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.

NCT05627076 | Completed

• 1 other identifier: AB-PSP-006
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Sepsis Bacterial

Keywords

Abionic; Pancreatic Stone Protein; Point-of-care device; Immunoassay; IVD

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Blood Sampling DEVICE

Blood samples will be collected for the PSP measurement using the abioSCOPE.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted at the hospital

You may qualify if:

• 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;
• Male or female, 18 years of age or older;
• Patient admitted to hospital
• Need for venous and arterial blood samples as part of standard of care
• Covered by a social security scheme.

You may not qualify if:

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

Sponsors & Collaborators

• Abionic SA: lead

Study Sites (1)

CHU Limoges, Réanimation Polyvalente

Limoges, 87042, France

Location

MeSH Terms

Conditions

Sepsis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 25, 2022
• Study Start: August 29, 2022
• Primary Completion: October 11, 2022
• Study Completion: October 31, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)