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

一种快速、准确且易于使用的性传播感染诊断方法

基本信息

批准号：
8713686
负责人：
SEASON S-S WONG
金额：
$ 22.49万
依托单位：
AI BIOSCIENCES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-02-07 至 2015-10-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8713686
关键词：
Address Advanced Development Affect Automation Bathing Bedside Testings Biological Assay Centers for Disease Control and Prevention (U.S.)Chlamydia Chlamydia trachomatis Clinic Collaborations Communities Consultations Detection Development Devices Diagnosis Diagnostic Disease Ectopic Pregnancy Epidemic Gonorrhea Hand Health Health Care Costs Health care facility Healthcare Healthcare Systems Infection Infertility Jail Left Legal patent Measures Medical Methods Molecular Motor Neisseria gonorrhoeae Nucleic Acids Patients Pelvic Inflammatory Disease Performance Phase Point-of-Care Systems Polymerase Chain Reaction Positioning Attribute Preparation Prevalence Process Public Health Pump Reaction Reagent Reporting Rest Sampling Sepsis Sexually Transmitted Diseases Signal Transduction Swab Syringes System Technology Testing Time Universities Urine Visit Water Work base commercialization cost cost effective detector detention center innovation instrument meetings novel outreach pathogen point of care public health relevance screening tool

项目摘要

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.

描述（由申请人提供）：本申请的目的是开发快速，易于使用且廉价的多样本诊断系统，以识别非交易卫生环境中的性传播感染（STI）病原体，例如沙眼衣原体（CT）和Neisseria Gonorrhoeae（NG）。根据CDC的说法，分别是沙眼梭状芽孢杆菌和淋病链球菌造成的衣原体和淋病是美国的第一和第二频繁报告的性传播感染性传播疾病以及世界其他地区。这些性传播感染常常被诊断不足，导致治疗延迟，持续差异和更高的公共医疗费用（每年约160亿美元）。由于其患病率和长期健康后果，需要快速，敏感的方法检测性传播感染，以便患者立即获得结果和治疗。重要的是，在第一次访问期间，患者很少返回第二次访问，因此必须在第一次患者访问期间获得结果和初步咨询或治疗。护理点（POC）测试是解决该性病流行的重要策略，因为许多受STI（年轻和/或穷人）影响的人通常在非传统环境中可以进行传统医疗保健，POC测试的机会有限（大学诊所，社区公共保健诊所，监狱，疏忽中心）可能会大大减少StiS。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CT和NG等性病病原体。该系统将结合AI Biosciences，Inc。的新型核酸提取弹药筒和快速实时热循环仪，形成一个多样本系统，用于许多非传统医疗机构。在第一阶段，将开发出高性能，低成本的核酸提取和纯化墨盒，以执行10分钟。萃取。提取的NA样品将放置在薄壁的PCR卡中，并使用创新的水基循环蛋白放大，以对CT和NG靶标进行快速（40个循环）多路复用的实时聚合酶链反应（PCR）。我们将证明可以在不到30分钟的时间内完成整个测定法。拟议的工作将与性传播感染和流体/热表征专家合作进行。我们的样品制备弹药筒和PCR技术非常适合平行，自动样品处理。与正在开发的其他集成系统相比，这是一个实质性的优势，因为所有这些系统都只能一次处理一个样本，从而使几个单位需要几个单位来满足最小吞吐量需求。我们技术的成功开发和商业化将影响如何在非传统医疗保健环境中实施复杂的分子诊断测定法。