Sepsis
Conditions
Keywords
In Vitro Diagnostic Device, Sepsis
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.
Interventions
DIAGNOSTIC_TESTblood 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.
Sponsors
Abionic SA
University Hospital, Limoges
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed