Feasibility Study of a New Immunoglobulin E (IgE) Assay Method in Urine and Blood

What this Trial Is About

Researchers are evaluating a new method called LuLISA, which uses bioluminescence to measure specific Immunoglobulin E (IgE) in blood and urine samples from both children and adults with allergies. This study aims to test the feasibility of this method compared to the standard ImmunoCAP enzyme immunoassay, which is more expensive, requires more blood, and takes longer to produce results. The new technique has been tested for peanut allergens and now needs to be extended to other major allergens. A secondary goal is to assess how quickly results can be obtained using LuLISA. Participants will have blood and urine samples collected during a routine blood test as part of their allergy follow-up. The study will compare IgE concentrations measured by the new LuLISA method with those from the traditional ImmunoCAP method, examining samples from venous and capillary blood as well as urine. This observational study involves people with sensitization or allergy to various allergens, and no experimental treatments are given. During the study visit, participants will provide blood and urine samples, which will be analyzed to evaluate the correlation between the new and existing IgE testing methods. The main measure is the correlation of specific IgE concentrations for given allergens on the day of sample collection. Researchers will also compare IgE results between blood types and between serum and urine. The trial will monitor how well the new method works overall and how quickly results become available. Participation duration corresponds to the scheduled blood test visit.

Feasibility Study of a New Immunoglobulin E (IgE) Assay Method