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: 10909458
• 负责人: Haim H Bau
• 金额: $ 71.11万
• 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 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10909458
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adherence; Adult; Agreement; Antibodies; Behavior; 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 Equipment; Diagnostic Sensitivity; Drug resistance; Dryness; Early treatment; Electricity; Encapsulated; Engineering; Fingers; Fostering; Freeze Drying; Generations; Goals; HIV; HIV Infections; HIV Seronegativity; HIV-1; Healthcare; Hepatitis B; Hepatitis C; Home; Human immunodeficiency virus test; Incubated; 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; Public Health; Reaction; Reagent; Refrigeration; Reporting; Research; Research Personnel; Resource-limited setting; Risk; Sampling; Schools; Scientist; Signal Transduction; Specimen; System; Target Populations; Temperature; Test Result; Testing; Viral Load result; Viremia; Whole Blood; antiretroviral therapy; beta Globin; burden of illness; clinical research site; co-infection; cost; design; detection limit; drug resistance development; empowerment; improved; individualized medicine; instrument; instrumentation; large scale production; 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; technology platform; 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.

最小蒙上的家庭艾滋病毒检测和护理连锁系统 项目摘要/摘要： 根据最近的估计，约有3700万成人和340万儿童患有艾滋病毒。高灵敏度 需要对HIV进行诊断测试，以减少疾病的传播和燃烧，并允许检测 血清转换窗口启用“测试和治疗”并修改行为。也有很大的需求 廉价的，家庭 /护理点病毒负荷测试，用于接受治疗以个性化治疗的艾滋病毒患者 控制HIV的抗药性菌株的出现和传播，并监测依从性。解决这些 需求，宾夕法尼亚州艾滋病研究中心宾夕法尼亚工程科学家的跨学科团队 （CFAR）和疾病控制与预防中心（CDC）提出了一个由 便宜的一次性诊断盒和便宜的可重复使用的处理器。我们的录音带将携带 从样品引入中的所有单位操作，包括从全血等离等离子体分离到多人 PLEX酶扩增，支持HIV-1进化枝B，乙型肝炎的共同检测和定量 （HBV），丙型肝炎（HCV）和β球蛋白（阳性对照）在样品中具有10个目标的检测极限 （例如，当全血样品体积为100µL时，350份/ml）和HIV-1组M（亚型 - 独立）在40分钟内。盒式磁带将所有试剂储存在保质期 超过12个月。我们的盒式搭配与简单的电池供电的处理器提供 温度控制，驱动和智能手机的接口。智能手机指示用户 操作设备；控制设备操作，监视和分析酶扩增 过程；向患者，医疗团队和公共卫生官员报告测试结果（in 遵守普遍法律）；并提供咨询。我们的系统执行所有必要的单元 样本简介到测试结果的操作。在这项工作结束时，我们将发展 HIV-1的家用/护理分子检测的显着系统和最少的共同感染 仪器。我们的系统将能够在血清转化过程中检测到艾滋病毒，以鼓励个人 尽早开始治疗并修改传播行为；监测病毒反弹以检测药物的发展 - 抗药性和不遵守性，并通过新颖的长效剂（例如广泛的）进行个性化治疗 中和抗体输注可能会在未来十年内出现；并发现婴儿出生的婴儿感染 艾滋病毒感染的母亲（尤其是在发展中国家）。因此，该系统有可能允许 快速检测病毒血症和快速干预措施，以防止HIV向未感染并减少 感染者艾滋病毒的并发症。更广泛地，我们的系统将使个人能够假设 对自己的照顾责任。