Development of a field-appropriate biosensor for detecting Mycobacterium tuberculosis infection

Tuberculosis (TB) is a disease caused by Mycobacterium tuberculosis (Mtb) that primarily affects the lungs. Approximately one third of the world"s population is latently infected with Mtb and at risk for developing active TB disease. Mtb grows slowly with visible growth appearing on solid media in 3 to 6 weeks. Automated broth systems requires a minimum of 9 days. Currently used rapid diagnostic assays are complex laboratory tests and do not differentiate between latent and active TB infection. There is an urgent need for inexpensive, sensitive, specific, rapid, simple to perform, point-of-care assay for correct TB diagnosis. Phase I research will entail: (1) developing an electrochemical multiplex nano-bead biosensor for measuring plasma cytokine and chemokine concentrations, (2) evaluating the potential of using IFN-Gamma -inducible CXC chemokines as biomarkers of Mtb infection, (3) designing a more refined point-of-care, simple-to-perform assay that is based on the detection of IFN-Gamma-inducible CXC chemokines (used in Phase II), and (4) writing a clinical protocol that will be used in Phase II for preliminary evaluation of the biosensor as an alternative to TST and IGRAs. The proposed immunoassay will facilitate the development of a more accurate, less expensive, point-of-care test for Mtb infection.