ELECTROCHEMICAL ENZYME IMMUNOASSAY TO TEST BLOOD HBV

B肝炎病毒（HBV）是一种常见的传染病。其中许多受害者没有理由相信自己被感染。有必要追踪美国数百万的乙肝病毒受害者，以及相应的创新技术，以测试血液中的乙肝病毒。HBV显然是国家医疗优先事项。该项目的总体目标是进一步开发核心传感器和酶免疫分析技术，并将其整合为一种快速准确测量血液中HBV水平的新技术。我们的目标是诊断（检测）应用以及定量测量需求（监测病毒水平和治疗效果）。具体的I期目标是证明将独特的电化学测量方法与专有的电化学酶免疫测定体系结构相结合的可行性，以产生新的诊断/监测能力，用于门诊环境中的“真实的”、具有成本效益的HBV评估。我们设想的产品是一种一次性的HBV测试条，可以通过便宜的小型（手持）仪器读取。这将是医疗诊断领域的一项重大发展，将满足国内和国际市场对低成本HBV筛查和监测的主要需求。拟议的商业应用：医疗保健市场对诊断设备有很大的需求，该诊断设备可以“真实的时间”筛查患者血液中的B型肝炎病毒（HBV），并且还可以定量监测血液的治疗反应。这样的设备将有助于卫生保健提供者识别和治疗许多未确诊的HBV感染病例。同样的设备可以在各种环境中为患者提供服务，例如床边，急诊室，诊所和家庭。

Millions of Americans are infected by the hepatitis B virus (HBV). Many of those victims have no reason to believe they are infected. There is a need to track down America's millions of HBV victims-as well as a corresponding need for innovative technology to test blood for HBV. HBV is clearly a national medical priority. The overall goal of this project is to further develop and then integrate core sensor and enzyme immunoassay technologies into a novel technique for the rapid and accurate measurement of HBV levels in blood. We are targeting diagnostic (detection) applications as well as quantitative measurement needs (to monitor viral levels and treatment efficacy). The specific Phase I goal is to demonstrate the feasibility of integrating a unique electrochemical measurement method with proprietary electrochemical enzyme immunoassay architecture to produce a new diagnostic/monitoring capability for "real time," cost- effective HBV assessment in an outpatient setting. The product we envision is a disposable HBV test strip that can be read by an inexpensive, small (hand-held) instrument. It would represent a key development in medical diagnostics that would address major domestic and international market needs for low-cost HBV screening and monitoring. PROPOSED COMMERCIAL APPLICATIONS: The health care market has a major need for a diagnostic device that can screen in "real time" for hepatitis B virus (HBV) in patient blood and can also quantitatively monitor the blood for therapeutic response. Such a device would assist health care providers in identifying and treating the numerous undiagnosed cases of HBV infection. The same device would service patients in various settings, such as bedside, emergency room, clinic, and home.