Point of Care Flu Drug Resistance Test

描述(由申请人提供)：我们第一阶段SBIR(AI082728-01)的研究表明，开发建议的检测方法是可行的，这是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方法，用于敏感地检测流感病毒的耐药性。目前，一家联邦机构正在使用这种检测方法，用于监测正在进行的猪流感大流行期间流感病毒的耐药性。该第二阶段项目的目标是将监测检测转变为适用于医疗保健(POC)使用的耐药性检测(例如，在医生办公室)，即一种快速(从样本收集到结果需要15分钟)、简单、敏感、特异、经济和易于使用的检测试剂盒。POC抗药性测试也将是流感诊断的第二要求权。因此，该检测是一种兼具流感诊断和耐药性检测功能的组合检测。第二阶段的活动包括GMP制造、临床前和临床研究。来自第二阶段研究的数据将提交给FDA，以批准流感诊断和流感耐药性检测声称的POC测试。 与公共卫生相关：季节性流感H1N1对达菲的广泛耐药性引发了人们对为大流行流感储备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。快速而灵敏的POC流感耐药性检测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策。没有这样的测试可用。拟议的第二阶段研究的主要目标是在我们第一阶段工作的基础上，开发一种适合护理地点使用的耐药性测试。

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.