Growth Differentiation Factor 15, Plasma
Use
Growth differentiation factor 15 (GDF15) is a circulating biomarker often elevated in patients with myopathy-related mitochondrial diseases, as well as other conditions. It is primarily used in the investigation of suspected mitochondrial myopathies, aiding as a screening tool for neuromuscular mitochondrial disease. The test can indicate elevated levels of GDF15 which may warrant further diagnostic investigations, including molecular studies and muscle biopsy, to confirm the presence of neuromuscular mitochondrial disorders. Although GDF15 can be a significant indicator of mitochondrial afflictions, it is not recommended for carrier detection.
Special Instructions
Additional workup may be necessary if abnormal results are observed. This test is not suitable for carrier detection. Patients under 3 months of age typically have naturally elevated GDF15 levels due to placental contributions; therefore, this test is not recommended for this age group. As a precaution, it is advised not to expose the specimen to heat or direct sunlight to maintain sample integrity.
Limitations
The test is a screening tool and may show elevated GDF15 levels in patients without mitochondrial disease, such as those with cancer, cardiovascular disease, diabetes, or pregnancy. Elevated results should be interpreted carefully alongside clinical findings, as the test can under-report growth differentiation factor 15 plasma values in individuals with the H202D variant in the GDF15 gene. It is also important to note that this test has not been cleared or approved by the US Food and Drug Administration (FDA).
New York Approved
Methodology
Immunoassay (ELISA)
Biomarkers
LOINC Codes
- 92665-9
- 92665-9
Result Turnaround Time
2-6 days
Related Documents
For more information, please review the documents below
Specimen
Plasma
Volume
0.5 mL
Minimum Volume
0.2 mL
Container
Lavender top (EDTA) or Green top (sodium heparin) tube
Collection Instructions
Draw blood and centrifuge immediately. Aliquot plasma into plastic vial. Avoid exposure to heat or direct sunlight.
Causes for Rejection
Specimen types like gross hemolysis, lipemia, and icterus are acceptable.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 28 days |
| Refrigerated | 90 days |
| Frozen | 90 days |