• Amyotroph Lateral Scler Frontotemporal Degener · Jul 2016

    Multicenter Study

    Multicenter validation of CSF neurofilaments as diagnostic biomarkers for ALS.

    • Patrick Oeckl, Claude Jardel, François Salachas, Foudil Lamari, Peter M Andersen, Robert Bowser, Mamede de Carvalho, Júlia Costa, Philip van Damme, Elizabeth Gray, Julian Grosskreutz, María Hernández-Barral, Sanna-Kaisa Herukka, André Huss, Andreas Jeromin, Janine Kirby, Magdalena Kuzma-Kozakiewicz, Maria Del Mar Amador, Jesús S Mora, Claudia Morelli, Petra Muckova, Susanne Petri, Koen Poesen, Heidrun Rhode, Anna-Karin Rikardsson, Wim Robberecht, Ana I Rodríguez Mahillo, Pamela Shaw, Vincenzo Silani, Petra Steinacker, Martin R Turner, Erdem Tüzün, Berrak Yetimler, Albert C Ludolph, and Markus Otto.
    • a Department of Neurology , Ulm University Hospital , 89081 Ulm , Germany ;
    • Amyotroph Lateral Scler Frontotemporal Degener. 2016 Jul 1; 17 (5-6): 404-13.

    ObjectiveNeurofilaments are leading neurochemical biomarkers for amyotrophic lateral sclerosis (ALS). Here, we investigated the effect of preanalytical factors on neurofilament concentrations in cerebrospinal fluid (CSF) in a "reverse" round-robin with 15 centers across Europe/U.S.MethodsSamples from ALS and control patients (5/5 each center, n = 150) were analyzed for phosphorylated neurofilament heavy chain (pNfH) and neurofilament light chain (NfL) at two laboratories.ResultsCSF pNfH was increased (p < 0.05) in ALS in 10 out of 15 centers and NfL in 5 out of 12 centers. The coefficient of variation (CV%) of pNfH measurements between laboratories was 18.7 ± 19.1%. We calculated a diagnostic cut-off of >568.5 pg/mL for pNfH (sensitivity 78.7%, specificity 93.3%) and >1,431pg/mL for NfL (sensitivity 79.0%, specificity 86.4%).ConclusionValues in ALS patients are already comparable between most centers, supporting eventual implementation into clinical routine. However, continuous quality control programs will be necessary for inclusion in the diagnostic work-up.

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