Validation of neurofilament light chain as laboratory developed test using electrochemiluminescence assay in serum and plasma

ADLM 2026 -- Neurofilament light chain (NfL) is an intermediate filament mainly found in axons and has structural functions mainly in the neuronal cytoskeleton. Increased NfL concentrations in both cerebrospinal fluid (CSF) and blood have been reported among individuals with traumatic brain injury, amyotrophic lateral sclerosis, multiple sclerosis, Alzheimer’s disease, and other neurodegenerative diseases. The objective of this validation was to evaluate the performance of NfL research-use only (RUO) kits in serum and plasma as a laboratory developed test (LDT) for clinical trials testing per Clinical and Laboratory Standards Institute (CLSI) guidelines.