Developing a highly sensitive, rapid, handheld vaginal swab test for the detection of Chlamydia trachomatis

项目摘要 阶段诊断公司的目标是为性行为检测创造新的黄金标准诊断 传播感染(STI)。该公司的目标是取代实验室检测沙眼衣原体(CT) 并将测试可访问性扩展到以前无法访问的设置。这项技术结合了易用性 以及具有基于实验室的测试的非常高的准确性的快速护理点(POC)诊断的非常低的成本， 在PoC和家庭中实现前所未有的可靠性。CT感染是中国最流行的性传播疾病之一 美国。据估计，每年有300万新病例发生，每年的直接医疗费用为 超过35亿美元。未经治疗的CT，无论是否有症状，都可能导致长期的妊娠并发症， 甚至是不孕不育。传统的基于实验室的CT分析无法在一次患者就诊期间进行检测和治疗。这 延误导致大量病例由于失去随访而得不到治疗(特别是对年轻人 性传播感染患者)和感染传播增加。现有的快速PoC诊断目前无法解决 这些问题的敏感度不到50%。Phase Diagnostics的信赖，手持一步式True棉签 CT检测将满足市场的需求，具有四个关键特征：(1)快速：患者在 不到15分钟；(2)负担得起：制造成本不到1美元；(3)准确：灵敏度和 特异性与实验室化验相当；(4)方便：手持，无需必要的设备或培训。 信任是唯一一种结合了所有测试选项的优势的产品之一，允许我们进入 现有诊断无法访问的测试设置。关键的创新是使用双水相系统 (ATPS)在检测前选择性地对致病菌进行预浓缩，从而显著 提高传统快速LFA POC技术的准确性，并使阴道拭子能够用于 CT的检测。该项目的第一阶段将涉及开发一种低风险、更容易实现两步法的装置， 以及高风险、高回报的一步诊断法。我们将使用在性病诊所采集的阴道拭子样本来 评估两种方法的可行性，获得更高灵敏度和特异度的方法将 在第二阶段进一步调查。成功完成第一阶段将导致最终诊断 第二阶段用于原型和评估的组件。该项目的第二阶段将包括开发 我们的信任装置的原型。将建立小规模制造，以确保能够进行试点 以高精度制造的。生产的中试批次将用于Alpha和Beta产品 测试中，设备将被送往多个临床地点，由临床医生进行现场评估。成功 第二阶段的完成将使设备准备好通过FDA 510(K)和CLIA豁免临床 学习。

Project Summary Phase Diagnostics is aiming to create the new gold standard diagnostic for the detection of sexually transmitted infections (STIs). The company aims to replace lab-based assays for Chlamydia trachomatis (CT) and expand testing accessibility to previously unreachable settings. The technology combines the ease-of-use and very low cost of rapid point-of-care (POC) diagnostics with the very 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 United States. 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. Existing rapid POC diagnostics currently fail to address these problems with sensitivities less than 50%. Phase Diagnostics’ TruST, a handheld, one-step True Swab Test for CT will address the market’s demands with four key characteristics: (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. TruST is one of the only products that combines the advantages of all testing options, allowing us to enter testing settings unreachable to existing diagnostics. The key innovation 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 vaginal swabs for the detection of CT. Phase I of the project will involve developing a low risk, easier to achieve two-step device, and a high risk, high reward one-step diagnostic. We will use vaginal swab samples collected in STI clinics to evaluate the feasibility of the two approaches, and the one that achieves superior sensitivity and specificity will be further investigated in Phase II. Successful completion of Phase I will result in finalized diagnostic components for prototyping and evaluation in Phase II. Phase II of the project will consist of developing a prototype of our TruST device. Small-scale manufacturing will be established to ensure a pilot lot can be manufactured with high precision. The manufactured pilot lot will then be used for Alpha and Beta product testing where the devices will be sent to multiple clinical sites for on-site evaluation by clinicians. Successful completion of Phase II will result in a device ready for FDA 510(k) clearance and CLIA waiver-enabling clinical studies.