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Test Code IGE; SQ: IGESER Immunoglobulin E (IgE), Serum

Reporting Name

Immunoglobulin E (IgE), S

Useful For

Evaluating patients with suspected diseases associated with elevations in total 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

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


Ordering Guidance


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



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

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

For only 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

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 14 days
  Frozen  90 days

Reference Values

0-5 months: ≤13 kU/L

6-11 months: ≤34 kU/L

1 and 2 years: ≤97 kU/L

3 years: ≤199 kU/L

4-6 years: ≤307 kU/L

7 and 8 years: ≤403 kU/L

9-12 years: ≤696 kU/L

13-15 years: ≤629 kU/L

16 and 17 years : ≤537 kU/L

18 years or older: ≤214 kU/L

Day(s) Performed

Monday through Friday

Test Classification

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

82785

LOINC Code Information

Test ID Test Order Name Order LOINC Value
IGE Immunoglobulin E (IgE), S 19113-0

 

Result ID Test Result Name Result LOINC Value
IGE Immunoglobulin E (IgE), S 19113-0

Clinical Information

Immunoglobulin E (IgE) is one of the 5 immunoglobulin classes 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.

Interpretation

Elevated concentrations of total 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.

Method Description

Anti-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)

Reject Due To

Gross hemolysis OK
Gross lipemia OK

Method Name

Fluorescence Enzyme Immunoassay (FEIA)

Secondary ID

8159