Journal article
A multi-center study of neurofilament assay reliability and inter-laboratory variability
- Abstract:
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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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Accepted manuscript, pdf, 170.2KB, Terms of use)
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(Preview, Figures/images, pdf, 329.8KB, Terms of use)
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- Publisher copy:
- 10.1080/21678421.2020.1779300
Authors
- Publisher:
- Taylor and Francis
- Journal:
- Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration More from this journal
- Volume:
- 21
- Issue:
- 5-6
- Pages:
- 452-458
- Publication date:
- 2020-06-19
- Acceptance date:
- 2020-06-03
- DOI:
- EISSN:
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2167-9223
- ISSN:
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2167-8421
- Language:
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English
- Keywords:
- Pubs id:
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1108699
- Local pid:
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pubs:1108699
- Deposit date:
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2020-06-03
- ARK identifier:
Terms of use
- Copyright holder:
- World Federation of Neurology on behalf of the Research Group on Motor Neuron Diseases
- Copyright date:
- 2020
- Rights statement:
- © 2020 World Federation of Neurology on behalf of the Research Group on Motor Neuron Diseases.
- Notes:
- This is the accepted manuscript version of the article. The final version is available online from Taylor and Francis at: https://doi.org/10.1080/21678421.2020.1779300
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