abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies

NCT04442932 | Withdrawn FDA Device

• 1 other identifier: AB-ALL-003.2
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 5

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.

Conditions

Allergy; Allergic Asthma; Allergy to Cats; Allergy to House Dust; Allergy to Dog Dander; Allergy Cockroach

Keywords

Allergy; Asthma; Point-of-Care; Immunoassay; In vitro Diagnostic; Total IgE; Specific allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determination of Positive Predictive Value (PPV), Negative Predictive Value (NPV), Concordance and study prevalence of allergen sensitization.

  Day 1

Study Arms (1)

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

Interventions

Blood Collection DEVICE

K3-EDTA venous whole blood 9 mL 1 venous draw

Interventions

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Male or female, ≥ 6 years of age.
• Consulting for signs and/or symptoms of IgE-mediated allergies to perennial allergens.
• 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.
• Male or female, ≥ 6 years of age.
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Abionic SA: lead
• NAMSA: collaborator
• Johns Hopkins University: collaborator

Study Sites (5)

George Washington University, Washington DC

Washington D.C., District of Columbia, 20037, United States

Location

Johns Hopkins University, Baltimore

Baltimore, Maryland, 21215, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Creticos Research Group, LLC

Crownsville, Maryland, 20132, United States

Location

The Bernstein Clinical Research Center Cincinnati

Cincinnati, Ohio, 45231, United States

Location

MeSH Terms

Conditions

Hypersensitivity; Asthma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 23, 2020
• Study Start: November 15, 2020
• Primary Completion: December 31, 2020
• Study Completion: March 15, 2021
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

US (5)