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. 项目摘要/摘要 早期诊断新感染和检测个体出现病毒反弹 在治疗上掌握着有效管理艾滋病毒的关键。在众多诊断中 近年来，自我测试已变得越来越可接受，但 以免疫分析为基础的家庭检测对早期诊断和 与治疗监测不相容。在这个项目中，我们建议开发一种快速、 灵敏、特异、简便、经济的RNA检测诊断技术 未经处理的血样。这项拟议的技术具有独特的化学创新 在生物分子分析方面(TARA)以及我们整合和自动化这些创新的能力 在简单的设备上使用精确的时间门控步骤。R61阶段(目标1-3)侧重于 技术开发、集成和优化；R33阶段(目标4-5)重点 使用存档样本和预期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团队来执行，该团队历史悠久 协作和互补的专业知识。如果成功，检测试剂盒将能够进行诊断 以及个人在家中或在药店中监测病毒载量，并适用于 最低资源--艾滋病毒最流行的地方。灵敏的诊断和监测 使更早的治疗和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.