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

呼吸面板 Flow-Strip：护理点分子诊断测试

• 批准号: 8314204
• 负责人: DARRELL P CHANDLER
• 金额: $ 30万
• 依托单位: AKONNI BIOSYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-03-01 至 2013-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8314204
• 关键词: Accounting; Acute respiratory infection; Address; Adenoviruses; Bacteria; Bedside Testings; Biological Assay; Bordetella pertussis; Cause of Death; Cessation of life; Child; Chlamydophila pneumoniae; Clinical; Communicable Diseases; DNA; Detection; Devices; Diagnostic; Diagnostic tests; Drug resistance; Evolution; Feasibility Studies; Freeze Drying; Genes; Genome; Genomics; Goals; Gold; Haemophilus influenzae; Health Care Costs; Human; Human Adenoviruses; Human Coronavirus 229E; Human Metapneumovirus; Human Parainfluenza Virus 1; Human respiratory syncytial virus; Immunoassay; Individual; Infection; Influenza; Influenza A virus; Influenza B virus; Injection of therapeutic agent; Lateral; Legionella pneumophila; Life; Marketing; Measures; Molds; Molecular; Molecular Diagnostic Testing; Morbidity - disease rate; Mycoplasma pneumoniae; Organism; Outcome; Para-Influenza Virus Type 1; Patients; Phase; Plastics; Pneumonia; Process; RNA; Readiness; Reverse Transcriptase Polymerase Chain Reaction; Rhinovirus; SARS coronavirus; Sampling; Sensitivity and Specificity; Sexually Transmitted Diseases; Specimen; Streptococcus; Streptococcus pneumoniae; Swab; System; Techniques; Testing; Translating; Tube; Virus; Work; biochip; evaluation/testing; flu; human coronavirus; improved; instrumentation; microorganism; mortality; operation; pandemic disease; pathogen; point of care; prototype; resistant strain; respiratory; respiratory virus; response; tool

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.

描述（由申请人提供）：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;超过40%是五岁以下儿童。常规技术通常要么太慢（例如，常规培养需要5至10天）或太不敏感（例如，一项研究发现流感的侧流免疫测定试验的灵敏度低至10.4%。尽管它们不敏感， 2009年，传染病检测市场增长超过40%。由于其敏感性和特异性，分子检测开始取代传统的培养作为金标准。然而，用于从单个样品鉴定多种呼吸道病原体的当前分子测试的局限性包括：高复杂性操作、缺乏灵敏度、缺乏呼吸道病原体覆盖和/或缺乏给定病原体的序列覆盖。因此，我们建议使用自动化样本到答案的即时分子设备来解决这些限制，该设备可以识别以下呼吸道病原体中的高变基因组：流感A病毒、流感B病毒、人呼吸道合胞病毒A/B、人腺病毒A/B/C/D/E/F、人冠状病毒229 E/NL 63/OC 43、偏肺病毒、人鼻病毒A/B/C、人博卡病毒1/2/3/4、人副流感病毒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、嗜肺军团菌和百日咳杆菌。 公共卫生相关性：急性呼吸道感染是全球第三大死因，每年造成420万人死亡，其中40%以上是5岁以下儿童。导致这些感染的病原体通常具有高度传染性，并在测试商业化之前感染易感个体。该项目旨在开发一种即时检测方法，从单个患者样本中识别一组细菌和病毒，包括耐药流感菌株。这种测试可以帮助防备全球大流行病，因为目前有一种测试可以识别一系列广泛的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必须迅速开发和商业化单一微生物检测的负担。