A multi-center study of neurofilament assay reliability and inter-laboratory variability
Document Type
Article
Abstract
© 2020 World Federation of Neurology on behalf of the Research Group on Motor Neuron Diseases. Objectives: Significantly elevated levels of neurofilament light chain (NfL) and phosphorylated neurofilament heavy chain (pNfH) have been described in the blood and cerebrospinal fluid (CSF) of amyotrophic lateral sclerosis (ALS) patients. The aim of this study was to evaluate the analytical performance of different neurofilament assays in a round robin with 10 centers across Europe/U.S. Methods: Serum, plasma and CSF samples from a group of five ALS and five neurological control patients were distributed across 10 international specialist neurochemical laboratories for analysis by a range of commercial and in-house neurofilament assays. The performance of all assays was evaluated for their ability to differentiate between the groups. The inter-assay coefficient of variation was calculated where appropriate from sample measurements performed across multiple laboratories using the same assay. Results: All assays could differentiate ALS patients from controls in CSF. Inter-assay coefficient of variation of analytical platforms performed across multiple laboratories varied between 6.5% and 41.9%. Conclusions: This study is encouraging for the growing momentum toward integration of neurofilament measurement into the specialized ALS clinic. It demonstrates the importance of ‘round robin’ studies necessary to ensure the analytical quality required for translation to the routine clinical setting. A standardized neurofilament probe is needed which can be used as international benchmark for analytical performance in ALS.
Keywords
Amyotrophic lateral sclerosis, biomarker, neurofilament
Publication Date
7-2-2020
Publication Title
Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration
ISSN
21678421
E-ISSN
21679223
Volume
21
Issue
5-6
First Page
452
Last Page
458
PubMed ID
32558597
Digital Object Identifier (DOI)
10.1080/21678421.2020.1779300
Recommended Citation
Gray, Elizabeth; Oeckl, Patrick; Amador, Maria D.M.; Andreasson, Ulf; An, Jiyan; Blennow, Kaj; Bowser, Robert; De Schaepdryver, Maxim; Heslegrave, Amanda; Kuhle, Jens; Maceski, Aleksandra; Koel-Simmelink, Marleen; Lamari, Foudil; Lombardi, Vittoria; Malaspina, Andrea; Nilsson, Irina; Poesen, Koen; Salachas, François; Steinacker, Petra; Teunissen, Charlotte E.; Van Damme, Philip; Zetterberg, Henrik; Ludolph, Albert; Jeromin, Andreas; Turner, Martin R.; and Otto, Markus, "A multi-center study of neurofilament assay reliability and inter-laboratory variability" (2020). Translational Neuroscience. 535.
https://scholar.barrowneuro.org/neurobiology/535