SBIR Phase II: 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）二期项目旨在开发一种手持式、一步式的纸质设备，用于性传播感染的快速自我检测。该公司的目标是取代沙眼衣原体（CT）的实验室检测方法，并将检测途径扩大到以前无法到达的地方。该技术将快速护理点（POC）诊断的易用性和极低成本与实验室测试的高精度相结合，在POC和家庭中实现了前所未有的可靠性。CT感染是美国最普遍的性传播感染之一。据估计，每年发生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，无论是否有症状，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分析阻止了在一次患者就诊中进行检测和治疗的能力。这种延误导致大量病例因无法随访而得不到治疗（特别是对年轻的性传播感染患者），并增加了感染传播。期诊断?新设备将：(1)快速：在不到15分钟的时间内给患者结果；(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，无需设备或培训。该公司新型设备的关键创新之处在于使用双水相系统（atps）在检测前选择性地预先浓缩致病菌，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CT检测。在第一阶段，该公司能够使ATPS适应尿液介质，提高了其系统的检测极限，并在将所有组件完全集成为真正的一步纸微流控试纸方面取得了相当大的进展。II期的目标是全面开发公司拟议的设备，以准备FDA 510(k)许可和CLIA豁免，以便进行临床研究。该公司将首先完成第一阶段启动的产品优化工作，并进行额外的设备稳健性研究。随着这些实验接近完成，该公司将与合同原型公司合作，根据最终优化的设备组件设计和开发原型。与此同时，该公司将建立小规模的制造工艺，以确保它能够产生可重复的中试批次。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，并从最终用户那里获得反馈，以确定需要优化的领域。

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.