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

Toulouse University Hospital

Status: Enrolling

Conditions: Allergy and Immunology

Treatments: Biological: collection of blood and urine

Study type: Observational

Funder types: Other

Identifiers

NCT04751760

RC31/20/0293

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,376 estimated patients

Sex: All

Ages: 6 months to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,376 participants in 1 patient group

People with sensitization or allergy

Description:

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

Treatment:

Biological: collection of blood and urine