A commercialization-ready technology for the rapid precision diagnosis of urinary tract infections - solving scalability and reproducibility challenges

尿路感染(UTIs)是社区治疗的最常见感染，约2%的社区会诊与UTIs有关。今天诊断尿路感染和选择治疗方法的临床方法依赖于长时间(16小时)的细菌生长培养。这会导致治疗延误或在检测或确定感染原因之前经验性地使用抗生素。延迟或无效使用抗生素会导致肾脏感染或尿毒症等严重后果，过度使用抗生素会增加抗生素耐药感染率。现有的快速尿路感染检测依赖于尿液浸渍棒，不能提供治疗选择所需的物种鉴定。 迫切需要一种平台，能够在一名医生会诊期间检测和识别引起尿路感染的病原体，以便能够开出精确的治疗处方。这对检测和识别引起尿路感染的病原体提出了可靠但简单、快速和成本效益高的测试的要求。我们一直在开发这样的快速测试，基于一种具有功能的电化学芯片 捕获细菌的功能性DNA序列，用于检测和识别导致尿路感染的主要微生物，并已显示出临床可接受的敏感性和特异性。 在这项提议中，我们将致力于开发一种基于芯片的上市原型，该原型可以使用不同功能的核酸序列(即多路复用)检测一组细菌，并可以使用可扩展的丝网印刷技术制造。然后，我们将进行一项小规模的试验性研究，以评估这个多路和可扩展的系统在分析临床尿液样本以检测和识别引起尿路感染的病原体方面的可行性。这项加拿大技术的市场翻译预计将：(1)实现以患者为中心

Urinary tract infections (UTIs) are the most common infections treated in the community, with about 2% of all community consultations being related to UTIs. Today's clinical methods for diagnosing UTIs and selecting treatment rely on lengthy (> 16 hours) bacterial growth cultures. This results in treatment delays or the empirical administration of antibiotics before detecting or identifying the cause of the infection. The delayed or ineffective use of antibiotics leads to serious consequences such as kidney infections or urosepsis, and the excessive use of antibiotics increases the rate of antibiotic-resistant infections. The existing rapid UTI tests, relying on urine dip sticks, do not provide the species identification that is needed for treatment selection. There is an urgent unmet need for a platform that can detect and identify the causative UTI pathogens during a single doctor's consultation to enable the prescription of precision treatments. This poses the requirement for a reliable yet simple, rapid, and cost-effective test for detecting and identifying pathogens that cause UTI. We have been developing such rapid test, based on an electrochemical chip functionalized with bacterium-capturing functional DNA sequences, for detecting and identifying the leading organisms that cause UTIs, and have demonstrated clinically-acceptable sensitivity and specificity. In this proposal, we will aim at developing a market-ready chip-based prototype that detects a panel of bacteria using different functional nucleic acid sequences (i.e. is multiplexed) and can be manufactured using the scalable screen printing technology. We will then run a small pilot study to assess the feasibility of this multiplexed and scalable system in analysing clinical urine samples for detecting and identifying UTI-causing pathogens. The market translation of this Canadian technology is expected to (1) enable patient-centered