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

Journal article
Authors L. M. Shaw
O. Hansson
E. Manuilova
C. L. Masters
J. D. Doecke
Q. X. Li
S. Rutz
M. Widmann
A. Leinenbach
Kaj Blennow
Published in Clinical Biochemistry
Volume 72
Issue October
Pages 7-14
ISSN 0009-9120
Publication year 2019
Published at Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
Pages 7-14
Language en
Keywords Alzheimer's disease, Amyloid-β peptide, Biomarker, Cerebrospinal fluid, Correlation, Immunoassay
Subject categories Neurosciences


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. © 2019

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