A RAPID LATERAL FLOW TEST FOR TB IN NONHUMAN PRIMATES

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The overall objective of this SBIR project is to develop and bring to market an improved diagnostic test for tuberculosis (TB) in nonhuman primates. The format of this test is a lateral flow assay that can use whole blood, serum, or plasma, and can detect antibodies to specific antigens within 15 minutes. The objective of the Phase II research is to validate the lateral flow diagnostic test in terms of sensitivity, specificity, and utility, and to meet the requirements for USDA licensure. In Phase I of this study, test antigens were selected using sera from monkeys inoculated with M. tuberculosis. In this study (Phase II) monkeys received environmental mycobacteria (M. kansasii and M. avium) to test for false positive reactions. The test remained negative through two inoculations of environmental mycobacteria. To validate the positive sensitivity of the test, monkeys were inoculated with a low dose of M. bovis. Analysis of these samples continues.