Analytical Validation of the abioSCOPE Device With a PSP Test: Point-of-Care Precision, Sample Type Comparison and Sample Stability
- Conditions
- Sepsis
- Interventions
- Diagnostic Test: blood sample
- Registration Number
- NCT04797117
- Lead Sponsor
- University Hospital, Limoges
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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.
- Subject suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure;
- Subject under juridical protection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description blood sample blood sample The blood samples for the study for each patient will be collected in the form of additional tubes.
- Primary Outcome Measures
Name Time Method Precision variance components Day 1 coefficient of variation, expressed in percent, for the different variance components, are determined
Sample type comparison Day 1 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.
Sample stability Day 1 Scatter plot and bias plot of PSP values versus storage time or freeze and thaw cycles, as well linear least square regression analysis
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHU de Limoges
🇫🇷Limoges, France