SIMULTANEOUS SCREENING FOR A/H3N2, A/H1N1, A/H5N1 AND B INFLUENZA VIRUSES

描述（由申请人提供）：该II期申请的目标是开发一种基于生物芯片的自动化分子诊断平台，以快速、经济高效地检测和识别流感病毒。该系统将自动化样品处理的所有关键功能，包括提取，扩增，低密度微阵列上的比色检测和图像/结果解释。这个想法是为了使系统易于使用，使没有PCR或微阵列经验的人员可以获得一个明确的答案与最少的动手时间。拟议工作的动机是流感病毒对人类和动物健康的巨大影响，以及对快速，廉价的菌株监测工具的需求。其目的是通过提供一种新的工具来显著增强流感病毒监测，该工具能够在没有PCR方法专业知识的情况下快速鉴定流感病毒，并且不完全依赖于现有的、有时表现不佳的快速免疫测定。营销计划涉及以无资本成本（即，“试剂租赁”概念）。因此，仪器的设计将考虑到简单和低成本。我们的市场切入点将是流感监测点，如州公共卫生实验室，在那里，FluChip检测可用于跟踪病毒，而无需诊断患者。从长远来看，我们将使用这些早期研究中获得的数据来制定FDA提交的510（k）许可，以用作体外诊断。 公共卫生相关性：拟议的工作的目标是建立在第一阶段取得的成功，通过开发一个自动化和独立的样本处理，包括提取，扩增和比色检测的低密度微阵列上的基于盒的系统，快速识别流感病毒。

DESCRIPTION (provided by applicant): The objective for this Phase II application is to develop a cartridge-based automated molecular diagnostic platform to rapidly and cost-effectively detect and identify influenza viruses. The system will automate all key functions for sample processing including extraction, amplification, colorimetric detection on a low- density microarray, and image/result interpretation. The idea is to make the system easy to use so that personnel with no PCR or microarray experience could obtain an unequivocal answer with minimal hands- on time. The motivation for the proposed work is the tremendous impact influenza viruses have on human and animal health and the need for rapid, inexpensive tools for strain surveillance. The intent is to significantly enhance influenza virus surveillance by providing a new tool to affordably and rapidly identify influenza viruses without expertise in PCR methods and without exclusive reliance on existing, sometimes poor performing, rapid immunoassays. The marketing plan involves providing the instrument to customers at no capital cost (i.e., the "reagent rental" concept). Therefore, the instrument will be designed with simplicity and low cost in mind. Our market entry point will be influenza surveillance sites, such as state public health labs, where the FluChip assay could be used to track viruses without the need to diagnose patients. Long term, we will use data acquired in these early studies to formulate an FDA submission for 510(k) clearance for use as an in vitro diagnostic. PUBLIC HEALTH RELEVANCE: The objective of the proposed work is to build on the success achieved in Phase I for rapidly identifying influenza viruses by developing a cartridge based system for automated and self-contained sample processing, including extraction, amplification, and colorimetric detection on a low-density microarray.