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SepsiTestTM CE IVDDetection of >345 bacteria and yeasts

Sepsis PCR Diagnostics

SepsiTest™ Specifications

>345Microbes Detectable HighClinicalUtility

Bacteriaand YeastsPCRs

RapidResults(4h)

2x1mlEDTA/ CitrateBlood

NoExtra Instrumentation

OpenSystem

CEIVDMarked (98/79EC)

Molecular Sepsis Diagnostics

Sepsis is an inflammatory response to infectionby bacteria or fungi, the estimated incidence ofsepsis reaching approx. 0.3% [1]. The mortalityofsepsisor,evenmore,septicshockisstillveryhigh (40% [1]). This places sepsis/septic shocktoamajorcauseofdeath in the ICUworldwide.Accordingly, there is an urgent need to reducetheuncertaintyandtimeof today’sbloodculturediagnosisforpathogenstoreducemorbidityandmortalityofpatients.Generally,thepositivityrateofbloodculturingisonly15to25%anditstime-to-first-results8to48hours[2],forslowgrowingbacteriaandfungievenlonger.

Molecularbiologicalmethods,particularlypolymer-asechainreaction(PCR),aregenerallyacceptedasapromisingmeansofculture-flankingmethodsforearlysepsisdiagnosis,mostlybecauseof itsrapidityoftime-to-resultandindependenceofthegrowth of strains. SepsiTest™ is a direct bloodPCRtest,designed for theneedsof fast routinesepsisdiagnosis.

Broad-Spectrum Diagnostics

SepsiTest™ is a broad-spectrum test detect-ingmore than345species,among themmostlypathogenic bacteria and yeasts (see last page).IncontrasttootherPCRsystems,coveringonlyalimitednumberofstrains,SepsiTest™ isthefirstkit worldwide enabling the detection and identi-fication of essentially any bacterial or yeastpathogen in whole blood. The high specificityandsensitivityofpathogendetection isobtainedbyMolzym’stechnologyofhumanDNAremoval.Becauseofitsbroad-spectrumdetectioncapability,thetestisparticularlyusefulalsoforlessfrequentlyoccurringbutproblematicinfectiousagents,includ-ing Neisseria, Haemophilus, Gemella, Proteus vulgaris, andothers.

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12 123

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12 123

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2x 1 ml Blood Sample

DNA Extraction

PCR/Gel Electrophoresis

DNA Sequencing

Homology Search

Therapy Monitoring

SepsiTest™ detects pathogens irrespective oftheadministrationofantibioticsandtheculturabil-ityofstrains.WhileexcludingfreebacterialDNAandhumanDNA,SepsiTest™specificallydetectspathogen DNA from intact live or dead cells.ThismakesSepsiTest™averypowerfultestforpathogendetectionandtherapymonitoring,includ-inghematologicalpatients.

Clinical UtilitySepsiTest™ is for whole blood analysis with atime to positive-negative results within only 4hours.Identificationofpathogensisperformedbysequencinganalysisofampliconsobtained frompositive PCR tests. Due to Molzym’s propriet-arytechnologyofreagentDNAdecontamination,SepsiTest™preventsfalsepositiveresults.

Inclinicalstudies,SepsiTest™hasprovenclinicalrelevanceby itshighdiagnosticsensitivity com-paredtobloodculture(e.g.87%,187patients[3,4])andhighanalyticalsensitivity(e.g.20to40cfu/ml,S. aureus [5]).Sampleanalysis bySepsiTest™isperformedinduplicateforreasonsofincreasingthesensitivityandreliabilityofpathogendetection.SepsiTest™reagentsareassembledinportions,thereby minimising the risk of contamination ofbuffers and reagents. SepsiTest™ is an opensystemandcanberunonstandardlabequipment(anyPCRcycler)anddoesnotrequireinvestmentsincostlyplatformsystems.

References[1]http://www.sepsis-gesellschaft.de/[2]Hunfeldetal. (2008)MolekularbiologischerErregernachweisbeiPatientenmitSepsis.DerAnaesthesist4:326-337[3]Disquéetal.(2008)PCRdetectionofsepsis-inducingpathogensinbloodusingSepsiTest™Blood.Int.J.Med.Microbiol.298:DVP06[4]C.Disqué,personalcommunication[5]Mühletal.(2008)ActivityandDNAcontaminationofcommercialpolymerasechainreactionreagentsfortheuniversal16SrDNAreal-time polymerase chain reaction detection of bacterial pathogens inblood.Diag.Microbiol.Infect.Dis.(inpress):doi:10.1016/j.diagmicrob-io.2008.07.011

Pathogen:x yes no

SpeciesIdentification: S. aureus..................

Product Content Order No.

SepsiTest™CEIVDPathogenDetection

12BloodSampleTests* A-020-024

24BloodSampleTests* A-020-048 * in duplicate

SepsiTest™ isatrademarkof

Sepsis-causing strains among the >345 microorganisms detectable bySepsiTest™ *

Molzym GmbH & Co. KGMary-Astell-Str.10D-28359Bremen,GermanyTel.:+49(0)421-696162-0 order@molzym.comFax:+49(0)421-696162-11 www.sepsitest.com

Order information:

Bacteria YeastsGram-negative Species Gram-negative Species Gram-positive Species

Achromobacter 1 Methylobacterium 1 Actinomyces 1 Candida albicansAcinetobacter 5 Moraxella 2 Aerococcus 1 Candida glabrataActinobacillus 2 Morganella 1 Arthrobacter 1 Candida kruseiAeromonas 7 Neisseria 2 Bacillus 20 Candida parapsilosisAggregatibacter 3 Ochrobactrum 2 Clostridium 2 Candida tropicalisAlcaligenes 2 Pantoea 2 Corynebacterium 2 Cryptococcus neoformansAlteromonas 1 Pasteurella 1 Enterococcus 7Anaplasma 1 Photobacterium 1 Erysipelothrix 1Bacteroides 2 Plesiomonas 1 Exiguobacterium 1Bifidobacterium 9 Proteus 2 Geobacillus 2Brevibacterium 1 Pseudomonas 18 Frankia 1Brevundimonas 2 Rahnella 1 Kocuria 1Burkholderia 6 Ralstonia 3 Lactobacillus 28Butyrivibrio 1 Riemerella 1 Lactococcus 3Campylobacter 2 Salmonella 2 Leifsonia 1Chlamydophila 2 Serratia 4 Leuconostoc 2Citrobacter 1 Shewanella 3 Microbacterium 2Comamonas 1 Sphingomonas 1 Micrococcus 1Delftia 1 Stenotrophomonas 1 Mycobacterium 10Ehrlichia 2 Vibrio 7 Nocardia 3Enterobacter 6 Xanthomonas 1 Paenibacillus 3Escherichia 1 Yersinia 2 Pediococcus 2Flavobacterium 3 Propionibacterium 1Haemophilus 4 Rhodococcus 3Hafnia 1 Staphylococcus 19Helicobacter 1 Streptococcus 6Klebsiella 2 Streptomyces 2Leptospira 5 Weissella 2Megasphaera 1 Sum: 114 Sum: 128

*thecompletelistofspeciesisavailableonrequest