Xpert-Flu-RSV-XC-ENGLISH-Package-Insert-301-2904-R

301-2904,Rev.AAugust2014Xpert®Flu/RSVXCIVDInVitroDiagnosticMedicalDeviceGXFLU/RSV-CE-10Trademark,PatentsandCopyrightStatementsCepheid®,theCepheidlogo,GeneXpert®andXpert®aretrademarksofCepheid.Windows®isatrademarkofMicrosoftCorporation.ArmoredRNA®isatrademarkofAsuragen,Inc.ZeptoMetrix™isatrademarkofZeptoMetrixCorporation.BD®isatrademarkofBecton,DickinsonandCompany.RemelM4®,RemelM4RT®andRemelM5®aretrademarksofThermoScientific.Zicam®isatrademarkofMatrixxInitiatives,Inc.Tamiflu®isatrademarkofGenentechUSA.FluMist®isaregisteredtrademarkofMedImmune,LLC.ArmoredRNA®isapatentedtechnologyjointlydevelopedbyAsuragenInc.andCenetronDiagnostics,LLCunderU.S.PatentNos.5,677,124,5,919,625,5,939,262andotherpatentspending.Thepurchaseofthisproductincludesalimited,non-transferablelicenseunderU.S.PatentsNos.6,787,338;6,503,720and6,303,305,andclaims9,10,11,56,76,80and107ofU.S.PatentNo.6,174,670,andcorrespondingclaimsinpatentsandpatentapplicationsoutsidetheUnitedStates,ownedbytheUniversityofUtahResearchFoundationandlicensedtoIdahoTechnology,Inc.,touseonlythisamountofproductandonlyinaninstrumentmarketed,distributed,sold,leasedorotherwisetransferredusingaCepheidtrademark.Norightisconveyed,expressly,byimplicationorestoppel,underanyotherpatentorpatentclaimsownedbytheUniversityofUtahResearchFoundationorIdahoTechnology,Inc.Withoutlimitingtheforegoing,noright,titleorlicenseishereingrantedwithrespecttotheusesthatareproprietarytoIdahoTechnologyortheUniversityofUtahResearchFoundationoffluorescencedoublestrandednucleicacidbindingdyes,specificallyincludingbutnotlimitedtoSYBR®GreenI,LCGreen®I,orLCGreen®Plus.THEPURCHASEOFTHISPRODUCTCONVEYSTOTHEBUYERTHENON-TRANSFERABLERIGHTTOUSEITINACCORDANCEWITHTHISPACKAGEINSERT.NOOTHERRIGHTSARECONVEYEDEXPRESSLY,BYIMPLICATIONORBYESTOPPEL.FURTHERMORE,NORIGHTSFORRESALEARECONFERREDWITHTHEPURCHASEOFTHISPRODUCT.Copyright©Cepheid2014.Allrightsreserved.CepheidCepheidEuropeSAS904CaribbeanDriveViraSolelhSunnyvale,CA9408981470Maurens-ScopontUSAFrance®Flu/RSVXC1301-2904,Rev.AAugust2014Xpert®Flu/RSVXCForInVitroDiagnosticUseOnly.1ProprietaryNameXpert®Flu/RSVXC2CommonorUsualNameXpertFlu/RSVXCAssay3IntendedUseTheCepheidXpertFlu/RSVXCAssay,performedontheGeneXpertInstrumentSystems,isanautomated,multiplexreal-time,reversetranscriptasepolymerasechainreaction(RT-PCR)assayintendedfortheinvitroqualitativedetectionanddifferentiationofinfluenzaA,influenzaB,andrespiratorysyncytialvirus(RSV)viralRNA.TheXpertFlu/RSVXCAssayusesnasopharyngealswabandnasalaspirate/washspecimenscollectedfrompatientswithsignsandsymptomsofrespiratoryinfection.TheXpertFlu/RSVXCAssayisintendedasanaidinthediagnosisofinfluenzaandrespiratorysyncytialvirusinfectionsinconjunctionwithclinicalandepidemiologicalriskfactors.Negativeresultsdonotprecludeinfluenzavirusorrespiratorysyncytialvirusinfectionandshouldnotbeusedasthesolebasisfortreatmentorotherpatientmanagementdecisions.PerformancecharacteristicsforinfluenzaAwereestablishedduringthe2013–2014influenzaseason.WhenothernovelinfluenzaAvirusesareemerging,performancecharacteristicsmayvary.IfinfectionwithanovelinfluenzaAvirusissuspectedbasedoncurrentclinicalandepidemiologicalscreeningcriteriarecommendedbypublichealthauthorities,specimensshouldbecollectedwithappropriateinfectioncontrolprecautionsfornovelvirulentinfluenzavirusesandsenttostateorlocalhealthdepartmentsfortesting.ViralcultureshouldnotbeattemptedinthesecasesunlessaBSL3+facilityisavailabletoreceiveandculturespecimens.4SummaryandExplanationInfluenza,ortheflu,isacontagiousviralinfectionoftherespiratorytract.Transmissionofinfluenzaisprimarilyairborne(i.e.,coughingorsneezing);thepeakoftransmissionusuallyoccursinthewintermonths.Symptomscommonlyincludefever,chills,headache,muscleaches,malaise,cough,andsinuscongestion.Gastrointestinalsymptoms(i.e.,nausea,vomiting,ordiarrhea)mayalsooccur,primarilyinchildren,butarelesscommoninadults.Symptomsgenerallyappearwithintwodaysofexposuretoaninfectedperson.Pneumoniamaydevelopasacomplicationofinfluenzainfection,causingincreasedmorbidityandmortalityinpediatric,elderly,andimmunocompromisedpopulations.1,2InfluenzavirusesareclassifiedintotypesA,B,andC,theformertwoofwhichcausemosthumaninfections.InfluenzaAisthemostcommontypeofinfluenzavirusinhumans,andisgenerallyresponsibleforseasonalfluepidemicsandoccasionallyforpandemics.InfluenzaAvirusescanalsoinfectanimalssuchasbirds,pigs,andhorses.InfectionswithinfluenzaBvirusaregenerallyrestrictedtohumansandarelessfrequentcausesofepidemics.InfluenzaAvirusesarefurtherdividedintosubtypesonthebasisoftwosurfaceproteins:hemagglutinin(H)andneuraminidase(N).SeasonalfluisnormallycausedbysubtypesH1,H2,H3,andN1andN2.Inadditiontoseasonalflu,anovelH1N1strainwasidentifiedinhumansintheUnitedStatesinearly2009.3Respiratorysyncytialvirus(RSV),amemberoftheParamyxoviridaefamilyconsistingoftwostrains(subgroupsAandB),isalsothecauseofacontagiousdiseasethatafflictsprimarilyinfantsandtheelderlywhoareimmunocompromised,e.g.,patientswithchroniclungorheartdiseaseorundergoingtreatm