Rapid Molecular Diagnostic for Chlamydia and Gonorrhea at the Point-of-Care

衣原体和淋病的即时快速分子诊断

• 批准号: 8897723
• 负责人: CATHERINE M. KLAPPERICH
• 金额: $ 40.38万
• 依托单位: BOSTON UNIVERSITY (CHARLES RIVER CAMPUS)
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-05 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8897723
• 关键词: Acquired Immunodeficiency Syndrome; Bacterial Infections; Bedside Testings; Biological Assay; Biology; Care Technology Points; Centers for Disease Control and Prevention (U.S.); Chlamydia; Clinic; Clinical; Clinical Research; Clinical Trials; DNA; Detection; Devices; Diagnosis; Diagnostic; Early Diagnosis; Ectopic Pregnancy; Ensure; Epidemiology; Genitourinary system; Goals; Gold; Gonorrhea; Health; Health Personnel; Human; Hybrids; Immune; Improve Access; Individual; Infection; Infertility; Laboratories; Lateral; Learning; Literature; Mammalian Oviducts; Microfluidics; Molecular; Molecular Diagnostic Testing; Multi-Drug Resistance; Neisseria gonorrhoeae; Nucleic Acids; Organism; Paper; Pathogen detection; Patients; Pelvic Inflammatory Disease; Point-of-Care Systems; Preparation; Process; Protocols documentation; Reagent; Reporting; Research; Running; Sampling; Sensitivity and Specificity; Sexually Transmitted Diseases; Simulate; Specimen; Sterility; Swab; Symptoms; System; Technology; Test Result; Testing; Time; United States; Universities; Urine; Uterus; Virus; Virus Diseases; Visual; Woman; Work; chronic pelvic pain; commercialization; cost; cross reactivity; design; diagnosis quality; innovation; instrument; instrumentation; internal control; pathogen; point of care; prospective; scale up; success; transmission process; validation studies

DESCRIPTION (provided by applicant): More than 4 million people in the United States are infected with chlamydia (CT) and gonorrhea (NG). These sexually transmitted infections (STIs) have few early symptoms but cause serious complications that range from sterility and infertility to multidrug resistance and increased HIV infection and transmission. Reducing the spread of these STIs will require early diagnosis, and treatment of infected individuals. Success requires the wide availability of low-cost, robust, and easy to use molecular diagnostics for use at the point-of-care (POC) for the earliest detection of the causative organism. We have developed sample-to-answer molecular diagnostic assays for CT and for NG detection in simulated urine. The hypothesis to be tested is that molecular diagnostic chips can detect and differentiate CT and NG in microliter-scale human urogenital samples with specificity and sensitivity better than presently available POC testing. We have previously demonstrated at the bench that the components of the chip work with simulated samples. Our goal is to develop a portable, inexpensive molecular diagnostic that can be used at the POC to diagnose and differentiate CT and NG infections. We have teamed up with Dr. Charlotte Gaydos at Johns Hopkins University Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases to perform an intermediate sized sensitivity and specificity study using previously collected and stored urogenital specimens that have been de-identified and well characterized. We will develop a low-cost, integrated sample-to-result molecular diagnostic assay system to detect chlamydia and gonorrhea that uses a simple, visual means of detecting nucleic acid amplification products. In order to develop this technology for real-world clinical and field use, the following aims are proposed: 1. To adapt our current test to a multiplexed CT and NG assay, we will optimize sample preparation, amplification, and detection of CT, NG, and a competitive internal control (CIC). 2. To enable testing at the POC, we will optimize the chip design and instrumentation to integrate sample-to-answer processes. 3. To clinically validate the new POC molecular diagnostic, we will determine if the integrated assay is comparable in specificity and sensitivity to gold standard real- time NAATs using human urogenital samples. The ultimate deliverable of the project is a fully-integrated, clinically validated molecular diagnostic for POC testing of STI that is ready for commercialization and scale- up to prospective clinical trials.

描述（由申请人提供）：美国有400万人感染了衣原体（CT）和Gonorrhea（NG）。这些性传播感染（性传播感染）几乎没有早期症状，但会引起严重的并发症，范围从不育和不育到多药耐药性以及增加的HIV感染和传播。减少这些性传播感染的传播将需要尽早诊断，并治疗受感染的个体。成功需要在最早检测因果生物的情况下使用低成本，鲁棒和易于使用的分子诊断。我们已经开发了用于CT的样品到回答分子诊断测定法和模拟尿液中的NG检测。要检验的假设是，分子诊断芯片可以比目前可用的POC测试更好，具有特异性和敏感性的微量尺度人类泌尿生殖器样品中的CT和NG。以前，我们在长凳上证明了芯片的组成部分与模拟样品一起工作。我们的目标是开发一种便携式，廉价的分子诊断，该诊断可在POC上用于诊断和区分CT和NG感染。我们已经与约翰·霍普金斯大学（Johns Hopkins University）的夏洛特·盖多斯（Charlotte Gaydos）博士合作，使用先前收集和存储的泌尿生殖器标本进行性传播疾病研究中心，以进行性传播疾病，以进行中等大小的敏感性和特异性研究，这些标本已被识别并且表征良好。我们将开发一种低成本的，集成的样品到星期分子诊断测定系统，以检测衣原体和淋病，使用一种简单的视觉手段来检测核酸扩增产物。为了开发用于现实世界中临床和现场使用的这项技术，提出了以下目的：1。为了使我们的当前测试适应多重CT和NG测定法，我们将优化样本准备，放大和检测CT，NG和竞争性内部控制（CIC）。 2。为了在POC上进行测试，我们将优化芯片设计和仪器以整合样品与答案过程。 3。为了临床验证新的POC分子诊断，我们将确定使用人类泌尿生殖器样品对黄金标准实时NAAT的特异性和敏感性是否具有比较。该项目的最终可交付是用于STI POC测试的完全集成，临床验证的分子诊断，该诊断已准备好进行商业化并扩展到前瞻性临床试验。