Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation
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|ClinicalTrials.gov Identifier: NCT04401631|
Recruitment Status : Withdrawn (Sponsor financial has been stopped)
First Posted : May 26, 2020
Last Update Posted : October 5, 2020
|Condition or disease||Intervention/treatment|
|Allergy Allergic Asthma Allergy to Cats Allergy to House Dust Allergy to Dog Dander (Finding) Allergy Mold Allergy Cockroach||Device: Blood Collection|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation|
|Estimated Study Start Date :||November 2020|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||December 2020|
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)
- POC variance components (in a POL environment): [ Time Frame: 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: [ Time Frame: 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 [ Time Frame: 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).
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401631
|United States, District of Columbia|
|George Washington University, Washington DC|
|Washington, District of Columbia, United States, 20037|
|United States, Maryland|
|Johns Hopkins University, Baltimore|
|Baltimore, Maryland, United States, 21215|
|United States, Ohio|
|The Bernstein Clinical Research Center Cincinnati|
|Cincinnati, Ohio, United States, 45231|