ELECTROCHEMICAL ENZYME IMMUNOASSAY TO TEST BLOOD HBV

数百万美国人感染了乙型肝炎病毒（HBV）。许多受害者没有理由相信他们被感染了。我们需要追踪美国数以百万计的乙肝病毒感染者，同时也需要相应的创新技术来检测血液中的乙肝病毒。乙肝病毒显然是国家的医疗重点。该项目的总体目标是进一步发展，然后将核心传感器和酶免疫测定技术整合到一种快速准确测量血液中HBV水平的新技术中。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期目标是证明将一种独特的电化学测量方法与专有的电化学酶免疫测定体系相结合的可行性，以产生一种新的诊断/监测能力，在门诊环境中进行“实时”、经济有效的HBV评估。我们设想的产品是一种一次性的乙肝病毒试纸，可以通过一种廉价的、小型的（手持）仪器来读取。这将是医疗诊断领域的一项关键发展，将满足国内和国际市场对低成本乙型肝炎病毒筛查和监测的主要需求。拟议的商业应用：医疗保健市场主要需要一种诊断设备，可以“实时”筛查患者血液中的乙型肝炎病毒（HBV），还可以定量监测血液中的治疗反应。这种装置将有助于卫生保健提供者识别和治疗大量未确诊的HBV感染病例。同样的设备可以在不同的环境中为病人服务，比如床边、急诊室、诊所和家里。

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.