This assay is used to detect allergen specific-IgE using an enzyme immunoassay (EIA). In vitro allergy testing is the primary testing mode for allergy diagnosis.
The test method is an enzyme immunoassay (EIA). Allergens are covalently coupled to the cellulose paper discs via the APT method. Alkaline phosphatase (AP) labelled anti-IgE is used to quantify the patient's specific IgE. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.
2-3 business days from receipt of specimen
|Specimen Type||Order Code||CPT Code||NY Approved||Volume||Assay Range||Special Instructions|
|Serum||44710S||86003||Yes||0.5 mL (min. 340uL)||See Scoring Guide||
Scoring System for the Allergen-specific IgE EIA.
|1||0.35 - 0.69||Low Positive|
|2||0.70 - 3.49||Moderate Positive|
|3||3.50 - 17.49||Positive|
|4||17.50 - 49.99||Strong Positive|
|5||50.00 - 99.99||Very Strong Positive|
|6||>99.99||Very Strong Positive|
Lipemic samples may lead to rejection.
Specimens are approved for testing in New York only when indicated in the Specimen Information field above.
The CPT codes provided are based on Viracor Eurofins' interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for general informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.
Position Statement 12 April 1990 published in Immunology and Allergy Practice.
Project Hope, Center for Health Affairs: "The Cost Implication and Cost Effectiveness of Allergy In Vitro Diagnostic Testing.", October 1988.
Hamilton, R and Adkinson, NF. Quantitation of allergen-specific IgE in serum using the RAST. Clin Immunoassay 1983; 6: 147-154.
Kelso,JM, Sodhi,N, Gosselin,VA and Yunginger,JW. Diagnostic performance characteristics of the standard Phadebas RAST, modified RAST, and Pharmacia CAP system vs skin testing. Annals of Allergy 67:511-514,1991.
Williams,PB, Dolen WK, Koepke, JW and Selner,JC. Comparison of skin testing and three in vitro assays for specific IgE in the clinical evaluation of immediate hypersensitivity. Annals of Allergy 69:48-52,1992.
Selner JC et al. Current issues relating to in vitro testing for allergen-specific IgE: a workshop report. Annals of Allergy 1999; 82:407 - 412.
Poon AW, Goodman CS, Rubin RJ. In vitro and skin testing for allergy: comparable clinical utility and costs. American Journal of Managed Care 1998; 4: 969 - 985.
Sampson HA et al. Clinical aspects of allergic disease: relationship between food-specific IgE concentration and the risk of positive food challenges. J Allergy Clin Immunol 1997;100:444-451.
Williams PB et al. Analytical precision and accuracy of commercial immunoassays for specific IgE: establishing a standard. J Allergy Clin Immunol 2000; 105:1221 - 1230.
Szeinbach S et al. Precision and accuracy of commercial laboratories ability to classify positive and/or negative allergen-specific IgE results. Ann Allergy, Asthma & Immunol 2001; 86: 373 - 381.