To provide reference ranges of cerebrospinal fluid (CSF), serum, and plasma neurofilament light (NfL) levels from a healthy donor cohort using the Quanterix NfL Advantage Kit™

Frozen CSF (N=30, Age Range 27-75), serum (N=133, Age Range 21-66) and plasma (N=133, Age Range 24-64) samples from individual procured and healthy donor program at Genentech Inc. cohort were assayed for NfL a using qualified version of the Quanterix NfL Advantage Kit™ on the SIMOA platform with acceptable precision, sensitivity and detectability for each matrix.

There was a strong correlation (r=0.95, N=118) between serum and plasma NfL levels in the same donor, but a weaker correlation between serum and CSF (r=0.31, N=20) or plasma and CSF (r=0.29, N=20)  than has been reported in patients with neurological injury or in disease states.  CSF, serum, and plasma; median, and 25-75% interquartile ranges were (334.6, 239.3-505.0 pg/mL); (7.0, 5.4-9.7 pg/mL); (5.9, 4.3-7.9 pg/mL) respectively.  Healthy donor NfL levels in CSF, serum, and plasma were influenced by donor age, similar to observations in previous reports.  Analytical methods for determining healthy donor reference ranges for comparison to disease states such as multiple sclerosis will be presented.

These data establish reference ranges for healthy donor levels of CSF, serum, and plasma levels using the Quanterix NfL Advantage Kit™ that can be used to help interpret pathologically elevated levels NfL in these matrices in neuronal injury or disease states.