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Test Code GDF15 Growth Differentiation Factor 15, Plasma

Useful For

A circulating biomarker in myopathy-related mitochondrial disease as well as other conditions

 

Investigation of patients suspected of having a mitochondrial myopathy

 

This assay is not suitable for carrier detection.

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

Growth Differentiation Factor 15, P
Seattle Children's Hospital Note:

Clinical System Name: Growth Differentiation Factor 15 (GDF15)

Specimen Type

Plasma


Specimen Required


Collection Container/Tube:

Preferred: Lavender top (EDTA)

Acceptable: Green top (sodium heparin)

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions:

1. Draw blood and centrifuge immediately.

2. Aliquot plasma into plastic vial.

3. Do not expose specimen to heat or direct sunlight.


Seattle Children's Hospital Note:

Collect at least 1 mL whole blood in a lavender tube, spin and aliquot 0.5 mL plasma into an amber vial. Place in refrigerated send outs box.

Specimen Minimum Volume

0.2 mL

Specimen Stability Information

Specimen Type Temperature Time
Plasma Refrigerated (preferred) 90 days
  Frozen  90 days
  Ambient  28 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Reference Values

3 months* and older: ≤750 pg/Ml

 

*This test is not recommended for infants younger than 3 months of age due to the high levels of growth differentiation factor 15 contributed from the placenta during pregnancy.

Method Description

Growth differentiation factor 15 (GDF15) enzyme-linked immunosorbent assay is a quantitative sandwich enzyme immunoassay technique. Specimen is incubated in wells that have been coated with anti-GDF15 antibody. After incubation and washing, the wells are incubated with an enzyme-linked polyclonal antibody specific for human GDF15. After a second incubation and washing step, the wells are incubated with a substrate solution producing a blue color. A stop solution is added turning the blue color to yellow, which is then read on a microplate reader. The resulting absorbance is directly proportional to the level of GDF15 in the specimen.(Unpublished Mayo method)

Day(s) Performed

Wednesday, Friday

Seattle Children's Hospital Note:

TAT: 10 - 17 days

Report Available

2 to 6 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

83520

LOINC Code Information

Test ID Test Order Name Order LOINC Value
GDF15 Growth Differentiation Factor 15, P 92665-9

 

Result ID Test Result Name Result LOINC Value
64637 Growth Differentiation Factor 15, P 92665-9

Forms

1. Biochemical Genetics Patient Information (T602)

2. If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Neurology Specialty Testing Client Test Request (T732)

-Biochemical Genetics Test Request (T798)