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Test Code GDF15 Growth Differentiation Factor 15 (GDF15), 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

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


Specimen Required


Preferred: Lavender top (EDTA) plasma

Acceptable: Green top (sodium heparin) plasma

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions:

1. Draw blood into an EDTA or sodium heparin tube and centrifuged immediately. 

2. 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


Mild OK; Gross OK


Mild OK; Gross OK


Mild OK; Gross OK



Reference Values

3 months* and older: ≤750 pg/mL

*This test is not recommended for infants <3 months of age due to the high levels of GDF15 contributed from the placenta during pregnancy.

Method Description

Growth differentiation factor 15 (GDF15) ELISA (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 at 450 and 570 nm on a microplate reader. The absorbance at 570 is subtracted from the absorbance at 450 to correct for optical imperfections and the resulting absorbance is directly proportional to the level of GDF15 in the specimen.(Package insert: Human GDF15 Immunoassay, R and D Systems, Inc, Minneapolis, MN, 2014)

Day(s) and Time(s) Performed


Seattle Children's Hospital Note:

TAT: 10 - 17 days

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

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

CPT Code Information


LOINC Code Information

Test ID Test Order Name Order LOINC Value
GDF15 Growth Differentiation Factor 15, P In Process


Result ID Test Result Name Result LOINC Value
64637 Growth Differentiation Factor 15, P 49853-5


1. If not ordering electronically, complete, print, and send a Neurology Specialty Testing Client Test Request (T732) with the specimen (

2. Biochemical Genetics Patient Information (T602) in Special Instructions.