Method for diagnosing primary biliary cirrhosis (pbc) using novel autoantigens

Abstract

Methods and compositions are described for the diagnosis of primary biliary cirrhosis. Novel autoantigens are described for use in assays which employ test samples from individuals.

1 - 14 . (canceled) 
     
     
         15 . A method of diagnosing primary biliary cirrhosis (PBC) in an individual comprising:
 a. contacting a test sample from the individual with one or more target antigens of kelch-like 12, a homolog of kelch-like 12, or a fragment thereof, said fragment comprising an epitope of said antigen; and   b. detecting binding of said one or more target antigens or said fragments thereof comprising an epitope to one or more antibodies in the test sample; and   c. comparing the level of autoantibody to a control sample from a healthy individual;   wherein an increased level of the one or more antibodies bound to the one or more target antigens or fragments thereof as compared to said control sample from said healthy individual is indicative of primary biliary cirrhosis (PBC).   
     
     
         16 . The method of  claim 15 , wherein the one or more target antigens or fragments thereof comprising an epitope are immobilized on a solid support. 
     
     
         17 . The method of  claim 15 , wherein said homolog of kelch-like 12 comprises a sequence selected from the group consisting of SEQ ID NOS: 12-18. 
     
     
         18 . The method of  claim 15 , wherein the test sample is contacted with two or more of the target antigens or fragments thereof comprising an epitope. 
     
     
         19 . The method of  claim 15 , wherein the test sample is contacted with three or more of the target antigens or fragments thereof comprising an epitope. 
     
     
         20 . The method of  claim 15 , wherein the test sample is contacted with four or more of the target antigens or fragments thereof comprising an epitope. 
     
     
         21 . The method of  claim 15 , wherein the test sample is contacted with five or more of the target antigens or fragments thereof comprising an epitope. 
     
     
         22 . The method of  claim 15 , wherein the test sample is contacted with six or more of the target antigens or fragments thereof comprising an epitope. 
     
     
         23 . The method of  claim 15 , wherein the test sample is cells, tissues or body fluids. 
     
     
         24 . The method of  claim 15 , wherein the test sample is blood, plasma or serum. 
     
     
         25 . The method of  claim 15 , wherein the one or more purified recombinant target antigens or fragments thereof comprising an epitope are produced recombinantly. 
     
     
         26 . The method of  claim 25 , wherein the one or more recombinant target antigens or fragments thereof comprising an epitope are produced using cell-free protein expression. 
     
     
         27 . The method of  claim 15 , wherein the one or more purified recombinant target antigens or fragments thereof comprising an epitope further comprise a tag sequence located at the C-terminal or N-terminal, or at both the C-terminal and N-terminal. 
     
     
         28 . The method of  claim 15 , wherein the detection step further comprises a labeled anti-immunoglobulin (IG) antibody and wherein the one or more target antigen or fragments thereof, autoantibody, and anti-IG antibody form a complex. 
     
     
         29 . An assay kit comprising:
 (a) one or more target antigens of kelch-like 12, a homolog of kelch-like 12, or a fragment thereof, said fragment comprising an epitope of said antigen;   (b) a labeled anti-immunoglobulin antibody; and   (c) a control.   
     
     
         30 . The assay kit of  claim 29 , wherein said one or more target antigens or fragments thereof comprising an epitope are recombinantly produced. 
     
     
         31 . The assay kit of  claim 29 , where said homolog of kelch-like 12 comprises a sequence selected from the group consisting of SEQ ID NOS: 12-18. 
     
     
         32 . The assay kit of  claim 29 , wherein the one or more target antigens or fragments thereof comprising an epitope further comprises a tag sequence located at the C-terminal, N-terminal, or at both the C-terminal and N-terminal. 
     
     
         33 . The assay kit of  claim 29 , further comprising a solid support to which the one or more recombinant target antigens or fragments thereof comprising an epitope are immobilized.