Analytical and clinical validation of the Lumipulse G plasma p‐tau217 assay for clinical implementation

INTRODUCTION: Although several plasma tau phosphorylated at threonine 217 (p-tau217) immunoassays are now available, comprehensive analytical validation remains limited. We therefore evaluated the Lumipulse G plasma p-tau217 assay and verified established cutoffs for clinical implementation. METHODS: This study was conducted in two phases: (1) analytical validation of the Lumipulse G plasma p-tau217 assay, assessing precision, lower limit of quantification (LLoQ), selectivity, stability, and interference; and (2) verification of previously established cutoffs using a two-threshold approach in 37 samples with confirmed cerebrospinal fluid (CSF) Aβ42/Aβ40 status. RESULTS: The assay demonstrated strong analytical performance, with repeatability and intermediate precision (%CV < 7%) and an LLoQ of 0.12 pg/mL. The p-tau217 was stable across freeze-thaw cycles but less so at 4°C, and hemolysis > 2% introduced variability. Cutoff verification showed 97% reproducibility with excellent agreement (ρ = 0.99, p < 0.0001). DISCUSSION: The Lumipulse assay showed robust analytical performance and reproducibility, supporting clinical use, though certified reference materials are still needed for standardization.

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Publication Details

Journal
Alzheimer s & Dementia
Published
2026-04-01
DOI
https://doi.org/10.1002/alz.71374
Primary Topic
Epilepsy research and treatment
Type
article
Field-Weighted Citation Impact
0.00

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article

Analytical and clinical validation of the Lumipulse G plasma p‐tau217 assay for clinical implementation

Hlin Kvartsberg, Burak Arslan, Tevy Chan, Ulf Andréasson et al.
Alzheimer s & Dementia
Epilepsy research and treatment
article

Analytical and clinical validation of the Lumipulse G plasma p‐tau217 assay for clinical implementation

Hlin Kvartsberg, Burak Arslan, Tevy Chan, Ulf Andréasson, Anna Dittrich, Pedro Rosa‐Neto, Henrik Zetterberg, Johan Gobom, Ingmar Skoog, Silke Kern, Laia Montoliu‐Gaya, Nesrine Rahmouni, Kaj Blennow, Nicholas J. Ashton, Andrea L. Benedet
article en

Abstract

INTRODUCTION: Although several plasma tau phosphorylated at threonine 217 (p-tau217) immunoassays are now available, comprehensive analytical validation remains limited. We therefore evaluated the Lumipulse G plasma p-tau217 assay and verified established cutoffs for clinical implementation. METHODS: This study was conducted in two phases: (1) analytical validation of the Lumipulse G plasma p-tau217 assay, assessing precision, lower limit of quantification (LLoQ), selectivity, stability, and interference; and (2) verification of previously established cutoffs using a two-threshold approach in 37 samples with confirmed cerebrospinal fluid (CSF) Aβ42/Aβ40 status. RESULTS: The assay demonstrated strong analytical performance, with repeatability and intermediate precision (%CV < 7%) and an LLoQ of 0.12 pg/mL. The p-tau217 was stable across freeze-thaw cycles but less so at 4°C, and hemolysis > 2% introduced variability. Cutoff verification showed 97% reproducibility with excellent agreement (ρ = 0.99, p < 0.0001). DISCUSSION: The Lumipulse assay showed robust analytical performance and reproducibility, supporting clinical use, though certified reference materials are still needed for standardization.

Alzheimer s & DementiaVol. 22(4)
University of Science and Technology of China (CN), Alzheimer's Association (US), Montreal Neurological Institute and Hospital (CA), University of Wisconsin–Madison (US), Sahlgrenska University Hospital (SE), McGill University Health Centre (CA), Sorbonne Université (FR), Region Västra Götaland (SE), Southwestern Medical Center (US), Institute for Neurodegenerative Disorders (US), Pitié-Salpêtrière Hospital (FR), University of Wisconsin Health (US), MRC Prion Unit (GB), Banner Sun Health Research Institute (US), Centre Intégré Universitaire de Santé et de Services Sociaux du Centre-Sud-de-l'Île-de-Montréal (CA), Institut du Cerveau (FR), Centres Intégré Universitaires de Santé et de Services Sociaux (CA), Banner Alzheimer’s Institute, University College London (GB), McGill University (CA), The University of Texas Southwestern Medical Center (US), University of Gothenburg (SE)
Alzheimer's Association, Familjen Erling-Perssons Stiftelse, Cure Alzheimer's Fund, Fondation Brain Canada, Weston Brain Institute, National Institute for Health and Care Research, European Commission, Hjärnfonden, Vetenskapsrådet, Göteborgs Universitet, UK Dementia Research Institute, HORIZON EUROPE Framework Programme, Canadian Institutes of Health Research
Openalex Percentile: Top 15%
Epilepsy research and treatment
DOIOpen Access PDFOpenAlex
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