Healthy, Sepsis, Septic Shock
Conditions
Keywords
Sepsis, Pancreatic Stone Protein, Immunoassay, Abionic, Healthy population, Point-of-care device
Brief summary
This is a single center, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on generally healthy adults representative of the US population.
Interventions
DEVICEBlood collection
9 mL K3-EDTA anticoagulated venous whole blood and 9 mL lithium heparin anticoagulated venous whole blood will be collected, processed in plasma and stored until the shipment to the sponsor for PSP measurement on the abioSCOPE device with IVD CAPSULE PSP kits
Sponsors
Boston Biomedical Associates
Ocean State Clinical Coordinating Center
Abionic SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. Male or female, aged ≥ 18 years. 2. Apparently healthy as determined by a subject questionnaire.
Exclusion criteria
1\) Current diagnosis, or history, of any underlying major medical condition determined by the investigator, including but not limited to: 1. Heart disease 2. Stroke 3. Renal disease 4. Liver disease 5. Pancreatic disease 6. Chronic obstructive pulmonary disorder 7. Bleeding disorders 8. Hypercalcitoninemia 9. HIV AIDS 10. Receiving antibiotic therapy 11. Suspected infection 12. Immunosuppression 2\) Underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months. 3\) Current diagnosis of uncontrolled hypertension, hypotension, or diabetes. 4\) Diagnosis of bacterial, fungal, or malaria infection within the last 3 months that required antimicrobial treatment. 5 )Experienced severe trauma, surgery, cardiac shock, or severe burn within the previous 3 months requiring medical care. 6\) Current diagnosis of cancer within the last 12 months. 7\) Received immunotherapy to stimulate or inhibit cytokines within the last 12 months. 8\) Hospitalization for more than 24 hours within the last 3 months. 9\) Reported as currently pregnant or nursing a child 10\) Unable or unwilling to provide the required blood sample for testing. 11\) Any other criteria that, in the opinion of the investigator, would render the participant unsuitable for inclusion in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of reference range interval of PSP | Day 1 | To determine the reference range intervals of PSP values measured using abioSCOPE device with the PSP assay in a generally healthy population representative of the US population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collect medical data of healthy volunteer | Day 1 | To collect medical data from the 150 study participants using a volunteer questionnaire |
| Obtain well characterised samples library to be used for future tests development | Day 1 | Whole blood collection from 150 healthy subject to be used for future tests development. |
Countries
United States
Outcome results
None listed