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.

Completed

• Conditions: Sepsis; Sepsis Bacterial

• Registration Number: NCT05627076
• Lead Sponsor: Abionic SA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-29
• Primary Completion: 2022-10-11
• Study Completion: 2022-10-31
• Status Verified: 2022-11
• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-11-21
• Last Update Submitted: 2022-11-21
• Study First Posted: 2022-11-25
• Last Update Posted: 2022-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Provide signed and dated written informed consent by patient or close / family / trusted person prior to any mandatory study-specific procedures, sample collection, or analysis;
2. Male or female, 18 years of age or older;
3. Patient admitted to hospital
4. Need for venous and arterial blood samples as part of standard of care
5. Covered by a social security scheme.

Exclusion Criteria

1. Subject suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure;
2. Subject under juridical protection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary assessment	through study completion, an average of 1.5 months	Pairwise comparability of test results when performed with K2-EDTA anticoagulated venous whole blood or K2-EDTA anticoagulated arterial whole blood, represented as percent recovery of arterial whole blood compared to venous whole blood, as well as scatter plots with Weighted Deming and Passing Bablok Regression, and bias plots.

Trial Locations

Locations (1)

CHU Limoges, Réanimation Polyvalente; 🇫🇷 Limoges, France