• Je něco špatně v tomto záznamu ?

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

J. Gobom, L. Parnetti, P. Rosa-Neto, M. Vyhnalek, S. Gauthier, S. Cataldi, O. Lerch, J. Laczo, K. Cechova, M. Clarin, AL. Benet, TA. Pascoal, N. Rahmouni, M. Vandijck, E. Huyck, N. Le Bastard, J. Stevenson, M. Chamoun, D. Alcolea, A. Lleó, U....

. 2022 ; 60 (2) : 207-219. [pub] 20211115

Jazyk angličtina Země Německo

Typ dokumentu časopisecké články, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc22011926

Grantová podpora
MOP-11-51-31 CIHR - Canada
RFN 152985 CIHR - Canada
159815 CIHR - Canada
162303 CIHR - Canada

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>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 409 ng/L for total tau, 50.2 ng/L for pTau 181, 526 ng/L for β-amyloid 1-42, and 0.072 for the Aβ 1-42/Aβ 1-40 ratio. CONCLUSIONS: 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.

1st Department of Neurology Faculty of Medicine Masaryk University and St Anne's University Hospital Brno Czech Republic

Centro de Investigación Biomédica en Red Enfermedades Neurodegenerativas Madrid Spain

Clinical Neurochemistry Laboratory Sahlgrenska University Hospital Mölndal Sweden

Department of Laboratory Medicine Radboud University Medical Center Nijmegen The Netherlands

Department of Neurodegenerative Disease UCL Institute of Neurology London UK

Department of Neurology 2nd Medical Faculty Charles University Prague Czech Republic

Department of Neurology and Neurosurgery McGill University Research Centre for Studies in Aging Douglas Research Institute Le Centre intégré universitaire de santé et de services sociaux de l'Ouest de l'Île de Montréal Psychiatry and Pharmacology and Therapeutics McGill University Montreal QC Canada

Department of Neurology Memory Unit Hospital de la Santa Creu i Sant Pau Biomedical Research Institute Sant Pau Universitat Autònoma de Barcelona Barcelona Spain

Department of Neurology Radboud Alzheimer Centre Radboud University Medical Center Donders Institute for Brain Cognition and Behaviour Nijmegen The Netherlands

Department of Psychiatry and Neurochemistry Institute of Neuroscience and Physiology The Sahlgrenska Academy University of Gothenburg Gothenburg Sweden

Fujirebio Europe N 5 Ghent Belgium

International Clinical Research Center St Anne's University Hospital Brno Czech Republic

King's College London Institute of Psychiatry Psychology and Neuroscience Maurice Wohl Clinical Neuroscience Institute London UK

Laboratory of Clinical Neurochemistry Section of Neurology University of Perugia Perugia Italy

Montreal Neurological Institute Montreal QC Canada

Motol University Hospital Prague Czech Republic

NIHR Biomedical Research Centre for Mental Health and Biomedical Research Unit for Dementia at South London and Maudsley NHS Foundation London UK

Translational Neuroimaging Laboratory McGill Centre for Studies in Aging McGill University Montreal QC Canada

UK Dementia Research Institute at UCL London UK

Wallenberg Centre for Molecular and Translational Medicine University of Gothenburg Gothenburg Sweden

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc22011926
003      
CZ-PrNML
005      
20220506130603.0
007      
ta
008      
220425s2022 gw f 000 0|eng||
009      
AR
024    7_
$a 10.1515/cclm-2021-0651 $2 doi
035    __
$a (PubMed)34773730
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a gw
100    1_
$a Gobom, Johan $u Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden $u Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden $1 https://orcid.org/0000000161936193
245    10
$a Validation of the LUMIPULSE automated immunoassay for the measurement of core AD biomarkers in cerebrospinal fluid / $c J. Gobom, L. Parnetti, P. Rosa-Neto, M. Vyhnalek, S. Gauthier, S. Cataldi, O. Lerch, J. Laczo, K. Cechova, M. Clarin, AL. Benet, TA. Pascoal, N. Rahmouni, M. Vandijck, E. Huyck, N. Le Bastard, J. Stevenson, M. Chamoun, D. Alcolea, A. Lleó, U. Andreasson, MM. Verbeek, G. Bellomo, R. Rinaldi, NJ. Ashton, H. Zetterberg, K. Sheardova, J. Hort, K. Blennow
520    9_
$a 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>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 409 ng/L for total tau, 50.2 ng/L for pTau 181, 526 ng/L for β-amyloid 1-42, and 0.072 for the Aβ 1-42/Aβ 1-40 ratio. CONCLUSIONS: 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.
650    12
$a Alzheimerova nemoc $x mozkomíšní mok $x diagnóza $7 D000544
650    _2
$a amyloidní beta-protein $x mozkomíšní mok $7 D016229
650    _2
$a biologické markery $x mozkomíšní mok $7 D015415
650    _2
$a lidé $7 D006801
650    _2
$a imunoanalýza $x metody $7 D007118
650    _2
$a peptidové fragmenty $x mozkomíšní mok $7 D010446
650    _2
$a reprodukovatelnost výsledků $7 D015203
650    _2
$a proteiny tau $x mozkomíšní mok $7 D016875
655    _2
$a časopisecké články $7 D016428
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Parnetti, Lucilla $u Laboratory of Clinical Neurochemistry, Section of Neurology, University of Perugia, Perugia, Italy
700    1_
$a Rosa-Neto, Pedro $u Department of Neurology and Neurosurgery, McGill University Research Centre for Studies in Aging, Douglas Research Institute, Le Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Ouest-de-l'Île-de-Montréal, Psychiatry and Pharmacology and Therapeutics, McGill University, Montreal, QC, Canada $u Montreal Neurological Institute, Montreal, QC, Canada
700    1_
$a Vyhnalek, Martin $u Department of Neurology, Second Medical Faculty, Charles University, Prague, Czech Republic $u Motol University Hospital, Prague, Czech Republic $u International Clinical Research Center, St. Anne's University Hospital, Brno, Czech Republic
700    1_
$a Gauthier, Serge $u Department of Neurology and Neurosurgery, McGill University Research Centre for Studies in Aging, Douglas Research Institute, Le Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Ouest-de-l'Île-de-Montréal, Psychiatry and Pharmacology and Therapeutics, McGill University, Montreal, QC, Canada $u Montreal Neurological Institute, Montreal, QC, Canada
700    1_
$a Cataldi, Samuela $u Laboratory of Clinical Neurochemistry, Section of Neurology, University of Perugia, Perugia, Italy
700    1_
$a Lerch, Ondrej $u Department of Neurology, Second Medical Faculty, Charles University, Prague, Czech Republic $u Motol University Hospital, Prague, Czech Republic $u International Clinical Research Center, St. Anne's University Hospital, Brno, Czech Republic
700    1_
$a Laczo, Jan $u Department of Neurology, Second Medical Faculty, Charles University, Prague, Czech Republic $u Motol University Hospital, Prague, Czech Republic $u International Clinical Research Center, St. Anne's University Hospital, Brno, Czech Republic
700    1_
$a Cechova, Katerina $u Department of Neurology, Second Medical Faculty, Charles University, Prague, Czech Republic $u Motol University Hospital, Prague, Czech Republic $u International Clinical Research Center, St. Anne's University Hospital, Brno, Czech Republic $1 https://orcid.org/0000000258451854
700    1_
$a Clarin, Marcus $u Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden $u Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden
700    1_
$a Benet, Andrea L $u Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden $u Translational Neuroimaging Laboratory, McGill Centre for Studies in Aging, McGill University, Montreal, QC, Canada
700    1_
$a Pascoal, Tharick A $u Translational Neuroimaging Laboratory, McGill Centre for Studies in Aging, McGill University, Montreal, QC, Canada
700    1_
$a Rahmouni, Neserine $u Translational Neuroimaging Laboratory, McGill Centre for Studies in Aging, McGill University, Montreal, QC, Canada
700    1_
$a Vandijck, Manu $u Fujirebio Europe N.V., Ghent, Belgium
700    1_
$a Huyck, Else $u Fujirebio Europe N.V., Ghent, Belgium
700    1_
$a Le Bastard, Nathalie $u Fujirebio Europe N.V., Ghent, Belgium
700    1_
$a Stevenson, Jenna $u Translational Neuroimaging Laboratory, McGill Centre for Studies in Aging, McGill University, Montreal, QC, Canada
700    1_
$a Chamoun, Mira $u Translational Neuroimaging Laboratory, McGill Centre for Studies in Aging, McGill University, Montreal, QC, Canada
700    1_
$a Alcolea, Daniel $u Department of Neurology, Memory Unit, Hospital de la Santa Creu i Sant Pau- Biomedical Research Institute Sant Pau-Universitat Autònoma de Barcelona, Barcelona, Spain $u Centro de Investigación Biomédica en Red Enfermedades Neurodegenerativas (CIBERNED), Madrid, Spain
700    1_
$a Lleó, Alberto $u Department of Neurology, Memory Unit, Hospital de la Santa Creu i Sant Pau- Biomedical Research Institute Sant Pau-Universitat Autònoma de Barcelona, Barcelona, Spain $u Centro de Investigación Biomédica en Red Enfermedades Neurodegenerativas (CIBERNED), Madrid, Spain
700    1_
$a Andreasson, Ulf $u Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden $u Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden
700    1_
$a Verbeek, Marcel M $u Department of Laboratory Medicine, Radboud University Medical Center, Nijmegen, The Netherlands $u Department of Neurology, Radboud Alzheimer Centre, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Nijmegen, The Netherlands
700    1_
$a Bellomo, Giovanni $u Laboratory of Clinical Neurochemistry, Section of Neurology, University of Perugia, Perugia, Italy
700    1_
$a Rinaldi, Roberta $u Laboratory of Clinical Neurochemistry, Section of Neurology, University of Perugia, Perugia, Italy
700    1_
$a Ashton, Nicholas J $u Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden $u Wallenberg Centre for Molecular and Translational Medicine, University of Gothenburg, Gothenburg, Sweden $u King's College London, Institute of Psychiatry, Psychology & Neuroscience, Maurice Wohl Clinical Neuroscience Institute, London, UK $u NIHR Biomedical Research Centre for Mental Health & Biomedical Research Unit for Dementia at South London & Maudsley NHS Foundation, London, UK
700    1_
$a Zetterberg, Henrik $u Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden $u Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden $u Department of Neurodegenerative Disease, UCL Institute of Neurology, London, UK $u UK Dementia Research Institute at UCL, London, UK
700    1_
$a Sheardova, Katerina $u Department of Neurology, Second Medical Faculty, Charles University, Prague, Czech Republic $u First Department of Neurology, Faculty of Medicine, Masaryk University and St. Anne's University Hospital, Brno, Czech Republic
700    1_
$a Hort, Jakub $u Department of Neurology, Second Medical Faculty, Charles University, Prague, Czech Republic $u Motol University Hospital, Prague, Czech Republic $u First Department of Neurology, Faculty of Medicine, Masaryk University and St. Anne's University Hospital, Brno, Czech Republic
700    1_
$a Blennow, Kaj $u Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden $u Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden
773    0_
$w MED00010886 $t Clinical chemistry and laboratory medicine $x 1437-4331 $g Roč. 60, č. 2 (2022), s. 207-219
856    41
$u https://pubmed.ncbi.nlm.nih.gov/34773730 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20220425 $b ABA008
991    __
$a 20220506130555 $b ABA008
999    __
$a ok $b bmc $g 1789498 $s 1163127
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2022 $b 60 $c 2 $d 207-219 $e 20211115 $i 1437-4331 $m Clinical chemistry and laboratory medicine $n Clin Chem Lab Med $x MED00010886
GRA    __
$a MOP-11-51-31 $p CIHR $2 Canada
GRA    __
$a RFN 152985 $p CIHR $2 Canada
GRA    __
$a 159815 $p CIHR $2 Canada
GRA    __
$a 162303 $p CIHR $2 Canada
LZP    __
$a Pubmed-20220425

Najít záznam

Citační ukazatele

Možnosti archivace