Neurofilament ELISA validation

被引:80
|
作者
Petzold, Axel [1 ]
Altintas, Ayse [2 ]
Andreoni, Laura [3 ]
Bartos, Ales [4 ,5 ]
Berthele, Achim [6 ]
Blankenstein, Marinus A. [7 ]
Buee, Luc [8 ]
Castellazzi, Massimiliano [9 ]
Cepok, Sabine [6 ]
Comabella, Manuel [10 ]
Constantinescu, Cris S. [11 ]
Deisenhammer, Florian [12 ]
Deniz, Gunnur [13 ]
Erten, Gaye [13 ]
Espino, Mercedes [14 ]
Fainardi, Enrico [15 ]
Franciotta, Diego [3 ]
Freedman, Mark S. [16 ]
Giedraitis, Vilmantas [26 ]
Gilhus, Nils Erik [17 ,18 ]
Giovannoni, Gavin [19 ]
Glabinski, Andrzej [20 ]
Grieb, Pawel [21 ]
Hartung, Hans-Peter [22 ]
Hemmer, Bernhard [6 ]
Herukka, Sanna-Kaisa [23 ,24 ]
Hintzen, Rogier [25 ]
Ingelsson, Martin [26 ]
Jackson, Samuel [19 ]
Jacobsen, Steve [27 ]
Jafari, Naghmeh [25 ]
Jalosinski, Marcin [20 ]
Jarius, Sven [28 ]
Kapaki, Elisabeth [29 ]
Kieseier, Bernd C. [22 ]
Koel-Simmelink, Marleen J. A. [30 ]
Kornhuber, Johannes [31 ]
Kuhle, Jens [32 ]
Kurzepa, Jacek [33 ]
Lalive, Patrice H. [34 ,35 ,36 ,37 ]
Lannfelt, Lars [26 ]
Lehmensiek, Vera [38 ]
Lewczuk, Piotr [31 ]
Livrea, Paolo [39 ]
Marnetto, Fabiana [40 ]
Martino, Davide [39 ]
Menge, Til [22 ]
Norgren, Niklas [41 ]
Papuc, Eva [33 ]
Paraskevas, George P. [29 ]
机构
[1] UCL Inst Neurol, Dept Neuroinflammat, London WC1N 3BG, England
[2] Istanbul Univ, Cerrahpasa Med Fac, Dept Neurol, Istanbul, Turkey
[3] Neurol Inst C Mondino, IRCCS, Lab Neuroimmunol, I-27100 Pavia, Italy
[4] Prague Psychiat Ctr, AD Ctr, Prague, Czech Republic
[5] Charles Univ Prague, Univ Hosp Kralovske Vinohrady, Fac Med 3, Dept Neurol, Prague, Czech Republic
[6] Tech Univ Munich, Klinikum Rechts Isar, Dept Neurol, D-81675 Munich, Germany
[7] Vrije Univ Amsterdam Med Ctr, Dept Clin Chem, Amsterdam, Netherlands
[8] Univ Lille 2, INSERM, Fac Med,JPArc Alzheimer & Tauopathies, Pole Rech Inst Med Predict & Rech Therapeut,U837,, F-59045 Lille, France
[9] Univ Ferrara, Lab Neurochim, Sez Clin Neurol, Dipartimento Discipline Med Chirurg Comunicaz & C, I-44100 Ferrara, Italy
[10] Hosp Univ Vall Hebron, Dept Neurol, Ctr Esclerosi Multiple Catalunya, Unitat Neuroimmunol Clin, Barcelona, Spain
[11] Univ Nottingham, Sch Med, Div Clin Neurol, Nottingham, England
[12] Innsbruck Med Univ, Dept Clin Neurol, A-6020 Innsbruck, Austria
[13] Istanbul Univ, Inst Expt Med, Dept Immunol, Istanbul, Turkey
[14] Hosp Ramon & Cajal, Dept Immunol, E-28034 Madrid, Spain
[15] Azienda Osped Univ, Neuroradiol Unit, Ferrara, Italy
[16] Ottawa Hosp Gen Campus, Ottawa Hosp Res Inst, Ottawa, ON, Canada
[17] Univ Bergen, Dept Clin Med, N-5020 Bergen, Norway
[18] Haukeland Hosp, Dept Neurol, N-5021 Bergen, Norway
[19] Queen Mary Univ London, Blizard Inst Cell Mol Sci, Barts & London Sch Med & Dent, London, England
[20] Med Univ Lodz, Kopermik Hosp, Dept Propedeut Neurol, Lodz, Poland
[21] Polish Acad Sci, Med Res Ctr, PL-02106 Pawinskiego, Poland
[22] Univ Dusseldorf, Dept Neurol, D-4000 Dusseldorf, Germany
[23] Univ Kuopio, Dept Neurol, FIN-70211 Kuopio, Finland
[24] Kuopio Univ Hosp, Kuopio 70211, Finland
[25] Erasmus MC, MS Ctr ErasMS, Dept Neurol, Rotterdam, Netherlands
[26] Uppsala Univ, Dept Publ Hlth Geriatr, Rudbeck Lab, S-75185 Uppsala, Sweden
[27] NINDS, NIH, Viral Immunol Sect, Bethesda, MD USA
[28] Univ Heidelberg, Dept Neurol, Div Mol Neuroimmunol, D-6900 Heidelberg, Germany
[29] Athens Natl Univ, Eginit Hosp, Dept Neurol, Athens 11528, Greece
[30] Vrije Univ Amsterdam Med Ctr, Dept Mol Cell Biol & Immunol, NeuroUnit Biomarkers Inflammat & Neurodegenerat, Amsterdam, Netherlands
[31] Univ Klinikum Erlangen, Dept Psychiat & Psychotherapy, Erlangen, Germany
[32] Univ Basel, Univ Hosp, CH-4003 Basel, Switzerland
[33] Med Univ Lublin, Dept Neurol, PL-20954 Lublin, Poland
[34] Univ Hosp Geneva, Dept Neurosci, Div Neurol, Neuroimmunol Lab, Geneva, Switzerland
[35] Fac Med, Geneva, Switzerland
[36] Univ Hosp Geneva, Dept Genet, Geneva, Switzerland
[37] Univ Hosp Geneva, Lab Med, Lab Med Serv, Geneva, Switzerland
[38] Univ Ulm, Dept Neurol, D-89081 Ulm, Germany
[39] Univ Bari, Dept Neurol & Psychiat Sci, I-70100 Bari, Italy
[40] Multiple Sclerosis Ctr ASO San Luigi Gonzaga Orba, Turin, Italy
[41] Umea Biotech Incubator, UmanDiagnostics, SE-90736 Umea, Sweden
[42] Univ Szeged, Dept Neurol, H-6725 Szeged, Hungary
[43] Univ Gothenburg, Sahlgrenska Univ Hosp, Inst Clin Neurosci, Dept Neurol, SE-41345 Gothenburg, Sweden
[44] McKnight Brain Inst, Dept Neurosci, Gainesville, FL 32610 USA
[45] NCHM, Neurochem Unit, Brussels, Belgium
[46] Umea Univ, Dept Immunol, SE-90187 Umea, Sweden
[47] Bakirkoy Prof Dr Mazhar Osman Teaching & Res Hosp, Istanbul, Turkey
[48] RPR Gent, Innogenet NV, BTW BE 0427 550 660, B-9052 Ghent, Belgium
[49] Haukeland Hosp, Dept Neurol, N-5021 Bergen, Norway
[50] Radboud Univ Nijmegen, Med Ctr, Donders Ctr Brain Cognit & Behav, Dept Neurol,Lab Pediat & Neurol,Alzheimer Ctr Nij, NL-6525 ED Nijmegen, Netherlands
关键词
Neurofilament; NfL; NF-L; NEFL; Biomarker; Validation; NEUROCHEMICAL DEMENTIA DIAGNOSTICS; CEREBROSPINAL-FLUID; ALZHEIMERS-DISEASE; MULTIPLE-SCLEROSIS; MARKERS; CSF; DEGENERATION; SUBUNIT; PROTEIN; ASSAYS;
D O I
10.1016/j.jim.2009.09.014
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
Background: Neurofilament proteins (Nf) are highly specific biomarkers for neuronal death and axonal degeneration. As these markers become more widely used, an inter-laboratory validation study is required to identify assay criteria for high quality performance. Methods: The UmanDiagnostics NF-light (R) enzyme-linked immunoabsorbent assays (ELISA) for the neurofilament light chain (NfL, 68 kDa) was used to test the intra-assay and inter-laboratory coefficient of variation (CV) between 35 laboratories worldwide on 15 cerebrospinal fluid (CSF) samples. Critical factors, such as sample transport and storage, analytical delays, reaction temperature and time, the laboratories' accuracy and preparation of standards were documented and used for the statistical analyses. Results: The intra-laboratory CV averaged 3.3% and the inter-laboratory CV 59%. The results from the test laboratories correlated with those from the reference laboratory (R = 0.60, p < 0.0001). Correcting for critical factors improved the strength of the correlation. Differences in the accuracy of standard preparation were identified as the most critical factor. Correcting for the error introduced by variation in the protein standards improved the correlation to R = 0.98, p < 0.0001 with an averaged inter-laboratory CV of 14%. The corrected overall inter-rater agreement was subtantial (0.6) according to Fleiss' multi-rater kappa and Gwet's AC1 statistics. Conclusion: This multi-center validation study identified the lack of preparation of accurate and consistent protein standards as the main reason for a poor inter-laboratory CV. This issue is also relevant to other protein biomarkers based on this type of assay and will need to be solved in order to achieve an acceptable level of analytical accuracy. The raw data of this study is available online. (C) 2009 Elsevier B.V. All rights reserved.
引用
收藏
页码:23 / 31
页数:9
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