DIAGNOSTIC REAGENTS
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 .