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

Abionic

Status: Completed

Conditions: Healthy; Septic Shock; Sepsis

Treatments: Device: Blood collection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04409561

AB-PSP-003

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

Interventions

Description:

This patient pool shall be representative of the US population in term of the relative proportion of race/ethnicities. In addition, the population shall be enriched with patients above 60 year old as the target population of the PSP test is mostly the elderly.

Treatment:

Device: Blood collection