Clinical and analytical comparison of six Simoa assays for plasma P-tau isoforms P-tau181, P-tau217, and P-tau231.

Alzheimer’s disease Analytical validation Blood biomarkers Clinical validation P-tau181 P-tau217 P-tau231 Phosphorylated tau proteins Simoa Ultra-sensitive immunoassays

Journal

Alzheimer's research & therapy
ISSN: 1758-9193
Titre abrégé: Alzheimers Res Ther
Pays: England
ID NLM: 101511643

Informations de publication

Date de publication:
04 12 2021
Historique:
received: 03 08 2021
accepted: 16 11 2021
entrez: 5 12 2021
pubmed: 6 12 2021
medline: 11 3 2022
Statut: epublish

Résumé

Studies using different assays and technologies showed highly promising diagnostic value of plasma phosphorylated (P-)tau levels for Alzheimer's disease (AD). We aimed to compare six P-tau Simoa assays, including three P-tau181 (Eli Lilly, ADx, Quanterix), one P-tau217 (Eli Lilly), and two P-tau231 (ADx, Gothenburg). We studied the analytical (sensitivity, precision, parallelism, dilution linearity, and recovery) and clinical (40 AD dementia patients, age 66±8years, 50%F; 40 age- and sex-matched controls) performance of the assays. All assays showed robust analytical performance, and particularly P-tau217 Eli Lilly; P-tau231 Gothenburg and all P-tau181 assays showed robust clinical performance to differentiate AD from controls, with AUCs 0.936-0.995 (P-tau231 ADx: AUC = 0.719). Results obtained with all P-tau181 assays, P-tau217 Eli Lilly assay, and P-tau231 Gothenburg assay strongly correlated (Spearman's rho > 0.86), while correlations with P-tau231 ADx results were moderate (rho < 0.65). P-tau isoforms can be measured robustly by several novel high-sensitive Simoa assays.

Identifiants

pubmed: 34863295
doi: 10.1186/s13195-021-00939-9
pii: 10.1186/s13195-021-00939-9
pmc: PMC8645090
doi:

Substances chimiques

Amyloid beta-Peptides 0
Biomarkers 0
Protein Isoforms 0
tau Proteins 0

Types de publication

Journal Article Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

198

Subventions

Organisme : NIA NIH HHS
ID : R01 AG068398
Pays : United States

Informations de copyright

© 2021. The Author(s).

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Auteurs

Sherif Bayoumy (S)

Neurochemistry Laboratory, Department of Clinical Chemistry, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Boelelaan 1117, Amsterdam, 1081 HV, The Netherlands. s.s.a.bayoumy@amsterdamumc.nl.

Inge M W Verberk (IMW)

Neurochemistry Laboratory, Department of Clinical Chemistry, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Boelelaan 1117, Amsterdam, 1081 HV, The Netherlands.

Ben den Dulk (B)

Neurochemistry Laboratory, Department of Clinical Chemistry, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Boelelaan 1117, Amsterdam, 1081 HV, The Netherlands.

Zulaiga Hussainali (Z)

Neurochemistry Laboratory, Department of Clinical Chemistry, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Boelelaan 1117, Amsterdam, 1081 HV, The Netherlands.

Marissa Zwan (M)

Alzheimer Center, Department of Neurology, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, The Netherlands.

Wiesje M van der Flier (WM)

Alzheimer Center, Department of Neurology, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, The Netherlands.
Department of Epidemiology and Data Science, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, The Netherlands.

Nicholas J Ashton (NJ)

Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden.
Wallenberg Centre for Molecular and Translational Medicine, University of Gothenburg, Gothenburg, Sweden.
King's College London, Institute of Psychiatry, Psychology and Neuroscience, Maurice Wohl Institute Clinical Neuroscience Institute, London, UK.
NIHR Biomedical Research Centre for Mental Health and Biomedical Research Unit for Dementia at South London and Maudsley NHS Foundation, London, UK.

Henrik Zetterberg (H)

Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden.
Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden.
Department of Neurodegenerative Disease, UCL Institute of Neurology, Queen Square, London, UK.
UK Dementia Research Institute at UCL, London, UK.
Hong Kong Center for Neurodegenerative Diseases, Hong Kong, China.

Kaj Blennow (K)

Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden.
Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden.

Jeroen Vanbrabant (J)

ADx NeuroSciences NV, Technologiepark 94, Gent, Belgium.

Erik Stoops (E)

ADx NeuroSciences NV, Technologiepark 94, Gent, Belgium.

Eugeen Vanmechelen (E)

ADx NeuroSciences NV, Technologiepark 94, Gent, Belgium.

Jeffrey L Dage (JL)

Eli Lilly and Company, Indianapolis, IN, 46285, USA.
Stark Neuroscience Research Institute, Indiana University School of Medicine, Indianapolis, IN, 46202, USA.

Charlotte E Teunissen (CE)

Neurochemistry Laboratory, Department of Clinical Chemistry, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Boelelaan 1117, Amsterdam, 1081 HV, The Netherlands.

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