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Soy Component rGly m 4, PR-10 IgE

Test Code: 521810
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Clinical and Procedure
Clinical Utility

This assay is used to detect allergen specific-IgE using the ImmunoCAP® FEIA method. In vitro allergy testing is the primary testing mode for allergy diagnosis.

Procedure

The ImmunoCAP® FEIA method uses as the solid phase a flexible, hydrophobic cellulosic polymer to which allergen has been covalently linked. The advantage of this system is that it has a very high antigen binding capacity when compared to other systems and it has minimal non-specific binding with high total IgE. Viracor Eurofins provides an optional low range calibrator at 0.1 kU/L and a 0/1 class. This test has been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Turnaround Time

1-2 business days from receipt of specimen

Specimen Information
Specimen Type Test Code CPT Code NY Approved Volume Assay Range Special Instructions
serum 521810 86008 Yes

0.5 mL (min. 340uL)

See Scoring Guide

  • Collect 1-2 mL whole blood in red top tube.
  • Centrifuge and transfer 0.5 mL serum into a transfer tube.
  • Ship at ambient or frozen temperature Monday through Friday.
  • Specimens are stable for 4 weeks refrigerated or ambient; freeze for longer storage.

ImmunoCAP® Quantitative Scoring Guide:

Class IgE (kU/L) Comment
0 <0.10 Negative
0/1 0.10-0.34 Equivocal/Borderline
1 0.35-0.69 Low Positive
2 0.70-3.49 Moderate Positive
3 3.50-17.49 High Positive
4 17.50-49.99 Very High Positive
5 50.00-99.99 Very High Positive
6 >99.99 Very High Positive

Note that Viracor Eurofins includes an extra calibrator at 0.10 kU/L and uses it to
define an optional equivocal class.

Causes for Rejection

Lipemic samples may lead to rejection.

Disclaimer

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.

References

Nicolaou N, Poorafshar M, Murray C, et al. Allergy or tolerance in children sensitized to peanut: prevalence and differentiation using component-resolved diagnostics. J Allergy Clin Immunol. 2010;125(1):191-97.

Valenta R, Twaroch, Swoboda I. Component-resolved diagnosis to optimize allergen-specific immunotherapy in the Mediterranean area. J Investig Allergol Clin immunol. 2007;17(suppl 1):36-40.

Asarnoj A, Moverare R, Ostblom E, et al. IgE to peanut allergen components: relation to peanut symptoms and pollen sensitization in 8-year-olds. Allergy. 2010;65: 1189-95.

Mittag D, Akkerdaas J, Ballmer-Weber BK, et al. Ara h 8, a Bet v 1-homologous allergen from peanut, is a major allergen in patients with combined birch pollen and peanut allergy. J Allergy Clin Immunol. Dec 2004;114:1410-17.

Mondoulet L, Paty E, Drumare MF, et al. Influence of thermal processing on the allergenicity of peanut proteins. J Agric Food Chem. 2005;53(11):4547-53.

Maleki SJ, Viquez O, Jacks T, et al. The major peanut allergen, Ara h 2, functions as a trypsin inhibitor, and roasting enhances this function. J Allergy Clin Immunol. 2003;112(1):190-5.

Vereda A, van Hage M, Ahlstedt S, et al. Peanut allergy: Clinical and immunologic differences among patients from 3 different geographic regions. J Allergy Clin Immunol. 2011 Mar; 127(3):603-7.

Codreanu F, Collignon O, Roitel O, et al. A Novel Immunoassay using recombinant allergens simplifies peanut allergy diagnosis. Int Arch Allergy Immunol. 2011;154:216-26.

 

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