Cited by 375Clinical Laboratory Practices and Quality ControlAlzheimer's disease research and treatmentsDementia and Cognitive Impairment Research

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Technical performance of a novel, fully automated electrochemiluminescence immunoassay for the quantitation of β‐amyloid (1–42) in human cerebrospinal fluid

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Bittner, Tobias, Zetterberg, Henrik, Teunissen, Charlotte E., Ostlund, Richard E., Militello, Michael, Andreasson, Ulf, Hubeek, Isabelle, Gibson, David, Chu, David C., Eichenlaub, Udo, Heiss, Peter, Kobold, Uwe, Leinenbach, Andreas, Madin, Kairat, Manuilova, Ekaterina, Rabe, Christina, Blennow, Kaj·2016·Alzheimer's & Dementia

DOI 10.1016/j.jalz.2015.09.009

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Abstract

INTRODUCTION: Available assays for quantitation of the Alzheimer's disease (AD) biomarker amyloid-beta 1-42 (Aβ [1-42]) in cerebrospinal fluid demonstrate significant variability and lack of standardization to reference measurement procedures (RMPs). We report analytical performance data for the novel Elecsys β-amyloid (1-42) assay (Roche Diagnostics). METHODS: Lot-to-lot comparability was tested using method comparison. Performance parameters were measured according to Clinical & Laboratory Standards Institute (CLSI) guidelines. The assay was standardized to a Joint Committee for Traceability in Laboratory Medicine (JCTLM) approved RMP. RESULTS: Limit of quantitation was <11.28 pg/mL, and the assay was linear throughout the measuring range (200-1700 pg/mL). Excellent lot-to-lot comparability was observed (correlation coefficients [Pearson's r] >0.995; bias in medical decision area <2%). Repeatability coefficients of variation (CVs) were 1.0%-1.6%, intermediate CVs were 1.9%-4.0%, and intermodule CVs were 1.1%-3.9%. Estimated total reproducibility was 2.0%-5.1%. Correlation with the RMP was good (Pearson's r, 0.93). DISCUSSION: The Elecsys β-amyloid (1-42) assay has high analytical performance that may improve biomarker-based AD diagnosis.

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Additional file 1 of Elecsys CSF biomarker immunoassays demonstrate concordance with amyloid-PET imaging
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Additional file 2 of BMI1 is associated with CS8F amyloid-β and rates of cognitive decline in Alzheimer’s disease
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Additional file 4 of BMI1 is associated with CS8F amyloid-β and rates of cognitive decline in Alzheimer’s disease
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Additional file 6 of Elecsys CSF biomarker immunoassays demonstrate concordance with amyloid-PET imaging
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Additional file 3 of Quantitative proteomics of cerebrospinal fluid from African Americans and Caucasians reveals shared and divergent changes in Alzheimer’s disease
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Additional file 3 of Elecsys CSF biomarker immunoassays demonstrate concordance with amyloid-PET imaging
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Additional file 4 of Elecsys CSF biomarker immunoassays demonstrate concordance with amyloid-PET imaging
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Additional file 3 of Utilization of fluid-based biomarkers as endpoints in disease-modifying clinical trials for Alzheimer’s disease: a systematic review
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Additional file 2 of Elecsys CSF biomarker immunoassays demonstrate concordance with amyloid-PET imaging
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Additional file 7 of Elecsys CSF biomarker immunoassays demonstrate concordance with amyloid-PET imaging
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Additional file 5 of Quantitative proteomics of cerebrospinal fluid from African Americans and Caucasians reveals shared and divergent changes in Alzheimer’s disease
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Additional file 2 of Quantitative proteomics of cerebrospinal fluid from African Americans and Caucasians reveals shared and divergent changes in Alzheimer’s disease
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Authors: Bittner, T., Zetterberg, H., Teunissen, C. E., Ostlund, R. E., Militello, M., Andreasson, U., Hubeek, I., Gibson, D., Chu, D. C., Eichenlaub, U., Heiss, P., Kobold, U., Leinenbach, A., Madin, K., Manuilova, E., Rabe, C., & Blennow, K.
Affiliations: Roche Diagnostics GmbH Penzberg Germany
UCL Queen Square Institute of Neurology (GB)
Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
Washington University in St. Louis (US)
Covance (United States) (US)
Clinical Neurochemistry Laboratory, Institute of Neuroscience and Physiology The Sahlgrenska Academy at University of Gothenburg Mölndal Sweden
University of Gothenburg (SE)
Corresponding author: Blennow, Kaj
ORCID: Bittner, Tobias
Zetterberg, Henrik
Teunissen, Charlotte E.
Kobold, Uwe
Blennow, Kaj
Venue: Alzheimer's & Dementia
Publisher: Wiley
Published: 2015-11-07
Volume: 12
Issue: 5
Pages: 517-526
ISSN: 1552-5260 (ISSN-L)
1552-5279
DOI: 10.1016/j.jalz.2015.09.009
OpenAlex: W2111951761
Cited by: 374
References: 37
Citations by year: 2026: 27 · 2025: 41 · 2024: 49 · 2023: 29 · 2022: 35 · 2021: 52 · 2020: 41 · 2019: 39 · 2018: 33 · 2017: 15 · 2016: 11
FWCI: 14.49
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc-nd
creativecommons.org/licenses/by-nc-nd/4.0/ (vor)
Locations: Alzheimer s & Dementia (publishedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
Digital Commons@Becker (Washington University School of Medicine) (submittedVersion, cc-by-nc-nd)
Pure Amsterdam UMC (submittedVersion, other-oa)
Data Archiving and Networked Services (DANS) (submittedVersion)
Funders: Roche Diagnostics GmbH
Torsten Söderberg Foundation
Topics: Health Sciences › Health Professions › Medical Laboratory Technology › Clinical Laboratory Practices and Quality Control
Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
Keywords: amyloid-beta 42, cerebrospinal fluid
MeSH terms: Alzheimer Disease, Humans, Immunoassay, Peptide Fragments, Reference Standards, Reproducibility of Results, Biomarkers, Amyloid beta-Peptides, Luminescence

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Technical performance of a novel, fully automated electrochemiluminescence immunoassay for the quantitation of β‐amyloid (1–42) in human cerebrospinal fluid

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