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
