Electrochemical Quantification of HCV RNA

描述（由申请人提供）：美国国家过敏和传染病研究所呼吁提供更好的工具来检测和诊断新出现和再出现的传染病。为了满足这一需求，Alderon Biosciences Inc. （ABI）提出开发具有足够灵敏度的创新、低成本检测HCV病毒载量的方法。可靠和负担得起的HCV病毒载量检测将有助于发现和治疗肝脏疾病。HCV是慢性肝病最重要的病因之一，影响约2%的美国人口，每年造成10,000至12,000人死亡。尽管高度建议对HCV RNA进行定量分子检测，但目前检测的高成本（100美元以上）、技术难度和可变性构成了HCV诊断和治疗的主要问题。ABI建议开发快速、简便、成本更低（低于25美元）的检测方法，在不使用PCR的情况下，将HCV RNA的水平量化到具有临床意义的水平，不需要昂贵的设备，可以在医生办公室或地区公共卫生实验室完成。该技术方法包括引物延伸信号放大法（PESA）和毛细管流量传感器元件，用于敏感和方便地执行低成本测试。仪器和传感器元件将被设计和开发，使HCV病毒载量测量将使用更少的分析时间，更少的步骤，更低的设置和每个结果的成本比目前最先进的核酸探针为基础的系统。初步调查表明，随着对更简单、更容易获得和广泛适用的分子检测工具的需求增加，在诊断、治疗和控制HCV等感染中测量临床样本的病毒载量，未来3至5年期间，拟议的技术在研究和公共卫生应用方面具有重要的市场。

DESCRIPTION (provided by applicant): The National Institutes of Allergy and Infectious Disease have called for better tools for the detection and diagnosis of emerging and re-emerging infectious diseases. To meet this need, Alderon Biosciences Inc. (ABI) proposes to develop innovative, low-cost tests with sensitivity adequate for determining HCV viral load. Reliable and affordable HCV viral load tests would aid in detection and treatment of liver disease. HCV is one of the most important causes of chronic liver disease, affecting about 2% of the U.S. population and causing 10,000 to 12,000 deaths annually. Although quantitative molecular assays for HCV RNA are highly advised, the high cost (above $100), technical difficulty and variability of current tests constitute a major problem for HCV diagnosis and treatment. ABI proposes to develop rapid, facile, and lower cost (less than $25) tests to quantify levels of HCV RNA at clinically significant levels without use of PCR that do not require expensive equipment and can be done in physician's offices or regional public health laboratories. The technical approach involves a primer-extension signal amplification method (PESA) and capillary-flow sensor elements for sensitive and facile execution of low-cost tests. The instrument and sensor elements will be designed and developed so that HCV viral load measurements will use less assay time, fewer steps, and much lower set-up and per-result cost than the current state-of-the-art nucleic acid probe-based system. Preliminary investigation indicates a significant market for the proposed technology in research and public health applications over the next 3-to 5-year period as the demand increases for simpler, more accessible, and widely applicable tools for molecular assays to measure clinical samples for viral load in the diagnosis, treatment, and control of infections such as HCV.