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.

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05627076
• Other study ID #: AB-PSP-006
• Status: Completed
• Start date: August 29, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: Abionic SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 31, 2022
• Est. primary completion date: October 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Sepsis Bacterial
• Toxemia

Intervention

Device:
• Blood Sampling
Blood samples will be collected for the PSP measurement using the abioSCOPE.

Locations

Country	Name	City	State
France	CHU Limoges, Réanimation Polyvalente	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
Abionic SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary assessment	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.	through study completion, an average of 1.5 months