Rapid detection of tuberculosis using DPP technology

描述（由申请人提供）：结核病是由结核分枝杆菌引起的慢性传染病，目前全球估计有20亿人感染，每年发现数百万新病例。目前的诊断方法是缓慢和/或不可靠的。因此，迫切需要新的诊断方法来解决全球结核病负担并改善控制规划。

DESCRIPTION (provided by applicant): Tuberculosis is a chronic infectious disease caused by Mycobacterium tuberculosis with an estimated 2 billion people currently infected worldwide and several million new cases detected each year. Current methods of diagnosis are slow and/or unreliable. Therefore, new diagnostics are urgently needed to address the global tuberculosis burden and improve control programs. The goal of this application is to develop a simple, rapid, accurate, and cost-effective serological test for active tuberculosis that can be utilized in resource-limited settings. This test will use the innovative Dual Path Platform (DPPTM) technology developed and patented by the investigator Chembio Diagnostic Systems, Inc., and selected antigens from a large panel of novel recombinant antigens identified at the Infectious Disease Research Institute (IDRI). The proposed assay will detect specific antibodies and demonstrate improved sensitivity and specificity over the existing rapid tests. Assay improvements will result from both the Chembio proprietary immunoassay advances and the extensive portfolio of novel antigens available from IDRI. The test will be developed for point-of-care or field application, with results produced within 15 minutes of addition of blood sample to the assay. In addition to the visual reading, there will be an option for automated readout of the test result. The two specific aims of the Phase I studies will result in a prototypic test and determine the feasibility of proceeding into Phase II work: 1. Define the selection of tuberculosis antigens for a DPP test prototype. Using a large panel of novel antigens discovered by IDRI and efficient screening method developed by Chembio (termed MAPIA) the most seroreactive antigens recognized by serum antibodies will be identified. 2. Develop a prototype DPP test for tuberculosis. Cocktails of the most seroreactive antigens will be designed and components of the DPP assay format will be optimized to develop a prototype diagnostic test to detect the greatest number of tuberculosis patients. The feasibility of proceeding to Phase II with the DPP prototype will be established if: 1) the test sensitivity is >80% and 2) the test specificity is >95%. No commercial product for rapid, point-of-care TB diagnosis with such functional and performance characteristics is available on the market. Thus, developing the proposed DPP-based test for tuberculosis will be a major improvement. PUBLIC HEALTH RELEVANCE Tuberculosis remains one of the leading causes of mortality due to infectious disease worldwide. The current methods for diagnosis of tuberculosis are time-consuming, complex and laborious, and/or too expensive for routine use in resource-limited settings where most of patients live. The delayed or missed diagnosis leads to spreading of infection, progression of disease, and increased mortality. The research proposed here aims at developing a simple and rapid point-of-care diagnostic test that would improve control programs by helping accurately detect new cases of tuberculosis, enabling timely antibiotic therapy, and preventing disease transmission.