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.

项目总结 此第二阶段提案的目标是开发一种快速、易用、廉价的多样本诊断方法 识别性传播感染(STI)病原体的系统，如沙眼衣原体(CT)和 非传统医疗环境中的淋球菌(NG)。我们的系统的特点很可能符合 这将是CLIA豁免的CT/NG测试。使用这种原型类型要达到的灵敏度和特异度 测试将与目前以实验室为基础的分子测试相媲美。这将是一个重大的 性传播感染的临床诊断学进展。根据疾控中心的说法，衣原体和淋病由C. 沙眼衣原体和淋病奈瑟菌是美国报告最频繁的两种性传播疾病，很可能是 世界。这些性传播感染往往被低估，导致延迟治疗、继续传播和更高的 公共医疗成本(每年约160亿美元)。由于它们的流行和长期健康 结果，需要快速和灵敏的检测性传播感染的方法，以便患者获得 结果并立即进行治疗。重要的是，患者得到结果和初步咨询或 在第一次就诊期间接受治疗，因为他们很少再回来第二次就诊。护理点(POC)测试是一种 应对性传播感染流行的重要战略，因为许多人(年轻人和/或穷人)经常受到性传播感染的影响 对可在非传统设置中执行的传统医疗保健、PoC测试的访问受限(例如， 大学诊所、社区公共卫生保健诊所、监狱和拘留中心)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S新型试剂盒，低成本 自动平台灵感来自3D打印机技术，以及快速实时热循环器，形成多个 用于非传统医疗保健环境的示例系统。一种低成本的自给核酸提取方法 并将研制的提纯小柱进行10分钟。6个样品的提取工艺。这个 提取的NA样品将被洗脱，并使用航天飞机热循环仪进行放大以进行多路复用 CT和NG靶点的实时聚合酶链式反应(PCR)(40个周期，15min)。我们计划优化 该化验和一次性服务满足了非传统医疗机构的需求，完善了 易于使用，并将错误结果的风险降至最低。我们将完成原型系统的验证和 验证以及确定CT/NG分析的灵敏度和特异性。拟议中的工作 将与美国的一名STI专家合作进行。我们建议的技术非常适合 用于并行、自动化处理。与其他集成系统相比，这是一个实质性的优势 开发为MOST一次只能处理一个样品，需要按顺序购买几个模块 以满足大多数护理地点或近距离患者设置中的吞吐量需求。成功的开发 我们中通量技术的商业化将影响分子诊断分析的水平 在非传统医疗保健环境中实施。