Patent ID: 11899027
Assignee: RUBIO METABOLOMICS, S.L.U.
Field: Measurement (Instruments)
Classification: CPC G | IPC G

Claim 0:
1. A method for discriminating between non-alcoholic steatohepatitis (NASH) and steatosis and correspondingly treating a patient diagnosed with non-alcoholic fatty liver disease (NAFLD), the method comprising:
(i) fractionating by liquid chromatography a sample isolated from the patient;
(ii) determining by mass spectrometry the levels of one or more metabolic markers selected from the group consisting of:
(a) metabolic marker TG(44:1) comprising at least one of analytes TG(14:0+18:1+12:0) and TG(16:0+16:1+12:0);
(b) metabolic marker TG(48:2) comprising at least one of analytes TG(14:0+18:1+16:1) and TG(16:0+18:2+14:0);
(c) metabolic marker TG(49:1) comprising analyte TG(15:0+18:1+16:0);
(d) metabolic marker TG(50:2) comprising at least one of analytes TG(16:0+18:1+16:1), TG(18:1+18:1+14:0), and TG(16:0+18:2+16:0);
(e) metabolic marker TG(51:1) comprising analyte TG(16:0+17:0+18:1);
(f) metabolic marker TG(51:2) comprising analyte TG (16:0+17:1+18:1);
(g) metabolic marker TG(51:3) comprising analyte TG(18:2+18:1+15:0);
(h) metabolic marker TG(52:0) comprising analyte TG(16:0+18:0+18:0);
(i) metabolic marker TG(52:3) comprising analyte TG(16:0+18:1+18:2);
(j) metabolic marker TG(52:4) comprising analyte TG(16:0+18:2+18:2);
(k) metabolic marker TG(53:3) comprising at least one of analytes TG(18:2+18:1+17:0) and TG(18:1+18:1+17:1);
(l) metabolic marker TG(54:2) comprising analyte TG(18:0+18:1+18:1);
(m) metabolic marker TG(54:3) comprising at least one of analytes TG(20:2+20:1+14:0), TG(20:2+18:1+16:0), TG(20:1+18:2+16:0), and TG(18:2+18:1+18:0);
(n) metabolic marker TG(54:5) comprising analyte TG(18:2+18:2+18:1);
(o) metabolic marker TG(54: 6) comprising analyte TG(20: 4+18:2+16: 0);
(p) metabolic marker TG(56:3) comprising analyte TG(18:1+20:1+18:1);
(q) metabolic marker TG(56:7) comprising at least one of analytes TG(22:5+18:2+16:0) and TG(20:4+18:2+18:1); and
(r) metabolic marker TG(56:8) comprising analyte TG(22:6+18:2+16:0),

(iii) generating a predictive score based on relative values of the metabolic markers in a logistic regression model to discriminate between NASH and steatosis, wherein the predictive score is given by formula (I), predictive
      ⁢
         
      score
     
     =
     
      1
      
       1
       +
       
        e
        
         -
         z
        
       
      
     
    
   
   
    
     (
     I
     )
    
   
  
 

 wherein, Z
  =
  
    
      ∑
      i
      
        
      
    
    ⁢
    
      
        
          c
          i
        
        ⁡
        
          [
          
            A
            i
            1
          
          ]
        
      
      ⁡
      
        [
        
          A
          i
          2
        
        ]
      
    
  

 ci is the coefficient estimated for the model for the parameter i, wherein each parameter i of the model includes Ai1 and Ai2, wherein Ai1 is a first metabolic marker of (a)-(r) determined in (ii) or a first metabolic marker logarithm, and Ai2 is a second metabolic marker of (a)-(r) determined in (ii), second metabolic marker logarithm, body mass index, or body mass index logarithm and [Ai1] and [Ai2] are corresponding relative values of Ai1 and Ai2 based on metabolic marker levels obtained in (ii); and
(iv) treating the patient for NASH when the predictive score is ≥0.5, and treating the patient for steatosis when the predictive score is <0.5.