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Validation of the L...
Validation of the LUMIPULSE automated immunoassay for the measurement of core AD biomarkers in cerebrospinal fluid.
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- Gobom, Johan (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
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Parnetti, Lucilla (author)
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Rosa-Neto, Pedro (author)
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Vyhnalek, Martin (author)
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Gauthier, Serge (author)
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Cataldi, Samuela (author)
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Lerch, Ondrej (author)
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Laczo, Jan (author)
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Cechova, Katerina (author)
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- Clarin, Marcus (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
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Benet, Andrea I (author)
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Pascoal, Tharick A (author)
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Rahmouni, Neserine (author)
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Vandijck, Manu (author)
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Huyck, Else (author)
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Le Bastard, Nathalie (author)
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Stevenson, Jenna (author)
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Chamoun, Mira (author)
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Alcolea, Daniel (author)
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Lleó, Alberto (author)
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- Andreasson, Ulf, 1968 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
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Verbeek, Marcel M (author)
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Bellomo, Giovanni (author)
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Rinaldi, Roberta (author)
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- Ashton, Nicholas J. (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
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- Zetterberg, Henrik, 1973 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
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Sheardova, Katerina (author)
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Hort, Jakub (author)
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- Blennow, Kaj, 1958 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
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(creator_code:org_t)
- 2021-11-15
- 2022
- English.
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In: Clinical chemistry and laboratory medicine. - : Walter de Gruyter GmbH. - 1437-4331 .- 1434-6621. ; 60:2, s. 207-219
- Related links:
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https://www.degruyte...
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
Subject headings
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- The core cerebrospinal fluid (CSF) biomarkers; total tau (tTau), phospho-tau (pTau), amyloid β1-42(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.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.The LUMIPULSE G assays showed strong correlation to all other immunoassays (r>0.93 for all assays). The repeatability (intra-laboratory) CVs ranged between 2.0 and 5.6%, with the highest variation observed for β-amyloid 1-40. The reproducibility (inter-laboratory) CVs ranged between 2.1 and 6.5%, with the highest variation observed for β-amyloid 1-42. The clinical cutpoints for AD were determined to be 409ng/L for total tau, 50.2ng/L for pTau 181, 526ng/L for β-amyloid 1-42, and 0.072 for the Aβ 1-42/Aβ 1-40 ratio.Our results suggest that the LUMIPULSE G assays for the CSF AD biomarkers are fit for purpose in clinical laboratory practice. Further, they corroborate earlier presented reference limits for the biomarkers.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Neurovetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Neurosciences (hsv//eng)
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Gobom, Johan
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Parnetti, Lucill ...
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Rosa-Neto, Pedro
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Vyhnalek, Martin
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Gauthier, Serge
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Cataldi, Samuela
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show more...
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Lerch, Ondrej
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Laczo, Jan
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Cechova, Katerin ...
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Clarin, Marcus
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Benet, Andrea I
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Pascoal, Tharick ...
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Rahmouni, Neseri ...
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Vandijck, Manu
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Huyck, Else
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Le Bastard, Nath ...
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Stevenson, Jenna
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Chamoun, Mira
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Alcolea, Daniel
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Lleó, Alberto
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Andreasson, Ulf, ...
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Verbeek, Marcel ...
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Bellomo, Giovann ...
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Rinaldi, Roberta
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Ashton, Nicholas ...
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Zetterberg, Henr ...
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Sheardova, Kater ...
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Hort, Jakub
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Blennow, Kaj, 19 ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Neurosciences
- Articles in the publication
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Clinical chemist ...
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University of Gothenburg