Clinical trial NCT04401631: Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation
Official title: Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Allergy
Allergic Asthma
Allergy to Cats
Allergy to House Dust
Allergy to Dog Dander (Finding)
Allergy Mold
Allergy Cockroach
Keywords: Allergy
Asthma
Point-of-Care
Immunoassay
In vitro Diagnostic
Total IgE
Specific allergy
Lead sponsor: Abionic SA
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
name: Johns Hopkins University
First posted: 2020-05-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 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.

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 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).


Eligibility criteria: 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.

Primary outcomes:
measure: POC variance components (in a POL environment):
timeFrame: Day 1
measure: Sample type comparison:
timeFrame: Day 1
measure: Method comparison
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University, Washington DC
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins University, Baltimore
state: Maryland
city: Cincinnati
country: United States
facility: The Bernstein Clinical Research Center Cincinnati
state: Ohio
Study officials:
References: