Rapid Prototyping Method and Design Library for Universal POC Application

通用POC应用的快速原型方法和设计库

• 批准号: 8001583
• 负责人: Vincent Jen-Jr Gau
• 金额: $ 9.72万
• 依托单位: GENEFLUIDICS, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-19 至 2010-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8001583
• 关键词: Address; Bedside Testings; Biochemical; Biocompatible; Biological Assay; Biological Sciences; Bioterrorism; Blood Chemical Analysis; Capital; Centers for Disease Control and Prevention (U.S.); Clinical; Clinical Research; Computer Systems Development; Custom; Databases; Detection; Development; Device or Instrument Development; Devices; Diagnosis; Diagnostic; Disease; Electrolytes; Emerging Communicable Diseases; Genetic; Genetic screening method; Glass; Goals; Hand; Hour; Immunoassay; Injection of therapeutic agent; Institution; Interleukin-6; Investments; Knowledge; Libraries; Link; Malignant Neoplasms; Medical; Methods; Microfluidics; Modeling; Molds; Molecular Analysis; National Institute of Dental and Craniofacial Research; Online Systems; Phase; Plastics; Point-of-Care Systems; Polyethylene Terephthalates; Polymers; Printing; Process; Property; Proteins; Protocols documentation; RNA; Reaction; Reagent; Research; Research Personnel; Risk; Sampling; Screening procedure; Services; Silicon; Small Business Innovation Research Grant; Surface Properties; System; Testing; Training; U-Series Cooperative Agreements; United States National Institutes of Health; Validation; base; commercialization; cost; design; experience; glucose monitor; interest; large scale production; pathogen; phase 1 study; point of care; point-of-care diagnostics; poly(dimethylsiloxane); polycarbonate; prevent; prototype; public health relevance; research and development; response; sensor

DESCRIPTION (provided by applicant): Most microfluidic point-of-care (POC) analysis devices have been fabricated using silicon (Si), glass and polymer as substrates for the microfluidic substrate. Plastic substrates, such as polycarbonate (PC), polyethylene terephthalate (PET), poly(dimethylsiloxane) (PDMS), polyimide, polymethamethylacrylate (PMMA), offer a wide range of biocompatible property parameters for biochemical or medical applications at low cost using conventional molding process. The wide variety of biocompatible surface properties of commercially available polymer/plastics provides a critical competitive advantage over conventional silicon or glass-based manufacturing method for the POC application. Currently, commercially available POC devices such as glucose meters or i-STAT blood chemistry assays do not provide microbiological diagnosis at the point of care, preventing rapid response to potential threats presented by bioterrorism and emerging infectious diseases. There is a significant amount of interest in POC device development among both academic and industrial research but the high initial capital investment and long development cycle significantly reduce the actual development effort. A rapid, inexpensive, POC test capable of adapting existing assay protocols with a high degree of accuracy would be a major advance. In addition, rather than building a POC system from scratch, a ready-to-use POC platform would accelerate development efforts to impede the rapid emergence of wide spread diseases. The overall goal of this SBIR Phase I application is to develop and validate the prototyping fabrication process of a universal point-of-care (POC) system that is capable of adapting existing assay protocols for life science research and clinical diagnostics. We propose to establish a design library of standard molecular analysis assays and make the POC prototyping service available for every researcher to address the high priority initiatives of NIH and CDC. We will start with a cartridge design that could perform 10 multiplexed assays (genetic assays and/or immunoassays) in Phase I and expand to more common assay protocols to enable cartridges for optimization, large scale production and clinical study of the POC system in Phase II. With an optimized cartridge design through the POC cartridge prototyping fabrication, large scale manufacturing of the cartridges can be done by injection molding after the analytical validation on the prototyping cartridges via the proposed rapid fabrication method. In this proposed 6-month Phase I study, we will establish a design library for POC cartridge prototyping and fabricate 10 assay-specific integrated cartridges (ASICs) from design order to shipment ready in 6 hours. The cost of good sold (COGS) of the prototype cartridge will be less than $20 for 10 assays in Phase 1. The COGS of the POC control system will be less than $5k. PUBLIC HEALTH RELEVANCE: In this proposal, we will leverage our ongoing Cooperative Agreements (NIDCR U01 DE017790 and U01 AI082457) for the development of point-of-care (POC) diagnostic cartridges for multiplexed cancer marker screening and rapid pathogen identification. Based upon the experience and knowledge gained by developing and producing these cartridges for our ongoing Cooperative Agreements, this proposed Phase I study will establish a design library to accommodate the most common molecular analysis assays including genetic testing, immunoassay and electrolyte detection. After the successful completion of Phase I, we will make the standard cartridge design modules commercially available and provide the rapid POC cartridge prototype fabrication service to any research institutions interested in exploring POC applications. With the prototype fabrication service, the high initial capital investment and long development cycle, which are often required for POC system development, will no longer be a road block to the scientific development and commercialization efforts for POC methiods. Using a multiplexed pathogen identification cartridge capable of both protein and RNA detection as a model, we will demonstrate a universal POC molecular analysis system that can be rapidly adapted by end users using existing protocols and reagents for hands-free POC field tests in one week. The system will have an enormous favorable impact in the field of molecular analysis research and development in nontraditional settings. Researchers can have their own customized version of a POC system without the development risk and capital investment to accelerate the advancement in Point-of- Care testing.

描述（由申请人提供）：大多数微流控护理点（POC）分析设备都是用硅（Si）、玻璃和聚合物作为微流控衬底制造的。塑料基材，如聚碳酸酯（PC），聚对苯二甲酸乙二醇酯（PET），聚（二甲基硅氧烷）（PDMS），聚酰亚胺，聚甲基丙烯酸甲酯（PMMA），为生物化学或医疗应用提供了广泛的生物相容性参数，使用常规成型工艺成本低。商用聚合物/塑料的各种生物相容性表面特性为POC应用提供了与传统硅或玻璃基制造方法相比的关键竞争优势。目前，市面上可买到的POC设备，如血糖仪或i-STAT血液化学测定仪，不能在护理点提供微生物诊断，从而无法对生物恐怖主义和新出现的传染病带来的潜在威胁做出快速反应。学术界和工业界都对POC设备的开发非常感兴趣，但高昂的初始资本投资和较长的开发周期大大减少了实际的开发工作。一种快速、廉价、能够适应现有分析方案并具有高度准确性的POC检测将是一项重大进步。此外，与其从零开始建立一个POC系统，一个现成的POC平台将加速发展工作，以阻止广泛传播的疾病的迅速出现。该SBIR I期申请的总体目标是开发和验证通用护理点（POC）系统的原型制造过程，该系统能够适应现有的生命科学研究和临床诊断检测方案。我们建议建立一个标准分子分析方法的设计库，并使POC原型服务可供每个研究人员使用，以解决NIH和CDC的高度优先倡议。我们将从一种可以在I期进行10项多重检测（遗传检测和/或免疫检测）的试剂盒设计开始，并扩展到更常见的检测方案，使POC系统在II期进行优化、大规模生产和临床研究。通过POC药盒原型制造优化药盒设计，通过提出的快速制造方法对原型药盒进行分析验证后，可以通过注射成型实现药盒的大规模生产。在这项为期6个月的第一阶段研究中，我们将为POC药盒原型设计建立一个设计库，并在6小时内从设计订单到发货准备好10个特定分析的集成药盒（asic）。在第一阶段的10次试验中，原型药盒的销售成本（COGS）将低于20美元。POC控制系统的COGS将低于5000美元。