Diagnosis of tuberculosis

Abstract

The invention comprises an oligonucleotide selected from the group comprising SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3; SEQ ID NO: 4; SEQ ID NO: 5 and SEQ ID NO: 6. The invention also comprises a complementary oligonucleotide of the oligonucleotide selected from the group comprising SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3; SEQ ID NO: 4; SEQ ID NO: 5 and SEQ ID NO: 6, an oligonucleotide being at least 80% homogolous thereto, a truncated portion of any of the aforementioned, or a pairing of any of the aforementioned.

1 - 14 . (canceled) 
     
     
         15 . An oligonucleotide which is a DNA aptamer, or a pairing of two DNA aptamers, that binds to a CFP-10.ESAT-6 heterodimer or to a CFP-10 monomer of a  Mycobacterium  strain. 
     
     
         16 . The oligonucleotide of  claim 15  which is selected from the group comprising SEQ ID NO: 1; SEQ ID NO: 2; SEQ ID NO: 3; SEQ ID NO: 4; SEQ ID NO: 5 and SEQ ID NO:
 6, a complementary oligonucleotide thereof, an oligonucleotide being at least 80% homologous thereto, or a pairing of any of the aforementioned. 
 
     
     
         17 . An in vitro method of diagnosing tuberculosis (TB), said method comprising:
 (a) contacting a sample taken from an individual suspected to be infected with TB with the oligonucleotide of  claim 15  in a CFP-10.ESAT-6 heterodimer binding assay; and   (b) determining whether or not the oligonucleotide has bound to a CFP-10.ESAT-6 heterodimer in the sample, with binding of the oligonucleotide to the CFP-10.ESAT-6 heterodimer thus confirming the presence of the CFP-10.ESAT-6 heterodimer, and hence TB infection in the sample.   
     
     
         18 . An in vitro method of diagnosing tuberculosis (TB), said method comprising:
 (a) contacting a sample taken from an individual suspected to be infected with active TB, or latent TB, with the oligonucleotide of  claim 15  in a CFP-10 monomer binding assay; and   (b) determining whether or not the oligonucleotide has bound to a CFP-10 monomer in the sample, with binding of the oligonucleotide to the CFP-10 monomer thus confirming the presence of the CFP-10 monomer, and hence TB infection in the sample.   
     
     
         19 . The method of  claim 17 , wherein the binding assay is a modified ELISA-type assay, wherein the antibodies against the CFP-10.ESAT-6 heterodimer or the CFP-10 monomer are replaced by the oligonucleotide of  claim 15 . 
     
     
         20 . The method of  claim 17 , wherein the oligonucleotide is that of SEQ ID NO: 3. 
     
     
         21 . A diagnostic kit for diagnosing tuberculosis (TB), said kit including:
 (a) a device for taking a sample from an individual suspected to be infected with TB;   (b) apparatus for applying the method of diagnosing TB according to  claim 17 ;   (c) the oligonucleotide of  claim 15 ; and   (d) optionally, a positive control and/or a negative control.   
     
     
         22 . The method of  claim 18 , wherein the binding assay is a modified ELISA-type assay, wherein the antibodies against the CFP-10.ESAT-6 heterodimer or the CFP-10 monomer are replaced by the oligonucleotide of  claim 15 . 
     
     
         23 . The method of  claim 18 , wherein the oligonucleotide is that of SEQ ID NO: 3. 
     
     
         24 . A diagnostic kit for diagnosing tuberculosis (TB), said kit including:
 (a) a device for taking a sample from an individual suspected to be infected with TB;   (b) apparatus for applying the method of diagnosing TB according to  claim 18 ;   (c) the oligonucleotide of  claim 15 ; and   (d) optionally, a positive control and/or a negative control.