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

用于快速精确诊断尿路感染的商业化技术 - 解决可扩展性和可重复性挑战

• 批准号: 557342-2020
• 负责人: Soleymani, Leyla
• 金额: $ 9.11万
• 依托单位: McMaster University
• 依托单位国家: 加拿大
• 项目类别: Idea to Innovation
• 财政年份: 2020
• 资助国家: 加拿大
• 起止时间: 2020-01-01 至 2021-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=706382
• 关键词: commercialization; ready; technology; rapid; precision

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

尿路感染 (UTI) 是社区治疗中最常见的感染，约 2% 的社区咨询与 UTI 相关。当今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。这会导致治疗延迟或在检测或确定感染原因之前凭经验使用抗生素。抗生素的延迟或无效使用会导致肾脏感染或尿脓毒症等严重后果，而过量使用抗生素会增加抗生素耐药性感染的发生率。现有的快速尿路感染检测依赖于尿液试纸，无法提供治疗选择所需的物种鉴定。 目前迫切需要一个平台，可以在单次医生咨询期间检测和识别致病的尿路感染病原体，从而能够开出精准治疗的处方。这就需要一种可靠、简单、快速且具有成本效益的测试来检测和识别引起尿路感染的病原体。我们一直在开发这种基于电化学芯片的快速测试 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，并已证明了临床可接受的敏感性和特异性。 在本提案中，我们的目标是开发一种可投入市场的基于芯片的原型，该原型可以使用不同的功能核酸序列（即多重核酸序列）检测一组细菌，并且可以使用可扩展的丝网印刷技术进行制造。然后，我们将进行一项小型试点研究，以评估这种多重且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转化预计将 (1) 实现以患者为中心