A Rapid HIV RNA Detection without Sample Preparation

一种无需样品制备的HIV RNA快速检测方法 CrossLife Technologies Inc. 项目总结/摘要 及早诊断新感染个案及发现病毒反弹 艾滋病治疗是有效管理艾滋病毒的关键。在许多诊断 近年来，自我测试越来越被接受，但 基于免疫测定的家庭测试对于早期诊断不够敏感， 与治疗监测不兼容。在这个项目中，我们建议开发一个快速， 灵敏、特异、简单、经济的RNA检测诊断技术， 未经处理的血液样本该技术具有独特的化学创新 在生物分子测定（塔拉）和我们的能力，在集成和自动化这些创新 在简单的设备上进行精确的时间控制。R61阶段（目标1-3）的重点是 技术开发、集成和优化; R33阶段（目标4-5）的重点是 使用存档样本和前瞻性临床样本进行技术验证。这些 具体任务将由一个高度多学科的小组执行， 合作和互补的专业知识。如果成功，检测试剂盒将启用诊断 和病毒载量监测的个人在他们的家或在药房，并适合于 艾滋病毒最流行的资源最少的环境。灵敏的诊断和监测 使人们能够及早接受治疗，减少艾滋病毒的传播。

A Rapid HIV RNA Detection without Sample Preparation CrossLife Technologies Inc. Project Summary/Abstract Early diagnosis of new infections and detection of emergence of viral rebound for individuals on treatment hold the key to effective management of HIV. Among many diagnostic approaches, self-testing has become increasingly acceptable in recent years, but immunoassay-based home tests are insufficiently sensitive for early diagnosis and incompatible with treatment monitoring. In this project, we propose to develop a rapid, sensitive, specific, simple, and cost-effective diagnostic technology for RNA detection in unprocessed blood samples. The proposed technology features unique chemistry innovations in biomolecular assays (TARA) and our ability in integrating and automating these innovations onto simple devices with precisely time-gated steps. The R61 phase (Aims 1-3) focuses on technology development, integration, and optimization; and the R33 phase (Aims 4-5) focuses on technology validation using archived samples and prospective clinical samples. These specific tasks will be carried out by a highly multidisciplinary team with well-established collaborations and complementary expertise. If successful, the test kit will enable diagnosis and viral load monitoring by individuals in their home or in a pharmacy and be appropriate for minimal-resource settings where HIV is most prevalent. Sensitive diagnosis and monitoring enable earlier treatment and reduce HIV transmission.