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Access NfL (RUO) Immunoassay
Neurofilament Light Chain (NfL)
Neurofilament Light Chain (NfL) is a structural protein of the neuronal axon. Research suggests that when neurons are damaged through disease or injury, NfL is released into the cerebrospinal fluid (CSF) and bloodstream. Studies have explored whether elevated plasma NfL levels could potentially serve as a valuable biomarker for investigating neuronal injury and for monitoring disease progression and therapeutic efficacy in neurodegenerative diseases.1,2
Further research into NfL as a general biomarker of neuronal injury is ongoing, including its potential role in understanding cognitive decline related to neurodegenerative processes.1,3,4
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% non-linearity on both the Access 2 and DxI 9000 analyzers
total CV (%) on the Access 2 and DxI 9000 analyzers
pg/mL Limit of Quantitation
All
NfL5
High levels of NfL in the blood or CSF may indicate: neurodegenerative diseases, including traumatic brain injury, stroke, spinal cord injury, and dementia. NfL
- Is a protein subunit forming part of the neurofilament
- Plays a role in maintaining the structural integrity and function of neurons
- Can be measured in blood or CSF
NfL in neurodegenerative disease research
NfL is a promising but non-specific biomarker of axonal injury that provides insight into neurodegenerative disease mechanisms and disease progression. Levels of NfL are being studied to understand disease presentation across different neurodegenerative diseases.2
Assay Characteristics
The following results are derived from internal studies and are intended solely for informational purposes. These findings are not intended to serve as official specifications or guarantees of performance.
Assay Characteristic |
Access Neurofilament Light Chain (RUO) |
| Assay format | One-step sandwich |
| Recommended sample type(s) | Plasma (K2 EDTA), Serum |
| Unit of measure | pg/mL |
| Analytical Measuring Range | 2.19 to 10,000 pg/mL |
| Open reagent pack stability | 2 to 10 °C for 14 days |
| Open calibrator pack stability | 2 to 10 °C for 14 days |
| Open QC vial stability | 2 to 10 °C for 14 days |
| Sample volume (uptake) | Access 2 analyzer: 110 µL DxI 9000 analyzer: 105 µL |
| Time to first result (approximate) | Access 2 analyzer: ~31 minutes DxI 9000 analyzer: ~25 minutes |
| Imprecision (%CV) Within-Laboratory | ~1.4 – 6.5% within-lab CV |
We are committed to research that advances neurodegenerative disease diagnostics to make them more accessible to people around the world. Leveraging our history of IVD development, we are empowering cutting-edge research with high-quality, innovative assays that deliver accurate and affordable testing solutions at scale. Learn more about our comprehensive solutions.
New High-Throughput, Fully Automated Immunoassay for Plasma Neurofilament Light Chain
Investigating NfL and neurodegenerative diseases
Research indicates that increased levels of NfL may be associated with neuronal damage in neurodegenerative conditions such as AD, TBI, and PD. Studies have shown correlations between elevated NfL blood levels and those in CSF. Further investigation into NfL levels may contribute to a deeper understanding of the pathology of multiple neurodegenerative disorders.
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neurodegenerative diseases
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References:
1. Jung Y, Damoiseaux JS. The potential of blood neurofilament light as a marker of neurodegeneration for Alzheimer’s disease. Brain. 2024;147(1):12-25. doi:10.1093/brain/awad267
2. Coppens S, Lehmann S, Hopley C, Hirtz C. Neurofilament-Light, a Promising Biomarker: Analytical, Metrological and Clinical Challenges. Int J Mol Sci. 2023;24(14). doi:10.3390/ijms241411624
3. Ashton NJ, Janelidze S, Al Khleifat A, et al. A multicentre validation study of the diagnostic value of plasma neurofilament light. Nat Commun. 2021;12(1):3400. doi:10.1038/s41467-021-23620-z
4. Götze K, Vrillon A, Dumurgier J, et al. Plasma neurofilament light chain as prognostic marker of cognitive decline in neurodegenerative diseases, a clinical setting study. Alzheimers Res Ther. 2024;16(1):231. doi:10.1186/s13195-024-01593-7
5. Khalil M, Teunissen CE, Otto M, et al. Neurofilaments as biomarkers in neurological disorders. Nat Rev Neurol. 2018;14(10):577-589. doi:10.1038/s41582-018-0058-z
