Analytical and clinical validation of the Lumipulse G plasma p‐tau217 assay for clinical implementation
Year: 2026
Type: article
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.
Source: Alzheimer s & Dementia
DOI: 10.1002/alz.71374
Institutions: Sahlgrenska University Hospital, University of Gothenburg, Region Västra Götaland, Banner Sun Health Research Institute, Banner Alzheimer’s Institute, Montreal Neurological Institute and Hospital, Research Institute of the McGill University Health Centre, McGill University, Douglas Mental Health University Institute, Centre intégré universitaire de santé et de services sociaux de l'Ouest-de-l’Île-de-Montréal, The University of Texas Southwestern Medical Center, University of Science and Technology of China, Sorbonne Université, Institut des Sciences Moléculaires, Pitié-Salpêtrière Hospital, Institut du Cerveau, University of Wisconsin–Madison, UCL Queen Square Institute of Neurology, University College London
Language: English
Subfield: Physiology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,200
Funders: 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
Awards: G1311708188, G1343867371, G150733400, G1546555014, G1588116593, G1625201577, G1771944843, G180825096, G1897540622, G1928552717, G201353144, G2080567650, G237833635, G2385484910, G2521197280, G2543812357, G2627246084, G3027168043, G308275008, G3167845995, Fluid biomarkers for neurodegenerative dementias, G3655537922, G366952799, G3842727039, G4244943609, G4260843567, G429241845, G4293249722, G4962764320, G5040492720, G506008078, Fluid biomarkers for neurodegenerative dementias, G5544413620, G5619554209, G5813287008, G5880387862, G5901863754, Analysing the heavy element factories of the Universe : photometric and spectroscopic sample study of kilonovae, CASCADE: CAuSe or Consequence in Alzheimer DiseasE?, G6142763750, G6158734006, G6168044258, Multi-omics Interdisciplinary Research Integration to Address DEmentia diagnosis, G6745400708, G691317373, G7077458143, G7524907754, G7764010130, G7804671150, G7964167928, G821247696, G8939766884, G8999236925
OpenAlex ID: W7154364461