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

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04401631
• Other study ID #: AB-ALL-3.1
• Status: Withdrawn
• Start date: November 2020
• Est. completion date: December 2020

Study information

• Verified date: October 2020
• Source: Abionic SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 a 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.

Related Conditions & MeSH terms

• Allergic Asthma
• Allergy
• Allergy Cockroach
• Allergy Mold
• Allergy to Cats
• Allergy to Dog Dander (Finding)
• Allergy to House Dust
• Hypersensitivity

Intervention

Device:
• Blood Collection
Between-Run Reproducibility K3-EDTA venous whole blood 3 mL 1 venous draw Operator-to-operator imprecision (abioSCOPE) K3-EDTA capillary whole blood 0.05 mL/draw; 0.15 mL total 3 finger sticks (3 different fingers) Sample type comparison (abioSCOPE) K3-EDTA capillary whole blood, venous serum, venous K3-EDTA plasma 0.35 mL (finger stick), 9 mL of whole blood to get a minimum of 3 mL of serum and 9 mL of whole blood K3-EDTA to get a minimum of 3 mL of plasma 1 finger stick; 1 venous draw into serum tube (9 mL) and 1 venous draw into K3-EDTA plasma tube (9 mL), in total 18 mL Method comparison (abioSCOPE and ImmunoCAP/Phadia) K3-EDTA capillary whole blood, venous K3-EDTA plasma 0.05 mL (finger stick), 9 mL of whole blood to get a minimum of 3 ml of plasma 1 finger stick; 1 venous draw into K3-EDTA plasma tube (9 mL tube)

Locations

Country	Name	City	State
United States	Johns Hopkins University, Baltimore	Baltimore	Maryland
United States	The Bernstein Clinical Research Center Cincinnati	Cincinnati	Ohio
United States	George Washington University, Washington DC	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Abionic SA	Johns Hopkins University, NAMSA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POC variance components (in a POL environment):	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.	Day 1
Primary	Sample type comparison:	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.	Day 1
Primary	Method comparison	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).	Day 1