Evidence map›Paper›PMID 35959400›Full record

ArticleFrontiers in neurology2022

Development of a Highly Sensitive Neurofilament Light Chain Assay on an Automated Immunoassay Platform.

Stephen Lee, Tatiana Plavina, Carol M Singh, Kuangnan Xiong, Xiaolei Qiu, Richard A Rudick, Peter A Calabresi, Lauren Stevenson, Danielle Graham, Denitza Raitcheva and 3 more

Open access · goldAbstract read
In one paragraph

Article in Frontiers in neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
5.0field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 41 citations in OpenAlex.

  1. Ultrasensitive Detection of Neurofilament Light in Plasma Using F(Ab')Small (Weinheim an der Bergstrasse, Germany) · 2026
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  17. Associations of sNfL with clinico-radiological measures in a large MS population.Annals of clinical and translational neurology · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 1 country.

Stephen LeeSiemens Healthcare Laboratory, LLC, Berkeley, CA, United States.
Tatiana PlavinaBiogen, Cambridge, MA, United States.
Carol M SinghBiogen, Cambridge, MA, United States.
Kuangnan XiongBiogen, Cambridge, MA, United States.
Xiaolei QiuSiemens Healthcare Laboratory, LLC, Berkeley, CA, United States.
Richard A RudickBiogen, Cambridge, MA, United States.
Peter A CalabresiDepartment of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United States.
Lauren StevensonBiogen, Cambridge, MA, United States.
Danielle GrahamBiogen, Cambridge, MA, United States.
Denitza RaitchevaBiogen, Cambridge, MA, United States.
Christopher GreenSiemens Healthcare Laboratory, LLC, Berkeley, CA, United States.
Madeleine MatiasSiemens Healthcare Laboratory, LLC, Berkeley, CA, United States.
Arejas J UzgirisSiemens Healthcare Laboratory, LLC, Berkeley, CA, United States.
Biogen (United States) · USSiemens Healthcare (United States) · USJohns Hopkins Medicine · US

Funding

Validation of Serum Neurofilament Light Chain as a Prognostic and Monitoring Biomarker in Multiple SclerosisU01NS111678 · NINDS · JOHNS HOPKINS UNIVERSITY · PI CALABRESI, PETER A · 2020 to 2024
$6.3M
NINDS NIH HHS U01 NS111678
6 · The paper itself

Abstract

Background: Neurofilament light chain (NfL) is an axonal cytoskeletal protein that is released into the extracellular space following neuronal or axonal injury associated with neurological conditions such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), and other diseases. NfL is detectable in the cerebrospinal fluid (CSF) and blood. Numerous studies on MS have demonstrated that NfL is correlated with disease activity, predicts disease progression, and is reduced by treatment with MS disease-modifying drugs, making NfL an attractive candidate to supplement existing clinical and imaging measures in MS. However, for NfL to achieve its potential as a clinically useful biomarker for clinical decision-making or drug development, a standardized, practical, and widely accessible assay is needed. Our objective was to develop a novel NfL assay on an automated, globally available immunoassay platform and validate its performance. Methods: A prototype NfL assay was first developed and evaluated on the ADVIA Centaur Results: In this study, an LLoQ of 1.85 pg/mL, within-lab precision <6%, and an assay range of up to 646 pg/mL were demonstrated with the serum prototype assay. Cross-reactivity of <0.7% with the neurofilament medium and heavy chains was observed. Serum and CSF NfL assay values were associated with radiological and clinical disease activity measures in patients with MS and ALS, respectively. The optimized version of the NfL assay demonstrated specimen equivalence with additional plasma tube types and was analytically validated as an LDT. Conclusion: The analytical performance of the NfL assay fulfilled all acceptance criteria; therefore, we suggest that the assay is acceptable for use in both research and clinical practice settings to determine elevated NfL levels in patients.

Indexed as

amyotrophic lateral sclerosisassaybiomarkermultiple sclerosisneurodegenerative article type: original research manuscript sectionneurofilament

Identifiers

PMID35959400
PMCPMC9359312
OpenAlexW4287447447

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.