ArticleAnnals of clinical and translational neurology2026
Predictive Ability of Plasma p-tau217 for β-Amyloid Status: A Prospective Multicenter Study.
Article in Annals of clinical and translational 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
objectivePlasma tau phosphorylated at threonine 217 (p-tau217) measured with fully automated platforms has shown high accuracy for Alzheimer's disease (AD) diagnosis, but real-world multicenter data remain limited. We aimed to validate the diagnostic performance of p-tau217 for identifying AD pathology in a real-world multicenter cohort across seven memory clinics in Catalonia (Spain), with only one tertiary hospital with prior experience in AD blood-based biomarkers.
methodsIn this prospective multicenter study, consecutive patients with cognitive impairment undergoing routine cerebrospinal fluid (CSF) biomarker testing were included. Plasma samples were collected following a standardized pre-analytical protocol and analyzed centrally using the Lumipulse G p-tau217 assay (Fujirebio). Diagnostic accuracy for Aβ status was assessed overall and across sites.
resultsA total of 185 participants were included. Plasma p-tau217 showed excellent accuracy for CSF-defined Aβ status (AUC 0.916) with consistent performance across centers. Using a single cut-off, diagnostic accuracy reached 84.9%, which prompted the use of a dual-threshold strategy to improve overall performance and to classify p-tau217 values into low, intermediate, and high probability categories of Aβ positivity. When applying a strict model with 97.5% sensitivity and specificity (cut-offs 0.146/0.486 pg/mL), 42.7% of participants fell within the intermediate zone, whereas the remaining 57.3% were confidently classified with 95.3% accuracy.
interpretationIn a real-world multicenter memory-clinic cohort, plasma p-tau217 measured on a fully automated platform accurately discriminated CSF Aβ status and enabled reliable rule-in/rule-out classification in over half of patients. These findings support its broader clinical use as an initial diagnostic tool for AD.
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