Multiplex On-site Device for Rapid Detection of 5 Infectious Diseases In Simians

描述(申请人提供)：芬威生物科学公司正在开发一种新的、易于使用、快速、灵敏和低成本的多重检测设备，用于检测非人类灵长类动物的感染性病原体。该分析使用一滴全血，提供了一个直观的终点，并且不需要样品准备或仪器。该设备将允许在实际的动物收容区测试单个动物中的病原体和潜在的人畜共患病病原体。该设备可用于现场筛选和选择动物，或在动物经过检疫逐步处理进入生物科学设施进行研究和测试时进行监测。该设备将使兽医人员能够确保单个动物的无特定病原体(SPF)状态，防止已建立的非人类灵长类动物群体之间的流行性感冒，并将疾病和/或生物变量引入研究和测试的程度降至最低。本应用的具体目的是开发一种可同时检测猴逆转录病毒病(SRVD)、猿猴免疫缺陷病毒(SIV)、猿猴T淋巴细胞病毒-1和2、猴疱疹病毒(B病毒)和麻疹的横向流动多重设备。根据美国国立卫生研究院的说法，这些病毒是最流行的病毒之一，对使用非人类灵长类动物的研究具有潜在的破坏性。该项目的成功将导致在同一平台上对不太流行的猿病进行测试。建议的方法是高度创新的，因为没有直接测试来检测非人类灵长类疾病病原体。在中国、印度尼西亚、柬埔寨、毛里求斯和越南，迫切需要进行实地检测，在这些国家，野外捕获的动物和群体在过境前无法随时进入实验室对正在检疫的动物进行检测。在美国和其他国家，大多数规模较小的非人类灵长类设施都没有现场实验室。使用该设备的较大设施将节省时间和降低成本。与公共卫生相关：在美国，大约56,000只猴子在生命科学研究中发挥着关键作用，因此它们必须没有传染病。许多猴子疾病可以传播给人类，造成严重后果。我们的设备承诺在30分钟内从一滴全血中检测出疾病，而不需要设备。目前在美国以外的育种和收集区进行的检测是不足的，这里对这种设备的需求非常迫切。

DESCRIPTION (provided by applicant): Fenway Bioscience is developing a new, easy to use, rapid, sensitive and low cost multiplex assay device to detect infectious agents of nonhuman primates. The assay uses a drop of whole blood, gives a visual endpoint and eliminates the need for sample preparation, or instrumentation. This device will allow testing in the actual animal holding areas for pathogenic and potentially zoonotic agents among individual animals. The device can be used in the field to screen and select animals, or monitor animals as they are progressively processed through quarantine into bioscience facilities for research and testing. This device will enable veterinary personnel to ensure the specific pathogen free (SPF) status of individual animals, prevent epizootics among colonies of established nonhuman primates and minimize the introduction of disease and/or biological variables into research and testing. The specific aim of this application is to develop a lateral flow multiplex device, which will simultaneously detect: Simian Retro Viruses Diseases (SRVD), Simian Immunodeficient Virus (SIV), Simian T- Lymphocyte Viruses-1 and 2, Herpes simiae virus (B Virus) and Measles. According to NIH, these viruses are among the most prevalent and potentially damaging to research using nonhuman primates. Success with this program will lead to tests, on the same platform, for less prevalent simian diseases. The proposed approach is highly innovative because there are no direct tests for detecting nonhuman primate disease agents. An urgent need exists for field-testing in China, Indonesia, Cambodia, Mauritius and Vietnam where field captured animals and colonies do not have ready access to laboratories for testing animals in quarantine prior to transit. In the US and other countries, most smaller nonhuman primate facilities do not have on-site laboratories. Larger facilities using this device will save time and reduce costs. PUBLIC HEALTH RELEVANCE: Some 56,000 monkeys perform critical roles in life science research in the USA, for which they must be free of infectious diseases. Many monkey diseases are transmissible to humans with severe consequences. Our device promises detection of diseases in less than 30 minutes from a drop of whole blood and without equipment. Current testing in breeding and collection areas outside the USA is deficient and here an extremely urgent need exists for such a device.