Analytical and clinical validation of a high accuracy fully automated digital immunoassay for plasma phospho-Tau 217 for clinical use in detecting amyloid pathology.

ABSTRACT:

Background

With the emergence of disease-modifying therapies for Alzheimer's disease (AD), there is an urgent need for scalable, accurate, and well-validated blood test alternatives to positron emission topography (PET) and lumbar punctures for identifying amyloid pathology to facilitate identification of candidates for therapy. Plasma p-Tau 217 has emerged as a plasma-based biomarker with sufficient sensitivity and specificity to both rule out and rule in amyloid pathology with high confidence, potentially serving as a readily scalable non-invasive test to aid AD diagnosis. In this report, we describe robust analytical and clinical validation of a lab developed test for plasma p-Tau 217 suitable for clinical diagnostic use.

Methods

A high sensitivity digital immunoassay usi

SUBMITTER: Wilson D 

PROVIDER: S-EPMC12287614 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature