Carmine/Red Dye Cochineal Extract (F340) IgE **

Test Code

10625

CPT Codes
86003

Preferred Specimen

0.3 mL serum

Minimum Volume

0.15 mL

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 14 days
Refrigerated: 14 days
Frozen: 30 days

Methodology
Immunoassay - Analyte Specific Reagents

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

A.M. Sets up 6 days a week.

Clinical Significance

This allergen-specific IgE antibody test quantifies an individual's IgE response to cochineal extract, a natural red coloring obtained from the insect Dactylopius coccus. Allergy to cochineal extract may be elicited by ingesting foods and beverages containing cochineal extract, or occupational exposure to cochineal extract [1]. This test is an in vitro quantitative assay that is intended to be used in conjunction with other clinical information to aid in the diagnosis of allergic diseases [2].

While allergen-specific serum IgE testing is considered comparable to skin testing in many instances, both the American Academy of Allergy, Asthma, and Immunology and the American College of Allergy, Asthma, and Immunology recognize that allergen-specific serum IgE testing may be preferred in some clinical situations. These include (1) the presence of widespread skin disease, (2) the recent use of antihistamines or other medications that can affect the results of allergy skin tests, (3) uncooperative patients, and (4) medical history suggesting that allergen skin testing would pose a significant risk for a serious allergic reaction [2].

Food-specific IgE tests are extremely sensitive. However, a positive test result only indicates that a patient is IgE sensitized to the food of concern. Many IgE-sensitized individuals do not develop any symptoms when the food is ingested. A diagnosis of food allergy should only be made by a trained medical provider after conducting a thorough clinical evaluation [3,4]. While food-specific IgE test results may contribute to that evaluation, they cannot replace it. Moreover, several forms of food hypersensitivity are not associated with the presence of food-specific IgE in serum.

More specific information about this allergen can be found on the following web page: https://www.thermofisher.com/diagnostic-education/hcp/us/en/resource-center/allergen-encyclopedia/whole-allergens.html?key=f340

References
1. Gultekin F, et al. Clin Rev Allergy Immunol. 2013;45(1):6-29.
2. Bernstein IL, et al. Ann Allergy Asthma Immunol. 2008;100(3 Suppl 3)S1-S148.
3. Sampson HA et al. J Allergy Clin Immunol. 2014;134(5):1016-25.
4. NIAID-Sponsored Expert Panel; Boyce et al. J Allergy Clin Immunol. 2010;126(6 Suppl):S1-S58.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.