Validation Study of NOVEOS® System (HYCOR)

University Hospital Center (CHU)

Status: Terminated

Conditions: Allergen-mediated IgE Allergy

Treatments: Device: NOVEOS® system

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03969862

7572

Details and patient eligibility

About

Background : The NOVEOS® method is a chemiluminescent immunoassay used to provide quantitative detection of total IgE and allergen-specific IgE antibodies in human serum.

The IgE antibody assay has an essential place in the diagnosis of mediated IgE allergies.

This system could become an alternative to the techniques used today. NOVEOS® uses a quick and convenient method to give results concerning the patient's sensitization profile towards allergens. The volume required for the assays is 4 μl (against more than 100 μl for current techniques), which is particularly important in pediatric and geriatric populations where it may be more difficult to take larger samples.

NOVEOS® also brings true autonomy. In fact, the incorporated reagents provide sufficient capacity for 8 hours of continuous testing.

Objective: Validate the NOVEOS® system as an allergy diagnostic tool, by estimating the sensitivity and specificity of the NOVEOS® assays compared to the gold standard diagnostic represented by the clinical history and PT positive, for a panel of 20 allergens

Methods: This is a validation study of a new immunoassay method (Système NOVEOS®).

The study includes :

• A preliminary phase to familiarize the team with the use of the NOVEOS® system. It is planned to analyze its technical characteristics: the precision, the sensitivity. Eight allergens will be tested, on a cohort of 136 patients
• A validation study of the technique as a diagnostic tool for allergy (sensitivity and specificity compared to the gold standard represented by clinical history and positive PT) and comparison between the new technique and the ImmunoCap® system. Twenty allergens will be tested prospectively, each on 50 cases and 10 controls. A single patient may be both a case for an allergen and a witness for another. For rare allergies, the blood database of the Allergy Service will be used, and affected patients will be contacted to request their non-opposition.

Enrollment: 536 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

IncInclusion criteria:

• Patient who is at least 6 years old
• The patient must be an affiliate or beneficiary of a health insurance plan

Exclusion criteria:

• Patient refusing to take part in the study
• Patient participated in another study that may influence test results
• The patient is in an exclusion period determined by a previous study
• The patient is under the protection of justice, under guardianship or under curatorship
• Patient under antihistaminic H1 treatment preventing the achievement of Prick-tests
• The patient is pregnant
• The patient is breastfeeding
• The patient has a history of tumor, autoimmune, or immune deficiency pathology
• The patient suffers from a hematological pathology (coagulation disorders, anemia) that could interfere with the blood test

Trial design

536 participants in 2 patient groups

Patient with an allergen-mediated IgE allergy

Description:

Patients with a clinical history consistent with an allergen-mediated IgE allergy \& with a sensitization demonstrated by a positive Prick-Test for the allergen source tested

Treatment:

Device: NOVEOS® system

Patient without an allergen-mediated IgE allergy

Description:

Patient without a clinical history compatible with an IgE allergy-mediated allergy and without PT sensitization to be allergen

Treatment:

Device: NOVEOS® system