Antibody Profiles Characteristic of Tuberculosis State

Abstract

Serum antibody assays capable of distinguishing cases of inactive TB from cases of active TB include a combination at least three M. tuberculosis protein antigens, at least one for which a positive response is consistent with inactive TB and antigens, and at least one for which a negative response is consistent with inactive TB. Preferred assays further distinguish other TB classes. Also, antigen kits for performing such assays.

1 - 19 . (canceled) 
     
     
         20 . A method of diagnosis of tuberculosis in a human subject, the method comprising exposing a serum sample of the human subject to at least three different  M. tuberculosis  protein antigens separately immobilized on different locations on a surface, wherein the at least three different  M. tuberculosis  protein antigens include at least one antigen of a first type selected from the group consisting of 16 kDa antigen (product of gene rv 2031c) and ESAT-6 antigen (product of gene rv 3875), at least one antigen of a second type selected from the group consisting of Rv2626c antigen, AlaDH antigen (product of gene rv 2780) and 38 kDa antigen (product of gene rv 0934), and at least one antigen of a third type selected from the group consisting of 16 kDa antigen (product of gene rv 2031c), ESAT-6 antigen (product of gene rv 3875), Rv2626c antigen, AlaDH antigen (product of gene rv 2780) and 38 kDa antigen (product of gene rv 0934) and detecting serum antibodies to the antigens. 
     
     
         21 . The method of  claim 20 , further comprising measuring the level of response of the serum antibodies to the antigens. 
     
     
         22 . The method of  claim 21 , further comprising determining the odds ratio of the antibody response. 
     
     
         23 . The method according to  claim 20 , wherein the at least three different  M. tuberculosis  protein antigens include at least 16 kDa antigen and ESAT-6 and at least two antigens of the second type. 
     
     
         24 . The method of  claim 20  wherein the at least three different  M. tuberculosis  protein antigens include at least 16 kDa antigen and ESAT-6 antigen, further comprising FdxA antigen (product of gene rv 2007c). 
     
     
         25 . A method of diagnosis of tuberculosis in a human subject, the method comprising exposing a serum sample of the human subject to at least three different  M. tuberculosis  protein antigens separately immobilized on different locations on a surface, detecting serum antibodies to the antigens, measuring the level of response of the serum antibodies to the antigens, and determining the odds ratio of the antibody response. 
     
     
         26 . The method of  claim 25 , wherein the at least three different  M. tuberculosis  protein antigens include at least one antigen of a first type selected from the group consisting of 16 kDa antigen (product of gene rv 2031c) and ESAT-6 antigen (product of gene rv 3875), at least one antigen of a second type selected from the group consisting of Rv2626c antigen, AlaDH antigen (product of gene rv 2780) and 38 kDa antigen (product of gene rv 0934), and at least one antigen of a third type selected from the group consisting of 16 kDa antigen (product of gene rv 2031c), ESAT-6 antigen (product of gene rv 3875), Rv2626c antigen, AlaDH antigen (product of gene rv 2780) and 38 kDa antigen (product of gene rv 0934). 
     
     
         27 . The method of  claim 26 , wherein the odds ratio is indicative of active tuberculosis, inactive tuberculosis or chest x-ray normal. 
     
     
         28 . The method according to  claim 25 , wherein the at least three different  M. tuberculosis  protein antigens include at least 16 kDa antigen and ESAT-6 and at least two antigens of the second type. 
     
     
         29 . The method of  claim 25  wherein the at least three different  M. tuberculosis  protein antigens include at least 16 kDa antigen and ESAT-6 antigen, further comprising FdxA antigen (product of gene rv 2007c).