Blennow, K., Galasko, D., Perneczky, R. orcid.org/0000-0003-1981-7435 et al. (7 more authors) (2023) The potential clinical value of plasma biomarkers in Alzheimer's disease. Alzheimer's & Dementia, 19 (12). pp. 5805-5816. ISSN 1552-5260
Abstract
INTRODUCTION Many people with cognitive complaints or impairment never receive an accurate diagnosis of the underlying condition, potentially impacting their access to appropriate treatment. To address this unmet need, plasma biomarker tests are being developed for use in Alzheimer's disease (AD). Plasma biomarker tests span various stages of development, including in vitro diagnostic devices (or tests) (IVDs), laboratory-developed tests (LDTs) and research use only devices (or tests) (RUOs). Understanding the differences between each test type is important for appropriate implementation into the AD diagnostic pathway and care continuum.
METHODS Authors reviewed scientific literature (PubMed, meeting abstracts and presentations, company press releases and websites) on AD plasma biomarkers.
RESULTS This article defines IVDs, LDTs, and RUOs, discusses potential clinical applications and highlights the steps necessary for their clinical implementation.
DISCUSSION Plasma biomarkers could revolutionize many areas of the AD diagnostic pathway and care continuum, but further research is needed.
HIGHLIGHTS There is a need for a minimally invasive Alzheimer's disease (AD) diagnostic tool. AD plasma biomarker tests exist at various stages of commercial development. Understanding the development stage of a test is important for its appropriate use. Plasma biomarker tests could function as a triage tool to streamline AD diagnosis. Further steps remain before AD plasma biomarkers can be used routinely.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2023 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited (https://creativecommons.org/licenses/by/4.0/). |
Keywords: | Alzheimer's disease; diagnosis; diagnosis pathway; diagnostic test; plasma biomarkers; triage tool |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > Department of Neuroscience (Sheffield) The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Medicine and Population Health |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 19 Sep 2023 15:50 |
Last Modified: | 04 Oct 2024 14:52 |
Status: | Published |
Publisher: | Wiley |
Refereed: | Yes |
Identification Number: | 10.1002/alz.13455 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:203461 |