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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Sampling | Participant completes a HepQUant DuO test during which the participant ingests a d4-tagged cholate solution and has blood samples drawn 20 and 60 minutes after ingesting oral solution. Blood samples are obtained through direct venipuncture of a peripheral vein, one is collected into a red-top tube and one is collected into a serum separator tube (SST), and simultaneously, a third blood sample is collected into Microtainer SST using a transcutaneous capillary blood collection device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HepQuant DuO Test | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in d4-cholate concentrations between RTs by VP (reference method) and the SSTs by VP (primary index method). | To evaluate the agreement of the HepQuant DuO 20- and 60-minute d4-cholate concentrations between samples collected using Serum Separator Tubes (SST) by venipuncture (VP) (the primary index method) and blood collection in Red-top Tubes (RTs) by VP (the reference method). | From screening to completion of blood collection at Visit 1 is 2 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants ranging from healthy to living with chronic liver disease will consist of:
50% healthy participants 25% CLD participants with non-cirrhotic fibrosis 25% CLD participants with cirrhosis of which no more than 10% of the total study participants will have Child-Pugh class of B or C.
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serum from blood samples.