Described herein is a Mycobacterium mutant, comprising at least one mutation in at least one gene sequence encoding global gene regulators (GGRs) selected from the group consisting of sigH, sigL, sigE, ECF-1, and mixtures thereof, wherein the GGR gene is at least partially inactivated. Described herein also is a vaccine based on the mutant and a method of differentiating between subjects that have been infected with Mycobacterium and subjects that have not been infected with Mycobacterium or have been vaccinated with a Mycobacterium vaccine.

An immunochromatography includes steps of mixing a specimen capable of containing an antigen and a modified particle, which is a particle modified with a substance having a specific affinity to the antigen, to obtain a mixture containing particle composite bodies; sedimenting the particle composite bodies in the mixture using a centrifuge; dissociating the sedimented particle composite bodies into the particles and the antigen by mixing the sedimented particle composite bodies with a dissociation solution, recovering an antigen-concentrated solution by sedimenting the dissociated particles using a centrifuge; neutralizing the antigen-concentrated solution using a neutralization solution; spreading particle composite bodies for labeling on an insoluble carrier having a reaction site, in a state where the particle composite bodies for labeling, which are composite bodies of the antigen in the neutralized antigen-concentrated solution and a modified particle for labeling, are formed; and capturing the particle composite bodies for labeling at the reaction site.

The present invention relates to a DNA aptamer binding specifically to early secretory antigenic target 6 kDa (ESAT6), a biosensor for diagnosis of tuberculosis, comprising the same, and a method for providing information for diagnosis of tuberculosis. The present inventors found that not only does a DNA aptamer according to the present invention have specific binding potential to ESAT6 protein, but also the binding affinity is excellent. When used, the DNA aptamer of the present invention can be thus expected to exhibit greater stability than a conventional ELISA method using an antibody. Hence, the aptamer is expected to find useful applications in the development of compositions for tuberculosis diagnosis, biosensors for tuberculosis diagnosis, and information providing methods for tuberculosis diagnosis.

Provided are high affinity Mycobacterium tuberculosis capsule-specific antibodies and fragments thereof, as well as methods of use and devices employing such antibodies and/or fragments.

The present invention relates to a method for detecting Mycobacterium tuberculosis, which can replace the conventional culture method that takes a long time of four to eight weeks to detect active tuberculosis, and which is a method for detecting active Mycobacterium tuberculosis by using isotopes on a sample of a patient's sputum or bronchoalveolar lavage fluid.

The present invention relates to methods and kits for detecting active tuberculosis infection in a subject using serological techniques and a first agent capable of binding an IgG, IgA and/or IgM directed to the first protein present in or on a Mycobacterium tuberculosis membrane vesicle or a Bacillus Calmette-Guerin (BCG) membrane vesicle. Also provided are methods of treating a subject with an active tuberculosis disease.

The present disclosure provides methods, reagents, systems, and devices that target β lactamase as a biomarker for the sensitive and specific detection of tuberculosis-complex bacteria. Specifically, the present disclosure relates to methods and compositions for the detection of specific β-lactamase protein and nucleic acid sequences to indicate the presence of tuberculosis-complex bacteria.

The present disclosure provides methods of detecting mycobacterium in an individual, generally involving detecting antibody to a mycobacterial lipid in a biological sample obtained from the individual. The present disclosure further provides compositions and kits for carrying out the methods.

A method and system for detecting TB in a bodily fluid sample are described. By extracting extracellular vesicles (EVs) from the bodily fluid sample and employing antibody-conjugated nanoparticles to capture Mtb-related biomarkers, it is shown that the test can be completed within hours instead of weeks, and the detection limit can be significantly lowered with high accuracy. Additionally, the method and system described is capable of distinguishing between active and latent TB infections.

The present invention refers to the use of gene sequences or portions thereof characterized in that the same belong to the classes of in vitro and ex vivo induced, repressed or conserved genes in Mycobacterium tuberculosis currently infected human macrophages and to corresponding peptides or consensus peptides or proteins for the preparation of specific bio-markers for the diagnosis and prevention of active or latent disease.