Diagnosis method of hepatic steatosis using biochemical markers

Abstract

The present invention is drawn to a new diagnosis method for detecting the extent of hepatic steatosis in a patient, in particular in a patient who suffers from a disease involving hepatic steatosis, or who already had a positive diagnosis test of liver fibrosis and/or presence of liver necroinflammatory lesions, by using the serum concentration of easily detectable biological markers. The invention is also drawn to diagnosis kits for the implementation of the method.

1 .- 10 . (canceled) 
     
     
         11 . A kit for diagnosis of hepatic steatosis in a patient comprising:
 (a) instructions for determining the presence of hepatic steatosis in said patient:   (b) reagents for measuring the serum values of the concentrations of 5 biochemical markers, wherein said markers are:
 ApoA1 (apolipoprotein A1) 
 alpha2-macroglobulin 
 ALT (alanine aminotransferase) 
 GGT (gammaglutamyl transpeptidase), and 
 triglycerides 
   (c) optionally, at least one reagent for measuring the serums values of the concentrations of total bilirubin, haptoglobin, AST (aspartate aminotransferase), glucose, or (cholesterol or HDL-cholesterol).   (d) instructions for using a logistic function that is used to combine said values with one clinical marker chosen in the group constituted of the body mass index (Weight/Height 2 ), the waist measurement, and the (waist measurement/hip measurement) ratio, in order to obtain an end value.   
     
     
         12 . The kit of  claim 11 , further comprising an ROC curve. 
     
     
         13 . The kit of  claim 11 , further comprising tables that allow to obtain the predictive values, depending of the expected prevalence of hepatic steatosis in the patient population. 
     
     
         14 . The kit of  claim 11 , further comprising instructions for the quantification of hepatic steatosis different grades (none=0%, mild=1-5%, moderate-6-32%, marked=33-66%, and severe=67-100%), and other intermediate grades.