Test Catalog

Test Id : GMCSF

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Granulocyte Monocyte-Colony Stimulating Factor, Plasma

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Measuring the concentration of granulocyte macrophage-colony stimulating factor (GM-CSF) in plasma

 

Understanding the etiology of chronic inflammatory diseases or infections, when used in conjunction with clinical information and other laboratory testing

 

Research studies in which an assessment of the GM-CSF response is needed

Highlights

This test may be useful in the evaluation and management of certain autoimmune diseases, such as rheumatoid arthritis.

 

Measurement may also be useful in the evaluation of patients with suspected hereditary or congenital pulmonary alveolar proteinosis or in cancers in which the granulocyte monocyte-colony stimulating factor signaling pathway is implicated.

Method Name
A short description of the method used to perform the test

Bead-Based Multiplex Immunoassay

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

GM-CSF, P

Aliases
Lists additional common names for a test, as an aid in searching

Cytokine storm

Cytokines

Granulocyte Macrophage Colony Stimulating Factor

GMCSF

Specimen Type
Describes the specimen type validated for testing

Plasma EDTA

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Lavender-top (EDTA)

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions:

1. Immediately after specimen collection, place tube on wet ice.

2. Centrifuge at 4 degrees C, 1500 x g for 10 minutes.

3. Aliquot plasma into plastic vial.

4. Freeze specimen within 2 hours of collection.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.3 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject
Heat-treated specimen Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Plasma EDTA Frozen 21 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Measuring the concentration of granulocyte macrophage-colony stimulating factor (GM-CSF) in plasma

 

Understanding the etiology of chronic inflammatory diseases or infections, when used in conjunction with clinical information and other laboratory testing

 

Research studies in which an assessment of the GM-CSF response is needed

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Granulocyte macrophage-colony stimulating factor (GM-CSF) was initially characterized as a hematopoietic growth factor, acting on bone marrow progenitor and inducing differentiation and proliferation of myeloid cells.(1) GM-CSF gene-deficient mice, however, displayed no changes in steady state myelopoiesis. In contrast, the predominant phenotype of the GM-CSF knock-out mouse was similar to that of human pulmonary alveolar proteinosis (PAP), a condition which is characterized by an accumulation of pulmonary surfactant.(2) Subsequently, it was observed that approximately 90% of human PAP, referred to as autoimmune PAP, is associated with autoantibodies specific for GM-CSF.(3) Taken together, evidence from mice and humans point to a critical role for GM-CSF in maintenance of proper alveolar macrophage function.

 

GM-CSF has also been shown to play an important role in the regulation of innate and adaptive immune responses. These observations led to additional studies probing the role of this molecule in chronic inflammatory and autoimmune diseases. One of the first studies in this area demonstrated that patients with severe and moderate rheumatoid arthritis (RA) had plasma GM-CSF concentrations that were significantly elevated compared to healthy controls.(5) In addition, treatment of patients with Felty syndrome and RA with GM-CSF, which was administered in an attempt to increase neutrophil counts, led to exacerbation of the inflammatory arthritis.(6) In a recent study, elevated serum concentrations of GM-CSF were detected in patients with radiographic axial spondyloarthropathy (SpA) compared to controls, and concentrations of this cytokine correlated with disease activity score.(7)

 

It is now well accepted that GM-CSF plays a role in the pathology of a variety of chronic inflammatory diseases and, as such, is a viable therapeutic target.(9) There are currently 4 monoclonal antibodies targeting the GM-CSF pathway.(8) One of the first, mavrilimumab, is specific for the alpha-chain of the GM-CSF receptor. Two phase IIb clinical trials in RA showed significant improvements in disease activity compared to placebo without any significant side effects or adverse events. Improvements were rapid (within 2 weeks) and dose dependent. The remaining 3 biologics, otilimab, namilumab, and lenzilumab, target GM-CSF directly. Several phase II clinical trials of namilumab in RA and plaque psoriasis have been completed, and a phase IIa trial in axial spondyloarthropathy is currently recruiting. Otilimab is being evaluated in 2 phase II clinical trials specifically targeting RA patients who have shown poor response to disease-modifying antirheumatic drugs or other treatments. Lenzilumab is currently being evaluated as a novel therapeutic in asthma.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

<15.0 pg/mL

Interpretation
Provides information to assist in interpretation of the test results

Elevated granulocyte macrophage-colony stimulating factor (GM-CSF) concentrations could be consistent with the presence of an inflammatory process or infection.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Results from granulocyte macrophage-colony stimulating factor (GM-CSF) testing should not be used to establish or exclude a specific diagnosis.

 

GM-CSF testing should only be used in conjunction with clinical information and other laboratory testing as part of a patient's overall assessment.

 

Normal concentration of GM-CSF does not exclude the possibility of infection or other inflammatory condition.

 

GM-CSF concentrations could be affected by immunomodulatory agents.

 

GM-CSF is a myelopoietic growth factor with pleiotropic effects; a comprehensive cytokine evaluation, such as CYPAN / Cytokine Panel, Plasma may be more useful in overall disease assessment or pathophysiology.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Hamilton JA. GM-CSF in inflammation. J Exp Med. 2020;21(1):e20190945

2. Stanley E, Lieschke GJ, Grail D, et al. Granulocyte/macrophage colony-stimulating factor-deficient mice show no major perturbation of hematopoiesis but develop a characteristic pulmonary pathology. Proc Natl Acad Sci USA. 1994;91(12):5592-5596

3. Sakagami T, Uchida K, Suzuk T, et al. Human GM-CSF autoantibodies and reproduction of pulmonary alveolar proteinosis. N Eng J Med. 2009;361(27):2679-2681

4. Wicks IP, Roberts AW. Targeting GM-CSF in inflammatory diseases. Nat Rev Rheumatol. 2016;12(1);37-48

5. Fiehn C, Wermann M, Pezzutto A, Hufner M, Heilig B. Plasma GM-CSF concentrations in rheumatoid arthritis, systemic lupus erythematosus and spondyloarthropathy. Z Rheumatol. 1992;51(3);121-126

6. Hazenberg BP, Van Leeuwen MA, Van Rijswijk MH, Stern AC, Vellenga E. Correction of granulocytopenia in Felty's syndrome by granulocyte-macrophage colony-stimulating factor. Simultaneous induction of interleukin-6 and flare-up of the arthritis. Blood. 1989;74(8);2769-2770

7. Papagoras C, Tsiami S, Chrysanthopoulou A, Mitroulis I, Baraliakos X. Serum granulocyte-macrophage colony-stimulating factor (GM-CSF) is increased in patients with active radiographic axial spondyloarthritis and persists despite anti-TNF treatment. Arthritis Res Ther. 2022;24(1):195

8. Lee KMC, Achuthan AA, Hamilton JA. GM-CSF: A promising target in inflammation and autoimmunity. Immunotargets Ther. 2020;9:225-240

9. Lazarus HM, Ragsdale CE, Gale RP, Lyman GH. Sargramostim (rhu GM-CSF) as cancer therapy (systematic review) and an immunomodulator. A drug before its time? Front Immunol. 2021;12:706186

Method Description
Describes how the test is performed and provides a method-specific reference

Analyte-specific antibodies are precoated onto color-coded magnetic microparticles. Samples are diluted 1:2 in a mixing plate. Then standards, samples, and microparticles are pipetted into wells, and the immobilized antibodies capture the analytes of interest. Unbound substances are washed away while the magnetic microparticles are immobilized. Next, a biotinylated analyte specific antibody cocktail is added to each well. Following a wash to remove any unbound biotinylated antibody, streptavidin-phycoerythrin conjugate (Streptavidin-PE), is added to each well. After removal of unbound Streptavidin-PE and resuspension of the microparticles in buffer, the plate is analyzed using a Luminex FLEXMAP 3D analyzer. A charged-coupled device camera captures an image of each well and data reduction is performed using the XPONENT software.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Wednesday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 8 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

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Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

83520

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
GMCSF GM-CSF, P 97054-1
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
618775 GM-CSF 97054-1

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports