Printed Disposable Sensor for Quantitative HIV RNA Measurement of Viral Load

用于定量测量病毒载量的 HIV RNA 的印刷一次性传感器

• 批准号: 7229174
• 负责人: ROBERT W HENKENS
• 金额: $ 14.12万
• 依托单位: ALDERON BIOSCIENCES, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-01 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7229174
• 关键词: Achievement; Acquired Immunodeficiency Syndrome; Address; Affect; Africa; Antibodies; Area; Arts; Bacteria; Base Sequence; Benchmarking; Biochemical; Biological Assay; Biological Warfare; Blood capillaries; Buffers; CD4 Positive T Lymphocytes; Cell Count; Characteristics; Clinical; Collaborations; Communicable Diseases; Computer software; Condition; Conflict (Psychology); Country; Coupled; DNA; Data; Detection; Developing Countries; Development; Devices; Diagnosis; Diagnostic; Diagnostics Research; Disasters; Disease; Doctor of Medicine; Effectiveness; Electrodes; Elements; Emerging Communicable Diseases; Ensure; Epidemic; Equipment; Foundations; Gender; Genes; Goals; Growth; HIV; Hand; Health; Health Benefit; Healthcare; Heterosexuals; Highly Active Antiretroviral Therapy; Human; Human Resources; Individual; Infant; Knowledge; Label; Left; Marketing; Measurable; Measurement; Measures; Medical Surveillance; Memory; Methods; Microbe; Military Personnel; Modification; Molecular; Monitor; National Institute of Allergy and Infectious Disease; Nucleic Acids; Nucleic acid sequencing; Organism; Parasites; Pathogen detection; Patients; Performance; Persons; Phase; Population; Printing; Protocols documentation; Public Health; Publications; RNA; Range; Reader; Reagent; Research; Research Personnel; Research Project Grants; Resources; Risk; Running; Safety; Signal Transduction; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Staging; Standards of Weights and Measures; System; Technology; Testing; Time; Touch sensation; Toxic effect; Toxin; Training; Treatment Efficacy; United States; United States Food and Drug Administration; Validation; Viral; Viral Load result; Viral load measurement; Virus; Water; Woman; Work; antiretroviral therapy; base; blood lead; capillary; clinically significant; commercialization; cost; design; disorder control; disorder prevention; experience; improved; innovation; instrument; instrumentation; interest; men; microbial; novel; pathogen; prevent; prognostic; programs; prototype; research and development; response; sensor; tool; transmission process

DESCRIPTION (provided by applicant): The National Institutes of Allergy and Infectious Disease have called for better tools for the detection and diagnosis of emerging and re-emerging infectious diseases. In response to this need, Alderon Biosciences proposes research to develop printed disposable sensors for quantification of HIV RNA in resource-poor settings. Our research is important for developing sensors for monitoring HIV infected patients because viral load is strongly correlated with the progression of HIV disease and the degree of viral load reduction is the best prognostic parameter for clinical benefit and for sustainability of treatment efficacy. Studies show that viral load is the most important predictor of HIV transmission between men and women, regardless of the gender of the transmitting individual. Our technical approach is to combine signal amplification probes for HIV-specific nucleic acid targets with Alderon's proprietary nucleic acid diagnostic platform using electrochemical sensors and low-cost handheld readers. We will do small business innovation research on printed disposable sensors and measurement technologies that will use less assay time, fewer steps, and much lower set-up and per- result cost than alternative technologies. Major milestones are to create probe-based sensors to measure HIV RNA targets to below 100 molecules/mL with less than 10% false negatives and less than 10% false positives. Market studies indicate a significant market for the proposed technology, which will be addressed through partnerships with larger bioscience companies. To our knowledge, only Alderon Biosciences is developing a technology capable of carrying out accurate, low-cost viral load assays that can be used in "real time" in essentially any public health setting. If successful this project will provide superior pathogenic, biochemical and viral load testing to the market. Alderon Biosciences proposes to develop innovative electrochemical instruments, sensors and assays for measurement of HIV viral load in resource-poor settings. Measurement of HIV viral load is used to guide therapy for infected persons, and therapies that reduce viral load may provide a means of controlling the AIDS epidemic. The proposed assays and test system to measure and monitor HIV viral load will be designed for application in the US and in resource poor settings to provide prognostic information that can help guide treatment decisions and enable public health workers to better prevent the spread of contagious disease.

描述（由申请人提供）：国家过敏和传染病研究所呼吁更好的工具来检测和诊断新出现和重新出现的传染病。为了满足这一需求，Alderon Biosciences提出研究开发打印的一次性传感器，用于在资源匮乏的环境中定量HIV RNA。我们的研究对于开发用于监测HIV感染患者的传感器非常重要，因为病毒载量与HIV疾病的进展密切相关，病毒载量降低的程度是临床获益和治疗效果可持续性的最佳预后参数。研究表明，病毒载量是男女之间艾滋病毒传播的最重要预测因素，无论传播者的性别如何。我们的技术方法是将针对HIV特异性核酸靶标的联合收割机信号放大探针与Alderon专有的核酸诊断平台结合起来，使用电化学传感器和低成本手持阅读器。我们将对打印的一次性传感器和测量技术进行小型企业创新研究，这些技术将使用更少的分析时间，更少的步骤，以及比替代技术更低的设置和单位结果成本。主要的里程碑是创建基于探针的传感器，以测量低于100个分子/mL的HIV RNA靶标，假阴性率低于10%，假阳性率低于10%。市场研究表明，拟议的技术有很大的市场，将通过与大型生物科学公司的伙伴关系加以解决。据我们所知，只有Alderon Biosciences正在开发一种能够进行准确，低成本病毒载量测定的技术，该技术可以在基本上任何公共卫生环境中“真实的时间”使用。如果成功，该项目将为市场提供上级致病性、生化和病毒载量检测。Alderon Biosciences提议开发创新的电化学仪器、传感器和测定方法，用于在资源匮乏的环境中测量艾滋病毒载量。HIV病毒载量的测量用于指导对感染者的治疗，减少病毒载量的治疗可以提供控制艾滋病流行的手段。用于测量和监测HIV病毒载量的拟议测定和测试系统将被设计用于美国和资源匮乏的环境，以提供有助于指导治疗决策的预后信息，并使公共卫生工作者能够更好地预防传染病的传播。