The Utility of Food-Specific IgE Measured With the IMMULITE 2000 Assay to Predict Symptomatic Food Allergy

Status: Completed
Location: See location...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

Food allergy is on the rise within the pediatric population. Having food allergy can cause medical, nutritional and psychological issues in those who suffer with it. Although making the appropriate diagnosis of food allergy is very important, properly diagnosing food allergy has been a challenge. Skin prick testing and food-specific IgE testing of the blood can give positive results that are false. Currently, Oral Food Challenges are the best way to diagnose a food allergy. Unfortunately, Oral Food Challenges are time consuming and may not be readily available to suspected food allergy sufferers. This study is designed to examine the effectiveness of an allergy-detecting blood test called IMMULITE 2000 manufactured by the study sponsor, Siemens.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 21
Healthy Volunteers: f
View:

• Age 3 to 21 years of either sex and any race

• Physician-diagnosed food allergy or convincing clinical history of food allergy to milk, egg, and/or peanut AND a Skin prick test positive to milk, egg, and/or peanut (diameter of wheal \> 3 mm or greater than negative control) orOR a detectable serum food-specific IgE level (ImmunoCAP and/or IMMULITE \> 0.35 kUA/L) to milk, egg, and/or peanut

• If no history of clinical reactivity to milk, egg, or peanut, then a positive skin prick test to milk, egg, and/or peanut (diameter of wheal \> 3 mm or greater than negative control) OR a detectable serum food-specific IgE level within the previous 4 months to milk, egg, and/or peanut

• Written informed consent from parent/guardian and assent (when age appropriate).

• Willingness to submit specimen for laboratory serum IgE testing

Locations
United States
Colorado
National Jewish Health
Denver
Time Frame
Start Date: 2013-09
Completion Date: 2017-03-29
Participants
Target number of participants: 102
Treatments
Peanut allergic
Subjects allergic to peanuts by oral food challenge
Milk allergic
Subjects allergic to milk by oral food challenge
Egg allergic
Subjects allergic to egg by oral food challenge
Related Therapeutic Areas
Sponsors
Leads: National Jewish Health

This content was sourced from clinicaltrials.gov