Test Catalog

Test Id : ALGAL

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Galactose-Alpha-1,3-Galactose (Alpha-Gal), IgE, Serum

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Overview

Test Catalog

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

As an aid in diagnosis of an IgE mediated hypersensitivity allergy to non-primate mammalian red meat, such as beef, pork, venison, and meat-derived products (eg, gelatin)

 

This test is not useful in patients previously treated with immunotherapy to determine if residual clinical sensitivity exists.

 

This test is not useful for patients in whom the medical management does not depend upon identification of allergen specificity.

Highlights

The presence of IgE antibodies against galactose-alpha-1,3-galactose (alpha-gal) is associated with red meat allergy.

 

Individuals with IgE antibodies against alpha-gal might develop anaphylactic reactions to the drug cetuximab.

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Other meat allergen IgE antibody tests may be considered in addition to galactose-alpha-1,3-galactose IgE antibody testing in cases of suspected red meat allergy.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

Fluorescence Enzyme Immunoassay (FEIA)

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

Galactose-alpha-1,3-galactose, IgE

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

Galactose IgE

Galactose-alpha-1,3

Alpha-Gal

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Other meat allergen IgE antibody tests may be considered in addition to galactose-alpha-1,3-galactose IgE antibody testing in cases of suspected red meat allergy.

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

For a listing of allergens available for testing, see Allergens - Immunoglobulin E (IgE) Antibodies.

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

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL for every 5 allergens requested

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

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

For 1 allergen: 0.3 mL

For more than 1 allergen: (0.05 mL x number of allergens) + 0.25 mL deadspace

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

Gross hemolysis OK
Gross lipemia OK

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 Refrigerated (preferred) 14 days
Frozen 90 days

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

As an aid in diagnosis of an IgE mediated hypersensitivity allergy to non-primate mammalian red meat, such as beef, pork, venison, and meat-derived products (eg, gelatin)

 

This test is not useful in patients previously treated with immunotherapy to determine if residual clinical sensitivity exists.

 

This test is not useful for patients in whom the medical management does not depend upon identification of allergen specificity.

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Other meat allergen IgE antibody tests may be considered in addition to galactose-alpha-1,3-galactose IgE antibody testing in cases of suspected red meat allergy.

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

Immunoglobulin E antibodies to galactose-alpha-1,3-galactose (alpha-gal), a carbohydrate commonly expressed on non-primate mammalian proteins, are capable of eliciting allergenic reactions.

 

Sensitization may occur through tick bites or exposure to the drug cetuximab. In the United States, individuals bitten by Amblyomma americanum, also known as the Lone Star tick, may develop IgE antibodies to alpha-gal, although sensitization to alpha-gal through other tick species has also been implicated.(1) The Lone Star tick was historically localized to the southern and southeastern United States but has now expanded its range into the central Midwest and northwards along the eastern seaboard. It is thought to be responsible for most cases of alpha-gal sensitization in the United States. The tick species that appears to be responsible for these responses in France is Ixodes ricinus, while in Australia it is Ixodes holocyclus.(2,3,4)

 

Signs and symptoms of an alpha-gal allergic reaction are often delayed compared with other food allergies. Upon exposure of sensitized subjects to non-primate mammalian meat (eg, beef, pork, venison) or meat-derived product such as gelatin, a delayed allergic response may ensue, often 3 to 6 hours after ingestion. Symptoms can include urticaria, angioedema, difficulty breathing, abdominal pain, vomiting, and even anaphylactic shock.

 

Individuals who have antibodies produced against alpha-gal following a tick bite or previous exposure to the drug cetuximab may experience anaphylaxis when given cetuximab. Cetuximab is a monoclonal antibody, which contains an alpha-gal epitope on the antigen binding fragment (Fab fragment) of the monoclonal drug. Unlike the delayed onset anaphylaxis associated with red meat consumption, individuals with IgE antibody response to alpha-gal can experience immediate onset anaphylaxis upon intravenous cetuximab administration.

 

Although most sensitizations to alpha-gal occur later in life, children who develop IgE antibodies to alpha-gal may also experience anaphylaxis and urticaria 3 to 6 hours after eating mammalian meat. Unlike their adult counterparts, who frequently present with anaphylaxis, the majority of children with this syndrome present with urticaria. Alpha-gal can also be found in mammalian milk, including cow and goat milk.

 

In vitro serum testing for IgE antibodies provides an indication of the immune response to allergens that may be associated with allergic disease.

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.

Class

IgE kU/L

Interpretation

0

<0.10

Negative

0/1

0.10-0.34

Borderline/equivocal

1

0.35-0.69

Equivocal

2

0.70-3.49

Positive

3

3.50-17.4

Positive

4

17.5-49.9

Strongly positive

5

50.0-99.9

Strongly positive

6

> or =100

Strongly positive

 

Concentrations of 0.70 Ku/L or more (Class 2 and above) will flag as abnormally high

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

Detection of IgE antibodies in serum (class 1 or greater) indicates an increased likelihood of allergic disease as opposed to other etiologies and defines the allergens that may be responsible for eliciting signs and symptoms.

 

The level of IgE antibodies in serum varies directly with the concentration of IgE antibodies expressed as a class score or kU/L.

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

Some individuals with clinically insignificant sensitivity to allergens may have measurable levels of IgE antibodies in serum, and results must be interpreted in the clinical context.

 

False-positive results for IgE antibodies may occur in patients with markedly elevated serum IgE (>2500 kU/L) due to nonspecific binding to allergen solid phases.

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

1. Berg EA, Platts-Mills TAE, Commins SP: Drug allergens and food--the cetuximab and galactose-alpha-1,3-galactose story. Ann Allergy Asthma Immunol. 2014 Feb;112(2):97-101

2. Commins SP, Platts-Mills TAE: Delayed anaphylaxis to red meat in patients with IgE Specific for Galactose alpha-1,3-Galactose (alpha-gal). Curr Allergy Asthma Rep. 2013 Feb;13(1):72-77

3. Commins SP, James HR, Kelly LA, et al: The relevance of tick bites to the production of IgE antibodies to the mammalian oligosaccharide galactose-alpha-1,3-galactose. J Allergy Clin Immunol. 2011 May;127(5):1286-1293

4. Wolver SE, Sun DR, Commins SP, Schwartz LB: A peculiar cause of anaphylaxis: no more steak? The journey to discovery of a newly recognized allergy to galactose-alpha-1,3-galactose found in mammalian meat. J Gen Intern Med. 2013 Feb;28(2):322-325

5. Commins SP, Platts-Mills TAE: Tick bites and red meat allergy. Curr Opin Allergy Clin Immunol. 2013 Aug;13(4):354-359

6. Hamsten C, Starkhammar M, Tran TA, et al: Identification of galactose-alpha-1,3-galactose in the gastrointestinal tract of the tick Ixodes ricinus; possible relationship with red meat allergy. Allergy. 2013 Apr;68(4):549-552

7. Steinke JW, Platts-Mills TAE, Commins SP: The alpha-gal story: lessons learned from connecting the dots. J Allergy Clin Immunol. 2015 Mar;135(3):589-597

8. Crispell G, Commins SP, Archer-Hartman SA, Choudhary S, Dharmarajan G, Azadi P, Karim S: Discovery of alpha-gal-containing antigens in North American tick species believed to induce red meat allergy. Front Immunol. 2019 May 17;10:1056

9. Homburger HA, Hamilton RG: Allergic diseases. In: McPherson RA, Pincus MR, eds. Henry's Clinical Diagnosis and Management by Laboratory Methods. 23rd ed. Elsevier; 2017:1057-1070

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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

Specific IgE from the patient's serum reacts with the allergen of interest, which is covalently coupled to an ImmunoCAP. After washing away nonspecific IgE, enzyme-labeled anti-IgE antibody is added to form a complex. After incubation, unbound anti-IgE is washed away, and the bound complex incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. Fluorescence is proportional to the amount of specific IgE present in the patient's sample (ie, the higher the fluorescence value, the more IgE antibody is present).(Package insert: ImmunoCAP System Specific IgE FEIA. Phadia AB; Rev 06/2020)

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 through Friday

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.

Same day/1 to 3 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 account representative. 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.

86008

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
ALGAL Galactose-alpha-1,3-galactose, IgE 73837-7
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.
ALGAL Galactose-alpha-1,3-galactose, IgE 73837-7

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