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 |
Abbreviations, alternative names: | Plasma NfL |
Methodology: | Chemiluminescent enzyme immunoassay (CLEIA) |
Validation: | Laboratory developed test (LDT) |
Requirements
Specimen type: | EDTA plasma |
Minimum volume: | 0.5 mL |
Preferred volume: | 5 mL |
Rejection criteria: | Grossly hemolytic, icteric, or lipemic. If the sample arrives at room temperature |
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 re-drawn.
Specimen
NfL is very sensitive to temperature and freeze/thaw cycles. Time at room temperature should be minimized.
Specimen collection: | Overnight fasting recommended |
Specimen handling: | Centrifuge EDTA tubes at 1800 - 2200 x g for 10-15 minutes |
Specimen storage: | Plasma samples must either be refrigerated and shipped chilled within 24 hours of collection, or frozen and shipped on dry ice |
Performance
Testing frequency: | Once a week |
Turnaround time: | 3-5 days |
Reference range: | Age group |
Validation: | Laboratory developed test (LDT) |
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).
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