Ultrasensitive, rapid, cost-effective, user-friendly test for respiratory viruses

超灵敏、快速、经济高效、用户友好的呼吸道病毒检测

• 批准号: 7539120
• 负责人: SADANAND GITE
• 金额: $ 20.96万
• 依托单位: FIRST LIGHT DIAGNOSTICS , INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-01 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7539120
• 关键词: Address; Antibiotics; Arts; Bacterial Infections; Bedside Testings; Biological Assay; Capital; Cessation of life; Child; Clinical; Clinical Medicine; Clinics and Hospitals; Community Hospitals; Complex; Computer software; Count; Data; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostic tests; Elderly; Environmental Microbiology; Equipment; Feasibility Studies; Goals; Gold; Health Personnel; Health Professional; Hospital Sizes; Hospitals; Hypersensitivity; Image; Immunoassay; Immunocompromised Host; Industrial Microbiology; Infant; Institutes; Invasive; Laboratories; Length of Stay; Lung diseases; Marketing; Medical; Methods; Modeling; Nucleic Acid Amplification Tests; Nucleic Acids; Numbers; Outcome; Patient Care; Patients; Performance; Phase; Physicians' Offices; Pregnancy Tests; Process; Public Health; Range; Reagent; Resources; Respiratory Tract Infections; Sampling; Screening procedure; Site; Source; Speed; Standards of Weights and Measures; System; Technical Expertise; Technology; Test Result; Testing; Time; Today; Training; United States; Viral; Viral Antigens; Viral meningitis; Virus Diseases; Work; antimicrobial; base; cost; cost effectiveness; day; design; digital imaging; improved; instrument; instrumentation; methicillin resistant Staphylococcus aureus; novel; particle; point of care; prevent; prototype; rapid technique; respiratory; respiratory infection virus; respiratory virus; user-friendly

DESCRIPTION (provided by applicant): We propose to develop a novel testing platform for enabling rapid, ultrasensitive, accurate, user-friendly, and cost-effective point-of-care respiratory diagnostics for viral infections. Viral respiratory infections result in hundreds of thousands of deaths and millions of illnesses each year and are especially serious in children, the elderly, and the immunocompromised patients. Rapid and accurate diagnosis of respiratory disease improves treatment, substantially lowers inappropriate antibiotic use, and minimizes costs from unnecessary exploratory testing. Current diagnostic methods for respiratory infections include culture, which takes days; rapid immunoassays, which can be insensitive; direct fluorescent immunoassays, which require technical expertise; and nucleic acid amplification, which is expensive and complex. Many small and medium sized hospitals lack the resources for the most sensitive viral diagnostics and therefore the ability to quickly diagnose patients for respiratory virus infections. We aim to develop a rapid and sensitive test for a panel of respiratory viruses based on our proprietary technology which uses a low-cost non-magnified digital imaging system that counts target molecules tagged with fluorescent particles. The system will require no specialized training and no pre- processing of samples. The Specific Aims of this feasibility study are to (1) demonstrate the technology's ability to rapidly (within 5 minutes) detect viral antigens in respiratory samples about 1000-fold more sensitively than current rapid tests; (2) develop an inexpensive prototype consumable that is as easy to use as an over-the- counter pregnancy test and that demonstrates the feasibility of testing for a panel of respiratory markers; (3) develop a simple low-cost prototype imaging instrument; and (4) using infected respiratory samples, demonstrate improved performance of the new assay compared to commercialized rapid methods by comparing the results of both methods to the results obtained using nucleic acid tests as the gold standard. Achieving these Aims should justify a Phase 2 project that will focus on developing pre-commercial prototypes of the consumable and instrument and increasing the range of the assay to include a panel of the most medically important respiratory viruses and indicators of other types of respiratory illness such as allergies and bacterial infection. The commercial impact of this unique point of care platform ranges beyond the large potential market for the clinical respiratory panel in community hospitals, clinics, and physicians' offices. The platform also has the potential to address other significant unmet needs in clinical medicine, industrial microbiology, and environmental microbiology. PUBLIC HEALTH RELEVANCE: The commercialized point-of-care testing system will have a substantial impact on the diagnosis and treatment of viral respiratory disease, which is a major source of illness in the United States with an estimated 1.5 billion respiratory infections causing hundreds of thousands of deaths every year. The new test will enable, for the first time, ultrasensitive, accurate, and cost-effective diagnosis of respiratory disease in community hospitals, clinics, and physicians' offices. Today, healthcare workers in these venues generally send samples to reference laboratories, precluding the ability to get early results. By delivering on-site results quickly, the test system proposed here has the potential to speed up delivery of the appropriate therapy, eliminate unnecessary and invasive testing, shorten hospital stays, and improve patient outcomes.

描述（由申请人提供）：我们建议开发一个新颖的测试平台，以实现病毒感染的快速，超敏感，准确，用户友好和具有成本效益的护理呼吸道诊断。病毒呼吸道感染每年导致数十万人死亡和数百万疾病，并且在儿童，老年人和免疫功能低下的患者中尤其严重。快速，准确的呼吸道疾病诊断可改善治疗方法，大大降低了不适当的抗生素使用，并通过不必要的探索性测试来最大程度地减少成本。当前的呼吸道感染诊断方法包括培养，这需要几天；快速免疫测定法可能不敏感；需要直接荧光免疫测定，需要技术专业知识；和核酸扩增，既昂贵又复杂。许多中小型医院缺乏用于最敏感的病毒诊断的资源，因此能够快速诊断患者患有呼吸道病毒感染的能力。我们旨在基于我们的专有技术，为一组呼吸道病毒开发快速和敏感的测试，该技术使用低成本的非磁化数字成像系统，该系统计算用荧光颗粒标记的目标分子。该系统将不需要专门的培训，也不需要对样品进行预先处理。这项可行性研究的具体目的是（1）证明该技术能够（在5分钟内）在呼吸样品中快速检测病毒抗原的能力比当前的快速测试高约1000倍； （2）开发出一种廉价的原型，它与反对妊娠试验一样易于使用，并证明了对一系列呼吸标记的测试的可行性； （3）开发一种简单的低成本原型成像仪器； （4）使用感染的呼吸样品，通过将两种方法的结果与使用核酸测试获得的结果作为金标准进行比较，证明了与商业化快速方法相比，新测定的性能提高了。实现这些目标应证明一个第2阶段项目的合理性，该项目将着重于开发耗材和仪器的商业前原型，并增加测定的范围，以包括最重要的医学重要呼吸道病毒和其他类型的呼吸道疾病（例如过敏和细菌感染）的小组。这个独特的护理平台的商业影响范围超出了社区医院，诊所和医师办公室临床呼吸小组的大型潜在市场。该平台还具有解决临床医学，工业微生物学和环境微生物学的其他重要未满足需求的潜力。公共卫生相关性：商业化的护理点测试系统将对病毒呼吸道疾病的诊断和治疗产生重大影响，这是美国的主要疾病来源，估计每年造成15亿次呼吸道感染。新的测试将首次使社区医院，诊所和医师办公室中的呼吸道疾病超敏，准确且具有成本效益的诊断。如今，这些场所中的医疗保健工人通常会发送样本来参考实验室，从而排除了获得早期结果的能力。通过迅速提供现场结果，此处提出的测试系统有可能加快适当的治疗，消除不必要和侵入性的测试，缩短住院并改善患者的结果。