A Rapid Lateral Flow Test for TB in Nonhuman Primates

描述(由申请人提供)：该项目的目标是开发一种新的非人类灵长类动物结核病(TB)诊断测试并将其推向市场。新的诊断是基于在受感染的动物身上检测到一组重组结核病抗原的抗体。拟议的格式是一种专有的侧向血流测试，它使用一滴血，并在15分钟内给出可视结果。 拥有互补专业知识领域的两家美国小型生物技术公司--Sequella Inc.和ChemBio诊断系统公司--已进入一项合作研究和开发合资企业，以开发和销售这种新型诊断设备。 在第一阶段可行性研究取得成功之后，第二阶段的拟议工作将紧紧集中在迅速完成测试的开发和验证上。 根据美国农业部的要求，将编制一份生产细节流程标准化、质量控制和确保每批诊断测试等价性的方法大纲，供美国农业部批准。最终商业格式的测试试剂盒将被制造出来，并用于获得获得许可的疗效数据。要寻求的是，该检测将在猕猴和鲑鱼物种中诊断由结核分枝杆菌(M.TB)或牛分枝杆菌引起的结核病，并且该检测不会因感染/暴露于禽分枝杆菌/细胞内分枝杆菌、堪萨斯分枝杆菌、戈登分枝杆菌或丝状分枝杆菌而给出假阳性结果。在可能的范围内，来自自然感染动物的血清将用于评估敏感性和特异性。将根据需要进行实验性感染，以提供美国农业部所需的数据。 由此产生的试验有望在敏感性、特异性和操作简单性方面优于目前的结核菌素皮肤试验。许多参与管理非人类灵长类动物群体的个人和实体，包括灵长类兽医协会、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、更可靠的非人类灵长类结核病检测方法，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.