Prospective evaluation of plasma pTau217 stability for the detection of Alzheimer's disease in a tertiary memory clinic

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�...

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Autores: Arranz Martínez, Javier|||0000-0003-0891-1215, Ferrer Pérez, Rosa|||0009-0004-9477-699X, Zhu, Nuole|||0000-0002-0015-9455, Rubio Guerra, Sara|||0000-0001-7652-8029, Rodríguez-Baz, Íñigo|||0000-0003-3039-9115, Arriola-Infante, J.E., Maure Blesa, Lucia|||0000-0001-5643-7971, Garcia Castro, Jesús|||0000-0003-1503-4775, Selma Gonzalez, Judit|||0009-0006-1021-4653, Carmona Iragui, Maria|||0000-0001-6914-2339, Barroeta, Isabel|||0000-0003-2764-7923, Illán-Gala, Ignacio|||0000-0002-5418-2052, Santos Santos, Miguel Ángel|||0000-0003-1567-617X, Fortea, Juan|||0000-0002-1340-638X, Lleó, Alberto|||0000-0002-2568-5478, Tondo Colomer, Mireia|||0000-0002-0301-9984, Alcolea, Daniel|||0000-0002-3819-3245
Tipo de recurso: artículo
Fecha de publicación:2025
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:324111
Acceso en línea:https://ddd.uab.cat/record/324111
https://dx.doi.org/urn:doi:10.1186/s13195-025-01779-7
Access Level:acceso abierto
Palabra clave:Stability
Plasma
Biomarkers
Alzheimer
Blood
Amyloid
Tau
id ES_3e27d74006feab46f2d676c4199950ee
oai_identifier_str oai:ddd.uab.cat:324111
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv Prospective evaluation of plasma pTau217 stability for the detection of Alzheimer's disease in a tertiary memory clinic
title Prospective evaluation of plasma pTau217 stability for the detection of Alzheimer's disease in a tertiary memory clinic
spellingShingle Prospective evaluation of plasma pTau217 stability for the detection of Alzheimer's disease in a tertiary memory clinic
Arranz Martínez, Javier|||0000-0003-0891-1215
Stability
Plasma
Biomarkers
Alzheimer
Blood
Amyloid
Tau
title_short Prospective evaluation of plasma pTau217 stability for the detection of Alzheimer's disease in a tertiary memory clinic
title_full Prospective evaluation of plasma pTau217 stability for the detection of Alzheimer's disease in a tertiary memory clinic
title_fullStr Prospective evaluation of plasma pTau217 stability for the detection of Alzheimer's disease in a tertiary memory clinic
title_full_unstemmed Prospective evaluation of plasma pTau217 stability for the detection of Alzheimer's disease in a tertiary memory clinic
title_sort Prospective evaluation of plasma pTau217 stability for the detection of Alzheimer's disease in a tertiary memory clinic
dc.creator.none.fl_str_mv Arranz Martínez, Javier|||0000-0003-0891-1215
Ferrer Pérez, Rosa|||0009-0004-9477-699X
Zhu, Nuole|||0000-0002-0015-9455
Rubio Guerra, Sara|||0000-0001-7652-8029
Rodríguez-Baz, Íñigo|||0000-0003-3039-9115
Arriola-Infante, J.E.
Maure Blesa, Lucia|||0000-0001-5643-7971
Garcia Castro, Jesús|||0000-0003-1503-4775
Selma Gonzalez, Judit|||0009-0006-1021-4653
Carmona Iragui, Maria|||0000-0001-6914-2339
Barroeta, Isabel|||0000-0003-2764-7923
Illán-Gala, Ignacio|||0000-0002-5418-2052
Santos Santos, Miguel Ángel|||0000-0003-1567-617X
Fortea, Juan|||0000-0002-1340-638X
Lleó, Alberto|||0000-0002-2568-5478
Tondo Colomer, Mireia|||0000-0002-0301-9984
Alcolea, Daniel|||0000-0002-3819-3245
author Arranz Martínez, Javier|||0000-0003-0891-1215
author_facet Arranz Martínez, Javier|||0000-0003-0891-1215
Ferrer Pérez, Rosa|||0009-0004-9477-699X
Zhu, Nuole|||0000-0002-0015-9455
Rubio Guerra, Sara|||0000-0001-7652-8029
Rodríguez-Baz, Íñigo|||0000-0003-3039-9115
Arriola-Infante, J.E.
Maure Blesa, Lucia|||0000-0001-5643-7971
Garcia Castro, Jesús|||0000-0003-1503-4775
Selma Gonzalez, Judit|||0009-0006-1021-4653
Carmona Iragui, Maria|||0000-0001-6914-2339
Barroeta, Isabel|||0000-0003-2764-7923
Illán-Gala, Ignacio|||0000-0002-5418-2052
Santos Santos, Miguel Ángel|||0000-0003-1567-617X
Fortea, Juan|||0000-0002-1340-638X
Lleó, Alberto|||0000-0002-2568-5478
Tondo Colomer, Mireia|||0000-0002-0301-9984
Alcolea, Daniel|||0000-0002-3819-3245
author_role author
author2 Ferrer Pérez, Rosa|||0009-0004-9477-699X
Zhu, Nuole|||0000-0002-0015-9455
Rubio Guerra, Sara|||0000-0001-7652-8029
Rodríguez-Baz, Íñigo|||0000-0003-3039-9115
Arriola-Infante, J.E.
Maure Blesa, Lucia|||0000-0001-5643-7971
Garcia Castro, Jesús|||0000-0003-1503-4775
Selma Gonzalez, Judit|||0009-0006-1021-4653
Carmona Iragui, Maria|||0000-0001-6914-2339
Barroeta, Isabel|||0000-0003-2764-7923
Illán-Gala, Ignacio|||0000-0002-5418-2052
Santos Santos, Miguel Ángel|||0000-0003-1567-617X
Fortea, Juan|||0000-0002-1340-638X
Lleó, Alberto|||0000-0002-2568-5478
Tondo Colomer, Mireia|||0000-0002-0301-9984
Alcolea, Daniel|||0000-0002-3819-3245
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Stability
Plasma
Biomarkers
Alzheimer
Blood
Amyloid
Tau
topic Stability
Plasma
Biomarkers
Alzheimer
Blood
Amyloid
Tau
description 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.
publishDate 2025
dc.date.none.fl_str_mv 2
2025-01-01
2025
2025-01-01
dc.type.none.fl_str_mv Article
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VoR
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dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/324111
https://dx.doi.org/urn:doi:10.1186/s13195-025-01779-7
url https://ddd.uab.cat/record/324111
https://dx.doi.org/urn:doi:10.1186/s13195-025-01779-7
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.relation.none.fl_str_mv Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI21/00791
Ministerio de Economía y Competitividad https://doi.org/10.13039/501100003329 PI14/01126
Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI17/01019
Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI20/01473
Ministerio de Economía y Competitividad https://doi.org/10.13039/501100003329 PI13/01532
Ministerio de Economía y Competitividad https://doi.org/10.13039/501100003329 PI16/01825
Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI18/00335
Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI22/00785
Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI19/00882
Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI18/00435
Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI22/00611
Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI17/01896
Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 AC19/00103
Generalitat de Catalunya https://doi.org/10.13039/501100002809 2017/SGR-00547
Generalitat de Catalunya https://doi.org/10.13039/501100002809 SLT006/17/125
Generalitat de Catalunya https://doi.org/10.13039/501100002809 SLT006/17/119
Generalitat de Catalunya https://doi.org/10.13039/501100002809 SLT002/16/408
"la Caixa" Foundation https://doi.org/10.13039/100010434 20141210
"la Caixa" Foundation https://doi.org/10.13039/100010434 044412
"la Caixa" Foundation https://doi.org/10.13039/100010434 20142610
Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI23/01786
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
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instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
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spelling Prospective evaluation of plasma pTau217 stability for the detection of Alzheimer's disease in a tertiary memory clinicArranz Martínez, Javier|||0000-0003-0891-1215Ferrer Pérez, Rosa|||0009-0004-9477-699XZhu, Nuole|||0000-0002-0015-9455Rubio Guerra, Sara|||0000-0001-7652-8029Rodríguez-Baz, Íñigo|||0000-0003-3039-9115Arriola-Infante, J.E.Maure Blesa, Lucia|||0000-0001-5643-7971Garcia Castro, Jesús|||0000-0003-1503-4775Selma Gonzalez, Judit|||0009-0006-1021-4653Carmona Iragui, Maria|||0000-0001-6914-2339Barroeta, Isabel|||0000-0003-2764-7923Illán-Gala, Ignacio|||0000-0002-5418-2052Santos Santos, Miguel Ángel|||0000-0003-1567-617XFortea, Juan|||0000-0002-1340-638XLleó, Alberto|||0000-0002-2568-5478Tondo Colomer, Mireia|||0000-0002-0301-9984Alcolea, Daniel|||0000-0002-3819-3245StabilityPlasmaBiomarkersAlzheimerBloodAmyloidTauBackground: 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. 22025-01-0120252025-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/324111https://dx.doi.org/urn:doi:10.1186/s13195-025-01779-7reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengInstituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI21/00791Ministerio de Economía y Competitividad https://doi.org/10.13039/501100003329 PI14/01126Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI17/01019Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI20/01473Ministerio de Economía y Competitividad https://doi.org/10.13039/501100003329 PI13/01532Ministerio de Economía y Competitividad https://doi.org/10.13039/501100003329 PI16/01825Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI18/00335Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI22/00785Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI19/00882Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI18/00435Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI22/00611Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI17/01896Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 AC19/00103Generalitat de Catalunya https://doi.org/10.13039/501100002809 2017/SGR-00547Generalitat de Catalunya https://doi.org/10.13039/501100002809 SLT006/17/125Generalitat de Catalunya https://doi.org/10.13039/501100002809 SLT006/17/119Generalitat de Catalunya https://doi.org/10.13039/501100002809 SLT002/16/408"la Caixa" Foundation https://doi.org/10.13039/100010434 20141210"la Caixa" Foundation https://doi.org/10.13039/100010434 044412"la Caixa" Foundation https://doi.org/10.13039/100010434 20142610Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI23/01786open accesshttp://purl.org/coar/access_right/c_abf2Aquest 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.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:3241112026-06-06T12:50:31Z
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