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

WithdrawnOBSERVATIONAL
0
Timeline

Start Date

November 30, 2020

Primary Completion Date

November 30, 2020

Study Completion Date

December 31, 2020

Conditions
AllergyAllergic AsthmaAllergy to CatsAllergy to House DustAllergy to Dog Dander (Finding)Allergy MoldAllergy Cockroach
Interventions
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)"

Trial Locations (3)

20037

George Washington University, Washington DC, Washington D.C.

21215

Johns Hopkins University, Baltimore, Baltimore

45231

The Bernstein Clinical Research Center Cincinnati, Cincinnati

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

NAMSA

OTHER

collaborator

Johns Hopkins University

OTHER

lead

Abionic SA

INDUSTRY