Hitachi-High-Technologies Corporation

Hitachi High-Tech Corporation

Kumiko Kamihara

Tomonori Mimura

Isao Yamazaki

Satoshi Mitsuyama

Chihiro Manri

Hideto Tamezane

Masaharu Nishida

Shinichi Fukuzono

Naomi Ishii

An automatic analyzer that allows appropriate setting of analytical parameters which incorporate batch-to-batch variations in reagents. The analytical parameters consist of fixed parameters and variable parameters. The fixed parameters include a reagent-dispensing quantity, a sample-dispensing quantity, measuring wavelength, and the like, each of which becomes a pivot for measurement of a sample, and parameters to be used are selected from an item code and bottle code assigned to a reagent bottle. The variable parameters include a linearity check value, a prozone check value, reaction limit absorbance, technical limits, first standard solution absorbance, variation allowable absorbance, and the like, each of which is associated with sample-measurement result checks. The automatic analyzer reads bar code information from the reagent bottle and adopts variable parameters of a corresponding version with the item code, the bottle code, and batch information relating to the reagent, as a key.

Automatic analyzer

An automatic analyzer includes sample vessels containing samples to be measured and; reaction vessels in which to mix a sample and a reagent. A sample dispenserdispenses a sample from any of the sample vessels to any of the reaction vessels. A reagent dispenser dispenses a reagent from a reagent vessel to a reaction vessel, and a stirrer stirs the sample-reagent mix contained in the reaction vessel. A photometric measurement unit is provided for obtaining multiple measurement data points during the progress of reaction of a mixed solution. At least one approximation formula is performed and an approximation curve from the measurement data points is generated. A shape descriptor is calculated from the approximation curve and abnormalities based on the shape descriptor are determined. This not only allows abnormalities to be detected accurately from each measurement result, but also allows the causes of the abnormalities to be identified.

Automatic analyzer for identifying a cause of abnormalities of measurement results

A pressure signal process unit acquires data under a predetermined condition and a statistic distance between the acquired data and determination-purpose reference data stored in a storage unit is calculated. It is determined whether or not dispensing is abnormal and whether the determination-purpose reference data is suitable for an abnormality detection function to be properly fulfilled. If the determination-purpose reference data is not suitable for an abnormality detection function to be properly fulfilled, temporary determination-purpose reference data is prepared so as to be compared with the previously acquired data under a predetermined condition. If a difference therebetween is greater than a predetermined threshold value, a possibility that an automatic analyzer may have an abnormal component or that a failure may occur in the automatic analyzer is determined, and the result is transmitted to cause a display device to display an alarm.

There is provided a technique for automatically determining or predicting a line range specific to a sample that appears in a reaction curve in an automated analyzer for mixing a specimen and a reagent and measuring a change in a mixture of the specimen and the reagent with time. This invention approximates reaction curve data by a function and automatically determines a curve part at an early stage or a second stage of a reaction. The invention determines a line range not including a curve part for each sample and calculates a laboratory test value using absorbance data within the determined line range. This invention also automatically determines a start time of line at the early stage of the reaction on the basis of absorbance data obtained up to a point halfway through the reaction curve, predicts a line range on the basis of the end time of line and a planned end time of line, and calculates a predictive value on the basis of a result of the prediction.

Automatic analysis device and automatic analysis method

An automatic analyzer that accurately detects dispensation abnormality in dispensation conditions with small suction quantities has a statistical distance calculation unit that calculates characteristic variables regarding a sucking operation in the first dispensation and calculates a statistical distance D from reference data to the characteristic variables extracted from a memory. A comparison unit compares the statistical distance D with a preset threshold value stored in memory and if the statistical distance D is less than the preset threshold value, the first discharging operation is performed. A controller judges whether a single-handed judgment based on a dispensation quantity condition of the second or subsequent dispensation is possible or not. If the single-handed judgment is impossible, reference data is selected based on a judgment quantity regarding the first dispensation. Whether the sucking operation in the second or subsequent dispensation is normal or abnormal is judged based on the selected reference data.

The dispensing mechanisms dips a dispensing nozzle in a dispensing target contained in a container, and, aspirates the dispensing target, and discharges the dispensing target to a reaction container. One item of determination-purpose reference data is selected from multiple items of the determination-purpose reference data which is stored in a storage unitand used in determining whether or not the dispensing mechanisms, andare abnormal, based on the detection result from a pressure sensorwhen the dispensing mechanisms, anddispense a reference dispensing target configured to contain a known ingredient; and whether or not the dispensing mechanisms, andare abnormal is determined, based on the detection result from the pressure sensorand the selected determination-purpose reference data when the dispensing mechanisms, anddispense a dispensing target used in analysis.

An automatic analysis device includes: a factor storage unitwhich stores each factor previously specified as a factor that could affect measurement accuracy of each of measurement items, while associating each factor with each measurement item; an abnormality judgment unitwhich judges the presence/absence of an abnormality in a measurement value of each measurement item on the basis of an approximation formula and approximation formula parameters stored in an approximation formula storage unit; and a factor judgment unitwhich refers to the results of the judgment by the abnormality judgment unitin a preset order, and would judge as an abnormality factor a factor stored in the factor storage unitin association with a measurement item as an abnormality factor in a case where a plurality of measurement values regarding the measurement item have consecutively been judged to be abnormal. The operator is informed of the abnormality factor on the basis of the result of the judgment by the factor judgment unit. With this configuration, deterioration in the measurement accuracy can be reduced through the detection of an abnormality in the measurement result and the determination of the causative factor.

Data processing device and automatic analysis device using same

A plunger is moved downwardly in predetermined distance while the tip of the sample probe is immersed in a sample to suck the sample into the probe. A pressure sensor detects the pressure fluctuation during the suction operation, an AD converter converting the signals into digital signals to send the signals for a signal processing unit. The signal processing unit extracts feature variables data of a suction waveform to calculate the Statistical distance from normal group data. The Statistical distance an a threshold value are compared with each other, it is judged that there is an abnormality in the suction operation when the Statistical distance is more than or equal to the threshold value. When the Statistical distance is smaller than the threshold value, an operation is proceeded to a discharge operation.

Accuracy control of an automatic analysis device that mixes a sample and a reagent to measure temporal change of a mixed solution is realized. A plurality of measurement point data is acquired from a reaction process of the sample and the reagent. Parameters and test values of approximate equations for approximating the plurality of measurement point data are accumulated in a storage unit. A distribution map of reference data corresponding to the parameters or the test values is created based on predetermined numbers of the parameters or the test values accumulated in the storage unit. Next, a plurality of screens for individually superimposing, on the distribution map, curved lines corresponding to a plurality of regression function candidates obtained by applying a plurality of regression functions are arranged and presented on a display screen, so as to approximate the data to the distribution map of the reference data.

Automatic analysis device and automatic analysis program

To change a photometric time for each item or to change a measurement time for each specimen so that time required for biochemical measurement can be reduced, an index that indicates an end of a reaction is required. Unfortunately, however, no methods have been available for determining the end of the reaction. In measuring a substance to be measured contained in a sample, a parameter in an approximate expression is calculated using a measured value that changes with time, a degree of convergence of a reaction is determined according to a degree of convergence of the parameter, and a measured value at the end of the reaction is calculated using the parameter at a point in time at which it is determined that the reaction has converged.

Provided are an automated analyzer and an automatic analysis method for highly accurately determining presence or absence of abnormality based on reaction process data obtained when concentration of a chemical component or an activity level of an enzyme is measured. The reaction process data is approximated by a function, and shape feature quantities indicating features of a shape of a curve section at an early stage of reaction are calculated. The obtained shape feature quantities are used to determine the presence or absence of abnormality.

Automatic analysis device and analysis method

An automatic analyzer which performs a suction operation a plurality of times on a same sample has a sample dispensing unit, a liquid level sensor which detects the liquid level of the sample in a sample vessel, an arithmetic unitwhich computes a liquid level height hat the end of a first suction operation of the two consecutive suction operations from a liquid level height hand a sample suction volume Vdetected at the start of the first suction operation, a storage unitwhich stores the liquid level height hcomputed by the arithmetic unit, and a determination unitwhich compares a liquid level height hdetected at the start of a second suction operation following the first suction operation with the liquid level height hat the end of the first suction operation.

Automatic analyzer and method for determining malfunction thereof

Abnormality causes are automatically identified during daily quality control, based on the focused consideration of complex uncertainty factors and, especially, of the causes of device-side abnormalities, the latter of which are often difficult to identify. The analyzer performance that affects measurement results can be estimated from analysis parameters and calibration results. Thus, uncertainty estimates are automatically calculated for each analysis item during quality control, and the estimates are compared with uncertainties obtained during actual QC sample measurement, thereby monitoring and evaluating the analyzer performance. Also, measurements are performed on QC samples of multiple concentrations that contain substances known to subject to particular influences such as those of the optical system, sample dispenser, and reagent dispenser, so that the causes of abnormalities can be identified. Uncertainty estimates calculated from the parameters set for the analysis items are compared with uncertainties obtained from the QC sample measurements.

Provided is an automatic analyzer capable of detecting not only clogging and air suction of the dispensation probe but also a decrease in the dispensation quantity caused by a bubble film, air bubbles or a highly viscous sample. Each of a sample/reagent suction operation time and a sample/reagent discharge operation time of a probe is segmented into multiple time sections. For each of the time sections determined by the segmentation, a parameter is calculated by applying a detected pressure waveform to an approximation formula. For each of the time section, the presence/absence of a dispensation abnormality is judged by comparing the calculated parameter with a parameter in cases of normal dispensation. An automatic analyzer capable of judging the presence/absence of an abnormality specific to each time section and making abnormality judgments difficult for conventional techniques can be realized.

In known automatic analyzers for detecting an abnormality by approximating reaction process data using a function, accuracy of detecting a reaction abnormality is degraded because of poor approximation accuracy depending on test items. Data processing means stores the absorbance and time of day at which the absorbance is measured as time-series data. Letting x denote absorbance, t denote time, and * denote a symbol representing multiplication, we have a function x=a0+a1*exp(&#x2212;k1*t)+a2*exp(&#x2212;k2*t). Values of parameters a0, a1, a2, ai, k1, and k2 are calculated so that a difference between the absorbance at the measured time calculated using the above expression and the time-series data is minimal, and presence of an abnormality is determined based on the parameter values.

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Mito, Japan

Kumiko Kamihara