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一种快速、易于使用且廉价的多样本诊断系统，以识别性传播感染（STI）病原体，例如沙眼衣原体（CT）和奈瑟菌非传统医疗机构中的淋病 (NG)。据美国疾病控制与预防中心称，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乃至世界其他地区第一和第二最常报告的性传播感染。这些性传播感染往往诊断不足，导致治疗延迟、持续传播和更高的公共医疗费用（每年约 160 亿美元）。由于其流行和长期健康影响，需要快速、灵敏的方法来检测性传播感染，以便患者立即获得结果和治疗。患者在第一次就诊期间获得结果和初步咨询或治疗非常重要，因为他们很少返回第二次就诊。护理点 (POC) 检测是应对性传播感染流行的一项重要策略，并且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，因此可以在非传统方式进行的 POC 检测环境（大学诊所、社区公共卫生保健诊所、监狱、拘留中心）可以大大减少性传播感染。该应用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 STI 病原体。该系统将结合 AI Biosciences, Inc. 的新型核酸提取盒和快速实时热循环仪，形成多样本系统，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盒，可以执行 10 分钟。萃取。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仪进行扩增，以对 CT 和 NG 靶标进行快速（20 分钟，40 个循环）多重实时聚合酶链反应 (PCR)。我们将证明整个测定可以在 30 分钟内完成。拟议的工作将与 STI 和流体/热特性专家合作进行。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，因为所有系统一次只能处理一个样品，因此需要多个单元才能满足最低吞吐量需求。我们技术的成功开发和商业化将影响复杂的分子诊断测定在非传统医疗保健环境中的实施方式。