Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population
Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population
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.
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.