abioSCOPE PSP Reference Range Study; Extension of AB-PSP-003 (AB-PSP-007)

Abionic

Status: Completed

Conditions: Sepsis

Treatments: Diagnostic Test: abioSCOPE

Study type: Observational

Funder types: Industry

Identifiers

NCT05849935

AB-PSP-007

Details and patient eligibility

About

This is a monocentric, 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: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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. Renal disease
   2. Stoke
   3. Liver disease
   4. Pancreatic disease (including diabetes)
   5. HIV AIDS
   6. Receiving antibiotic therapy
   7. Suspected infection
   8. Immunosuppression

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

3. Current diagnosis of uncontrolled diabetes.

4. Diagnosis of bacterial, fungal, or malaria infection within the last 3 months that required antimicrobial treatment.

5. Experienced severe trauma, surgery, cardiac arrest, or severe burn within the previous 3 months requiring medical care.

6. Diagnosis and/or treatment of cancer within the last 12 months.

7. Received immunosuppressive therapy.

8. Hospitalization for more than 24 hours within the last month.

9. Reported as currently pregnant or nursing a child

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