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Test ID: IGE
Immunoglobulin E (IgE), Serum

Secondary ID A test code used for billing and in test definitions created prior to November 2011

8159

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

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

As an initial (screening) test for allergic disease

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

Fluorescence Enzyme Immunoassay (FEIA)

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

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 needed for testing

Serum

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 0.5 mL

Forms: If not ordering electronically, submit an Allergen Request Form (Supply T236) with the specimen.

Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.

For 1 allergen: 0.3 mL/For more than 1 allergen: 0.05 mL x number of allergens + 0.25 mL dead space

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

Hemolysis

Mild OK; Gross OK

Lipemia

Mild OK; Gross OK

Icterus

NA

Other

NA

 

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
SerumRefrigerated (preferred)14 days
 Frozen 14 days

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

IgE antibodies mediate allergic diseases by sensitizing mast cells and basophils to release histamine and other inflammatory mediators on exposure to allergens.

 

Serum levels of IgE are increased in many patients with allergic diseases, parasitic diseases, allergic bronchopulmonary aspergillosis, and the rare hyper IgE syndrome.

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

Mean

+1SD

+2SD

0-6 weeks

0.6

2.3

8.8

7 weeks-3 months

1.0

4.1

17.0

4-6 months

1.8

7.3

30.0

7-9 months

2.6

10.0

39.0

10-23 months

3.2

13.0

53.0

2 years

5.7

23.0

93.0

3 years

8.0

32.0

128.0

4 years

10.0

40.0

160.0

5 years

12.0

48.0

192.0

6 years

14.0

56.0

224.0

7 years

16.0

63.0

248.0

8 years

18.0

71.0

280.0

9 years

20.0

78.0

304.0

10 years

22.0

85.0

328.0

Adults

13.2

41.0

127.0

 

Interpretation Provides information to assist in interpretation of the test results

Serum levels of IgE greater than the mean +1 standard deviation (SD) for age suggest the presence of allergic disease.

 

Levels greater than the mean +2 SD strongly suggest the presence of allergic disease.

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

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

 

A normal level of IgE in serum does not eliminate the possibility of allergic disease.

 

Normal levels of 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 Provides recommendations for further in-depth reading of a clinical nature

Homburger HA: Chapter 53: Allergic diseases. In Clinical Diagnosis and Management by Laboratory Methods. 21st edition. Edited by RA McPherson, MR Pincus. WB Saunders Company, New York, 2007, Part VI, pp 961-971

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

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. issued August 2000, revised June 2010)

Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.

Monday through Friday; 9 a.m.-8 p.m., Saturday; 8 a.m.-3 p.m.

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

Same day/1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

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 The location of the laboratory that performs the test

Rochester

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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

This test has been cleared or approved by the U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

82785

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
IGEImmunoglobulin E (IgE), S19113-0