Diagnostic reagents
View Patent ↗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 consisting of amino acid sequence QANLGEAAGTYVAADAAAAS (SEQ ID NO:8), wherein the diagnostic reagent is a sterile injectable preparation, and the diagnostic reagent optionally further comprises a polypeptide consisting of amino acid sequence MTENLTVQPERLGVLASHHDNAAVDASSGVEAAAGLGESVAITHGPYCSQFNDTLNVYLTAHNALGSSLHTAGVDLAKSLRIAAKIYSEADEAWRKAIDGLFT (SEQ ID NO:46).
2. 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 claim 1 ; and
(ii) determining whether the cells of said population recognise the diagnostic reagent;
optionally wherein the population of cells includes T-cells.
3. The method of claim 2 , comprising a cell-mediated immunity (CMI) assay, optionally wherein the CMI assay detects interferon gamma (IFN-γ).
4. 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 as defined in claim 1 .
5. A diagnostic kit comprising at least one diagnostic reagent as defined in claim 1 .
6. The kit of claim 5 in which the diagnostic reagent is able to detect a tuberculosis infection in an animal, or exposure of an animal to a tuberculosis agent.
7. The diagnostic reagent of claim 1 , wherein the sterile injectable preparation is an aqueous or an oleaginous suspension, or a suspension in a non-toxic parenterally-acceptable diluent or solvent.
8. The diagnostic reagent of claim 1 , which is suitable for use to differentiate between an animal having a tuberculosis infection and an animal vaccinated against tuberculosis infection.
9. A diagnostic reagent comprising a polypeptide consisting of amino acid sequence QANLGEAAGTYVAADAAAAS (SEQ ID NO:8), the diagnostic reagent optionally further comprising a polypeptide consisting of amino acid sequence MTENLTVQPERLGVLASHHDNAAVDASSGVEAAAGLGESVAITHGPYCSQFNDTLNVYLTAHNALGSSLHTAGVDLAKSLRIAAKIYSEADEAWRKAIDGLFT (SEQ ID NO:46),
wherein the diagnostic reagent is a sterile injectable preparation,
and wherein the diagnostic reagent is capable of eliciting a positive result when used in an assay to determine whether an animal has a tuberculosis infection or has been exposed to a tuberculosis agent, is capable of eliciting a negative result when the animal has been vaccinated against infection by a tuberculosis agent, and is capable of eliciting a negative result when the animal is unvaccinated and uninfected or unexposed to a tuberculosis agent.
10. The diagnostic reagent of claim 9 , wherein the sterile injectable preparation is an aqueous or an oleaginous suspension, or a suspension in a non-toxic parenterally-acceptable diluent or solvent.