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Test Code GAL3 Galectin-3, Serum

Reporting Name

Galectin-3, S

Useful For

An aid in prognosis for patients diagnosed with heart failure

 

Risk-stratification of heart failure patients

 

An early indication of treatment failure and as a therapeutic target

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Performing Laboratory

Mayo Medical Laboratories in Rochester

Specimen Type

Serum Red


Specimen Required


Collection Container/Tube: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL


Specimen Minimum Volume

0.2 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Red Frozen (preferred) 365 days
  Refrigerated  24 hours

Reject Due To

Hemolysis

Mild reject; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

NA

Other

NA

Reference Values

<24 months: not established

2-17 years: ≤25.0 ng/mL

≥18 years: ≤22.1 ng/mL

Day(s) and Time(s) Performed

Monday; 9 a.m.

CPT Code Information

82777-Galectin-3

LOINC Code Information

Test ID Test Order Name Order LOINC Value
GAL3 Galectin-3, S 62419-7

 

Result ID Test Result Name Result LOINC Value
86202 Galectin-3, S 62419-7

Analytic Time

1 day

Cautions

Galectin-3 has not been shown to be useful in the acute diagnosis of heart failure, and natriuretic peptides (BNP or NT-proBNP) should be utilized for this purpose.

 

Hemolysis has been shown to interfere with the galectin-3 assay due to intracellular release of galectin-3. Specimens that are visibly hemolyzed will be rejected.

 

Heterophile antibodies, in particular human-antimouse antibodies in human serum, may cause falsely elevated galectin-3 results. Heterophile antibodies may react with reagent immunoglobulins and subsequently interfere with in vitro immunoassays. Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous high or low values can be observed.

 

Patients with high concentrations of rheumatoid factor, as well as other autoimmune disorders, may also yield falsely elevated results and should be interpreted with caution.

Method Description

The galectin-3 assay is a diagnostic, quantitative 2-site manual enzyme-linked immunosorbent assay (ELISA) validated for use in human sera. The capture monoclonal antibody (rat IgG2a) is immobilized on 96-well plates, while the detection antibody utilizes a mouse monoclonal antibody that targets the human galectin-3 protein and is conjugated with horseradish peroxidase. This is an FDA 510K-cleared in vitro diagnostic device.(Package insert: BGM Galectin-3 Assay, Nov 2014, BG Medicine, Inc., Waltham, MA)

Interpretation

Clinically, galectin-3 concentrations may be categorized into 3 risk categories, substantiated by results from several large chronic heart failure studies:(2-4)

≤17.8 ng/mL (low risk)

17.9-25.9 ng/mL (intermediate risk)

>25.9 ng/mL (higher risk)

 

Results should be interpreted in the context of the individual patient presentation. Elevated galectin-3 results indicate an increased risk for adverse outcomes and signal the presence of galectin-3-mediated fibrosis and adverse remodeling. Once galectin-3 concentrations are elevated they are relatively stable over time in the absence of intervention.

 

Knowledge of a heart failure patient's galectin-3 results may assist in risk stratification and lead to more aggressive management. There are no specific galectin-3 inhibitors available at this time and heart failure patients with elevated galectin-3 concentrations should be treated and monitored according to established guidelines. Angiotensin receptor blockers (ARBs) and aldosterone antagonists are thought to be particularly effective. 

 

A large multicenter, prospective, observational study was conducted to derive the reference intervals for galectin-3 that included 1,092 subjects between the ages of 55 and 80 years without any known cardiac disease (520 males, 572 females).(5) The 97.5th percentile of galectin-3 in that cohort was 22.1 ng/mL. Individuals with concentrations >22.1 ng/mL had a significant association with mortality and New York Heart Association (NYHA) classification. However, this was an older population and definitive evidence of cardiac disease was not documented. 

Specimen Retention Time

14 Days

Clinical Information

Heart failure is a complex cardiovascular disorder with a variety of etiologies and heterogeneity with respect to the clinical presentation of the patient. Heart failure is significantly increasing in prevalence with an aging population and is associated with high short- and long-term mortality rate. Over 80% of patients diagnosed and treated for acute heart failure syndromes in the emergency department are readmitted within the forthcoming year, incurring costly treatments and therapies.(1)

 

The development and progression of heart failure is a clinically silent process until manifestation of the disorder, which typically occurs late and irreversibly into its progression. Mechanistically, heart failure, whether due to systolic or diastolic dysfunction, is thought to progress primarily through adverse cardiac remodeling and fibrosis in response to cardiac injury and/or stress. Galectin-3 is a biomarker that appears to be actively involved in both the inflammatory and fibrotic pathways that are thought to be involved.

 

Galectin-3 is a carbohydrate-binding lectin whose expression is associated with inflammatory cells including macrophages, neutrophils, and mast cells. Galectin-3 has been linked to cardiovascular physiological processes including myofibroblast proliferation, tissue repair, and cardiac remodeling in the setting of heart failure. Concentrations of galectin-3 have been used to predict adverse remodeling after a variety of cardiac insults.

Test Classification

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

Forms

If not ordering electronically, complete, print, and send a Cardiovascular Test Request Form (T724) with the specimen (http://www.mayomedicallaboratories.com/it-mmfiles/cardiovascular-request-form.pdf).