Integrated molecular diagnostic system for the point-of-care

用于现场护理的综合分子诊断系统

基本信息

批准号：
8339922
负责人：
Huimin Kong
金额：
$ 24.09万
依托单位：
BIOHELIX CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-30 至 2013-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8339922
关键词：
Bedside Testings Biological Assay Boston Buffers Centers for Disease Control and Prevention (U.S.)Chemistry Chlamydia trachomatis Client Clinic Clinical Cytolysis DNA DNA amplification Detection Device Designs Devices Diagnostic Engineering Eye Hand Health Personnel Housing Laboratories Lateral Learning Liquid substance Literature Manufacturer Name Marketing Microfluidic Microchips Molecular Movement National Institute of Allergy and Infectious Disease Neisseria gonorrhoeae Nucleic Acids Patients Phase Point-of-Care Systems Polymerase Chain Reaction Process Reaction Reader Reagent Research Risk Sampling Sexually Transmitted Diseases Small Business Technology Transfer Research Solid Solutions Staging Surgical Flaps System Technical Expertise Technology Temperature Test Result Testing Tube Universities Urine Validation Vent Visual Work base commercialization cost design experience fluorescence microscope helicase high throughput screening inhibitor/antagonist instrument internal control micro-total analysis system pathogen point of care prototype

项目摘要

DESCRIPTION (provided by applicant): This STTR-AT-NIAID seeks to develop an integrated nucleic acid system based on research done by Catherine Klapperich's laboratory at Boston University. The BU lab-on-a-chip includes a micro solid phase extraction (<SPE) column, flap valves and hydrophobic vents to gate fluid movements through micro channels, and multiple reaction chambers for experimental replicates and control reactions. Dr. Klapperich's laboratory has successfully performed nucleic acid amplifications in the chip using BioHelix's isothermal amplification process. Biohelix's proprietary technology is called helicase-dependent amplification (HDA). It uses DNA helicases to separate DNA strands during exponential amplification at a constant temperature of 65:C. Like the polymerase chain reaction (PCR), HDA assays use a competitive internal control (i.e., a template DNA of known concentration spiked into the raw sample) that can be amplified by the same primers as the analyte, but detected separately; hence allowing us to detect amplification inhibitors in direct clinical samples. The objectives of Phase I are to: 1) modify the BU microfluidic device design to incorporate a lateral flow strip as a means of detecting amplification products using the naked eye; and 2) demonstrate the feasibility of performing integrated tests using the device from aim 1 using CT and NG spiked at 104 in 1 mL urine to establish proof of concept for integrated assays performed in a modified BU chip that includes a lateral flow strip. Our specific aims for Phase II will be to develop a lateral flow reader sub-system, integrate it with the BU instrument to build a pre-commercial looks-like / works-like prototypes, simplify chip design and fabrication to allow for pilot scale manufacturing, and implement a pilot scale manufacturing for the disposable at BioHelix / Quidel. At this stage Qiagen is the most likely manufacturer for the reader. At the conclusion of Phase II, we should be ready for clinical validation of the new assay system.

描述（由申请人提供）：这种Sttr-at-Niaid试图根据波士顿大学凯瑟琳·克拉普里奇（Catherine Klapperich）的实验室进行的研究开发综合的核酸系统。 BU实验室芯片包括微型固相提取（<spe）柱，瓣阀和疏水通风孔通过微通道，以及用于实验重复和控制反应的多个反应室。 Klapperich博士的实验室已使用Biohelix的等温扩增过程在芯片中成功地进行了核酸扩增。 Biohelix的专有技术称为解旋酶依赖性扩增（HDA）。它在指数放大过程中使用DNA解旋酶在65：c的恒定温度下分离DNA链。像聚合酶链反应（PCR）一样，HDA测定使用竞争性的内部对照（即，已知浓度的模板DNA中飙升到原始样品中的模板DNA）可以通过与分析物相同的引物进行扩增，但被分别检测到。因此，我们可以在直接临床样品中检测放大抑制剂。第一阶段的目标是：1）修改BU微流体设备设计以结合横向流条作为使用肉眼检测放大产品的手段； 2）证明使用AIM 1的设备使用CT进行集成测试的可行性，并使用CT和NG在104 in 1 ml尿液中升高，以建立概念验证验证验证验证，以在包括横向流动条的改良的BU芯片中进行的集成测定法。我们对第二阶段的具体目的是开发横向流量读取器子系统，将其与BU仪器集成在一起，以构建类似于商业的外观 /类似工作的原型，简化芯片设计和制造，以允许进行试验量表制造，并在Biohelix / Quidel上实施试验量表制造。在此阶段，Qiagen是读者最有可能的制造商。在第二阶段结束时，我们应该准备好对新测定系统的临床验证。