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有形颗粒组成。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。常规尿液分析包括物理（颜色、澄清度、气味）、化学（蛋白质、葡萄糖、亚硝酸盐等），和显微镜检查（细胞、晶体、细菌等）的尿液。迄今为止，尿液分析中最引人注目的进步是自动化仪器的发展，以取代化学和视觉显微镜分析。尽管自动尿液化学分析仪已被广泛使用，但颗粒分析仪尚未发现类似的接受程度，因为病理管型和其他颗粒仍然必须在显微镜下手动确认。此外，这些系统是昂贵的，并且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环境中，体外诊断（IVD）的未来正朝着床旁检测（PQCT）发展。POCT提供了一个以合理的成本向医疗界提供高质量、高效和及时的实验室检测的机会。考虑到全球尿液分析市场价值5.52亿美元，其中显微镜成分高达约1.1亿美元（全球进行约2.2亿次显微镜尿液分析测试），本研究的最终目标是开发一种增强型自动化低成本尿液分析系统，该系统对POCT市场（即小型实验室和医生办公室）和大型实验室都有吸引力。我们的方法是进行计算机化的形态和光谱微量分析的尿沉渣，从而提高了检测形成的颗粒，如细胞，管型和颗粒。该仪器将基于一个简单的离心系统与光学耦合，以允许以较低的成本对尿沉渣进行自动目视检查。在这项I期研究中，我们将测试与现有技术相比，使用形态测量和光谱数据来改善细胞、病理性管型和其他颗粒识别的可行性。具体目标是（1）获取尿液中形成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）为低成本尿液分析仪器的开发提出设计方案。如果第一阶段研究成功，第二阶段将开发一个原型仪器，并在临床环境中进行测试。所提出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。