Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation

Abionic

Status: Withdrawn

Conditions: Allergy Cockroach; Allergy Mold; Allergy to Dog Dander (Finding); Allergy to House Dust; Allergic Asthma; Allergy; Allergy to Cats

Treatments: Device: Blood Collection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04401631

AB-ALL-3.1

Details and patient eligibility

About

This is a multicenter, prospective, observational study to evaluate the analytical performance of the Abionic IgE Multi-Allergen Test Panel on the abioSCOPE® device in a U.S. point-of-care environment within a clinical laboratory operating under a CLIA certificate for tests of moderate complexity. The study will assess point-of-care ('external') precision, sample type comparison and correlation with a reference method (Phadia Laboratory System, ThermoFisher Scientific).

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision and understanding of signed and dated written informed consent by the subject prior to any mandatory study-specific procedures, sample collection, or analysis.
• Male or female, 18 years of age or older.

Exclusion criteria

• Subject participating in another study that may influence test results.
• Subject taking any of the following medications: 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.
• History of cancer, autoimmune, or immune deficiency disease.
• Suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure.

Trial design

0 participants in 1 patient group

Interventions

Description:

* A minimum of 20 subjects with targeted levels of total IgE are needed to participate in the Operator-to-Operator whole blood study. * A minimum of 20 subjects with targeted levels of allergen-specific and total IgE are needed to participate in the capillary whole blood between-run imprecision study in the POL environment. * A minimum of 40 subjects with targeted levels of Fel d 1-specific IgE and total IgE are needed to participate in the sample type comparison study. These subjects will be recruited, and their samples analyzed at 1 POL. * A minimum of 300 subjects (approximately 100 subjects enrolled and evaluated at each of three sites) and with targeted levels of total IgE are needed to participate in the method comparison study.

Treatment:

Device: Blood Collection