Development of an Alternative Screening Method for Detecting Evidence of Mycobacterium Tuberculosis Infections

The objective of this proposal is to develop an alternative to the tuberculin test and interferon- & #61543; & #61472;release assays for the diagnosis of active and latent tuberculosis. Toward this end, a rapid lateral flow test based on the detection of blood antibodies specific to Mycobacteria tuberculosis antigens will be devised for the serodiagnosis of active and latent TB. Selected and highly immunogenic antigen panel from regions of difference in the genome of M. tuberculosis will be attempted. An extensive TB serum collection that will also contain a sufficient number of co-infected HIV and TB samples and multidrug resistant TB samples will be assembled to ensure statistically significant analysis. A number of novel approaches to enhance the overall sensitivity of the lateral flow immunochromatographic devices will be investigated. The recombinant antigens will be screened by ELISAs and lateral flow immunochromatographic assays using our TB and control serum collections. It is expected that an optimal combination of antigens will be formulated to achieve highest possible response rate for TB detection with the lateral flow format. Site(s) for clinical evaluation of the best performing lateral flow devices will be selected such that clinical data needed for a 510K FDA application can be collected.