Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Wilson, D; Chan, D; Chang, L; Mathis, R; Verberk, I; Montalban, X; Comabella, M; Fissolo, N; Bielekova, B; Masvekar, R; Chitnis, T; Ziemssen, T; Akgün, K; Blennow, K; Zetterberg, H; Brück, 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.
Development and multi-center validation of a fully automated digital immunoassay for neurofilament light chain: toward a clinical blood test for neuronal injury.
Clin Chem Lab Med. 2024; 62(2):322-331
Doi: 10.1515/cclm-2023-0518
Web of Science
PubMed
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- Co-Autor*innen der Med Uni Graz
- Khalil Michael
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- Abstract:
- 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.
- Find related publications in this database (using NLM MeSH Indexing)
- Humans - administration & dosage
- Reproducibility of Results - administration & dosage
- Intermediate Filaments - administration & dosage
- Immunoassay - administration & dosage
- Neurons - administration & dosage
- Neurofilament Proteins - administration & dosage
- Biomarkers - administration & dosage
- Hematologic Tests - administration & dosage
- Find related publications in this database (Keywords)
- digital immunoassay
- neuronal injury
- multiple sclerosis
- validation