Test Catalog

Test Id : GLT

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Gluten, IgE, Serum

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Overview

Test Catalog

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

Establishing a diagnosis of an allergy to gluten

 

Defining the allergen responsible for eliciting signs and symptoms

 

Identifying allergens:

-Responsible for allergic response and/or anaphylactic episode

-To confirm sensitization prior to beginning immunotherapy

-To investigate the specificity of allergic reactions to insect venom allergens, drugs, or chemical allergens

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

Gluten, IgE

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

Alpha Gliadin

Gamma Gliadin

Gliadin

Tri a Gluten

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

If not ordering electronically, complete, print, and send an Allergen Test Request (T236) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

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

Establishing a diagnosis of an allergy to gluten

 

Defining the allergen responsible for eliciting signs and symptoms

 

Identifying allergens:

-Responsible for allergic response and/or anaphylactic episode

-To confirm sensitization prior to beginning immunotherapy

-To investigate the specificity of allergic reactions to insect venom allergens, drugs, or chemical allergens

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

Clinical manifestations of immediate hypersensitivity (allergic) diseases are caused by the release of proinflammatory mediators (histamine, leukotrienes, and prostaglandins) from IgE-sensitized effector cells (mast cells and basophils) when cell-bound IgE antibodies interact with an allergen.

 

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

 

The allergens chosen for testing often depend upon the age of the patient, history of allergen exposure, season of the year, and clinical manifestations. In individuals predisposed to develop allergic disease, the sequence of sensitization and clinical manifestations proceed as follows: eczema and respiratory disease (rhinitis and bronchospasm) in infants and children less than 5 years due to food sensitivity (milk, egg, soy, and wheat proteins) followed by respiratory disease (rhinitis and asthma) in older children and adults due to sensitivity to inhalant allergens (dust mite, mold, and pollen inhalants).

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

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

Testing for IgE antibodies is not useful in patients previously treated with immunotherapy to determine if residual clinical sensitivity exists or in patients in whom the medical management does not depend upon identification of allergen specificity.

 

Some individuals with clinically insignificant sensitivity to allergens may have measurable levels of IgE antibodies in serum, and test 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

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

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; 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.

86003

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
GLT Gluten, IgE 6125-9
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.
GLT Gluten, IgE 6125-9

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