Point-of-care Detection of HIV Antibodies and RNA in Blood and Saliva

描述（由申请人提供）：全球艾滋病毒/艾滋病流行继续由大量不知道自己被感染的人推动。疾病预防控制中心正在支持通过鼓励对所有年龄组进行更频繁的测试以及增加测试场所来减少这一数字的计划，包括最近FDA批准的抗HIV抗体的口服HIV筛查测试。也就是说，反应性（即，阳性）测试仍然需要进行确认测试，这通常需要第二次访问健康专业人员。此外，从感染到可以检测到病毒抗体，有一个数周的"血清转换"窗口。在此期间，艾滋病毒载量处于最高水平， 传播给其他人的机会。在过去的几年里，Rheonix Inc.和纽约大学合作开发了一种新型的即时检测设备，可以在不到1小时的时间内同时检测抗HIV抗体和病毒核酸。从一滴血液或唾液样本开始，我们已经能够将使用侧向流的筛选测试（抗体）与利用等温扩增（LAMP）的病毒RNA的确认性分子测试相结合。采用Rheonix的专利技术，正在开发的设备利用基于微流体的一次性CARD，只需按下按钮即可简单操作，在不到60分钟的时间内提供抗体和核酸的是/否结果，该设备便携且实用，适用于小型诊所或现场使用。本快速SBIR提案的结果将在2年内完成该双通道器械的开发，利用我们关于该创新方法各个方面的初步数据。双途径护理点方法的影响将允许“检测和治疗”计划快速识别感染个体并加速其治疗，最终降低社区的病毒负担。

DESCRIPTION (provided by applicant): The global HIV/AIDS epidemic continues to be fueled by the large number of individuals who do not know that they are infected. The CDC is supporting programs to decrease this number by encouraging more frequent testing of all age groups as well as increasing the venues for testing including the recent FDA approval of an oral HIV Screening test for anti-HIV antibodies. That said, a reactive (i.e., positive) test still requies a confirmatory test that often requires a second visit to a health professional. Additionally, ther is a "seroconversion" window of many weeks from the time of infection until antibodies to the virus can be detected. In this interval HIV viral loads are at their highest levels, increasing the chance for transmission to other individuals. Over the past several years, Rheonix Inc. and NYU have been collaborating on a novel point-of-care device to simultaneously detect both anti-HIV antibodies and viral nucleic acid in less than 1 hour. Starting with a drop of blood or a saliva sample, we have been able to combine a screening test (antibody) using lateral flow with a confirmatory molecular test for viral RNA utilizing isothermal amplification (LAMP). Employing Rheonix's patented technology, the device being developed utilizes a microfluidic-based disposable CARD" that can be simply operated with the push of a button to provide a yes/no result for both antibody and nucleic acid in less than 60 minutes on a device that is portable and practical for both small clinics or field use. The results from the present fast-track SBIR proposa will complete the development of this dual pathway device in 2 years utilizing our preliminary data on all aspects of this innovative approach. The impact of the dual pathway point-of-care approach will permit a "test and treat" program to rapidly identify infected individuals and accelerate their treatment, ultimately decreasing the viral burden in a community.