Rapid Paper-based Diagnostics of CT / Trich

CT/Trich 纸质快速诊断

• 批准号: 9048981
• 负责人: CATHERINE M. KLAPPERICH
• 金额: $ 14.72万
• 依托单位: MICRO ANALYSIS INTEGRATION, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-15 至 2017-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9048981
• 关键词: Acquired Immunodeficiency Syndrome; Antimicrobial Resistance; Bacterial Infections; Bedside Testings; Biological Assay; Boston; Cells; Centers for Disease Control and Prevention (U.S.); Chlamydia; Chlamydia trachomatis; Clinic; Clinical; Clinical Trials; Cohort Studies; Communicable Diseases; Contracts; Country; DNA; DNA purification; Detection; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostic tests; Engineering; Epidemiology; Fetus; Goals; Gold; Health Policy; Hour; Human; Hybrids; Immune; Immunoassay; In Situ; Incidence; Industry; Infection; Lateral; Lead; Learning; Literature; Measurement; Measures; Medical; Methods; Microfluidic Microchips; Microscopy; Molecular; Neisseria gonorrhoeae; Nucleic Acid Amplification Tests; Organism; Paper; Patients; Perception; Polymerase Chain Reaction; Preparation; Process; Public Health; Reporting; Risk Factors; Sampling; Sexual Transmission; Sexually Transmitted Diseases; Specimen; Speed; Syphilis; System; Technology; Test Result; Testing; Time; Trichomonas Infections; Trichomonas vaginalis; United States; Universities; Urine; Validation; Virus; Virus Diseases; Visual; Woman; Work; World Health Organization; amplification detection; antimicrobial; base; commercialization; cost; design; disorder prevention; health practice; high risk; instrumentation; molecular diagnostics; multiplex detection; novel; point of care; prenatal; primary care setting; prototype; public health relevance; research clinical testing; scale up; screening; transmission process

 DESCRIPTION (provided by applicant): We propose to rapidly diagnose chlamydia (CT) and trichomoniasis (Trich) with a low cost disposable and highly sensitive molecular diagnostic device. Currently available diagnostic methods including nucleic acid amplification tests (NAATs), immunoassay-based rapid diagnostic tests, culture and microscopy, and emerging near patient molecular tests suffer from the tradeoff between costs, time, and sensitivity. Previously, we designed a paper-based micro-chip to enable sample-to-answer diagnostics of CT, with the limit of detection (LOD) close or superior to the current gold standard NAAT methods, and at a speed of less than an hour, tens of times more rapid. In preliminary studies, we have demonstrated the novel concept of the device and its potential ability to detect other STI infections, such as Trich. The project milestone for successful completion is the demonstration of an integrated system to perform the entire paper-based multiplex sample- to-detection molecular diagnostic process on CT and Trich in less than one hour with a colorimetric readout. To achieve this goal, we will build upon our prototype device, which has shown significant sensitivity in rapidly detecting of CT in simulated urine, by implementing assay and hardware changes that would lead to sensitivity (LOD) that would enable the measurement of both CT and Trich in urine. This fully-integrated and validated molecular diagnostic for POC testing of STDs will be ready for commercialization and scale-up to clinical trials at project delivery.

 描述（由申请人提供）：我们提出用低成本的一次性高灵敏度分子诊断装置快速诊断衣原体（CT）和滴虫病（Trich）。目前可用的诊断方法，包括核酸扩增测试（NAAT），基于免疫测定的快速诊断测试，培养和显微镜检查，以及新兴的近患者分子测试遭受成本，时间和灵敏度之间的权衡。此前，我们设计了一种纸基微芯片，可以实现CT的样本到答案诊断，检测限（LOD）接近或上级于目前的金标准NAAT方法，而且速度不到一小时，快了数十倍。在初步研究中，我们已经证明了该设备的新概念及其检测其他STI感染（如Trich）的潜在能力。该项目成功完成的里程碑是展示了一个集成系统，该系统可在不到一小时的时间内通过比色读数在CT和Trich上执行整个基于纸张的多重样品到检测分子诊断过程。为了实现这一目标，我们将在原型设备的基础上进行构建，该原型设备在快速检测模拟尿液中的CT方面表现出显著的灵敏度，方法是对检测试剂盒和硬件进行变更，以提高灵敏度（LOD），从而能够测量尿液中的CT和Trich。这种完全集成和验证的用于性病POC检测的分子诊断将在项目交付时准备商业化和扩大到临床试验。