|英文要約||Title: Technology Innovation Program for Small Business Innovation Research / The study of early detection in high sensitive endotoxin assay, Endotoxin Scattering Photometry method (FY2011-FY2012) FY2011 Annual Report
To elucidate for getting accurate endotoxin concentration in medical samples,we have found and established highly sensitive endotoxin assay system, Endotoxin Scattering Photometry (ESP) method with observing Laser scattering in LAL reaction with endotoxin. (JPN Pat.#4551980, 2010.03) This new method can detect 0.001pg/mL (0.0048mEU/mL) within 110 min.The principle of ESP method is based on detecting LAL gel particle under agitating condition with endotoxin by Laser Scattering. The assay system also based on detecting the timing of appearance of gel particle with ESP condition, and the appearance of timing depends on the concentration of endotoxin.On the contrary,ordinary endotoxin assay, Turbidmetric assay, has detected gelation process with gel turbidity after finishing ESP assay observation.In medical usage for assaying endotoxin, it should be faster the better.We have examined the possibility to detect earlier event before gelation. This idea was estimated by the observation of ESP method principle. We have found the physical change during this latent phase using viscosity measurement. This new method has shown fine calibrated LAL reaction from 480 to 0.48 mEU/mL within 20 min. There are many problems to assay this short term measurement experiment with viscosity. From the view point of ESP principle, there would be many problem to assay only viscosity within 20 min, we also has planned to follow these problem to solve and support determination accurately by hybridizing ESP systems and viscosity measurement system. We have estimated the possibility to hybridize two systems setting in compact compartment for carrying in medical field directly.