| Kitsize | 12x8 |
| Method | ELISA |
| Incubationtime | 1x2h,1x1h,1x30min. |
| Standardrange | 7,81-125pg/mL |
| Specimen/Volumes | 5µLCSF |
| Substrate/isotope | TMB450nm |
| RegulatoryStatus: | EU:CE |
Overthelast15yearsmeasuringAmyloid–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)
| Peptide | Amyloid–beta (1–40)ELISA | Amyloid–beta (1–42)ELISA |
| Amyloid–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% |
Tabelle1
Kreuzreaktivitäten(bestimmtnachDeshpande,SS(1996))
BothAssaysshowexcellentinter–andintra–assayCVs(Table2)andinter–lotCVs(Table3)profilesduetointernalqualitycontrolstandards.
| Amyloid–beta(1–40)ELISA | Amyloid–beta(1–42)ELISA | |||
| SampleNo. | mean | CV | mean | CV |
| [pg/mL] | [%] | [pg/mL] | [%] | |
| 1 | 4732 | 1.8 | 548 | 3.4 |
| 2 | 9937 | 2.1 | 1023 | 3.0 |
| 3 | 3080 | 4.5 | 849 | 3.0 |
| 4 | 10497 | 1.9 | 951 | 3.1 |
| 5 | 13506 | 2.8 | 1034 | 3.1 |
Table2
Intra–assayCV(n=20)
| Amyloid–beta(1–40)ELISA | Amyloid–beta(1–42)ELISA | |||
| SampleNo. | mean | CV | mean | CV |
| [pg/mL] | [%] | [pg/mL] | [%] | |
| 1 | 2418 | 5.4 | 193 | 4.5 |
| 2 | 3830 | 6.3 | 476 | 7.6 |
| 3 | 19407 | 4.1 | 661 | 6.9 |
| 4 | 13164 | 5.8 | 728 | 4.7 |
| 5 | 9405 | 2.7 | 873 | 7.4 |
Table3
Inter–lotand–operatorCV(n=10,3lots,3-4operators)
MethodcomparisonwithcommerciallyavailableAmyloid–beta(1–40)ELISA:R2=0.944
MethodcomparisonforthedetectionofAmyloid–beta(1–40)in119nativeCSFSamples
MethodcomparisonwithcommerciallyavailableAmyloid–beta(1–42)ELISA:R2=0.9492
MethodcomparisonforthedetectionofAmyloid–beta(1–42)in120nativeCSFSamples
Toclinicallyvalidatetheassaysanexternalstudywasdoneatthe"KlinikundPoliklinikfürPsychiatrieundPsychotherapie,KlinikumrechtsderIsarderTechnischenUniversitätMünchen,München,Germany"withoverall83clinicallyknownsamples.Theratioofbothassayvaluesshowshighclinicalsensitivityandspecificity
Amyloid–beta(1–42)⁄Amyloid–beta(1–40)ratiosuperiortoAmyloid–beta(1–42)alone
| Ratio:Amyloid–beta(1–42) ⁄Amyloid–beta(1–40) | |||
| AD | control | ||
| Diagnosis | AD | 39 | 1 |
| control | 4 | 39 | |
SimilarresultswereobtainedbyProf.Dr.med.PiotrLewczuk,LabforClinicalNeuRochemistryandNeurochemicalDementiaDiagnostics,UniversitätsklinikumErlangen,DepartmentofPsychiatryandPsychotherapy,Erlangen,Germany.(tobepublishedsoon)
ExcerptfromtheInstructionsforUse
In2010,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.
IBL赋予生命科学和诊断能力
Tecan是自动化实验室仪器和解决方案的全球领先提供商。我们的系统和组件可帮助从事临床诊断，基础和转化研究以及药物发现的人们将他们的科学带入生活。
特别是，我们开发，生产，销售和支持自动化工作流程解决方案，使实验室能够实现更多目标。我们的Cavro品牌仪器部件由跨多个领域的领先仪器供应商选择。
永远为我们的客户服务
我们与众多客户并肩合作，包括诊断实验室，制药和生物技术公司以及大学研究中心。我们的专业知识扩展到由合作伙伴公司销售的开发和制造OEM仪器和组件。无论项目大小（无论大小，简单或复杂）如何，帮助我们的客户实现其目标都是最重要的。
改变全球实验室的工作方式
我们在我们工作的所有部门中都处于领先地位，并且已经改变了全球研发实验室的工作方式。例如，在诊断方面，我们提高了测试的可重复性和通量。
在不到四十年的时间里，Tecan已从一家瑞士家族企业发展成为一个在全球生命科学舞台上树立良好声誉的品牌。从农场的开拓活动到今天，我们的业务一直担当领导角色-增强研究，诊断和全球许多应用市场的能力。
本网站将在规定时间内给予删除等相关处理。
