Abstract
Cerebrospinal fluid (CSF) biomarkers have been extensively utilized in the diagnosis of Alzheimer's disease (AD) and characterization of progression. One important CSF biomarker is the amyloid beta 42 (Aβ(42)) peptide, a key player in AD pathogenesis. The INNOTEST® Aβ(42) ELISA kit has been widely used but an advanced level of method development and validation has not been reported. To support a clinical trial in AD, we successfully completed a Good Laboratory Practices (GLP)-level validation of the method to establish the parameters of precision, accuracy, parallelism, selectivity, specificity, and linearity of dilution of the assay in CSF matrix, as well as CSF storage stability. Several modifications were required to optimize the assay and ensure consistent results in a clinical-trial setting. These included the use of additional calibrators, an adjusted standard curve range, a minimum required dilution (MRD) of CSF by 6-fold to avoid matrix interference and mitigation of analyte adsorption to labware by the addition of Tween-20. The optimized method displayed a quantitative range of 375-4,500 pg/mL. The inter-assay precision was ≤12.1 % CV and the inter-assay relative accuracy was ≤10.9 % absolute bias, bringing the total e...Continue Reading
References
Jun 16, 1999·Archives of Neurology·N AndreasenK Blennow
Oct 3, 1999·Neuroscience Letters·N AndreasenK Blennow
Nov 22, 2001·Experimental Neurology·M MaruyamaH Sasaki
Sep 17, 2003·Archives of Neurology·Alessia MaddalenaChristoph Hock
Nov 5, 2003·Neurological Sciences : Official Journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology·L ParnettiV Gallai
Dec 31, 2003·Molecular Psychiatry·H HampelK Buerger
Jan 7, 2004·Archives of General Psychiatry·Harald HampelKaj Blennow
Apr 5, 2005·Neurocase·Adrian Ivanoiu, Christian J M Sindic
Nov 9, 2005·Mechanisms of Ageing and Development·Lucilla ParnettiPaolo Reboldi
Jan 7, 2006·Pharmaceutical Research·Jean W LeeJohn A Wagner
Jan 26, 2006·Neurochemistry International·Sebastiaan EngelborghsPeter P De Deyn
Feb 2, 2006·Clinical Chemistry·Piotr LewczukJens Wiltfang
Apr 27, 2007·Pharmaceutical Research·C T ViswanathanRussell Weiner
Sep 6, 2007·Neurology·F H BouwmanP Scheltens
Sep 22, 2007·The World Journal of Biological Psychiatry : the Official Journal of the World Federation of Societies of Biological Psychiatry·Breno S O DinizOrestes Vicente Forlenza
Apr 12, 2008·Neurobiology of Aging·Femke H BouwmanWiesje M van der Flier
Mar 20, 2009·Annals of Neurology·Leslie M ShawUNKNOWN Alzheimer's Disease Neuroimaging Initiative
Jun 16, 2009·Lancet Neurology·Pieter Jelle VisserKaj Blennow
Jul 23, 2009·JAMA : the Journal of the American Medical Association·Niklas MattssonKaj Blennow
Feb 12, 2010·The Journal of Neuroscience : the Official Journal of the Society for Neuroscience·Anders M FjellUNKNOWN Alzheimer's Disease Neuroimaging Initiative
Apr 14, 2010·Biomarkers in Medicine·Eric SiemersRobert A Dean
Apr 14, 2010·Biomarkers in Medicine·Henrik ZetterbergKaj Blennow
Jun 12, 2010·Neurobiology of Aging·Liana G ApostolovaUNKNOWN Alzheimer's Disease Neuroimaging Initiative
Jul 27, 2010·Clinica Chimica Acta; International Journal of Clinical Chemistry·Arnaldo M Pica-MendezOmar F Laterza
Aug 28, 2010·International Journal of Alzheimer's Disease·Maria BjerkeKaj Blennow
May 11, 2011·Archives of Neurology·Anne M FaganDavid M Holtzman
Jul 26, 2011·Alzheimer's & Dementia : the Journal of the Alzheimer's Association·Niklas MattssonKaj Blennow
Citations
Oct 23, 2012·Alzheimer's Research & Therapy·Hugo VandersticheleAndreas Jeromin
Apr 30, 2013·Biosensors & Bioelectronics·Paola GagniMarcella Chiari
Sep 27, 2013·The Journal of Maternal-fetal & Neonatal Medicine : the Official Journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians·Laura D SerperoDiego Gazzolo
Jun 21, 2015·Alzheimer's & Dementia : the Journal of the Alzheimer's Association·Ann De VosEugeen Vanmechelen
Oct 21, 2015·Journal of Alzheimer's Disease : JAD·Guro BergeLinda Rosemary White
Jul 18, 2015·Biopreservation and Biobanking·Olga A KofanovaFay Betsou
Jul 23, 2016·Journal of Alzheimer's Disease : JAD·Davide ChiasseriniLucilla Parnetti
Jun 4, 2016·Journal of Alzheimer's Disease : JAD·Hugo Marcel Johan VandersticheleOskar Hansson
Apr 24, 2013·Journal of Proteome Research·Atsushi MiyachiKen-Ichi Harada
Dec 17, 2016·Alzheimer's Research & Therapy·Linan SongRobert A Dean
Nov 25, 2017·Journal of Alzheimer's Disease : JAD·James D DoeckeUNKNOWN AIBL Research Group
Jun 26, 2018·Alzheimer's & Dementia : the Journal of the Alzheimer's Association·Oskar HanssonKaj Blennow
Oct 21, 2015·Journal of Alzheimer's Disease : JAD·Leandro García BarradoTomasz Burzykowski
Feb 22, 2017·Alzheimer's & Dementia : the Journal of the Alzheimer's Association·Eline WillemseCharlotte Teunissen
Nov 30, 2018·Alzheimer's Research & Therapy·Stephen P SchauerKristin R Wildsmith
Jan 13, 2019·Journal of Molecular Neuroscience : MN·Erdinç DursunDuygu Gezen-Ak
Oct 2, 2020·Alzheimer's & Dementia : Diagnosis, Assessment & Disease Monitoring·Ashvini KeshavanJonathan M Schott
Jul 22, 2019·Alzheimer's Research & Therapy·Shorena JanelidzeOskar Hansson
Sep 4, 2015·Journal of Neurochemistry·J Randall SlemmonKaj Blennow
Feb 19, 2021·Alzheimer's & Dementia : Diagnosis, Assessment & Disease Monitoring·Ashvini KeshavanJonathan M Schott
May 23, 2021·Journal of Internal Medicine·D O T AlawodeH Zetterberg