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Protocol - Immunoglobulin E (Total and Specific)

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Protocol Name from Source:

Not Applicable; see source

Availability:

Publicly available

Description:

This protocol is a bioassay for ascertaining levels of immunoglobulin E.

Protocol:

Draw 2-4 cc of blood into one 5 ml SST gold top Vacutainer® tube for IgE. The tube should be allowed to sit at room temperature for 30 minutes to clot. The sample should then be spun at 2,000 rpm (room temperature: 20-24oC) for 10 minutes to separate off the serum.

The serum should be aliquoted in 1.8 ml screw-top cryogenic microcontainer tubes (0.5 cc minimum per tube).

The IgE can be processed immediately or kept frozen (-20oC to -70oC) and processed in batches.

Vacutainer® is a trademark of Becton, Dickinson and Company.

Personnel and Training Required

A phlebotomist, nursing staff, or other health care professional who is trained to draw blood and laboratory staff who are trained to perform this assay

Equipment Needs

One 5 ml Serum Separation Tubes (SST™) gold top Vacutainer® tube

Centrifuge for serum separation

Freezer for sample storage is required

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentYes
Specialized requirements for biospecimen collectionYes
Specialized trainingYes

Mode of Administration

Self-administered

Life Stage:

Infant, Toddler, Child, Adolescent, Adult, Senior

Specific Instructions:

Licensing and guideline requirements for manufacturers and laboratories performing these tests have been set forth by the Food and Drug Administration and the Clinical Laboratory Improvement Amendment of 1988. These measures have ensured results that are more consistent but do not address either accuracy or precision parameters in a comprehensive fashion. In summary, one of the major challenges in the development of consistent allergy testing is the need to identify and accept a well-recognized test standard.

An ideal immunoassay for specific immunoglobulin E (IgE) antibodies should meet certain analytic performance criteria. These criteria include a slope of unity over the useful measurement range for all allergens, low variation across replicate measurements, statistically determined limits of detection, a practical cut-off point, and defined saturation points. An assay would need to closely approximate these criteria to be considered as a standard. There is currently no established standard in this field.

Research Domain Information

Release Date:

January 29, 2010

Definition

Immunoglobulin E (IgE), Total and Specific, are the class of antibodies produced in the lungs, skin, and mucous membranes, and are responsible for allergic reactions.

Purpose

Total and allergen-specific serum immunoglobulin E (IgE) concentrations were chosen because they have been used extensively in studies of allergy-associated lung diseases. Measurement of total and allergen-specific IgE permits quantitative differentiation of individuals with atopy from those without atopy.

Selection Rationale

Immunoassays for total and allergen-specific serum immunoglobulin E (IgE) are sensitive, relatively inexpensive, and available in most clinical laboratories.

Language

English

Standards

StandardNameIDSource
Common Data Elements (CDE)Person Immunoglobulin Measurement Text2970246CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)Resp immunoglobulin E proto62621-8LOINC

Process and Review

[link[phenx.org/node/118|Expert Review Panel #6]] (ERP 6) reviewed the measures in the Respiratory domain.

Guidance from ERP 6 includes:

• No significant changes to measure

Back-compatible: no changes to Data Dictionary

Source

Williams, P. B., Barnes, J. H., Szeinbach, S. L., & Sullivan, T. J. (2000). Analytic precision and accuracy of commercial immunoassays for specific IgE: Establishing a standard. Journal of Allergy and Clinical Immunology, 105(6), 1221-1230.

General References

Dolen, W. K. (2003). IgE antibody in the serum--Detection and diagnostic significance. Allergy, 58(5), 717-723.

Protocol ID:

90701

Variables:

Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX090701_IgE_ConcentrationPX090701010000Concentration of Immunoglobulin E4Variable Mapping