Test Overview


This test is for the quantification of NfL in plasma to assist in the clinical assessment of neurological disorders. NfL is a nonspecific biomarker for axonal degeneration; elevated NfL levels are associated with a range of neurological disorders including AD, ALS, MS, FTD, and TBI.

 

Test Code:

NfL

Synonyms:

Plasma NfL, Nf-L

Methodology:

Chemiluminescent enzyme immunoassay (CLEIA)

Validation:

Laboratory Developed Test (LDT)

Reference Range:

Age Group
20 – 29 (≤ 8.4 ng/L)
30 – 39 (≤ 11.4 ng/L)
40 – 49 (≤ 15.4 ng/L)
50 – 59 (≤ 20.8 ng/L)
60 – 69 (≤ 28.0 ng/L)
70 – 79 (≤ 37.9 ng/L)
≥ 80 (≤ 51.2 ng/L)

Performance


Frequency:

Once a week

Expected Turnaround:

3 - 5 days

Sample Report:

Coming Soon

Our offices are only able to receive samples Mon-Fri, so samples must be shipped Mon-Thur. Samples arriving over the weekend may need to be redrawn.

Specimen


Specimen Type:

EDTA Plasma

Container:

Lavender-top EDTA tube

Preferred Volume:

1 mL

Minimum Volume:

0.5 mL

Rejection Criteria:

Grossly hemolytic, icteric, or lipemic. If the sample arrives at room temperature.

Collection and Processing:

No patient preparation is required for sample collection.

Draw blood in tube(s) with EDTA activator.
Invert tubes 8 times to ensure complete mixing.

Centrifuge tubes at 1800 - 2200 x g for 10-15 minutes.

Draw off plasma (top layer) into aliquot tubes with pipette, ensuring not to take RBCs (middle/bottom layers).

Store aliquot tubes in refrigerator (2° C - 8° C) until shipping.

Specimen Handling:

Transport refrigerated or frozen

Specimen Stability:

7 days at room temperature (15⁰ C – 25⁰ C)
7 days refrigerated (2⁰ C - 8⁰ C)
1 week frozen (-20⁰ C)
6 months at ultra-low (-70⁰ C)

Up to 4 freeze / thaw cycles

NfL is very sensitive to temperature and freeze/thaw cycles. Time at room temperature should be minimized.

Additional Information


  • This is a laboratory developed test, its performance was determined by Neurocode USA Inc. It has not been cleared or approved by the Food and Drug Administration.
  • Elevated NfL is not a disease specific factor and may be caused by a neurodegenerative disease or traumatic brain injury. Results should be used in conjunction with clinical signs and symptoms.
  • NfL levels measured in the evening may be more than 10% lower than those measured in the morning (Benedict et al 2020).
  • Higher levels of NfL can occur in patients with a history of stoke, atrial fibrillation, myocardial infarction, chronic kidney disease, pregnancy, and diabetes. Lower levels may be found in person who are obese (BMI ≥ 30) (Syrjanen et al 2022).