Ordering Recommendation

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation

Multiple patient encounters should be avoided.

Collect

Serum separator tube.

Specimen Preparation

Separate serum from cells ASAP or within 2 hours of collection. Transfer 0.5 mL serum to an ARUP standard transport tube. (Min: 0.35 mL). For multiple allergen orders refer to "Allergen Specimen Collection Instructions" at www.aruplab.com/testing/resources/specimen.

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Hemolyzed, icteric, or lipemic specimens.

Remarks
Stability

After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 month

Methodology

Quantitative ImmunoCAP Fluorescent Enzyme Immunoassay

Performed

Sun-Sat

Reported

1-3 days

Reference Interval

Test Number
Components
Reference Interval
  Allergen, Food, Wheat IgE Less than or equal to 0.34 kU/L
  Allergen, Food, Wheat nGliadin IgE Less than or equal to 0.09 kU/L

Interpretive Data

Allergen results of 0.10-0.34 kU/L are intended for specialist use as the clinical relevance is undetermined. Even though increasing ranges are reflective of increasing concentrations of allergen-specific IgE, these concentrations may not correlate with the degree of clinical response or skin testing results when challenged with a specific allergen. The correlation of allergy laboratory results with clinical history and in vivo reactivity to specific allergens is essential. A negative test may not rule out clinical allergy or even anaphylaxis.


Reporting Range
(reported in kU/L)
Probability of IgE Mediated
Clinical Reaction
Class Scoring
Less than 0.10 No significant level detected 0
0.10-0.34 Clinical relevance undetermined 0/1
0.35-0.70 Low 1
0.71-3.50 Moderate 2
3.51-17.50 High 3
17.51-50.00 Very high 4
50.01-100.00 Very high 5
Greater than 100.00 Very high 6

Compliance Category

Laboratory Developed Test (LDT)

Note

This assay will initially test wheat whole allergen and purified gliadin. If the wheat whole allergen result is greater than or equal to 0.1 kU/L, wheat component Tri a 14 will be ordered. If the purified gliadin is greater than or equal to 0.1 kU/L, wheat component Tri a 19 will be ordered. Additional charges apply.

Hotline History

N/A

CPT Codes

86003; 86008 if reflexed add 86008 x2

Components

Component Test Code* Component Chart Name LOINC
0055034 Allergen, Food, Wheat IgE 6276-0
3017570 Allergen, Food, Wheat nGliadin IgE 82583-6
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

Allergen, Food, Wheat and nGliadin With Reflex to Components, IgE