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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
CSF Aβ 42 levels correlate with amyloid-neuropathology in a population-based autopsy study
Strozyk, D., Blennow, K., White, L. R., & Launer, L. J. (2003) · Neurology · doi:10.1212/01.wnl.0000046581.81650.d0 · Cited by 621
Evaluation of CSF-tau and CSF-Aβ42 as diagnostic markers for Alzheimer disease in clinical practice
Andreasen, N., Minthon, L., Davidsson, P., Vanmechelen, E., Vanderstichele, H., Winblad, B., & Blennow, K. (2001) · Archives of Neurology · doi:10.1001/archneur.58.3.373 · Cited by 573
(1997) · doi:10.1073/pnas.94.4.1550 · Cited by 535
Amyloid biomarkers in Alzheimer's disease
Blennow, K., Mattsson, N., Schöll, M., Hansson, O., & Zetterberg, H. (2015) · Trends in Pharmacological Sciences · doi:10.1016/j.tips.2015.03.002 · Cited by 470
Hampel, H., Buerger, K., Zinkowski, R., Teipel, S. J., Goernitz, A., Andreasen, N., Sjoegren, M., DeBernardis, J., Kerkman, D., Ishiguro, K., et al. (2004) · Archives of General Psychiatry · doi:10.1001/archpsyc.61.1.95 · Cited by 434
Comparing positron emission tomography imaging and cerebrospinal fluid measurements of β‐amyloid
Landau, S. M., Lu, M., Joshi, A. D., Pontecorvo, M., Mintun, M. A., Trojanowski, J. Q., Shaw, L. M., Jagust, W. J., & Initiative, F. T. A. D. N. (2013) · Annals of Neurology · doi:10.1002/ana.23908 · Cited by 401
CSF biomarker variability in the Alzheimer's Association quality control program
Mattsson, N., Andréasson, U., Persson, S., Carrillo, M. C., Collins, S. J., Chalbot, S., Cutler, N. E., Dufour‐Rainfray, D., Fagan, A. M., Heegaard, N. H. H., et al. (2013) · Alzheimer s & Dementia · doi:10.1016/j.jalz.2013.01.010 · Cited by 389
Palmqvist, S., Zetterberg, H., Blennow, K., Vestberg, S., Andreasson, U., Brooks, D. J., Owenius, R., Hägerström, D., Wollmer, P., Minthon, L., et al. (2014) · JAMA Neurology · doi:10.1001/jamaneurol.2014.1358 · Cited by 368
Self-citationVanderstichele, H., Bibl, M., Engelborghs, S., Le Bastard, N., Lewczuk, P., Molinuevo, J. L., Parnetti, L., Perret‐Liaudet, A., Shaw, L. M., Teunissen, C., et al. (2012) · Alzheimer's & Dementia · doi:10.1016/j.jalz.2011.07.004 · Cited by 358
Self-citationConfounding Factors Influencing Amyloid Beta Concentration in Cerebrospinal Fluid
Bjerke, M., Portelius, E., Minthon, L., Wallin, A., Anckarsäter, H. S., Anckarsäter, R., Andreasen, N., Zetterberg, H., Andréasson, U., & Blennow, K. (2010) · International Journal of Alzheimer s Disease · doi:10.4061/2010/986310 · Cited by 239
Riemenschneider, M., Wagenpfeil, S., Vanderstichele, H., Otto, M., Wiltfang, J., Kretzschmar, H., Vanmechelen, E., Förstl, H., & Kurz, A. (2003) · Molecular Psychiatry · doi:10.1038/sj.mp.4001220 · Cited by 238
Skillbäck, T., Rosén, C., Asztely, F., Mattsson, N., Blennow, K., & Zetterberg, H. (2014) · JAMA Neurology · doi:10.1001/jamaneurol.2013.6455 · Cited by 207
The Cost of Dementia in Europe
Jönsson, L., & Wimo, A. (2009) · PharmacoEconomics · doi:10.2165/00019053-200927050-00004 · Cited by 172
Leinenbach, A., Pannee, J., Dülffer, T., Huber, A., Bittner, T., Andréasson, U., Gobom, J., Zetterberg, H., Kobold, U., Portelius, E., et al. (2014) · Clinical Chemistry · doi:10.1373/clinchem.2013.220392 · Cited by 158
Kang, J., Korecka, M., Toledo, J. B., Trojanowski, J. Q., & Shaw, L. M. J. (2013) · Clinical Chemistry · doi:10.1373/clinchem.2013.202937 · Cited by 147
Injury markers predict time to dementia in subjects with MCI and amyloid pathology
van Rossum, I. A., Vos, S. J. B., Burns, L., Knol, D. L., Scheltens, P., Soininen, H., Wahlund, L.-O., Hampel, H., Tsolaki, M., Minthon, L., et al. (2012) · Neurology · doi:10.1212/wnl.0b013e3182704056 · Cited by 136
Self-citationLow frequency of post-lumbar puncture headache in demented patients
Blennow, K., Wallin, A., & Häger, O. (2009) · Acta Neurologica Scandinavica · doi:10.1111/j.1600-0404.1993.tb04221.x · Cited by 130
Low Incidence of Post-Lumbar Puncture Headache in 1,089 Consecutive Memory Clinic Patients
Zetterberg, H., Tullhög, K., Hansson, O., Minthon, L., Londos, E., & Blennow, K. (2010) · European Neurology · doi:10.1159/000311703 · Cited by 108
Variability of CSF Alzheimer’s Disease Biomarkers: Implications for Clinical Practice
Vos, S. J. B., Visser, P. J., Verhey, F. R. J., Aalten, P., Knol, D. L., Ramakers, I. H. G. B., Scheltens, P., Rikkert, M. G. M. O., Verbeek, M. M., & Teunissen, C. E. (2014) · PLoS ONE · doi:10.1371/journal.pone.0100784 · Cited by 92
Mattsson, N., Zegers, I., Andréasson, U., Bjerke, M., Blankenstein, M. A., Bowser, R. P., Carrillo, M. C., Gobom, J., Heath, T., Jenkins, R. G., et al. (2012) · Biomarkers in Medicine · doi:10.2217/bmm.12.39 · Cited by 79
Quantification of Alzheimer Amyloid β Peptides Ending at Residues 40 and 42 by Novel ELISA Systems
Jensen, M., Hartmann, T., Engvall, B., Wang, R., Uljon, S., Sennvik, K., Näslund, J., Muehlhauser, F., Nordstedt, C., Beyreuther, K. T., et al. (2000) · Molecular Medicine · doi:10.1007/bf03401938 · Cited by 71
Safety of Lumbar Puncture Procedures in Patients with Alzheimers Disease
Peskind, E., Nordberg, A., Darreh-Shori, T., & Soininen, H. (2009) · Current Alzheimer Research · doi:10.2174/156720509788486509 · Cited by 66
Severity of family distress of schizophrenia—fact or artifact?
Damodaran, S. S. (1993) · Acta Psychiatrica Scandinavica · doi:10.1111/j.1600-0447.1993.tb03443.x · Cited by 57
Targeted proteomics in Alzheimer’s disease: focus on amyloid-β
Portelius, E., Zetterberg, H., Gobom, J., Andréasson, U., & Blennow, K. (2008) · Expert Review of Proteomics · doi:10.1586/14789450.5.2.225 · Cited by 52
Rosa‐Neto, P., Hsiung, G. R., Masellis, M., & participants, O. B. O. T. C. (2013) · Alzheimer s Research & Therapy · doi:10.1186/alzrt223 · Cited by 24
Cefoxitin concentrations in the cerebrospinal fluids of patients with meningitis
Humbert, G., Leroy, A., Rogez, J. P., & Cherubin, C. E. (1980) · Antimicrobial Agents and Chemotherapy · doi:10.1128/aac.17.4.675 · Cited by 18
Coric, V., Seibyl, J. P., Mintun, M. A., Ross, J., Brody, M., Curtis, C. T., RICHTER, R. W., Hayes, W., McHugh, B., Yoo, B., et al. (2011) · Alzheimer s & Dementia · doi:10.1016/j.jalz.2011.05.588 · Cited by 1
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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Self-citationDefeating Alzheimer's disease and other dementias: a priority for European science and society
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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
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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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