system workflow urinary tract infection (uti) cartridge · working time 60 seconds working time 20...

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Working time 60 seconds Working time 20 seconds Working time 30 seconds Transfer patient sample to Unyvero Sample Tube Scanning and inserting the Unyvero Cartridge in the A50 (Max. 2 cartridges simultaneously) Results displayed in Cockpit – PDF export 30 minutes lysis in Lysator Assembling Unyvero Cartridge with Sample and Master Mix Tube Panel Overview System Workflow Unyvero L4 Lysator Unyvero C8 Cockpit Unyvero A50 Analyzer A C B D Curetis GmbH | Max-Eyth-Str. 42 | 71088 Holzgerlingen | Germany Tel.: +49 (0)7031 49195 10 | Email: [email protected] | Unyvero is designed to expand with your growing needs 00299 Rev 7.0 © Curetis GmbH Caution – Investigational Device. Limited by Federal US Law to investigational Use. Not available for Sale in the United States. www.curetis.com Blood Culture – BCU Hospitalized Pneumonia – HPN Implant & Tissue Infection – ITI Intra-Abdominal Infection – IAI Urinary Tract Infection – UTI Urinary Tract Infection (UTI) Cartridge Staphylococcus aureus Coagulase negative staphylococci Staphylococcus saprophyticus Streptococcus agalactiae Enterococcus spp. Enterococcus faecalis Enterococcus faecium Corynebacterium urealyticum Gram-positive bacteria Enterobacteriaceae Citrobacter freundii / koseri Enterobacter aerogenes Enterobacter cloacae complex Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Klebsiella variicola Proteus spp. Providencia spp. Enterobacteriaceae Candida spp. Candida albicans Candida auris Candida glabrata Fungi Gene Resistance Acinetobacter baumannii complex Pseudomonas aeruginosa Non-fermenting bacteria Detection of prokaryotic genetic sequence Universal Bacteria Bacteroides spp. / Prevotella spp. Anaerobic bacteria mecA vanA vanB ctx-M imp kpc ndm oxa-23 oxa-24/40 oxa-48 vim mcr-1 qnrB qnrS sul1 3rd generation Cephalosporins Glycopeptides Fluoroquinolones Sulfonamide Carbapenem Polypeptides / polymyxins Oxacillin Urine (mid-stream, suprapubic, fresh catheter) and tissue. Sample Types *88 Pathogens, 15 Resistance Genes 4 to 5 hour analysis process 103*

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Working time 60 seconds

Working time 20 seconds

Working time 30 seconds

Transfer patient sample to Unyvero Sample Tube

Scanning and inserting the Unyvero Cartridge in the A50

(Max. 2 cartridges simultaneously)

Results displayed in Cockpit – PDF export

30 minutes lysis in Lysator

Assembling Unyvero Cartridge with Sample and Master Mix Tube

Panel Overview

System WorkflowUnyvero L4 Lysator Unyvero C8 Cockpit Unyvero A50 Analyzer

A

C

B

D

Curetis GmbH | Max-Eyth-Str. 42 | 71088 Holzgerlingen | Germany

Tel.: +49 (0)7031 49195 10 | Email: [email protected] |

Unyvero is designed to expand with your growing needs

00299 Rev 7.0 © Curetis GmbH

Caution – Investigational Device. Limited by Federal US Law to investigational Use. Not available for Sale in the United States.

www.curetis.com

Blood Culture – BCU

Hospitalized Pneumonia – HPN

Implant & Tissue Infection – ITI

Intra-Abdominal Infection – IAI

Urinary Tract Infection – UTI

Urinary Tract Infection (UTI) Cartridge

Staphylococcus aureus

Coagulase negative staphylococci

Staphylococcus saprophyticus

Streptococcus agalactiae

Enterococcus spp.

Enterococcus faecalis

Enterococcus faecium

Corynebacterium urealyticum

Gram-positive bacteria

Enterobacteriaceae

Citrobacter freundii / koseri

Enterobacter aerogenes

Enterobacter cloacae complex

Escherichia coli

Klebsiella oxytoca

Klebsiella pneumoniae

Klebsiella variicola

Proteus spp.

Providencia spp.

Enterobacteriaceae

Candida spp.

Candida albicans

Candida auris

Candida glabrata

Fungi

GeneResistance

Acinetobacter baumannii complex

Pseudomonas aeruginosa

Non-fermenting bacteria

Detection of prokaryotic genetic sequence

Universal Bacteria

Bacteroides spp. / Prevotella spp.

Anaerobic bacteria

mecA

vanA vanB

ctx-M

imp kpc ndm oxa-23 oxa-24/40 oxa-48 vim

mcr-1

qnrB qnrS

sul1

3rd generation Cephalosporins

Glycopeptides

Fluoroquinolones

Sulfonamide

Carbapenem

Polypeptides / polymyxins

Oxacillin

Urine (mid-stream, suprapubic, fresh catheter) and tissue.

Sample Types

*88 Pathogens, 15 Resistance Genes

4 to 5 hour analysis process

103*

Staphylococcus aureus

Coagulase negative staphylococci

Streptococcus spp.

Streptococcus agalactiae

Streptococcus pneumoniae

Streptococcus pyogenes / dysgalactiae

Enterococcus spp.

Enterococcus faecalis

Listeria monocytogenes

Gram-positive bacteria

Staphylococcus aureus

Coagulase negative staphylococci

Streptococcus spp.

Streptococcus agalactiae

Streptococcus pneumoniae

Streptococcus pyogenes /dysgalactiae

Granulicatella adiacens

Abiotrophia defectiva

Enterococcus spp.

Enterococcus faecalis

Gram-positive bacteria

Coagulase negative staphylococci

Enterococcus faecalis

Enterococcus spp.

Streptococcus spp.

Staphylococcus aureus

Gram-positive bacteria

Staphylococcus aureus

Streptococcus pneumoniae

Gram-positive bacteria

Citrobacter freundii / koseri

Escherichia coli

Enterobacter cloacae complex

Enterobacter aerogenes

Klebsiella oxytoca

Klebsiella pneumoniae

Klebsiella variicola

Proteus spp.

Serratia marcescens

Enterobacteriaceae

Corynebacterium spp.

Citrobacter freundii / koseri

Escherichia coli

Enterobacter cloacae complex

Enterobacter aerogenes

Klebsiella pneumoniae

Klebsiella oxytoca

Klebsiella variicola

Proteus spp.

Detection of prokaryotic genetic sequence

Citrobacter freundii

Escherichia coli

Enterobacter cloacae complex

Enterobacter aerogenes

Proteus spp.

Klebsiella pneumoniae

Klebsiella oxytoca

Klebsiella variicola

Serratia marcescens

Morganella morganii

Corynebacteriaceae

Enterobacteriaceae

Universal Bacteria

Enterobacteriaceae

Aspergillus spp.

Candida spp.

Candida albicans

Candida dubliniensis

Candida glabrata

I. orientalis (C. krusei)

Candida parapsilosis

Candida tropicalis

Candida spp.

Candida albicans

Candida glabrata

I.orientalis (C.krusei)

Candida tropicalis

Candida spp.

Candida albicans

Candida glabrata

Candida tropicalis

Issatchenkia orientalis (Candida krusei)

Fungi Fungi

Fungi

GeneResistance

aac(6´)/aph(2´´) aacA4

ermA

mecA mecC

vanA vanB

ctx-M

imp kpc ndm oxa-23 oxa-24/40 oxa-48 oxa-58 vim

3rd generation Cephalosporins

Carbapenem

Macrolide/ Lincosamide

Oxacillin

Glycopeptides

Aminoglycoside

Gene

Gene

Resistance

Resistance

GeneResistance

Acinetobacter baumannii complex

Pseudomonas aeruginosa

Stenotrophomonas maltophiliaAcinetobacter baumannii complex

Pseudomonas aeruginosa

Moraxella catarrhalis

Pseudomonas aeruginosa

Acinetobacter baumannii complex

Stenotrophomonas maltophilia

Legionella pneumophilaNon-fermenting bacteriaNon-fermenting bacteria

Non-fermenting bacteria

Detection of prokaryotic genetic sequence

Universal Bacteria

Haemophilus influenzae

Neisseria meningitidis

Corynebacterium spp.

Acinetobacter baumannii complex

Pseudomonas aeruginosa

Detection of prokaryotic genetic sequence

Escherichia coli

Enterobacter aerogenes

Enterobacter cloacae complex

Klebsiella pneumoniae

Klebsiella oxytoca

Klebsiella variicola

Proteus spp.Other Gram-negativebacteria

Corynebacteriaceae

Non-fermentingbacteria

Universal Bacteria

Enterobacteriaceae

Mycobacterium spp.

Mycobacteriaceae

Propionibacterium acnes

Propionibacterium acnes

Finegoldia magna

Bacteroides fragilis group

Aeromonas spp.

Bacteroides fragilis group

Bacteroides spp. / Prevotella spp.

Clostridium difficile

Clostridium perfringens

Finegoldia magna

Propionibacterium acnes

Pneumocystis jirovecii

Haemophilus influenzae

Mycoplasma pneumoniae

Chlamydophila pneumoniae

Anaerobic bacteriaAnaerobic bacteria

Anaerobic/facultativeanaerobic bacteria

Others/Fungi

Blood Culture (BCU) Cartridge Hospitalized Pneumonia (HPN) Cartridge Implant & Tissue Infection (ITI) Cartridge Intra-Abdominal Infection (IAI) Cartridge

ermB

mecA mecC

tem shv

ctx-M

imp kpc ndm oxa-23 oxa-24/40 oxa-48 oxa-58 vim

sul1

gyrA83 gyrA87

Oxacillin

Penicillin

Carbapenem

Sulfonamide

Fluoroquinolone

3rd generation Cephalosporins

Macrolide/Lincosamide

Oxacillin

Aminoglycoside

Carbapenem

Glycopeptides

3rd generation Cephalosporins

Macrolide/Lincosamide

ermA ermC

aac(6´)/aph(2´´) aacA4

mecA mecC

vanA vanB

ctx-M

imp kpc ndm oxa-23 oxa-24/40 oxa-48 oxa-58 vim

MarkerToxin

Shiga Toxin stx1/2

Toxin B tcdB

mecA mecC

vanA vanB

aacA4

ctx-M

fosA3

mcr-1

nimA nimB

qnrA qnrB qnrS

tetA

imp kpc ndm oxa-23 oxa-24/40 oxa-48 oxa-58 vim

Glycopeptides

Aminoglycoside

Tetracycline

Carbapenem

Fosfomycin

Polypeptides/polymyxins

Nitroimidazole

Fluoroquinolone

3rd generation Cephalosporins

Oxacillin

Ascites and peritoneal fluid, pancreatic juice, bile, tissue, puncture fluid,swabs, catheter/drainage tips, and samples from positive blood culturebottles that have been inoculated with ascites/puncture fluid.

Sonication fluids, swabs, tissue, pus, aspirate/exudate, bone fragments, etc.Sputum, bronchoalveolar lavage, tracheal aspiratesPositively flagged blood cultures

Sample Types Sample Types Sample Types Sample Types

*105 Pathogens, 3 Toxins, 22 Resistance Genes*85 Pathogens, 17 Resistance Genes*86 Pathogens, 17 Resistance Genes *29 Pathogens, 19 Resistance Genes

103* 102* 130*48*