A Rapid Lateral Flow Test for TB in Nonhuman Primates

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DESCRIPTION (provided by applicant): The goal of this project is to develop and bring to market a new diagnostic test for tuberculosis (TB) in nonhuman primates. The new diagnostic is based upon the detection, in infected animals, of antibodies to a set of recombinant TB antigens. The proposed format is a proprietary lateral flow test that uses a drop of blood and gives a visual result within 15 minutes. Two small U.S. biotechnology companies with complementary areas of expertise, Sequella Inc. and Chembio Diagnostic Systems, have entered into a cooperative research and development venture to develop and market the new diagnostic. Following on the success of a Phase I feasibility study, the work proposed for Phase II is tightly focused on rapidly completing the development and validation of the test. As required by the USDA, an Outline of Production detailing process standardization, quality control, and the method for assuring equivalency of each lot of diagnostic tests will be prepared for the approval of the USDA. Test kits in the final commercial format will be manufactured and used to obtain the efficacy data for licensure. The claims to be sought are that the test will diagnose TB caused by either Mycobacterium tuberculosis (M. tb) or M. bovis in macaque and saimiri species of primates, and that the test does not give false positive results due to infections/exposures to M. avium/intracellulare, M. kansasii, M. gordonae, or M. scrofulaceum. To the extent possible, sera from naturally infected animals will used to estimate sensitivity and specificity. Experimental infections will be conducted as needed to provide the data required by the USDA. The resulting test is expected to have advantages over the present tuberculin skin test in terms of sensitivity, specificity, and operational simplicity. Many individuals and entities involved in the management of nonhuman primate colonies, including the Association of Primate Veterinarians, the NIH National Center for Research Resources, and the Centers for Disease Control have called for the development of a better, more reliable test for TB in nonhuman primates, and it has been termed an "urgent need" by the NIH SBIR program.