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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Allergy and Immunology
• Intervention / Treatment: Biological: collection of blood and urine

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 1376

Contacts and Locations

• Study Contact: Name: Marine Michelet, MD; Phone Number: 33-5 34 55 85 85; Email: michelet.m@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31000
    • Recruiting
    • University Hospital
    • Contact: Marine Michelet, MD; Phone Number: 0033 5 34 55 85 86; Email: michelet.m@chu-toulouse.fr
    • Contact: Françoise Auriol, PhD; Phone Number: 0033 561779103; Email: auriol.f@chu-toulouse.fr
  • Toulouse, France, 31059
    • Recruiting
    • Larrey hospital
    • Contact: Laurent Guilleminault, MD; Phone Number: 0033 567771624; Email: guilleminault.l@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients followed at the Toulouse University Hospital and presenting sensitization or allergy towards a trophallergen, an aeroallergen, hymenoptera venom or drug

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
People with sensitization or allergy; blood and urine will be collected during a blood test scheduled for the follow-up of the patient	Biological: collection of blood and urine; blood and urine will be collected during a blood test scheduled for the follow-up of the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation of the the correlation of specific IgE concentrations for a given allergen analyzed using two different methods	specific IgE concentrations for a given allergen will be measured by both LuLISA and ImmunoCAP and the results will be compared	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To study the correlation between the results of specific serum and urinary IgE dosages by LuLISA	specific IgE concentrations for a given allergen will be measured in the sera and the urine from the same patient and the results will be compared	Day 0
To study the correlation between the results of specific IgE dosages in the venous blood and the capillary blood	specific IgE concentrations for a given allergen will be measured in the venous blood and the capillary blood from the same patient and the results will be compared	Day 0

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Marine MICHELET, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Estimated): April 20, 2026
• Study Completion (Estimated): April 20, 2026

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: IgE assay; food allergy/ hypersensitivity; respiratory allergy/ hypersensitivity; hymenopter allergy/ hypersensitivity
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Reproductive and Urinary Physiological Phenomena; Urinary Tract Physiological Phenomena; Urination
• Other Study ID Numbers: RC31/20/0293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No