SBIR Phase I: A Handheld, One Step Paper-Based Device for Rapid Self-Testing of Sexually Transmitted Infections

SBIR 第一阶段：一种手持式、一步式纸基设备，用于快速自检性传播感染

• 批准号: 1549003
• 负责人: Ricky Yin To Chiu
• 金额: $ 15万
• 依托单位: Phase Diagnostics, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-01-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1549003&HistoricalAwards=false
• 关键词: SBIR; Phase; Handheld; Step; Paper

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to create a new gold standard diagnostic for the detection of sexually transmitted infections (STIs). The project proposes to replace slow and expensive lab-based assays and expand regular testing to previously unreachable settings. The proposed technology combines the ease-of-use and very low cost of rapid point-of-care diagnostics with the very high accuracy of lab-based tests, enabling unprecedented reliability at the clinics and at home. Chlamydia is the leading sexually transmitted infection in the United States. An estimated 4 million new cases occur each year with direct annual medical costs of greater than $3.5 billion. Due to the asymptomatic nature of the infections, along with the social stigma and embarrassment for testing, sexually active individuals undergo limited screening. This inadequate screening and the inability to provide same visit testing and treatment results in continued transmission to and from partners. If successful, the proposed technology will enable same visit testing and treatment in clinics, overcoming a major hurdle towards controlling treatable STIs. Furthermore, the ability to provide at home self screening will eliminate the embarrassment of testing, thereby increasing the current inadequate rate of screening in the United States. The proposed project is to develop a novel diagnostic that can achieve lab-based sensitivity at the point-of-care. Existing rapid point-of-care technologies, such as the lateral-flow immunoassay utilized by consumer pregnancy tests, are simple, fast, and inexpensive, however are severely limited when the concentrations of the target biomarkers in the sample are low. To overcome this problem, we integrated proprietary paper-based sample concentration components prior to the conventional lateral-flow immunoassay to significantly enhance its performance without additional equipment, training, or increased time-to-result. The proposed device is aimed at simultaneously and seamlessly concentrate and detect target pathogens within a single device that is made entirely with paper materials. This paper-based platform technology is expected to create countless new applications for clinical, safety, and resource-poor needs. This project will investigate the feasibility of the technology for the detection of chlamydia. The proposed technology will be compared with lab assays and existing rapid tests in the market.

该小企业创新研究 (SBIR) 第一阶段项目的更广泛影响/商业潜力是为检测性传播感染 (STI) 创建新的黄金标准诊断方法。该项目建议取代缓慢且昂贵的实验室检测，并将定期检测范围扩大到以前无法达到的设置。所提出的技术将快速现场诊断的易用性和极低的成本与实验室测试的极高准确性相结合，在诊所和家庭中实现前所未有的可靠性。衣原体是美国主要的性传播感染。据估计，每年会出现 400 万新病例，每年直接医疗费用超过 35 亿美元。由于感染的无症状性质，加上社会耻辱和检测的尴尬，性活跃的个体接受的筛查有限。这种不充分的筛查以及无法提供相同的就诊检测和治疗导致了伴侣之间的持续传播。如果成功，拟议的技术将能够在诊所进行同一次就诊检测和治疗，克服控制可治疗性传播感染的主要障碍。此外，提供在家自我筛查的能力将消除检测的尴尬，从而增加美国目前筛查不足的比率。拟议的项目是开发一种新型诊断方法，可以在护理点实现基于实验室的敏感性。现有的快速护理点技术，例如消费者妊娠测试所使用的侧流免疫测定，简单、快速且廉价，但当样品中目标生物标志物的浓度较低时，其技术受到严重限制。为了克服这个问题，我们在传统的侧流免疫测定之前集成了专有的纸基样品浓缩组件，以显着提高其性能，而无需额外的设备、培训或增加获得结果的时间。所提出的设备旨在在完全由纸材料制成的单个设备中同时无缝地集中和检测目标病原体。这种基于纸质的平台技术预计将为临床、安全和资源匮乏的需求创造无数新的应用。该项目将研究衣原体检测技术的可行性。拟议的技术将与实验室检测和市场上现有的快速检测进行比较。