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

Sponsor

Centre Hospitalier Universitaire Vaudois (Other)

Overall Status

Completed

CT.gov ID

NCT03599908

Collaborator

Abionic SA (Industry)

105

Enrollment

47.6

Actual Duration (Months)

Study Details

Study Description

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® .

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis Asthma

Study Design

Study Type:

Observational

Actual Enrollment :

105 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Evaluation and Validation of Novel Diagnostic Tool for Allergists (AbioSCOPE) in Volunteer Population With Respiratory Allergies

Actual Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Nov 14, 2016

Actual Study Completion Date :

Dec 21, 2016

Outcome Measures

Primary Outcome Measures

Diagnostic agreement between AbioSCOPE and Phadia Laboratory System [12 months]
Comparison of the diagnostic agreement obtain went clinical samples are measured with AbioSCOPE or with Phadia Laboratory System

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.