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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1376 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-20

Study Completion Date

2026-01-07

Brief Summary

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The main objective is to study the feasibility of a new specific IgE assay using a bioluminescence technique in a pediatric and adult allergic population. For this, we will collect blood, and urine during a blood test scheduled for the follow-up of the patient.

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Detailed Description

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Allergy is a raising public health problem. Specific IgE assays are useful tools to investigate the physiopathology of allergies. This method is achieved mainly by the ImmunoCAP enzyme immunoassay technique. This is an expensive test that requires a significant amount of blood. This is a limitation particularly in children. The time to get the results is long and a second consultation has to be scheduled in order to communicate the results to the patients. The main objective of this study is to assess the feasibility of a new specific IgE assay, named LuLISA, using a bioluminescence technique in urine and blood samples from pediatric and adult allergic population. This technique was recently published for the quantification of IgE against two peanut allergens and needs to be extended for the detection of other major allergens. A secondary objective is the evaluation of the time needed to obtain results.

Conditions

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Allergy and Immunology

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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People with sensitization or allergy

blood and urine will be collected during a blood test scheduled for the follow-up of the patient

collection of blood and urine

Intervention Type BIOLOGICAL

blood and urine will be collected during a blood test scheduled for the follow-up of the patient

Interventions

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collection of blood and urine

blood and urine will be collected during a blood test scheduled for the follow-up of the patient

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Males or females 6 months' old or older
* Sensitization or allergy towards a trophallergen, an aeroallergen, hymenoptera venom or drug proven by:

* positive skin test (s)
* and / or IgE specific (s)\> 0.1 kUA / L
* and / or anamnesis in favor of an allergic reaction of mediated IgE
* Social coverage up to date

Exclusion Criteria

* Children younger than 6 months'old
* Children's weight less than 10 kg
* Pregnant or breastfeeding women
* Patients with cystic fibrosis
* Patients with dysimmune or autoimmune pathology
* Anamnesis in favor of a delayed allergy or a contact allergy.

Minimum Eligible Age

6 Months

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No