Point-of-care HIV viral load system using RPA and MXR

摘要 监测抗逆转录病毒治疗疗效的最准确方法是通过核酸 直接测量HIV RNA（病毒载量）的扩增试验（NAAT）。发展中国家和 发达国家这些测试主要在城市中心的集中实验室进行。 然而，大量艾滋病毒感染者居住在农村地区， 缺乏交通、财政限制或这些因素的结合会更好 通过更接近护理点（POC）的测试来服务。尽管便携式核酸技术取得了进步， 酸放大技术仍然有很大的机会，以提高负担能力，时间， POC HIV病毒载量（VL）检测的简单易用性。为此，我们将完成 我们开发了快速、样本到答案的HIV VL检测，在这些方面实现了更好的指标 比今天的商业平台。 在这个第二阶段的项目中，我们将继续与PATH的诊断程序合作 （西雅图，华盛顿州）完成并测试完成的器械。在Aim 1中，Redbud Labs将完成并 将测试盒和设备集成到一个紧凑、坚固的仪器中。In Aim 2 Redbud Labs 将验证自动检测试剂盒的定量和基因组覆盖率。在Aim 3中， 使用临床样本对系统进行分析验证，将这些结果与 黄金标准。在这个项目的完成，我们将有一个平台准备多个网站的临床 验证。

ABSTRACT The most accurate way to monitor the efficacy of antiretroviral therapy is through nucleic acid amplification tests (NAATs) that directly measure HIV RNA (viral load). In the developing and developed world these tests are primarily conducted in centralized laboratories in urban centers. However, a significant number of persons living with HIV reside in rural locations, and due tolack of transportation, financial constraints, or a combination of these factors, would be better served by a test closer to the point-of-care (POC). Despite advancements in portable nucleic acid amplification technology there remains significant opportunity to improve affordability, time- to-result, and ease-of-use of POC HIV viral load (VL) testing. To this end we will complete development of our rapid, sample-to-answer HIV VL test that achieves better metrics in these areas than today’s commercial platforms. In this Phase II project, we will continue our collaboration with the Diagnostics Program at PATH (Seattle, WA) to finalize and test the completed device. In Aim 1 Redbud Labs will finalize and integrate the test cartridge and device into a compact, robust instrument. In Aim 2 Redbud Labs will verify quantitation and genomic coverage of the automated assay. In Aim 3 PATH will perform analytic validation of the system using clinical samples, comparing those results against a gold standard. At this project’s completion we will have a platform ready for multi-site clinical validation.