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Background <p>Knowledge on the effect of analytical variability and storage conditions are essential for the successful implementation of plasma pTau<sub>217</sub> in prospective settings.</p> Aims <p>To investigate the performance of plasma pTau<sub>217</sub>, 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.</p> Methods <p>We prospectively measured pTau<sub>217</sub> 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.</p> Results <p>We included 280 participants, divided into two groups: those with (<i>n</i> = 109) and without CSF data (<i>n</i> = 171). Among the subset with CSF, 48% were A + , with a plasma pTau<sub>217</sub> fold-change of 4.5 × compared to A-. We found no differences in plasma pTau<sub>217</sub> concentrations between either short-term storage conditions. The overall coefficients of analytical variation ranged from 1.8% to 3.2%. Plasma pTau<sub>217</sub> 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<sub>217</sub> ranged between 45.9% and 18.3% using our previously reported strict or lenient cutoffs (overall accuracy 96.6% and 92.1%, respectively).</p> Conclusions <p>The robust stability and low lot-to-lot variability of plasma pTau<sub>217</sub> 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.</p>

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

  • 期刊论文

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  • 发表日期：

    2025年7月5日

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  • 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

摘要

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.