title: Guidelines for the standardization of preanalytic variables for blood-based biomarker studies in Alzheimer's disease research.
abstract: The lack of readily available biomarkers is a significant hindrance toward progressing to effective therapeutic and preventative strategies for Alzheimer's disease (AD). Blood-based biomarkers have potential to overcome access and cost barriers and greatly facilitate advanced neuroimaging and cerebrospinal fluid biomarker approaches. Despite the fact that preanalytical processing is the largest source of variability in laboratory testing, there are no currently available standardized preanalytical guidelines. The current international working group provides the initial starting point for such guidelines for standardized operating procedures (SOPs). It is anticipated that these guidelines will be updated as additional research findings become available. The statement provides (1) a synopsis of selected preanalytical methods utilized in many international AD cohort studies, (2) initial draft guidelines/SOPs for preanalytical methods, and (3) a list of required methodological information and protocols to be made available for publications in the field to foster cross-validation across cohorts and laboratories.
authors.affiliation: Institute for Aging & Alzheimer's Disease Research and Department of Internal Medicine, University of North Texas Health Science Center, Fort Worth, TX, USA. Electronic address: sid.o'bryant@unthsc.edu.
authors.forename: Sid E
authors.initials: SE
authors.lastname: O'Bryant
authors.affiliation: Centre of Excellence for Alzheimer's Disease Research & Care, School of Medical Sciences, Edith Cowan University, Joondalup, WA, Australia.
authors.forename: Veer
authors.initials: V
authors.lastname: Gupta
authors.affiliation: Nordic Bioscience Biomarkers and Research, Neurodegenerative Diseases, Herlev, Denmark.
authors.forename: Kim
authors.initials: K
authors.lastname: Henriksen
authors.affiliation: Department of Psychology, University of North Texas, Denton, TX, USA.
authors.forename: Melissa
authors.initials: M
authors.lastname: Edwards
authors.affiliation: Quanterix, Inc., Lexington, MA, USA.
authors.forename: Andreas
authors.initials: A
authors.lastname: Jeromin
authors.affiliation: AXA Research Fund & UPMC Chair, Paris, France.
authors.forename: Simone
authors.initials: S
authors.lastname: Lista
authors.affiliation: Department of Old Age Psychiatry, King's College London, Institute of Psychiatry, London, UK.
authors.forename: Chantal
authors.initials: C
authors.lastname: Bazenet
authors.affiliation: Bristol-Myers Squibb, Wallingford, CT, USA.
authors.forename: Holly
authors.initials: H
authors.lastname: Soares
authors.affiliation: Department of Old Age Psychiatry, King's College London, Institute of Psychiatry, London, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Lovestone
authors.affiliation: AXA Research Fund & UPMC Chair, Paris, France; Sorbonne Universités, Université Pierre et Marie Curie, Paris 06, Institut dela Mémoire et de la Maladie d'Alzheimer (IM2A) & Institut du Cerveau et dela Moelle épinière (ICM), Département de Neurologie, Hôpital de laPitié- Salpétrière, Paris, France; Département de Neurologie, Institut du Cerveau et de la Moelle épinière (ICM), Hôpital de la Pitié-Salpétrière, Paris, France.
authors.forename: Harald
authors.initials: H
authors.lastname: Hampel
authors.affiliation: Department of Pathology, University of Washington, Seattle, WA, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Montine
authors.affiliation: Clinical Neurochemistry Laboratory, Department of Neuroscience and Physiology, University of Goteborg, Sahlgrenska University Hospital, Molndal, Sweden.
authors.forename: Kaj
authors.initials: K
authors.lastname: Blennow
authors.affiliation: Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Tatiana
authors.initials: T
authors.lastname: Foroud
authors.affiliation: Alzheimer's Association, Chicago, IL, USA.
authors.forename: Maria
authors.initials: M
authors.lastname: Carrillo
authors.affiliation: Department of Neurology, Mayo Clinic Jacksonville, Jacksonville, FL, USA.
authors.forename: Neill
authors.initials: N
authors.lastname: Graff-Radford
authors.affiliation: Department of Neurodegeneration, Center of Neurology, Section for Dementia Research, Hertie-Institute of Clinical Brain Research, University of Tubingen, Tubingen, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Laske
authors.affiliation: Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany; German Center for Neurodegenerative Diseases (DZNE), Tübingen, Germany.
authors.forename: Monique
authors.initials: M
authors.lastname: Breteler
authors.affiliation: Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany; German Center for Neurodegenerative Diseases (DZNE), Tübingen, Germany.
authors.forename: Leslie
authors.initials: L
authors.lastname: Shaw
authors.affiliation: Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany; German Center for Neurodegenerative Diseases (DZNE), Tübingen, Germany.
authors.forename: John Q
authors.initials: JQ
authors.lastname: Trojanowski
authors.affiliation: Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Nicole
authors.initials: N
authors.lastname: Schupf
authors.affiliation: Department of Epidemiology, Joseph P Mailman School of Public Health, Columbia University, New York, NY, USA.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Rissman
authors.affiliation: Alzheimer's Disease Cooperative Study, Department of Neurosciences, UCSD School of Medicine, La Jolla, CA, USA.
authors.forename: Anne M
authors.initials: AM
authors.lastname: Fagan
authors.affiliation: Department of Neurology, Washington University School of Medicine, St. Louis, MO, USA.
authors.forename: Pankaj
authors.initials: P
authors.lastname: Oberoi
authors.affiliation: Meso Scale Discovery, Rockville, MD, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Umek
authors.affiliation: Department of Medicine, Radiology and Psychiatry, University of California, San Francisco, CA, USA.
authors.forename: Michael W
authors.initials: MW
authors.lastname: Weiner
authors.affiliation: Texas Tech University Health Science Center, Garrison Institute on Aging, Lubbock, TX, USA.
authors.forename: Paula
authors.initials: P
authors.lastname: Grammas
authors.affiliation: Pfizer Inc., New York, NY, USA.
authors.forename: Holly
authors.initials: H
authors.lastname: Posner
authors.affiliation: Centre of Excellence for Alzheimer's Disease Research & Care, School of Medical Sciences, Edith Cowan University, Joondalup, WA, Australia.
authors.forename: Ralph
authors.initials: R
authors.lastname: Martins
mesh_terms: D000544:Alzheimer Disease / Q000097:blood* / Q000134:cerebrospinal fluid; D015415:Biomarkers / Q000097:blood* / Q000134:cerebrospinal fluid; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans
chemical_list: D015415:Biomarkers
keywords: Alzheimer's disease; Biomarkers; Blood; Dementia; Diagnosis; Plasma; Serum; Treatment