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

Shaw, Leslie M.; Hansson, Oskar LU ; Manuilova, Ekaterina; Masters, Colin L.; Doecke, James D.; Li, Qiao Xin; Rutz, Sandra; Widmann, Monika; Leinenbach, Andreas and Blennow, Kaj LU (2019) In Clinical Biochemistry
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... (More)

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.

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author
organization
publishing date
type
Contribution to journal
publication status
epub
subject
keywords
Alzheimer's disease, Amyloid-β peptide, Biomarker, Cerebrospinal fluid, Correlation, Immunoassay
in
Clinical Biochemistry
publisher
Elsevier
external identifiers
  • scopus:85066802796
ISSN
0009-9120
DOI
10.1016/j.clinbiochem.2019.05.006
language
English
LU publication?
yes
id
ffc8f64a-640f-4ef4-a6b6-02dc05adea44
date added to LUP
2019-06-24 13:11:43
date last changed
2019-07-09 04:49:22
@article{ffc8f64a-640f-4ef4-a6b6-02dc05adea44,
  abstract     = {<p>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.</p>},
  author       = {Shaw, Leslie M. and Hansson, Oskar and Manuilova, Ekaterina and Masters, Colin L. and Doecke, James D. and Li, Qiao Xin and Rutz, Sandra and Widmann, Monika and Leinenbach, Andreas and Blennow, Kaj},
  issn         = {0009-9120},
  keyword      = {Alzheimer's disease,Amyloid-β peptide,Biomarker,Cerebrospinal fluid,Correlation,Immunoassay},
  language     = {eng},
  month        = {05},
  publisher    = {Elsevier},
  series       = {Clinical Biochemistry},
  title        = {Method comparison study of the Elecsys® β-Amyloid (1–42) CSF assay versus comparator assays and LC-MS/MS},
  url          = {http://dx.doi.org/10.1016/j.clinbiochem.2019.05.006},
  year         = {2019},
}