Point of Care Instrument for Viral Respiratory Diagnosis

用于病毒呼吸道诊断的护理点仪器

• 批准号: 6577585
• 负责人: Jeffrey T. Ives
• 金额: $ 38.41万
• 依托单位: XTRANA, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2005-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6577585
• 关键词: Orthomyxoviridae; clinical research; consumable /disposable biomedical equipment; cooperative study; diagnosis design /evaluation; human tissue; parainfluenza virus type 1; parainfluenza virus type 2; polymerase chain reaction; respiratory disorder diagnosis; respiratory infections; respiratory syncytial virus; respiratory virus; rhinovirus

DESCRIPTION (provided by applicant): The common respiratory viruses (influenza, parainfluenza, respiratory syncytial virus or RSV, and rhinovirus) cause millions of cases of upper and lower respiratory tract disease every year. The spectrum of illness induced directly by the viruses is very broad, ranging from mild colds and simple ear infections to more serious and sometimes life-threatening diseases such as bronchiolitis, pneumonia, and asthma. In spite of the importance of diagnosing and treating these viral infections, current diagnostic methods of physical exam or rapid immunoassays or culture in reference laboratories do not provide the accuracy, sensitivity, or timely information that the primary care physician needs for treatment. Antiviral therapeutics are becoming increasingly viable, but they require accurate identification of the infectious virus(es). While sensitive, newer assays and instrumentation based on nucleic acid technologies are not cost effective or practical for point of care in a physician's office. To provide a cost effective, point of care system for diagnosing respiratory viruses, this application describes an integrated and unique device that will begin with a nasal wash sample and use nucleic acid-based technologies to accurately identify eight respiratory viruses: RSV A and B; parainfluenza 1, 2, and 3; influenza A and B; and rhinovirus. After loading the sample, proprietary steps of sample preparation, RNA extraction, multiplexed amplification, and detection by lateral flow strips will be automatically performed. These processing steps will be directed on a disposable, microfluidic card that both minimizes the reagent costs and provides an enclosed container for convenient, biosafe disposal. To develop this diagnostic device, a series of technical milestones will be accomplished. First, a novel method of multiplexed target amplification will be optimized on respiratory viral targets. Second, nasal wash samples will be directly prepared for multiplexed amplification by flow through extraction and unique solid phase analysis. Sample preparation and amplification will be managed by developing disposable, laminated microfluidics cards with channels, reagents, and valves. Using a protoype workstation, the described system will be tested with patient samples and spiked samples to verify the utility, specificity, sensitivity, and reproducibility of the system.

描述（由申请方提供）：常见的呼吸道病毒（流感、副流感、呼吸道合胞病毒或RSV和鼻病毒）每年导致数百万例上呼吸道和下呼吸道疾病。 由病毒直接引起的疾病范围非常广泛，从轻度感冒和简单的耳部感染到更严重的，有时甚至危及生命的疾病，如细支气管炎，肺炎和哮喘。 尽管诊断和治疗这些病毒感染的重要性，但目前的体检或快速免疫测定或参考实验室培养的诊断方法不能提供初级保健医生治疗所需的准确性，灵敏度或及时信息。 抗病毒疗法正变得越来越可行，但它们需要准确鉴定感染性病毒。 虽然灵敏，但基于核酸技术的较新的测定和仪器对于医生办公室中的护理点来说不是成本有效的或实用的。 为了提供一种用于诊断呼吸道病毒的成本有效的护理点系统，本申请描述了一种集成且独特的装置，该装置将开始于鼻洗液样品并使用基于核酸的技术来准确地识别八种呼吸道病毒：RSV A和B;副流感病毒1、2和3;流感病毒A和B;以及鼻病毒。 加载样本后，将自动执行样本制备、RNA提取、多重扩增和侧向流条带检测的专有步骤。 这些处理步骤将在一次性微流体卡上进行，该卡既最大限度地降低了试剂成本，又提供了用于方便的生物安全处置的封闭容器。 为了开发这种诊断装置，将完成一系列技术里程碑。 首先，将在呼吸道病毒靶标上优化多重靶标扩增的新方法。 其次，将直接制备鼻洗液样品，用于通过流通萃取和独特的固相分析进行多重扩增。 将通过开发具有通道、试剂和阀门的一次性层压微流体卡来管理样本制备和扩增。 使用原型工作站，将使用患者样本和加标样本对所述系统进行测试，以验证系统的实用性、特异性、灵敏度和重现性。