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
This study was performed using Simoa Homebrew assays.
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.
Share this page