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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sepsis

Intervention / Treatment
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* Diagnostic Test: blood sample


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: blood sample<br>The blood samples for the study for each patient will be collected in the form of additional tubes. | Diagnostic Test: blood sample<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In Vitro Diagnostic Device, Sepsis