Now showing 1 - 6 of 6
  • 2019Journal Article
    [["dc.bibliographiccitation.firstpage","126"],["dc.bibliographiccitation.issue","1"],["dc.bibliographiccitation.journal","Journal of Neurochemistry"],["dc.bibliographiccitation.lastpage","138"],["dc.bibliographiccitation.volume","149"],["dc.contributor.author","Mollenhauer, Brit"],["dc.contributor.author","Bowman, Frederick DuBois"],["dc.contributor.author","Drake, Daniel"],["dc.contributor.author","Duong, Jimmy"],["dc.contributor.author","Blennow, Kaj"],["dc.contributor.author","El‐Agnaf, Omar"],["dc.contributor.author","Shaw, Leslie M."],["dc.contributor.author","Masucci, Jennifer"],["dc.contributor.author","Taylor, Peggy"],["dc.contributor.author","Umek, Robert M."],["dc.contributor.author","Dunty, Jill M."],["dc.contributor.author","Smith, Chris L."],["dc.contributor.author","Stoops, Erik"],["dc.contributor.author","Vanderstichele, Hugo"],["dc.contributor.author","Schmid, Adrian W."],["dc.contributor.author","Moniatte, Marc"],["dc.contributor.author","Zhang, Jing"],["dc.contributor.author","Kruse, Niels"],["dc.contributor.author","Lashuel, Hilal A."],["dc.contributor.author","Teunissen, Charlotte"],["dc.contributor.author","Schubert, Tanja"],["dc.contributor.author","Dave, Kuldip D."],["dc.contributor.author","Hutten, Samantha J."],["dc.contributor.author","Zetterberg, Henrik"],["dc.date.accessioned","2019-07-09T11:50:53Z"],["dc.date.available","2019-07-09T11:50:53Z"],["dc.date.issued","2019"],["dc.description.abstract","α-Synuclein is the major component of Lewy bodies and a candidate biomarker for neurodegenerative diseases in which Lewy bodies are common, including Parkinson's disease and dementia with Lewy bodies. A large body of literature suggests that these disorders are characterized by reduced concentrations of α-synuclein in cerebrospinal fluid (CSF), with overlapping concentrations compared to healthy controls and variability across studies. Several reasons can account for this variability, including technical ones, such as inter-assay and inter-laboratory variation (reproducibility). We compared four immunochemical methods for the quantification of α-synuclein concentration in 50 unique CSF samples. All methods were designed to capture most of the existing α-synuclein forms in CSF ('total' α-synuclein). Each of the four methods showed high analytical precision, excellent correlation between laboratories (R2 0.83-0.99), and good correlation with each other (R2 0.64-0.93), although the slopes of the regression lines were different between the four immunoassays. The use of common reference CSF samples decreased the differences in α-synuclein concentration between detection methods and technologies. Pilot data on an immunoprecipitation mass spectrometry (IP-MS) method is also presented. Our results suggest that the four immunochemical methods and the IP-MS method measure similar forms of α-synuclein and that a common reference material would allow harmonization of results between immunoassays."],["dc.identifier.doi","10.1111/jnc.14569"],["dc.identifier.pmid","30125936"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/16020"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/59849"],["dc.language.iso","en"],["dc.notes.intern","Merged from goescholar"],["dc.rights","CC BY 4.0"],["dc.rights.uri","https://creativecommons.org/licenses/by/4.0"],["dc.subject.ddc","610"],["dc.title","Antibody‐based methods for the measurement of α‐synuclein concentration in human cerebrospinal fluid – method comparison and round robin study"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]
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  • 2018Journal Article
    [["dc.bibliographiccitation.firstpage","461"],["dc.bibliographiccitation.journal","Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring"],["dc.bibliographiccitation.lastpage","470"],["dc.bibliographiccitation.volume","10"],["dc.contributor.author","Kruse, Niels"],["dc.contributor.author","Heslegrave, Amanda"],["dc.contributor.author","Gupta, Vandana"],["dc.contributor.author","Foiani, Martha"],["dc.contributor.author","Villar-Piqué, Anna"],["dc.contributor.author","Schmitz, Matthias"],["dc.contributor.author","Lehmann, Sylvain"],["dc.contributor.author","Teunissen, Charlotte"],["dc.contributor.author","Blennow, Kaj"],["dc.contributor.author","Zetterberg, Henrik"],["dc.contributor.author","Mollenhauer, Brit"],["dc.contributor.author","Zerr, Inga"],["dc.contributor.author","Llorens, Franc"],["dc.date.accessioned","2019-07-09T11:49:35Z"],["dc.date.available","2019-07-09T11:49:35Z"],["dc.date.issued","2018"],["dc.description.abstract","ntroduction: Cerebrospinal fluid α-synuclein level is increased in sporadic Creutzfeldt-Jakob disease cases. However, the clinical value of this biomarker remains to be established. In this study, we have addressed the clinical validation parameters and the interlaboratory reproducibility by using an electrochemiluminescent assay. Methods: Cerebrospinal fluid α-synuclein was quantified in a total of 188 sporadic Creutzfeldt-Jakob disease and non-Creutzfeldt-Jakob-disease cases to determine sensitivity and specificity values and lot-to-lot variability. Two round robin tests with 70 additional cases were performed in six independent laboratories. Results: A sensitivity of 93% and a specificity of 96% were achieved in discriminating sporadic Creutzfeldt-Jakob disease. No differences were detected between lots. The mean interlaboratory coefficient of variation was 23%, and the intralaboratory coefficient of variations ranged 2.70%-11.39%. Overall, 97% of samples were correctly diagnosed. Discussion: The herein validated α-synuclein assay is robust, accurate, and reproducible in identifying Creutzfeldt-Jakob disease cases. Thus, it is ready for implementation in the clinical practice to support the diagnosis of Creutzfeldt-Jakob disease."],["dc.identifier.doi","10.1016/j.dadm.2018.06.005"],["dc.identifier.pmid","30294658"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/15718"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/59586"],["dc.language.iso","en"],["dc.notes.intern","Merged from goescholar"],["dc.rights","CC BY-NC-ND 4.0"],["dc.rights.uri","https://creativecommons.org/licenses/by-nc-nd/4.0"],["dc.subject.ddc","610"],["dc.title","Interlaboratory validation of cerebrospinal fluid α-synuclein quantification in the diagnosis of sporadic Creutzfeldt-Jakob disease"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]
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  • 2015Journal Article
    [["dc.bibliographiccitation.artnumber","UNSP 179"],["dc.bibliographiccitation.journal","Frontiers in Neurology"],["dc.bibliographiccitation.volume","6"],["dc.contributor.author","Andreasson, Ulf"],["dc.contributor.author","Perret-Liaudet, Armand"],["dc.contributor.author","van Waalwijk van Doorn, Linda J. C."],["dc.contributor.author","Blennow, Kaj"],["dc.contributor.author","Chiasserini, Davide"],["dc.contributor.author","Engelborghs, Sebastiaan"],["dc.contributor.author","Fladby, Tormod"],["dc.contributor.author","Genc, Sermin"],["dc.contributor.author","Kruse, Niels"],["dc.contributor.author","Kuipenj, H. Bea"],["dc.contributor.author","Kulic, Luka"],["dc.contributor.author","Lewczuk, Piotr"],["dc.contributor.author","Mollenhauer, Brit"],["dc.contributor.author","Mroczko, Barbara"],["dc.contributor.author","Pametti, Lucille"],["dc.contributor.author","Vanmechelen, Eugeen"],["dc.contributor.author","Verbeek, Marcel M."],["dc.contributor.author","Winblad, Bengt"],["dc.contributor.author","Zetterberg, Henrik"],["dc.contributor.author","Koel-Simmelink, Marleen J. A."],["dc.contributor.author","Teunissen, Charlotte E."],["dc.date.accessioned","2018-11-07T09:53:12Z"],["dc.date.available","2018-11-07T09:53:12Z"],["dc.date.issued","2015"],["dc.description.abstract","Biochemical markers have a central position in the diagnosis and management of patients in clinical medicine, and also in clinical research and drug development, also for brain disorders, such as Alzheimer's disease. The enzyme-linked immunosorbent assay (ELISA) is frequently used for measurement of low-abundance biomarkers. However, the quality of ELISA methods varies, which may introduce both systematic and random errors. This urges the need for more rigorous control of assay performance, regardless of its use in a research setting, in clinical routine, or drug development. The aim of a method validation is to present objective evidence that a method fulfills the requirements for its intended use. Although much has been published on which parameters to investigate in a method validation, less is available on a detailed level on how to perform the corresponding experiments. To remedy this, standard operating procedures (SOPs) with step-by-step instructions for a number of different validation parameters is included in the present work together with a validation report template, which allow for a well-ordered presentation of the results. Even though the SOPs were developed with the intended use for immunochemical methods and to be used for multicenter evaluations, most of them are generic and can be used for other technologies as well."],["dc.identifier.doi","10.3389/fneur.2015.00179"],["dc.identifier.isi","000363861800001"],["dc.identifier.pmid","26347708"],["dc.identifier.purl","https://resolver.sub.uni-goettingen.de/purl?gs-1/12620"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/36285"],["dc.notes.intern","Merged from goescholar"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.relation.issn","1664-2295"],["dc.rights","CC BY 4.0"],["dc.rights.uri","https://creativecommons.org/licenses/by/4.0"],["dc.title","A practical guide to immunoassay method validation"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]
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  • 2016Journal Article
    [["dc.bibliographiccitation.firstpage","2243"],["dc.bibliographiccitation.issue","21"],["dc.bibliographiccitation.journal","Bioanalysis"],["dc.bibliographiccitation.lastpage","2254"],["dc.bibliographiccitation.volume","8"],["dc.contributor.author","Miller, Anne-Marie"],["dc.contributor.author","Rutkowska, Aleksandra"],["dc.contributor.author","Bahl, Justyna M. C."],["dc.contributor.author","Herukka, Sanna-Kaisa"],["dc.contributor.author","Koel-Simmelink, Marleen J. A."],["dc.contributor.author","Kruse, Niels"],["dc.contributor.author","Mollenhauer, Brit"],["dc.contributor.author","Siloaho, Maritta"],["dc.contributor.author","Skinningsrud, Anders"],["dc.contributor.author","Zetterberg, Henrik"],["dc.contributor.author","Teunissen, Charlotte E."],["dc.contributor.author","Lawlor, Brian A."],["dc.date.accessioned","2018-11-07T10:06:38Z"],["dc.date.available","2018-11-07T10:06:38Z"],["dc.date.issued","2016"],["dc.description.abstract","Aim: Neurofilament light (NfL) chain, a putative cerebrospinal fluid biomarker, can support neurodegenerative disease diagnosis and indicate disease severity and prognosis. Universal validation protocols when used to measure biomarkers can reduce pre and analytical laboratory variation, thus increasing end-user confidence in the consistency of validation data across sites. Methodology: Here, a commercially available NfL ELISA (UmanDiagnostics, Ume dagger, Sweden) was validated in a multicentered setting using comprehensive newly developed standard operating procedures. Results: The data showed good assay sensitivity and intra and interassay precision. Interlaboratory precision was, however, suboptimal. Conclusion: The UmanDiagnostics assay is suitable for the quantification of NfL in human cerebrospinal fluid. However, sources of interlaboratory variation in the data require further investigation."],["dc.identifier.doi","10.4155/bio-2016-0114"],["dc.identifier.isi","000386046700008"],["dc.identifier.pmid","27684648"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/39132"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.relation.issn","1757-6199"],["dc.relation.issn","1757-6180"],["dc.title","Multicenter immunoassay validation of cerebrospinal fluid neurofilament light: a biomarker for neurodegeneration"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dspace.entity.type","Publication"]]
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  • 2020Journal Article
    [["dc.bibliographiccitation.firstpage","1999"],["dc.bibliographiccitation.issue","11"],["dc.bibliographiccitation.journal","Movement Disorders"],["dc.bibliographiccitation.lastpage","2008"],["dc.bibliographiccitation.volume","35"],["dc.contributor.author","Mollenhauer, Brit"],["dc.contributor.author","Dakna, Mohammed"],["dc.contributor.author","Kruse, Niels"],["dc.contributor.author","Galasko, Douglas"],["dc.contributor.author","Foroud, Tatiana"],["dc.contributor.author","Zetterberg, Henrik"],["dc.contributor.author","Schade, Sebastian"],["dc.contributor.author","Gera, Roland G."],["dc.contributor.author","Wang, Wenting"],["dc.contributor.author","Gao, Feng"],["dc.contributor.author","Frasier, Mark"],["dc.contributor.author","Chahine, Lana M."],["dc.contributor.author","Coffey, Christopher S."],["dc.contributor.author","Singleton, Andrew B."],["dc.contributor.author","Simuni, Tanya"],["dc.contributor.author","Weintraub, Daniel"],["dc.contributor.author","Seibyl, John"],["dc.contributor.author","Toga, Arthur W."],["dc.contributor.author","Tanner, Caroline M."],["dc.contributor.author","Kieburtz, Karl"],["dc.contributor.author","Marek, Kenneth"],["dc.contributor.author","Siderowf, Andrew"],["dc.contributor.author","Cedarbaum, Jesse M."],["dc.contributor.author","Hutten, Samantha J."],["dc.contributor.author","Trenkwalder, Claudia"],["dc.contributor.author","Graham, Danielle"],["dc.date.accessioned","2021-04-14T08:24:53Z"],["dc.date.available","2021-04-14T08:24:53Z"],["dc.date.issued","2020"],["dc.description.abstract","Abstract Background The objective of this study was to assess neurofilament light chain as a Parkinson's disease biomarker. Methods We quantified neurofilament light chain in 2 independent cohorts: (1) longitudinal cerebrospinal fluid samples from the longitudinal de novo Parkinson's disease cohort and (2) a large longitudinal cohort with serum samples from Parkinson's disease, other cognate/neurodegenerative disorders, healthy controls, prodromal conditions, and mutation carriers. Results In the Parkinson's Progression Marker Initiative cohort, mean baseline serum neurofilament light chain was higher in Parkinson's disease patients (13 ± 7.2 pg/mL) than in controls (12 ± 6.7 pg/mL), P = 0.0336. Serum neurofilament light chain increased longitudinally in Parkinson's disease patients versus controls (P \\u0026lt; 0.01). Motor scores were positively associated with neurofilament light chain, whereas some cognitive scores showed a negative association. Conclusions Neurofilament light chain in serum samples is increased in Parkinson's disease patients versus healthy controls, increases over time and with age, and correlates with clinical measures of Parkinson's disease severity. Although the specificity of neurofilament light chain for Parkinson's disease is low, it is the first blood‐based biomarker candidate that could support disease stratification of Parkinson's disease versus other cognate/neurodegenerative disorders, track clinical progression, and possibly assess responsiveness to neuroprotective treatments. However, use of neurofilament light chain as a biomarker of response to neuroprotective interventions remains to be assessed. © 2020 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society."],["dc.description.sponsorship","AbbVie http://dx.doi.org/10.13039/100006483"],["dc.description.sponsorship","Avid Radiopharmaceuticals http://dx.doi.org/10.13039/100014392"],["dc.description.sponsorship","Biogen Idec http://dx.doi.org/10.13039/100006314"],["dc.description.sponsorship","Bristol‐Myers Squibb http://dx.doi.org/10.13039/100002491"],["dc.description.sponsorship","Covance"],["dc.description.sponsorship","Eli Lilly \\u0026 Co"],["dc.description.sponsorship","F. Hoffman‐La Roche, Ltd"],["dc.description.sponsorship","GE Healthcare http://dx.doi.org/10.13039/100006775"],["dc.description.sponsorship","Genentech http://dx.doi.org/10.13039/100004328"],["dc.description.sponsorship","GlaxoSmithKline http://dx.doi.org/10.13039/100004330"],["dc.description.sponsorship","Lundbeck http://dx.doi.org/10.13039/501100013327"],["dc.description.sponsorship","Merck http://dx.doi.org/10.13039/100004334"],["dc.description.sponsorship","MesoScale"],["dc.description.sponsorship","Michael J. Fox Foundation for Parkinson's Research http://dx.doi.org/10.13039/100000864"],["dc.description.sponsorship","Pfizer http://dx.doi.org/10.13039/100004319"],["dc.description.sponsorship","Piramal"],["dc.description.sponsorship","UCB http://dx.doi.org/10.13039/100011110"],["dc.identifier.doi","10.1002/mds.28206"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/81454"],["dc.language.iso","en"],["dc.notes.intern","DOI Import GROB-399"],["dc.publisher","John Wiley \\u0026 Sons, Inc."],["dc.relation.eissn","1531-8257"],["dc.relation.issn","0885-3185"],["dc.rights","This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited."],["dc.title","Validation of Serum Neurofilament Light Chain as a Biomarker of Parkinson's Disease Progression"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dspace.entity.type","Publication"]]
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  • 2015Journal Article
    [["dc.bibliographiccitation.firstpage","2587"],["dc.bibliographiccitation.issue","9"],["dc.bibliographiccitation.journal","Neurobiology of Aging"],["dc.bibliographiccitation.lastpage","2596"],["dc.bibliographiccitation.volume","36"],["dc.contributor.author","Kruse, Niels"],["dc.contributor.author","Persson, Staffan"],["dc.contributor.author","Alcolea, Daniel"],["dc.contributor.author","Bahl, Justyna M. C."],["dc.contributor.author","Baldeiras, Ines"],["dc.contributor.author","Capello, Elisabetta"],["dc.contributor.author","Chiasserini, Davide"],["dc.contributor.author","Chiavetto, Luisella Bocchio"],["dc.contributor.author","Emersic, Andreja"],["dc.contributor.author","Engelborghs, Sebastiaan"],["dc.contributor.author","Eren, Erden"],["dc.contributor.author","Fladby, Tormod"],["dc.contributor.author","Frisoni, Giovanni B."],["dc.contributor.author","Garcia-Ayllon, Maria-Salud"],["dc.contributor.author","Genc, Sermin"],["dc.contributor.author","Gkatzima, Olymbia"],["dc.contributor.author","Heegaard, Niels H. H."],["dc.contributor.author","Janeiro, Andre M."],["dc.contributor.author","Kovacech, Branislav"],["dc.contributor.author","Kuiperij, H. Bea"],["dc.contributor.author","Leitao, Maria J."],["dc.contributor.author","Lleo, Alberto"],["dc.contributor.author","Martins, Madalena"],["dc.contributor.author","Matos, Mafalda"],["dc.contributor.author","Mollergard, Hanne M."],["dc.contributor.author","Nobili, Flavio"],["dc.contributor.author","Ohrfelt, Annika"],["dc.contributor.author","Parnetti, Lucilla"],["dc.contributor.author","de Oliveira, Catarina Resende"],["dc.contributor.author","Rot, Uros"],["dc.contributor.author","Saez-Valero, Javier"],["dc.contributor.author","Struyfs, Hanne"],["dc.contributor.author","Tanassi, Julia T."],["dc.contributor.author","Taylor, Peggy"],["dc.contributor.author","Tsolaki, Magda"],["dc.contributor.author","Vanmechelen, Eugeen"],["dc.contributor.author","Verbeek, Marcel M."],["dc.contributor.author","Zilka, Norbert"],["dc.contributor.author","Blennow, Kaj"],["dc.contributor.author","Zetterberg, Henrik"],["dc.contributor.author","Mollenhauer, Brit"],["dc.date.accessioned","2018-11-07T09:53:03Z"],["dc.date.available","2018-11-07T09:53:03Z"],["dc.date.issued","2015"],["dc.description.abstract","Decreased levels of alpha-synuclein (aSyn) in cerebrospinal fluid (CSF) in Parkinson's disease and related synucleinopathies have been reported, however, not consistently in all cross-sectional studies. To test the performance of one recently released human-specific enzyme-linked immunosorbent assay (ELISA) for the quantification of aSyn in CSF, we carried out a round robin trial with 18 participating laboratories trained in CSF ELISA analyses within the BIOMARKAPD project in the EU Joint Program -Neurodegenerative Disease Research. CSF samples (homogeneous aliquots from pools) and ELISA kits (one lot) were provided centrally and data reported back to one laboratory for data analysis. Our study showed that although factors such as preanalytical sample handling and lot-to-lot variability were minimized by our study design, we identified high variation in absolute values of CSF aSyn even when the same samples and same lots of assays were applied. We further demonstrate that although absolute concentrations differ between laboratories the quantitative results are comparable. With further standardization this assay may become an attractive tool for comparing aSyn measurements in diverse settings. Recommendations for further validation experiments and improvement of the interlaboratory results obtained are given. (C) 2015 Elsevier Inc. All rights reserved."],["dc.identifier.doi","10.1016/j.neurobiolaging.2015.05.003"],["dc.identifier.isi","000358803400015"],["dc.identifier.pmid","26093515"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/36249"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.publisher","Elsevier Science Inc"],["dc.relation.issn","1558-1497"],["dc.relation.issn","0197-4580"],["dc.title","Validation of a quantitative cerebrospinal fluid alpha-synuclein assay in a European-wide interlaboratory study"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.status","published"],["dspace.entity.type","Publication"]]
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