Search: onr:"swepub:oai:gup.ub.gu.se/330382" >
Development and mul...
Development and multi-center validation of a fully automated digital immunoassay for neurofilament light chain: toward a clinical blood test for neuronal injury
- Article/chapterEnglish2024
Publisher, publication year, extent ...
Numbers
-
LIBRIS-ID:oai:gup.ub.gu.se/330382
-
https://gup.ub.gu.se/publication/330382URI
-
https://doi.org/10.1515/cclm-2023-0518DOI
-
http://kipublications.ki.se/Default.aspx?queryparsed=id:153695669URI
Supplementary language notes
Part of subdatabase
Classification
-
Subject category:ref swepub-contenttype
-
Subject category:art swepub-publicationtype
Notes
-
Objectives Neurofilament light chain (NfL) has emerged as a promising biomarker for detecting and monitoring axonal injury. Until recently, NfL could only be reliably measured in cerebrospinal fluid, but digital single molecule array (Simoa) technology has enabled its precise measurement in blood samples where it is typically 50-100 times less abundant. We report development and multi-center validation of a novel fully automated digital immunoassay for NfL in serum for informing axonal injury status.Methods A 45-min immunoassay for serum NfL was developed for use on an automated digital analyzer based on Simoa technology. The analytical performance (sensitivity, precision, reproducibility, linearity, sample type) was characterized and then cross validated across 17 laboratories in 10 countries. Analytical performance for clinical NfL measurement was examined in individual patients with relapsing remitting multiple sclerosis (RRMS) after 3 months of disease modifying treatment (DMT) with fingolimod.Results The assay exhibited a lower limit of detection (LLoD) of 0.05 ng/L, a lower limit of quantification (LLoQ) of 0.8 ng/L, and between-laboratory imprecision <10 % across 17 validation sites. All tested samples had measurable NfL concentrations well above the LLoQ. In matched pre-post treatment samples, decreases in NfL were observed in 26/29 RRMS patients three months after DMT start, with significant decreases detected in a majority of patients.Conclusions The sensitivity characteristics and reproducible performance across laboratories combined with full automation make this assay suitable for clinical use for NfL assessment, monitoring in individual patients, and cross-comparisons of results across multiple sites.
Subject headings and genre
Added entries (persons, corporate bodies, meetings, titles ...)
-
Chan, D. D.
(author)
-
Chang, L.
(author)
-
Mathis, R.
(author)
-
Verberk, I.
(author)
-
Montalban, X.
(author)
-
Comabella, M.
(author)
-
Fissolo, N.
(author)
-
Bielekova, B.
(author)
-
Masvekar, R.
(author)
-
Chitnis, T.
(author)
-
Ziemssen, T.
(author)
-
Akguen, K.
(author)
-
Blennow, Kaj,1958Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry(Swepub:gu)xbleka
(author)
-
Zetterberg, Henrik,1973Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry(Swepub:gu)xzethe
(author)
-
Brueck, W.
(author)
-
Giovannoni, G.
(author)
-
Gnanapavan, S.
(author)
-
Bittner, S.
(author)
-
Zipp, F.
(author)
-
Comi, G.
(author)
-
Furlan, R.
(author)
-
Lehmann, S.
(author)
-
Thebault, S.
(author)
-
Freedman, M.
(author)
-
Bar-Or, A.
(author)
-
Kramer, M.
(author)
-
Otto, M.
(author)
-
Halbgebauer, S.
(author)
-
Hrusovsky, K.
(author)
-
Plavina, T.
(author)
-
Khalil, M.
(author)
-
Piehl, F.Karolinska Institutet
(author)
-
Wiendl, H.
(author)
-
Kappos, L.
(author)
-
Maceski, A.
(author)
-
Willemse, E.
(author)
-
Leppert, D.
(author)
-
Teunissen, C.
(author)
-
Kuhle, J.
(author)
-
Göteborgs universitetInstitutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi
(creator_code:org_t)
Related titles
-
In:Clinical Chemistry and Laboratory Medicine62:2, s. 322-3311434-66211437-4331
Internet link
Find in a library
To the university's database
- By the author/editor
-
Wilson, D.
-
Chan, D. D.
-
Chang, L.
-
Mathis, R.
-
Verberk, I.
-
Montalban, X.
-
show more...
-
Comabella, M.
-
Fissolo, N.
-
Bielekova, B.
-
Masvekar, R.
-
Chitnis, T.
-
Ziemssen, T.
-
Akguen, K.
-
Blennow, Kaj, 19 ...
-
Zetterberg, Henr ...
-
Brueck, W.
-
Giovannoni, G.
-
Gnanapavan, S.
-
Bittner, S.
-
Zipp, F.
-
Comi, G.
-
Furlan, R.
-
Lehmann, S.
-
Thebault, S.
-
Freedman, M.
-
Bar-Or, A.
-
Kramer, M.
-
Otto, M.
-
Halbgebauer, S.
-
Hrusovsky, K.
-
Plavina, T.
-
Khalil, M.
-
Piehl, F.
-
Wiendl, H.
-
Kappos, L.
-
Maceski, A.
-
Willemse, E.
-
Leppert, D.
-
Teunissen, C.
-
Kuhle, J.
-
show less...
- About the subject
-
- MEDICAL AND HEALTH SCIENCES
-
MEDICAL AND HEAL ...
-
and Basic Medicine
-
and Neurosciences
- Articles in the publication
-
Clinical Chemist ...
- By the university
-
University of Gothenburg
-
Karolinska Institutet