A rapid, accurate, and easy-to-use diagnostic assay for STIs

描述（由申请人提供）：本申请的目的是开发一种快速、易于使用、廉价的多样本诊断系统，用于在非传统医疗保健环境中识别性传播感染（STI）病原体，如沙眼衣原体（CT）和淋病奈瑟菌（NG）。根据疾病预防控制中心的数据，分别由沙眼衣原体和淋病奈瑟菌引起的衣原体和淋病是美国和世界其他地区报告的第一和第二大最常见的性传播感染。这些性传播感染往往未得到充分诊断，导致治疗延误、持续传播和更高的公共医疗费用（每年约160亿美元）。由于性传播感染的普遍性和对健康的长期影响，需要有快速、灵敏的方法来检测性传播感染，以便患者立即得到结果和治疗。重要的是，患者在第一次就诊时获得结果和初步咨询或治疗，因为他们很少再次就诊。即时检测是应对性传播感染流行的一项重要战略，由于许多受性传播感染影响的人（年轻人和/或穷人）获得传统医疗保健的机会往往有限，因此可以在非传统环境（大学诊所、社区公共卫生保健诊所、监狱、拘留中心）进行即时检测，可以大大减少性传播感染。该应用程序的目的是开发一种快速、易于使用、廉价的诊断系统，用于识别STI病原体，如CT和NG。该系统将结合AI Biosciences公司的新型核酸提取盒和快速实时热循环器，形成一个多样本系统，用于许多非传统医疗保健环境。在第一阶段，将开发一种高性能，低成本的独立核酸提取和纯化试剂盒，进行10分钟的提取。提取的NA样品将放置在薄壁PCR卡中，并使用创新的水基循环器进行扩增，对CT和NG目标进行快速（20分钟40个循环）多路实时聚合酶链反应（PCR）。我们将证明整个分析可以在不到30分钟内完成。拟议的工作将与sti和流体/热表征专家合作进行。我们的样品制备盒和PCR技术非常适合并行，自动化样品处理。与正在开发的其他集成系统相比，这是一个巨大的优势，因为它们一次只能处理一个样品，因此需要几个单元来满足最低吞吐量需求。我们的技术的成功开发和商业化将影响如何复杂的分子诊断分析可以在非传统医疗环境中实施。

DESCRIPTION (provided by applicant): The aim of this application is to develop a rapid, easy-to-use, and inexpensive multi-sample diagnostic system to identify sexually transmitted infection (STI) pathogens, such as Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in non-traditional healthcare settings. According to the CDC, chlamydia and gonorrhea, caused by C. trachomatis and N. gonorrhoeae, respectively, are the first and second most frequently reported STIs in the US and likely the rest of the world. These STIs are often under-diagnosed, leading to delayed treatment, continued spread and higher public healthcare costs (~$16 billion annually). As a result of their prevalence and long term health consequences, there is a need for rapid, sensitive methods of detecting STIs in order for patients to get results and treatment immediately. It is important that patients receive results and initial consultation or treatment during the first patient visit, as they rarely return for a second visit. Point-of- care (POC) tests are an important strategy to address the STI epidemic, and because many affected by STIs (young and/or poor) often have limited access to traditional healthcare, POC tests that can be performed in non-traditional settings (university clinics, community public health care clinics, jails, detention centers) could greatly reduce STIs. The aim of this application is to develop a rapid, easy-to-use, inexpensive diagnostic system for identifying STI pathogens such as CT and NG. The system will combine AI Biosciences, Inc.'s novel nucleic acid extraction cartridge and a rapid real-time thermal cycler to form a multi-sample system for use in many non-traditional healthcare settings. In Phase I, a high performance, low-cost self-contained nucleic acid extraction and purification cartridge will be developed to perform a 10 min. extraction. The extracted NA samples will be placed in an thin-walled PCR card and amplified using an innovative water based cycler to perform rapid (20 min for 40 cycles) multiplexed real-time polymerase chain reaction (PCR) for CT and NG targets. We will demonstrate that the entire assay can be completed in less than 30 min. The proposed work will be carried out in collaboration with STIs and fluidic/thermal characterization experts. Our sample preparation cartridge and the PCR technologies are highly suitable for parallel, automated sample processing. This is a substantial advantage over other integrated systems being developed as all of them can only process one sample at a time, making several units necessary to meet the minimum throughput demand. The successful development and commercialization of our technology will impact how sophisticated molecular diagnostic assays can be implemented in non-traditional healthcare settings.