abioSCOPE PSP Reference Range Study; Extension of AB-PSP-003

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05849935

Acronym

AB-PSP-007

Enrollment

Registered

2023-05-09

Start date

2023-07-17

Completion date

2023-07-31

Last updated

2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Brief summary

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.

Interventions

DIAGNOSTIC_TESTabioSCOPE

The abioSCOPE device with the PSP assay is intended to be indicated for ICU admitted patients at risk of developing sepsis. Results of abioSCOPE PSP assay may aid to identify sepsis in critically ill patients, together with all other clinical assessment and laboratory findings.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
To determine the reference range intervals of PSP values measured using abioSCOPE device with the PSP assay in a generally healthy population representative of the US population.	through study completion, an average of 2 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026