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

Alzheimer’s & Dementia | May 27, 2021

Triana-Baltzer G, Moughadam S, Slemmon R, Van Kolen K, Theunis C, Mercken M and Kolb HC

Alzheimers Dement (Amst). 2021 May 27;13(1):e12204

DOI: 10.1002/dad2.12204

This study was performed using Simoa Homebrew assays.

Abstract

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.

This study was performed using the Quanterix HD-1 Analyzer.

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