Test Catalog

Test Id : GAL3

Galectin-3, Serum

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

Aiding in the 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
A short description of the method used to perform the test

Enzyme-Linked Immunosorbent Assay (ELISA)

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

Galectin-3, S

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

Cardiac Remodeling

Cardiac Fibrosis

Galectin

Heart Failure

Lectin

GAL3

Specimen Type
Describes the specimen type validated for testing

Serum Red

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

Collection Container/Tube: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial.

Forms

If not ordering electronically, complete, print, and send a Cardiovascular Test Request Form (T724) with the specimen.

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

0.2 mL

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

Gross hemolysis Reject
Gross lipemia 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
Serum Red Frozen (preferred) 365 days
Refrigerated 24 hours

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

Aiding in the prognosis for patients diagnosed with heart failure

 

Risk-stratification of heart failure patients

 

An early indication of treatment failure and as a therapeutic target

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

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.

 

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 some fibrotic pathways.

 

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.

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.

<24 months: not established

2-17 years: < or =25.0 ng/mL

> or =18 years: < or =22.1 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

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

< or =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). The 97.5th percentile of galectin-3 in that cohort was 22.1 ng/mL. Individuals with concentrations greater than 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.

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

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.

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

1. Van der Velde AR, Meijers WC, Van den Heuvel ER, et al: Determinants of temporal changes in galectin-3 level in the general population: Data of PREVEND. Int J Cardiol 2016;222:385-390. doi: 10.1016/j.ijcard.2016.07.241

2. Mueller T, Gegenhuber A, Leitner I, et al: Diagnostic and prognostic accuracy of galectin-3 and soluble ST2 for acute heart failure. Clin Chim Acta 2016;463:158-164. doi: 10.1016/j.cca.2016.10.034

3. Sudharshan S, Novak E, Hock K, et al: Use of biomarkers to predict readmission for congestive heart failure. Am J Cardiol 2017;119:445-451. doi: 10.1016/j.amjcard.2016.10.022

4. Meijers WC, van der Velde AR, Muller Kobold AC, et al: Variability of biomarkers in patients with chronic heart failure and healthy controls. Eur J Heart Fail 2017;19:357-365. doi: 10.1002/ejhf.669

5. Meeusen JW, Johnson JN, Gray A, et al: Soluble ST2 and galectin-3 in pediatric patients without heart failure. Clin Biochem 2015;Dec;48(18):1337-1340. doi: 10.1016/j.clinbiochem.2015.08.007

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

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, BG Medicine, Inc. 05/2015)

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.

Monday

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.

1 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.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

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 has been cleared, approved, or is exempt by the US 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.

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.

82777-Galectin-3

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 | 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