Diagnostic accuracy of automated Lumipulse plasma pTau-217 in Alzheimer’s disease

Abstract INTRODUCTION Considerable advancements have occurred in blood-based Alzheimer’s disease (AD) biomarkers, with automated assays emerging for clinical use. Demonstrating the reliability of these automated systems is crucial with upcoming AD therapies. METHODS This cross-sectional study in a Memory Center enrolled 98 patients along the AD continuum or affected by other neurodegenerative disorders, stratified by CSF A/T status and clinical syndrome. Plasma pTau-217, pTau-181, and Aβ42/Aβ40 were measured using Lumipulse. Relationships with CSF and glomerular filtration rate (GFR) were explored. ROC analysis was conducted to assess diagnostic performance. RESULTS GFR effect was lowered by the use of ratios and pTau-217 correlation with CSF was strong. Plasma pTau-217 discriminated A+/T+ status with excellent accuracy in both dementia and mild cognitive impairment (AUC 0.93-0.97), outperforming pTau-181 and Aβ42/Aβ40. Cutoffs displayed high diagnostic performance. DISCUSSION Lumipulse automated pTau-217 and identified cutoffs exhibit excellent diagnostic accuracy for CSF A+/T+ status and clinical group detection, facilitating future clinical translation.