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

NCT04797117 | Completed

• 1 other identifier: 87RI21_0003 (AB-PSP-005)
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis

Keywords

In Vitro Diagnostic Device; Sepsis

Outcome Measures

Primary Outcomes (3)

• Precision variance components

  coefficient of variation, expressed in percent, for the different variance components, are determined

  Day 1

• 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

• 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

Study Arms (1)

blood sample

OTHER

The blood samples for the study for each patient will be collected in the form of additional tubes.

Diagnostic Test: blood sample

Interventions

blood sample DIAGNOSTIC_TEST

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.

blood sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;
• Hospitalized patient;
• 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

• University Hospital, Limoges: lead
• Abionic SA: collaborator

Study Sites (1)

CHU de Limoges

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: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: April 29, 2021
• Primary Completion: November 26, 2021
• Study Completion: November 26, 2021
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)