Method for assessment of hepatic function and portal blood flow

Abstract

A method for estimating portal blood flow and hepatic function in a subject is provided. In one example, the STAT test is an in vitro simplified, convenient test intended for screening purposes that can reasonably estimate the portal blood flow from a single blood sample taken 60 minutes after orally administered deuterated-cholate. The test can be administered to a patient having, or suspected of having, Chronic Hepatitis C, Primary Sclerosing Cholangitis (PSC), Non-Alcoholic Fatty Liver Disease (NAFLD), or any chronic liver disease.

1 .- 15 . (canceled) 
     
     
         16 . A kit of components for estimation of portal blood flow in a subject by a method comprising
 administering orally a distinguishable cholate compound to a subject with, or suspected of having or developing, a hepatic disorder, wherein no other distinguishable cholate is intravenously co-administered;   collecting a blood or serum sample from the subject at a single, specific time point after oral administration of the distinguishable cholate compound to the subject;   measuring the concentration of the orally administered distinguishable cholate compound in the blood or serum sample; and   comparing the concentration of the distinguishable cholate compound in the blood or serum sample to a distinguishable cholate compound concentration cutoff value or cutoffs of values established from a known patient population, wherein the concentration of distinguishable cholate compound in the sample compared to distinguishable cholate compound concentration cutoff value or cutoffs of values in the known patient population is an estimation of portal blood flow in the subject; the kit comprising   a first component comprising one or more vials, each vial comprising a single oral dose of the distinguishable cholate compound; and   a second component comprising one or more sets of labeled sterile blood-serum sample collection tubes.   
     
     
         17 . The kit of  claim 16 , further comprising
 one or more sets of labeled transport vials, each transport vial containing an internal cholic acid standard.   
     
     
         18 . The kit of  claim 17 , 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. 
   
     
     
         19 . The kit of  claim 22 , wherein the stable isotope labeled distinguishable cholate compound is 2,2,4,4- 2 H cholic acid. 
     
     
         20 . The kit of  claim 19 , wherein the  2 H-cholic acid is in a powder form or in a solution form. 
     
     
         21 . The kit of  claim 16 , wherein the distinguishable cholate compound is a stable isotope labeled distinguishable cholate compound. 
     
     
         22 . The kit of  claim 21 , wherein the stable isotope labeled distinguishable cholate compound is a  13 C- and/or  2 H-labeled cholic acid compound. 
     
     
         23 . The kit of  claim 16 , further comprising instructions for comparing the amount of distinguishable cholate compound to a cutoff value or cutoffs of values to determine state of portal blood flow and/or hepatic function in the subject. 
     
     
         24 . The kit of  claim 16 , wherein each vial of the first component comprises a diagnostic pharmaceutical composition comprising the single oral dose of the distinguishable cholate compound and one or more pharmaceutically acceptable excipients, diluents and/or vehicles. 
     
     
         25 . The kit of  claim 24 , wherein the pharmaceutically acceptable excipient is sodium bicarbonate. 
     
     
         26 . The kit of  claim 24 , wherein the diagnostic pharmaceutical composition comprises a diluent. 
     
     
         27 . The kit of  claim 24 , further comprising a diluent for diluting the diagnostic pharmaceutical composition. 
     
     
         28 . The kit of  claim 27 , wherein said diluent is selected from grape juice or apple juice. 
     
     
         29 . The kit of  claim 16 , further comprising one or more quality control samples. 
     
     
         30 . The kit of  claim 16 , further comprising one or more syringes for drawing a blood sample from the subject.