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

使用 RPA 和 MXR 的护理点 HIV 病毒载量系统

• 批准号: 10484628
• 负责人: Jay Kenneth Fisher
• 金额: $ 95.26万
• 依托单位: REDBUD LABS, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10484628
• 关键词: Address; Agitation; Agreement; Area; Biological Assay; Bulla; Caring; Clinical; Cold Chains; Collaborations; Country; Coupled; Detection; Development; Devices; Diagnostic; Diagnostic Sensitivity; Diagnostic Specificity; Equipment; Filtration; Genomics; Goals; Gold; HIV; HIV-1; Hour; Human Resources; Human immunodeficiency virus test; Income; Individual; Infrastructure; Laboratories; Left; Life; Liquid substance; Magnetism; Measures; Methods; Microfluidic Microchips; Microfluidics; Molecular; Monitor; Nucleic Acid Amplification Tests; Nucleic Acids; Performance; Persons; Phase; Plasma; Polymerase; Quantitative Reverse Transcriptase PCR; RNA; Reaction; Reagent; Resolution; Sampling; Sensitivity and Specificity; Small Business Innovation Research Grant; Specificity; Speed; Surface; System; Technology; Temperature; Testing; Time; Training; Transportation; Validation; Viral Load result; Virion; antiretroviral therapy; base; clinical research site; cost; detection limit; flexibility; improved; instrument; laboratory equipment; magnetic beads; operation; point of care; point of care testing; portability; programs; recombinase; rural area; success

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.

摘要 监测抗逆转录病毒治疗效果最准确的方法是通过核酸 直接测量HIV RNA(病毒载量)的扩增测试(NAAT)。在发展和发展中 发达国家的这些测试主要是在城市中心的中央实验室进行的。 然而，相当数量的艾滋病毒携带者居住在农村地区，并应 交通不便，经济困难，或这些因素的组合，都会更好。 由更接近看护点(POC)的测试提供服务。尽管便携式核技术取得了进步 酸放大技术仍然有很大的机会来提高可负担性，时间- 因此，POC HIV病毒载量(VL)检测简单易用。为此，我们将完成 开发我们的快速、样本到答案的HIV VL测试，在这些方面实现更好的指标 而不是今天的商业平台。 在此第二阶段项目中，我们将继续与Path上的诊断计划合作 (华盛顿州西雅图)最终确定和测试完成的设备。在AIM 1中，Redbud实验室将完成并 将测试墨盒和设备集成到一个紧凑、坚固的仪器中。在Aim 2 Redbud实验室 将验证自动化验的数量和基因组覆盖率。在Aim 3中，路径将 使用临床样本对系统进行分析验证，并将结果与 金本位制。在这个项目完成后，我们将有一个平台为多地点临床做好准备 验证。