# US 9,494,525 B2 · Automated analyzer and automated analysis method > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,494,525 B2 - Document ID: US9494525B2 - Status: Granted - Kind: B2 - Application number: 14/646,150 - Filed: 2013-11-05 - Published: 2015-11-05 - Granted: 2016-11-15 - Earliest claimed: 2012-11-26 - Assignees: Hitachi High-Technologies Corporation - Applicants: Hitachi High-Technologies Corporation - Inventors: Shinji Tarumi; Chie Yabutani; Akihisa Makino; Chihiro Manri; Satoshi Mitsuyama - Web page: https://patentgrep.com/patent/US9494525B2 ## CPC - G01N 21/82: producing a precipitate or turbidity - G01N 21/17: Systems in which incident light is modified in accordance with the properties of the material investigated (where the material investigated is optically excited causing a change in wavelength of the incident light G01N21/63) - G01N 21/272: {for following a reaction, e.g. for determining photometrically a reaction rate (photometric cinetic analysis)} - G01N 33/49: Blood {(chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80)} - G01N 33/4905: {Determining clotting time of blood (by chemical methods G01N33/86, C12Q1/56)} - G01N 35/00: Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor - G01N 35/00584: {Control arrangements for automatic analysers} - G01N 21/25: Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands - G01N 21/27: using photo-electric detection (G01N21/31 takes precedence){; circuits for computing concentration (logarithmic circuits G06G7/24; photometric circuits in general G01J)} - G01N 30/8693: {Models, e.g. prediction of retention times, method development and validation} - G01N 33/53: Immunoassay; Biospecific binding assay; Materials therefor - G01N 33/86: involving blood coagulating time {or factors, or their receptors} - G01N 2021/513: {Cuvettes for scattering measurements} - G01N 2021/5961: {using arrays of sources and detectors} - G01N 2035/00425: {Heating or cooling means associated with pipettes or the like, e.g. for supplying sample/reagent at given temperature} - G01N 2035/00702: {Curve-fitting; Parameter matching; Calibration constants} - G01N 2035/0097: {monitoring reactions as a function of time} - G01N 2035/0453: {Multiple carousels working in parallel} - G16H 30/20: for handling medical images, e.g. DICOM, HL7 or PACS - G16Z 99/00: Subject matter not provided for in other main groups of this subclass - 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) - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA - G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR ## Abstract Provided is technology for blood clotting reactions capable of analyzing a blood clotting reaction with a high degree of precision, by precisely detecting and removing noise, regardless of the location where the noise is generated in the light intensity data. This automated analyzer approximates, with an approximation curve, time series data for transmitted light intensity or scattered light intensity of light emitted onto a sample, and, in this process, removes abnormal data points that deviate from the approximation curve (see FIG. 2). ## Claims ### Claim 1 An automated analysis device that analyzes a blood clotting reaction comprising: a reaction container for mixing a sample with a reagent to cause a reaction; a measuring unit that irradiates light onto a reaction solution in the reaction container and that measures a scattered light intensity or a transmitted light intensity; a controller that processes chronological light intensity data measured by the measuring unit; a storage unit that stores one or more of approximation functions approximating a chronological variation of the light intensity data; and an output unit that outputs a processed result of the controller, wherein the controller selects one of the approximation functions stored in the storage unit, wherein the controller is programmed to perform: a first process calculating an approximated curve representing a chronological variation of the light intensity data using the selected approximation function; a second process detecting, using the approximated curve, an abnormal data point included in the light intensity data; and a third process removing the abnormal data point from the light intensity data, wherein the controller is configured to analyze the blood clotting reaction using at least one of the light intensity data and the approximated curve, and wherein when detecting the abnormal data point in the third process, the controller is configured to detects, as the abnormal data point, only one of a data point in the light intensity data having a light intensity value larger than that of the approximated curve and a data point in the light intensity data having a light intensity value smaller than that of the approximated curve. ### Claim 2 (depends on 1) The automated analysis device according to claim 1, wherein the measuring unit detects the scattered light intensity, and wherein the controller is configured to detects, as the abnormal data point, a data point in the light intensity data having a light intensity value larger than that of the approximated curve. ### Claim 3 (depends on 1) The automated analysis device according to claim 1, wherein the measuring unit detects the transmitted light intensity, and wherein the controller is configured to detects, as the abnormal data point, a data point in the light intensity data having a light intensity value smaller than that of the approximated curve. ### Claim 4 (depends on 1) The automated analysis device according to claim 1, wherein the controller repeats the first process, the second process, and the third process for at least one or more times, and wherein the controller is configured to analyze the blood clotting reaction using at least one of the light intensity data and the approximated curve at a time when a predetermined convergence condition is satisfied. ### Claim 5 (depends on 1) The automated analysis device according to claim 1, wherein the controller selects a subset from the light intensity data, and wherein the controller is configured to detects the abnormal data point included in the light intensity data using differences between the light intensity data and the approximated curve for each of data points and using a standard deviation of differences between the subset and the approximated curve for each of data points. ### Claim 6 (depends on 4) The automated analysis device according to claim 4, wherein the controller selects a subset from the light intensity data, and wherein the controller is configured to determine whether the convergence condition is satisfied using a standard deviation of differences between the subset and the approximated curve for each of data points. ### Claim 7 (depends on 5) The automated analysis device according to claim 5, wherein the controller uses, as the subset, the light intensity data after a predetermined time has passed from when the measuring unit starts measuring the light intensity data. ### Claim 8 An automated analysis device that analyzes a blood clotting reaction comprising: a reaction container for mixing a sample with a reagent to cause a reaction; a measuring unit that irradiates light onto a reaction solution in the reaction container and that measures a scattered light intensity or a transmitted light intensity; a controller that processes chronological light intensity data measured by the measuring unit; a storage unit that stores one or more of approximation functions approximating a chronological variation of the light intensity data; and an output unit that outputs a processed result of the controller, wherein the controller selects one of the approximation functions stored in the storage unit, wherein the controller is programmed to perform: a first process calculating an approximated curve representing a chronological variation of the light intensity data using the selected approximation function; a second process detecting, using the approximated curve, an abnormal data point included in the light intensity data; and a third process removing the abnormal data point from the light intensity data, wherein the controller repeats the first process, the second process, and the third process for at least one or more times, and wherein the controller is configured to analyze the blood clotting reaction using at least one of the light intensity data and the approximated curve with a state using a predetermined convergence condition. ### Claim 9 (depends on 1) The automated analysis device according to claim 1, wherein the controller is programmed to calculate the approximated curve by varying a coefficient of the approximation function so that a squared error between the approximation function and the light intensity data becomes smallest. ### Claim 10 (depends on 1) The automated analysis device according to claim 1, wherein the approximation function is a function having a first region in which an amount of variation of light intensity with respect to time becomes gradually large and a second region in which an amount of variation of light intensity with respect to time is smaller than that of the first region at a time after the first region. ### Claim 11 (depends on 1) The automated analysis device according to claim 1, wherein the controller is programmed to calculate a clotting time of the blood clotting reactions using at least one of the light intensity data and the approximated curve. ### Claim 12 (depends on 1) The automated analysis device according to claim 1, wherein the output unit outputs one or more of: (1) the light intensity data using time as a first axis and using light intensity as a second axis; (2) the approximated curve using time as a first axis and using light intensity as a second axis; (3) a result of the analysis; and (4) an equation of the approximation function. ### Claim 13 An automated analysis method for analyzing a blood clotting reaction comprising: a measuring step of irradiating light onto a reaction solution in a reaction container for mixing a sample with a reagent to cause a reaction and of measuring a scattered light intensity or a transmitted light intensity; a control step of processing chronological light intensity data measured in the measuring step; and an output step of outputting a processed result in the control step, wherein the control step includes a step of selecting and reading an approximation function approximating a chronological variation of the light intensity data from a storage unit that stores one or more of the approximation functions, wherein the control step includes a step of performing: a first process calculating an approximated curve representing a chronological variation of the light intensity data using the selected approximation function; a second process detecting, using the approximated curve, an abnormal data point included in the light intensity data; and a third process removing the abnormal data point from the light intensity data, wherein the control step includes a step of analyzing the blood clotting reaction using at least one of the light intensity data and the approximated curve, and wherein when detecting the abnormal data point in the third process, only one of a data point in the light intensity data having a light, intensity value larger than that of the approximated curve and a data point in the light intensity data having a light intensity value smaller than that of the approximated curve is detected as the abnormal data point.