Diagnostic Influenza RT-PCR Array

描述（由申请人提供）：流感病毒是高度传染性的负义RNA病毒，每年造成约114，000例住院和20，000例死亡。美国食品和药物管理局（FDA）批准了几种药物用于治疗流感感染，但成功的治疗取决于了解特定的抗原亚型并在疾病的前48小时内给予这些药物。最近在东亚爆发的H5 N1禽流感引发了对另一次大流行的担忧，并强调了在监测和诊断应用中需要全面的毒株亚型分型。因此，该第2阶段项目的目标是开发和现场测试用于诊断和监测环境中的流感检测和抗原分型的样品-应答RT-PCR阵列试剂盒，重点是可以在外围医院实验室部署和使用的简单，低成本的微阵列技术。性能目标是在输入目标浓度为102个病毒颗粒/mL鼻咽拭子时，在2小时或更短时间内获得样本-应答结果。沃兹沃斯中心、哥伦比亚大学、玛丽医院的小公司和疾病预防控制中心的早期采用者将协助对修正和盲态临床样本的技术进行临床前验证。公共卫生相关性：流感RT-PCR阵列将是第一个将PCR和微阵列技术结合在一起的简单、廉价的检测试剂盒，用于疾病监测和诊断。本文开发的基础平台同样将在传染病诊断的许多领域中得到广泛应用。

DESCRIPTION (provided by applicant): Influenza viruses are highly contagious negative-sense RNA viruses cause approximately 114,000 hospitalizations and 20,000 deaths annually. Several drugs are approved by the US Food and Drug Administration (FDA) for treating influenza infections, but successful treatment depends on knowing the specific antigenic subtype and administering these drugs within the first 48 h of illness. Recent outbreaks of avian influenza H5N1 in East Asia have fueled concern over another pandemic and emphasize the need for comprehensive strain sub-typing in surveillance and diagnostic applications. The objective of this Phase 2 Project is therefore to develop and field test a sample-to-answer RT-PCR array kit for influenza detection and antigenic sub-typing in diagnostic and surveillance settings, with an emphasis on simple, low-cost microarray technology that can be deployed and used in peripheral hospital labs. The performance goal is a sample-to answer result in 2 hours or less at an input target concentration of 102 viral particles per mL nasopharyngeal swab. Early adopters at Wadsworth Center, Columbia University, Little Company of Mary Hospital and the CDC will assist in the pre-clinical verification of the technology on amended and blind clinical samples. PUBLIC HEALTH RELEVANCE: The influenza RT-PCR array will be the first-of-its-kind combination of PCR and microarray technology in a simple, inexpensive test kit for disease surveillance and diagnosis. The underlying platform developed herein will likewise find broad application in many areas of infectious disease diagnostics.