Respiratory Panel Flow-Strip: a Point-of-Care Molecular Diagnostic Test

描述(申请人提供)：急性呼吸道感染是全球第三大死亡原因，每年造成420万人死亡；40%以上是五岁以下儿童。传统技术通常要么太慢(例如，传统培养需要5至10天)，要么太不敏感(例如，一项研究发现，后来的流动免疫检测流感的灵敏度低至10.4%)。尽管他们不敏感，但侧向流动 2009年，传染病检测市场增长了40%以上。由于其敏感性和特异性，分子检测开始取代传统培养成为金标准。然而，目前用于从单个样本中识别多个呼吸道病原体的分子测试的局限性包括：操作高度复杂，缺乏敏感性，缺乏呼吸道病原体的覆盖范围，和/或缺乏对给定病原体的序列覆盖。因此，我们建议使用一种自动化的样本到应答点分子设备来识别以下呼吸道病原体的高变量基因组：流感病毒A、流感B病毒、人类呼吸道合胞病毒A/B、人腺病毒A/B/C/D/E/F、人类冠状病毒229E/NL63/OC43、偏肺病毒、人类鼻病毒A/B/C、人类博卡病毒1/2/3/4、人类副流感病毒1/2/3/4、流感嗜血杆菌、肺炎链球菌、肺炎支原体、肺炎衣原体、肺炎莱金氏杆菌和百日咳杆菌。 公共卫生相关性：急性呼吸道感染是全球第三大死亡原因，每年造成420万人死亡；40%以上是五岁以下儿童。导致这些感染的病原体通常具有很高的传染性，在试验商业化之前就会感染易感人群。该项目寻求开发一种护理点测试，从单个患者样本中识别一组细菌和病毒，包括抗药性流感病毒株。这项检测有助于为全球大流行做好准备，因为目前正在进行一项检测，可以确定一大批传染性呼吸道病原体。这一战略有可能消除为应对新出现的大流行而不得不迅速开发单一生物测试并将其商业化的负担。

DESCRIPTION (provided by applicant): Acute respiratory infections are the third leading cause of death worldwide, and account for 4.2 million deaths annually; more than 40% are children under five. Conventional techniques are often either too slow (e.g., conventional cultures require 5 to 10 days) or too insensitive (e.g., one study found the sensitivity of a laterl flow immunoassay test for flu to be as low as 10.4%). Despite their insensitivity, the lateral flow test market for infectious disease grew over 40% in 2009. Because of its sensitivity and specificity, molecular testing are beginning to supplant conventional culture as the gold standard. However, limitations with current molecular tests for identifying multiple respiratory pathogens from a single sample include: high complexity operation, lack of sensitivity, lack of respiratory pathogen coverage, and/or lack of sequence coverage for a given pathogen. Thus, we propose to address these limitations with an automated sample-to-answer point-of- care molecular device that identifies hypervariable genomes across the following panel of respiratory pathogens: influenza A virus, influenza B virus, human respiratory syncytial virus A/B, human adenovirus A/B/C/D/E/F, human coronavirus 229E/NL63/OC43, metapneumovirus, human rhinovirus A/B/C, human bocavirus 1/2/3/4, human parainfluenza virus 1/2/3/4, Haemophilus influenzae, Streptococcus pneumoniae, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Legionella pneumophila, and Bordetella pertussis. PUBLIC HEALTH RELEVANCE: Acute respiratory infections are the third leading cause of death worldwide, and account for 4.2 million deaths annually; more than 40% are children under five. The pathogens that cause these infections often are highly contagious, and infect susceptible individuals before tests can be commercialized. This project seeks to develop a point-of-care test that identifies a panel of bacteria and viruses, including drug-resistant strain of flu, from a single patient sample. This test could assist in the preparedness for global pandemics because of the ongoing availability of a test that can identify a broad panel of contagious respiratory pathogens. This strategy has the potential to eliminate the burden of having to quickly develop and commercialize single-organism tests in response to an emerging pandemic.