Fully-Integrated, Non-Instrumented Device for Molecular Diagnostics

描述（由申请人提供）：导师职业发展奖（K25）提供的培训和研究经验将使我成功地从化学（学士和硕士），电子工程（博士）和机械工程（博士后）的背景过渡到成为一名独立的生物医学研究者。为了实现这一目标，我将与我的导师Haim H. Bau博士（微流体学和纳米流体学专家）、Robert Gross博士（传染病领域的国际权威，专注于HIV）、Frederic Bushman博士（分子病毒学家）和Paul H. Edelstein博士（临床微生物学专家）密切合作。培训内容包括：1)遗传学、流行病学、生物统计学、分子生物学和纳米医学课程；2)传染病分析、分子生物学和临床治疗方面的实验技能培训；3)通过研讨会和交流机会开展专业发展活动。这次培训的目的是让我获得申请NIH独立资助所需的知识和技能（例如，R01奖）。为了补充培训，我提出了一项研究计划，旨在研究和开发一种完全集成的、低成本的、无仪器的POC设备，用于使用血液样本测量HIV病毒载量。该装置将几乎与“试纸”免疫测定一样简单，其性能可与台式PCR相媲美。艾滋病毒是一个重大的全球健康问题。最近的估计表明，约有3300万人感染艾滋病毒，其中96%居住在发展中国家。虽然抗逆转录病毒治疗是有效的，而且越来越容易获得，但对患者进行定量监测对于个体化药物治疗和控制耐药艾滋病毒菌株的出现和传播是必要的。血浆中循环病毒的水平，或“病毒载量”，是监测疾病进展和做出治疗决定的关键指标。通常需要基于pcr的定量检测来评估病毒载量，这需要昂贵的设备、熟练的技术人员和实验室设施，而且在资源有限的环境中不能广泛用于即时检测。本K25中提出的创新POC测试设备将满足这一需求。我的职业目标是成为一名独立的、多学科的、成熟的生物医学研究人员，在为全球卫生保健和个体化医疗开发低成本诊断技术方面具有专长。

DESCRIPTION (provided by applicant): The training and research experience provided by this Mentored Career Development Award (K25) will enable me to successfully transition from a background in chemistry (B.S. and M.S.), electronic engineering (Ph.D.) and mechanical engineering (Postdoc) to become an independent biomedical researcher. To achieve this, I will work closely with my mentors, Dr. Haim H. Bau (an expert in microfluidics and nanofluidics), Dr. Robert Gross (an international authority in infectious disease, with a focus on HIV), Dr. Frederic Bushman (a Molecular Virologist) and Dr. Paul H. Edelstein (a Clinical Microbiology expert). The training includes 1) coursework in genetics, epidemiology, biostatistics, molecular biology and nanomedicine, 2) experimental-skill training in infectious disease assays, molecular biology, and clinical treatment 3) professional development activities through workshops and networking opportunities. The goal of this training is to allow me to gain the knowledge and skills necessary to apply for independent NIH funding (e.g., R01 awards). To complement the training, I propose a research plan aimed at researching and developing a fully-integrated, low-cost, non-instrumented, POC device for HIV viral load measurement using blood samples. This device will be nearly as simple as a 'dipstick' immunoassay with performance that is comparable to that of benchtop PCR. HIV is a significant global health problem. Recent estimates suggest ~33 million people are living with HIV, with 96% residing in the developing world. While antiretroviral therapy is effective and increasingly available, quantitative monitoring of patients is necessary t individualize drug treatment, and to control the emergence and spread of drug-resistant strains of HIV. The level of circulating virus in the blood plasma, or "viral load," is a critical measure used to monitor disease progression and make treatment decisions. Typically, quantitative PCR-based assays, which require expensive equipment, skilled technicians, and laboratory facilities and that are not widely available for point-of-care testing in resource-limited settings are needed to assess viral load. The innovative POC test devices proposed in this K25 will address this need. My career goal is to become an independent, multidisciplinary and well established biomedical researcher with expertise in developing low-cost diagnostic technology for global health care and for individualized medicine.