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

• 批准号: 9347683
• 负责人: SEASON S-S WONG
• 金额: $ 69.76万
• 依托单位: AI BIOSCIENCES, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-02-07 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9347683
• 关键词: 3D Print; Address; Advanced Development; Affect; Bedside Testings; Biological Assay; Biological Sciences; Centers for Disease Control and Prevention (U.S.); Chlamydia; Chlamydia trachomatis; Clinic; Collaborations; Comb animal structure; Communities; Consultations; Coupled; DNA; Detection; Development; Devices; Diagnosis; Diagnostic; Disease; Ectopic Pregnancy; Ensure; Epidemic; Fluorescence; Future; Gonorrhea; Health; Health Care Costs; Health care facility; Healthcare; Healthcare Systems; Human; Individual; Infection; Infertility; Jail; Laboratories; Magnetism; Medical; Methods; Molecular; Molecular Diagnostic Testing; Movement; Neisseria gonorrhoeae; Nucleic Acids; Patients; Pelvic Inflammatory Disease; Performance; Phase; Play; Point-of-Care Systems; Polymerase Chain Reaction; Preparation; Prevalence; Process; Protocols documentation; Public Health; Reporting; Rest; Sampling; Sensitivity and Specificity; Sepsis; Sexually Transmitted Diseases; Swab; System; Technology; Testing; Time; Tube; Universities; Urine; Vagina; Validation; Visit; Work; amplification detection; artist; base; clinical diagnostics; commercialization; cost; cost effective; design; detention center; diagnostic assay; improved; innovation; molecular diagnostics; novel; outreach; particle; pathogen; point of care; professor; prototype; risk minimization; screening; tool; verification and validation

PROJECT SUMMARY The aim of this Phase II proposal 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. The features of our system will likely qualify it to be a CLIA-waived CT/NG test. The sensitivity and specificity to be achieved using this prototype type assay will be comparable with those of current laboratory-based molecular tests. This would present a major advancement in clinical diagnostics for STIs. According to the CDC, chlamydia and gonorrhea, caused by C. trachomatis and N. gonorrhoeae, are the two 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 and 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 (e.g., university clinics, community public health care clinics, jails, and detention centers) could greatly reduce STIs. The system we propose to further develop will combine AI Biosciences, Inc.’s novel assay cartridge, low-cost automatic platform inspired by 3D printer technology, and a rapid real-time thermal cycler to form a multi- sample system for use in non-traditional healthcare settings. A low-cost self-contained nucleic acid extraction and purification cartridge will be developed to perform a 10 min. extraction process for 6 samples. The extracted NA samples will then be eluted and amplified using shuttle thermal cycler to perform multiplexed real-time polymerase chain reaction (PCR) for CT and NG targets (15 min for 40 cycles). We plan to optimize the assay and disposable to meet the needs of non-traditional healthcare settings, improve the system for ease-of-use, and minimize risk of erroneous result. We will complete prototype system validation and verification as well as determine analytical sensitivity and specificity of the CT/NG assay. The proposed work will be carried out in collaboration with a STI expert in the US. Our proposed technologies are highly suitable for parallel, automated processing. This is a substantial advantage over other integrated systems being developed as most can only process one sample at a time, requiring the purchase of several modules in order to meet the throughput demand in most point-of-care or near-patient settings. The successful development and commercialization of our medium-throughput technology will impact how molecular diagnostic assays are implemented in non-traditional healthcare settings.

项目概要 该第二阶段提案的目的是开发一种快速、易于使用且廉价的多样本诊断方法 识别性传播感染 (STI) 病原体的系统，例如沙眼衣原体 (CT) 和 非传统医疗机构中的淋病奈瑟氏菌 (NG)。我们系统的功能可能符合条件 它是 CLIA 豁免的 CT/NG 测试。使用该原型类型可实现的灵敏度和特异性 测定将与当前基于实验室的分子测试相当。这将提出一个主要的 STI 临床诊断的进展。根据疾病预防控制中心的说法，衣原体和淋病是由衣原体引起的。 沙眼衣原体和淋病奈瑟菌是美国最常报告的两种性传播感染，并且可能是其他国家最常见的性传播感染 世界。这些性传播感染往往诊断不足，导致治疗延迟、持续传播和更高的发病率 公共医疗保健费用（每年约 160 亿美元）。由于它们的流行和长期健康 因此，需要快速、灵敏的方法来检测性传播感染，以便患者获得 立即得到结果和治疗。患者收到结果和初步咨询或 在第一次患者就诊期间接受治疗，因为他们很少返回第二次就诊。即时护理 (POC) 测试是一种 解决性传播感染流行的重要战略，并且因为许多受性传播感染影响的人（年轻人和/或穷人）经常 获得传统医疗保健的机会有限，可以在非传统环境中进行 POC 测试（例如， 大学诊所、社区公共卫生保健诊所、监狱和看守所）可以大大减少性传播感染。 我们建议进一步开发的系统将结合 AI Biosciences, Inc. 的新型检测盒、低成本 受 3D 打印机技术启发的自动平台和快速实时热循环仪形成多 用于非传统医疗保健环境的示例系统。低成本的独立核酸提取 纯化盒将被开发以执行 10 分钟。 6个样品的提取过程。这 然后使用穿梭热循环仪对提取的 NA 样品进行洗脱和扩增，以执行多重检测 CT 和 NG 目标的实时聚合酶链反应 (PCR)（15 分钟，40 个循环）。我们计划优化 分析和一次性满足非传统医疗保健环境的需求，改进系统 易于使用，并最大限度地减少错误结果的风险。我们将完成原型系统验证并 验证以及确定 CT/NG 测定的分析灵敏度和特异性。拟议的工作 将与美国的 STI 专家合作进行。我们提出的技术非常适合 用于并行、自动化处理。与其他集成系统相比，这是一个巨大的优势 由于大多数一次只能处理一个样品，需要按顺序购买多个模块 满足大多数护理点或患者附近环境中的吞吐量需求。开发成功 我们的中等通量技术的商业化将影响分子诊断测定的方式 在非传统医疗保健环境中实施。