# US 7,608,404 B2 · Disease determination method, data generation method for disease determination and data generation system for disease determination > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 7,608,404 B2 - Document ID: US7608404B2 - Status: Granted - Kind: B2 - Application number: 10/533,116 - Filed: 2003-10-30 - Published: 2006-10-19 - Granted: 2009-10-27 - Earliest claimed: 2002-11-01 - Assignees: Hamamatsu Photonics K.K. - Inventors: Akimitsu Kakui; Katsu Honzawa; Yukiko Sato - Web page: https://patentgrep.com/patent/US7608404B2 ## CPC - G01N 21/6428: {Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" (in vivo A61B5/00; immunoassay G01N33/53)} - G01N 21/77: by observing the effect on a chemical indicator - G01N 2021/6417: {Spectrofluorimetric devices} - G01N 2021/7786: {Fluorescence} - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract Supernatant of the urinary sample (SP1) was mixed with an acid or alkali and heated (SP2) and the sample for fluorescence assay was prepared after adjusting its acidity to alkaline (SP3). Next, using fluorometry, three-dimensional fluorescence spectrum consisted of an excitation light wavelength, fluorescence wavelength and fluorescence intensity (SP4). Then, a relative maximum peak is detected as a specific point in the three-dimensional fluorescence spectrum to specify a specific point attribute (peak number, peak position and fluorescence intensity) and then the urinary sample is sorted based on the attribute (SP5). Finally, the presence or absence of a disease such as a malignant tumor is determined based on the sorting results of the urinary sample (P6). ## Claims ### Claim 1 Data generation method for disease determination for generating data for disease determination using a biological sample obtained from the subject, comprising; pretreatment process to add an acidic or alkaline solution to the sample and to heat the sample, excitation light irradiation process to irradiate the sample with the excitation light and to continuously or intermittently change the wavelength of the excitation light, emission light measurement process to measure the wavelength and intensity of the emission light emitted from the sample in response to the excitation light, and analyzing and sorting process to detect a specific point in the three-dimensional optical spectrum composed of the excitation light wavelength, emission light wavelength and emission light intensity and to sort the sample based on an attribute of the specific point, wherein the specific point is a relative maximum peak or a relative minimum peak of a fluorescence intensity and is utilized for disease determination. ### Claim 2 (depends on 1) The data generation method for disease determination according to claim 1, wherein a specific point attribute is determined by at least one of the parameters selected from the group consisting of wavelength coordinates of said specific point, number of the specific points, intensity of said emission light of the specific point, rate of change in the emission light intensity on the periphery of the specific point and said three-dimensional optical spectrum shape in said analyzing and sorting process. ### Claim 3 (depends on 1) The data generation method for disease determination according to claim 1, wherein urine is used as said sample. ### Claim 4 (depends on 1) The data generation method for disease determination according to claim 1, wherein fluorescence is measured as said emission light. ### Claim 5 (depends on 1) The data generation method for disease determination according to claim 1, wherein the light having a wavelength in a range of 200-900 nm as said excitation light in said excitation light irradiation process and fluorescence having a wavelength in a range of 200-900 nm as said emission light in said emission light measurement process. ### Claim 6 (depends on 1) The data generation method for disease determination according to claim 1, wherein the acidity adjustment process to adjust acidity of said sample is further included after said pretreatment process is performed. ### Claim 7 (depends on 6) The data generation method for disease determination according to claim 6, wherein acidity of said sample is arbitrarily selected from acidic, alkaline, neutral or almost neutral and an acid, alkali or buffer is added to the sample to achieve the acidity selected during said acidity adjustment process. ### Claim 8 (depends on 7) The data generation method for disease determination according to claim 7, wherein the acidity of said sample is maintained in alkaline during said acidity adjustment process. ### Claim 9 (depends on 1) The data generation method for disease determination according to claim 1, wherein said specific point is at least one of a relative maximum peak, a relative minimum peak and a point having 1/n of the intensity of the relative maximum peak (n>1) of said emission light in said three-dimensional optical spectrum in said analyzing and sorting process. ### Claim 10 (depends on 9) The data generation method for disease determination according to claim 9, wherein specific point detection maps selected from the group consisting of a numerical matrix, contour map and vector diagram on said three-dimensional coordinate system are prepared and said specific point is detected based on the specific point detection map in said analyzing and sorting process. ### Claim 11 (depends on 1) The data generation method for disease determination according to claim 1, wherein the specific point attribute of said sample subject for the examination and the known specific point attributes detected in advance using the standard samples from the bodies having a known specific type of disease are compared and the sample is sorted according to the comparison results in said analyzing and sorting process. ### Claim 12 (depends on 11) The data generation method for disease determination according to claim 11, wherein the standard data generation process is included to generate said known specific point attributes based on the comparison results of the specific point attribute detected using the standard samples from the healthy bodies with the specific point attribute detected using the standard samples from the bodies having a known specific type of disease. ### Claim 13 (depends on 1) The data generation method for disease determination according to claim 1, wherein said disease is a malignant tumor.