Diagnosis Method for Lupus

Abstract

The present invention relates to an in vitro method for diagnosing lupus in a subject, said method comprising the step of detecting in a biological sample obtained from the subject the autoantibody recognizing the protein biomarker THEX1. More, the invention relates to kits and array useful for carrying out diagnosis methods according to the present invention.

1 . An in vitro method for diagnosing lupus in a subject, said method comprising the step of detecting in a biological sample obtained from the subject autoantibody recognizing a protein biomarker THEX1. 
     
     
         2 . The method according to  claim 1  wherein said method further comprises the steps of:
 contacting the biological sample obtained from the subject with the protein biomarker THEX1 and detecting a biomarker-antibody complex formed, wherein detection of the biomarker-antibody complex is indicative of lupus in the subject. 
 
     
     
         3 . The method according to  claim 1 , further comprising contacting the biological sample obtained from the subject with one or both of nuclear antigen or extractable nuclear antigen. 
     
     
         4 . A kit for the in vitro diagnosis of lupus in a subject, said kit comprising a protein biomarker THEX1; and
 at least one reagent for detecting a biomarker-antibody complex formed between the protein biomarker THEX1 and an autoantibody recognizing the protein biomarker THEX1.   
     
     
         5 . An array for diagnosing of lupus in a subject, said array comprising, attached to its surface, the protein biomarker THEX1. 
     
     
         6 . An analytical method, comprising
 obtaining a biological sample from a subject who might have lupus;   contacting the biological sample with a protein biomarker THEX1 for a time and under conditions that allow formation of a biomarker-antibody complex between the protein biomarker THEX1 and autoantibody recognizing the protein biomarker THEX1; and   detecting biomarker-antibody complexes formed during the contacting step.   
     
     
         7 . The method of  claim 2 , wherein the step of detecting is performed using an immunoassay. 
     
     
         8 . The method of  claim 2 , wherein the protein biomarker THEX1 is immobilized on a solid carrier or support. 
     
     
         9 . The method of  claim 1 , wherein the method also comprises detecting one or both of: i) autoantibodies recognizing nuclear antigen and ii) autoantibodies recognizing extractable nuclear antigen. 
     
     
         10 . The method of  claim 6 , wherein the step of detecting is performed using an immunoassay. 
     
     
         11 . The method of  claim 6 , wherein the protein biomarker THEX1 is immobilized on a solid carrier or support. 
     
     
         12 . The method of  claim 6 , wherein the step of contacting includes one or both of
 i) contacting the biological sample with nuclear antigen for a time and under conditions that allow formation of a biomarker-antibody complex between the nuclear antigen and autoantibody recognizing the nuclear antigen; and   ii) contacting the biological sample with extractable nuclear antigen for a time and under conditions that allow formation of a biomarker-antibody complex between the extractable nuclear antigen biomarker and autoantibody recognizing the extractable nuclear antigen biomarker.   
     
     
         13 . The kit of  claim 4 , further comprising one or both of:
 i) nuclear antigen and at least one reagent for detecting biomarker-antibody complexes formed between the nuclear antigen and an autoantibody recognizing the nuclear antigen; and   ii) extractable nuclear antigen and at least one reagent for detecting biomarker-antibody complexes formed between the extractable nuclear antigen and an autoantibody recognizing the extractable nuclear antigen.   
     
     
         14 . The array of  claim 7 , further comprising, attached to its surface, one or both of nuclear antigen and extractable nuclear antigen.