Clinical trial NCT04442932: abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies
Official title: Validation of the abioSCOPE Device With an IgE Test Panel: Clinical Sensitivity and Specificity Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
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
Lead sponsor: Abionic SA
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
name: Johns Hopkins University
First posted: 2020-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Sensitivity and Specificity of the abioSCOPE
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
measure: Determination of Positive Predictive Value (PPV), Negative Predictive Value (NPV), Concordance and study prevalence of allergen sensitization.
timeFrame: Day 1
Locations:
city: Washington
country: United States
facility: George Washington University, Washington DC
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins University, Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Crownsville
country: United States
facility: Creticos Research Group, LLC
state: Maryland
city: Cincinnati
country: United States
facility: The Bernstein Clinical Research Center Cincinnati
state: Ohio
Study officials:
References: