A RAPID LATERAL FLOW TEST FOR TB IN NONHUMAN PRIMATES

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这个SBIR项目的总体目标是开发一种改进的非人类灵长类动物结核病(TB)诊断测试，并将其推向市场。这种检测的形式是一种侧向流动分析，可以使用全血、血清或血浆，并可以在15分钟内检测到特定抗原的抗体。第二阶段研究的目标是验证横向流动诊断试验的敏感性、特异性和实用性，并满足美国农业部许可的要求。在这项研究的第一阶段，使用接种了结核分枝杆菌的猴子的血清来选择测试抗原。在这项研究(第二阶段)中，猴子接受了环境分枝杆菌(堪萨斯分枝杆菌和航空分枝杆菌)以测试假阳性反应。通过两次接种环境分枝杆菌，检测仍为阴性。为了验证试验的阳性敏感性，给猴子接种了低剂量的牛分支杆菌。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.