Sponsored Content by QuanterixReviewed by Olivia FrostJun 4 2024
Neurofilament light (NfL) is a 68 kDa cytoskeletal intermediate filament protein highly expressed in neuronal axons. It is associated with the 125 kDa Neurofilament medium (NfM) and the 200 kDa Neurofilament heavy (NfH) to form neurofilaments.
Neurofilaments are a crucial component of the neuronal cytoskeleton. Their purpose is to provide structural stability to neurons and regulate axon diameter. In normal circumstances, neurofilaments are released into the extracellular space and cerebrospinal fluid (CSF). They can be released into the blood at low levels in an age-specific manner.
Following neuro-axonal injury or neurodegeneration, the release of neurofilaments increases considerably.
CSF and blood NfL can increase in patients with Alzheimer’s Disease (AD), Multiple Sclerosis (MS), Parkinson’s Disease (PD), Amyotrophic Lateral Sclerosis (ALS), Huntington’s Disease (HD) stroke, traumatic brain injury (TBI), and other neurological conditions. This positions NfL as a promising biomarker.
How to measure NfL
The Simoa® NfL assay is an exceptionally sensitive digital immunoassay for the quantitative establishment of NfL in serum, plasma, and CSF. The antibodies (Uman Diagnostics, Umeå Sweden) cross-react with murine, bovine, and macaque NfL epitopes, allowing the assay to be utilized when researching with these species.
Quanterix only offers Simoa® NfL testing in human serum as a Laboratory Developed Test (NfL-LDT) validated under CLIA. The US Food and Drug Administration (FDA) has yet to authorize this test for in vitro diagnostics.
What is the Simoa® difference?
Simoa® is a valuable digital immunoassay technology that provides up to x1000 greater sensitivity than standard sandwich-based immunoassay methods. Traditional ELISA measurements are restricted to pg/ml levels of identification. Quanterix Simoa® can obtain sensitivity measurements at the lower femtogram (fg/ml) levels.
Quanterix delivers the gold standard in early, ultra-sensitive detection and quantification of proteins substantially below typical lower limits of quantification (LLOQ).
Simoa® is based on the isolation of individual immunocomplexes on paramagnetic beads utilizing standard ELISA reagents. A significant distinction between Simoa® and conventional immunoassays is its ability to confine single molecules in femtoliter-sized wells. This provides a “digital” reading for each individual bead, determining if it is bound to the target analyte.
Quanterix offers Simoa® NfL testing as a lab-developed test (NfL-LDT) per CLIA and CLSI guidelines. Quanterix’s state-of-the-art facility has a CLIA-licensed lab that supports over 400 global customers. Using sizeable normative reference range databases, the Simoa NfL-LDT has been chosen for clinical use in numerous applications.
Neurological disorders are among the hardest to diagnose and treat early. Neuronal injury and neurodegeneration conditions are unlike “visible” illnesses, making it easier to overlook or mistake them for other conditions.
The symptoms can be subtle and subjective, making it difficult for current assessments to diagnose these diseases early. There are currently no definitive tests providing early detection for neurodegenerative diseases such as MS, AD, and PD.
A conclusive diagnosis by a clinician can only be formed once symptoms start to present. This means that many patients wait years for a diagnosis or clear treatment plan.
NfL has emerged recently as a blood-based biomarker with the potential to improve early diagnosis and patient care of neuro-axonal injury and neurodegeneration.
Multiple studies have supported the efficacy of Simoa® and the utilization of NfL as a critical tool for early detection, prognosis, and treatment monitoring across various neurodegenerative conditions.
About Quanterix 
From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Quanterix’s Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Limit of Quantification (LoQ) of conventional analog methods.
Its industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology and infectious disease. Quanterix has been a trusted partner of the scientific community for nearly two decades, powering research published in more than 2,500 peer-reviewed journals.
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