A RAPID LATERAL FLOW TEST FOR TB IN NONHUMAN PRIMATES

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。该SBIR项目的总体目标是开发并将改进的非人灵长类动物结核病（TB）诊断测试推向市场。该测试的格式是一个侧流分析，可以使用全血，血清或血浆，并可以在15分钟内检测抗体的特定抗原。第二阶段研究的目的是验证侧流诊断试验的灵敏度、特异性和实用性，并满足USDA许可的要求。在本研究的I期，使用接种M.结核在这项研究中（第二阶段），猴子接受环境分枝杆菌（M。kansasii和M. avium）以测试假阳性反应。通过两次环境分枝杆菌接种，试验保持阴性。为了验证试验的阳性灵敏度，用低剂量的M.牛对这些样本的分析仍在继续。

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.