Detection of mycobacteria

Abstract

The present invention is directed to methods and compositions for the detection of infection and disease due to members of the genus Mycobacterium. In particular, the present invention is well-suited to the detection and identification of patients with disease or infection due to M. tuberculosis or MAC.

What is claimed is:  
     
         1 . A kit for the detection of Mycobacterium in a test sample, comprising: 
 a) a solid support; and    b) a monoclonal antibody directed against a portion of alpha antigen immobilized on said solid support.    
     
     
         2 . The kit of  claim 1 , further comprising a primary antibody.  
     
     
         3 . The kit of  claim 2 , further comprising a reporter antibody.  
     
     
         4 . The kit of  claim 3 , further comprising an amplifier system.  
     
     
         5 . The kit of  claim 1 , wherein said Mycobacterium is  Mycobacterium tuberculosis.    
     
     
         6 . The kit of  claim 1 , wherein said Mycobacterium is  Mycobacterium avium.    
     
     
         7 . A method for detecting Mycobacterium in a sample comprising: 
 a) providing: 
 i) a sample suspected of containing at least a portion of alpha antigen of said Mycobacterium and  
 ii) a monoclonal antibody directed against a portion of Mycobacterium alpha antigen;  
   b) adding said sample to said monoclonal antibody under conditions such that said antibody binds to said portion of said Mycobacterium alpha antigen in said sample to form an antibody-antigen complex; and    c) detecting said binding.    
     
     
         8 . The method of  claim 7 , wherein said detecting comprises adding a primary antibody to said antigen-antibody complex so that said primary antibody binds to said antigen to form an antibody-antigen-antibody sandwich.  
     
     
         9 . The method of  claim 8 , wherein said detecting further comprises adding a reporter reagent to said antibody-antigen-antibody sandwich to form an antibody-antigen-antibody-antibody sandwich.  
     
     
         10 . The method of  claim 9 , wherein said detecting further comprises adding an amplifier to said antibody-antigen-antibody-antibody sandwich.  
     
     
         11 . The method of  claim 7 , wherein said portion of said Mycobacterium alpha antigen is selected from the group comprising SEQ ID NOS: 1, 2, 3, 4, 5, 6, 7 and 8.  
     
     
         12 . The method of  claim 7 , wherein said Mycobacterium is selected from the group consisting of  Mycobacterium tuberculosis, Mycobacterium avium  and  Mycobacterium intracellulare.    
     
     
         13 . The method of  claim 7 , wherein said test sample is selected from the group consisting of urine samples, sputum samples, blood samples, and serum samples.  
     
     
         14 . The method of  claim 7 , wherein said monoclonal antibody comprises a murine monoclonal antibody.  
     
     
         15 . The method of  claim 14 , wherein said murine monoclonal antibody is biotinylated.  
     
     
         16 . The method of  claim 7 , wherein said detecting is selected from the group consisting of enzyme immunoassay, radioimmunoassay, fluorescence immunoassay, flocculation, particle agglutination, and in situ chromogenic assay.  
     
     
         17 . A method for detecting Mycobacterium in a urine sample comprising: 
 a) providing: 
 i) a urine sample suspected of containing at least a porition of alpha antigen of said Mycobacterium; and  
 ii) a monoclonal antibody directed against a portion of Mycobacterium alpha antigen;  
   b) adding said urine sample to said monoclonal antibody under conditions such that said antibody binds to said portion of said Mycobacterium alpha antigen in said urine sample to form an antibody-antigen complex; and    c) detecting said binding.    
     
     
         18 . The method of  claim 17 , wherein said detecting comprises adding a primary antibody to said antigen-antibody complex so that said primary antibody binds to said antigen to form an antibody-antigen-antibody sandwich.  
     
     
         19 . The method of  claim 17 , wherein said detecting further comprises adding a reporter reagent to said antibody-antigen-antibody sandwich to form an antibody-antigen-antibody-antibody sandwich.  
     
     
         20 . The method of claim  29 , wherein said detecting further comprises adding an amplifier to said antibody-antigen-antibody-antibody sandwich.  
     
     
         21 . The method of  claim 17 , wherein said portion of said Mycobacterium alpha antigen is selected from the group comprising SEQ ID NOS: 1, 2, 3, 4, 5, 6, 7 and 8.  
     
     
         22 . The method of  claim 17 , wherein said portion of said Mycobacterium is selected from the group consisting of  Mycobacterium tuberculosis, Mycobacterium avium  and  Mycobacterium intracellulare.    
     
     
         23 . The method of  claim 17 , wherein said monoclonal antibody comprises a murine monoclonal antibody.  
     
     
         24 . The method of  claim 23 , wherein said murine monoclonal antibody is biotinylated.  
     
     
         25 . The method of  claim 17 , wherein said detecting is selected from the group consisting of enzyme immunoassay, radioimmunoassay, fluorescence immunoassay, flocculation, particle agglutination, and in situ chromogenic assay.