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Test Code NFLP Neurofilament Light Chain, Plasma


Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Lavender top (EDTA)

Acceptable: None

Submission Container/Tube: Plastic screw-top vial

Specimen Volume: 0.6 mL

Collection Information: Centrifuge and aliquot plasma into a plastic vial. Do not submit specimen in original tube.


Useful For

Assessing neuronal damage related to various neurodegenerative diseases

Method Name

Chemiluminescent Enzyme Immunoassay

Reporting Name

Neurofilament Light Chain, P

Specimen Type

EDTA Plasma

Specimen Minimum Volume

0.50 mL

Specimen Stability Information

Specimen Type Temperature Time
EDTA Plasma Refrigerated (preferred) 14 days
  Frozen  90 days
  Ambient  7 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK

Clinical Information

Neurofilaments (NF) are exclusively located in the neuronal cytoskeleton and are released to the interstitial fluid upon axonal injury or neurodegeneration. NF concentrations in cerebrospinal fluid (CSF) and blood have been shown to correlate with the extent of axonal damage or neurodegeneration in various neurodegenerative diseases. Of the family of NF proteins, neurofilament light chain (NfL) has gained the most interest as a candidate marker of neurodegeneration. During axonal damage, NfL is released into the CSF, and eventually into the blood where concentrations are 40-fold lower than in the CSF. Concentrations of NfL in plasma have been shown to be approximately 5% to 10% lower than those measured in serum.

 

Circulating NfL concentrations increase with age with at a rate approximately 2% to 3% per year of age in both male and female individuals. While the specific cause of this increase has not been elucidated, it is believed to be related to the aging process as well as to the development of subclinical ischemic events. NfL concentrations in blood (plasma or serum) reflect the extent of axonal damage, making them a generic marker of disease activity. Increases in NfL concentrations have been reported in individuals with traumatic brain injury, amyotrophic lateral sclerosis, multiple sclerosis, frontotemporal dementia, Alzheimer disease (AD), and other neurodegenerative diseases.

 

Plasma neurofilament light chain (NfL) is a non-specific marker of neuro-axonal injury showing promising associations with outcomes in several neurological conditions. In neurodegenerative diseases, NfL may also serve as a prognostic marker of disease progression and drug efficacy biomarker of experimental therapies. In a meta-analysis of AD, frontotemporal dementia, and amyotrophic lateral sclerosis, plasma NfL concentrations were elevated in patients compared to controls with utility in differentiating neurodegenerative conditions from non-neurodegenerative mimics. However, due to a lack of specificity to a particular neurodegenerative disease, its role as a diagnostic marker may be limited.

Reference Values

<2.5 years: ≤12.8 pg/mL

2.5 to 4 years: ≤11.8 pg/mL

5 to 9 years: ≤10.4 pg/mL

10 to 14 years: ≤8.8 pg/mL

15 to 19 years: ≤9.2 pg/mL

20 to 24 years: ≤10.4 pg/mL

25 to 29 years: ≤11.9 pg/mL

30 to 34 years: ≤13.5 pg/mL

35 to 39 years: ≤15.3 pg/mL

40 to 44 years: ≤17.3 pg/mL

45 to 49 years: ≤19.7 pg/mL

50 to 54 years: ≤22.4 pg/mL

55 to 59 years: ≤25.4 pg/mL

60 to 64 years: ≤28.8 pg/mL

65 to 69 years: ≤32.7 pg/mL

70 to 74 years: ≤37.1 pg/mL

75 to 79 years: ≤42.1 pg/mL

80 to 84 years: ≤ 47.8 pg/mL

≥85 years: ≤54.3 pg/mL

Day(s) Performed

Monday through Friday

Report Available

1 to 3 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

83884