Clinical trial NCT03599908: Evaluation and Validation of Novel Diagnostic Tool for Allergists (AbioSCOPE)
Official title: Evaluation and Validation of Novel Diagnostic Tool for Allergists (AbioSCOPE) in Volunteer Population With Respiratory Allergies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Asthma
Keywords: IgE
skin prick tests
diagnosis
rhinitis
asthma
allergy
laboratory
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: Abionic SA
First posted: 2018-07-26
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with history of allergic rhinitis and asthma

Brief summary: In this study, investigators evaluated for the first time the diagnostic efficacy of abioSCOPE® versus Phadia Laboratory System as an aid in the diagnosis of allergic diseases. Investigators targetted the agreement between test results obtained in abioSCOPE® and a laboratory reference method (Phadia Laboratory System, ThermoFisher Scientific, Uppsala, Sweden), considered as a quasi-gold standard in IgE (immunoglobulin E) antibody assays. Investigators also reported the medical decision taken by a panel of allergy experts who had access to patient history, skin tests and IgE antibody assay, but blinded to the method used, i,e, the reference method or the abioSCOPE® .


Eligibility criteria: Inclusion Criteria:

* Subjects examined at ambulatory medicine medicine center CHUV / PMU and for wich serum sample is required for the research of specific IgE (allergic patients, allergic group) or for any other reason (immunological) (non-allergic control patients, control group)
* Subjects for which it is expected (allergic group subjects) or who will be asked (non-allergic control group) to perform a panel of standard prick tests as basic allergological investigation, including pollen birch, grasses, mites (D pter, D far), cat dander.
* Obtain informed consent from each subject before any study procedure.

Exclusion Criteria:

* Presence of positive HIV-1 viremia by the ultra-sensitive method in the 12 months preceding the study.
* Use of any investigational or non-registered product (drug or vaccine)
* Chronic administration (more than 14 days) of immunosuppressive or immunomodulatory drugs in the 6 months preceding the study for corticosteroids. This means a dose of Prednisone or equivalent substance greater than or equal to 0.5 mg per kg / day. Inhaled topical steroids are allowed.
* Administration of any immunoglobulin, any immunotherapy or administration of some blood products in the 3 months preceding the study, or planned during the study period.
* Any health condition or patient history, in the opinion of the investigator, could interfere with the evaluation of the study's objectives.
* Participation in another experimental protocol during the period of the study.
* Demonstration, confirmation or suspicion of a condition of immunosuppression or immunodeficiency (including HIV infection) based on medical history and physical examination (no laboratory test).
* A family history of congenital or hereditary immunodeficiency.
* Subjects taking any of the following medications: antihistamines in the week preceding the consultation, systemic steroids (inhaled or nasal steroids are allowed), anti-cytokines or cytokines, systemic interferon (injection local interferon α for the treatment of HPV is allowed) or treated with systemic chemotherapy.

Primary outcomes:
measure: Diagnostic agreement between AbioSCOPE and Phadia Laboratory System
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Francois Spertini, MD
role: PRINCIPAL_INVESTIGATOR
References: