Diagnostic Performance of the Fully Automated Roche Elecsys Plasma p-tau217 Assay for Amyloid Pathology in a Taiwanese Memory Clinic Cohort

Yung-Shuan Lina, Meng-Ju Tsaia, Chien-Liang Laib, Hsiang-Ling Hob†, Jong-Ling Fuha†
aDepartment of Neurology, Neurological Institute, Taipei Veterans General Hospital, Taipei, 112201, Taiwan.
bDepartment of Pathology and Laboratory Medicine, Taipei Veterans General Hospital, Taipei 112201, Taiwan
†Hsiang-Ling Ho and Jong-Ling Fuh share corresponding authorship.

Highlights

• Roche plasma p-tau217 showed high accuracy for Aβ positivity. • Roche and Simoa p-tau217 AUCs did not differ significantly. • A dual-cutoff framework classified 88.1% into definitive zones. • Lower eGFR increased p-tau217 but did not impair classification. • Findings support scalable plasma p-tau217 triage in East Asian memory clinics.

INTRODUCTION
Automated plasma p-tau217 assays may enable scalable identification of Alzheimer’s disease (AD) amyloid pathology, but validation in East Asian cohorts and clinical implementation strategies remain limited.

METHODS
We evaluated plasma Roche p-tau217 in 139 participants from a Taiwanese memory clinic using amyloid PET or CSF biomarkers as reference standards. Diagnostic performance, dual-cutoff classification, biomarker comparisons, and renal function effects were assessed using ROC analyses and subgroup comparisons.

RESULTS
Plasma Roche p-tau217 showed high accuracy for Aβ positivity (AUC 0.973). In the subgroup with complete biomarker profile, its AUC did not differ significantly from Simoa p-tau217 and exceeded those of p-tau181 and NfL. A dual-cutoff framework classified 88.1% of participants into definitive zones. Lower eGFR was associated with higher p-tau217 concentrations but did not affect classification performance.

CONCLUSIONS
Plasma Roche p-tau217 showed high diagnostic performance for identifying brain Aβ pathology in this Taiwanese memory clinic cohort. The cohort-derived dual-cutoff framework supports its potential role as a scalable triage biomarker, although external validation is needed, particularly in independent cohorts, earlier-stage clinical populations, and individuals advanced renal impairment.

 

CONTACT
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