Analytical Validation of the abioSCOPE Device With a PSP Test: Point-of-Care Precision, Sample Type Comparison and Sample Stability

Sepsis Clinical Trial

— AB-PSP-005  

Official title:

Analytical Validation of the abioSCOPE Device With a PSP Test: Point-of-Care Precision, Sample Type Comparison and Sample Stability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04797117
• Other study ID #: 87RI21_0003 (AB-PSP-005)
• Status: Completed
• Phase: N/A
• Start date: April 29, 2021
• Est. completion date: November 26, 2021

Study information

• Verified date: September 2022
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Abionic SA has developed a novel point-of-care (POC) platform, the abioSCOPE, and an in vitro diagnostic kit for the quantification of the pancreatic stone protein (PSP) to be analyzed specifically with the abioSCOPE® device. This test is intended to be used to aid in the early recognition of sepsis. The test is extremely easy to use and has a total turnaround time of approximately 8 minutes. This test uses only 30 microliters of K2/K3-EDTA anticoagulated whole blood or plasma. Results are quantitative (ng/ml). The product is for Investigational Use Only in the US and bears CE-marking. It is commercially available in selected European and non-European countries. The test has also been clinically validated in a multicentric, prospective, observational study performed (AB-PSP-001, clinicaltrials.gov identifier NCT03474809).

The main goals of this study are to evaluate certain analytical performances components of this product in a point-of-care environment, in particular the precision, sample type comparability and specimen stability of the product. Such data will support regulatory filing of a US FDA 510(k) premarket notification file and of a European IVD Regulation technical file to continue product commercialization in 2022, when this novel regulation will be effective.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 26, 2021
• Est. primary completion date: November 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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;

• Hospitalized patient;

• Covered by a social security scheme.

Exclusion Criteria:

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

• Subject under juridical protection.

Related Conditions & MeSH terms

• Sepsis

Intervention

Diagnostic Test:
• blood sample
The blood samples for the study for each patient will be collected in the form of additional tubes. either 1 tube of blood of 4 ml and 2 tubes of blood of 10 ml once a day for 1 or 2 days maximum (or 48 ml maximum) during his hospitalization either 2 tubes of 10 ml or 20 ml maximum once during his hospitalization.

Locations

Country	Name	City	State
France	CHU de Limoges	Limoges

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	Abionic SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Precision variance components	coefficient of variation, expressed in percent, for the different variance components, are determined	Day 1
Primary	Sample type comparison	pairwise comparability of test results when performed with K2-EDTA anticoagulated venous whole blood or K2-EDTA anticoagulated venous plasma, represented as percent recovery of whole blood compared to plasma, as well as scatter plots with Weighted Deming and Passing Bablok Regression, and bias plots.	Day 1
Primary	Sample stability	Scatter plot and bias plot of PSP values versus storage time or freeze and thaw cycles, as well linear least square regression analysis	Day 1