abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies

Validation of the abioSCOPE Device With an IgE Test Panel: Clinical Sensitivity and Specificity Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Allergy; Allergic Asthma; Allergy to Cats; Allergy to House Dust; Allergy to Dog Dander; Allergy Cockroach
• Intervention / Treatment: Device: Blood Collection

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University, Washington DC
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins
    • Baltimore, Maryland, United States, 21215
      • Johns Hopkins University, Baltimore
    • Crownsville, Maryland, United States, 20132
      • Creticos Research Group, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • The Bernstein Clinical Research Center Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity of the abioSCOPE	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.	Day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of Positive Predictive Value (PPV), Negative Predictive Value (NPV), Concordance and study prevalence of allergen sensitization.	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.	Day 1

Collaborators and Investigators

• Sponsor: Abionic SA
• Collaborators: Johns Hopkins University; NAMSA

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): March 15, 2021

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Asthma; Allergy; Immunoassay; Point-of-Care; In vitro Diagnostic; Total IgE; Specific allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: AB-ALL-003.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No