Status:
WITHDRAWN
Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation
Lead Sponsor:
Abionic SA
Collaborating Sponsors:
NAMSA
Johns Hopkins University
Conditions:
Allergy
Allergic Asthma
Eligibility:
All Genders
18+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04401631
Start Date
November 1 2020
End Date
December 1 2020
Last Update
October 5 2020
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
George Washington University, Washington DC
Washington D.C., District of Columbia, United States, 20037
2
Johns Hopkins University, Baltimore
Baltimore, Maryland, United States, 21215
3
The Bernstein Clinical Research Center Cincinnati
Cincinnati, Ohio, United States, 45231