Printed Disposable Sensor for Quantitative HIV RNA Measurement of Viral Load

描述(由申请人提供)：国家过敏和传染病研究所呼吁开发更好的工具来检测和诊断新出现和再次出现的传染病。为了回应这一需求，Alderon Biosciences建议进行研究，开发打印的一次性传感器，用于在资源匮乏的环境中量化艾滋病毒RNA。我们的研究对于开发监测HIV感染患者的传感器非常重要，因为病毒载量与HIV疾病的进展密切相关，而病毒载量减少的程度是临床益处和治疗效果可持续性的最佳预测参数。研究表明，病毒载量是艾滋病毒在男性和女性之间传播的最重要预测因素，无论传播者的性别如何。我们的技术方法是将针对HIV特异性核酸靶标的信号放大探头与Alderon的专有核酸诊断平台结合起来，使用电化学传感器和低成本的手持读取器。我们将对打印的一次性传感器和测量技术进行小型企业创新研究，这些技术将比替代技术使用更少的分析时间、更少的步骤，以及更低的设置和每次结果成本。主要的里程碑是创造基于探测器的传感器，以测量低于100分子/毫升的艾滋病毒RNA目标，假阴性和假阳性低于10%。市场研究表明，拟议的技术有很大的市场，将通过与更大的生物科学公司建立伙伴关系来解决这一问题。据我们所知，只有奥德龙生物科学公司正在开发一种能够进行准确的、低成本的病毒载量分析的技术，这种技术基本上可以在任何公共卫生环境中“实时”使用。如果成功，该项目将向市场提供卓越的致病、生化和病毒载量检测。Alderon Biosciences建议开发创新的电化学仪器、传感器和分析方法，用于在资源匮乏的环境中测量艾滋病毒病毒载量。艾滋病毒病毒载量的测量被用来指导对感染者的治疗，而降低病毒载量的治疗可能提供一种控制艾滋病流行的手段。拟议的检测和监测艾滋病毒病毒载量的化验和测试系统将设计用于在美国和资源匮乏的环境中应用，以提供预后信息，帮助指导治疗决定，并使公共卫生工作者能够更好地防止传染病的传播。

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. In response to this need, Alderon Biosciences proposes research to develop printed disposable sensors for quantification of HIV RNA in resource-poor settings. Our research is important for developing sensors for monitoring HIV infected patients because viral load is strongly correlated with the progression of HIV disease and the degree of viral load reduction is the best prognostic parameter for clinical benefit and for sustainability of treatment efficacy. Studies show that viral load is the most important predictor of HIV transmission between men and women, regardless of the gender of the transmitting individual. Our technical approach is to combine signal amplification probes for HIV-specific nucleic acid targets with Alderon's proprietary nucleic acid diagnostic platform using electrochemical sensors and low-cost handheld readers. We will do small business innovation research on printed disposable sensors and measurement technologies that will use less assay time, fewer steps, and much lower set-up and per- result cost than alternative technologies. Major milestones are to create probe-based sensors to measure HIV RNA targets to below 100 molecules/mL with less than 10% false negatives and less than 10% false positives. Market studies indicate a significant market for the proposed technology, which will be addressed through partnerships with larger bioscience companies. To our knowledge, only Alderon Biosciences is developing a technology capable of carrying out accurate, low-cost viral load assays that can be used in "real time" in essentially any public health setting. If successful this project will provide superior pathogenic, biochemical and viral load testing to the market. Alderon Biosciences proposes to develop innovative electrochemical instruments, sensors and assays for measurement of HIV viral load in resource-poor settings. Measurement of HIV viral load is used to guide therapy for infected persons, and therapies that reduce viral load may provide a means of controlling the AIDS epidemic. The proposed assays and test system to measure and monitor HIV viral load will be designed for application in the US and in resource poor settings to provide prognostic information that can help guide treatment decisions and enable public health workers to better prevent the spread of contagious disease.