Protocol - Immunoglobulin E (Total and Specific)
This protocol is a bioassay for ascertaining levels of immunoglobulin E.
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
One 5 ml Serum Separation Tubes (SST™) gold top Vacutainer® tube
Centrifuge for serum separation
Freezer for sample storage is required
|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
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).
Immunoassays for total and allergen-specific serum immunoglobulin E (IgE) are sensitive, relatively inexpensive, and available in most clinical laboratories.
|caDSR Common Data Elements (CDE)||Person Immunoglobulin Measurement Text||2970246||CDE Browser|
|Logical Observation Identifiers Names and Codes (LOINC)||Resp immunoglobulin E proto||62621-8||LOINC|
|Human Phenotype Ontology||Abnormal immunoglobulin Level||HP:0010701||HPO|
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.
Dolen, W. K. (2003). IgE antibody in the serum--Detection and diagnostic significance. Allergy, 58(5), 717-723.
|Variable Name||Variable ID||Variable Description||dbGaP Mapping|
|PX090701010000||Concentration of Immunoglobulin E||Variable Mapping|
Immunoglobulin E (Total and Specific)
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