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墨盒的自动分子诊断平台，以快速和经济有效地检测和识别流感病毒。该系统将自动完成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，以便没有PCR或微阵列经验的人员可以用最少的动手时间获得明确的答案。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，以及需要快速、廉价的毒株监测工具。其目的是通过提供一种新的工具来显著加强流感病毒监测，以负担得起的方式快速识别流感病毒，而无需PCR方法的专门知识，也无需完全依赖现有的、有时性能不佳的快速免疫测定法。营销计划包括向客户免费提供仪器（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检测可以用于跟踪病毒，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，用于体外诊断。

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.