Prospective evaluation of plasma pTau217 stability for the detection of Alzheimer’s disease in a tertiary memory clinic
Abstract Background Knowledge on the effect of analytical variability and storage conditions are essential for the successful implementation of plasma pTau217 in prospective settings. Aims To investigate the performance of plasma pTau217, measured in consecutive samples with LUMIPULSE, for detecting...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2025-07-01
|
| Series: | Alzheimer’s Research & Therapy |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13195-025-01779-7 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849334859917426688 |
|---|---|
| author | Javier Arranz Rosa Ferrer Nuole Zhu Sara Rubio-Guerra Íñigo Rodríguez-Baz José Enrique Arriola-Infante Lucía Maure-Blesa Jesús Garcia-Castro Judit Selma-González María Carmona-Iragui Isabel Barroeta Ignacio Illán-Gala Miguel Santos-Santos Juan Fortea Alberto Lleó Mireia Tondo Daniel Alcolea |
| author_facet | Javier Arranz Rosa Ferrer Nuole Zhu Sara Rubio-Guerra Íñigo Rodríguez-Baz José Enrique Arriola-Infante Lucía Maure-Blesa Jesús Garcia-Castro Judit Selma-González María Carmona-Iragui Isabel Barroeta Ignacio Illán-Gala Miguel Santos-Santos Juan Fortea Alberto Lleó Mireia Tondo Daniel Alcolea |
| author_sort | Javier Arranz |
| collection | DOAJ |
| description | Abstract Background Knowledge on the effect of analytical variability and storage conditions are essential for the successful implementation of plasma pTau217 in prospective settings. Aims To 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. Methods We 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 (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 pTau217 fold-change of 4.5 × 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). Conclusions The 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. |
| format | Article |
| id | doaj-art-ab366199f4fb43c0a80a024dd3f6de9c |
| institution | Kabale University |
| issn | 1758-9193 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Alzheimer’s Research & Therapy |
| spelling | doaj-art-ab366199f4fb43c0a80a024dd3f6de9c2025-08-20T03:45:27ZengBMCAlzheimer’s Research & Therapy1758-91932025-07-0117111310.1186/s13195-025-01779-7Prospective evaluation of plasma pTau217 stability for the detection of Alzheimer’s disease in a tertiary memory clinicJavier Arranz0Rosa Ferrer1Nuole Zhu2Sara Rubio-Guerra3Íñigo Rodríguez-Baz4José Enrique Arriola-Infante5Lucía Maure-Blesa6Jesús Garcia-Castro7Judit Selma-González8María Carmona-Iragui9Isabel Barroeta10Ignacio Illán-Gala11Miguel Santos-Santos12Juan Fortea13Alberto Lleó14Mireia Tondo15Daniel Alcolea16Sant Pau Memory Unit, Department of Neurology, IR SANT PAU, Hospital de La Santa Creu I Sant PauServei de Bioquímica, IR SANT PAU, Hospital de La Santa Creu I Sant Pau, Universitat Autònoma de BarcelonaSant Pau Memory Unit, Department of Neurology, IR SANT PAU, Hospital de La Santa Creu I Sant PauSant Pau Memory Unit, Department of Neurology, IR SANT PAU, Hospital de La Santa Creu I Sant PauSant Pau Memory Unit, Department of Neurology, IR SANT PAU, Hospital de La Santa Creu I Sant PauCentro de Investigación Biomédica en Red en Enfermedades Neurodegenerativas (CIBERNED)Sant Pau Memory Unit, Department of Neurology, IR SANT PAU, Hospital de La Santa Creu I Sant PauSant Pau Memory Unit, Department of Neurology, IR SANT PAU, Hospital de La Santa Creu I Sant PauSant Pau Memory Unit, Department of Neurology, IR SANT PAU, Hospital de La Santa Creu I Sant PauSant Pau Memory Unit, Department of Neurology, IR SANT PAU, Hospital de La Santa Creu I Sant PauSant Pau Memory Unit, Department of Neurology, IR SANT PAU, Hospital de La Santa Creu I Sant PauSant Pau Memory Unit, Department of Neurology, IR SANT PAU, Hospital de La Santa Creu I Sant PauSant Pau Memory Unit, Department of Neurology, IR SANT PAU, Hospital de La Santa Creu I Sant PauSant Pau Memory Unit, Department of Neurology, IR SANT PAU, Hospital de La Santa Creu I Sant PauSant Pau Memory Unit, Department of Neurology, IR SANT PAU, Hospital de La Santa Creu I Sant PauServei de Bioquímica, IR SANT PAU, Hospital de La Santa Creu I Sant Pau, Universitat Autònoma de BarcelonaSant Pau Memory Unit, Department of Neurology, IR SANT PAU, Hospital de La Santa Creu I Sant PauAbstract Background Knowledge on the effect of analytical variability and storage conditions are essential for the successful implementation of plasma pTau217 in prospective settings. Aims To 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. Methods We 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 (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 pTau217 fold-change of 4.5 × 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). Conclusions The 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.https://doi.org/10.1186/s13195-025-01779-7StabilityPlasmaBiomarkersAlzheimerBloodAmyloid |
| spellingShingle | Javier Arranz Rosa Ferrer Nuole Zhu Sara Rubio-Guerra Íñigo Rodríguez-Baz José Enrique Arriola-Infante Lucía Maure-Blesa Jesús Garcia-Castro Judit Selma-González María Carmona-Iragui Isabel Barroeta Ignacio Illán-Gala Miguel Santos-Santos Juan Fortea Alberto Lleó Mireia Tondo Daniel Alcolea Prospective evaluation of plasma pTau217 stability for the detection of Alzheimer’s disease in a tertiary memory clinic Alzheimer’s Research & Therapy Stability Plasma Biomarkers Alzheimer Blood Amyloid |
| title | 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_short | 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 |
| topic | Stability Plasma Biomarkers Alzheimer Blood Amyloid |
| url | https://doi.org/10.1186/s13195-025-01779-7 |
| work_keys_str_mv | AT javierarranz prospectiveevaluationofplasmaptau217stabilityforthedetectionofalzheimersdiseaseinatertiarymemoryclinic AT rosaferrer prospectiveevaluationofplasmaptau217stabilityforthedetectionofalzheimersdiseaseinatertiarymemoryclinic AT nuolezhu prospectiveevaluationofplasmaptau217stabilityforthedetectionofalzheimersdiseaseinatertiarymemoryclinic AT sararubioguerra prospectiveevaluationofplasmaptau217stabilityforthedetectionofalzheimersdiseaseinatertiarymemoryclinic AT inigorodriguezbaz prospectiveevaluationofplasmaptau217stabilityforthedetectionofalzheimersdiseaseinatertiarymemoryclinic AT joseenriquearriolainfante prospectiveevaluationofplasmaptau217stabilityforthedetectionofalzheimersdiseaseinatertiarymemoryclinic AT luciamaureblesa prospectiveevaluationofplasmaptau217stabilityforthedetectionofalzheimersdiseaseinatertiarymemoryclinic AT jesusgarciacastro prospectiveevaluationofplasmaptau217stabilityforthedetectionofalzheimersdiseaseinatertiarymemoryclinic AT juditselmagonzalez prospectiveevaluationofplasmaptau217stabilityforthedetectionofalzheimersdiseaseinatertiarymemoryclinic AT mariacarmonairagui prospectiveevaluationofplasmaptau217stabilityforthedetectionofalzheimersdiseaseinatertiarymemoryclinic AT isabelbarroeta prospectiveevaluationofplasmaptau217stabilityforthedetectionofalzheimersdiseaseinatertiarymemoryclinic AT ignacioillangala prospectiveevaluationofplasmaptau217stabilityforthedetectionofalzheimersdiseaseinatertiarymemoryclinic AT miguelsantossantos prospectiveevaluationofplasmaptau217stabilityforthedetectionofalzheimersdiseaseinatertiarymemoryclinic AT juanfortea prospectiveevaluationofplasmaptau217stabilityforthedetectionofalzheimersdiseaseinatertiarymemoryclinic AT albertolleo prospectiveevaluationofplasmaptau217stabilityforthedetectionofalzheimersdiseaseinatertiarymemoryclinic AT mireiatondo prospectiveevaluationofplasmaptau217stabilityforthedetectionofalzheimersdiseaseinatertiarymemoryclinic AT danielalcolea prospectiveevaluationofplasmaptau217stabilityforthedetectionofalzheimersdiseaseinatertiarymemoryclinic |