Diagnostic Influenza RT-PCR Array

描述(申请人提供)：流感病毒是高度传染性的负义RNA病毒，每年导致约114,000人住院和20,000人死亡。美国食品和药物管理局(FDA)批准了几种治疗流感感染的药物，但成功的治疗取决于了解特定的抗原亚型，并在患病后48小时内服用这些药物。最近在东亚爆发的H5N1禽流感引发了人们对另一场大流行的担忧，并强调在监测和诊断应用中需要全面的毒株亚型。因此，该第二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流感检测和抗原亚型分型的样本到答案RT-PCR阵列试剂盒，重点是可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每毫升鼻咽拭子102个病毒颗粒的情况下，在2小时或更短的时间内获得样本对答案的结果。沃兹沃斯中心、哥伦比亚大学、玛丽医院小公司和疾病预防控制中心的早期采用者将协助对修改后的和盲目的临床样本进行临床前验证。公共卫生相关性：流感RT-PCR阵列将是首个将聚合酶链式反应和微阵列技术结合在一起的简单、廉价的疾病监测和诊断检测试剂盒。本文开发的底层平台同样将在传染病诊断的许多领域得到广泛应用。

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.