Breath test device and method

Abstract

There is provided a method of evaluating a liver condition of a subject, the method includes computing a fluctuation parameter from a liver breath test based on at least one of a percentage dose recovery (PDR) curve and a delta over baseline (DOB) curve of an isotope labeled methacetin, or a salt or a derivative thereof, and evaluating at least one liver condition of the subject, based at least on the fluctuation parameter. There is provided herein a method of evaluating a liver condition of a subject, the method includes computing a hepatic impairment score based at least on a breath test related parameter and on a demographic parameter.

1 . A methacetin composition for use in a breath test, the composition comprising methacetin, or a salt or derivative thereof substantially dissolved in water, wherein the composition is substantially free of a by-product of methacetin decomposition. 
     
     
         2 . The methacetin composition of  claim 1 , wherein the by-product of methacetin decomposition comprises anisidine. 
     
     
         3 . The methacetin composition of  claim 2 , wherein the anisidine is p-anisidine. 
     
     
         4 . The methacetin composition of  claim 2 , wherein the anisidine is m-anisidine. 
     
     
         5 . The methacetin composition of  claim 2 , wherein the anisidine is o-anisidine. 
     
     
         6 . The methacetin composition of  claim 1 , wherein the composition comprises less than 1% anisidine. 
     
     
         7 . The methacetin composition of  claim 1 , wherein the composition comprises less than 0.2% anisidine. 
     
     
         8 . The methacetin composition of  claim 1 , being stable for at least one week when stored at room temperature. 
     
     
         9 . The methacetin composition of  claim 1 , being ready for oral administration. 
     
     
         10 . The methacetin composition of  claim 1 , comprising a single dose of methacetin. 
     
     
         11 . The methacetin composition of  claim 1 , comprising a total aerobic microbial count of 100 cfu/ml or less. 
     
     
         12 . The methacetin composition of  claim 1 , comprising a total aerobic microbial count of 10 cfu/ml or less. 
     
     
         13 . The methacetin composition of  claim 1 , being substantially free of preservatives. 
     
     
         14 . The methacetin composition of  claim 1 , being substantially free of excipients adapted to inhibit methacetin decomposition. 
     
     
         15 . The methacetin composition of  claim 1 , being further comprising a container within which the methacetin composition is contained. 
     
     
         16 . The methacetin composition of  claim 15 , wherein the container is a polymeric container. 
     
     
         17 . The methacetin composition of  claim 16 , wherein the polymeric container comprises polyethylene, polystyrene, polyester or any combination thereof. 
     
     
         18 . The methacetin composition of  claim 15 , wherein the container is a glass container. 
     
     
         19 . The methacetin composition of  claim 1 , wherein the concentration of methacetin decreases by no more than 1% after 26 weeks from manufacturing of the composition. 
     
     
         20 . The methacetin composition of  claim 1 , having a pH range of about 5.2 to 7.8.