The World Health Organization estimates that more than one-third of the worldwide population is infected with Mycobacterium tuberculosis (MTB), the causative agent of most cases of tuberculosis (TB). Patients who are infected with MTB, but do not have active TB disease have latent tuberculosis infection (LTBI), a non-communicable, asymptomatic condition which might develop into active TB disease months or years later. Early diagnosis of LTBI is critical for the management, containment, and prophylactic treatment necessary in order to prevent active disease and future epidemics. We propose to develop the novel PACeR-Gold multiplex pathogen identification platform for sequence-specific MTB-derived nucleic acid detection. The PACeR-Gold assay will be optimized in Phase I and incorporated into an accurate, automated, and user-friendly device for assay performance and detection during Phase II. We will develop a uniform PACeR-Gold instrument platform with a plug-and-play system of disposable assay cartridges for early, specific, and rapid detection of MTB DNA. Our closed cartridge system allows for consistent and reproducible results, eliminates the risk for amplicon contamination in the assay, and does not require highly trained operators. The PACeR-Gold diagnostic platform will be continuously expanded to include assays to detect nontuberculous mycobacteria, multidrug-resistant-TB, extensively drug-resistant-TB, and other MTB variants.
Keywords: Nucleic Acid Amplification, Molecular Diagnostics, Mycobacterium Tuberculosis
