abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04442932
• Other study ID #: AB-ALL-003.2
• Status: Withdrawn
• Start date: November 15, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: October 2020
• Source: Abionic SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 15, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

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 a 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

Related Conditions & MeSH terms

• Allergic Asthma
• Allergy
• Allergy Cockroach
• Allergy to Cats
• Allergy to Dog Dander
• Allergy to House Dust
• Hypersensitivity

Intervention

Device:
• Blood Collection
K3-EDTA venous whole blood 9 mL 1 venous draw

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland
United States	Johns Hopkins University, Baltimore	Baltimore	Maryland
United States	The Bernstein Clinical Research Center Cincinnati	Cincinnati	Ohio
United States	Creticos Research Group, LLC	Crownsville	Maryland
United States	George Washington University, Washington DC	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Abionic SA	Johns Hopkins University, NAMSA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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