|英文要約||Title: Technology Innovation Program for Small Business Innovation Research/ The research and development of an endotoxin sensor for clinical work fronts by the optical wave-guiding mode (FY2011-FY2012) FY2011 Annual Report
We carried out five following subtheme as a feasibility study. (1) The market survey of an endotoxin sensor for monitor use (1-a) Market trend search (1-b) Technical trend research (2) Trial manufacture of sensor chip for endotoxin (3) Primary trial manufacture of the small detection system (4) Data acquisition test about the endotoxin detection and superiority analysis (5) Development of the business plan. As a result, we got the following outcome about each subtheme. (1-a) We investigated market trend from various viewpoints by two times of Committees invited the well-informed person of the endotoxin examination field etc. And, we determined the sector that a portable mode endotoxin sensor was promising and the features such as the market sizes. (1-b) As a result of search, we paid attention to four technologies of Endosafe, Endotoxin Scatting Photometry (ESP), A process using variant luciferase, Endotoxin Activity Assay (EAA). Adding our optical wave-guiding mode sensor to these technologies, we compared features about five note technologies. (2) We produced sensor chip corresponding to the measurement with small amount of sample experimentally to reduce the used amount of an expensive LAL reagent. The surface area of the sample solution enlarged it by a sample hall in the shape of thin pillar, and temperature control characteristics improved. (3) We produced the small detection system that put up all functions except the controller module (PC) in one housing experimentally. The feature of the test model was noted as follows. Main body: Dimension of a slightly bigger lunch box (50mm X 300mm X 200mm), Weight is 2kg, Easily lift with one hand. Sensor chip: Installed in the main body upper part center when use. Inner structure: Very simple, Low packaging density, Room of the downsizing is left still more. Optical Module: Succeeded by downsizing/power-saving with LED light source. (4) We examined the detection of the endotoxin standard sample with sensor chip for endotoxin and the engineering model which made in subtheme (2), (3). And, we succeeded in high-speed (less than 10 minutes) quantitative detection in a range of 0.01-10EU/mL, and ultrahigh sensitivity detection (0.001EU/mL). As a result, we confirmed the market superiority of our optical wave-guiding mode sensor. (5) For industrialization, we investigated external business partners, selected it, and discussed about business plan. As a result, we planned to put a product on sale in 2015, to expand subjects of examination in 2016, and to perform actions for full-scale diffusion in 2019. According to our forecast, the sales of measuring instrument and sensor chip increase from fifty-three million yen in 2015, to about one billion yen in 2019.