ABSTRACT
Background Plasma phosphorylated-tau217 (p-tau217) has been shown to be one of the most accurate diagnostic markers for Alzheimer’s disease (AD). No studies have compared the clinical performance of p-tau217 as assessed by the fully automated Lumipulse and SIMOA ALZpath p-tau217.
Aim To evaluate the diagnostic accuracy of Lumipulse and SIMOA plasma p-tau217 assays for AD.
Methods The study included 392 participants, 162 with AD, 70 with other neurodegenerative diseases (NDD) 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 AD from NDD and controls was investigated using ROC analyses.
Results Both techniques showed high internal consistency of p-tau217 with similar correlation with CSF p-tau181 levels. In head-to-head comparison, Lumipulse and SIMOA showed similar diagnostic accuracy for differentiating AD from NDD (area under the curve [AUC] 0.952, 95%CI 0.927–0.978 vs 0.955, 95%CI 0.928–0.982, respectively) and HC (AUC 0.938, 95%CI 0.910-0.966 and 0.937, 95% CI0.907-0.967 for both assays).
Conclusions This study demonstrated the high precision and diagnostic accuracy of p-tau217 for the clinical diagnosis of Alzheimer’s disease using either fully automated or semi-automated techniques.
Competing Interest Statement
The authors have declared no competing interest.
Funding Statement
The research is supported by Airalzh Foundation AGYR2021 Life-Bio Grant, the Italian Ministry of University and Research PRIN COCOON (2017MYJ5TH) and PRIN 2021 RePlast (20202THZAW), the Italian Ministry of Health, Grant/Award Number: RF-2018-12366209 and PNRR-Health PNRR-MAD-2022-12376110.
Author Declarations
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Ethics Comittee of ASST SPedali CIvili of Brescia gave ethical approval for this work.
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Footnotes
updated corrected author list (in line wih manuscript)
DATA AVAILABILITY
The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.