Oeckl, P., Jardel, C., Salachas, F. et al. (32 more authors) (2016) Multicenter validation of CSF neurofilaments as diagnostic biomarkers for ALS. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration. pp. 1-10. ISSN 2167-8421
Abstract
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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2016 World Federation of Neurology on behalf of the Research Group on Motor Neuron Diseases |
Keywords: | Cerebrospinal fluid; neurofilament; biomarker; amyotrophic lateral sclerosis; round robin |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > Department of Neuroscience (Sheffield) The University of Sheffield > Sheffield Teaching Hospitals |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 17 Oct 2016 14:51 |
Last Modified: | 04 Nov 2016 01:03 |
Published Version: | http://dx.doi.org/10.3109/21678421.2016.1167913 |
Status: | Published |
Publisher: | Informa Healthcare |
Refereed: | Yes |
Identification Number: | 10.3109/21678421.2016.1167913 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:105925 |