Diagnostic Tests

High-Sensitivity Neurofilament Test (phosphorylated / pNf-H)

ANTIGENS / BIOMARKERS

Neurofilament (pNf-H) Levels

TURNAROUND-TIME (TAT)

7 Days

SKU / TEST CODE

pNfH

PROCEDURE / TECHNIQUE

ELISA

REFERENCE RANGE

Semi- Quantitative: • CSF: Negative <0.69 ng/mL, Borderline: 0.69-1.52 ng/mL, Positive >1.52 ng/mL • Serum: Negative <0.17 ng/mL, Borderline: 0.17-0.29 ng/mL, Positive >0.29 ng/ml

SENSITIVIY / SPECIFICITY

TBD

CLINICAL ASSOCIATIONS

Mitogen’s Neurofilament assay is a high-sensitivity Health Canada approved ELISA that detects neurofilament (pNfH) Levels. Neurofilaments (NF) are localized in the cytoplasm of neurons and function along with microtubules and microfilaments to form the neuronal cytoskeleton. The primary function of NFs is believed to provide structural support for axons and to regulate axon diameter, which influences nerve conduction velocity. NfH is one of the five neurofilament proteins (NfL, NfM, NfH, internexin-alpha and peripherin) and pNfH refers to phosphorylated NfH. This diagnostic test is used primarily as an adjunct to the diagnosis of ALS. The reported sensitivity is 93.3% and specificity 94.2% (borderline values were not included in the calculation). While reviewing results it is important to keep in mind that cross-reactions with the neurofilament medium chain (NfM) cannot be excluded. Other cross-reactivities are also known.

Reference: Schaepdryver M, et al. Clin Chem.Lab Med. 57:e199-e202, 2019.

Other Tests To Consider