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

NCT03599908 | Completed

• 1 other identifier: 309/12
• Study Type: observational
• Target: 105
• Locations: 0 countries
• Sites: N/A

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® .

Conditions

Allergic Rhinitis; Asthma

Keywords

IgE; skin prick tests; diagnosis; rhinitis; asthma; allergy; laboratory

Outcome Measures

Primary Outcomes (1)

• Diagnostic agreement between AbioSCOPE and Phadia Laboratory System

  Comparison of the diagnostic agreement obtain went clinical samples are measured with AbioSCOPE or with Phadia Laboratory System

  12 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with history of allergic rhinitis and asthma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead
• Abionic SA: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood collection prepared to obtain serum

MeSH Terms

Conditions

Rhinitis, Allergic; Asthma; Disease; Rhinitis; Hypersensitivity

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections

Study Officials

• Francois Spertini, MD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/Doctor

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: January 1, 2013
• Primary Completion: November 14, 2016
• Study Completion: December 21, 2016
• Last Updated: July 26, 2018

Record last verified: 2018-07