Method comparison study of the Elecsys® β-Amyloid (1-42) CSF assay versus comparator assays and LC-MS/MS.
Alzheimer Disease
/ cerebrospinal fluid
Amyloid beta-Peptides
/ cerebrospinal fluid
Biomarkers
/ cerebrospinal fluid
Chromatography, Liquid
/ methods
Electrochemical Techniques
/ methods
Enzyme-Linked Immunosorbent Assay
/ methods
Humans
Immunoassay
/ methods
Peptide Fragments
/ cerebrospinal fluid
Tandem Mass Spectrometry
/ methods
Alzheimer's disease
Amyloid-β peptide
Biomarker
Cerebrospinal fluid
Correlation
Immunoassay
Journal
Clinical biochemistry
ISSN: 1873-2933
Titre abrégé: Clin Biochem
Pays: United States
ID NLM: 0133660
Informations de publication
Date de publication:
Oct 2019
Oct 2019
Historique:
received:
09
05
2019
accepted:
19
05
2019
pubmed:
28
5
2019
medline:
4
12
2019
entrez:
27
5
2019
Statut:
ppublish
Résumé
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. 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). 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). 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.
Sections du résumé
BACKGROUND
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
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
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
CONCLUSIONS
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.
Identifiants
pubmed: 31129181
pii: S0009-9120(19)30488-6
doi: 10.1016/j.clinbiochem.2019.05.006
pii:
doi:
Substances chimiques
Amyloid beta-Peptides
0
Biomarkers
0
Peptide Fragments
0
amyloid beta-protein (1-42)
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
7-14Informations de copyright
Copyright © 2019 Roche Diagnostics. Published by Elsevier Inc. All rights reserved.