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

NCT04409561 | Completed FDA Device

• 1 other identifier: AB-PSP-003
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis; Septic Shock; Healthy

Keywords

Sepsis; Pancreatic Stone Protein; Immunoassay; Abionic; Healthy population; Point-of-care device

Outcome Measures

Primary Outcomes (1)

• Determination of reference range interval of PSP

  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.

  Day 1

Secondary Outcomes (2)

• Collect medical data of healthy volunteer

  Day 1

• Obtain well characterised samples library to be used for future tests development

  Day 1

Study Arms (1)

Interventions

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.

Device: Blood collection

Interventions

Blood collection DEVICE

9 mL K3-EDTA anticoagulated venous whole blood and 9 mL lithium heparin anticoagulated venous whole blood will be collected, processed in plasma and stored until the shipment to the sponsor for PSP measurement on the abioSCOPE device with IVD CAPSULE PSP kits

Interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

150 generally healthy adults. 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.

You may qualify if:

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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Abionic SA: lead
• Boston Biomedical Associates: collaborator
• Ocean State Clinical Coordinating Center: collaborator

Study Sites (1)

Mercy Health St. Vincent

Toledo, Ohio, 43608, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

9 mL K3-EDTA anticoagulated venous whole blood and 9 mL lithium heparin anticoagulated venous whole blood will be collected, processed in plasma and stored until the shipment to the sponsor for PSP measurement on the abioSCOPE device with IVD CAPSULE PSP kits

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: June 1, 2020
• Study Start: November 15, 2021
• Primary Completion: November 15, 2021
• Study Completion: January 15, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

US (1)