Abstract
INTRODUCTION: For routine clinical implementation of Alzheimer's disease (AD) plasma biomarkers, fully automated random-access platforms are crucial to ensure reproducible measurements. We aimed to perform an analytical validation and to establish cutoffs for AD plasma biomarkers measured with Lumipulse.
METHODS: Two cohorts were included. UNIPG: n = 450 paired cerebrospinal fluid (CSF)/plasma samples from subjects along the AD-continuum, subjects affected by other neurodegenerative diseases, and controls with known CSF profile; AMS: n = 40 plasma samples from AD and n = 40 controls. Plasma amyloid β (Aβ)42, Aβ40, and p-tau181 were measured with Lumipulse. We evaluated analytical and diagnostic performance.
RESULTS: Lumipulse assays showed high analytical performance. Plasma p-tau181 levels accurately reflected CSF A+/T+ profile in AD-dementia and mild cognitive impairment (MCI)-AD, but not in asymptomatic-AD. Plasma and CSF Aβ42/40 values were concordant across clinical AD stages. Cutoffs and probability-based models performed satisfactorily in both cohorts.
DISCUSSION: The identified cutoffs and probability-based models represent a significant step toward plasma AD molecular diagnosis.
Original language | English |
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Pages (from-to) | 2453-2468 |
Number of pages | 16 |
Journal | Alzheimer's & dementia : the journal of the Alzheimer's Association |
Volume | 20 |
Issue number | 4 |
Early online date | 7 Feb 2024 |
DOIs | |
Publication status | Published - Apr 2024 |
Keywords
- Alzheimer's disease
- Aβ
- automated platforms
- p-tau
- plasma biomarkers