Allergic Asthma, Allergy, Allergy Cockroach, Allergy to Cats, Allergy to Dog Dander, Allergy to House Dust
Conditions
Keywords
Allergy, Asthma, Point-of-Care, Immunoassay, In vitro Diagnostic, Total IgE, Specific allergy
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.
Interventions
DEVICEBlood Collection
K3-EDTA venous whole blood 9 mL 1 venous draw
Sponsors
NAMSA
Johns Hopkins University
Abionic SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity of the abioSCOPE | 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
| Measure | Time frame | Description |
|---|---|---|
| Determination of Positive Predictive Value (PPV), Negative Predictive Value (NPV), Concordance and study prevalence of allergen sensitization. | 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. |
Countries
United States
Outcome results
None listed