ArticleJournal of neurology2026
Clinical performance and decision thresholds of an automated plasma p-tau217 assay for amyloid pathology in a Taiwanese memory clinic.
Article in Journal of neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundFully automated plasma p-tau217 assays may facilitate clinical implementation of blood-based testing for Alzheimer's disease (AD) amyloid pathology. However, data on assay-specific decision thresholds and clinical utility in East Asian memory-clinic populations remain limited.
methodsWe evaluated plasma Roche p-tau217 in 139 participants from a Taiwanese memory clinic using amyloid PET or CSF biomarkers as reference standards. Diagnostic performance and single- and dual-cutoff decision thresholds were assessed. Head-to-head comparisons with Simoa p-tau217, Roche p-tau181, and neurofilament light chain (NfL) were performed in participants with complete biomarker profiles. Associations with body mass index and renal function were also examined.
resultsRoche p-tau217 showed high diagnostic accuracy for amyloid β (Aβ) positivity (AUC 0.973). In the primary threshold-analysis cohort, a dual-cutoff approach using thresholds of 0.225 and 0.336 pg/mL classified 88.1% of participants into definitive negative or positive zones, with an overall percent agreement of 95.0% within these zones. Sensitivity analyses showed similar performance. In participants with complete biomarker profiles, no statistically significant difference in AUC was detected between Roche p-tau217 and Simoa p-tau217, whereas Roche p-tau217 showed significantly higher AUC than p-tau181 and NfL. Lower estimated glomerular filtration rate (eGFR) was independently associated with higher p-tau217 concentrations.
conclusionsFully automated Roche p-tau217 showed high diagnostic performance for identifying Aβ pathology. Cohort-derived dual decision thresholds classified most participants into definitive zones and may support plasma p-tau217-based triage for confirmatory amyloid testing in memory-clinic practice. External validation is required before clinical implementation.
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