ULTRASENSITIVE NEUROFILAMENT LIGHT CHAIN (NfL) IMMUNOASSAY FOR THE SMCxPRO™ ASSAY PLATFORM

Abstract

AbstractBackgroundThe recent advent of ultrasensitive assay technologies has enabled the measurement of low‐abundance blood‐based biomarkers of neurodegenerative conditions, thereby addressing the need for invasive nature of cerebrospinal fluid (CSF) collection, allowing for large scale sample acquisition and screening in research, and empowering studies into the transition between health and disease. Utilizing the SMCxPRO™ ultrasensitive immunoassay platform, we have developed an assay for the detection of neurofilament light chain (NfL) in human serum, plasma and CSF samples across healthy and diseased states. NfL is a valuable neurodegenerative biomarker for accessing progression and treatment of Alzheimer’s Disease (AD), Multiple Sclerosis (MS) and Huntington’s Disease, and is under investigation as a potential biomarker for several other neurological disorders.MethodRigorous assay development procedures were undertaken in an effort to produce an NfL immunoassay capable of accurately and reproducibly detecting NfL in human serum, plasma, and CSF samples.ResultA robust kit for consistent and reliable NfL measurement at sub‐pg/mL concentrations has been developed and characterized using Single Molecule Counting (SMC™) ultrasensitive immunoassay technology. The developed assay demonstrates excellent performance characteristics for spike/recovery values and dilutional linearity (90‐110% for all three matrices). NfL was detected in all sample types tested. Increased NfL sample levels in AD and MS samples as compared to normal serum, plasma and CSF samples was also observed.ConclusionOur SMC™ NfL immunoassay kit provides a valuable tool for research in the areas of neurodegenerative disease and neurological injury.