NCT05627076

Analytical Validation of the abioSCOPE Device With the IVD CAPSULE PSP Test: Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.

Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: Abionic SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Abionic has developed a targeted, rapid test for pancreatic stone protein (PSP) in human K2-EDTA venous whole blood using the abioSCOPE instrument. Currently no PSP study comparaison has been done between venous and arterial whole blood. Abionic would like to confirm the equivalence of the PSP between venous whole blood and arterial whole blood.

Conditions

• Sepsis
• Sepsis Bacterial

Interventions

Type	Name	Description
DEVICE	Blood Sampling	Blood samples will be collected for the PSP measurement using the abioSCOPE.

Timeline

• Start date: 2022-08-29
• Primary completion: 2022-10-11
• Completion: 2022-10-31
• First posted: 2022-11-25
• Last updated: 2022-11-25

Locations

1 site across 1 country: France