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Neurofilament Light Chain (NfL), Serum

Test ID: NFL S

Test

Specimen

Performance / Interpretation

Interface / Setup

Method

SIMOA ELISA

Method Description

Single molecule array Immunoassay (SIMOA)

Platform

Quanterix HD-X

Report Includes

Neurofilament Light Chain

Specimens

Serum

Clinical Utility

Multiple sclerosis, other neurodegenerative disorders, traumatic brain injury.
Neurofilament Light Chain (NfL) is a biomarker of neuraxonal damage and disease activity and is associated with clinical and MRI outcomes in Multiple Sclerosis patients. High or increasing values are suggestive of increased neurodegeneration and increased risk of progression. Normalized or decreasing values are suggestive of a better prognosis and/or effective treatment.

Test Location

The Ottawa Hospital General Campus, 501 Smyth Road, Ottawa ON K1H 8L6

Test Version

20-Mar-2024

Specimens

Serum

Collection Containers

Gold top (SST); Red top (no additive)

Sample Volume

2.0 mL

Minimum Volume

0.5 mL

Pediatric Volume

1.0 mL

Collection & Handling

Handling Information

Store and send frozen.

Stability

Ambient	48 hours
Refrigerated	7 days
Frozen	>7 days

Additional Stability Information

Stable for up to 4 freeze-thaw cycles.

Test Version

20-Mar-2024

Method

SIMOA ELISA

Method Description

Single molecule array Immunoassay (SIMOA)

Platform

Quanterix HD-X

Turnaround Time

32 days

Results

Name	Units	Reference Range	Conversion Factor
Neurofilament Light Chain	pg/mL	17 years: ≤5.5 18 years: ≤5.8 19 years: ≤6.1 20 years: ≤6.4 21 years: ≤6.7 22 years: ≤7.0 23 years: ≤7.2 24 years: ≤7.5 25 years: ≤7.8 26 years: ≤8.0 27 years: ≤8.3 28 years: ≤8.5 29 years: ≤8.7 30 years: ≤8.9 31 years: ≤9.1 32 years: ≤9.3 33 years: ≤9.5 34 years: ≤9.7 35 years: ≤9.9 36 years: ≤10.2 37 years: ≤10.4 38 years: ≤10.6 39 years: ≤10.9 40 years: ≤11.2 41 years: ≤11.5 42 years: ≤11.7 43 years: ≤12.0 44 years: ≤12.3 45 years: ≤12.6 46 years: ≤13.0 47 years: ≤13.3 48 years: ≤13.6 49 years: ≤14.0 50 years: ≤14.4 51 years: ≤14.8 52 years: ≤15.2 53 years: ≤15.6 54 years: ≤16.1 55 years: ≤16.5 56 years: ≤17.0 57 years: ≤17.5 58 years: ≤18.1 59 years: ≤18.6 60 years: ≤19.1 61 years: ≤19.7 62 years: ≤20.3 63 years: ≤20.8 64 years: ≤21.4 65 years: ≤22.0 66 years: ≤22.6 67 years: ≤23.2 68 years: ≤23.8 69 years: ≤24.4 70 years: ≤25.1 71 years: ≤25.7 72 years: ≤26.3 73 years: ≤26.9 74 years: ≤27.5 75 years: ≤28.2 76 years: ≤28.8 77 years: ≤29.4 78 years: ≤30.0 79 years: ≤30.7 80 years: ≤31.3 81 years: ≤31.9 82 years: ≤32.5 83 years: ≤33.2 84 years: ≤33.8 85 years: ≤34.4
Neurofilament Light Chain	Analysis performed by SIMOA using Quanterix Nf-light Advantage assay. NfL is a biomarker of neuraxonal damage and disease activity and is associated with clinical and MRI outcomes in Multiple Sclerosis patients. High or increasing values are suggestive of increased neurodegeneration and increased risk of progression. Normalized or decreasing values are suggestive of a better prognosis and/or effective treatment. In a cohort of patients tested within 5 years of MS onset, NfL <7.6 pg/mL was 50% sensitive and 89% specific for identifying patients 4.7 times less likely to reach EDSS >4. NfL >15.6 pg/mL were 84% sensitive and 29% specific for progression to EDSS >4 in 15 years. A change in NfL values >30% is beyond the analytical variation and is suggestive of clinically relevant increase/decrease in NfL results. This test has been validated for clinical use. Reference intervals (95%ile) determined using BMI = 27.2 kg/m^2 from Benkert et. Al. (The Lancet Neurology. 21 (2022) 246-257).

Sample Reports

View Sample Report

Test Location

The Ottawa Hospital General Campus, 501 Smyth Road, Ottawa ON K1H 8L6

Test Version

20-Mar-2024

HL7 Interface Codes

Order Code	Result Codes	Units
NFL S	64244Neurofilament Light Chain	pg/mL

Sample Reports

View Sample Report

Test Version

20-Mar-2024