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GFAP (Glial Fibrillary Acidic Protein) in Plasma by CLEIA

Order Code
2925035
CPT
83520
Test Details
Synonyms

GFAP, Plasma, CLEIA

TAT

Up to 7 days

Methodology

Chemiluminescent enzyme immunoassay (CLEIA)

Remarks

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

Age adjusted references
Age: 45 -59 < 48.1 ng/L
Age: 60-69 < 64.9 ng/L
Age: 70-83 < 90.7 ng/L

GFAP is a general marker for reactive astrogliosis, and it is blood biomarker for assessing neurodegeneration and gliosis in routine clinical practice. The GFAP reference range was established based on the 95th percentile of healthy subjects aged 45–69 years. It is important to note that GFAP levels increase with age; the applicability of this reference range to populations below 45 years has not yet been fully validated, and caution is advised when interpreting GFAP levels in individuals outside this range.

Plasma GFAP is a laboratory-developed test performed using the Lumipulse (Fujirebio) assay with a chemiluminescent immunoassay (CLEIA) method, which has been analytically validated but does not currently have US FDA approval for conditions other than Traumatic Brain Injury (TBI).

Performing Location

Accredited NRL Laboratory

Testing Frequency

Weekly

Test Overview

Glial Fibrillary Acidic Protein (GFAP) is a general marker for reactive astrogliosis, and for assessing neurodegeneration and gliosis in routine clinical practice. It is a type III intermediate filament protein that is expressed in the Schwann cells, mature glial cells in the gut, hepatic stellate cells, and other non-neural cells. GFAP is specifically present in mature astrocytes in the central nervous system, and is a marker of astroglial injury, with elevated levels reported across multiple neurological conditions.

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.

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
2925035
CPT
83520
Test Details
Synonyms

GFAP, Plasma, CLEIA

TAT

Up to 7 days

Methodology

Chemiluminescent enzyme immunoassay (CLEIA)

Remarks

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

Age adjusted references
Age: 45 -59 < 48.1 ng/L
Age: 60-69 < 64.9 ng/L
Age: 70-83 < 90.7 ng/L

GFAP is a general marker for reactive astrogliosis, and it is blood biomarker for assessing neurodegeneration and gliosis in routine clinical practice. The GFAP reference range was established based on the 95th percentile of healthy subjects aged 45–69 years. It is important to note that GFAP levels increase with age; the applicability of this reference range to populations below 45 years has not yet been fully validated, and caution is advised when interpreting GFAP levels in individuals outside this range.

Plasma GFAP is a laboratory-developed test performed using the Lumipulse (Fujirebio) assay with a chemiluminescent immunoassay (CLEIA) method, which has been analytically validated but does not currently have US FDA approval for conditions other than Traumatic Brain Injury (TBI).

Performing Location

Accredited NRL Laboratory

Testing Frequency

Weekly

Test Overview

Glial Fibrillary Acidic Protein (GFAP) is a general marker for reactive astrogliosis, and for assessing neurodegeneration and gliosis in routine clinical practice. It is a type III intermediate filament protein that is expressed in the Schwann cells, mature glial cells in the gut, hepatic stellate cells, and other non-neural cells. GFAP is specifically present in mature astrocytes in the central nervous system, and is a marker of astroglial injury, with elevated levels reported across multiple neurological conditions.

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.

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