Protocol - Immunoglobulin E (Total and Specific)

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

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.




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

Requirement CategoryRequired
Major equipment Yes
Specialized training Yes
Specialized requirements for biospecimen collection Yes
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration



Infant, Toddler, Child, Adolescent, Adult, Senior


All ages

NOTE: This assay can be performed on cord blood-however, the volume of blood that can be taken from newborns or infants is less than 2-4 cc (probably < 1 cc).

Selection Rationale

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


Chinese, English

Logical Observation Identifiers Names and Codes (LOINC) Resp immunoglobulin E proto 62621-8 LOINC
Human Phenotype Ontology Abnormal immunoglobulin Level HP:0010701 HPO
caDSR Form PhenX PX090701 - Immunoglobulin E Total And Specific 5969401 caDSR Form
Derived Variables


Process and Review

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

Protocol Name from Source

Williams, P. B., et al, Analytic precision and accuracy of commercial immunoassays for specific IgE: Establishing a standard, J ALLERGY CLIN IMMUN, 2000


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


Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
PX090701010000 Concentration of Immunoglobulin E Variable Mapping
Measure Name

Immunoglobulin E (Total and Specific)

Release Date

January 29, 2010


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.


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.


Respiratory, allergy, allergic, immunoassay, IgE

Measure Protocols
Protocol ID Protocol Name
90701 Immunoglobulin E (Total and Specific)

There are no publications listed for this protocol.