Neurofilament Light Chain (NfL)* Testing Service
Overview
What is Neurofilament Light?
NfL is a structural protein found in neurons. Axonal injury and degeneration of neurons results in the release of NfL into CSF and blood, making it a candidate specific biomarker for a range of neurodegenerative diseases.
Testing for level of NfL may provide valuable data in clinical trials for neurological disorders such as amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, Huntington’s disease, multiple sclerosis and Parkinson’s disease.
Siemens Healthineers blood-based NfL assay uses high-sensitivity Acridinium Ester (AE) technology designed to run on the Atellica® Immunoassay system for serum, plasma, or CSF samples.
We have extensive experience in NfL assay development on our proprietary immunoassay platforms and clinical trial assay testing, supporting clinical trials of NIH and top pharmaceutical companies.
Our NfL testing service is available through our CLIA-certified lab in Berkeley, CA, USA to support clinical trials.
Test Description
The Neurofilament Light (NFL) assay is a laboratory developed test (LDT) used to quantify neurofilament light chain (NFL) in human serum, plasma or CSF using the Atellica® Immunoassay system.
- Sample Type: Serum, EDTA Plasma, or CSF
- Sample Size: 1.0mL Serum or EDTA Plasma 0.5 mL of cerebral spinal fluid (CSF)
- Specimen Storage: Freeze serum and plasma at ≤ –20°C in a non-frost-free freezer or, preferably, –60 to –90°C for long term storage.
Webinar: Neurofilament Light Chain Testing for
Neurodegenerative Diseases
Get an overview of various applications of NfL in neurological disease clinical trail programs and learn more about the highly sensitive chemiluminescent acridinium ester (AE) immunoassay technology, which is being used for the NfL testing services at the Siemens Healthineers CLIA laboratory to support clinical trails.
Originally recorded on June 27, 2022
Publications
- ECTRIM 2019 Poster: Development of a Sensitive Serum Neurofilament Light Assay on Siemens Routine Immunoassay Platforms (pdf) 0.21 MB
- AAIC 2020 Poster: Equivalence of Serum and Plasma Neurofilament Light Chain Levels Using a Highly Sensitive Automated Immunoassay (pdf) 0.25 MB
- AACC 2022 Poster: Laboratory Validation of a Neurofilament Light Chain (NfL) Clinical Trial Assay for Applications in Neurological Diseases Testing Services (pdf) 0.41 MB
- Development of a Highly Sensitive Neurofilament Light Chain Assay on an Automated Immunoassay Platform
- Contributors to Serum NfL Levels in People without Neurologic Disease
- Type of serum collection tube does not impact neurofilament light chain levels
- Dendrimer nanotherapy for severe COVID-19 attenuates inflammation and neurological injury markers and improves outcomes in a phase2a clinical trial
- Assessing the commutability of candidate reference materials for the harmonization of neurofilament light measurements in blood
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Reference: Gaetani L, Blennow K, Calabresi P, et al. J Neurol Neurosurg Psychiatry. 2019;90:870-881
*NfL is currently not for sale for diagnostic purpose. The NfL assay testing service is available from Siemens Healthcare Laboratory in Berkeley, California
