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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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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Fully automated immunoassays have been developed by several different vendors with improved reliability and precision for CSF Aβ and tau species.
“Recently, fully automated immunoassays have been developed by several different vendors with improved reliability and precision for CSF Aβ and tau species.23,24,25”
From Performance of Fully Automated Plasma Assays as Screening Tests for Alzheimer Disease–Related β-Amyloid Status (2019) · cites this paper as [23]
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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
- Venue
- Alzheimer's & Dementia
- Publisher
- Wiley
- Published
- 2015-11-07
- Volume
- 12
- Issue
- 5
- Pages
- 517-526
- ISSN
- 1552-5260 (ISSN-L)
- 1552-5279
- 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 · 2013: 1
- FWCI
- 14.49
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- 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 › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Physiology › 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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