Point of Care Flu Drug Resistance Test

护理点流感耐药性测试

基本信息

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
项目类别：
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&apos 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

项目摘要

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（由申请人提供）：我们的 I 期 SBIR (AI082728-01) 的研究表明，开发所提出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，用于灵敏检测流感病毒耐药性。该检测方法目前被联邦机构用于监测猪流感大流行期间流感病毒的耐药性。该第二阶段项目的目标是将监测测试转化为适合即时护理 (POC) 使用（例如在医生办公室）的耐药性测试，即快速（<15 分钟）的测试套件从样品采集到结果），简单、灵敏、特异、经济、易于使用。 POC耐药性测试还将有流感诊断的次要要求。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，以批准用于流感诊断和流感耐药检测声明的 POC 测试。公共卫生相关性：季节性 H1N1 流感对达菲（最常用和储存的药物）的广泛耐药性引发了有关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、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努力的基础上开发一种适合现场护理使用的耐药性测试。