@article{894cfe409235489685e9e5c472d4bf94,
title = "Detection of Alzheimer's disease amyloid beta 1-42, p-tau, and t-tau assays",
abstract = "Introduction: We aimed to provide cut points for the automated Elecsys Alzheimer's disease (AD) cerebrospinal fluid (CSF) biomarkers. Methods: Cut points for Elecsys amyloid beta 42 (Aβ42), total tau (t-tau), hyperphosphorylated tau (p-tau), and t-tau/Aβ42 and p-tau/Aβ42 ratios were evaluated in Mayo Clinic Study of Aging (n = 804) and Mayo Clinic Alzheimer's Disease Research Center (n = 70) participants. Results: The t-tau/Aβ42 and p-tau/Aβ42 ratios had a higher percent agreement with normal/abnormal amyloid positron emission tomography (PET) than the individual CSF markers. Reciever Operating Characteristic (ROC)-based cut points were 0.26 (0.24–0.27) for t-tau/Aβ42 and 0.023 (0.020–0.025) for p-tau/Aβ42. Ratio cut points derived from other cohorts performed as well in our cohort as our own did. Individual biomarkers had worse diagnostic properties and more variable results in terms of positive and negative percent agreement (PPA and NPA). Conclusion: CSF t-tau/Aβ42 and p-tau/Aβ42 ratios are very robust indicators of AD. For individual biomarkers, the intended use should determine which cut point is chosen.",
keywords = "Alzheimer's disease, CSF, biomarkers, cut point",
author = "{van Harten}, {Argonde C.} and Wiste, {Heather J.} and Weigand, {Stephen D.} and Mielke, {Michelle M.} and Kremers, {Walter K.} and Udo Eichenlaub and Dyer, {Roy B.} and Alicia Algeciras-Schimnich and Knopman, {David S.} and Jack, {Clifford R.} and Petersen, {Ronald C.}",
note = "Funding Information: ELECSYS is a trademark of Roche. All other product names and trademarks are the property of their respective owners. The authors thank Ekaterina Manuilova for her review of the manuscript. Funding was provided by the following foundations: NIA: U01 AG006786, P50 AG016574, GHR Foundation, and Mayo Foundation for Medical Education and Research. Roche Diagnostics provided the assay kits for CSF biomarker analysis. Funding Information: Dr. A.C. van Harten, H.J. Wiste, S.D. Weigand, Dr. W Kremers, Dr. R.B. Dyer, and Dr. A. Algeciras‐Schimnich report no disclosures. Dr. Mielke served as a consultant to Eli Lilly and Lysosomal Therapeutics, Inc. She receives research support from the National Institutes of Health (NIH) (R01 AG49704, P50 AG44170, U01 AG06786, RF1 AG55151), Department of Defense (W81XWH‐15‐1), and unrestricted research grants from Biogen, Roche, and Lundbeck. Dr. Eichenlaub is an employee of Roche Diagnostics International Ltd, Rotkreuz, Switzerland. Dr. Knopman serves on a Data Safety Monitoring Board for Lundbeck Pharmaceuticals and for the DIAN study; is an investigatorin clinical trials sponsored by Biogen, Lilly Pharmaceuticals and the Alzheimer's Disease Cooperative Study; and receives research support from the NIH. Dr. C. Jack Jr. has provided consulting services for Eli Lilly Co. He receives research funding from the NIH (R01 AG011378, U01 HL096917, U01 AG024904, RO1 AG041851, R01 AG037551, R01 AG043392, U01 AG006786) and the Alexander Family Alzheimer's Disease Research Professorship of the Mayo Foundation. Dr. Petersen is a consultant for Roche, Inc., Merck, Inc., Biogen, Inc., Genentech, Inc. Eisai, Inc., and GE Healthcare. The Elecsys β‐Amyloid (1‐42) CSF assay, the Elecsys Phospho‐Tau (181P) CSF assay, and the Elecsys Total‐Tau CSF assay are not approved for clinical use in the United States. Publisher Copyright: {\textcopyright} 2021 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",
year = "2021",
doi = "10.1002/alz.12406",
language = "English",
journal = "Alzheimers & Dementia",
issn = "1552-5260",
publisher = "Elsevier",
}