Methods for diagnosis and intervention of hepatic disorders
View Patent ↗The disclosure provides a method for quantification of hepatic function in a subject comprising measuring the clearance of an orally administered isotopically labeled cholic acid in a subject with, or suspected of having or developing, a hepatic disorder, for example, chronic hepatitis C. The disclosure further provides methods and kits for assessment of hepatic function.
1. A kit of components for determining one or both of cholate clearance and cholate shunt in a subject with, or suspected of having or developing, a hepatic disorder; the kit comprising
a first component comprising one or more vials, each vial comprising a single oral dose of a first stable isotope labeled distinguishable cholate compound; and
a second component comprising one or more vials, each vial comprising a single intravenous dose of a second stable isotope labeled distinguishable cholate compound in a bicarbonate solution, wherein
each single intravenous dose comprises the second stable isotope labeled distinguishable cholate compound prebound to human albumin.
2. The kit of claim 1 , further comprising
one or more sets of labeled sterile blood-serum sample collection tubes, wherein each set consists of enough tubes for collection of samples from the subject over a period of no more than 180 minutes after simultaneous administration of the distinguishable cholate compounds.
3. The kit of claim 2 , further comprising
one or more sets of labeled transport vials, each transport vial containing an internal cholic acid standard.
4. The kit of claim 3 , further comprising
a single box for both
shipping the vials to a health care practitioner and
shipping the samples from the health care practitioner to a reference lab for analysis.
5. The kit of claim 3 , wherein each set of the one or more sets of labeled transport vials consists of 6 transport vials, wherein each transport vial contains an internal cholic acid standard.
6. The kit of claim 2 , wherein each set of the one or more sets of labeled sterile blood-serum sample collection tubes consists of enough tubes for collecting blood or serum samples from the subject over intervals of two to seven time points spanning time periods of 5 to no more than 180 minutes.
7. The kit of claim 2 , wherein each set of the one or more sets of labeled sterile blood-serum sample collection tubes consists of enough tubes for collection of 5 samples from the subject over a period of 90 minutes after administration of the distinguishable cholate compounds.
8. The kit of claim 2 , wherein each set of the one or more sets of labeled sterile blood-serum sample collection tubes consists of 5 or 6 sample collection tubes.
9. The kit of claim 1 , wherein the first stable isotope labeled distinguishable cholate compound is 2,2,4,4- 2 H cholic acid and the second stable isotope labeled distinguishable cholate compound is 24- 13 C cholic acid.
10. The kit of claim 9 , wherein the 2,2,4,4- 2 H-cholic acid is in a powder form or in a solution form.
11. The kit of claim 1 , wherein each single intravenous dose comprises the second stable isotope labeled distinguishable cholate compound prebound to human serum albumin.
12. The kit of claim 11 , wherein each single oral dose of the first distinguishable cholate compound comprises a stable isotope labeled cholate in a bicarbonate solution.
13. The kit of claim 12 , wherein the kit further comprises a flavoring for adding to each single oral dose of the first stable isotope labeled distinguishable cholate compound.