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Alzheimer's & dementia : the journal of the Alzheimer's Association
Published

The Alzheimer's Association Global Biomarker Standardization Consortium (GBSC) plasma phospho-tau Round Robin study

Authors

Nicholas J Ashton, Ashvini Keshavan, Wagner S Brum, Ulf Andreasson, Burak Arslan, Mathias Droescher, Stefan Barghorn, Jeroen Vanbrabant, Charlotte Lambrechts, Maxime Van Loo, Erik Stoops, Shweta Iyengar, HaYeun Ji, Xiaomei Xu, Alex Forrest-Hay, Bingqing Zhang, Yuling Luo, Andreas Jeromin, Manu Vandijck, Nathalie Le Bastard, Hartmuth Kolb, Gallen Triana-Baltzer, Divya Bali, Shorena Janelidze, Shieh-Yueh Yang, Catherine Demos, Daniel Romero, George Sigal, Jacob Wohlstadter, Kishore Malyavantham, Meenakshi Khare, Alexander Jethwa, Laura Stoeckl, Johan Gobom, Przemysław R Kac, Fernando Gonzalez-Ortiz, Laia Montoliu-Gaya, Oskar Hansson, Robert A Rissman, Maria C Carrillo, Leslie M Shaw, Kaj Blennow, Jonathan M Schott, Henrik Zetterberg

Abstract

Alzheimers Dement. 2025 Feb 5:e14508. doi: 10.1002/alz.14508. Online ahead of print.

ABSTRACT

INTRODUCTION: The Alzheimer's Association Global Biomarker Standardization Consortium conducted a blinded case-control study to learn which phosphorylated tau (p-tau) assays provide the largest fold-changes in Alzheimer's disease (AD) versus non-AD and show commutability in measuring patient samples and candidate certified reference materials (CRMs).

METHODS: Thirty-three different p-tau assays measured paired plasma and cerebrospinal fluid (CSF) from 40 participants (25 with "AD pathology" and 15 with "non-AD pathology" by CSF amyloid beta [Aβ]42/Aβ40 and p-tau181 criteria). Four CRMs were assessed.

RESULTS: Plasma p-tau217 demonstrated higher fold-changes between AD and non-AD than other p-tau epitopes. Fujirebio LUMIPULSE G, UGOT IPMS, and Lilly MSD p-tau217 provided the highest fold-changes. Plasma p-tau217 showed the strongest correlations between plasma assays (rho = 0.81-0.97). The CRMs were not commutable across assays.

DISCUSSION: Plasma p-tau217 showed larger fold-changes and better accuracy for detecting AD pathology in symptomatic individuals, with greater cross-platform agreement than other p-tau variants. Further work is needed to develop suitable CRMs facilitating cross-assay standardization.

HIGHLIGHTS: Paired plasma and cerebrospinal fluid (CSF) samples from twenty-five Alzheimer's disease (AD) and 15 non-AD patients were measured blind. Thirty-three plasma assays were compared, for phosphorylated tau-181 (p-tau181), 205, 212, 217 and 231. Plasma p-tau217 consistently had the highest fold-change and was best correlated between assays. Plasma-CSF correlations were weak to moderate. There was lack of commutability for four candidate reference materials.

PMID:39907496 | DOI:10.1002/alz.14508

UK DRI Authors

Profile picture of Henrik Zetterberg

Prof Henrik Zetterberg

Group Leader

Pioneering the development of fluid biomarkers for dementia

Prof Henrik Zetterberg