Point of Care Flu Drug Resistance Test

描述（由申请人提供）：我们I期SBIR （AI082728-01）的研究表明，开发拟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化发光检测方法，用于流感病毒耐药性的敏感检测。目前，在猪流感大流行期间，该检测方法正被一家联邦机构用于监测流感病毒的耐药性。该二期项目的目标是将监测检测转化为一种适用于医疗点（POC）使用的耐药检测（例如，在医生办公室），即一种快速（样品采集到结果<15分钟）、简单、敏感、特异、经济且易于使用的检测试剂盒。POC耐药试验也将在流感诊断中具有次要要求。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。二期活动包括GMP生产、临床前和临床研究。II期研究的数据将提交给FDA，以批准POC测试用于流感诊断和流感耐药性检测。

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.