Development and validation of a high‐sensitivity assay for measuring p217+tau in plasma

• Published in: Alzheimer's & dementia : diagnosis, assessment & disease monitoring Vol. 13; no. 1; pp. e12204 - n/a
• Main Authors: Triana‐Baltzer, Gallen, Moughadam, Setareh, Slemmon, Randy, Van Kolen, Kristof, Theunis, Clara, Mercken, Marc, Kolb, Hartmuth C.
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 2021; John Wiley and Sons Inc; Wiley
• Subjects: Alzheimer's disease; biomarker; Biomarkers; Blood‐based Biomarkers; Clinical trials; Dementia; Demographics; Enzymes; Informed consent; p212tau; p217tau; Peptides; Phosphorylation; Plasma; Reagents; tau; Tomography; United States > US; p212tau; p217tau; tau; biomarker; plasma; Alzheimer's disease; phosphorylation
• ISSN: 2352-8729; 2352-8729
• DOI: 10.1002/dad2.12204

Introduction Diagnosis of Alzheimer's disease (AD) based on amyloid beta (A), pathologic tau (T), and neurodegeneration (N) biomarkers in peripheral fluids promises to accelerate clinical trials and intercept disease earlier. Methods Qualification of a Simoa plasma p217+tau assay was performed, followed by clinical utility evaluation in a cohort of 227 subjects with broad A and T spectrum. Results The p217+tau plasma assay was accurate, precise, dilution linear, and highly sensitive. All measured samples were within linear range of the assay, presented higher concentration in AD versus healthy controls (P < .0001), and plasma and cerebrospinal fluid levels correlated (r2 = 0.35). The plasma p217+tau results were predictive of central T and A status (area under the curve = 0.90 and 0.90, respectively) with low false +/– rates. Discussion The assay described here exhibits good technical performance and shows potential as a highly accurate peripheral biomarker for A or T status in AD and cognitively normal subjects.