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: 10665089
• 负责人: Jay Kenneth Fisher
• 金额: $ 95.04万
• 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/10665089
• 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; Dryness; Equipment; Filtration; Genomics; Goals; 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; Rod; Sampling; Sensitivity and Specificity; Small Business Innovation Research Grant; Specific qualifier value; Specificity; Speed; Surface; System; Technology; Temperature; Testing; Time; Training; Transportation; Validation; Viral Load result; Virion; antiretroviral therapy; 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.

抽象的 监测抗逆转录病毒治疗效果的最准确方法是通过核酸检测 扩增测试 (NAAT) 直接测量正在开发和使用的 HIV RNA（病毒载量）。 发达国家这些测试主要在城市中心的集中实验室进行。 然而，大量艾滋病毒感染者居住在农村地区，因此 没有交通、财务限制或这些因素的组合会更好 尽管便携式核酸技术取得了进步，但仍通过更接近现场护理 (POC) 的测试来提供服务。 酸放大技术仍有很大机会提高可承受性、时间 为此，我们将完成 POC HIV 病毒载量 (VL) 检测。 开发我们的快速、从样本到答案的 HIV VL 测试，该测试在这些方面实现了更好的指标 比今天的商业平台更广阔的领域。 在这个第二阶段项目中，我们将继续与 PATH 诊断项目合作 （华盛顿州西雅图）In Aim 1 Redbud Labs 将完成并测试已完成的设备。 将测试盒和设备集成到紧凑、坚固的仪器中 In Aim 2 Redbud Labs。 将验证自动化检测的定量和基因组覆盖率。 In Aim 3 PATH 将验证自动化检测的定量和基因组覆盖率。 使用临床样本对系统进行分析验证，将这些结果与 该项目完成后，我们将拥有一个可用于多站点临床的平台。 验证。