NCT04409561

Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population

A Study to Establish a Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Abionic SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This is a single center, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on generally healthy adults representative of the US population.

Conditions

• Sepsis
• Septic Shock
• Healthy

Interventions

Type	Name	Description
DEVICE	Blood collection	9 mL K3-EDTA anticoagulated venous whole blood and 9 mL lithium heparin anticoagulated venous whole blood will be collected, processed in plasma and stored until the shipment to the sponsor for PSP measurement on the abioSCOPE device with IVD CAPSULE PSP kits

Timeline

• Start date: 2021-11-15
• Primary completion: 2021-11-15
• Completion: 2022-01-15
• First posted: 2020-06-01
• Last updated: 2022-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study