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

描述（由申请人提供）：Fenway Bioscience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装置，用于检测非人灵长类动物的感染因子。该分析使用一滴全血，给出了一个视觉终点，并消除了对样品制备或仪器的需要。该设备将允许在实际动物饲养区对单个动物中的病原体和潜在的人畜共患病因子进行测试。该设备可用于现场筛选和选择动物，或监测动物，因为它们通过检疫逐步进入生物科学设施进行研究和测试。该设备将使兽医人员能够确保个体动物的无特定病原体（SPF）状态，防止已建立的非人灵长类动物群体中的动物流行病，并将疾病和/或生物变量引入研究和测试的可能性降至最低。本申请的具体目的是开发一种侧流多路装置，其将同时检测：猿猴逆转录病毒病（SRVD）、猿猴免疫缺陷病毒（SIV）、猿猴T淋巴细胞病毒-1和2、猿猴疱疹病毒（B病毒）和麻疹。根据NIH的说法，这些病毒是使用非人类灵长类动物进行研究的最普遍和潜在破坏性的病毒之一。该项目的成功将导致在同一平台上对不太流行的猿类疾病进行测试。所提出的方法是高度创新的，因为没有检测非人灵长类动物疾病病原体的直接测试。中国、印度尼西亚、柬埔寨、毛里求斯和越南迫切需要进行现场测试，因为现场捕获的动物和群体在过境前无法随时进入实验室进行检疫测试。在美国和其他国家，大多数规模较小的非人类灵长类动物设施没有现场实验室。使用该设备的大型设施将节省时间并降低成本。公共卫生相关性：在美国，大约有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。许多猴子疾病可传染给人类，并造成严重后果。我们的设备承诺在不到30分钟的时间内从一滴全血中检测出疾病，而无需设备。目前在美国以外的繁殖和收集地区的测试是有缺陷的，这里存在对这种设备的极其迫切的需求。

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.