Clinical trial NCT03969862: Validation Study of NOVEOS® System (HYCOR)
Official title: Validation Study of Noveos® System as a Diagnostic Tools for Allergy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Allergen-mediated IgE Allergy
Keywords: Allergy diagnostic tool
Specific IgE assays
Allergens
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Hycor Biomedical
First posted: 2019-05-31
Enrollment: 536
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient consulting in our allergy unit for a suspicion of allergy (respiratory, food, drug, hymenoptera venoms)

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Sensitivity and specificity of the NOVEOS® assay compared to the gold standard diagnosis.
timeFrame: 24 months
Secondary outcomes:
measure: Specific IgE assessed by NOVEOS®
timeFrame: 24 months
measure: Specific IgE assessed by Thermo-Fisher ImmunoCAP®
timeFrame: 24 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
state: Occitanie
Study officials:
affiliation: University Hospital, Montpellier
name: Pascal DEMOLY, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: