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.

最小仪器家庭艾滋病毒检测和护理联动系统