Rapid Paper-based Diagnostics of CT / Trich

CT/Trich 纸质快速诊断

基本信息

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
项目类别：
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

项目摘要

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（由适用提供）：我们建议用低成本可支配且高度敏感的分子诊断装置快速诊断衣原体（CT）和毛诺病（TRICH）。当前可用的诊断方法，包括核酸扩增测试（NAATS），基于免疫测定的快速诊断测试，培养和显微镜以及近乎患者分子测试的出现在成本，时间和敏感性之间的折衷。以前，我们设计了一个基于纸张的微芯片，以实现CT的样品到答案诊断，其检测极限（LOD）接近或优于当前的金标准NAAT方法，并且以少于一个小时的速度，速度较快。在初步研究中，我们证明了该设备的新概念及其检测其他性传播感染的潜在能力，例如Trich。成功完成的项目里程碑是一个集成系统的演示，该系统可以在不到一个小时的时间内对CT和Trich进行整个基于纸张的多个样品 - 检测分子诊断过程，并使用比色的读数。为了实现这一目标，我们将建立原型设备，该原型设备在模拟尿液中快速检测CT的敏感性很大，通过实施测定和硬件变化，这将导致灵敏度（LOD），从而可以测量尿液中CT和Trich的测量。这种完全综合的和经过验证的用于STD的POC测试的分子诊断将准备好进行商业化，并在项目分娩时进行临床试验扩大规模。