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.
Study Type
OBSERVATIONAL
Enrollment
150
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
Mercy Health St. Vincent
Toledo, Ohio, United States
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.
Time frame: Day 1
Collect medical data of healthy volunteer
To collect medical data from the 150 study participants using a volunteer questionnaire
Time frame: Day 1
Obtain well characterised samples library to be used for future tests development
Whole blood collection from 150 healthy subject to be used for future tests development.
Time frame: Day 1
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