Blood biomarkers for Alzheimer's disease with the Lumipulse automated platform: Age-effect and clinical value interpretation

Clin Chim Acta. 2025 Jan 15:565:120014. doi: 10.1016/j.cca.2024.120014. Epub 2024 Oct 22.

Abstract

Background: Advances in analytical methods have recently paved the way to Alzheimer's disease (AD) biomarkers testing in blood along with the more established CSF testing. To ensure a forthcoming application of this low-invasive diagnostic that might allow to recognize early onset of dementia, appropriate pathological cut-points need to be defined.

Methods: In this cross-sectional study we measured blood and CSF neurofilament light chain (NFL), phosphorylated tau (pTau 181), Amyloid-β1-42 (AB 1-42) and Amyloid-β1-40 (AB 1-40) on a fully automated chemiluminescent platform (Lumipulse, Fujirebio) in 80 cognitively impaired patients and 55 cognitively unimpaired subjects. Clinical cut points were calculated with receiver-operator characteristic (ROC) curve analysis and a head-to-head comparison of blood and CSF testing was performed.

Results: Blood NFL best discriminant thresholds to distinguish neurodegenerative diseases from controls varied age-dependently, being 19 and 33 pg/mL in subjects 50-65 years and > 65 years respectively. AD was best framed by AB 1-42/1-40 ratio < 0.079 and ptau181 > 1 pg/mL. Though a strong correlation for all biomarkers, only blood AB ratio was equal to CSF testing for AD diagnosis.

Conclusions: The specific context of use might be considered to define the cut-offs of blood biomarkers of neurodegenerative diseases. Future efforts towards reference materials for each AD blood biomarker will improve clinical cut-offs.

Keywords: Alzheimer’s Disease; Amyloid-β 1–42/1–40 ratio; Blood biomarkers; Chemiluminescence immunoassay; Neurofilament light chain; Phosphorylated tau 181.

MeSH terms

  • Age Factors
  • Aged
  • Aged, 80 and over
  • Alzheimer Disease* / blood
  • Alzheimer Disease* / diagnosis
  • Amyloid beta-Peptides / blood
  • Amyloid beta-Peptides / cerebrospinal fluid
  • Automation
  • Biomarkers* / blood
  • Biomarkers* / cerebrospinal fluid
  • Cross-Sectional Studies
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neurofilament Proteins / blood
  • Neurofilament Proteins / cerebrospinal fluid
  • Peptide Fragments / blood
  • Peptide Fragments / cerebrospinal fluid
  • tau Proteins / blood
  • tau Proteins / cerebrospinal fluid

Substances

  • Biomarkers
  • tau Proteins
  • Amyloid beta-Peptides
  • Neurofilament Proteins
  • neurofilament protein L
  • Peptide Fragments