Validation of the LUMIPULSE automated immunoassay for the measurement of core AD biomarkers in cerebrospinal fluid

Objectives: The core cerebrospinal fluid (CSF) biomarkers; total tau (tTau), phospho-tau (pTau), amyloid β 1-42 (Aβ 1-42), and the Aβ 1-42/Aβ 1-40 ratio have transformed Alzheimer's disease (AD) research and are today increasingly used in clinical routine laboratories as diagnostic tools. Fully...

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Detalles Bibliográficos
Autores: Gobom, Johan|||0000-0001-6193-6193, Parnetti, Lucilla|||0000-0001-5722-3967, Rosa-Neto, Pedro|||0000-0001-9116-1376, Vyhnalek, Martin, Gauthier, Serge, Cataldi, Samuela, Lerch, Ondrej, Laczo, Jan, Cechova, Katerina, Clarin, Marcus, Benet, Andrea L., Pascoal, Tharick A., Rahmouni, Neserine, Vandijck, Manu, Huyck, Else, Le Bastard, Nathalie, Stevenson, Jenna, Chamoun, Mira, Alcolea, Daniel|||0000-0002-3819-3245, Lleó, Alberto|||0000-0002-2568-5478, Andreasson, Ulf, Verbeek, Marcel M., Bellomo, Giovanni|||0000-0003-0456-5650, Rinaldi, Roberta, Ashton, Nicholas J.|||0000-0002-3579-8804, Zetterberg, Henrik|||0000-0003-3930-4354, Sheardova, Katerina, Hort, Jakub|||0000-0002-1080-3726, Blennow, Kaj|||0000-0002-1890-4193
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:280914
Acceso en línea:https://ddd.uab.cat/record/280914
https://dx.doi.org/urn:doi:10.1515/cclm-2021-0651
Access Level:acceso abierto
Palabra clave:Alzheimer's disease
Biomarkers
Immunoassay
LUMIPULSE
Validation
Descripción
Sumario:Objectives: The core cerebrospinal fluid (CSF) biomarkers; total tau (tTau), phospho-tau (pTau), amyloid β 1-42 (Aβ 1-42), and the Aβ 1-42/Aβ 1-40 ratio have transformed Alzheimer's disease (AD) research and are today increasingly used in clinical routine laboratories as diagnostic tools. Fully automated immunoassay instruments with ready-to-use assay kits and calibrators has simplified their analysis and improved reproducibility of measurements. We evaluated the analytical performance of the fully automated immunoassay instrument LUMIPULSE G (Fujirebio) for measurement of the four core AD CSF biomarkers and determined cutpoints for AD diagnosis. Methods: Comparison of the LUMIPULSE G assays was performed with the established INNOTEST ELISAs (Fujirebio) for hTau Ag, pTau 181, β-amyloid 1-42, and with V-PLEX Plus Aβ Peptide Panel 1 (6E10) (Meso Scale Discovery) for Aβ 1-42/Aβ 1-40, as well as with a LC-MS reference method for Aβ 1-42. Intra- and inter-laboratory reproducibility was evaluated for all assays. Clinical cutpoints for Aβ 1-42, tTau, and pTau was determined by analysis of three cohorts of clinically diagnosed patients, comprising 651 CSF samples. For the Aβ 1-42/Aβ 1-40 ratio, the cutpoint was determined by mixture model analysis of 2,782 CSF samples. Results: The LUMIPULSE G assays showed strong correlation to all other immunoassays (r.

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