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

描述(申请人提供)：全球艾滋病毒/艾滋病流行继续因大量不知道自己感染了艾滋病毒的人而加剧。美国疾病控制与预防中心正在支持减少这一数字的计划，鼓励对所有年龄段的人进行更频繁的检测，并增加检测场所，包括最近FDA批准对抗HIV抗体进行口服HIV筛查测试。也就是说，反应(即阳性)测试仍然需要验证性测试，这通常需要第二次去看健康专业人员。此外，从感染到检测到病毒抗体，还有几个星期的“血清转换”窗口。在这段时间里，HIV病毒载量处于最高水平，增加了 传播给其他人的机会。在过去的几年里，Rheonix Inc.和纽约大学一直在合作开发一种新型的医疗设备，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动的筛查测试(抗体)与使用等温扩增(LAMP)的病毒RNA确认性分子测试相结合。利用Rheonix的专利技术，正在开发的设备利用基于微流控的一次性卡，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，该设备便于携带，适用于小型诊所或现场使用。目前的快速通道SBIR提案的结果将在两年内完成这种双通道设备的开发，利用我们关于这一创新方法所有方面的初步数据。双路径护理点方法的影响将使“检测和治疗”计划能够快速识别感染者并加速他们的治疗，最终减轻社区的病毒负担。

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.