Test Catalog

Test Id : IGE

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Immunoglobulin E (IgE), Serum

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Overview

Test Catalog

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

Evaluating patients with suspected diseases associated with elevations in total immunoglobulin E (IgE), including allergic disease, primary immunodeficiencies, infections, malignancies, or other inflammatory diseases 

 

Diagnostic evaluation of patients with suspected allergic bronchopulmonary aspergillosis

 

 Identifying candidates for omalizumab (anti-IgE) therapy

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

Immunoglobulin E (IgE), S

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

IgE (Immunoglobulin E)

IgE, Total

Immune Competence

Total IgE (Immunoglobulin E)

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

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

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

For total IgE: 0.3 mL

For total IgE and more than 1 allergen: 0.05 mL x number of allergen-specific tests + 0.25 mL dead space

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

Evaluating patients with suspected diseases associated with elevations in total immunoglobulin E (IgE), including allergic disease, primary immunodeficiencies, infections, malignancies, or other inflammatory diseases 

 

Diagnostic evaluation of patients with suspected allergic bronchopulmonary aspergillosis

 

 Identifying candidates for omalizumab (anti-IgE) therapy

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

Immunoglobulin E (IgE) is one of the 5 classes of immunoglobulins and is defined by the presence of the epsilon heavy chain. It is the most recently described immunoglobulin, having first been identified in 1966. IgE exists as a monomer and is present in circulation at very low concentrations, approximately 300-fold lower than that of IgG. The physiologic role of IgE is not well characterized, although it is thought to be involved in defense against parasites, specifically helminths.

 

The function of IgE is also distinct from other immunoglobulins in that it induces activation of mast cells and basophils through the cell-surface receptor Fc epsilon RI. Fc epsilon RI is a high-affinity receptor specific for IgE that is present at a high density on tissue-resident mast cells and basophils. Because of this high-affinity interaction, almost all IgE produced by B cells is bound to mast cells or basophils, which explains the low concentration present in circulation. Cross-linking of the Fc epsilon RI-bound IgE leads to cellular activation, resulting in immediate release of preformed granular components (histamine and tryptase) and subsequent production of lipid mediators (prostaglandins and leukotrienes) and cytokines (interleukin-4 and interleukin-5).

 

Elevated concentrations of IgE are generally thought of in the context of allergic disease. However, increases in the amount of circulating total serum IgE can also be found in various other diseases, including primary immunodeficiencies, infections, inflammatory diseases, and malignancies. Total IgE measurements have limited utility for diagnostic evaluation of patients with suspected allergic disease, except for allergic bronchopulmonary aspergillosis (ABPA). ABPA is a hypersensitivity reaction against the fungi Aspergillus that occurs most frequently in patients with asthma or cystic fibrosis. An elevation of total IgE is part of the diagnostic criteria for ABPA, although the specific diagnostic concentration is dependent on certain patient characteristics.

 

For patients with an established diagnosis of allergic disease, measurement of total IgE is necessary for identification of candidates for omalizumab (anti-IgE) therapy and for determination of proper dosing. In addition to specific patient demographics and clinical presentations, candidates for omalizumab must have total IgE concentrations between 30 and 700 KU/L.

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.

Results reported in kU/L

Age

Reference interval

0-5 months

< or =13

6-11 months

< or =34

1 and 2 years

< or =97

3 years

< or =199

4-6 years

< or =307

7 and 8 years

< or =403

9-12 years

< or =696

13-15 years

< or =629

16 and 17 years

< or =537

18 years and older

< or =214

Interpretation
Provides information to assist in interpretation of the test results

Elevated concentrations of total immunoglobulin E (IgE) may be found in a variety of clinical diseases including allergic disease, certain primary immunodeficiencies, infections, inflammatory diseases, and malignancies.

 

Elevated total IgE concentrations may be consistent with a diagnosis of allergic bronchopulmonary aspergillosis, provided other laboratory and clinical criteria are fulfilled.

 

Total IgE concentrations between 30 to 700 KU/L may identify candidates for omalizumab therapy and may help to determine proper therapeutic dosing.

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

An elevated concentration of total immunoglobulin E (IgE) is not diagnostic for allergic disease and must be interpreted in the clinical context of the patient including age, sex, travel history, potential allergen exposure, and family history. 

 

A normal concentration of total IgE does not eliminate the possibility of allergic disease. In patients with a high index of suspicion for allergic disease, testing for allergen-specific IgE may be warranted.

 

The probability of finding an increased level of total IgE in serum in a patient with allergic disease varies directly with the number of different allergens to which the patient is sensitized. 

Normal levels of total IgE in serum occur in some patients with allergic disease, especially if there is sensitivity to a limited number of allergens and limited end organ involvement.

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

1. Homburger HA: Allergic diseases. In: Clinical Diagnosis and Management by Laboratory Methods. 21st ed. WB Saunders Company. 2007;961-971

2. Martins TB, Bandhauer ME, Bunker AM, Roberts WL, Hill HR: New childhood and adult reference intervals for total IgE. J Allergy Clin Immunol. 2014 Feb;133(2):589-591

3. Bernstein IL, Li JT, Bernstein DI, et al: Allergy diagnostic testing: An updated practice parameter. Ann Allergy Asthma Immunol. 2008 Mar;100(3 Suppl 3):S1-148

4. Ansotegui IJ, Melioli G, Canonica GW, et al: IgE allergy diagnostics and other relevant tests in allergy, a World Allergy Organization position paper. World Allergy Organ J. 2020 Feb;13(2):100080. doi: 10.1016/j.waojou.2019.100080

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

Anti-immunoglobulin E (IgE), covalently coupled to ImmunoCAP, reacts with the IgE in a serum specimen. After washing, enzyme-labeled anti-IgE antibodies are added to form a complex. After incubation, unbound enzyme-labeled anti-IgE is washed away and the bound complex is incubated with a developing agent. After stopping the reaction, fluorescence of the eluate in the well is measured. The fluorescence is directly proportional to the concentration of IgE in the test specimen.(Package insert: Phadia CAP System IgE FEIA. Phadia; revised 04/2019)

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 day 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.

82785

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
IGE Immunoglobulin E (IgE), S 19113-0
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.
IGE Immunoglobulin E (IgE), S 19113-0

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