Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation
Withdrawn before enrolling
Conditions studied: Allergy, Allergic Asthma, Allergy to Cats, Allergy to House Dust, Allergy to Dog Dander (Finding), Allergy Mold, Allergy Cockroach
In brief
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).
Key facts
- Study ID
- NCT04401631
- Run by
- Abionic SA
- People needed
- 0
- Starts
- 2020-11-01
- Expected to finish
- 2020-12-01
- Last updated by the study team
- 2020-10-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- George Washington University, Washington DC — Washington D.C., District of Columbia, United States
- Johns Hopkins University, Baltimore — Baltimore, Maryland, United States
- The Bernstein Clinical Research Center Cincinnati — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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