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NfL (Neurofilament Light Chain) in Plasma by CLEIA

Order Code
2925034
CPT
83520
Test Details
Synonyms

NfL, Plasma, CLEIA

TAT

Up to 7 days

Methodology

Chemiluminescent enzyme immunoassay (CLEIA)

Remarks

Plasma NfL levels are interpreted using age-adjusted reference ranges:

Age adjusted reference intervals

Age: 20–29 < 8.4 ng/L
Age: 30–39 < 11.4 ng/L
Age: 40-49 < 15.4 ng/L
Age: 50-59 <20.8 ng/L
Age: 60-69 < 28.0 ng/L
Age: 70-79 < 37.9 ng/L
Age > 80 < 51.2 ng/L

NfL is a biomarker of axonal injury and rapid neurodegeneration. Although elevated levels are not disease-specific, they may reflect disease activity, progression or response to treatment in neurodegenerative and neuroinflammatory disorders. NfL levels from samples collected in the evening may be about 10% lower than those collected in the morning. Higher levels of NfL may also occur in patients with a history of stroke, atrial fibrillation, myocardial infarction, chronic kidney disease, pregnancy, and diabetes, while lower levels may be observed in people with a BMI ≥ 30.

Plasma NfL is a laboratory-developed test performed using the Lumipulse (Fujirebio) assay with a chemiluminescent immunoassay (CLEIA) method, which has been analytically validated. It has also been clinically validated on a large diverse cohort, including healthy controls. While the measurement of NfL is well-established in practice, it does not currently have US FDA approval.

Performing Location

Accredited NRL Laboratory

Testing Frequency

Weekly

Test Overview

Neurofilament light (NfL) is an intermediate filament protein found specifically in the neuronal cytoskeleton which releases during the axil damage. NfL is a biomarker of axonal injury and neurodegeneration, with elevated levels observed across a range of neurodegenerative and neuroinflammatory disorders.

Specimen Type

K2-EDTA Plasma

Volume

Minimum 1 mL

Specimen Container

K2-EDTA Plasma (Lavender Top)

Patient Preparation

Samples should be collected following overnight fasting. If patients are taking biotin (Vitamin B7), they should stop taking it 72 hours prior to sample collection. NfL levels measured in the evening may be about 10% lower than those measured in the morn

Collection

Transport to the laboratory immediately following collection; samples must be centrifuged in a refrigerated centrifuge and separated within 24 hours at 2-8°C . If this is not possible, centrifuge in a refrigerated centrifuge and aliquot samples, then store and transport samples refrigerated (2-8°C).

Specimen Stability
Temperature Period
Refrigerated 3 days
Frozen 2 weeks at -20° C
Order Code
2925034
CPT
83520
Test Details
Synonyms

NfL, Plasma, CLEIA

TAT

Up to 7 days

Methodology

Chemiluminescent enzyme immunoassay (CLEIA)

Remarks

Plasma NfL levels are interpreted using age-adjusted reference ranges:

Age adjusted reference intervals

Age: 20–29 < 8.4 ng/L
Age: 30–39 < 11.4 ng/L
Age: 40-49 < 15.4 ng/L
Age: 50-59 <20.8 ng/L
Age: 60-69 < 28.0 ng/L
Age: 70-79 < 37.9 ng/L
Age > 80 < 51.2 ng/L

NfL is a biomarker of axonal injury and rapid neurodegeneration. Although elevated levels are not disease-specific, they may reflect disease activity, progression or response to treatment in neurodegenerative and neuroinflammatory disorders. NfL levels from samples collected in the evening may be about 10% lower than those collected in the morning. Higher levels of NfL may also occur in patients with a history of stroke, atrial fibrillation, myocardial infarction, chronic kidney disease, pregnancy, and diabetes, while lower levels may be observed in people with a BMI ≥ 30.

Plasma NfL is a laboratory-developed test performed using the Lumipulse (Fujirebio) assay with a chemiluminescent immunoassay (CLEIA) method, which has been analytically validated. It has also been clinically validated on a large diverse cohort, including healthy controls. While the measurement of NfL is well-established in practice, it does not currently have US FDA approval.

Performing Location

Accredited NRL Laboratory

Testing Frequency

Weekly

Test Overview

Neurofilament light (NfL) is an intermediate filament protein found specifically in the neuronal cytoskeleton which releases during the axil damage. NfL is a biomarker of axonal injury and neurodegeneration, with elevated levels observed across a range of neurodegenerative and neuroinflammatory disorders.

Specimen Type

K2-EDTA Plasma

Volume

Minimum 1 mL

Specimen Container

K2-EDTA Plasma (Lavender Top)

Patient Preparation

Samples should be collected following overnight fasting. If patients are taking biotin (Vitamin B7), they should stop taking it 72 hours prior to sample collection. NfL levels measured in the evening may be about 10% lower than those measured in the morn

Collection

Transport to the laboratory immediately following collection; samples must be centrifuged in a refrigerated centrifuge and separated within 24 hours at 2-8°C . If this is not possible, centrifuge in a refrigerated centrifuge and aliquot samples, then store and transport samples refrigerated (2-8°C).

Specimen Stability
Temperature Period
Refrigerated 3 days
Frozen 2 weeks at -20° C