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Comparative Study
. 2025 Feb 3;148(2):408-415.
doi: 10.1093/brain/awae368.

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

Andrea Pilotto  1   2   3 , Virginia Quaresima  1   2   3   4   5 , Chiara Trasciatti  1   2   3   4 , Chiara Tolassi  1   2   3   4 , Diego Bertoli  5 , Cristina Mordenti  5 , Alice Galli  1   2 , Andrea Rizzardi  1   2 , Salvatore Caratozzolo  1   2 , Andrea Zancanaro  1   2 , José Contador  6   7   8 , Oskar Hansson  9   10   11 , Sebastian Palmqvist  9   10   11 , Giovanni De Santis  12 , Henrik Zetterberg  12   13   14   15   16   17 , Kaj Blennow  12   18   19 , Duilio Brugnoni  5 , Marc Suárez-Calvet  6   7   8 , Nicholas J Ashton  12   20   21   22 , Alessandro Padovani  1   2   3   22
Affiliations
Comparative Study

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

Andrea Pilotto et al. Brain. .

Erratum in

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.

Keywords: ALZPath; Alzheimer’s disease; Lumipulse; SIMOA; p-tau217; plasma markers.

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Conflict of interest statement

A.Pi. received consultancy/speaker fees from Abbvie, Angelini, Bial, Lundbeck, Roche and Zambon pharmaceuticals. O.H. has acquired research support (for the institution) from AVID Radiopharmaceuticals, Biogen, C2N Diagnostics, Eli Lilly, Eisai, Fujirebio, GE Healthcare and Roche. In the past 2 years, he has received consultancy/speaker fees from AC Immune, Alzpath, BioArctic, Biogen, Bristol Meyer Squibb, Cerveau, Eisai, Eli Lilly, Fujirebio, Merck, Novartis, Novo Nordisk, Roche, Sanofi and Siemens. S.P. has acquired research support (for the institution) from ki elements/ADDF and Avid. In the past 2 years, he has received consultancy/speaker fees from Bioartic, Biogen, Esai, Lilly and Roche. H.Z. has served on scientific advisory boards and/or as a consultant for Abbvie, Acumen, Alector, Alzinova, ALZPath, Amylyx, Annexon, Apellis, Artery Therapeutics, AZTherapies, Cognito Therapeutics, CogRx, Denali, Eisai, Merry Life, Nervgen, Novo Nordisk, Optoceutics, Passage Bio, Pinteon Therapeutics, Prothena, Red Abbey Labs, reMYND, Roche, Samumed, Siemens Healthineers, Triplet Therapeutics and Wave, has given lectures in symposia sponsored by Alzecure, Biogen, Cellectricon, Fujirebio, Lilly and Roche, and is a co-founder of Brain Biomarker Solutions in Gothenburg AB (BBS), which is a part of the GU Ventures Incubator Program (outside submitted work). K.B. reported having served as a consultant and on advisory boards for Acumen, ALZpath, BioArctic, Biogen, Eisai, Lilly, Moleac, Novartis, Ono Pharma, Prothena, Roche Diagnostics and Siemens Healthineers; having served at data monitoring committees for Julius Clinical and Novartis; having given lectures, produced educational materials and participated in educational programs for AC Immune, Biogen, Celdara Medical, Eisai and Roche Diagnostics; and being a co-founder of Brain Biomarker Solutions in Gothenburg AB (BBS), which is a part of the GU Ventures Incubator Program. M.S.C. has given lectures in symposia sponsored by Almirall, Eli Lilly, Novo Nordisk, Roche Diagnostics and Roche Farma; received consultancy fees (paid to the institution) from Roche Diagnostics; and served on advisory boards of Roche Diagnostics and Grifols. He was granted a project and is a site investigator of a clinical trial (funded to the institution) by Roche Diagnostics. In-kind support for research (to the institution) was received from ADx Neurosciences, Alamar Biosciences, Avid Radiopharmaceuticals, Eli Lilly, Fujirebio, Janssen Research & Development and Roche Diagnostics. N.J.A. has received consultancy/speaker fees from Bioartic, Biogen, Lilly, Quanterix and Alamar Biosciences. A.Pa. received grant support from Ministry of Health (MINSAL) and Ministry of Education, Research and University (MIUR), from the CARIPLO Foundation; personal compensation as a consultant/scientific advisory board member for Biogen, Lundbeck, Roche, Nutricia and General Healthcare (GE).

Figures

Figure 1
Figure 1
Plasma p-tau217 levels detected by Lumipulse and SIMOA in the whole cohort and subgroups of participants. Passing-Bablok regression in A shows the comparison between the two testing platforms Lumipulse (L) and SIMOA (S), which highlights a constant, systematic and proportional error between the two detection methods. In B, p-tau217 levels in Alzheimer’s disease (AD), healthy control (HC) and non-Alzheimer’s neurodegenerative disorders (NDD) groups measured using Lumipulse (L) and SIMOA (S). p-Tau217 is significantly higher in AD compared with both HC and NDD, for both testing platforms. p-tau217 (L)/(S) = phosphorylated tau 217 tested on Lumipulse (L) and SIMOA (S). SIMOA = single molecule array.
Figure 2
Figure 2
Diagnostic accuracy of p-tau217 for Alzheimer’s disease diagnosis using Lumipulse and SIMOA. Alzpath assessment or receiver operating characteristic (ROC) curve of Alzheimer’s disease-healthy control (AD-HC) and Alzheimer’s disease-non-Alzheimer’s neurodegenerative disorders (AD-NDD) populations with the area under the curve (AUC) and optimal Youden cut-off represented by the dashed grey line in the distribution plots for (A) Lumipulse (L) and (B) SIMOA (S). p-tau217 (L)/(S) = phosphorylated tau 217 tested on Lumipulse (L) and SIMOA (S). SIMOA = single molecule array.
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References

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