LSPR Nanosensor for Simplified Clinical Assays

描述（由申请人提供）：床旁（POC）检测（也称为近患者、床旁或实验室外检测）可改善医疗护理的临床结局。这些改进包括更快的决策，更早的治疗开始，更好的治疗依从性，减少并发症的发生率，更快的治疗优化，降低再入院率，以及更好的患者满意度。还可以产生额外的业务和经济效益。这些潜在的好处为POC测试创造了一个不断增长的市场，可以帮助诊断和治疗各种各样的医学疾病和病症。为了实现有效和准确的POC测试，测定方法必须易于使用，提供准确的答案，提供时间尺度上的结果，需要手持或小型台式仪器，并且需要对测定执行者进行最少的培训。目前寻求满足POC测试需求的方法的局限性是所用仪器的成本和复杂性，以及正确执行测定程序所需的培训。为了克服这种限制，智能光学系统公司提出将简单的无标记临床测定系统扩展到广泛的POC应用，并且稍后使用这种相同的技术来解决高通量筛选应用。在第一阶段工作中开发的雌二醇测定，其基于对Ag纳米片阵列上的局部表面等离子体共振（LSPR）的观察，将扩展到用于卵巢癌早期诊断的临床测定组的开发。这些面板将同时分析用于乳腺癌预后和生育治疗的几个指标。这些是医学上重要的、商业上有吸引力的应用，其将允许将基本LSPR测定系统开发成商业产品。将开发检测化学品、一次性检测基质和用于所有检测操作的手持式仪器的设计。这些产品的商业化预计将导致分析技术的进一步扩展，并作为广泛的POC测试平台。该检测系统也将扩展到解决高通量筛选应用。预计这两种类型的测定在时间和成本方面都将节省大量费用。公共卫生相关性：现在可以在短时间内在病人护理地点进行许多临床医学测试。从这种快速检测中可以获得许多医疗益处。所提出的简单护理点临床测定系统具有以较低成本使更多测试可用于更多患者的潜力。

DESCRIPTION (provided by applicant): Point of care (POC) testing (also referred to as near patient, bed side, or extra laboratory testing) can result in improved clinical outcomes in medical care. These improvements include faster decision making, earlier start of treatment, improved adherence to treatment, reduced incidence of complications, more rapid optimization of treatment, reduced hospital readmission rate, and better patient satisfaction. Additional operational and economic benefits can also accrue. These potential benefits have created a growing market for POC tests that can aid in the diagnosis and treatment of a wide variety of medical diseases and conditions. To achieve effective and accurate POC testing, the assay methodology must be easy to use, provide accurate answers, provide results on a time scale, require handheld or small bench top instrumentation, and require minimal training of assay performers. A limitation to the methodologies currently seeking to meet the needs of POC testing is the cost and complexity of the instruments used, and the training required to correctly perform the assay procedures. To overcome this limitation, Intelligent Optical Systems proposes to extend a simple label- free clinical assay system to a wide range of POC applications, and to later use this same technology to address high throughput screening applications. The estradiol assay developed in Phase I work, which is based on the observation of localized surface plasmon resonance (LSPR) on an array of Ag nanoplates, will be extended to the development of a clinical assay panel for the early diagnosis of ovarian cancer. These panels will simultaneously assay several indicators used for the prognosis of breast cancer, and for fertility treatment. These are medically significant, commercially attractive applications that will allow the basic LSPR assay system to be developed into a commercial product. Designs will be developed for assay chemistries, disposable assay substrates, and a handheld instrument for operation of all assays. The commercialization of these products is expected to lead to further expansions of the assay technology, and as a platform for a wide range of POC testing. The assay system will also be expanded to address high throughput screening applications. Considerable savings in the time and cost of both types of assays is anticipated. PUBLIC HEALTH RELEVANCE: It is now possible to perform many clinical medical tests in a short period of time at the location where patient care is being given. Many medical benefits can be gained from such rapid testing. The proposed simple point of care clinical assay system has the potential of making more tests available to more patients at a lower cost.