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: 10017288
• 负责人: Haim H Bau
• 金额: $ 46.98万
• 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 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10017288
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adherence; Adult; Agreement; Antibodies; 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 environment; 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; antiretroviral therapy; base; beta Globin; burden of illness; clinical research site; co-infection; cost; design; 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; 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.

家庭艾滋病毒检测和护理联系系统 项目概要/摘要： 根据最近的估计，约有3 700万成年人和340万儿童感染艾滋病毒。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 血清转换窗口，以启用“测试和治疗”和修改行为。此外，还非常需要 为正在接受治疗的艾滋病毒患者进行廉价的家庭/护理点病毒载量测试，以个性化治疗， 控制艾滋病毒耐药菌株的出现和传播，并监测遵守情况。解决这些 需要，一个跨学科的科学家团队，来自宾夕法尼亚大学工程，宾夕法尼亚大学艾滋病研究中心 （CFAR）和疾病控制和预防中心（CDC）提出了一个系统， 廉价一次性诊断盒和廉价可重复使用的处理器。我们的录音带将携带 所有单元操作，从样品导入，包括从全血中分离血浆，到多个 复合酶扩增，促进HIV-1进化枝B、乙型肝炎B的共检测和定量 (HBV)、丙型肝炎病毒（HCV）和β珠蛋白（阳性对照），样本中的检测限为10个靶标 (e.g., 350拷贝/mL（当全血样本体积为100µL时）和HIV-1 M组（亚型- 在40分钟内独立。试剂卡储存所有试剂，无需冷藏，并具有有效期 超过12个月。我们的磁带与一个简单的电池供电的处理器， 温度控制、致动和用于智能电话接口。智能手机指示用户 操作设备;控制设备操作、监测和分析酶扩增 过程;向患者、医疗团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元 从样品导入到检测结果的操作。在这项工作结束时，我们将开发出 这是一个用于家庭/护理点HIV-1和合并感染分子检测的卓越系统， 仪器仪表我们的系统将能够在血清转换期间检测艾滋病毒，以鼓励个人 及早开始治疗，改变传播行为;监测病毒反弹，以发现药物发展- 耐药性和非依从性，并能够使用新型长效药物进行个性化治疗， 中和抗体注射可能在未来十年出现;并检测出生于 感染艾滋病毒的母亲（特别是在发展中国家）。因此，该系统有可能允许 快速检测病毒血症和快速干预，以防止艾滋病毒传播给未感染者， 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。