Point of Care Flu Drug Resistance Test

护理点流感耐药性测试

• 批准号: 7909768
• 负责人: XING-XIANG LI
• 金额: $ 100万
• 依托单位: CELLEX, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-03-15 至 2012-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7909768
• 关键词: Bedside Testings; Biological Assay; Blood Circulation; Centers for Disease Control and Prevention (U.S.); Characteristics; Clinical; Clinical Research; Data; Detection; Diagnosis; Drug resistance; Drug usage; Economics; Effectiveness; Flu virus; Generations; Goals; Gold; Infection; Influenza; Influenza A Virus, H1N1 Subtype; Inhibitory Concentration 50; Intervention; Life Cycle Stages; Measurement; Measures; Monitor; Nasal Lavage Fluid; Neuraminidase; Neuraminidase inhibitor; One-Step dentin bonding system; Oseltamivir; Patients; Performance; Pharmaceutical Preparations; Phase; Physicians; Physicians' Offices; Play; Reagent; Regulation; Resistance; Role; Sampling; Seasons; Signal Transduction; Small Business Innovation Research Grant; Testing; Therapeutic; Tube; Variant; Vial device; Viral; Virus; anti-influenza drug; carboxylate; drug candidate; flu; influenza epidemic; influenzavirus; meetings; novel; pandemic disease; pandemic influenza; phase 1 study; phase 2 study; point of care; pre-clinical; preclinical study; programs; public health relevance; sample collection; seasonal influenza; swine flu; virus culture; zanamivir

DESCRIPTION (provided by applicant): The studies from our Phase I SBIR (AI082728-01) demonstrated that it is feasible to develop the proposed assay, a biochemiluminescence assay that uses a novel flu virus neuraminidase substrate, for sensitive detection of influenza virus drug resistance. The assay is now being used by a federal agency for monitoring influenza virus drug resistance during the on-going swine flu pandemic. The goal of this Phase II project is to convert the surveillance test into a drug resistance test suitable for point-of-care (POC) use (e.g., in physician's offices), i.e., a test kit that is rapid (<15 min for sample collection to results), simple, sensitive, specific, economic, and easy-to-use. The POC drug resistance test will also have a secondary claim for influenza diagnosis. Thus, the test is a combo test with both flu diagnosis and drug resistance detection functions. Phase II activities include GMP manufacturing, preclinical and clinical studies. The data from the Phase II studies will be submitted to the FDA for clearance of the POC test for both the influenza diagnosis and flu drug resistance detection claims. PUBLIC HEALTH RELEVANCE: Widespread resistance of seasonal influenza H1N1 to Tamiflu, the most commonly used and stockpiled drug, raises serious issue about the effectiveness of Tamiflu stockpiled for pandemic influenza, and posts a challenge for physicians who treat influenza patients. A rapid and sensitive POC flu drug resistance test would promote rational use of the drug, thereby prolonging the effectiveness of a drug, and aid the physicians in making a better prescription decision. There is no such a test available. The primary objective of the proposed Phase II studies is to build on our Phase I efforts and develop a drug resistance test that is suitable for point-of-care use.

描述（由申请方提供）：我们的I期SBIR（AI 082728 -01）研究证明，开发拟定检测试剂盒（一种使用新型流感病毒神经氨酸酶底物的生物化学发光检测试剂盒）用于灵敏检测流感病毒耐药性是可行的。 该检测方法目前正被一家联邦机构用于监测猪流感大流行期间流感病毒的耐药性。该II期项目的目标是将监测试验转换为适用于床旁（POC）使用的耐药性试验（例如，在医生的办公室），即，一种快速（从样品收集到结果<15分钟）、简单、灵敏、特异、经济和易于使用的检测试剂盒。 POC耐药性检测也将作为流感诊断的次要要求。 因此，该测试是具有流感诊断和耐药性检测功能的组合测试。 II期活动包括GMP生产、临床前和临床研究。来自II期研究的数据将提交给FDA，以批准用于流感诊断和流感耐药性检测的POC测试。 公共卫生相关性：季节性流感H1N1对最常用和储存的药物达菲的广泛耐药性提出了关于储存用于大流行性流感的达菲有效性的严重问题，并对治疗流感患者的医生提出了挑战。快速和敏感的POC流感耐药性测试将促进药物的合理使用，从而延长药物的有效性，并帮助医生做出更好的处方决定。没有这样的测试可用。拟议的II期研究的主要目标是建立在我们的I期工作基础上，并开发适用于床旁使用的耐药性测试。