Method for the diagnosis of tuberculosis

Abstract

Method for the diagnosis of a tuberculosis infection caused by Mycobacteria belonging to the Mycobacteria tuberculosis complex group (MTC) in an animal including a human being, which comprises in vitro-detection of cell-mediated immune response to OmpAtb and/or antibodies against OmpAtb in a sample taken from that animal.

1 . A method for the diagnosis of a tuberculosis infection caused by Mycobacteria belonging to the Mycobacteria tuberculosis complex group (MTC) in an animal including a human being, which comprises in vitro-detection of cell-mediated immune response to OmpAtb and/or antibodies against OmpAtb in a sample taken from that animal. 
     
     
         2 . Method according to  claim 1 , wherein the sample is contacted with a test reagent including an antigen having the antigenicity of OmpAtb. 
     
     
         3 . Method according to  claim 2 , wherein the antigen is OmpAtb, or at least one peptide subsequence thereof. 
     
     
         4 . Method according to  claim 2 , wherein the test reagent includes at least one further mycobacterial antigen. 
     
     
         5 . Method according to  claim 4 , wherein the further antigen is selected from a group consisting of tuberculin (PPD), ESAT-6, CFP-10, MPB83, TB10.4 and TB27.4. 
     
     
         6 . Method according to  claim 4 , wherein the test reagent includes the antigen, a mixture of antigens and the antigen in form of a fusion-protein. 
     
     
         7 . Method according to  claim 1 , wherein the animal is selected from a group consisting of cattle, sheep, goats, deer, pigs, horses, badgers, dogs, cats, non-human primates, elephants, opossums, buffaloes, llamas, alpacas and other exotic animals. 
     
     
         8 . Method according to  claim 1 , wherein the sample is selected from a group of tissues including blood, serum, plasma, lymph nodes, skin, saliva, urine, cerebrospinal fluid, milk and other tissue samples. 
     
     
         9 . Method according to  claim 1 , wherein a possible cell-mediated immune response is detected by an assay based on release of gamma interferon or other cellular products signaling mycobacterial immunity or a lymphocyte proliferation assay. 
     
     
         10 . Method according to  claim 9 , wherein the cellular products indicating cell-mediated immune response are detected by one of the following assays: ELISA, immunoblot techniques, RIA, flow cytometry, fluorescence polarization, latex agglutination, lateral flow assay, immunochromatographic assay, immunochips, dip stick immunotesting, bead-based technology, and determination of the RNA coding for the relevant cellular product by use of nucleic acid amplification technique. 
     
     
         11 . Method according to  claim 2 , wherein the presence of antibodies to OmpAtb in the sample is detected by testing whether or not a binding reaction of antibodies in the sample with the antigen in the test reagent has occurred. 
     
     
         12 . Method according to  claim 11 , wherein a possible binding reaction is detected by one of the following assays: ELISA, immunoblot techniques, RIA, flow cytometry, fluorescence polarization, latex agglutination, lateral flow assay, immunochromatographic assay, immunochips, dip stick immunotesting, bead-based technology, and determination of the RNA coding for the relevant cellular product by use of nucleic acid amplification technique. 
     
     
         13 . Test reagent for the diagnosis of tuberculosis by antibody or cellular as-says, including an antigen having the antigenicity of OmpAtb or at least one peptide subsequence thereof. 
     
     
         14 . Test reagent according to  claim 13  including at least one further antigen. 
     
     
         15 . Test reagent according to  claim 14 , wherein the further antigen is selected from a group consisting of tuberculin (PPD), ESAT-6, CFP-10, MPB83, TB10.4 and TB27.4. 
     
     
         16 . Test reagent according to  claim 13  including the antigen, a mixture of antigens and the antigen in form of a fusion-protein. 
     
     
         17 . Vaccine for immunizing an animal, including a human being, against tuberculosis caused by mycobacteria belonging to the tuberculosis-complex, comprising as the effective component an antigen with the antigenicity of OmpAtb or at least one peptide subsequence thereof. 
     
     
         18 . Vaccine according to  claim 17  including at least one further antigen. 
     
     
         19 . Vaccine according to  claim 18 , wherein the further antigen is selected from a group consisting of tuberculin (PPD), ESAT-6, CFP-10, MPB83, TB10.4 and TB27.4. 
     
     
         20 . Vaccine according to  claim 17  including the antigen, a mixture of antigens and the antigen in form of a fusion-protein. 
     
     
         21 . Fusion-protein including a polypeptide portion having the antigenicity of OmpAtb and a further polypeptide portion. 
     
     
         22 . Fusion protein according to  claim 21  in which the further polypeptide fraction has the antigenicity of a further antigen specific for mycobacterial infections. 
     
     
         23 . A kit for the diagnosis of a tuberculosis infection caused by mycobacteria belonging to the Mycobacteria tuberculosis complex group in a sample taken from an animal, which comprises the test reagent according to  claim 13  and means for the detection of antibodies against OmpAtb and/or means for the detection of a cell-mediated immune response to OmpAtb by the animal. 
     
     
         24 . A kit according to  claim 16  in which the test reagent is already included in sample collection containers prior to sample taking. 
     
     
         25 . Use of the test reagent according to  claim 13  to manufacture a diagnostic preparation for tuberculosis.