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

Inclusion criteria

• Male or female, aged ≥ 18 years.
• Apparently healthy as determined by a subject questionnaire.

Exclusion criteria

• Current diagnosis, or history, of any underlying major medical condition determined by the investigator, including but not limited to:

• Heart disease
• Stroke
• Renal disease
• Liver disease
• Pancreatic disease
• Chronic obstructive pulmonary disorder
• Bleeding disorders
• Hypercalcitoninemia
• HIV AIDS
• Receiving antibiotic therapy
• Suspected infection
• Immunosuppression

• Underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months.

• Current diagnosis of uncontrolled hypertension, hypotension, or diabetes.

• 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.

• Current diagnosis of cancer within the last 12 months.

• Received immunotherapy to stimulate or inhibit cytokines within the last 12 months.

• Hospitalization for more than 24 hours within the last 3 months.

• Reported as currently pregnant or nursing a child

• Unable or unwilling to provide the required blood sample for testing.

• Any other criteria that, in the opinion of the investigator, would render the participant unsuitable for inclusion in the trial.