METHOD FOR PREDICTING TUBERCULOUS INFECTION, RECOMBINANT PLASMID DNA CODING THE SYNTHESIS OF CFP10-ESAT6 HYBRID PROTEIN OUT OF MYCOBACTERIUM TUBERCULOSIS, THE METHOD OF ITS OBTAINING, CFP10-ESAT6 HYBRID PROTEIN AND ITS APPLICATION Russian patent published in 2006 - IPC C07K19/00 C12N15/63 C12P21/00 C12Q1/04 A61K39/04 C12R1/32 

FIELD: biotechnology, medicine.

SUBSTANCE: the present innovation deals with CFP10-ESAT6 hybrid protein that is able to induce Mycobacterium tuberculosis-specific hypersensitivity reaction of delayed type. This hybrid protein contains complete protein CFP10 out of M.tuberculosis combined with complete protein ESAT6 out of M.tuberculosis through linker amino acid sequence. It is, also, [presented a recombinant plasmid DNA pTBD16 for expression of hybrid protein CFP10-ESAT6. The latter should be obtained due to applying DLT1270 E.coli strain transformed with the obtained recombinant plasmid DNA pTBD16. The innovation suggests to apply the above-mentioned protein as a diagnostic kit of tuberculous infection both in mammalians and human beings. The method for predicting tuberculous infection has been revealed. Tuberculous infection should be predicted due to induction of hypersensitivity reaction of delayed type in case of subcutaneous injection of hybrid protein. Application of the present innovation enables to obtain a Mycabacterium tuberculosis-referring diagnostic kit, at specificity being 100%, sensitivity - 80%, not less.

EFFECT: higher accuracy and efficiency of diagnostics.

6 cl, 4 dwg, 4 ex