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

NCT03599908 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2018-07-26

No results posted yet for this study

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

Sponsors & Collaborators

  • Abionic SA

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Principal Investigators

  • Francois Spertini, MD · Centre Hospitalier Universitaire Vaudois

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-11-14
Completion
2016-12-21

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03599908 on ClinicalTrials.gov