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

Launched by ABIONIC SA · May 27, 2020

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• 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.