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

SBIR 第二阶段：一种手持式、一步式纸质设备，用于快速自检性传播感染

• 批准号: 1660130
• 负责人: Ricky Yin To Chiu
• 金额: $ 74.98万
• 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: 2017
• 资助国家: 美国
• 起止时间: 2017-05-01 至 2019-04-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1660130&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Handheld; Step

This Small Business Innovation Research (SBIR) Phase II project is to develop a handheld, one-step paper-based device for rapid self-testing of sexually transmitted infections. The company aims to replace lab-based assays for Chlamydia trachomatis (CT) and expand testing access to previously unreachable settings. The technology combines the ease-of-use and very low cost of rapid point-of-care (POC) diagnostics with the high accuracy of lab-based tests, enabling unprecedented reliability at the POC and at home. CT infection is one of the most prevalent STIs in the US. An estimated three million new cases occur each year with direct annual medical costs of greater than $3.5 billion. Untreated CT, symptomatic or not, may cause long term pregnancy complications, even infertility. Traditional lab-based CT assays prevent the ability to test-and-treat within one patient visit. This delay results in a high number of cases that do not get treatment due to loss-to-follow up (especially for young STI patients) and increased infection transmission. Phase Diagnostics? novel device will be: (1) Fast: Results to the patient in less than 15 minutes; (2) Affordable: Costs less than $1 to manufacture; (3) Accurate: Sensitivity and specificity on par with lab-based assays; (4) Convenient: Handheld with no required equipment or training. The key innovation of the company's novel device is to use aqueous two-phase systems (ATPSs) to selectively pre-concentrate the pathogenic bacteria prior to detection, thereby dramatically enhancing the accuracy of conventional rapid LFA POC technology and enabling the use of urine samples for the detection of CT. During Phase I, the company was able to adapt ATPS to urine medium, attain improved limits of detection of its system and make considerable progress in fully integrating all components into a true one-step paper microfluidic strip. The objective of Phase II is to fully develop the company's proposed device to be ready for FDA 510(k) clearance and CLIA waiver enabling clinical studies. The company will first complete the product optimization work initiated in Phase I and perform additional device robustness studies. As these experiments near completion, the company will work with a contract prototyper to design and develop prototypes based on the final optimized device components. At the same time, the company will establish small scale manufacturing processes to ensure that it can generate a reproducible pilot batch. The company will then perform Alpha and Beta product testing to determine the clinical performance of its prototype as well as obtain feedback from end-users to determine areas for optimization.

这个小型企业创新研究（SBIR）第二阶段项目是开发一种手持式，一步纸基设备，用于快速自我检测性传播感染。该公司的目标是取代基于实验室的沙眼衣原体（CT）检测，并将检测范围扩大到以前无法到达的环境。该技术结合了快速护理点（POC）诊断的易用性和极低成本与基于实验室的测试的高准确性，从而在POC和家中实现了前所未有的可靠性。CT感染是美国最常见的性传播感染之一。据估计，每年有300万新病例，每年直接医疗费用超过35亿美元。未经治疗的CT，无论有无症状，都可能导致长期妊娠并发症，甚至不孕。传统的基于实验室的CT检测无法在一次患者就诊中进行检测和治疗。这种延误导致大量病例因失访而得不到治疗（特别是年轻的性传播感染患者），并增加了感染传播。阶段诊断？新型器械将：（1）快速：在不到15分钟的时间内为患者提供结果;（2）经济实惠：制造成本低于1美元;（3）准确：灵敏度和特异性与实验室检测相当;（4）方便：手持式，无需设备或培训。该公司的新型设备的关键创新是使用水两相系统（ATPS）在检测前选择性地预浓缩病原菌，从而大大提高了传统快速LFA POC技术的准确性，并使尿液样本能够用于检测CT。在第一阶段，该公司能够使ATPS适应尿液介质，提高其系统的检测限，并在将所有组件完全集成到真正的一步式纸微流控条中方面取得了相当大的进展。第二阶段的目标是全面开发该公司的拟议设备，以准备FDA 510（k）许可和CLIA豁免，使临床研究。该公司将首先完成第一阶段启动的产品优化工作，并进行额外的器械稳健性研究。随着这些实验接近完成，该公司将与合同原型设计师合作，根据最终优化的设备组件设计和开发原型。与此同时，公司将建立小规模生产工艺，以确保能够产生可重现的中试批次。然后，该公司将进行Alpha和Beta产品测试，以确定其原型的临床性能，并获得最终用户的反馈，以确定优化领域。