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Gluten (Allergen Specific IgE)

Wheat protein, Gluten (f79)

Test Codes

Antrim #31519, EPIC: LAB5642, SOFT: EGLT

Department

Special Testing Allergens

Specimen Collection Criteria

Collect: One Gold-top SST tube.

Twenty individual allergen assays or allergen screens can be performed on one 5 mL Gold-top SST tube. Each allergen assay requires 100 mcL of serum.

Physician Office/Draw Specimen Preparation

Let specimen clot 30-60 minutes then immediately centrifuge to separate serum from cells. Refrigerate (2-8°C or 36-46°F) the centrifuged collection tube within two hours of collection.

Preparation for Courier Transport

Transport: Centrifuged collection tube, refrigerated (2-8°C or 36-46°F).

Rejection Criteria

Plasma specimens.

Severely lipemic or hemolyzed specimens.

In-Lab Processing

Let specimen clot 30-60 minutes then immediately centrifuge to separate serum from cells. Room temperature is acceptable for a maximum of two hours.

Storage

Specimen Stability for Testing:

Centrifuged SST Tubes and Microtainers^® with Separator Gel
Room Temperature (20-26°C or 68-78.8°F): 2 hours
Refrigerated (2-8°C or 36-46°F): 7 days
Frozen (-20°C/-4°F or below): Unacceptable

Red-top Tubes and Microtainers^® without Separator Gel
Room Temperature (20-26°C or 68-78.8°F): 2 hours
Refrigerated (2-8°C or 36-46°F): Unacceptable
Frozen (-20°C/-4°F or below): Unacceptable

Serum Specimens (Pour-Overs)
Room Temperature (20-26°C or 68-78.8°F): 2 hours
Refrigerated (2-8°C or 36-46°F): 7 days
Frozen (-20°C/-4°F or below): 1 month

Specimen Storage in Department Prior to Disposal:

Refrigerated (2-8°C or 36-46°F): 7 days

Laboratory

Royal Oak Special Testing Laboratory

Performed

Monday – Friday.
Results available the next business day.

Reference Range

Allergy Reference Range: Less than 0.35 kU/L. 

Range (kU/L)	Class	Interpretation
Less than or equal to 0.34	0	Negative
0.35-0.69	1	Low
0.70-3.49	2	Medium
3.50-17.49	3	High
17.50-49.99	4	Very High
50.0-100.0	5	Very High
Greater than 100	6	Very High

Test Methodology

Fluorescence Enzyme Immunoassay (FEIA).

Interpretation

The allergen class may not be predictive of clinical disease in some patients. The diagnosis of allergy should be based upon patient history and clinical findings. The diagnosis of allergy should not be based upon laboratory findings alone.

Clinical Utility

A positive test result (class 1 or greater) is indicative of the presence of allergen-specific IgE and suggests an increased likelihood of allergic disease.

Clinical Disease

Gluten is a mix of proteins found in wheat, oats, rye, and barley (1).

Sensitivity to gluten is also known as "Celiac Disease", "Non-Tropical- Sprue", or "Gluten-enteropathy" in bowel disorders and Dermatitis Herpetformis in skin disorders.

Symptoms can include diarrhea, bulky malodorous stools, streatorrhea (fecal fat excretion exceeding 6 g in 24 hours), and weight loss with malabsorption of proteins, carbohydrates, vitamins, minerals, electrolytes, and water (1). Gluten consumed in a meal inhibits starch absorption, and gluten eaten in large doses (100-150 g) on a daily basis can lead to malabsorption of fat. Gluten sensitivity can lead to enteropathy (Celiac Disease). The European Society of Padiatric Gastroenterology and Nutrition has provided a working definition for gluten sensitivity:

1. Celiac disease is a life-long conditon of intolerance to gluten.
2. at the onset of this condition the mucosal lesion is flat, and recovers when the person adopts a gluten-free diet.
3. a histologic relapse of the jejunal mucosa will occur within 2 years of gluten becoming apart of the diet again.

Celiac disease is a permanent sensitivity to gluten. Histologic abnormalities of the jejunal mucosa is a common observation (2).

Persons suffering from Celiac disease tend to have more allergies than the general population. Gluten causes damage to the small intestine, which may lead to exposure to the host's immune system.

There are several sources that can activate Celiac disease in gluten sensitive individuals such as a sudden increase in wheat- based products commonly from low fat diets. Postpartum women due to their immune system adjusting after delivery. Viral infections can also trigger symptoms. True food allergy is less common than popularly believed. It is estimated that only 1 to 4% of the general population suffers from a definite food allergy. Food allergy tends to be more common in children (up to 6%) than adults. In selected groups, such as children with eczema, the prevalence of food allergy may be as high as 25%.

The majority of the food allergies are due to the consumption of milk, egg, wheat, peanut, soy, tree nuts, fish and shellfish, however, allergic responses can occur with all types of food in a sensitized individual.

An anaphylactic reaction to food, which is life-threatening, occurs in approximately 1 million individuals each year according to the National Institutes of Health. Anaphylactic reactions are most commonly found in patients with allergies to peanuts, nuts, eggs, fish and shellfish. Anaphylactic responses occur approximately 5-15 minutes after food consumption and can lead to difficulty in breathing, constriction of the airways, and unconsciousness.

Certain factors such as alcohol consumption and exercise appear to enhance the reactivity to a food allergen in sensitized individuals. Individuals with food allergies usually have other allergies as well, including allergies to pollen or dust.

Reference

1. Patterson, Roy M.D., C. Raymond Zeiss, Jr., M.D., Leslie Carroll Grammar, M.D., Paul A. Greenberger, M.D. Allergic Diseases: Diagnosis and Management, 4th ed. J.B. Lippincott Company: Philadelphia, 1993, pg. 369-371.
2. Metcalfe, Dean D. M.D., Hugh A. Sampson, M.D., Ronald A. Simon, M.D., Food Allergy: Adverse Reactions to Foods and Food Additives. Blackwell Scientific Publications: Boston, 1991, pg. 100, 186-187, 145.

CPT Codes

86003
LOINC: 6125-9

Contacts

Last Updated

2/23/2023