Rapid, Cost-Effective Nucleic Acid Testing for Active Surveillance and Molecular

用于主动监测和分子检测的快速、经济高效的核酸检测

基本信息

批准号：
8129464
负责人：
Ben Hindson
金额：
$ 42.79万
依托单位：
QUANTALIFE, INC.
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-08-15 至 2011-10-05
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8129464
关键词：
Address Antibiotic Resistance Area Automation Bacteria Bedside Testings Benchmarking Biological Biological Assay Cells Clinical Clinics and Hospitals Clostridium difficile Communicable Diseases Computer software Coupled Cytolysis DNA Data Analyses Decontamination Detection Development Diagnostic Electrical Engineering Emulsions Encapsulated Engineering Ensure Feces Fingerprint Fluorescence Generations Genes Genetic Goals Health Professional Healthcare Hour In Vitro Individual Industry Infection Infection Control Intervention Laboratories Marketing Measurement Measures Mechanics Medical center Methods Microfluidics Mississippi Molecular Molecular Diagnosis Multi-Drug Resistance Nature Nose Nucleic Acid Amplification Tests Nucleic Acids Oils Optics Organism Patient Care Patients Performance Polymerase Chain Reaction Preparation Prevention Procedures Process Property Proteins Reaction Reagent Reporting Research Running Sampling Scientist Screening procedure Sexually Transmitted Diseases Skin Software Engineering Solutions Specimen Specimen Handling Staphylococcus aureus Surveillance Program Swab System Technology Test Result Testing Time Toxin Training Translations United States Food and Drug Administration Universities Validation Water antimicrobial base commercialization cost cost effective design effectiveness measure experience flexibility improved instrument instrumentation methicillin resistant Staphylococcus aureus multidisciplinary nanolitre pathogen point of care prevent programs prospective prototype public health relevance rectal standard of care transmission process wound

项目摘要

DESCRIPTION (provided by applicant): Methicillin-resistant Staphylococcus aureus (MRSA) is the most common multidrug-resistant pathogen in healthcare settings worldwide. The use of active detection and isolation (ADI) is a proven method to prevent MRSA infections that requires the detection of the MRSA-colonized patient through active surveillance testing (AST). Our long-term goal is to develop accurate tests with rapid turn-around times (<15 minutes) that could increase the efficacy of ADI and AST for MRSA prevention and control programs and molecular diagnosis across all healthcare settings. Our hypothesis is that droplet PCR will provide accurate test results with reduced analysis time, complexity and cost thereby making nucleic acid amplification tests viable near point-of- care. We propose to develop two in vitro point-of-care nucleic acid amplification tests for detecting MRSA in patient specimens. In addition to supporting development, this project would enable a mechanism and provide support for partnership between technology developers in private industry at QuantaLife Inc. and healthcare professionals at the University of Mississippi Medical Center (UMMC). QuantaLife scientists and engineers have decades of experience developing and fielding diagnostics for biological pathogens, and will be responsible for designing and building the prototype droplet PCR instrumentation and accompanying assays. UMMC has the requisite clinical expertise, specifically in the area of healthcare acquired infections, to guide test design and requirements and critically evaluate droplet PCR performance and potential impact in real- world clinical settings. These partnerships could accelerate the translation of droplet PCR technology from the laboratory into an instrument for near-point-of-care testing thereby impacting healthcare sooner. PUBLIC HEALTH RELEVANCE: We propose to develop rapid tests for detecting the DNA of antibiotic resistant bacteria from patient samples. If implemented near the point of patient care these tests could quickly identify people who carry these bacteria and prevent subsequent infections within hospitals and clinics. This technology makes billions of copies of DNA in tiny droplets that accurately fingerprints the bacteria.

描述（由申请人提供）：耐甲氧西林金黄色葡萄球菌（MRSA）是全球医疗保健环境中最常见的多药耐药病原体。使用主动检测和隔离（ADI）是一种可预防MRSA感染的方法，该方法需要通过主动监视测试（AST）检测MRSA-ColoNical的患者。我们的长期目标是在快速的转弯时间（<15分钟）开发准确的测试，这可能会增加ADI和AST对MRSA预防和控制程序的疗效，以及在所有医疗机构中的分子诊断。我们的假设是，液滴PCR将通过缩短的分析时间，复杂性和成本提供准确的测试结果，从而使核酸扩增测试可在附近可行。我们建议开发两个体外护理核酸扩增测试，以检测患者标本中的MRSA。除了支持开发外，该项目还将为Quantalife Inc.的私营企业技术开发人员与密西西比大学医学中心（UMMC）的医疗保健专业人员之间的技术开发人员之间的合作提供支持。量化科学家和工程师拥有数十年的生物病原体诊断经验，并将负责设计和构建原型液滴PCR仪器和随附的测定法。 UMMC具有必要的临床专业知识，特别是在医疗保健获得的感染领域，以指导测试设计和需求，并严格评估液滴PCR的性能和对现实世界临床环境中的潜在影响。这些合作伙伴关系可以加快将液滴PCR技术从实验室转化为近距离护理测试的工具，从而很快影响医疗保健。公共卫生相关性：我们建议开发快速测试，以检测患者样品中抗生素抗生素抗生素的DNA。如果在患者护理点附近实施，这些测试可能会迅速识别携带这些细菌的人并防止随后的医院和诊所内感染。这项技术在细菌准确地指纹的细小液滴中生产了数十亿份DNA。