Biological variation of serum neurofilament light chain.
biological variation
biomarker
monitoring
neurofilament proteins
Journal
Clinical chemistry and laboratory medicine
ISSN: 1437-4331
Titre abrégé: Clin Chem Lab Med
Pays: Germany
ID NLM: 9806306
Informations de publication
Date de publication:
28 03 2022
28 03 2022
Historique:
received:
21
08
2020
accepted:
15
03
2021
pubmed:
25
3
2021
medline:
26
3
2022
entrez:
24
3
2021
Statut:
epublish
Résumé
The neurofilament light chain (NfL) has emerged as a versatile biomarker for CNS-diseases and is approaching clinical use. The observed changes in NfL levels are frequently of limited magnitude and in order to make clinical decisions based on NfL measurements, it is essential that biological variation is not confused with clinically relevant changes. The present study was designed to evaluate the biological variation of serum NfL. Apparently healthy individuals (n=33) were submitted to blood draws for three days in a row. On the second day, blood draws were performed every third hour for 12 h. NfL was quantified in serum using the Simoa™ HD-1 platform. The within-subject variation (CV The overall median value of NfL was 6.3 pg/mL (range 2.1-19.1). The CV Serum NfL is subject to tight homeostatic regulation with none or neglectable semidiurnal and day-to-day variation, but considerable between-subject variation exists. This emphasizes serum NfL as a well-suited biomarker for disease monitoring, but warrants caution when interpreting NfL levels in relation to reference intervals in a diagnosis setting. Furthermore, NfL's tight regulation requires that the analytical variation is kept at a minimum.
Identifiants
pubmed: 33759425
pii: cclm-2020-1276
doi: 10.1515/cclm-2020-1276
doi:
Substances chimiques
Biomarkers
0
Neurofilament Proteins
0
neurofilament protein L
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
569-575Informations de copyright
© 2021 Walter de Gruyter GmbH, Berlin/Boston.
Références
Khalil, M, Teunissen, CE, Otto, M, Piehl, F, Sormani, MP, Gattringer, T, et al.. Neurofilaments as biomarkers in neurological disorders. Nat Rev Neurol 2018;14:577–89. https://doi.org/10.1038/s41582-018-0058-z.
Lu, CH, Macdonald-Wallis, C, Gray, E, Pearce, N, Petzold, A, Norgren, N, et al.. Neurofilament light chain: a prognostic biomarker in amyotrophic lateral sclerosis. Neurology 2015;84:2247–57. https://doi.org/10.1212/wnl.0000000000001642.
Moseby-Knappe, M, Mattsson, N, Nielsen, N, Zetterberg, H, Blennow, K, Dankiewicz, J, et al.. Serum neurofilament light chain for prognosis of outcome after cardiac arrest. JAMA Neurol 2019;76:64–71. https://doi.org/10.1001/jamaneurol.2018.3223.
Rojas, JC, Karydas, A, Bang, J, Tsai, RM, Blennow, K, Liman, V, et al.. Plasma neurofilament light chain predicts progression in progressive supranuclear palsy. Ann Clin Transl Neurol 2016;3:216–25. https://doi.org/10.1002/acn3.290.
Yuan, A, Rao, MV, Veeranna, Nixon, RA. Neurofilaments at a glance. J Cell Sci 2012;125:3257–63. https://doi.org/10.1242/jcs.104729.
Disanto, G, Barro, C, Benkert, P, Naegelin, Y, Schadelin, S, Giardiello, A, et al.. Serum Neurofilament light: a biomarker of neuronal damage in multiple sclerosis. Ann Neurol 2017;81:857–70. https://doi.org/10.1002/ana.24954.
Zetterberg, H, Skillback, T, Mattsson, N, Trojanowski, JQ, Portelius, E, Shaw, LM, et al.. Association of cerebrospinal fluid neurofilament light concentration with alzheimer disease progression. JAMA Neurol 2016;73:60–7. https://doi.org/10.1001/jamaneurol.2015.3037.
Hviid, CVB, Lauridsen, SV, Gyldenholm, T, Sunde, N, Parkner, T, Hvas, AM. Plasma neurofilament light chain is associated with poor functional outcome and mortality rate after spontaneous subarachnoid hemorrhage. Transl Stroke Res 2020;11:671–7. https://doi.org/10.1007/s12975-019-00761-4.
Meeter, LH, Dopper, EG, Jiskoot, LC, Sanchez-Valle, R, Graff, C, Benussi, L, et al.. Neurofilament light chain: a biomarker for genetic frontotemporal dementia. Ann Clin Transl Neurol 2016;3:623–36, https://doi.org/10.1002/acn3.325.
Shahim, P, Gren, M, Liman, V, Andreasson, U, Norgren, N, Tegner, Y, et al.. Serum neurofilament light protein predicts clinical outcome in traumatic brain injury. Sci Rep 2016;6:36791. https://doi.org/10.1038/srep36791.
Hviid, CVB, Gyldenholm, T, Lauridsen, SV, Hjort, N, Hvas, AM, Parkner, T. Plasma neurofilament light chain is associated with mortality after spontaneous intracerebral hemorrhage. Clin Chem Lab Med 2020;58:261–7. https://doi.org/10.1515/cclm-2019-0532.
Shahim, P, Tegner, Y, Wilson, DH, Randall, J, Skillback, T, Pazooki, D, et al.. Blood biomarkers for brain injury in concussed professional ice hockey players. JAMA Neurol 2014;71:684–92. https://doi.org/10.1001/jamaneurol.2014.367.
Shahim, P, Zetterberg, H, Tegner, Y, Blennow, K. Serum neurofilament light as a biomarker for mild traumatic brain injury in contact sports. Neurology 2017;88:1788–94. https://doi.org/10.1212/wnl.0000000000003912.
Rissin, DM, Kan, CW, Campbell, TG, Howes, SC, Fournier, DR, Song, L, et al.. Single-molecule enzyme-linked immunosorbent assay detects serum proteins at subfemtomolar concentrations. Nat Biotechnol 2010;28:595–9. https://doi.org/10.1038/nbt.1641.
Pujol-Calderon, F, Portelius, E, Zetterberg, H, Blennow, K, Rosengren, LE, Hoglund, K. Neurofilament changes in serum and cerebrospinal fluid after acute ischemic stroke. Neurosci Lett 2019;698:58–63. https://doi.org/10.1016/j.neulet.2018.12.042.
Wilke, C, Preische, O, Deuschle, C, Roeben, B, Apel, A, Barro, C, et al.. Neurofilament light chain in FTD is elevated not only in cerebrospinal fluid, but also in serum. J Neurol Neurosurg Psychiatry 2016;87:1270–2. https://doi.org/10.1136/jnnp-2015-312972.
Hviid, CVB, Knudsen, CS, Parkner, T. Reference interval and preanalytical properties of serum neurofilament light chain in Scandinavian adults. Scand J Clin Lab Invest 2020;80:291–5. https://doi.org/10.1080/00365513.2020.1730434.
Mattsson, N, Andreasson, U, Zetterberg, H, Blennow, K. Association of plasma neurofilament light with neurodegeneration in patients with alzheimer disease. JAMA Neurol 2017;74:557–66. https://doi.org/10.1001/jamaneurol.2016.6117.
Madsen, AT, Hojbjerg, JA, Sorensen, BS, Winther-Larsen, A. Day-to-day and within-day biological variation of cell-free DNA. EBioMedicine 2019;49:284–90. https://doi.org/10.1016/j.ebiom.2019.10.008.
Aarsand, AK, Røraas, T, Fernandez-Calle, P, Ricos, C, Díaz-Garzón, J, Jonker, N, et al.. The biological variation data critical appraisal checklist: a standard for evaluating studies on biological variation. Clin Chem 2018;64:501–14. https://doi.org/10.1373/clinchem.2017.281808.
Bartlett, WA, Braga, F, Carobene, A, Coşkun, A, Prusa, R, Fernandez-Calle, P, et al.. A checklist for critical appraisal of studies of biological variation. Clin Chem Lab Med 2015;53:879–85. https://doi.org/10.1515/cclm-2014-1127.
Fraser, CG, Harris, EK. Generation and application of data on biological variation in clinical chemistry. Crit Rev Clin Lab Sci 1989;27:409–37. https://doi.org/10.3109/10408368909106595.
Braga, F, Panteghini, M. Generation of data on within-subject biological variation in laboratory medicine: an update. Crit Rev Clin Lab Sci 2016;53:313–25. https://doi.org/10.3109/10408363.2016.1150252.
Røraas, T, Støve, B, Petersen, PH, Sandberg, S. Biological variation: evaluation of methods for constructing confidence intervals for estimates of within-person biological variation for different distributions of the within-person effect. Clin Chim Acta 2017;468:166–73.
Fokkema, MR, Herrmann, Z, Muskiet, FA, Moecks, J. Reference change values for brain natriuretic peptides revisited. Clin Chem 2006;52:1602–3. https://doi.org/10.1373/clinchem.2006.069369.
van der Linden, N, Hilderink, JM, Cornelis, T, Kimenai, DM, Klinkenberg, LJJ, van Doorn, WP, et al.. Twenty-four-hour biological variation profiles of cardiac troponin I in individuals with or without chronic kidney disease. Clin Chem 2017;63:1655–6. https://doi.org/10.1373/clinchem.2017.275107.
European federation of clinical chemistry and laboratory medicine the EFLM biological variation database. Available from: https://biologicalvariation.eu/ [Accessed 08 Feb 21].
Carobene, A, Guerra, E, Locatelli, M, Ceriotti, F, Sandberg, S, Fernandez-Calle, P, et al.. Providing correct estimates of biological variation-not an easy task. The example of S100-β protein and neuron-specific Enolase. Clin Chem 2018;64:1537–9. https://doi.org/10.1373/clinchem.2018.292169.
Onatsu, J, Vanninen, R, Jakala, P, Mustonen, P, Pulkki, K, Korhonen, M, et al.. Serum neurofilament light chain concentration correlates with infarct volume but not prognosis in acute ischemic stroke. J Stroke Cerebrovasc Dis 2019;28:2242–9. https://doi.org/10.1016/j.jstrokecerebrovasdis.2019.05.008.
Ashton, NJ, Leuzy, A, Lim, YM, Troakes, C, Hortobágyi, T, Höglund, K, et al.. Increased plasma neurofilament light chain concentration correlates with severity of post-mortem neurofibrillary tangle pathology and neurodegeneration. Acta Neuropathol Commun 2019;7:5. https://doi.org/10.1186/s40478-018-0649-3.
Jakimovski, D, Kuhle, J, Ramanathan, M, Barro, C, Tomic, D, Hagemeier, J, et al.. Serum neurofilament light chain levels associations with gray matter pathology: a 5-year longitudinal study. Ann Clin Transl Neurol 2019;6:1757–70. https://doi.org/10.1002/acn3.50872.
Harris, EK. Statistical aspects of reference values in clinical pathology. Prog Clin Pathol 1981;8:45–66.
Fraser, CG. Making better use of differences in serial laboratory results. Ann Clin Biochem 2012;49:1–3. https://doi.org/10.1258/acb.2011.011203.
Kuhle, J, Barro, C, Andreasson, U, Derfuss, T, Lindberg, R, Sandelius, A, et al.. Comparison of three analytical platforms for quantification of the neurofilament light chain in blood samples: ELISA, electrochemiluminescence immunoassay and Simoa. Clin Chem Lab Med 2016;54:1655–61. https://doi.org/10.1515/cclm-2015-1195.
Coskun, A, Braga, F, Carobene, A, Tejedor Ganduxe, X, Aarsand, AK, Fernández-Calle, P, et al.. Systematic review and meta-analysis of within-subject and between-subject biological variation estimates of 20 haematological parameters. Clin Chem Lab Med 2019;58:25–32. https://doi.org/10.1515/cclm-2019-0658.
González-Lao, E, Corte, Z, Simón, M, Ricós, C, Coskun, A, Braga, F, et al.. Systematic review of the biological variation data for diabetes related analytes. Clin Chim Acta 2019;488:61–7. https://doi.org/10.1016/j.cca.2018.10.031.
Jonker, N, Aslan, B, Boned, B, Marqués-García, F, Ricós, C, Alvarez, V, et al.. Critical appraisal and meta-analysis of biological variation estimates for kidney related analytes. Clin Chem Lab Med 2022;60:469–78. https://doi.org/10.1515/cclm-2020-1168.
Díaz-Garzón, J, Fernández-Calle, P, Minchinela, J, Aarsand, AK, Bartlett, WA, Aslan, B, et al.. Biological variation data for lipid cardiovascular risk assessment biomarkers. A systematic review applying the biological variation data critical appraisal checklist (BIVAC). Clin Chim Acta 2019;495:467–75. https://doi.org/10.1016/j.cca.2019.05.013.