A Rapid HIV RNA Detection without Sample Preparation

无需样品制备的快速 HIV RNA 检测

• 批准号: 10017696
• 负责人: HyunDae Cho
• 金额: $ 48.97万
• 依托单位: CROSSLIFE TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-12 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10017696
• 关键词: Acquired Immunodeficiency Syndrome; Acute; Address; Adopted; Africa; Antibodies; Antibody Response; Archives; Asia; Automation; Awareness; Biological Assay; Blood; Blood specimen; Brazil; Buffers; Chemicals; Chemistry; Clinical; Collaborations; Communicable Diseases; Complementary DNA; Cytolysis; Detection; Developed Countries; Devices; Diagnosis; Diagnostic; Drug resistance; Early Diagnosis; Early treatment; Engineering; Epidemic; Equipment; Family health status; Feedback; Fingers; Fostering; Generations; Goals; HIV; HIV Infections; HIV-1; Health; Healthcare; Home environment; Human immunodeficiency virus test; Immunoassay; Individual; Infection; Infection Control; Intervention; Knowledge; Laboratories; Latin America; Letters; Malaysia; Medical; Microfluidic Microchips; Microfluidics; Molecular; Molecular Analysis; Monitor; Morbidity - disease rate; Mothers; Newborn Infant; Nucleic Acids; Outcome Measure; Patients; Performance; Pharmacy facility; Phase; Plasma; Preparation; Prevention; Privacy; Process; Quantitative Reverse Transcriptase PCR; RNA; RNA purification; Reaction; Reagent; Resistance; Resources; Risk; Risk Reduction Behavior; Saliva; Sampling; Serum; Specificity; Swab; System; Technology; Temperature; Testing; Time; Urine; Validation; Viral Load result; Viral load measurement; Viremia; acute infection; amplification detection; antiretroviral therapy; base; co-infection; cost; cost effective; design; digital; drug development; global health; high risk population; improved; innovation; instrument; mortality; multidisciplinary; multiplex detection; nucleic acid detection; nucleic acid purification; point of care; prevent; prospective; prospective test; screening; seroconversion; social stigma; technology development; technology validation; transmission process; viral rebound

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.

无需样品准备的快速HIV RNA检测 Crosslife Technologies Inc. 项目摘要/摘要 新感染的早期诊断并发现个体病毒反弹的出现 治疗是有效治疗艾滋病毒的关键。在许多诊断中 方法，近年来自我测试变得越来越可以接受，但是 基于免疫测定的家庭测试对早期诊断不足和 与治疗监测不兼容。在这个项目中，我们建议开发一个快速的， 敏感，特定，简单和具有成本效益的诊断技术，用于RNA检测 未经处理的血液样本。拟议的技术具有独特的化学创新 在生物分子测定法（TARA）以及我们整合和自动化这些创新的能力 在具有精确时间门控步骤的简单设备上。 R61阶段（目标1-3）重点 技术开发，整合和优化； R33阶段（目标4-5）聚焦 使用存档样品和前瞻性临床样品进行技术验证。这些 具体的任务将由一个高度跨学科的团队执行 合作和补充专业知识。如果成功，测试套件将实现诊断 以及个人在家里或药房中监测的病毒负荷监测，适合 艾滋病毒最普遍的最小资源设置。敏感诊断和监测 启用早期治疗并减少HIV传播。