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| Pàgina inicial > Articles > Articles publicats > Prospective evaluation of plasma pTau217 stability for the detection of Alzheimer's disease in a tertiary memory clinic |
(Institut de Recerca Sant Pau) (Institut de Recerca Sant Pau) (Institut de Recerca Sant Pau) (Institut de Recerca Sant Pau) (Institut de Recerca Sant Pau) (Institut de Recerca Sant Pau) (Institut de Recerca Sant Pau) (Institut de Recerca Sant Pau) (Institut de Recerca Sant Pau) (Institut de Recerca Sant Pau) (Institut de Recerca Sant Pau) (Institut de Recerca Sant Pau)
| Data: | 2025 |
| Resum: | Background: Knowledge on the effect of analytical variability and storage conditions are essential for the successful implementation of plasma pTau in prospective settings. Aims: To investigate the performance of plasma pTau, 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. Methods: We prospectively measured pTau 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 (4ºC vs -20ºC) 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. Results: We 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 pTau fold-change of 4. 5 × compared to A-. We found no differences in plasma pTau concentrations between either short-term storage conditions. The overall coefficients of analytical variation ranged from 1. 8% to 3. 2%. Plasma pTau 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 pTau ranged between 45. 9% and 18. 3% using our previously reported strict or lenient cutoffs (overall accuracy 96. 6% and 92. 1%, respectively). Conclusions: The robust stability and low lot-to-lot variability of plasma pTau 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. |
| Ajuts: | Instituto de Salud Carlos III PI21/00791 Ministerio de Economía y Competitividad PI14/01126 Instituto de Salud Carlos III PI17/01019 Instituto de Salud Carlos III PI20/01473 Ministerio de Economía y Competitividad PI13/01532 Ministerio de Economía y Competitividad PI16/01825 Instituto de Salud Carlos III PI18/00335 Instituto de Salud Carlos III PI22/00785 Instituto de Salud Carlos III PI19/00882 Instituto de Salud Carlos III PI18/00435 Instituto de Salud Carlos III PI21/00791 Instituto de Salud Carlos III PI22/00611 Instituto de Salud Carlos III PI17/01896 Instituto de Salud Carlos III AC19/00103 Generalitat de Catalunya 2017/SGR-00547 Generalitat de Catalunya SLT006/17/125 Generalitat de Catalunya SLT006/17/119 Generalitat de Catalunya SLT002/16/408 "la Caixa" Foundation 20141210 "la Caixa" Foundation 044412 "la Caixa" Foundation 20142610 Instituto de Salud Carlos III PI20/01473 Instituto de Salud Carlos III PI23/01786 |
| Drets: | Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.  |
| Llengua: | Anglès |
| Document: | Article ; recerca ; Versió publicada |
| Matèria: | Stability ; Plasma ; Biomarkers ; Alzheimer ; Blood ; Amyloid ; Tau |
| Publicat a: | Alzheimer's research & therapy, Vol. 17, Num. 1 (July 2025) , ISSN 1758-9193 |
