Alzheimer's & dementia (Amsterdam, Netherlands) · 2026
Comparison of three plasma p-tau217 assays to detect PET-confirmed Alzheimer's pathologies.
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Matsuura Sayo, Tagai Kenji, Tatebe Harutsugu, Goto Ryoji, Matsumoto Hideki, Oyama Asaka, Momota Yuki, Ichihashi Masanori, Kataoka Yuko, Matsuoka Kiwamu, Kokubo Naomi, Kamada Tetsuji, Osawa Kenta, Chishiki Yoshikazu, Moriguchi Sho, Komatsu Yuki, Seki Chie, Takahata Keisuke, Endo Hironobu, Kudo Takashi, Higuchi Makoto, Tokuda Takahiko
Аннотация
INTRODUCTION: Plasma phosphorylated tau 217 (p-tau217) has emerged as a promising blood-based biomarker for Alzheimer's disease (AD) diagnosis, but cross-platform comparability remains unclear. We evaluated three platforms-single-molecule array (Simoa), Ella, and Lumipulse.
METHODS: We measured plasma p-tau217 from 113 participants underwent amyloid and tau positron emission tomography (PET; 55 AD, 36 controls, 22 non-AD; classified by amyloid PET status). Diagnostic performance and PET correlations were assessed across all three platforms.
RESULTS: All assays distinguished amyloid-positive from -negative individuals with high accuracy (89%-95%). Simoa showed superior sensitivity, Ella the smallest gray zone in a two-cutoff framework, and Lumipulse strongest tau correlation (r = 0.770). Multiple regression revealed higher amyloid β-values for Simoa/Ella (0.420-0.518) and higher tau β-values for Lumipulse (0.630). All platforms detected elevated p-tau217 in amyloid-positive individuals with substantial tau pathology despite relatively low Centiloid.
DISCUSSION: All platforms accurately detect AD with platform-specific differences, which inform platform selection for clinical and research applications.
TRIAL REGISTRATION: Clinical Trial Registration: UMIN Clinical Trials Registry (UMIN-CTR), Trial ID: UMIN000057548, Registration Date: April 8, 2025.
METHODS: We measured plasma p-tau217 from 113 participants underwent amyloid and tau positron emission tomography (PET; 55 AD, 36 controls, 22 non-AD; classified by amyloid PET status). Diagnostic performance and PET correlations were assessed across all three platforms.
RESULTS: All assays distinguished amyloid-positive from -negative individuals with high accuracy (89%-95%). Simoa showed superior sensitivity, Ella the smallest gray zone in a two-cutoff framework, and Lumipulse strongest tau correlation (r = 0.770). Multiple regression revealed higher amyloid β-values for Simoa/Ella (0.420-0.518) and higher tau β-values for Lumipulse (0.630). All platforms detected elevated p-tau217 in amyloid-positive individuals with substantial tau pathology despite relatively low Centiloid.
DISCUSSION: All platforms accurately detect AD with platform-specific differences, which inform platform selection for clinical and research applications.
TRIAL REGISTRATION: Clinical Trial Registration: UMIN Clinical Trials Registry (UMIN-CTR), Trial ID: UMIN000057548, Registration Date: April 8, 2025.