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Journal article

Multicenter validation of CSF neurofilaments as diagnostic biomarkers for ALS

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.
Publication status:
Published
Peer review status:
Peer reviewed

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Files:
Publisher copy:
10.3109/21678421.2016.1167913

Authors


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Funder identifier:
https://ror.org/03x94j517
Funding agency for:
Turner, MR
Grant:
MR/K01014X/1
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Funder identifier:
https://ror.org/00k4n6c32
Grant:
01ED1202A
Programme:
SOPHIA
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Funder identifier:
https://ror.org/00k4n6c32
Grant:
01ED1203F
Programme:
BiomarkAPD
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Grant:
E-rare 12-093
Programme:
PYRAMID
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Funder identifier:
https://ror.org/04w9kkr77
Grant:
TUBITAK 112S362


Publisher:
Taylor and Francis
Journal:
Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration More from this journal
Volume:
17
Issue:
5-6
Pages:
403-413
Publication date:
2016-04-11
Acceptance date:
2016-02-12
DOI:
EISSN:
2167-9223
ISSN:
2167-8421


Language:
English
Keywords:
Pubs id:
pubs:617696
UUID:
uuid:97983edf-8c2d-4d49-80a8-d3dd0eb3bb35
Local pid:
pubs:617696
Source identifiers:
617696
Deposit date:
2016-04-28
ARK identifier:

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