Biomarkers

Area of Science:

• Neuroscience
• Biochemistry
• Clinical Diagnostics

Background:

• The BD-Tau immunoassay is under development for differentiating dementia types and indicating neurologic injury.
• Analytical performance of BD-Tau on Beckman Coulter Access 2 and DxI 9000 analyzers is evaluated.

Purpose of the Study:

• To describe the analytical performance characteristics of the BD-Tau immunoassay.
• To assess BD-Tau's utility in distinguishing between Alzheimer's disease (AD), frontotemporal dementia (FTD), and healthy controls.

Main Methods:

• A two-step sandwich immunoassay using anti-N-terminal Tau monoclonal antibodies.
• Evaluation of 69 patient samples (AD, FTD) and 20 controls using EDTA plasma and serum.
• Method comparison between Beckman Coulter Access 2 and DxI 9000 platforms.

Main Results:

• The BD-Tau assay demonstrated a measuring range up to ~2000 pg/mL with low variability (<4.0% CV).
• High correlation (r=0.999) observed between Access 2 and DxI 9000 platforms.
• Significant differences in BD-Tau levels were found between AD/FTD patients and controls, with high selectivity.

Conclusions:

• The automated BD-Tau assay is fast, sensitive, and precise on Beckman Coulter platforms.
• The assay shows high selectivity in differentiating neurodegenerative disease patients from healthy individuals.
• BD-Tau measurements are suitable for both plasma and serum samples.