IBLcomplementsits
dementiaMarkerrange

Alongwithamyloid-βplaques,theformationoftaufibrilswithinthenervecells,particularlyinthecerebralcortexandnotablyinthelimbiclobe,isanotherpathologicalhallmarkofAlzheimer"sdisease.TheconcentrationofTauintheCSFisamarkerofneuronalcelldeath.InAlzheimer"sdisease,however,itincreasesonlyatalaterstageofthediseasewhenthepatientalreadydisplayssignificantcognitiveimpairment.Therefore,thedeterminationoftotaltauinCSFisimportantforthediagnosisofAlzheimer"sdiseaseinadditiontothedeterminationofamyloidβ-peptides.However,increasedtaulevelsarefoundinotherneurodegenerativediseasesaswell.Thesedisordersaregenerallyreferredtoastauopathiesandinclude,interalia,frontotemporallobardegeneration(FTLD),Pick"sdiseaseandcorticobasaldegeneration(CBD).TaulevelsaremarkedlyelevatedinCreutzfeldt-Jakobdisease.

ThehTAUtotalELISAfromAnalytikJena,manfuacturedbyAJRoboscreenanddistributedbyIBLInternational,wasoptimizedsothatitcanbeprocessedinparallelwiththeIBLAmyloid-βCSFELISA.

Asthegraphbelowshows,thehTAUtotalELISAfromAnalytikJena,manufacturedbyAJRoboscreenanddistributedbyIBLInternational,correlatessuperblywiththeINNOTEST^®hTAU.

ClinicalvalidationoftheTAUtotalELISAwasperformedattheUniversityHospitalErlangenintheCSFLaboftheDepartmentofPsychiatryandPsychotherapy(Prof.Dr.Lewczuk).TaulevelsinthecerebrospinalfluidofpatientswithAlzheimer"sdiseaseandmildcognitiveimpairment(collectivelyAD(n=72)andcontrolsubjects(n=41))showhighlysignificantdifferencesbetweenthegroups.

Naturally,theTAUtotalELISA,justlikeourAmyloid-βCSFELISAs,displaysanexcellentanalyticalprecisionwithaninter-assayvarianceof<5% (Table 1), intra-assay variance of <5% (Table 2) and inter- LOT and operator variance of <6% (Table 3).

AdditionaladvantagesofourELISAare:

• Dayassay(4hours)
• SameprotocolasAmyloid-βCSFELISAs
• Kitcontrols
• Itlendsitselftoautomation

GeneralInformation

In2010,thenumberofdementiapatientsworldwidewasestimatedat36million.Assuminganongoinglackofsufficientpreventiveandcurativetreatments,thisisexpectedtodoubleevery20years.Alzheimer’sDiseaseaccountsforroughly60‐70%ofalldementiacases.Bothprevalenceandincidenceincreasewithage.Prevalenceisaround1%
inthoseaged65‐69,andmorethan30%inthoseaged90orolder.

ThefirstcaseofAlzheimer’sDiseasewasdefinedandreportedin1907byGermanscientistDr.AloisAlzheimer.HedescribedtwohallmarksoftheDisease‐theplaquesandtanglesinthebrainsofAlzheimer’spatients.TheplaquesareformedbyAmyloid-betapeptidedepositsandthetanglesarecomposedofhyperphosphorylatedTauproteins.

Amyloidosisoccursasearlyasthepreclinicalstage.Thefirstcognitivedeficitscanmanifestthemselvesinthemildcognitiveimpairment(MCI)stage,whileinthedementiastagepatientsareunabletodoanyworkordailychores.
TheconcentrationofTAUinCSFisthereforerecognizedasaonebiomarkerindiagnosingAlzheimer’sDisease.
Moreover,anumberofindependentstudiesshowedthatcombiningTAU‐proteinandamyloid‐beta(1‐42)levelswillenhancespecificityandsensitivityofdiagnosisofAlzheimer’sDisease,whichisfurtherenhancedwhencombiningTAUlevelstoAmyloid-betaratiomeasurement.