Nanodroplet PCR Lab-Chip for Clinical Pathogen Detection

用于临床病原体检测的纳米液滴 PCR 实验室芯片

• 批准号: 7808487
• 负责人: MICHAEL G POLLACK
• 金额: $ 99.81万
• 依托单位: ADVANCED LIQUID LOGIC
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-07-01 至 2013-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7808487
• 关键词: Academic Medical Centers; Accounting; Antibiotic Resistance; Architecture; Bacteria; Biological Assay; Cessation of life; Clinical; Clinical Research; Clinical Trials; Collaborations; Communicable Diseases; Complex; Computer software; Custom; Detection; Development; Diagnostic; Electrodes; Environment Design; Foundations; Funding Agency; Goals; Health Care Costs; Healthcare; Hospitals; Infection; Liquid substance; Logic; Medical; Microfluidic Microchips; Microfluidics; Molecular; Molecular Diagnosis; Morbidity - disease rate; Nosocomial Infections; Nucleic Acid Amplification Tests; Nucleic Acids; Pathogen detection; Patients; Performance; Phase; Preparation; Printing; Protocols documentation; Provider; Reaction; Research Personnel; Sampling; Screening procedure; Services; Solid; Staphylococcus aureus; System; Systems Analysis; Technology; Testing; Time; Validation; base; cost; design; digital; flexibility; improved; innovation; instrument; instrumentation; magnetic beads; meetings; methicillin resistant Staphylococcus aureus; micro-total analysis system; microbial; mortality; nanoDroplet; pathogen; point of care; pre-clinical; prototype; public health relevance; rapid technique; usability

DESCRIPTION (provided by applicant): It is estimated that 2 million health-care associated infections are acquired each year by hospitalized patients resulting in 90,000 deaths and about $4.5 billion in excess health care costs. A large and growing percentage of these infections can be attributed to Staphylococcus aureus and, in particular, to methicillin-resistant S. aureus (MRSA). Rapid PCR-based tests have been developed for screening MRSA in health-care settings, but the high cost and complexity of existing nucleic acid testing platforms have limited their acceptance for routine screening in most health-care settings. The goal of this project is to develop a rapid, low-cost, easy-to-use nucleic acid testing platform that can be deployed for MRSA screening in a wide range of health-care settings. The proposed testing platform is based on Advanced Liquid Logic's "digital microfluidics" technology which enables programmable micro-manipulation of sub-microliter sized droplets using an electrode array formed on a low-cost and disposable printed circuit board substrate. In Phase I of this project Advanced Liquid Logic developed chip-based methods for rapid thermocycling, real-time PCR detection, magnetic-bead based sample preparation, and reaction preparation and mixing. In Phase II, these results will serve as the foundation for the development of a product prototype nucleic acid analysis system for near-patient and point-of-care use. An MRSA screening test will be developed on the platform and extensively validated in preparation for an FDA submission. Ultimately, additional cartridges could be developed for screening and detection of other health-care associated infections. This lab-on-a-chip platform will offer significant advantages over other approaches in terms of flexibility, scalability, performance and cost. PUBLIC HEALTH RELEVANCE: A system for the detection of methicillin-resistant Staphylococcus aureus will be developed to help control the spread of antibiotic-resistant bacteria in hospital settings.

描述（由申请人提供）：据估计，住院患者每年会发生 200 万例与医疗保健相关的感染，导致 90,000 人死亡，并导致约 45 亿美元的超额医疗保健费用。这些感染中很大一部分是由金黄色葡萄球菌引起的，而且这一比例还在不断增加，尤其是耐甲氧西林金黄色葡萄球菌 (MRSA)。基于快速 PCR 的检测已被开发用于在医疗机构中筛查 MRSA，但现有核酸检测平台的高成本和复杂性限制了其在大多数医疗机构中常规筛查的接受度。该项目的目标是开发一个快速、低成本、易于使用的核酸检测平台，可部署用于广泛的医疗保健环境中的 MRSA 筛查。所提出的测试平台基于Advanced Liquid Logic 的“数字微流体”技术，该技术能够使用形成在低成本一次性印刷电路板基板上的电极阵列对亚微升大小的液滴进行可编程微操作。在该项目的第一阶段，Advanced Liquid Logic 开发了基于芯片的方法，用于快速热循环、实时 PCR 检测、基于磁珠的样品制备以及反应制备和混合。在第二阶段，这些结果将作为开发用于患者附近和护理点的产品原型核酸分析系统的基础。 MRSA 筛查测试将在该平台上开发并进行广泛验证，为 FDA 提交做准备。最终，可以开发更多的试剂盒来筛查和检测其他医疗保健相关感染。与其他方法相比，该芯片实验室平台在灵活性、可扩展性、性能和成本方面具有显着优势。 公共卫生相关性：将开发一种检测耐甲氧西林金黄色葡萄球菌的系统，以帮助控制医院环境中耐抗生素细菌的传播。