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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
Open accessAbstract
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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“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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McKhann, G. M., Knopman, D. S., Chertkow, H., Hyman, B. T., Jack, C. R., Kawas, C. H., Klunk, W. E., Koroshetz, W. J., Manly, J. J., Mayeux, R., et al. (2011) · Alzheimer's & Dementia · doi:10.1016/j.jalz.2011.03.005 · Cited by 18,657
Advancing research diagnostic criteria for Alzheimer's disease: the IWG-2 criteria
Dubois, B., Feldman, H. H., Jacova, C., Hampel, H., Molinuevo, J. L., Blennow, K., DeKosky, S. T., Gauthier, S., Selkoe, D., Bateman, R., et al. (2014) · The Lancet Neurology · doi:10.1016/s1474-4422(14)70090-0 · Cited by 3,321
Alzheimer disease in the United States (2010–2050) estimated using the 2010 census
Hebert, L. E., Weuve, J., Scherr, P. A., & Evans, D. A. (2013) · Neurology · doi:10.1212/wnl.0b013e31828726f5 · Cited by 2,642
Cerebrospinal fluid biomarker signature in Alzheimer's disease neuroimaging initiative subjects
Shaw, L. M., Vanderstichele, H., Knapik‐Czajka, M., Clark, C. M., Aisen, P. S., Petersen, R. C., Blennow, K., Soares, H., Simon, A., Lewczuk, P., et al. (2009) · Annals of Neurology · doi:10.1002/ana.21610 · Cited by 2,065
Two Phase 3 Trials of Bapineuzumab in Mild-to-Moderate Alzheimer's Disease
Salloway, S., Sperling, R., Fox, N. C., Blennow, K., Klunk, W., Raskind, M., Sabbagh, M., Honig, L. S., Porsteinsson, A. P., Ferris, S., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1304839 · Cited by 1,960
Self-citationAlzheimer’s disease drug-development pipeline: Few candidates, frequent failures
Cummings, J. L., Morstorf, T., & Zhong, K. (2014) · Alzheimer's Research & Therapy · doi:10.1186/alzrt269 · Cited by 1,744
Phase 3 Trials of Solanezumab for Mild-to-Moderate Alzheimer's Disease
Doody, R. S., Thomas, R. G., Farlow, M., Iwatsubo, T., Vellas, B., Joffe, S., Kieburtz, K., Raman, R., Sun, X., Aisen, P. S., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1312889 · Cited by 1,668
Passing, H., & Bablok, W. (1983) · cclm · doi:10.1515/cclm.1983.21.11.709 · Cited by 1,513
Buchhave, P. (2012) · Archives of General Psychiatry · doi:10.1001/archgenpsychiatry.2011.155 · Cited by 664
Clinical Pharmacokinetics of Metformin
Scheen, A. J. (1996) · Clinical Pharmacokinetics · doi:10.2165/00003088-199630050-00003 · Cited by 649
Research works printed but not linked: 8
- Clinical Laboratory and Standards Institute (CLSI), 2012, Evaluation of detection capability for clinical laboratory measurement procedures: Approved guideline—Second edition. CLSI Document EP17–A2
- Clinical Laboratory and Standards Institute (CLSI), 2003, Evaluation of the linearity of quantitative measurement procedures: A statistical approach; approved guideline. CLSI Document EP06‐A
- Clinical Laboratory and Standards Institute (CLSI), 2013, Measurement procedure comparison and bias estimation using patient samples; approved guideline—Third edition. CLSI Document EP09–A3
- Clinical Laboratory and Standards Institute (CLSI), 2005, Interference testing in clinical chemistry; approved guideline—Second edition. CLSI Document EP7–A2
- Clinical Laboratory and Standards Institute (CLSI), 2008, Immunoassay interference by endogenous antibodies; approved guideline. CLSI Document I/LA30‐A
- Clinical Laboratory and Standards Institute (CLSI), 2014, Evaluation of precision of quantitative measurement procedures; approved guideline—Third edition. CLSI Document EP05–A3
- Clinical Laboratory and Standards Institute (CLSI), 2014, User verification of performance for precision and trueness; approved guideline—Second edition. CLSI Document EP15–A2
- Scheltens P, 2014, Baseline patient characteristics from the phase 3 SCarlet RoAD trial, a study of gantenerumab in patients with prodromal AD, J Prev Alzheimers Dis, 1, 231
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Preclinical Alzheimer’s Disease: Definition, Natural History, and Diagnostic Criteria
Dubois, B., Hampel, H., Feldman, H. H., Scheltens, P., Aisen, P., Andrieu, S., Bakardjian, H., Benali, H., Bertram, L., Blennow, K., et al. (2016) · Alzheimer's & Dementia · doi:10.1016/j.jalz.2016.02.002 · Cited by 1,925
Self-citationDefeating Alzheimer's disease and other dementias: a priority for European science and society
Winblad, B., Amouyel, P., Andrieu, S., Ballard, C., Brayne, C., Brodaty, H., Cedazo-Minguez, A., Dubois, B., Edvardsson, D., Feldman, H., et al. (2016) · The Lancet Neurology · doi:10.1016/s1474-4422(16)00062-4 · Cited by 1,676
Biomarkers for Alzheimer's disease: current status and prospects for the future
Blennow, K., & Zetterberg, H. (2018) · Journal of Internal Medicine · doi:10.1111/joim.12816 · Cited by 1,000
Hansson, O., Seibyl, J., Stomrud, E., Zetterberg, H., Trojanowski, J. Q., Bittner, T., Lifke, V., Corradini, V., Eichenlaub, U., Batrla, R., et al. (2018) · Alzheimer's & Dementia · doi:10.1016/j.jalz.2018.01.010 · Cited by 808
Self-citationMattsson, N., Cullen, N. C., Andreasson, U., Zetterberg, H., & Blennow, K. (2019) · JAMA Neurology · doi:10.1001/jamaneurol.2019.0765 · Cited by 726
Metadata
- 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
- 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 › 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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