Clinical performance of scalable automated p-tau 217 multi-analyte algorithmic blood test with reduced intermediate zone using multiplexed digital immunoassay.

ABSTRACT:

Introduction

To address an urgent need for a scalable, accurate blood test for brain amyloid pathology that provides a conclusive result for the greatest number of patients, we developed a multi-analyte algorithmic test combining phosphorylated tau (p-tau) 217 with four other biomarkers.

Methods

Multiplexed digital immunoassays measured p-tau 217, amyloid beta 42/40, glial fibrillary acidic protein, and neurofilament light chain in 730 symptomatic individuals (training set) to establish an algorithm with cutoffs, and 1082 symptomatic individuals (validation set) from three independent cohorts to identify brain amyloid pathology.

Results

The algorithmic in validation gave an area under the curve = 0.92, yielding 90% agreement with amyloid positron emission tomography a

SUBMITTER: Wilson DH 

PROVIDER: S-EPMC12635865 | biostudies-literature | 2025 Oct-Dec

REPOSITORIES: biostudies-literature