decisions at an earlier stage.
INTRA-ABDOMINAL INFECTIONs 04 – 05
ANTIbIOTIC ReSISTANCeS ARe INCReASINg 06 – 07
UNYVERO IAI INTRA-ABDOMINAL
INFECTION APPLICATION 08 – 09
UNyveRO SySTem – UNIveRSAL PLATFORm 10
COVERAGE – DIVERsITY – RELIABILITY 11
A COmPReheNSIve PANeL 12 – 13
NATIVE sAMPLE TYPEs 14 – 15
eSTAbLISheD TeChNOLOgIeS
IN A New FORmAT 16 – 17
UNYVERO wORkFLOw 18 – 19
UNyveRO SySTem AND APPLICATIONS 20 – 21
UNYVERO AT A GLANCE 22 – 23
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INTRA-ABDOMINAL INFECTIONSeCOND mOST COmmON CAUSe OF mORTALITy FROm INFeCTIONS IN INTeNSIve CARe
Improving treatment of patients with
acute abdomen, including peritonitis,
acute pancreatitis and megacolon
requires rapid pathogen identification.
Intra-abdominal infections (IAI), associated with abdominal
cavity exudations, elicit within the peritoneum complex
inflammatory responses to microorganisms and their
toxins. IAI is the second most common type of infections in
patients with severe sepsis and ranks second as cause of
death in US intensive care units.
In addition, complicated IAIs, with a yearly incidence rate
of 300,000 cases in the US, present a significant burden to
health care systems.
INTRA-ABDOMINAL INFECTIONs ARE
CLAssIFIED As:
> community-acquired intra-abdominal infection (CA-IAI)
> healthcare-acquired intra-abdominal infection (hA-IAI)
The acute abdomen, a case of emergency, often caused
by severe infections and necessitate timely medical
attention.
Sources of infections are mostly the appendix, gall
bladder, or are associated with colon or gastro-duodenal
perforations, or diverticulitis.
INTRA-AbDOmINAL INFeCTION
The medical challenge of today is to treat complex IAI
infections that are due to multiple pathogens, together
with the significant risk of complications. Therefore, in
cases of nosocomial intra-abdominal infections, the first
choice of antimicrobial treatment is of major importance.
According to various publications, unsuitable antimicrobial
therapy seems to be linked to longer inpatient residence
and higher fatality rates.
An increasing resistance to gram–negative pathogens,
which are responsible for serious nosocomial infections,
e.g. intra-abdominal infections such as:
> ß-lactam resistance Enterobacteriacea
> carbapenem resistance Enterobacteriacea
> mDR P. aeruginosa
is the result of an increasing acquisition of resistance
genes worldwide.
The global alliance to optimize rational use of antimicrobials
for intra-abdominal infections (AgORA) recommended:
An optimal antimicrobial approach to treating IAI involves
a delicate balance between the optimization of empiric
therapy, which improves clinical outcomes, and the
reduction of excessive antimicrobial use that increases the
rate of emergence of antimicrobial-resistant strains.
early pathogen and antibiotic resistance gene identification
with rapid molecular tests may overcome those problems.
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ANTIBIOTIC REsIsTANCEgeT The beTTeR OF A SeRIOUS PRObLem by eARLy IDeNTIFICATION
ANTIbIOTIC ReSISTANCeS ARe INCReASINg
DNA purification
PCR set-up
Multiplex PCRwith array detection
1. Unyvero T1/B1 sample Tube for preparation of the patient sample, pre-filled with specific lysis reagents.
2. Unyvero T1/B1 sample Tube Cap seals the Unyvero Sample Tube and contains proteinase K and an internal control gene for quality control.
3. Unyvero T1 sample Pre-Treatment Tool is an aid for preparation and processing of sample materials.
4. Unyvero M1 Master Mix Tube containing reagents for DNA amplification.
1
4
THE UNIQUE UNYVERO IAI CARTRIDGE COVERs
PATHOGENs, ANTIBIOTIC REsIsTANCE MARkERs
AND TOXINs, AND COMBINEs
> DNA purification
> PCR set-up
> multiplex endpoint PCR
> detection by array hybridization
Therefore, the closed Unyvero Cartridge is equipped
with integrated reagent containers, a DNA purification
column, eight PCR chambers, and an according number
of detection arrays.
The cartridge is pre-filled with buffers for DNA clean-up,
reagents, and fluorescence-labeled primers for PCR ampli-
fication, and for array hybridization of the PCR product.3
2
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sOLUTION – UNYVERO IAIAPPLICATION
UNIQUE sOLUTION
TAILORED TO CLINICAL NEEDs
> Comprehensive, disease-specific test panels
run on an easy to operate platform, requiring
neither the special infrastructure of a laboratory
environment nor specially trained personnel.
> Translates a complex laboratory process into
an easy to use format. In addition to the un-
processed patient sample, only enzymes for
DNA amplification are required for the analytical
process.
> Generates complete diagnostic information
in 4 – 5 hours, without any further operator
interaction.
UNyveRO IAI INTRA-AbDOmINAL INFeCTION APPLICATION
10 11
UNyveRO SySTem AND APPLICATIONS
INTRA-ABDOMINAL INFECTION AssAY
> DETECTION OF COMPLICATED
INTRA-ABDOMINAL INFECTIONs
> ANY INFECTION FOCUs
> VARIOUs NATIVE sAMPLE TYPEs
> OVER 100 TARGETs
> 1 CARTRIDGE
3. sPEED
Delivers clinically relevant
answers in time
4 – 5 H
2. DIVERsITY
Enables testing of clinically
relevant sample types of
abdominal cavity
> BILE, PERITONEAL
FLUID AND AsCITEs
> TIssUE
> swABs, CATHETER
TIPs
> POsITIVE IAI FLUID
IN BLOOD CULTURE
BOTTLE
1. COVERAGE
A selection of pathogens,
toxins, and antibiotic
resistances based
on incidence, clinical
importance, and treatment
guidlines
> OVER 100 TARGETs
PReReqUISITeS
Caution – Investigational Device, Limited by Federal (or US) Law to Investigational Use. Not available for Sale in the United States.
UNYVERO sYsTEM – UNIVERsAL PLATFORMFeATURINg mANy DIFFeReNT APPLICATIONS
UNYVERO APPLICATION CARTRIDGEs
UNYVERO A50 ANALYzERUNYVERO C8 COCkPITUNYVERO L4 LYsATOR
GOLDEN HOUR
In the face of emerging multiresistant organisms, antimicrobioal
selection becomes more and more difficult, because many
different genetic mechanisms are involved. Therefore, testing a
broad spectrum with over 100 targets is required to get accurate
information for guiding adequate, targted therapy.
UNYVERO HELPs TO
> focus on the appropriate therapy
> choose the right antibiotic
> improve disease outcome
1 incl. S. saprophyticus, S. hominis, S. epidermidis, S. warneri, S. haemolyticus, S. capitis, S. lugdunensis
2 incl. E. faecalis, E. faecium, E. gallinarum, E. casseliflavus, E. avium, E. hirae, E. durans, E. raffinosus
3 incl. S. pneumoniae, S. constellatus, S. agalactiae, S. pyogenes, S. anginosus4 incl. A. hydrophila subsp. hydrophila, A. sobria, A. media, A. veronii, A. caviae5 incl. B. fragilis, B. ovatus, B. thetaiotaomicron, B. uniformis6 incl. B. fragilis, B. ovatus, B. heparinolyticus, B. pyogenes, B. thetaiotaomicron,
B. uniformis, B. vulgatus, Parabacteroides distasonis, P. bivia, P. buccae, P. disiens, P. intermedia, P. jejuni, P. melaninogenica, P. nigrescens, P. oris, P. denticola
7 incl. E. cloacae, E. asburiae, E. hormaechei8 incl. Klebsiella pneumoniae Cluster kp I + II, Alves et al., J Clin Microbiol, 44(10),
2006; 9 incl. Klebsiella variicola (Cluster kpIII; formerly K. pneumoniae, 2004 classified as its
own species10 incl. P. vulgaris, P. mirabilis, P. penneri, P. hauseri11 incl. A. baumannii, A. oleivorans, A. calcoaceticus, A. pittii
GROUP PATHOGEN
Universal bacteria
gram-positive bacteria
Coagulase negative staphylococci (CNS) 1
Enterococcus faecalis
Enterococcus spp. 2
Streptococcus spp. 3
Staphylococcus aureus
Anaerobic / facultative anaerobic bacteria
Aeromonas spp. 4
Bacteroides fragilis group 5
Bacteroides spp. / Prevotella spp. 6
Clostridium difficile
Clostridium perfringens
Finegoldia magna
Propionibacterium acnes
Enterobacteriaceae
Escherichia coli
Enterobacter cloacae complex 7
Klebsiella pneumoniae 8
Klebsiella oxytoca
Klebsiella variicola 9
Proteus spp. 10
GROUP PATHOGEN
Non-fermenting bacteriaAcinetobacter baumannii complex 11
Pseudomonas aeruginosa
Fungi
Candida spp.
Candida albicans
Candida glabrata
Candida tropicalis
Issatchenkia orientalis (Candida krusei)
GENE REsIsTANCE AGAINsT
mecA Oxacillin
mecC Oxacillin
vanA vancomycin
vanB vancomycin
aacA4 Aminoglycoside
ctx-m 3rd generation Cephalosporin
fosA3 Fosfomycin
mcr-1 Polypeptides/polymyxins
nimA Nitroimidazole
nimb Nitroimidazole
qnrA Fluoroquinolone
qnrb Fluoroquinolone
qnrS Fluoroquinolone
tetA Tetracycline
kpc Carbapenem
oxa-23 Carbapenem
oxa-24/40 Carbapenem
oxa-48 Carbapenem
oxa-58 Carbapenem
vim Carbapenem
imp Carbapenem
ndm Carbapenem
TOXIN MARkER TOXIN
tcdb Toxin b
stx1/2 Shiga Toxin
12 13
A COmPReheNSIve PANeL
COVERAGE - ANTIBIOTIC REsIsTANCEs, CLINICALLY RELEVANT PATHOGENs AND TOXINsINCLUDINg UNIveRSAL bACTeRIA PRImeR
THE COMPREHENsIVE UNYVERO INTRA-
ABDOMINAL INFECTION PANEL COVERs
MANY CLINICALLY RELEVANT PATHOGENs –
UNIVERsAL BACTERIA AND Candida sPP. –
AND IMPORTANT ANTIBIOTIC REsIsTANCE
MARkERs AND TOXINs
Caution – Investigational Device, Limited by Federal (or US) Law to Investigational Use. Not available for Sale in the United States.
14 15Caution – Investigational Device, Limited by Federal (or US) Law to Investigational Use. Not available for Sale in the United States.
wIDE RANGE OF NATIVE sAMPLE TYPEs OveRCOmINg ChALLeNgeS IN DIAgNOSINg IAI
Intra-abdominal infections include a wide range of clinical
pictures ranging from infections of the peritoneum,
pancreas and colon, requiring the testing of many different
and complex sample types, of various natures and
qualities.
The Unyvero IAI application improves the identification
of pathogens and resistance genes in acute bacterial
infections of the abdomen, and uniquely combines it with
the detection of toxin markers in one test. It facilitates
testing of ascites- and peritoneal fluid, pancreatic juice, as
well as bile. Additionally, it handles e.g. catheter tips and
drainage fluid, swabs tissue, and samples from positive
flagged blood cultures.
Compared to traditional IAI diagnostic measures, which
are laborious and time consuming based on growing
cultures and microscopy, multiple closely related non-
pathogenic organisms, prior medication, and the number
of involved pathogens no longer pose a problem.
NATIve SymPLe TyPeS
BILE
PERITONEAL
FLUID
sAMPLEs
FROM BLOOD
CULTURE
BOTTLEs
DRAINAGE
FLUID
swABs
TIssUE
BIOPsY
AsCITEs
BECAUsE OF ITs UNIVERsAL APPLICABILITY
THE CURETIs TECHNOLOGY CAN UsE A sINGLE
sAMPLE PREPARATION PROTOCOL FOR MANY
DIFFERENT sAMPLE TYPEs OF ANY CLINICAL
APPLICATION
One of Curetis‘ core competencies is the design of reliable
bio-assays in self-contained cartridges to enable sensitive
multiplex testing. The required multiplex grade is achieved
by combining the unmatched sample preparation and PCR
technology with a proprietary detection array. endpoint-
PCR can deliver higher multiplex grades than most other
amplification methods, and in that respect holds clear
advantages over e.g. real-time PCR.
The array was optimized for hybridization times to
only a few minutes compared to standard arrays. To
enhance specificity, the dissociation kinetics of the array
hybridization are automatically assessed. Additionally with
each patient sample, an artificial gene is simultaneously
processed as internal process control. The control verifies
all PCR steps, as well as the array hybridization.
> liquid> samples cultured in blood culture bottles> tissue ...
sample Types
Pathogen DNAspecific
Amplificationspecific Target Hybridization
Detection and specific Control
toxin B
Candida albicans
Clostridium difficile
sample Quality
Curetis‘ proprietary and universal sample preparation
technology prepares DNA from any native clinical sample
type without losing time needed for preculturing.
16 17
DIVERsITY – HIGHLY sPECIFIC MULTIPLEX PCRAND FAST ARRAy-bASeD DeTeCTION
Caution – Investigational Device, Limited by Federal (or US) Law to Investigational Use. Not available for Sale in the United States.
eSTAbLISheD TeChNOLOgIeS IN A New FORmAT
The Unyvero IAI Application combines all analytical
steps in one closed test format, thus reducing the work
involved for testing. Only a few simple manual steps allow
simultaneous detection of various microorganisms, toxins,
and antibioticresistance markers simultaneously in native
patient samples and samples from positive flagged blood
cultures within approximately five hours.
The intuitive simple workflow is consistent across all clinical applications and
sample types, thus drastically reducing invalid tests due to operator errors.
sTEP 1 TRANSFeR OF SAmPLeS AND LySIS
sTEP 2 ASSembLINg The UNyveRO CARTRIDge
sTEP 4 FOUR TO FIve hOURS ANALySIS PROCeSS
sTEP 3 SCANNINg AND INSeRTINg The UNyveRO CARTRIDge
~ 30 seconds:
2. After 30 minutes the Unyvero Sample Tube is removed from the Lysator. Then the IAI Cartridge is assembled with the Unyvero Sample Tube and Unyvero master mix Tube.
~ 20 seconds:
3. The Cartride is scanned and insert into the Unyvero Analyzer. Two cartridges per analyzer can be analyzed simultaneously.
It takes just a few minutes for subsequent result analysis:
4. The Unyvero analysis runs for four to five hours. The results are displayed on the screen or can be exported as a PDF.
~ 60 seconds:
1. The patient sample is transferred to the Unyvero Sample Tube, sealed in with the Unyvero Sample Tube Cap, and lysed for 30 minutes in the Unyvero Lysator.
working time
18 19
sPEED – UNYVERO sOLUTIONSImPLIFIeD wORKFLOw
UNyveRO wORKFLOw UNyveRO wORKFLOw
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20 21
UNYVERO sYsTEM – UNIVERsAL PLATFORMFeATURINg mANy DIFFeReNT APPLICATIONS
UNyveRO SySTem AND APPLICATIONS
THE UNYVERO sOLUTION FEATUREs A
»sAMPLE TO ANswER« APPROACH AND
CONsIsTs OF:
> the Unyvero L4 Lysator for sample lysis
> the application specific Unyvero Cartridge
> the Unyvero A50 Analyzer prozessing the
Unyvero Cartridge
> the Unyvero C8 Cockpit for intuitive user
interaction
The Unyvero System translates a complex laboratory
process into an easy-to-use format. The analytical
process requires merely the addition of the unprocessed
patient sample and enzymes for DNA amplification.
All other reagents are preloaded into a self-contained,
contamination-safe cartridge. After the patient sample
and the master mix are inserted into the cartridge, the
cartridge is loaded into the analyzer and processed fully
automatically. The Unyvero System generates complete
diagnostic information in 4 – 5 hours, without any further
operator interaction.
Caution – Investigational Device, Limited by Federal (or US) Law to Investigational Use. Not available for Sale in the United States.
UNYVEROAT A gLANCe
THE UNYVERO sOLUTION
> detects a broad panel of pathogens and antibiotic
resistances, as well as toxins from a single sample in
one run
> enables the testing of many clinically relevant native
samples
> delivers clinically relevant information in 4 – 5 hours,
helps with fact-based treatment decisions as early
as possible
> allows point of need testing
> provides high productivity by
- minimizing operator time to a few minutes with
full walk-away automation, based on a simple and
consistent workflow for any clinical application
- low implementation requirements and low total
ownership cost, as neither skilled molecular biology
staff nor special infrastructure is needed
- configurations that meet individual customer needs,
satisfying processing time requirements
- optimizing routine hospital workflow by sophisticated
information management
Caution – Investigational Device, Limited by Federal (or US) Law to Investigational Use. Not available for Sale in the United States.22 23
AT A gLANCe
Curetis gmbh | max-eyth-Str. 42 | 71088 holzgerlingen | germany
Tel.: +49 (0)7031 49195 10 | email: [email protected]
www.unyvero.com | www.curetis.com
0041
4 R
ev1.
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© C
uret
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mbh