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Validation Study of NOVEOS® System (HYCOR) (HYCOR)

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ClinicalTrials.gov Identifier: NCT03969862
Recruitment Status : Not yet recruiting
First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
HYCOR Biomedical LLC
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Background : The NOVEOS® method is a chemiluminescent immunoassay used to provide quantitative detection of total IgE and allergen-specific IgE antibodies in human serum.

The IgE antibody assay has an essential place in the diagnosis of mediated IgE allergies.

This system could become an alternative to the techniques used today. NOVEOS® uses a quick and convenient method to give results concerning the patient's sensitization profile towards allergens. The volume required for the assays is 4 μl (against more than 100 μl for current techniques), which is particularly important in pediatric and geriatric populations where it may be more difficult to take larger samples.

NOVEOS® also brings true autonomy. In fact, the incorporated reagents provide sufficient capacity for 8 hours of continuous testing.

Objective: Validate the NOVEOS® system as an allergy diagnostic tool, by estimating the sensitivity and specificity of the NOVEOS® assays compared to the gold standard diagnostic represented by the clinical history and PT positive, for a panel of 20 allergens

Methods: This is a validation study of a new immunoassay method (Système NOVEOS®).

The study includes :

  • A preliminary phase to familiarize the team with the use of the NOVEOS® system. It is planned to analyze its technical characteristics: the precision, the sensitivity. Eight allergens will be tested, on a cohort of 136 patients
  • A validation study of the technique as a diagnostic tool for allergy (sensitivity and specificity compared to the gold standard represented by clinical history and positive PT) and comparison between the new technique and the ImmunoCap® system. Twenty allergens will be tested prospectively, each on 50 cases and 10 controls. A single patient may be both a case for an allergen and a witness for another. For rare allergies, the blood database of the Allergy Service will be used, and affected patients will be contacted to request their non-opposition.

Condition or disease Intervention/treatment
Allergen-mediated IgE Allergy Device: NOVEOS® system

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Study Type : Observational
Estimated Enrollment : 536 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Validation Study of Noveos® System as a Diagnostic Tools for Allergy
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
Patient with an allergen-mediated IgE allergy
Patients with a clinical history consistent with an allergen-mediated IgE allergy & with a sensitization demonstrated by a positive Prick-Test for the allergen source tested
Device: NOVEOS® system

The NOVEOS® System is a fully automated, high-throughput immunoassay platform that uses magnetic microbeads as a solid phase.

This is a partially closed system that is primarily intended for the determination of specific IgE with NOVEOS® Hycor allergens. It has the CE mark.


Patient without an allergen-mediated IgE allergy
Patient without a clinical history compatible with an IgE allergy-mediated allergy and without PT sensitization to be allergen
Device: NOVEOS® system

The NOVEOS® System is a fully automated, high-throughput immunoassay platform that uses magnetic microbeads as a solid phase.

This is a partially closed system that is primarily intended for the determination of specific IgE with NOVEOS® Hycor allergens. It has the CE mark.





Primary Outcome Measures :
  1. Sensitivity and specificity of the NOVEOS® assay compared to the gold standard diagnosis. [ Time Frame: 24 months ]
    In order to validate the NOVEOS® system as an allergy diagnostic tool, We have to estimate the sensitivity and specificity of the NOVEOS® assays compared to the gold standard diagnostic represented by the clinical history and Prick Test positive, for a panel of 20 allergens.


Secondary Outcome Measures :
  1. Specific IgE assessed by NOVEOS® and by the Thermo-Fisher ImmunoCAP® [ Time Frame: 24 months ]

    The serum-specific IgE assay is an in vitro assay of IgE antibodies that are able to bind specifically to their allergen.

    Today, there are techniques that allow the assay of both the IgE reactivity against sources of allergens, but also against the different allergenic components. There are already commercially available, validated and standardized methods; the most used is the Thermo-Fisher ImmunoCAP® (capable of detecting specific IgE amounts> 0.1 kUA / L).

    The results of the NOVEOS® method will be considered acceptable according to the following criteria:

    • Total agreement ratio of sample recovery ≥ 0.8
    • Linear Regression / Correlation between the 2 techniques, R ≥ 0.8



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient consulting in our allergy unit for a suspicion of allergy (respiratory, food, drug, hymenoptera venoms)
Criteria

IncInclusion criteria:

  • Patient who is at least 6 years old
  • The patient must be an affiliate or beneficiary of a health insurance plan

Exclusion criteria:

  • Patient refusing to take part in the study
  • Patient participated in another study that may influence test results
  • The patient is in an exclusion period determined by a previous study
  • The patient is under the protection of justice, under guardianship or under curatorship
  • Patient under antihistaminic H1 treatment preventing the achievement of Prick-tests
  • The patient is pregnant
  • The patient is breastfeeding
  • The patient has a history of tumor, autoimmune, or immune deficiency pathology
  • The patient suffers from a hematological pathology (coagulation disorders, anemia) that could interfere with the blood test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03969862


Contacts
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Contact: Davide P CAIMMI, MD,PHD (0) 467 336 107 ext +33 davide.caimmi@gmail.com
Contact: Anca M CHIRIAC, MD,PHD (0) 467 336 107 ext +33 ancamirelachiriac@gmail.com

Locations
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France
University Hospital of Montpellier Not yet recruiting
Montpellier, Occitanie, France, 34295
Contact: Davide P CAIMMI, MD,PHD    (0) 467 336 107 ext +33    davide.caimmi@gmail.com   
Contact: Anca M CHIRIAC, MD,PHD    (0) 467 336 107 ext +33    ancamirelachiriac@gmail.com   
Sponsors and Collaborators
University Hospital, Montpellier
HYCOR Biomedical LLC
Investigators
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Principal Investigator: Pascal DEMOLY, MD,PHD University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03969862     History of Changes
Other Study ID Numbers: 7572
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
Allergy diagnostic tool
Specific IgE assays
Allergens

Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases