Minimally-instrumented home HIV detection and care linkage system

最少仪表化的家庭艾滋病毒检测和护理联动系统

• 批准号: 10242792
• 负责人: Haim H Bau
• 金额: $ 46.14万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10242792
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adherence; Adult; Agreement; Behavior; Behavior monitoring; Benchmarking; Blood; Blood Volume; Blood specimen; Caring; Cellular Phone; Centers for Disease Control and Prevention (U.S.); Child; Clinic; Clinical; Communicable Diseases; Computer software; Counseling; Custom; Detection; Developed Countries; Development; Devices; Diagnosis; Diagnostic; Diagnostic Sensitivity; Drug resistance; Early treatment; Electricity; Encapsulated; Engineering; Fostering; Freeze Drying; Generations; Goals; HIV; HIV Infections; HIV Seronegativity; HIV-1; Healthcare; Hepatitis B; Hepatitis C; Home; Human immunodeficiency virus test; Individual; Infant; Infection; Infusion procedures; Institutional Review Boards; Instruction; Intervention; Laws; Life; Manuals; Medical; Mental Health; Molecular; Monitor; Mothers; Newborn Infant; Nucleic Acids; Oral; Paraffin; Partner in relationship; Patients; Performance; Phase; Plasma; Process; Production; Public Health; Reaction; Reagent; Refrigeration; Reporting; Research; Research Personnel; Resources; Risk; Sampling; Schools; Scientist; Signal Transduction; Specimen; System; Target Populations; Technology; Temperature; Test Result; Testing; Viral Load result; Viremia; Whole Blood; antibody test; antiretroviral therapy; base; beta Globin; burden of illness; clinical research site; co-infection; cost; design; detection limit; drug development; empowered; improved; individualized medicine; instrument; instrumentation; multiplex detection; neutralizing antibody; novel; operation; pathogen; personalized medicine; point of care; prevent; prototype; rapid detection; resistant strain; response; screening; self testing; seroconversion; smartphone Application; transmission process; usability; viral rebound; web app

Minimally-instrumented home HIV detection and care linkage system Project Summary/Abstract: According to recent estimates, ~37 million adults and 3.4 million children live with HIV. High sensitivity diagnostic tests for HIV are needed to reduce the spread and burden of the disease and allow detection during the seroconversion window to enable “test and treat” and modify behavior. There is also a great need for inexpensive, home / point of care viral load tests for HIV patients undergoing therapy to individualize treatment, control the emergence and spread of drug-resistant strains of HIV, and monitor adherence. To address these needs, an interdisciplinary team of scientists from Penn Engineering, Penn Center for Aids Research (CFAR), and Centers of Disease Control and Prevention (CDC) is proposing a system consisting of an inexpensive disposable diagnostic cassette and inexpensive reusable processor. Our cassette will carry out all unit operations from sample introduction, including plasma separation from whole blood, to multi- plex enzymatic amplification, facilitating co-detection and quantification of HIV-1 clade B, Hepatitis B (HBV), Hepatitis C (HCV), and beta Globin (positive control) with detection limit of 10 targets in a sample (e.g., 350 copies/mL when whole blood sample volume is 100µL) and of HIV-1 Group M (subtype- independent) in under 40 minutes. The cassette stores all reagents refrigeration-free with a shelf-life exceeding 12 months. Our cassette mates with a simple battery-powered processor that provides temperature-control, actuation, and an interface for a smartphone. The smartphone instructs the user in operating the device; controls device operation, monitors and analyzes enzymatic amplification processes; reports test results to the patient, to the medical team and public health officials (in compliance with prevailing laws); and provides counseling. Our system carries out all the necessary unit operations from sample introduction to test results. At the conclusion of this effort, we will have developed a remarkable system for home/point-of-care molecular detection of HIV-1 and co-infections with minimal instrumentation. Our system will be able to detect HIV during seroconversion to encourage individuals to start therapy early and modify transmission behavior; monitor viral rebound to detect development of drug- resistance and non-adherence, and enable personalized therapy with novel long-acting agents such as broadly neutralizing antibody infusions likely to emerge over the next decade; and detect infection in infants born to HIV–infected mothers (particularly in the developing world). As such, this system has the potential to allow rapid detection of viremia and rapid intervention to prevent HIV transmission to the uninfected and reduce the complications of HIV in those infected. More broadly, our system will enable individuals to assume responsibility for their own care.

最小仪器的家庭艾滋病毒检测和护理联动系统 项目摘要/摘要： 根据最近的估计，大约3700万成年人和340万儿童携带艾滋病毒。高灵敏度 需要对艾滋病毒进行诊断测试，以减少疾病的传播和负担，并允许在 启用“检测和治疗”并修改行为的“血清转换”窗口。也有很大的需求 为接受个体化治疗而接受治疗的艾滋病毒患者进行廉价的家庭/护理点病毒负载测试， 控制艾滋病毒耐药毒株的出现和传播，并监测依从性。要解决这些问题 来自宾夕法尼亚大学工程学院艾滋病研究中心的跨学科科学家团队 (CFAR)和疾病控制和预防中心(CDC)正在提出一个由 廉价的一次性诊断磁带和廉价的可重复使用的处理器。我们的盒式磁带可以携带 从样品引入到多个单元操作，包括从全血中分离血浆 Plex酶扩增，促进HIV-1 B分支、乙肝的联合检测和定量 (乙肝病毒)、丙型肝炎病毒(丙型肝炎病毒)和β-珠蛋白(阳性对照)，检测限为样品中的10个靶点 (例如，全血采样量为100微克L时为350拷贝/毫升)和艾滋病毒-1 M组(亚型- 独立)在不到40分钟内。盒式磁带储存所有试剂，无需冷藏，保质期长 超过12个月的。我们的盒式磁带与一个简单的电池供电的处理器配对，它提供 智能手机的温度控制、驱动和界面。智能手机指示用户 操作设备；控制设备操作，监控和分析酶扩增 流程；向患者、医疗队和公共卫生官员报告检测结果(在 遵守现行法律)；并提供咨询。我们的系统执行所有必要的单位 从样品介绍到测试结果的操作。在这一努力结束时，我们将开发出 一种卓越的家庭/护理地点HIV-1及其混合感染的分子检测系统 仪器仪表。我们的系统将能够在血清转换过程中检测到艾滋病毒，以鼓励个人 及早开始治疗并改变传播行为；监测病毒反弹以检测药物的发展- 耐药性和非粘附性，并允许使用新型长效剂进行个性化治疗 中和抗体输注可能在未来十年出现；并检测出生的婴儿感染 感染艾滋病毒的母亲(特别是在发展中国家)。因此，这个系统有可能允许 病毒血症的快速检测和快速干预，以防止艾滋病毒传播给未感染的人，并减少 艾滋病病毒感染者的并发症。更广泛地说，我们的系统将使个人能够承担 对自己的照顾负责。