Diagnostic reagents

Abstract

There is provided a diagnostic reagent useful to determine whether an animal has a tuberculosis infection or has been exposed to a tuberculosis agent, for example a Mycobacterium . The reagent is useful to distinguish between such an animal and an animal which has been vaccinated against a tuberculosis infection.

1 . A diagnostic reagent comprising a polypeptide comprising amino acid sequence SEQ ID NO:7 and/or SEQ ID NO:8 or a functional variant of SEQ ID NO:7 or SEQ ID NO:8, characterised in that the reagent elicits a negative diagnostic assay result when a tuberculosis infection assay is carried out on a sample from an animal which has been vaccinated against infection by a tuberculosis agent. 
     
     
         2 . (canceled) 
     
     
         3 . A diagnostic reagent according to  claim 1  comprising amino acid sequence SEQ ID NO:7 and SEQ ID NO:8 or functional variants thereof. 
     
     
         4 . A diagnostic reagent according to  claim 1  further comprising at least one of the amino acid sequences SEQ ID NO:1, 2, 3, 4, 5, 6 or 9 or functional variants thereof, or comprising all of SEQ ID NOs:1-9. 
     
     
         5 . (canceled) 
     
     
         6 . A diagnostic reagent according to  claim 1  further comprising amino acid sequence SEQ ID NO:10 or a functional variant thereof. 
     
     
         7 . A diagnostic reagent according to any preceding claim further comprising at least one of the amino acid sequences SEQ ID NOs:11-69 or functional variants thereof. 
     
     
         8 . (canceled) 
     
     
         9 . (canceled) 
     
     
         10 . (canceled) 
     
     
         11 . (canceled) 
     
     
         12 . (canceled) 
     
     
         13 . A diagnostic reagent according to  claim 1  comprising amino acid sequences SEQ ID NOs:7 and 50-59. 
     
     
         14 . A diagnostic reagent according to  claim 1  comprising amino acid sequences SEQ ID NO:8 and 60-69. 
     
     
         15 . A diagnostic reagent according to  claim 1  comprising amino acid sequences SEQ ID NOs:7, 8, 11-42 and 50-69. 
     
     
         16 . (canceled) 
     
     
         17 . (canceled) 
     
     
         18 . A method of detecting a tuberculosis infection in an animal, or exposure of an animal to a tuberculosis agent, comprising the steps of
 (i) contacting a population of cells from the animal with at least one diagnostic reagent as defined in  claims 1 ; and   (ii) determining whether the cells of said population recognise the diagnostic reagent.   
     
     
         19 . The method according to  claim 18  wherein the population of cells includes T-cells. 
     
     
         20 . The method according to  claim 18 , comprising a cell-mediated immunity (CMI) assay. 
     
     
         21 . The method according to  claim 20  wherein the CMI assay detects interferon gamma (IFN-γ). 
     
     
         22 . A method of detecting a tuberculosis infection in an animal, or exposure of an animal to a tuberculosis agent, comprising conducting a skin test on the animal using at least one diagnostic reagent according to  claims 1 . 
     
     
         23 . A diagnostic kit comprising a diagnostic reagent according to  claims 1 . 
     
     
         24 . (canceled) 
     
     
         25 . A kit according to  claim 23  in which the diagnostic reagent is able to detect a tuberculosis infection in an animal, or exposure of an animal to a tuberculosis agent. 
     
     
         26 . A kit according to  claim 25  in which the diagnostic reagent is suitable for use to differentiate between an animal having a tuberculosis infection and an animal vaccinated against tuberculosis infection. 
     
     
         27 . A polypeptide comprising the amino acid sequence of any of SEQ ID NOs:1-10 and or 50-69 or a functional variant thereof. 
     
     
         28 . A nucleic acid encoding a polypeptide comprising at least one polypeptide according to  claim 27 . 
     
     
         29 . A vector comprising at least one nucleic acid according to  claim 28 . 
     
     
         30 . A cell transformed with the vector according to  claim 29 .