system workfl ow urinary tract infection (uti) cartridge

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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 8.0 © 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 Klebsiella aerogenes (E. aerogenes) Enterobacter cloacae complex Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Klebsiella variicola Proteus spp. Providencia spp. Enterobacteriales 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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Page 1: System Workfl ow Urinary Tract Infection (UTI) Cartridge

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 Workfl owUnyvero L4 Lysator Unyvero C8 Cockpit Unyvero A50 AnalyzerUnyvero L4 Lysator Unyvero C8 Cockpit Unyvero A50 Analyzer

A

C

B

D

Curetis GmbH | Max-Eyth-Str. 42 | 71088 Holzgerlingen | GermanyTel.: +49 (0)7031 49195 10 | Email: [email protected] |

Unyvero is designed to expand with your growing needs

00299 Rev 8.0 © 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 aureusCoagulase negative staphylococciStaphylococcus saprophyticusStreptococcus agalactiaeEnterococcus spp.Enterococcus faecalisEnterococcus faeciumCorynebacterium urealyticum

Gram-positive bacteria

EnterobacteriaceaeCitrobacter freundii / koseriKlebsiella aerogenes (E. aerogenes)Enterobacter cloacae complexEscherichia coliKlebsiella oxytocaKlebsiella pneumoniaeKlebsiella variicolaProteus spp.Providencia spp.

Enterobacteriales

Candida spp.Candida albicansCandida auris Candida glabrata

Fungi

GeneResistance

Acinetobacter baumannii complexPseudomonas aeruginosa

Non-fermenting bacteria

Detection of prokaryotic genetic sequence

Universal Bacteria

Bacteroides spp. / Prevotella spp.

Anaerobic bacteria

mecA

vanAvanB

ctx-M

impkpcndmoxa-23oxa-24/40oxa-48vim

mcr-1

qnrBqnrS

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*

Page 2: System Workfl ow Urinary Tract Infection (UTI) Cartridge

Staphylococcus aureusCoagulase negative staphylococciStreptococcus spp. Streptococcus agalactiaeStreptococcus pneumoniaeStreptococcus pyogenes / dysgalactiaeEnterococcus spp.Enterococcus faecalisListeria monocytogenes

Gram-positive bacteria

Staphylococcus aureusCoagulase negative staphylococci Streptococcus spp. Streptococcus agalactiaeStreptococcus pneumoniaeStreptococcus pyogenes /dysgalactiaeGranulicatella adiacensAbiotrophia defectivaEnterococcus spp. Enterococcus faecalis

Gram-positive bacteria

Coagulase negative staphylococciEnterococcus faecalisEnterococcus spp.Streptococcus spp.Staphylococcus aureus

Gram-positive bacteria

Staphylococcus aureusStreptococcus pneumoniae

Gram-positive bacteria

Citrobacter freundii / koseriEscherichia coliEnterobacter cloacae complexKlebsiella aerogenes (E. aerogenes)Klebsiella oxytocaKlebsiella pneumoniaeKlebsiella variicolaProteus spp. Serratia marcescens

Enterobacteriales

Corynebacterium spp.

Citrobacter freundii / koseriEscherichia coliEnterobacter cloacae complex Klebsiella aerogenes (E. aerogenes)Klebsiella pneumoniaeKlebsiella oxytocaKlebsiella variicolaProteus spp.

Detection of prokaryotic genetic sequence

Citrobacter freundiiEscherichia coliEnterobacter cloacae complexKlebsiella aerogenes (E. aerogenes)Proteus spp.Klebsiella pneumoniaeKlebsiella oxytocaKlebsiella variicolaSerratia marcescensMorganella morganii

Corynebacteriaceae

Enterobacteriales

Universal Bacteria

Enterobacteriales

Aspergillus spp.Candida spp.Candida albicansCandida dubliniensisCandida glabrataI. orientalis (C. krusei)Candida parapsilosisCandida tropicalis

Candida spp.Candida albicansCandida glabrataI.orientalis (C.krusei)Candida tropicalis

Candida spp.Candida albicansCandida glabrataCandida tropicalisIssatchenkia 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 complexPseudomonas aeruginosaStenotrophomonas maltophilia

Acinetobacter baumannii complexPseudomonas aeruginosa

Moraxella catarrhalisPseudomonas aeruginosaAcinetobacter baumannii complexStenotrophomonas maltophiliaLegionella pneumophilaNon-fermenting bacteria

Non-fermenting bacteria

Non-fermenting bacteria

Detection of prokaryotic genetic sequence

Universal Bacteria

Haemophilus influenzaeNeisseria meningitidis

Corynebacterium spp.

Acinetobacter baumannii complexPseudomonas aeruginosa

Detection of prokaryotic genetic sequence

Escherichia coliKlebsiella aerogenes (E. aerogenes) Enterobacter cloacae complex Klebsiella pneumoniae Klebsiella oxytocaKlebsiella variicola Proteus spp.Other Gram-negative

bacteria

Corynebacteriaceae

Non-fermentingbacteria

Universal Bacteria

Enterobacteriales

Mycobacterium spp.

Mycobacteriaceae

Cutibacterium acnes (P. acnes)

Cutibacterium acnes (P. acnes)

Finegoldia magna

Bacteroides fragilis group

Aeromonas spp.

Bacteroides fragilis group

Bacteroides spp. / Prevotella spp.

Clostridioides difficile (C. difficile)

Clostridium perfringens

Finegoldia magna

Cutibacterium acnes (P. acnes)

Pneumocystis jirovecii

Haemophilus influenzae

Mycoplasma pneumoniae

Chlamydia (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 mecCtem shv

ctx-M

imp kpc ndm oxa-23 oxa-24/40 oxa-48 oxa-58 vimsul1gyrA83 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

FosfomycinPolypeptides/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*