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abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04442932
Recruitment Status : Withdrawn (Sponsor financial has been stopped.)
First Posted : June 23, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborators:
NAMSA
Johns Hopkins University
Information provided by (Responsible Party):
Abionic SA

Brief Summary:
This is a multicenter, prospective, observational study designed to determine the clinical sensitivity and specificity of the Abionic IVD CAPSULE Allergic Asthma panel performed on Abionic's abioSCOPE device using K3-EDTA anticoagulated plasma samples from atopic and non-atopic pediatric and adult patients. Patients' sensitization determined with the abioSCOPE will be compared to the clinical assessment of allergy.

Condition or disease Intervention/treatment
Allergy Allergic Asthma Allergy to Cats Allergy to House Dust Allergy to Dog Dander Allergy Cockroach Device: Blood Collection

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the abioSCOPE Device With an IgE Test Panel: Clinical Sensitivity and Specificity Study
Estimated Study Start Date : November 15, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
Interventions
Per test, a minimum of 40 atopic subjects for a given allergy and a total of at least 100 non-atopic subjects. To ensure that sufficient subjects with valid results are enrolled, the atopic enrollment goal per allergy is approximately 50 subjects. For each allergen, approximately 20% of the samples must be in the range of 0.70 to 3.5 IUA/mL and the remainder must cover a measuring range that is representative of the target population. Results from a single positive subject can be used in the analyses of more than one allergen if the subject is sensitized for more than one allergen.
Device: Blood Collection
K3-EDTA venous whole blood 9 mL 1 venous draw




Primary Outcome Measures :
  1. Sensitivity and Specificity of the abioSCOPE [ Time Frame: Day 1 ]
    The primary objective will be evaluated by estimating the Sensitivity and Specificity of the abioSCOPE to detect sensitization to each of the five allergens or group of allergens. The estimates will be accompanied by 95% Clopper-Pearson Confidence Intervals. The acceptance criteria will be compared to the lower bound of the 95% confidence interval. The ability of the abioSCOPE to detect sensitization to each allergen will be considered acceptable if both the sensitivity and specificity of the allergen meet both performance goals.


Other Outcome Measures:
  1. Determination of Positive Predictive Value (PPV), Negative Predictive Value (NPV), Concordance and study prevalence of allergen sensitization. [ Time Frame: Day 1 ]
    Presentation of Positive Predictive Value (PPV), Negative Predictive Value (NPV), Concordance and study prevalence of allergen sensitization based of the classification of 40 subjects for each allergen.



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:   Yes
Sampling Method:   Non-Probability Sample
Study Population
• Per test, a minimum of 40 atopic subjects for a given allergy and a total of at least 100 non-atopic subjects (). To ensure that sufficient subjects with valid results are enrolled, the atopic enrollment goal per allergy is approximately 50 subjects. For each allergen, approximately 20% of the samples must be in the range of 0.70 to 3.5 IUA/mL and the remainder must cover a measuring range that is representative of the target population. Results from a single positive subject can be used in the analyses of more than one allergen if the subject is sensitized for more than one allergen.
Criteria

Inclusion Criteria:

Atopic and non-atopic individuals are needed for this study. For enrollment in the atopic arm, patients must meet all of the inclusion criteria listed below to be eligible for participation:

  1. Provide signed and dated written informed consent by patient or legally designated representative prior to any mandatory study-specific procedures, sample collection, or analysis. Assent will be obtained from pediatric patients who are ≥ 6 years of age and less than 18 years of age.
  2. Male or female, ≥ 6 years of age.
  3. Consulting for signs and/or symptoms of IgE-mediated allergies to perennial allergens.

For enrollment in the non-atopic arm, patients must meet all of the inclusion criteria list below to be eligible for participation:

  1. Provide signed and dated written informed consent by patient or legally designated representative prior to any mandatory study-specific procedures, sample collection, or analysis. Assent will be obtained from pediatric patients who are ≥ 6 years of age and less than 18 years of age.
  2. Male or female, ≥ 6 years of age.
  3. Apparently healthy individuals who exhibit no signs/symptoms of IgE-mediated allergies including rhinitis, conjunctivitis, asthma, eczema, urticaria or food allergy symptoms upon exposure to animal danders, dust mites, cockroaches, pollens or food allergens (non-atopic).

Exclusion Criteria:

Patients must not meet any exclusion criteria below to be eligible for participation:

  1. Patient participating in another study that may influence test results.
  2. 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), anti-IgE therapy (approved or investigational) or treated with systemic chemotherapy.
  3. On-going allergen immunotherapy or prior allergen immunotherapy within the prior 3 years.
  4. Patient with a history of cancer, autoimmune, or immune deficiency disease.
  5. Patient suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood test.
  6. Known severe allergic reaction to any of the IVD CAPSULE Allergic Asthma panel allergen components

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): NCT04442932


Locations
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United States, District of Columbia
George Washington University, Washington DC
Washington, District of Columbia, United States, 20037
United States, Maryland
Johns Hopkins University, Baltimore
Baltimore, Maryland, United States, 21215
Johns Hopkins
Baltimore, Maryland, United States, 21287
Creticos Research Group, LLC
Crownsville, Maryland, United States, 20132
United States, Ohio
The Bernstein Clinical Research Center Cincinnati
Cincinnati, Ohio, United States, 45231
Sponsors and Collaborators
Abionic SA
NAMSA
Johns Hopkins University
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Responsible Party: Abionic SA
ClinicalTrials.gov Identifier: NCT04442932    
Other Study ID Numbers: AB-ALL-003.2
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Abionic SA:
Allergy
Asthma
Point-of-Care
Immunoassay
In vitro Diagnostic
Total IgE
Specific allergy
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases