Diagnostic performance of an automated plasma p-tau217 chemiluminescent assay for detecting Aβ pathology in…

Cohort studyThe journal of prevention of Alzheimer's disease· Aug 2026

Diagnostic performance of an automated plasma p-tau217 chemiluminescent assay for detecting Aβ pathology in a Chinese memory clinic cohort.

Shuai Chen, Feng-Yu Wang, Rong Li … Jie-Wen Zhang

Neurologic ImagingCohort studyDiagnosisQ1IF 6.0

Plasma p-tau217 accurately detects amyloid-beta pathology in memory clinic patients

Diagnostic performance of an automated plasma p-tau217 chemiluminescent assay for detecting Aβ pathology in a Chinese memory clinic cohort.

Shuai Chen … Jie-Wen Zhang

The journal of prevention of Alzheimer's disease · Aug 2026

Background

Blood-based biomarkers have emerged as promising tools for detecting Alzheimer's disease (AD) pathology, but validation of automated plasma assays in Chinese clinical populations remains limited.

Purpose

This study evaluated the diagnostic performance of a fully automated chemiluminescent plasma biomarker assay for detecting amyloid-β (Aβ) pathology in a Chinese memory clinic cohort under different pre-analytical conditions.

Methods

We enrolled 409 cognitively impaired participants from a single-center memory clinic, using amyloid-β positron emission tomography (Aβ-PET) as the reference standard.

n = 95 participants

AUCs 0.92-0.95

Results

AUCs 0.92-0.95

AUROC scale to 1.0; higher means better separation of amyloid-positive from negative patients

n = 95 participants

More results

GFAP (AUCs 0.82-0.83) and the Aβ42/40 ratio (AUCs 0.76-0.81) showed moderate discriminative performance.

Plasma p-tau217 alone achieved diagnostic accuracy comparable to composite biomarker models.

More results

A dual cut-point strategy reduced the indeterminate zone to <30%, with positive predictive values of 0.97-0.99 and negative predictive values of 0.86-0.87.

Plasma p-tau217 was also significantly associated with tau-PET burden in both meta-temporal and neocortical regions (P < 0.001).

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Conclusion · 1 of 2

This automated chemiluminescent plasma biomarker assay demonstrated high diagnostic accuracy for detecting Aβ pathology in a Chinese memory clinic cohort under different pre-analytical conditions.

Conclusion · 2 of 2

The findings support its potential utility as a practical blood-based biomarker approach in specialized clinical settings, while further multicenter studies are needed to confirm its generalizability across broader populations and healthcare environments.

Diagnostic performance of an automated plasma p-tau217 chemiluminescent assay for detecting Aβ pathology in a Chinese memory clinic cohort.

Diagnostic performance of an automated plasma p-tau217 chemiluminescent assay for detecting Aβ pathology in a Chinese memory clinic cohort.

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