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Journal Article Comparative Study Ppublish 12 citations

PubMed: 39679606 DOI: 10.1093/brain/awae368

Plasma p-tau217 in Alzheimer's disease: Lumipulse and ALZpath SIMOA head-to-head comparison.

Brain 148(2):408-415

Authors: Andrea Pilotto, Virginia Quaresima, Chiara Trasciatti, Chiara Tolassi, Diego Bertoli, Cristina Mordenti, Alice Galli, Andrea Rizzardi, Salvatore Caratozzolo, Andrea Zancanaro, José Contador, Oskar Hansson, Sebastian Palmqvist, Giovanni De Santis, Henrik Zetterberg, Kaj Blennow, Duilio Brugnoni, Marc Suárez-Calvet, Nicholas J Ashton, Alessandro Padovani

Affiliations

  • Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia 25123, Italy.
  • Department of continuity of care and frailty, Neurology Unit, ASST Spedali Civili Hospital, Brescia 25123, Italy.
  • Neurobiorepository and Laboratory of advanced biological markers, University of Brescia and ASST Spedali Civili Hospital, Brescia 25123, Italy.
  • Residency Program in Clinical Pathology and Clinical Biochemistry, Department of Molecular and Translational Medicine, University of Brescia, Brescia 25123, Italy.
  • Department of Clinical Laboratory, ASST Spedali Civili Hospital, Brescia 25123, Italy.
  • Barcelonaβeta Brain Research Center, Pasqual Maragall Foundation, Barcelona 08005, Spain.
  • Department of Neurology, Hospital del Mar Research Institute, Barcelona 08005, Spain.
  • Cognitive Decline Unit, Department of Neurology, Hospital del Mar, Barcelona 08005, Spain.
  • Department of Clinical Sciences, Clinical Memory Research Unit, Malmö 205 02, Sweden.
  • Memory Clinic, Skåne University Hospital, Malmö 205 02, Sweden.
  • Clinical Memory Research Unit, Department of Clinical Sciences Malmö, Faculty of Medicine, Lund University, Malmö 205 02, Sweden.
  • Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg 405 30, Sweden.
  • Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal 431 30, Sweden.
  • Dementia Research Center, Institute of Neurology, University College London, London WC1E 6BT, UK.
  • UK Dementia Research Institute, University College London, London WC1E 6BT, UK.
  • Hong Kong Center for Neurodegenerative Diseases, Hong Kong, China.
  • Wisconsin Alzheimer's Disease Research Center, University of Wisconsin School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI 53707, USA.
  • Paris Brain Institute, ICM, Pitié-Salpêtrière Hospital, Sorbonne University, Paris 75013, France.
  • Neurodegenerative Disorder Research Center, Division of Life Sciences and Medicine, and Department of Neurology, Institute on Aging and Brain Disorders, University of Science and Technology of China and First Affiliated Hospital of USTC, Hefei 230001, P.R. China.
  • Banner Sun Health Research Institute, Sun City, AZ 85351, USA.
  • Banner Alzheimer's Institute, Phoenix, AZ 85006, USA.
  • Brain Health Center, University of Brescia, Brescia 25123, Italy.

Abstract

Plasma phosphorylated-tau217 (p-tau217) has been shown to be one of the most accurate diagnostic markers for Alzheimer's disease. No studies have compared the clinical performance of p-tau217 as assessed by the fully automated Lumipulse and single molecule array (SIMOA) AlZpath p-tau217. The study included 392 participants, 162 with Alzheimer's disease, 70 with other neurodegenerative diseases with CSF biomarkers and 160 healthy controls. Plasma p-tau217 levels were measured using the Lumipulse and ALZpath SIMOA assays. The ability of p-tau217 assessed by both techniques to discriminate Alzheimer's disease from other neurodegenerative diseases and controls was investigated using receiver operating characteristic analyses. The p-tau217 levels measured by the two techniques demonstrated a strong correlation, showing a consistent relationship with CSF p-tau181 levels. In head-to-head comparison, Lumipulse and SIMOA showed similar diagnostic accuracy for differentiating Alzheimer's disease from other neurodegenerative diseases [area under the curve (AUC) 0.952, 95% confidence interval (CI) 0.927-0.978 versus 0.955, 95% CI 0.928-0.982, respectively] and healthy controls (AUC 0.938, 95% CI 0.910-0.966 and 0.937, 95% CI 0.907-0.967 for both assays). This study demonstrated the high precision and diagnostic accuracy of p-tau217 for the clinical diagnosis of Alzheimer's disease using fully automated or semi-automated techniques.

MeSH

Alzheimer Disease, Neurology, Neurodegenerative Diseases, Plasma

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