Low Cost Automated Urinalysis using Spectral Data

使用光谱数据进行低成本自动化尿液分析

• 批准号: 6883492
• 负责人: Fatima Aziz Merchant
• 金额: $ 10万
• 依托单位: ADVANCED DIGITAL IMAGING RESEARCH, LLC
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-05-15 至 2006-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6883492
• 关键词: biomedical automation; centrifugation; clinical research; computer program /software; computer system design /evaluation; cost effectiveness; diagnosis design /evaluation; fluorescence spectrometry; human tissue; imaging /visualization /scanning; morphometry; spectrometry; urinalysis

DESCRIPTION (provided by applicant): Clinical urinalysis is performed to examine the chemical and formed particle composition of urine. It is used as a screening and/or diagnostic tool to detect different metabolic and kidney disorders, urinary tract infections, diabetes and pregnancy. Routine urinalysis consists of a physical (color, clarity, odor), chemical (protein, glucose, nitrites, etc.), and microscopic examination (cells, crystals, bacteria, etc.) of the urine. The most dramatic advances in urinalysis to date, has been the evolution of automated instruments to replace both the chemical and visual microscopic analysis. Although, the automated urine chemistry analyzers have found widespread use, the particle analyzers have not found similar levels of acceptance because pathologic casts and other particles still must be manually confirmed under the microscope. Moreover, these systems are expensive and their use is limited to hospitals and large clinical laboratories. In today's rapidly changing healthcare environment, the future of in-vitro diagnostics (IVD) is moving towards point-of care testing (PQCT). POCT provides an opportunity for high-quality, efficient, and timely laboratory testing to be available to the healthcare community at a reasonable cost. Given the $552 million global urinalysis market, with the microscopic component amounting to ~$110 million (about 220 million microscopic urinalysis tests are performed worldwide), the ultimate goal of this study is to develop an enhanced automated low cost urinalysis system, that is appealing to both the POCT market (i.e. smaller laboratories and the physician's office) and larger laboratories. Our approach is to perform a computerized morphometric and spectroscopic microanalysis of the urinary sediment, thus enhancing the detection of formed particles such as cells, casts and particles. The instrumentation will be based on a simple centrifugation system coupled with optics to allow automated visual examination of the urinary sediment at a reduced cost. In this Phase I study we will test the feasibility of using morphometric and spectral data to improve the identification of cells, pathological casts, and other particles, when compared to the existing technology. The specific aims are (1) Acquire the fluorescence and absorption spectra of formed particles in the urine, (2) Develop software, to classify and identify the particles based on morphometric and spectral data, and (3) Propose design options for the development of the low-cost urinalysis instrument. If the Phase I study is successful, Phase II will develop a prototype instrument and test it in the clinical environment. The proposed low-cost automated urinalysis instrument will provide POCT, and become a popular screening method for the detection of metabolic and renal disorders.

描述（由申请人提供）：进行临床尿液分析以检查尿液的化学和形成的颗粒组成。它被用作筛查和/或诊断工具，以检测不同的代谢和肾脏疾病，尿路感染，糖尿病和妊娠。常规的尿液分析由尿液的物理（颜色，清晰度，气味），化学（蛋白质，葡萄糖，亚硝酸盐等）和尿液的显微镜检查（细胞，晶体，细菌等）组成。迄今为止，尿液分析中最引人注目的进步是自动化仪器的演变，以替代化学和视觉微观分析。尽管自动化的尿液化学分析仪发现广泛使用，但粒子分析仪没有发现相似的接受水平，因为病理铸造和其他颗粒仍必须在显微镜下手动确认。此外，这些系统很昂贵，它们的使用仅限于医院和大型临床实验室。在当今快速变化的医疗保健环境中，维特罗诊断（IVD）的未来正在朝着医疗点测试（PQCT）迈进。 POCT为医疗保健社区提供了高质量，高效且及时的实验室测试的机会，以合理的成本提供。鉴于全球5.52亿美元的全球尿液分析市场，显微镜成分约1.1亿美元（大约2.2亿个微观尿液分析测试，全球进行了），这项研究的最终目标是开发增强的自动化低成本尿液分析系统，对POCT市场和较小的实验室和较大的实验室和物理学的办公室和较小的物理学群体和物理学较小的办公室和较大的物理学）。我们的方法是对尿液沉积物进行计算机化的形态计量学和光谱微分析，从而增强对细胞，铸件和颗粒等形成的颗粒的检测。该仪器将基于一个简单的离心系统，并加上光学仪，以降低的成本允许自动对尿液沉积物进行自动检查。在此阶段I研究中，与现有技术相比，我们将测试使用形态计量和光谱数据以改善细胞，病理铸造和其他颗粒的鉴定的可行性。具体目的是（1）获取尿液中形成的颗粒的荧光和吸收光谱，（2）开发软件，根据形态和光谱数据对颗粒进行分类和识别，以及（3）为开发低估尿液分析仪器的设计选择。如果I期研究成功，II期将开发一种原型仪器并在临床环境中进行测试。拟议的低成本自动尿液分析仪器将提供POCT，并成为检测代谢和肾脏疾病的流行筛查方法。