One Step H. pylori Test--Screening and Individual Assays

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The aim of this project is to demonstrate feasibility of four different types of H. pylori assays. Assays will be developed for both the H. pylori organism and its antibody. The specific goal will be to develop a test which is rapid and very-low cost for screening of populations and for clinical laboratories. H. pylori is significant as a cancer risk as it can cause two types of malignancies: gastric adenocarcinoma and primary - gastric MALT lymphoma. The gastric adenocarcinoma is the second leading cause of cancer death around the world and it is expected by 2010 to be the eighth leading cause of all death. The method proposed is a Surface Enhanced Raman ImmunoAssay (SERIA) that has several significant advantages. Foremost, the surface localized enhancement of the SERIA method eliminates spectroscopic interference from matrix effects. Furthermore, it eliminates the need for washing steps that create biohazardous waste and personnel exposure in other immunoassays configurations. The project will examine sensitivity, selectivity, shelf-- life, and cost of production for H. pylori SERIA. The SERIA will be optimized with sterile buffer solutions. Once typical protocols are established with buffers we will examine animal samples supplied in the for of mice tissue, blood, feces, and gastric juices. When optimization with the animals samples has been established we will look at human blood. tissue, feces, and vomitus samples. Comparisons will made to commercially available kits. PROPOSED COMMERCIAL APPLICATIONS: The number one goal of this project is to produce a microwell format assay for H. pylori. Secondary is a single sample format for low-volume testing The market for the first goal is wide open as no high-volume low-cost procedure exists. The market would be instruments and assays for screening large populations for H pylori infections.