A Rapid HIV RNA Detection without Sample Preparation

无需样品制备的快速 HIV RNA 检测

基本信息

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
项目类别：
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

项目摘要

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.

无需样品制备的快速 HIV RNA 检测十字生命科技公司项目概要/摘要早期诊断新感染并检测个体病毒反弹的出现治疗是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被接受，但是基于免疫测定的家庭测试对于早期诊断和诊断不够敏感与治疗监测不相容。在这个项目中，我们建议开发一个快速、灵敏、特异、简单且具有成本效益的 RNA 检测诊断技术未经处理的血液样本。所提出的技术具有独特的化学创新生物分子检测 (TARA) 以及我们整合和自动化这些创新的能力到具有精确时间选通步骤的简单设备上。 R61 阶段（目标 1-3）重点关注技术开发、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团队来执行，该团队拥有完善的合作和互补的专业知识。如果成功，测试套件将能够进行诊断个人在家中或药房进行病毒载量监测，并适用于艾滋病毒最流行的资源匮乏环境。灵敏的诊断和监测实现早期治疗并减少艾滋病毒传播。