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

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是创造一种新的检测性传播感染（sti）的金标准诊断方法。该项目建议取代缓慢和昂贵的实验室检测，并将常规检测扩展到以前无法到达的环境。拟议的技术将快速即时诊断的易用性和极低成本与实验室检测的极高准确性相结合，从而在诊所和家庭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，每年发生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，以及社会耻辱感和检测的尴尬，性活跃个体接受的筛查有限。这种不充分的筛查和无法提供相同的上门检测和治疗，导致在合作伙伴之间和在合作伙伴之间继续传播。如果成功，该技术将使同一次上门检测和诊所治疗成为可能，从而克服了控制可治疗性传播感染的一个主要障碍。此外，提供家庭自我筛查的能力将消除检测的尴尬，从而增加目前在美国筛查率不足。拟议的项目是开发一种新的诊断方法，可以在护理点实现基于实验室的灵敏度。现有的快速点护理技术，如消费者妊娠试验使用的侧流免疫分析法，简单、快速、廉价，但在样品中目标生物标志物浓度较低时受到严重限制。为了克服这个问题，我们在传统的横向流动免疫分析之前集成了专有的纸质样品浓度组件，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。该设备旨在同时无缝地集中和检测完全由纸质材料制成的单个设备中的目标病原体。这种基于纸张的平台技术有望为临床、安全和资源贫乏的需求创造无数的新应用。本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分析和市场上现有的快速测试进行比较。

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.