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Trials / Withdrawn

WithdrawnNCT04401631

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

Status
Withdrawn
Phase
—
Study type
Observational
Enrollment
0 (actual)
Sponsor
Abionic SA · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
DEVICEBlood CollectionBetween-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)

Timeline

Start date
2020-11-01
Primary completion
2020-11-01
Completion
2020-12-01
First posted
2020-05-26
Last updated
2020-10-05

Locations

3 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04401631. Inclusion in this directory is not an endorsement.