Prospective evaluation of plasma pTau217 stability for the detection of Alzheimer's disease in a tertiary memory clinic
Por:
Arranz, J, Ferrer, R, Zhu, NL, Rubio-Guerra, S, Rodríguez-Baz, I, Arriola-Infante, JE, Maure-Blesa, L, Garcia-Castro, J, Selma-González, J, Carmona-Iragui, M, Barroeta, I, Illán-Gala, I, Santos-Santos, M, Fortea, J, Lleó, A, Tondo, M, Alcolea, D
Publicada:
5 jul 2025
Resumen:
BackgroundKnowledge on the effect of analytical variability and storage conditions are essential for the successful implementation of plasma pTau217 in prospective settings.AimsTo investigate the performance of plasma pTau217, measured in consecutive samples with LUMIPULSE, for detecting Alzheimer's disease in a prospective memory clinic setting, along with evaluating its pre-analytical and analytical stability.MethodsWe prospectively measured pTau217 using the LUMIPULSE automated platform in consecutive patient plasma samples collected between May and November 2024 at the Sant Pau Memory Unit (Barcelona). A subset of participants also underwent paired lumbar puncture for CSF AD biomarkers. We compared biomarker concentrations under different short-term storage conditions (4 degrees C vs -20 degrees C) and different protocol pipelines, and assessed lot-to-lot variability. In the subset with available CSF biomarkers, logistic regression was used to evaluate the association between plasma pTau217 and the likelihood of a positive (A +) or a negative (A-) CSF amyloid status. Using ROC analysis, in this prospective cohort we evaluated the accuracy of previously established thresholds derived from historical samples.ResultsWe included 280 participants, divided into two groups: those with (n = 109) and without CSF data (n = 171). Among the subset with CSF, 48% were A + , with a plasma pTau217 fold-change of 4.5 x compared to A-. We found no differences in plasma pTau217 concentrations between either short-term storage conditions. The overall coefficients of analytical variation ranged from 1.8% to 3.2%. Plasma pTau217 concentrations were slightly higher in paired samples of the clinical protocol. Following a two-threshold approach, the need of confirmatory tests (grey zones) after measuring plasma pTau217 ranged between 45.9% and 18.3% using our previously reported strict or lenient cutoffs (overall accuracy 96.6% and 92.1%, respectively).ConclusionsThe robust stability and low lot-to-lot variability of plasma pTau217 measurement in an automated platform result in high diagnostic performance of this biomarker in the prospective evaluation of patients in a memory clinic setting. These findings support its implementation into clinical routine, offering clinicians an accessible biomarker for AD diagnosis.
Filiaciones:
Arranz, J:
Hosp Santa Creu & Sant Pau, Dept Neurol, St Pau Memory Unit, IR St PAU, Barcelona, Spain
Fundacio Catalana Sindrome, Barcelona Med Ctr, Barcelona, Spain
Univ Autonoma Barcelona, Barcelona, Spain
Ferrer, R:
Univ Autonoma Barcelona, Hosp Santa Creu & St Pau, Serv Bioquim, IR St PAU, Barcelona, Spain
Zhu, NL:
Hosp Santa Creu & Sant Pau, Dept Neurol, St Pau Memory Unit, IR St PAU, Barcelona, Spain
Univ Autonoma Barcelona, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Neurodegenerat, Madrid, Spain
Rubio-Guerra, S:
Hosp Santa Creu & Sant Pau, Dept Neurol, St Pau Memory Unit, IR St PAU, Barcelona, Spain
Univ Autonoma Barcelona, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Neurodegenerat, Madrid, Spain
Rodríguez-Baz, I:
Hosp Santa Creu & Sant Pau, Dept Neurol, St Pau Memory Unit, IR St PAU, Barcelona, Spain
Fundacio Catalana Sindrome, Barcelona Med Ctr, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Neurodegenerat, Madrid, Spain
Arriola-Infante, JE:
Ctr Invest Biomed Red Enfermedades Neurodegenerat, Madrid, Spain
Torrecardenas Univ Hosp, Dept Neurol, Almeria, Spain
Maure-Blesa, L:
Hosp Santa Creu & Sant Pau, Dept Neurol, St Pau Memory Unit, IR St PAU, Barcelona, Spain
Fundacio Catalana Sindrome, Barcelona Med Ctr, Barcelona, Spain
Univ Autonoma Barcelona, Barcelona, Spain
Garcia-Castro, J:
Hosp Santa Creu & Sant Pau, Dept Neurol, St Pau Memory Unit, IR St PAU, Barcelona, Spain
Univ Autonoma Barcelona, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Neurodegenerat, Madrid, Spain
Selma-González, J:
Hosp Santa Creu & Sant Pau, Dept Neurol, St Pau Memory Unit, IR St PAU, Barcelona, Spain
Univ Autonoma Barcelona, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Neurodegenerat, Madrid, Spain
Carmona-Iragui, M:
Hosp Santa Creu & Sant Pau, Dept Neurol, St Pau Memory Unit, IR St PAU, Barcelona, Spain
Fundacio Catalana Sindrome, Barcelona Med Ctr, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Neurodegenerat, Madrid, Spain
Barroeta, I:
Hosp Santa Creu & Sant Pau, Dept Neurol, St Pau Memory Unit, IR St PAU, Barcelona, Spain
Fundacio Catalana Sindrome, Barcelona Med Ctr, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Neurodegenerat, Madrid, Spain
Illán-Gala, I:
Hosp Santa Creu & Sant Pau, Dept Neurol, St Pau Memory Unit, IR St PAU, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Neurodegenerat, Madrid, Spain
Santos-Santos, M:
Hosp Santa Creu & Sant Pau, Dept Neurol, St Pau Memory Unit, IR St PAU, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Neurodegenerat, Madrid, Spain
Fortea, J:
Hosp Santa Creu & Sant Pau, Dept Neurol, St Pau Memory Unit, IR St PAU, Barcelona, Spain
Fundacio Catalana Sindrome, Barcelona Med Ctr, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Neurodegenerat, Madrid, Spain
Lleó, A:
Hosp Santa Creu & Sant Pau, Dept Neurol, St Pau Memory Unit, IR St PAU, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Neurodegenerat, Madrid, Spain
Tondo, M:
Univ Autonoma Barcelona, Hosp Santa Creu & St Pau, Serv Bioquim, IR St PAU, Barcelona, Spain
Ctr Invest Biomed Red Diabet & Enfermedades Metab, Madrid, Spain
Alcolea, D:
Hosp Santa Creu & Sant Pau, Dept Neurol, St Pau Memory Unit, IR St PAU, Barcelona, Spain
Ctr Invest Biomed Red Enfermedades Neurodegenerat, Madrid, Spain
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