Method comparison study of the Elecsys® β-Amyloid (1–42) CSF assay versus comparator assays and LC-MS/MS

Leslie M. Shaw, Oskar Hansson, Ekaterina Manuilova, Colin L. Masters, James D. Doecke, Qiao Xin Li, Sandra Rutz, Monika Widmann, Andreas Leinenbach, Kaj Blennow

Research output: Contribution to journalArticlepeer-review

15 Citations (SciVal)

Abstract

Background: Alzheimer's disease (AD) biomarkers, such as cerebrospinal fluid (CSF) amyloid-β (1–42; Aβ42), can provide high diagnostic accuracy. Several immunoassays are available for Aβ42 quantitation, but standardisation across assays remains an issue. We compared the Elecsys® β-Amyloid (1–42) CSF assay with three assays and two liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. Methods: Three method comparison studies evaluated the correlation between the Elecsys® β-Amyloid (1–42) CSF assay versus: INNOTEST® β-AMYLOID(1–42) (860 samples) and the Roche Diagnostics-developed LC-MS/MS method (250 samples); INNO-BIA AlzBio3 and the University of Pennsylvania (UPenn)-developed LC-MS/MS method (250 samples); and ADx-EUROIMMUN Beta-Amyloid (1–42) enzyme-linked immunosorbent assay (ELISA) (49 samples). Results: High correlation was demonstrated between Elecsys® β-Amyloid (1–42) CSF and comparator assays: INNOTEST® β-AMYLOID(1–42) (Spearman's ρ, 0.954); INNO-BIA AlzBio3 (Spearman's ρ, 0.864); ADx-EUROIMMUN Beta-Amyloid (1–42) ELISA (Pearson's r, 0.925). Elecsys® assay and LC-MS/MS measurements were highly correlated: Pearson's r, 0.949 (Roche Diagnostics-developed method) and 0.943 (UPenn-developed method). Conclusion: Findings from this multicentre evaluation further support use of the Elecsys® β-Amyloid (1–42) CSF assay to aid AD diagnosis. CSF-based certified reference materials should improve agreement across assays and mass spectrometry-based methods, which is essential to establish a global uniform CSF Aβ42 cut-off to detect amyloid pathology.

Original languageEnglish
Pages (from-to)7-14
JournalClinical Biochemistry
Volume72
Early online date2019 May 23
DOIs
Publication statusPublished - 2019

Subject classification (UKÄ)

  • Medicinal Chemistry

Keywords

  • Alzheimer's disease
  • Amyloid-β peptide
  • Biomarker
  • Cerebrospinal fluid
  • Correlation
  • Immunoassay

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