Sample Preparation and Real-Time PCR System for Non-Traditional Settings

适用于非传统设置的样品制备和实时 PCR 系统

• 批准号: 7608852
• 负责人: SEASON S-S WONG
• 金额: $ 13.56万
• 依托单位: LYNNTECH, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-01-02 至 2010-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608852
• 关键词: Algorithms; Anthrax disease; Automation; Avian Influenza; Be++ element; Beds; Beryllium; Biological; Biological Assay; Biological Testing; Biology; Blood; Buffers; Cells; Chemical Engineering; Chemicals; Clinics and Hospitals; Communities; Complex; Consult; Convection; Country; Cytolysis; DNA; DNA amplification; DNA purification; Detection; Development; Diagnostic; Dyes; Elements; Environment; Equipment; Force of Gravity; Generations; Goals; Hand; Health Personnel; Health Professional; Heating; Hepatitis B; Hour; Human Resources; In Vitro; Influenza A Virus, H5N1 Subtype; Laboratories; Lead; Liquid substance; Magnetism; Mechanics; Medical; Microfluidics; Microspheres; Molecular; Movement; Nucleic Acid Amplification Tests; Nucleic Acids; Nurses; Nursing Homes; Office Nursing; Operating System; Patients; Phase; Physicians; Plasma; Preparation; Procedures; Process; Protocols documentation; RNA; RNA purification; Ramp; Reaction; Reagent; Research; Resources; Reverse Transcriptase Polymerase Chain Reaction; Running; Sampling; Series; Side; Silicon Dioxide; Sonication; Speed; Surface; System; Techniques; Technology; Technology Transfer; Temperature; Testing; Texas; Thigh structure; Time; Training; Universities; Viral; Zirconium; base; chemical reaction; commercialization; cost; cost effective; design; experience; flu; fluid flow; innovation; magnetic beads; milliliter; next generation; novel; nucleic acid purification; pathogen; point of care; professor; prototype; public health relevance; research and development; seal; tool; weapons; zirconium oxide

DESCRIPTION (provided by applicant): Real-time PCR and real-time reverse transcriptase PCR assays are highly specific for determining the presence of pathogens. However these assays are traditionally confined to the laboratory as result of the need for trained technicians to perform key steps in the process, particularly sample preparation, as well as cost and size of equipment to run these assays. New equipment platforms are needed to allow these sensitive and highly selective assays to be used in non-traditional settings such as a doctor's office and nursing homes. Lynntech proposes an innovative, easy-to-operate system that automates well-established sample preparation protocols for nucleic acid extraction and purification with a novel microfluidic thermocycler to perform real-time PCR on disposable analysis cartridges for determination of pathogens in biological samples. Fluid control is achieved on-cartridge through use of low cost components (<$0.60 per component). The PCR based system provides random access nucleic acid testing in one hour, from nucleic acid extraction and purification to amplification and real-time detection. The technology is anticipated to be able to detect a broad range of pathogens at a level between 102 to 103 units per milliliter. The system's random-access nucleic acid analysis capability allows for samples to be run whenever needed. The implementation of the system will significantly reduce diagnostic lead times. Also, important is the simplicity of the system which leads to low-cost systems. Lynntech's real-time PCR system is a next generation tool for molecular diagnostics that will enable non- specialized operators in non-traditional settings (e.g., nurse at doctor's office or nursing home) to perform sophisticated biological tests in any setting with greater speed at low cost. The automation provided in this system significantly simplifies and accelerates testing, thus delivering molecular diagnostics into the hands of health-care professionals (i.e., doctors and nurses). The system will be a great resource for poor communities and countries where traditional tests are not available or are cost prohibitive. PUBLIC HEALTH RELEVANCE: The technology provides needed simplification and automation to nucleic acid based diagnostic assays to bring them out of the laboratory and into non-traditional environments. The system will have great commercial potential and medical value in providing rapid, low-cost, easy-to-use in vitro diagnostics in doctors' offices, clinics, hospitals, and even in poor communities and countries.

描述（由申请人提供）：实时 PCR 和实时逆转录酶 PCR 测定对于确定病原体的存在具有高度特异性。然而，这些测定传统上仅限于实验室，因为需要训练有素的技术人员来执行过程中的关键步骤，特别是样品制备，以及运行这些测定的设备的成本和尺寸。需要新的设备平台来允许这些敏感且高度选择性的检测方法用于非传统环境，例如医生办公室和疗养院。 Lynntech 提出了一种易于操作的创新系统，该系统可以使用新型微流体热循环仪自动执行用于核酸提取和纯化的成熟样品制备方案，从而在一次性分析盒上执行实时 PCR，以确定生物样品中的病原体。通过使用低成本组件（每个组件<0.60 美元）在墨盒上实现流体控制。基于PCR的系统可在一小时内提供随机访问核酸检测，从核酸提取和纯化到扩增和实时检测。该技术预计能够以每毫升 102 至 103 单位的水平检测多种病原体。该系统的随机访问核酸分析功能允许在需要时运行样本。该系统的实施将显着缩短诊断周期。此外，重要的是系统的简单性，这会导致系统成本降低。 Lynntech 的实时 PCR 系统是下一代分子诊断工具，使非专业操作人员能够在非传统环境（例如医生办公室或疗养院的护士）中以更快的速度、更低的成本在任何环境中执行复杂的生物测试。该系统提供的自动化显着简化并加速了测试，从而将分子诊断交付到医疗保健专业人员（即医生和护士）手中。对于无法进行传统检测或成本过高的贫困社区和国家来说，该系统将成为宝贵的资源。公共卫生相关性：该技术为基于核酸的诊断测定提供了所需的简化和自动化，使其走出实验室并进入非传统环境。该系统将具有巨大的商业潜力和医疗价值，可以为医生办公室、诊所、医院甚至贫困社区和国家提供快速、低成本、易于使用的体外诊断。