Diagnostic methods for liver disorders

Abstract

The present invention relates to methods of diagnosing a liver disorder in a patient, as well as methods of monitoring the progression of a liver disorder and/or methods of monitoring a treatment protocol of a therapeutic agent or a chemotherapeutic regimen. The invention also relates to assay methods used in connection with the diagnostic methods described herein.

1 .- 57 . (canceled) 
     
     
         58 . A kit for conducting assays for the detection of liver disorders configured to measure a level of a plurality of biomarkers in a patient sample, said plurality of biomarkers comprise: AFP and at least one additional biomarker selected from the group consisting of CEA, CA 125, CA 19-9, OPN, MMP-9, E-cadherin, erbB2 and combinations thereof. 
     
     
         59 . The kit of  claim 58 , wherein said kit is further configured to compare said level to a level of a normal control. 
     
     
         60 . The kit of  claim 58 , wherein said kit is configured to measure said level using an immunoassay. 
     
     
         61 . The kit of  claim 58  wherein said kit comprises a multi-well assay module including a plurality of assay wells used in an assay conducted in said kit, said plurality of assay wells configured to measure said level of said plurality of biomarkers in said sample. 
     
     
         62 . The kit of  claim 61  wherein a well of said assay module comprises a plurality of assay domains, at least two of said assay domains comprising reagents for measuring different biomarkers. 
     
     
         63 . A kit for the analysis of hepatocellular carcinoma (HCC) in a patient, said kit comprising:
 (a) a multi-well assay module comprising a plurality of wells, each well comprising a multi-plex array of capture antibodies against one or more of a plurality of biomarkers selected from the group consisting of AFP and at least one additional biomarker selected from the group consisting of CEA, CA 125, CA 19-9, OPN, MMP-9, E-cadherin, erbB2 and combinations thereof, and   (b) in one or more vials, containers or compartments, a set of labeled detection antibodies specific for said biomarkers.   
     
     
         64 . The kit of  claim 63  wherein said kit further comprises one or more diluents. 
     
     
         65 . The kit of  claim 63  wherein said kit further comprises a blocking solution. 
     
     
         66 . The kit of  claim 63  wherein said kit further comprises a washing buffer. 
     
     
         67 . The kit of  claim 63  wherein said kit further comprises a read buffer.