The goal of the research is to develop a rapid, lateral flow, antibody-based diagnostic test for tuberculosis (TB) in nonhuman primates. The unreliability of the present TB skin test underlies the frequent devastating outbreaks of TB among primates in zoos, quarantine facilities, and in colonies maintained for use in medical research. False positive responses to the present skin test result in the needless destruction of many healthy animals each year. An improved method of diagnosing TB in nonhuman primates is urgently needed. The research proposed is a feasibility study of a new approach to the diagnosis of simian TB, based upon the occurrence of antibodies to TB antigens during the course of the disease. Two U.S. biotechnology companies will pool their resources, which include a bank of stored serum samples and a valuable collection of recombinant proteins and peptides from Mycobacterium tuberculosis. The Phase I research would assess the feasibility of developing a rapid lateral flow diagnostic that would require only a drop of blood and would provide accurate results within minutes. The proposed assay is based upon an innovative proprietary technology. Quantitative criteria for establishing the feasibility of this novel approach are stated, and require demonstrating high sensitivity and specificity of a prototype assay during Phase I.
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