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

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

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).

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.