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IBL/Amyloid-beta (1-42) CSF ELISA/RE59661/

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Kitsize12x8MethodELISAIncubationtime1x2h,1x1h,1x30min.Standardrange7,81-125pg/mLSpecimen/Volumes5µLCSFSubstrate/isotopeTMB450nmRegulatoryStatus:EU:CEDetailsfor: Amyloid-beta(1-42)CSFELISAImproveddiagnosisofAlzheimers´diseaseOverthelast15yearsmeasuringAmyloid–beta(1–42)peptidehasgainedacceptanceasatooltoaidinthediagnosisofAlzheimer´sdisease.Yet,clinicalsensitivityandspecificityusuallyislessthan85%.ThiscanbelargelyattributedtotheGaussiandistributionofAmyloid–betaproductioninthepopulation.Itleadstofalsepositivesinthegroupof"low"Abetaproducersandtofalsenegativesinthegroupof"high"Abetaproducers.NormalizingtheAmyloid–beta(1–42)valuestothemostabundantandstablyproducedAbeta(1–40)isoformovercomesthislimitationandsignificantlyimprovesthediagnosticvaluetowellabove90%.IBLInternationalhassetitsgoaltodevelophighqualityimmunoassaysforconvenientandaccuratemeasurementofAmyloid–beta(1–40)andAmyloid–beta(1–42)inCSFforoptimalratioDeterminationascanbeseenbyexcellentcrossreactivitydataofbothassays(Table1)PeptideAmyloid–beta(1–40)ELISAAmyloid–beta(1–42)ELISAAmyloid–beta(1–42)0,84%100%Amyloid–beta(1–40)100%0,003%Amyloid–beta(1-38)0,01%0,57%Amyloid–beta(2-40)1,29%0,02%Tabelle1Kreuzreaktivitäten(bestimmtnachDeshpande,SS(1996))BothAssaysshowexcellentinter–andintra–assayCVs(Table2)andinter–lotCVs(Table3)profilesduetointernalqualitycontrolstandards. Amyloid–beta(1–40)ELISAAmyloid–beta(1–42)ELISASampleNo.meanCVmeanCV[pg/mL][%][pg/mL][%]147321.85483.4299372.110233.0330804.58493.04104971.99513.15135062.810343.1Table2Intra–assayCV(n=20) Amyloid–beta(1–40)ELISAAmyloid–beta(1–42)ELISASampleNo.meanCVmeanCV[pg/mL][%][pg/mL][%]124185.41934.5238306.34767.63194074.16616.94131645.87284.7594052.78737.4Table3Inter–lotand–operatorCV(n=10,3lots,3-4operators)MethodcomparisonwithcommerciallyavailableAmyloid–beta(1–40)ELISA:R2=0.944Figure1:MethodcomparisonforthedetectionofAmyloid–beta(1–40)in119nativeCSFSamplesMethodcomparisonwithcommerciallyavailableAmyloid–beta(1–42)ELISA:R2=0.9492Figure2:MethodcomparisonforthedetectionofAmyloid–beta(1–42)in120nativeCSFSamplesToclinicallyvalidatetheassaysanexternalstudywasdoneatthe"KlinikundPoliklinikfürPsychiatrieundPsychotherapie,KlinikumrechtsderIsarderTechnischenUniversitätMünchen,München,Germany"withoverall83clinicallyknownsamples.TheratioofbothassayvaluesshowshighclinicalsensitivityandspecificityAmyloid–beta(1–42)⁄Amyloid–beta(1–40)ratiosuperiortoAmyloid–beta(1–42)alone Ratio:Amyloid–beta(1–42)⁄Amyloid–beta(1–40)ADcontrolDiagnosisAD391control439SimilarresultswereobtainedbyProf.Dr.med.PiotrLewczuk,LabforClinicalNeuRochemistryandNeurochemicalDementiaDiagnostics,UniversitätsklinikumErlangen,DepartmentofPsychiatryandPsychotherapy,Erlangen,Germany.(tobepublishedsoon)ExcerptfromtheInstructionsforUseIn2010,thenumberofdementiapatientsworldwidewasestimatedat36million.Assuminganongoinglackofsufficientpreventiveandcurativetreatments,thisisexpectedtodoubleevery20years.Alzheimer’sDiseaseaccountsforroughly60-70%ofalldementiacases.Bothprevalenceandincidenceincreasewithage.Prevalenceisaround1%inthoseaged65-69,andmorethan30%inthoseaged90orolder.ThedevelopmentoftheDiseaseischaracterizedbythreestages,asdefinedbytheUSNationalInstituteonAgingworkgroups.ApreclinicalstageofAlzheimer’sDisease,themildcognitiveimpairment(MCI)stageduetoAD,andthedementiastageduetoAD[9-11].Amyloidosisoccursasearlyasthepreclinicalstage.ThefirstcognitivedeficitscanmanifestthemselvesinMCIstage,whileinthedementiastagepatientsareunabletodoanyworkordailychores.Theconcentrationofamyloid-beta(1-42)isthereforerecognizedasausefulbioMarker(incombinationwithotherbiomarkerssuchasTauandPhospho-Tau)indiagnosingAlzheimer’sDisease.Moreover,anumberofindependentstudies(forexample[3-5])showedtheratioofamyloid-beta(1-42)toamyloid-beta(1-40)tobeasuperiordiagnosticmarkerforAlzheimer’sDisease.ForconcretedatapleaseconsulttheInstructionforUseinthedownloadboxontherightside.

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