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Validation of Different Methods for HepQuant DuO® Blood Sample Collection
Sponsor: HepQuant, LLC
Summary
This is a study to see the agreement of blood samples collected through different means and tube types for the HepQuant DuO Test. The HepQuant DuO Test is a blood-based test that involves a drink of a natural compound, cholate, and blood samples at 20 and 60 minutes. The study team is collecting clinical and laboratory data from patients living with chronic liver disease and healthy adult volunteers. The study has up to 2 study visits at an outpatient clinic and can take up to 4 weeks for a participant to complete study. At these visits, participants will undergo a HepQuant DuO test and other standard lab tests. In addition, the study team will ask about a participant's experience with different blood sampling methods.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2026-04-20
Completion Date
2027-04-20
Last Updated
2026-03-16
Healthy Volunteers
Yes
Interventions
HepQuant DuO Test
HepQuant DuO is commercially available in the U.S. as a Laboratory Developed Test (LDT), but it will be used in this study as a nonsignificant risk investigational device to measure change in liver function over time.