Electrochemical bDNA probe-based measurement of HIV 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。需要在资源匮乏的情况下，如不发达国家的地方公共卫生部门、任何地方的灾害情况和军事冲突地区，提供实用和负担得起的检测。这一问题对人类免疫缺陷病毒(HIV)感染尤其重要，因为病毒载量与艾滋病毒疾病的进展密切相关，在接受抗逆转录病毒治疗的患者中，病毒载量减少的程度是临床受益和治疗效果可持续性的最佳预测参数。在艾滋病毒感染率最高的资源匮乏环境中进行的研究报告称，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。Alderon Biosciences，Inc.建议开发和测试一种创新的电化学分支DNA分析方法，用于测量和监测艾滋病毒病毒载量，这是预测感染者传播病毒、发展为艾滋病或死亡的风险的唯一最佳方法。该技术方法包括将由CHIRON诊断公司(加利福尼亚州埃默里维尔)开发的针对HIV核酸靶标的分支DNA信号放大探针与 Alderon Biosciences的专利核酸诊断平台，将电化学传感器与现场使用的恒电位器结合在一起。仪器和传感器元件的设计和开发将使艾滋病毒病毒载量测量比目前最先进的基于核酸探针的系统使用更少的分析时间、更少的步骤，以及更低的安装和每结果成本。预期的结果是，一种基于电化学核酸探针的分析技术将在资源匮乏的环境中测量HIV RNA，其最低分子数为每毫升样本50个分子。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分析工具的需求增加，拟议中的技术在未来三到五年内在研究和公共卫生应用中将有很大的市场。分子分析工具用于在诊断、治疗和控制艾滋病毒等感染时测量临床样本的病毒载量。

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. The need is for tests that are practical and affordable for use in resource poor settings, such as local public health departments in underdeveloped countries, disaster situations anywhere, and areas of military conflict. This problem is particularly important for human immunodeficiency virus (HIV) infections because viral load is strongly correlated with the progression of HIV disease, and in patients receiving antiretroviral therapy, the degree of viral load reduction is the best prognostic parameter for clinical benefit and for sustainability of treatment efficacy. Studies done in resource poor settings where HIV infection rates are highest report that viral load is the most important predictor of HIV transmission between men and women, regardless of the gender of the transmitting individual. Alderon Biosciences, Inc. proposes to develop and test an innovative electrochemical branched DNA assay for measuring and monitoring HIV viral load which is the single best way to predict an infected person's risk of transmitting the virus, for developing AIDS, or dying. The technical approach involves combining the branched DNA signal amplification probes for HIV nucleic acid targets developed by Chiron Diagnostics (Emeryville, CA) with Alderon Biosciences' proprietary nucleic acid diagnostic platform of electrochemical sensors coupled with field-use potentiostats. The instrument and sensor elements will be designed and developed so that HIV viral load measurement 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. The expected result is an electrochemical nucleic acid probe-based assay technology will measure HIV RNA down to 50 molecules/ mL sample in resource poor settings. Preliminary investigation indicates a significant market for the proposed technology in research and public health applications over the next three- to five-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 HIV.