Elecsys CSF AD immunoassays: Sample stability for a new pre-analytical protocol for fresh CSF

Alzheimers Dement. 2025 Oct;21(10):e70797. doi: 10.1002/alz.70797.

Abstract

Introduction: Amyloid beta 1-42 (Aβ42), tau phosphorylated at threonine-181 (p-tau181), and total tau (t-tau) are cerebrospinal fluid (CSF) biomarkers for Alzheimer's disease diagnosis.

Methods: We prospectively examined storage time, temperature, and freeze/thaw effects on Aβ42, p-tau181, and t-tau stability in fresh CSF samples using Elecsys® CSF immunoassays.

Results: All three biomarkers were stable at 2-8°C for ≤15 days, and -25°C to -15°C for ≤8 weeks, and after one freeze/thaw cycle. p-Tau181 and t-tau were also stable at 15-25°C for ≤8 days and at -25°C to -15°C for 12-15 weeks. Aβ42 recovery declined slightly after storage at 15-25°C for ≤8 days and -25°C to -15°C for 12-15 weeks, and one freeze/thaw cycle.

Discussion: For optimal immunoassay performance, it is recommended to store CSF samples at 15-25°C for ≤5 days, 2-8°C for ≤15 days, and -25°C to -15°C for ≤8 weeks.

Highlights: Cerebrospinal fluid (CSF) biomarkers aid in Alzheimer's disease diagnosis. Fresh CSF stored at 15-25°C for ≤5 days is optimal for Elecsys CSF immunoassays. Fresh CSF stored at 2-8°C for ≤15 days is optimal for Elecsys CSF immunoassays. Fresh CSF stored at -25°C to -15°C for ≤8 weeks is optimal for Elecsys CSF immunoassays.

Keywords: Alzheimer's disease; Aβ42; Elecsys CSF immunoassay; biomarkers; fresh CSF; pre‐analytical handling; p‐tau; sample stability; storage conditions; t‐tau.

MeSH terms

  • Aged
  • Alzheimer Disease* / cerebrospinal fluid
  • Alzheimer Disease* / diagnosis
  • Amyloid beta-Peptides* / cerebrospinal fluid
  • Biomarkers / cerebrospinal fluid
  • Female
  • Humans
  • Immunoassay / methods
  • Male
  • Peptide Fragments* / cerebrospinal fluid
  • Phosphorylation
  • Prospective Studies
  • Specimen Handling* / methods
  • Temperature
  • Time Factors
  • tau Proteins* / cerebrospinal fluid

Substances

  • Amyloid beta-Peptides
  • tau Proteins
  • Biomarkers
  • Peptide Fragments
  • amyloid beta-protein (1-42)