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

Ashton, Nicholas J. ; Keshavan, Ashvini ; Brum, Wagner S. ; Andreasson, Ulf ; Arslan, Burak ; Droescher, Mathias ; Barghorn, Stefan ; Vanbrabant, Jeroen ; Lambrechts, Charlotte and Van Loo, Maxime , et al. (2025) In Alzheimer's and Dementia 21(2).
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... (More)

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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Alzheimer's disease, candidate reference materials, cerebrospinal fluid, commutability, immunoassay, phosphorylated tau, plasma
in
Alzheimer's and Dementia
volume
21
issue
2
article number
e14508
publisher
Wiley
external identifiers
  • scopus:85217055299
  • pmid:39907496
ISSN
1552-5260
DOI
10.1002/alz.14508
language
English
LU publication?
yes
id
b3888eed-fee2-4832-b580-cb93985c3730
date added to LUP
2025-04-09 09:29:01
date last changed
2025-07-17 00:56:55
@article{b3888eed-fee2-4832-b580-cb93985c3730,
  abstract     = {{<p>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.</p>}},
  author       = {{Ashton, Nicholas J. and Keshavan, Ashvini and Brum, Wagner S. and Andreasson, Ulf and Arslan, Burak and Droescher, Mathias and Barghorn, Stefan and Vanbrabant, Jeroen and Lambrechts, Charlotte and Van Loo, Maxime and Stoops, Erik and Iyengar, Shweta and Ji, Ha Yeun and Xu, Xiaomei and Forrest-Hay, Alex and Zhang, Bingqing and Luo, Yuling and Jeromin, Andreas and Vandijck, Manu and Bastard, Nathalie Le and Kolb, Hartmuth and Triana-Baltzer, Gallen and Bali, Divya and Janelidze, Shorena and Yang, Shieh Yueh and Demos, Catherine and Romero, Daniel and Sigal, George and Wohlstadter, Jacob and Malyavantham, Kishore and Khare, Meenakshi and Jethwa, Alexander and Stoeckl, Laura and Gobom, Johan and Kac, Przemysław R. and Gonzalez-Ortiz, Fernando and Montoliu-Gaya, Laia and Hansson, Oskar and Rissman, Robert A. and Carrillo, Maria C. and Shaw, Leslie M. and Blennow, Kaj and Schott, Jonathan M. and Zetterberg, Henrik}},
  issn         = {{1552-5260}},
  keywords     = {{Alzheimer's disease; candidate reference materials; cerebrospinal fluid; commutability; immunoassay; phosphorylated tau; plasma}},
  language     = {{eng}},
  number       = {{2}},
  publisher    = {{Wiley}},
  series       = {{Alzheimer's and Dementia}},
  title        = {{The Alzheimer's Association Global Biomarker Standardization Consortium (GBSC) plasma phospho-tau Round Robin study}},
  url          = {{http://dx.doi.org/10.1002/alz.14508}},
  doi          = {{10.1002/alz.14508}},
  volume       = {{21}},
  year         = {{2025}},
}