A Rapid Lateral Flow Test for TB in Nonhuman Primates

非人类灵长类动物结核病的快速侧向层析检测

• 批准号: 6691933
• 负责人: Carol A. Nacy
• 金额: $ 98.64万
• 依托单位: SEQUELLA, INC.
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-01 至 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6691933
• 关键词: Rapid; Lateral; Flow; Test; TB

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.

描述（由申请人提供）：该项目的目的是开发并推销非人类灵长类动物的结核病（TB）的新诊断测试。 新的诊断基于感染动物的检测，对一组重组TB抗原的抗体。提出的格式是专有的侧向流程测试，它使用一滴血液，并在15分钟内产生视觉结果。 具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，已经从事合作研究和开发事业，以开发和销售新的诊断。 在一项I期可行性研究的成功之后，II期提出的工作紧密着重于快速完成测试的开发和验证。 根据USDA的要求，生产详细的过程标准化，质量控制以及确保每次诊断测试的等效性的方法将准备好供美国农业部的批准。最终商业格式的测试套件将被制造并用于获得许可功效数据。寻求的说法是，该测试将诊断由结核分枝杆菌（M. TB）或猕猴中的Bovis引起的结核病，并且该测试因对M. avium/avium/avium intace ellulare，M.Kansasii，M。kansasii，m. gordonae，或M. gordonae，或M. gordonae，或M. gordonae，或M. scrofoface，Scrofoface scrofoface scrofoface scrofoface scrofface scrofface s scrofoface n M. avium/avium scrofoface n.在可能的范围内，来自自然感染动物的血清将用于估计敏感性和特异性。将根据需要进行实验感染，以提供USDA所需的数据。 预计所得的测试将在敏感性，特异性和操作简单性方面具有比当前结核蛋白皮肤测试的优势。许多参与非人类灵长类动物殖民地管理的个人和实体，包括灵长类动物兽医协会，美国国立卫生研究院国家研究资源中心和疾病控制中心，呼吁在非人类灵长类动物中开发更好，更可靠的结核病测试，并被NIH SBIR计划称为“紧急需要”。