Evaluation and Validation of Novel Diagnostic Tool for Allergists (AbioSCOPE)

Vaud University Hospital Center

Status: Completed

Conditions: Asthma; Allergic Rhinitis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03599908

309/12

Details and patient eligibility

About

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® .

Enrollment: 105 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.