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OBJECTIVE: Neurofilaments 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. METHODS: Samples 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. RESULTS: CSF 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%). CONCLUSION: Values 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.

Original publication

DOI

10.3109/21678421.2016.1167913

Type

Journal article

Journal

Amyotroph Lateral Scler Frontotemporal Degener

Publication Date

07/2016

Volume

17

Pages

404 - 413

Keywords

Cerebrospinal fluid, amyotrophic lateral sclerosis, biomarker, neurofilament, round robin, Adult, Aged, Amyotrophic Lateral Sclerosis, Biomarkers, Enzyme-Linked Immunosorbent Assay, Europe, Female, Humans, Intermediate Filaments, Male, Middle Aged, Phosphorylation, Reproducibility of Results, Statistics, Nonparametric, United States