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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05627076

Enrollment

Registered

2022-11-25

Start date

2022-08-29

Completion date

2022-10-31

Last updated

2022-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Sepsis Bacterial

Keywords

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

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.

Interventions

DEVICEBlood Sampling

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026