A Rapid Lateral Flow Test for TB in Nonhuman Primates

描述（由申请人提供）：本项目的目标是开发一种新的非人灵长类动物结核病（TB）诊断测试并推向市场。 新的诊断方法是基于在受感染的动物中检测到一组重组结核抗原的抗体。拟议的格式是一种专有的侧流测试，使用一滴血，并在15分钟内给出目视结果。 两家拥有互补专业领域的美国小型生物技术公司Sequella Inc.和Chembio诊断系统公司已经进入了一个合作研究和开发企业，以开发和销售新的诊断。 在第一阶段可行性研究取得成功之后，第二阶段的工作重点是快速完成测试的开发和验证。 根据USDA的要求，将编制详细说明工艺标准化、质量控制和确保每批诊断检测等效性的方法的生产大纲，以供USDA批准。将生产最终商业格式的检测试剂盒，并用于获得许可的有效性数据。所寻求的声明是，该测试将诊断结核病引起的结核分枝杆菌（M。tb）或M.在猕猴和saimiri种灵长类动物中，该试验不会由于感染/暴露于牛支原体而产生假阳性结果。avium/intracellulare，M. kansasii，M. gordonae或M.淋巴结核在可能的范围内，将使用来自自然感染动物的血清来估计灵敏度和特异性。将根据需要进行实验感染，以提供USDA要求的数据。 由此产生的测试，预计有优势，目前结核菌素皮肤试验的敏感性，特异性和操作简单。许多参与非人灵长类动物群体管理的个人和实体，包括灵长类动物兽医协会、NIH国家研究资源中心和疾病控制中心，都呼吁开发一种更好、更可靠的非人灵长类动物结核病检测方法，NIH SBIR计划将其称为“迫切需要”。

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.