Validation of Different Methods for HepQuant DuO® Blood Sample Collection

Validation of Different Methods for HepQuant DuO® Blood Sample Collection

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.

Inclusion Criteria:

• adult healthy participant with no major comorbidities and lean body mass (BMI 18-25.5)
• adult participant with all etiologies of parenchymal chronic liver disease or PBC or PSC with F2-F3 fibrosis or cirrhosis.

Exclusion Criteria:

• under the age of 18
• pregnancy
• Unable to absorb orally administered cholate (examples could include underlying severe gastroparesis or having undergone extensive small bowel resection, conditions or post-operative state that could impair the absorption of the orally administered d4-cholate)
• NPO (nothing through the mouth) status or those who are unable to ingest a thin liquid by mouth
• for patients with cirrhosis, any hospital admission within 3 months of enrollment in the study.