Antigen Detection Assay for Tuberculosis

DESCRIPTION (provided by applicant): Antigen detection assay in contrast to conventional serological test, detects disease status and not the host antibody response to the disease etiological agent. It can therefore be used for both diagnosis and disease treatment follow-up purposes. Antigen detection assay has recently been successfully introduced for the diagnosis of different infectious diseases including hepatitis, pneumonia caused by Streptococcus pneumoniae or Legionella pneumophilla, sore throat cause by Streptococcus pyogenes, and amoebiasis. Although antigen detection assay has the potential to discriminate latent from adult tuberculosis, paradoxically this test has not yet been developed for this disease. Using the ultra-sensitive mass spectrometry technology we have recently described the presence of M. tuberculosis proteins in urine of infected mice. The proteins were sequenced, the encoding genes were cloned, and the recombinant proteins were obtained. One such molecule revealed to be a promising tool for the diagnosis of tuberculosis. Using similar approach we have recently identified M. tuberculosis antigens in urine of human patients with pulmonary tuberculosis. The present project aims to produce the corresponding recombinant proteins and use them as well as the ones previously described in mouse model to develop antigen detection assays for the diagnosis of tuberculosis disease.