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

Withdrawn

• Conditions: Allergy to Cats; Allergy to House Dust; Allergy to Dog Dander (Finding); Allergy Mold; Allergy; Allergic Asthma; Allergy Cockroach
• Interventions: Device: Blood Collection

• Registration Number: NCT04401631
• Lead Sponsor: Abionic SA

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-26
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-01
• Last Update Posted: 2020-10-05
• Study Start: 2020-11
• Primary Completion: 2020-11
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Interventions	Blood Collection	* 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.

Primary Outcome Measures

Name	Time	Method
POC variance components (in a POL environment):	Day 1	* External Precision Study ('reproducibility study' 'site-to-site precision study'): Demonstrate that the imprecision of K3-EDTA venous plasma using the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device (all 5 allergens/allergen mixes and total IgE) in the hands of trained Healthcare Professionals in a Physician Office Laboratory (POL) is within the expected range of the imprecision established in the clinical laboratory by Laboratory Scientists.; * Operator-to-Operator imprecision on whole blood: Demonstrate that the between-Operator reproducibility of the total IgE of the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device test results is within the expected range of variability.; * Between-run reproducibility: Demonstrate that the between-run reproducibility of venous whole blood samples measured with the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device (all 5 allergens/allergen mixes and total IgE) is within the expected range of variability.
Sample type comparison:	Day 1	Demonstrate that the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device test results obtained from capillary whole blood correlates well with values obtained from K3-EDTA anticoagulated venous plasma and serum samples.
Method comparison	Day 1	Demonstrate that test results obtained with the total IgE test of the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device correlates with total IgE test results from the reference method (Phadia Laboratory System, ThermoFisher Scientific).

Trial Locations

Locations (3)

George Washington University, Washington DC; 🇺🇸 Washington, District of Columbia, United States

The Bernstein Clinical Research Center Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Johns Hopkins University, Baltimore; 🇺🇸 Baltimore, Maryland, United States