Microchip-Based Field Assay to Detect Dengue Virus

描述(申请人提供)：多达1亿名登革热病毒感染者 每年在世界范围内发生。相关病理(登革出血热、 登革热休克综合症)每年导致20,000人死亡，主要是 孩子们。登革热病毒是热带/亚热带地区的地方性疾病， 发展中国家的发病率。目前，没有具体的治疗方法或 目前已有疫苗可用。此外，快速、灵敏和特异的诊断是 缺乏。抗体EL ISA检测缺乏特异性，需要宿主免疫 反应；组织培养分析需要专门的实验室和长时间 孵化时间。这项SBIR的第一阶段展示了链接的可行性 一种简单的核酸提取技术--等温法核酸 酸性放大及脂质体-微芯片生物传感器检测技术 登革病毒的临床检测/分型。这种技术联系 允许在以下地区的患者中特异和敏感地检测登革热感染 5小时，对设备的要求最低，并且可以按成本提供 与疫区经济相适应。第二阶段建议继续 这一检测系统的开发/优化。第一阶段设计规范 将用于生产和验证JAB批量生产的原型分析 数量。将实施已确定的设计和生产修改 生产中试批次的分析，将得到验证和临床应用 已评估。 建议的商业应用：不可用

DESCRIPTION (provided by applicant): Up to 100 million Dengue virus infections occur annually world wide. Associated pathologies (Dengue Hemorrhagic Fever, Dengue Shock Syndrome) result in >20,000 deaths annually, primarily in children. Dengue virus is endemic to tropical/subtropical regions, with high incidence rates in developing countries. Currently, no specific treatments or vaccines are available. Moreover, rapid, sensitive and specific diagnostics are lacking. Antibody ELISA tests lack specificity and require a host immune response; tissue culture assays require specialized laboratories and long incubation times. Phase I of this SBIR demonstrated the feasibility of linking a simple nucleic acid isolation technology to an isothermal method of nucleic acid amplification and a liposome-microchip biosensor detection technology for the clinical detection/subtyping of Dengue virus. This technology linkage permits specific and sensitive detection of Dengue infection in patients within 5 hours, has minimal equipment requirements, and can be provided at costs compatible with endemic area economies. Phase II proposes continued development/optimization of this assay system. Phase I design specifications will be used to produce and validate a prototype assay, produced in Jab batch quantities. Identified design and production modifications will be implemented to produce pilot batch lots of the assay that will be validated and clinically evaluated. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE