JP6234812B2 - Automatic analyzer - Google Patents

Description

  Embodiments described herein relate generally to an automatic analyzer.

  An automatic analyzer is a device that measures a component of a reaction solution by reacting a specimen such as blood or urine with a reagent. Some automatic analyzers are capable of analyzing a single sample with a plurality of analysis items (hereinafter sometimes simply referred to as “items”). Examples of items include biochemical test items and immunological test items.

  For example, the automatic analyzer is requested to examine a plurality of items for a sample such as blood of a patient (subject), and measurement is performed based on the request. Data after the end of the measurement (hereinafter sometimes referred to as measurement data) is displayed on the display unit as an analysis result through a predetermined process.

  The analysis result is displayed for each item, for example. For example, when the value of the analysis result of an item is outside the range of values set in advance as normal values for the item, it is determined that the analysis result of the item is abnormal. A sample determined to have an abnormal item in the analysis result (hereinafter sometimes referred to as an abnormal sample) is reexamined for that item.

  Conventionally, the determination of this re-examination has been made by visual inspection of the analysis results displayed on the display unit or the like by an inspection engineer, a doctor, or the like. Therefore, performing this determination work on all the samples requires a great amount of time and labor.

  In view of this, an automatic analyzer has been proposed in which information indicating an abnormal sample is added to the analysis result and displayed on a display unit.

JP 2010-256260 A

  However, some abnormal factors cannot be determined only by the analysis results of the items. That is, among the factors causing an abnormality, it is sometimes necessary to check not only the items determined to be abnormal but also other measurement data, apparatus information, and the like.

  For example, when the cause of the abnormality is derived from a sample such as M protein, it is necessary to confirm the reaction process of all items in the measurement.

  This confirmation work is complicated to display the reaction process sequentially for each item. In addition, when it is desired to compare reaction processes in different specimens, different items, etc., it is inconvenient to display the sequential reaction processes by designating specimens and items.

  For this reason, this troublesome confirmation work may be omitted, and the cause of the abnormality may be overlooked. On the other hand, performing this complicated confirmation work on all abnormal specimens requires a lot of time and labor.

  This embodiment solves the above-described problem, and an object thereof is to provide an automatic analyzer that can easily perform confirmation and comparison of a reaction process when an abnormality is detected.

  In order to solve the above-described problem, the automatic analyzer according to the embodiment includes an analysis unit, a processing unit, an abnormality detection unit, a classification processing unit, and a display unit. The analysis unit dispenses each liquid of the sample and the reagent into a reaction container to generate a mixed solution, and measures the components of the mixed solution. The processing unit receives the measurement result output from the analysis unit, calculates the concentration of the specific substance in the mixed solution, and creates reaction curve data based on the concentration. The abnormality detection unit receives the measurement result output from the analysis unit and detects the presence or absence of abnormality. The classification processing unit receives the detection of the abnormality in the abnormality detection unit, and groups the data of the reaction curve according to the type of the cause of the abnormality. The display unit displays a list of the graphs including the grouped reaction curves.

1 is a block diagram showing the overall configuration of an automatic analyzer according to a first embodiment. The figure which shows the detail of a structure of an analysis part, and the input-output to an analysis part. The block diagram which shows the detail of the whole structure of an automatic analyzer. The flowchart which shows an example of the process which displays the graph which shows the reaction time course as a list on a display part. A table showing an example of a list of analysis results. The figure which shows the list of the graph which shows the reaction time course. The figure which showed the detailed screen of the measurement result of sample measurement. The figure which showed the report creation screen. The figure which shows an example of the report produced in the report creation screen. The figure which shows the setting screen of a group. The flowchart which shows an example of the process which displays the graph which shows the reaction time course as a list on a display part. The figure which shows the list of the graph which shows the reaction time course.

<First Embodiment>
[Automatic analyzer]
The automatic analyzer of this embodiment will be described with reference to each drawing. The automatic analyzer of this embodiment mixes and reacts a dispensed test sample (hereinafter sometimes referred to as “specimen”) and a reagent, and analyzes the reaction solution (mixed solution). An apparatus for measuring the components of a reaction solution.

  The configuration of the automatic analyzer 10 will be described with reference to FIGS. FIG. 1 is a block diagram showing the overall configuration of the automatic analyzer 10.

[Overall configuration of automatic analyzer]
As shown in FIG. 1, the automatic analyzer 10 includes an analysis unit 24, an analysis control unit 25, a data processing unit 30, an abnormal data detection unit 60, a classification processing unit 50, a system control unit 70, and an operation unit. 80, an output unit 40, and a storage unit 90.

  The analysis unit 24 generates a mixed solution containing the sample and reagent liquids, and measures the components of the mixed solution. The analysis control unit 25 controls each analysis unit of the analysis unit 24.

  The data processing unit 30 receives the measurement result of the component of the mixed solution output from the analyzing unit 24, calculates the concentration of the specific substance in the mixed solution, and creates analysis data, calibration data, and the like. Further, the data processing unit 30 creates graph data including a reaction curve indicating a time-series change in the calculated concentration. A reaction curve showing a time-series change in concentration is generally called a reaction time course.

  The concentration calculation process is performed based on a calibration curve. A calibration curve is created by measuring a standard sample with a known concentration and obtaining calibration data (standard data). The concentration calculation process can also be performed based on a calibration curve and accuracy management data. The accuracy control data (accuracy management data) is acquired by measuring an accuracy control sample whose concentration and measurement fluctuation range are known.

  The abnormal data detection unit 60 detects abnormal data by analyzing the measurement result of the sample measurement. The detection of abnormal data is performed on the final measurement value of the sample measurement, and is performed by determining whether or not this value is normal. For example, when the threshold value of the final measurement value of the sample measurement is set, it is determined as abnormal data when the measurement value is larger or smaller than a predetermined threshold value. Alternatively, when the final measurement value range of the sample measurement is set, it is determined as abnormal data when it is out of the range.

  The abnormal data detection unit 60 calculates a change rate value or a change amount value of the sample measurement data from the sample measurement data at a predetermined time interval. The abnormal data detection unit 60 compares the preset change rate or change amount upper limit value and lower limit value of the sample measurement data with the calculated change rate value or change amount value, Determine and detect whether there is an abnormality in the measurement.

  The analysis unit 24 measures a plurality of items for one specimen. The abnormal data detection unit 60 detects abnormal data, for example, for each item measurement.

  The classification processing unit 50 receives the information on the abnormal data output from the abnormal data detection unit 60, and classifies the graph data created based on the measurement result of the sample measurement according to the type of the abnormality (hereinafter referred to as a group). (Also known as).

  The grouping may be performed before creating the graph data. In this case, the measurement results of the sample measurement corresponding to the graph data are grouped.

  The type of abnormality is an item when the abnormality is determined, the type of the cause of the abnormality, or the like. When the cause of the abnormality is derived from the specimen, the type of the causative substance of the abnormality can be mentioned. In addition, when the specimen has a plurality of types of abnormal data, the graph data to be grouped may be determined by a combination of the types of abnormal data.

  The system control unit 70 controls the analysis control unit 25, the data processing unit 30, the abnormal data detection unit 60, the classification processing unit 50, and the output unit 40 in an integrated manner. The operation unit 80 inputs various command signals to the system control unit 70.

  The output unit 40 receives information received from the data processing unit 30, the classification processing unit 50, the abnormal data detection unit 60, the operation unit 80, and the like through print output, display output, a network, and the like based on the control of the system control unit 70. Output to the outside. For example, the printing unit 41 and the display unit 42 are used for this external output.

  Examples of the information received by the output unit 40 include various data generated by the data processing unit 30, reaction curves, and the like. The information received by the output unit 40 includes, for example, information on abnormal data detected by the abnormal data detection unit 60. Examples of the information received by the output unit 40 include graph data grouped by the classification processing unit 50. Further, information received by the output unit 40 includes information on operation input input from the operation unit 80.

  Examples of the operation unit 80 include those having an independent operation input function such as a mouse and a keyboard. Further, the operation unit 80 may be combined with the display unit 42. This is a combination of an operation input function such as a touch panel and a display function. The operation unit 80 inputs, for example, what is directly input to the system control unit 70 as a command to the automatic analyzer 10. Further, for example, an object such as a button displayed on the display unit 42 is selected with a mouse or the like. As a result, a command corresponding to this operation is input to the system control unit 70 as a command to the automatic analyzer 10.

  The storage unit 90 stores information received from the data processing unit 30, the classification processing unit 50, the abnormal data detection unit 60, the operation unit 80, and the like. Further, the storage unit 90 outputs information stored based on the control of the system control unit 70 to each unit.

  The analyzing unit 24 absorbs the reaction solution of the sample and the reagent and outputs measurement data. Examples of the measurement data include test data. The measurement data includes preliminary measurement data such as calibration data, accuracy control data, sample blank data, and reagent blank data in addition to the test data.

  Test data can be obtained by using the patient's blood or the like as the sample in the above-described absorbance measurement. Calibration data is measurement data in which the sample is a standard sample whose concentration is known in the above-described absorption measurement.

  As described above, calibration data is obtained by measuring the absorbance of a sample having a known concentration. Calibration data defines the correspondence of absorbance to concentration in the sample. By performing the sample measurement based on this data, the measurement accuracy of the sample measurement is improved.

  In the above-described absorbance measurement, the accuracy control data can be obtained by using an accuracy control sample whose concentration and measurement fluctuation range are known. As described above, the accuracy control data measures the absorbance of a sample having a known concentration and a measurement variation range, thereby defining the measurement variation of the absorbance with respect to the concentration of the sample. By performing sample measurement based on this data, the measurement accuracy of sample measurement is improved.

  Reagent blank data can be obtained by using purified water or physiological saline as the reagent in the absorbance measurement. The sample blank data is obtained by using purified water or physiological saline as a sample in the above-described absorption measurement. These blank data are used, for example, to correct the test data by taking a difference from the test data.

  In this embodiment, abnormal data derived from the specimen is detected. Abnormal data is detected by, for example, comparing preliminary measurement data, which will be described later, with test data, and determining that an abnormal reaction occurs when the final measurement value of the sample measurement is outside a predetermined range. Done. In addition, for example, when the difference between the final measurement value of the specimen measurement and the final measurement value of the preliminary measurement is equal to or greater than a predetermined threshold value, the abnormal reaction is determined.

[Configuration of analysis unit]
FIG. 2 is a diagram illustrating the detailed configuration of the analysis unit 24 and the input / output of the analysis unit 24. The configuration of the analysis unit 24 will be described in detail with reference to FIG.

  The analysis unit 24 is controlled by the analysis control unit 25. The analysis control unit 25 includes a mechanism unit 26 and a control unit 27.

  The mechanism unit 26 includes a motor, a gear, and the like, and drives each unit of the analysis unit 24 by generating a driving force and transmitting the generated driving force to each unit of the analysis unit 24.

  The control unit 27 controls the driving of each unit included in the analysis unit 24 by instructing the mechanism unit 26. Each unit includes a first reagent container 2, a second reagent container 3, a reaction container 5, a disk sampler 6, and an arm 14 (sample dispensing probe 7, first reagent dispensing probe 8, and second reagent dispensing probe 9). Each arm).

  The sample is stored in the sample container 61. The sample container 61 is placed on a rotatable circular disc sampler 6. The reagent is accommodated in the reagent container 4. The reagent container 4 is placed in the first reagent container 2 and the second reagent container 3. The reagent container 4 stores various first reagents that selectively react to the item of the specimen or various second reagents that are paired with the first reagent. The reagent container 4 containing the first reagent is placed in the first reagent store 2, and the reagent container 4 containing the second reagent is placed in the second reagent store 3. The first reagent store 2 and the second reagent store 3 contain a rotatable circular reagent rack 1. Each reagent container 4 is accommodated in the reagent rack 1 in a ring shape.

  A reaction vessel 51 into which a sample and a reagent are dispensed is placed in the reaction chamber 5. The reaction vessel 51 is placed in a circular shape on a rotatable circular cassette member (not shown).

  The sample and the reagent are dispensed by the sample dispensing probe 7, the first reagent dispensing probe 8, and the second reagent dispensing probe 9.

  The sample dispensing probe 7 sucks the sample from the sample container 61 transported to the specified suction position by the rotation of the disk sampler 6, and discharges the sample to the reaction container 51 transported to the specified discharge position.

  The first reagent dispensing probe 8 sucks the first reagent from the reagent container 4 transported to the specified suction position by the rotation of the reagent rack 1 of the first reagent storage 2, and the reaction transported to the specified discharge position. The first reagent is discharged into the container 51.

  The second reagent dispensing probe 9 sucks the second reagent from the reagent container 4 transported to the specified suction position by the rotation of the reagent rack 1 of the second reagent store 3, and the reaction transported to the specified discharge position. The second reagent is discharged into the container 51.

  A stirring unit 11, a photometric unit 12, and a cleaning unit 13 are further provided on the outer periphery of the reaction chamber 5.

  The reaction container 51 into which the sample and the reagent are dispensed is sequentially transported to the stirring, measuring, and cleaning positions of the stirring unit 11, the photometry unit 12, and the cleaning unit 13 by rotation of a cassette member (not shown).

  The agitation unit 11 is an agitation unit that agitates the reaction liquid of the specimen and the reagent (first reagent and second reagent) in the reaction vessel 51 stopped at the agitation position for each cycle.

  The cleaning unit 13 aspirates the reaction liquid that has been measured in the reaction container 51 stopped at the cleaning / drying position, and cleans / drys the reaction container 51.

  The photometric unit 12 is a measuring unit that measures the reaction solution from the photometric position. The photometric unit 12 measures the absorbance of the reaction solution, and then outputs the measurement data to the data processing unit 30. The data processing unit 30 obtains the concentration of the reaction solution from the absorbance based on the calibration curve. Thereby, it becomes possible to measure the components of the reaction solution.

  This embodiment is characterized by a list display of a graph showing a reaction time course (reaction process). The reaction time course represents the time series change of the reaction. Hereinafter, the list display of the graph showing the reaction time course will be described.

  A graph indicating the reaction time course is displayed on the display unit 42, for example. The graph indicating the reaction time course is displayed based on the graph data of the reaction time course.

  The graph data of the reaction time course is created by the graph creation unit 32 based on the measurement data output from the analysis unit 24.

  The graph data is grouped by the graph classification unit 54 based on a predetermined condition. The grouped graph data is output to the display unit 42 and the like. Thereby, a graph showing the reaction time course is displayed in a list on the display unit 42.

  At this time, the graph data of the reaction time course may include a plurality of reaction time courses created based on a plurality of measurement data.

[Detailed configuration of automatic analyzer]
FIG. 3 is a block diagram showing details of the overall configuration of the automatic analyzer 10. The automatic analyzer 10 according to this embodiment groups the reaction time course graph data according to the type of abnormality detected by the abnormality data detection unit 60 and outputs the grouped graph data to the display unit 42.

  The data processing unit 30 includes a calculation unit 31, a graph creation unit 32, and a data storage unit 33.

  The calculation unit 31 processes standard data and test data output from the photometry unit 12 of the analysis unit 24 to generate calibration data and analysis data for each item. These data are generated by calculating the concentration of the specific substance in the liquid.

  The graph creation unit 32 creates graph data including at least one reaction curve data from the standard data and analysis data generated by the calculation unit 31. The graph data is created based on the measurement result by the analysis unit 24.

  The graph data is, for example, graph data of a reaction time course. The graph data includes graph data of one reaction time course corresponding to at least one measurement. The graph data may include graph data of a plurality of reaction time courses corresponding to a plurality of measurements. The graph showing the reaction time course includes, in addition to the graph showing the reaction process of the sample measurement, the graph showing the reaction process of the preliminary measurement described above.

  The graph data may be graph data including a plurality of types of graph data. That is, the graph data may be any graph data as long as it represents some relationship with the measured absorbance value.

  Examples of the reaction curve include a test curve indicating a reaction time course based on test data, a standard curve indicating a reaction time course in calibration measurement, an accuracy control curve indicating a reaction time course in accuracy control measurement, and reagent blank measurement data. A reagent blank curve showing the reaction time course of the sample, a sample blank curve showing the reaction time course of the sample blank measurement data, and the like. Of these, the standard curve, accuracy control curve, reagent blank curve and sample blank curve are referred to as preliminary measurement curves.

  The created graph shows at least a test curve as a response curve. In addition to the test curve, this graph may show that at least one of a calibration curve, an accuracy control curve, a reagent blank curve, and a sample blank measurement can be compared with the test curve. Since a specimen is usually analyzed by a plurality of items, a plurality of graphs are created for each item, for example.

  The data storage unit 33 stores the standard data and analysis data generated by the calculation unit 31 and the graph data created by the graph creation unit 32.

  The classification processing unit 50 includes a search unit 52, a classification condition storage unit 53, a graph classification unit 54, and a classification graph storage unit 55.

  The graph classification unit 54 calls a plurality of graph data from the data storage unit 33 according to the type of abnormality, and groups them under a predetermined condition. The classification condition that is a grouping condition corresponding to the type of abnormality is stored, for example, in the classification condition storage unit 53, and the graph classification unit 54 groups the graph data based on the classification condition.

  This grouping is performed based on the specimen, for example. This groups, for example, a plurality of graph data created based on measurement results of the same patient. That is, a plurality of graph data created based on the measurement results of the same patient measured within a predetermined time are grouped. It is also possible to group a plurality of graph data created on the basis of the measurement results of a plurality of items of the same patient that are measured in one measurement.

  The graph classification unit 54 can call up graph data that has not been created by the graph creation unit 32. That is, this graph data is graph data in the process of being created based on measurement data that has not been completely measured for absorbance. Further, this graph data is, for example, graph data of a reaction time course of sample measurement.

  In this way, the graph showing the reaction time course of the specimen can be referred to in real time by calling the graph data in the process of creation. Thereby, for example, when an abnormality is detected from the graph displayed on the display unit 42, the measurement of the sample corresponding to the abnormality can be stopped.

  For example, the grouped graph data may include information indicating how to display the graph data when it is output to the display unit 42. As this information, the display conditions mentioned later are mentioned, for example.

  The grouped graph data may be output to the output unit 40 as it is, or may be stored in the classification graph storage unit 55.

  In the classification condition storage unit 53, classification conditions are stored in advance. The classification condition is correspondence information between the type of abnormality and the graph data to be grouped. The type of abnormality refers to, for example, the type of factor causing the measurement abnormality. The classification condition includes, for example, correspondence information between the abnormality type and the classification type. The classification condition may include a display condition that is correspondence information between the type of abnormality and the type of display.

  The classification type is, for example, a grouping type. As described above, the grouping type includes, for example, an item. Sample measurement may be performed on a plurality of items. That is, graph data of a plurality of reaction time courses created based on the measurement results of a plurality of items in the same sample are grouped. Moreover, the display mode defined on the display unit 42 is defined by the display conditions, for example. As this display mode, for example, side-by-side display, overlapping display, and the like can be mentioned.

  The classification conditions can be set by arbitrarily selecting correspondence information and display conditions, and can also be set in combination.

  The classification condition can be arbitrarily set. The grouping of the graph data is performed based on the classification conditions stored in advance in the classification condition storage unit 53, but may be performed based on the classification conditions input from the operation unit 80.

  The determination of the type of abnormality is automatically performed by the abnormality data detection unit 60, for example. If the abnormal data detection unit 60 determines that the reaction is abnormal, the abnormal data detection unit 60 transmits the data of the abnormal reaction to the graph classification unit 54.

  The abnormal reaction data includes subject information (patient ID), measurement raw data, error information, and the like over all items of sample measurement in which the abnormal reaction is determined. In addition, for example, the operator may determine the type of abnormality. In this case, when the operator inputs the determination result of the abnormal reaction from the operation unit 80, the abnormal data detection unit 60 automatically outputs the same information as described above to the graph classification unit 54.

  The graph data of the reaction time course grouped in the graph classification unit 54 is, for example, the graph data of the reaction time course created based on the measurement related to the measurement in which the abnormality is detected. That is, the graph data of the reaction time courses to be grouped is measurement graph data related to the measurement in which an abnormality detection is input to the graph classification unit 54.

  The measurement related to the sample measurement is, for example, a measurement in which the sample measurement and the sample are the same or related. The same sample refers to a sample dispensed from the same sample container, for example. The related sample refers to a sample collected from the same subject, for example.

  The measurement related to the measurement with the input of the abnormality detection is, for example, all the measurements made in the sample measurement when abnormality is detected in one item among the measurement of a plurality of items made in the sample measurement. This refers to the measurement of items.

  When an abnormality is detected for one item in the sample measurement, the graph classification unit 54 groups the graph data of the reaction time course corresponding to all items made in the sample measurement.

  The display conditions include, for example, conditions for displaying the graphs side by side and conditions for displaying the graphs in a superimposed manner. Conditions for displaying the graphs side by side include, for example, conditions such as the order of the graphs displayed side by side, the size of the displayed graphs, and the like.

  The order of the graphs to be displayed is displayed from right to left and from top to bottom, for example, in order from the oldest measured date and time and from the smallest item number.

  A condition for displaying the graphs in a superimposed manner includes a combination of the graphs to be superimposed.

  Examples of the combination of graphs to be superimposed include a combination of sample measurement and measurement related to the sample measurement. The sample measurement graph is displayed based on the graph data of the reaction time course created based on the test data.

  In addition, as the measurement graph related to the sample measurement, any graph can be selected from the graph data of the reaction time course created based on the various preliminary measurement data. The combination of graphs to be overlaid can be changed after the graph is displayed on the display unit 42 by an input from the operation unit 80, for example.

  The graph indicating the reaction time course displayed on the display unit 42 is displayed, for example, in order from left to right and from top to bottom in ascending order of item numbers.

  Each of the graphs includes a curve 102 indicating a reaction time course created based on preliminary measurement data corresponding to this measurement, in addition to a curve 101 showing a reaction time course created based on the test data. ˜104 are superimposed and displayed. A curve 102 indicating the reaction time course of the preliminary measurement is a calibration measurement, a curve 103 is a reagent blank measurement, and a curve 104 is a sample blank measurement.

  The arithmetic processing described above is performed over all items of measurement. Based on the calculation results, graph data including a reaction time course for sample measurement, a reaction time course for standard sample measurement, and a reaction time course for reagent blank measurement are created for all items. By outputting this graph data to the display unit 42, a plurality of graphs are displayed side by side on the display unit 42.

  In response to an instruction from the graph classification unit 54, the search unit 52 acquires graph data of a plurality of reaction time courses from the data storage unit 33 and / or the classification graph storage unit 55. Further, the acquired plurality of graph data is output to the graph classification unit 54. Graph data of a plurality of reaction time courses are grouped in the graph classification unit 54.

  The classification graph storage unit 55 stores group data that is graph data of reaction time courses grouped as described above. This group data is created, for example, by grouping various preliminary measurements performed prior to sample measurement for each item so as to correspond to this sample measurement.

  Based on the above processing, graph data of reaction time courses of various preliminary measurements are grouped in advance for each classification condition and stored in the storage unit 90, for example. Thereby, when it is desired to refer to the information of the preliminary measurement at the time of the sample measurement, it can be quickly displayed on the display unit 42. For example, when a graph showing the reaction time course created based on the test data is displayed in real time on the display unit 42, the reaction time course created based on the preliminary measurement data is shown. The graph can be recalled quickly.

  Thereby, for example, during the sample measurement, the graph data corresponding to the sample measurement and the graph data corresponding to the preliminary measurement can be quickly called up and displayed in a superimposed manner.

  In addition to displaying a list of graphs showing the reaction time course and the like, the display unit 42 also displays operation buttons for causing the system control unit 70 to control each unit. In addition, by selecting a graph indicating the reaction time course, it is possible to select an item corresponding to the graph.

  As the operation buttons, for example, a reexamination button for instructing reexamination of the selected item, an export button for instructing external output of error data in the selected item, and an instruction for creating a report of error data in the selected item Examples include a report button.

[Operation of automatic analyzer]
Next, operation | movement of the automatic analyzer 10 of this embodiment is demonstrated with reference to FIGS. In this embodiment, a case will be described in which it is determined that the detected abnormality is caused by a substance derived from the specimen.

  FIG. 4 is a flowchart showing an example of processing for displaying a list of graphs showing reaction time courses when it is determined that the detected abnormality is caused by the substance derived from the specimen. In this processing, FIGS. 1 to 3 and FIGS.

  As shown in FIG. 4, the classification processing unit 50 groups the graph data of the reaction time course and displays the grouped data on the display unit 42. Specifically, after the sample measurement is completed, the reaction time course graph data is grouped according to the detection signal of the abnormal reaction being input to the classification processing unit 50, and this is output to the display unit 42. Is done. Prior to the sample measurement, a preliminary measurement is performed in advance. In one sample measurement and one preliminary measurement, a plurality of items are performed.

  First, preliminary measurement is performed on all items in the analysis unit 24, and the measurement result is transmitted to the data processing unit 30. The graph creation unit 32 processes the received measurement result of the preliminary measurement and creates graph data of the reaction time course (step S001).

  Based on the measurement results of the measurement of all items performed in this measurement, graph data of this reaction time course is created and stored in the data storage unit 33. In the preliminary measurement, the reagent blank measurement and the standard sample measurement are selected from those described above.

  Next, sample measurement is performed on all items in the analysis unit 24, and the measurement result is output to the data processing unit 30. The graph creation unit 32 processes the received measurement result of the sample measurement and creates graph data of the reaction time course (step S002).

  The graph data indicating the reaction time course is created over all items and stored in the data storage unit 33. During the sample measurement, the abnormal data detection unit 60 detects an abnormal reaction. Abnormal reaction detection is performed, for example, by determining whether the measured value is within a range of values set in advance for the item.

  When the sample measurement is completed, the system control unit 70 displays a list of analysis results on the display unit 42 (step S003). The displayed analysis result includes the analysis result generated by the data processing unit 30 and the analysis result determined to be an abnormal reaction by the abnormal data detection unit 60 based on the analysis result.

  FIG. 5 is a table showing an example of the analysis result list 34. As shown in FIG. 5, in this list 34, the request time, the measurement time, the items A to D, and the presence or absence of errors in the items A to D are shown corresponding to the patient ID. Here, the patient ID indicates which patient the sample to be measured belongs to. The requested time is the time when this measurement is requested, and the measured time is the time when the measurement is started. Items A to D show the measurement of a plurality of items made in one measurement.

  Referring to the list 34 of the analysis results, an error number “A01” indicating that the measurement result of the item C of the patient ID “12348” is an error is displayed. The error number is given a number and a symbol according to the type of error.

  In the list 34 displayed on the display unit 42, the system control unit 70 highlights the cells 34A constituting the column of the sample in which the error is detected (step S004).

  This highlighting is performed, for example, by coloring the cells constituting the column of the patient ID “12348”. Thus, the operator can confirm that the measurement result of the sample with the patient ID “12348” has an error. The error with the error number “A01” is output when the final absorbance value of the sample measurement is outside the predetermined range in the first reaction.

  Next, the system control unit 70 displays a list of sample measurement graphs corresponding to the patient ID “12348” grouped under a predetermined condition on the display unit 42 (steps S005 to S007).

  FIG. 6 shows a list of graphs showing reaction time courses. In this figure, the measurement results of all items in the sample in which the error is detected are acquired and shown as a list of graphs. As shown in FIG. 6, the display unit 42 displays a plurality of graphs created for each item of the patient ID “12348”.

  On the display unit 42, a plurality of graphs 33A to 33F are displayed in the order of items A to F, arranged from left to right and from top to bottom with a predetermined interval. In addition, check boxes 35A to 35F for selecting the graph are displayed in the vicinity of each graph.

  The graph list 43 includes buttons for instructing the analysis unit 24, the data processing unit 30, and the like as necessary. This button includes, for example, a re-examination button 36A for instructing re-inspection of a selected item, a report button 36B for moving to a report creation screen, an export button 36C for externally outputting the measurement result of the selected item, and FIG. Examples include a result list button 36D for displaying a list of analysis results shown, a display group button 36E for changing a display group to be displayed in the graph list, and the like.

  By checking a check box and selecting at least a desired item, a desired operation can be performed on the desired item by pressing a desired button. For example, by inputting a check into the check box 35C corresponding to the item C in which the error is detected and pressing the retest button 36A, the retest order is made for the item C.

  For example, when an error is automatically detected for item C and re-examination is automatically ordered, even if there is an order for re-examination for item C by the re-examination button 36A, the order is automatically canceled. Can do. In this case, for example, it is possible to prevent a check from being entered in the check box 35C.

  The plurality of graphs displayed on the display unit 42 are grouped under a predetermined condition. Grouping is performed in the graph classification unit 54. When the graph classification unit 54 receives the error detection signal (step S005), the graph classification unit 54 groups the graphs created for each item under the condition associated with the error type (step S006). Grouping is performed based on the classification conditions stored in the classification condition storage unit 53.

  When it is determined that the detected abnormality is caused by the substance derived from the specimen, for example, the graph data of the reaction time courses of all items in the measurement result of the specimen are grouped according to the classification condition.

  In this case, the detected abnormality means that the absorbance of the sample measurement in the first reaction is higher than a predetermined threshold value, so the graph data of each reaction time course in the items A to F are grouped and displayed on the display unit 42. Listed. The group of graphs can be arbitrarily changed by the operator. Subgroups such as time and items can also be set.

  In the graph showing the reaction time course, the vertical axis represents the absolute value of absorbance and the horizontal axis represents time. Further, time T = 0 in this graph corresponds to the measurement time shown in FIG. The same applies to the following. The system control unit 70 displays a graph having at least a curve 101 indicating a reaction time course (absorbance time-series change) corresponding to the test data on the display unit 42 (step S007).

  Further, in this graph, a curve 102 indicating a reaction time course corresponding to the preliminary measurement data is displayed in an overlapping manner. Curves 102 to 104 show reaction time courses corresponding to the preliminary measurement data. Curve 102 corresponds to reagent blank data. A curve 103 corresponds to the calibration data. Curve 104 corresponds to accuracy control data.

  By superimposing and displaying the curves 102 to 104 indicating the reaction time course of the preliminary measurement on the curve 101 indicating the reaction time course corresponding to the test data, it is possible to easily compare the two. Thereby, the determination of abnormal reaction can be performed easily and quickly.

  The combination of curves displayed in the graph is set in advance, but the combination can be arbitrarily changed by an operation input by the operator even during the display of the graph. Thereby, for example, all the curves are selected or individually selected by the operation of the operator.

  Further, the display unit 42 further displays a link 37 to the result detail screen of each item. For example, the link 37 may be directly associated with a graph corresponding to each item, or may be displayed independently in the vicinity of the graph. By selecting this link 37, the operator can know the details of the measurement results for each item.

  The operator refers to the graphs 43A to 43F of the items A to F displayed on the display unit 42. Then, since the initial value of the absorbance of the first reaction of item A is high, the operator determines that an abnormal reaction is suspected in the sample measurement of item A. When the operator selects the item A graph by clicking with the mouse or the like based on the determination (step S008), a detailed screen 44 of the measurement result of the sample measurement as shown in FIG. 7 is displayed.

  In addition to the graph 45 indicating the reaction time course, the measurement result detail screen 44 displays a graph 46 indicating a calibration curve and detailed information 47 on the sample measurement and the preliminary measurement. In addition, various buttons such as an adjustment button 38A, an export button 38B, a report button 38C, and a calibration curve button 38D are displayed on the detail screen 44.

  The adjustment button 38A is a button used when adjusting the display items on the detailed screen 44. The export button 38B is a button used when outputting details of measurement results to the outside. The report button 38C is a button used when creating a report based on the details of the measurement result. The calibration curve button 38D is a button used when changing the display setting of the graph 46 on which a line indicating a calibration curve is displayed.

  The detailed measurement information 47 is also called raw measurement data. On the detailed screen 44, it is possible to display in real time also about the sample under measurement for which the reaction has not ended.

  The operator inputs a check into the check box 35A corresponding to the item A determined to be abnormal in the graph list 43, the detailed screen 44, etc., and presses the retest button 36A (step S009). As a result, the retesting of the item A for sample measurement is ordered.

  When the graph list 43 is displayed on the display unit 42, the operator selects a desired item and presses the report button 36B. Then, a report creation screen 48 as shown in FIG.

  The report creation screen 48 is configured so that a report can be created for each item. In addition to the information displayed on the detail screen 44, the report creation screen 48 includes a comment field 49 that allows an operator such as an inspection engineer to leave a memo. The report 71 created on the report creation screen 48 displays, for example, a graph 62 showing a reaction time course as shown in FIG. 9, a table 63 showing a part of raw data of measurement, and a comment 64 by an operator. Is done. The report 71 can be output externally or printed.

  The processing shown in the flowchart shown in FIG. 4 can be performed even before the end of sample measurement. Thereby, the operator can confirm an abnormal reaction even before the end of the sample measurement. As a result, a re-examination order or the like becomes possible at a timing at which it can be determined that the reaction is abnormal during measurement.

[Operation and effect of automatic analyzer]
Based on the detected error, the automatic analyzer 10 of this embodiment groups the test data corresponding to this error under a predetermined condition and outputs the grouped data to the display unit. Specifically, the classification processing unit 50 receives the error signal transmitted from the abnormal data detection unit 60 or the like, and groups the test data corresponding to the error signal under a predetermined condition. The classification processing unit 50 causes the display unit 42 to display each grouped test data as a list. The test data displayed on the display unit 42 is, for example, a graph having a curve indicating a reaction time course of sample measurement.

  In the conventional automatic analyzer, an error due to an abnormality in the absorbance value is output when the final absorbance value of the sample measurement is higher than a predetermined threshold value. That is, if the final value of the absorbance of the sample measurement was not abnormal, it was determined that the reaction was normal. That is, the occurrence of an abnormal reaction in which the reaction process is abnormal may be overlooked.

  If an error derived from the sample is detected in the sample measurement, the operator (labor engineer, etc.) opens a separate screen for all items, not just the item that caused the error, to confirm this error. There was something to do. However, this has been a very laborious task.

  On the other hand, when an error derived from the sample is detected in the sample measurement, the automatic analyzer 10 of this embodiment superimposes the reaction time courses of the sample measurement and the preliminary measurement of all items including the item in which the error is detected. List the indicated graph.

  Thereby, when a sample-derived error is detected in the sample measurement, the reaction time course of a plurality of items including the item in which the error is detected can be confirmed at a time. As a result, the operator can check whether there are any items suspected of abnormal reactions or items that need reexamination other than items determined to be errors.

  Further, in the conventional automatic analyzer, when an abnormality is detected, the operator manually saves error data including raw data of measurement data such as sample measurement and preliminary measurement of the corresponding item. The raw data of the measurement data is often stored by hard copy (screen shot or the like) of the image displayed on the display unit 42, and it has been troublesome to perform over a plurality of items.

  On the other hand, the automatic analyzer 10 of this embodiment displays a list of graphs on the display unit 42 that superimpose the reaction time courses of the sample measurement and the preliminary measurement of all items including the item in which the error is detected. Furthermore, the graph displayed in a list can be selected. Thus, the operator can select a graph and press a button displayed on the display unit 42 to perform a re-examination order, data output, report creation, and the like.

  As a result, in the measurement of the same sample, re-examination judgment can be made quickly and re-examination order can be made quick. In addition, a re-examination order for a plurality of items can be performed simultaneously on one screen. Furthermore, it is possible to easily save error data of a desired item, create a report, and print. In addition, error data for a plurality of items, report creation, and printing can be performed simultaneously on one screen.

  As described above, according to the automatic analyzer 10 of this embodiment, the graph showing the reaction time course in an arbitrary group is displayed on the display unit 42, so that the measurement result data can be confirmed and the report can be created・ Can be saved easily and quickly. In addition, since the re-examination order can be made on the screen on which the graph showing the reaction time course is displayed as a list, the re-examination order can be made while confirming the data such as the reaction time course. This helps with a more accurate re-examination order.

<Second Embodiment>
[Automatic analyzer]
The overall configuration and detailed configuration of the automatic analyzer 10 of this embodiment are the same as those of the automatic analyzer 10 of the first embodiment.

  In the automatic analyzer 10 of this embodiment, when the abnormality detected in the abnormality data detection unit 60 or the like is caused by the device, the graph data of the reaction time course is grouped according to the type of abnormality and displayed on the display unit 42 as a list. To do.

  The abnormal data detection unit 60 detects abnormal data by analyzing the measurement result of the sample measurement, for example. The detection of abnormal data is performed, for example, when the absorbance value increases or decreases abnormally during absorbance measurement. The abnormal data detection unit 60 designates the reaction vessel 51 that has detected the abnormal data. This may be the case where the rate of increase or decrease in absorbance is not within a predetermined range or when a predetermined threshold is exceeded.

  Further, the abnormal data detection unit 60 can also take a statistic of occurrence of abnormal data in a predetermined period and designate a device suspected of causing abnormal data as an abnormal device. The abnormal apparatus can be applied to, for example, the reaction vessel 51, a dispensing probe, and the like.

  Further, the abnormal data detection unit 60 takes statistics of occurrence of abnormal data in a predetermined period. When abnormal data is concentrated at a predetermined time in this statistic, this time can also be designated as an abnormal time when the cause of the abnormal data is suspected.

  The classification processing unit 50 receives the device information output from the abnormal data detection unit 60, and classifies the graph data created based on the measurement performed using the device. Examples of the apparatus include the reaction vessel 51 and the probes used for dispensing.

  Further, the classification processing unit 50 receives the time information output from the abnormal data detection unit 60, and groups the graph data of the reaction time course created based on the measurement performed at that time.

  In the classification processing unit 50, the graph data of the reaction time courses grouped is output to the display unit 42, and is displayed side by side on the display unit 42 in the same manner as shown in FIG.

  In the case of grouping based on reaction vessels, for example, they are displayed in order of measurement start time. In this case, “measurement start time” or the like is displayed in the “item” portion of the graph shown in FIG. Moreover, when grouping based on start time, it arranges and displays in order of patient ID of a sample, for example. In this case, “patient ID” or the like is displayed in the “item” portion of the graph shown in FIG.

  The classification condition storage unit 53 stores classification conditions in advance. For example, depending on the type, installation position, etc. of the reaction container 51, either a process for outputting measurement data for sample measurement and preliminary measurement or a process for outputting measurement data for sample measurement is associated. Further, for example, depending on the time at which an abnormality is detected, one of processing for outputting measurement data for sample measurement and preliminary measurement and processing for outputting measurement data for sample measurement are associated.

  The classification type is, for example, a grouping type. The type of grouping includes, for example, for each item, for each measurement start time, for each reaction container 51, for each used dispensing probe, and the like. Grouping is performed, for example, for the same classification type.

  This classification type may be automatically determined by the classification processing unit 50, or the operator may arbitrarily set a plurality of groups as shown in FIG. A plurality of arbitrarily set groups may be stored in the classification condition storage unit 53, the storage unit 90, or the like.

  FIG. 10 shows a group setting screen 56. As shown in FIG. 10, any one of patient ID, item, time, or reaction container is set on the setting screen 56, and grouping is performed based on this.

  The operator can arbitrarily set conditions for groups 5 to 16. Here, the time refers to, for example, a measurement start time.

[Operation of automatic analyzer]
Next, operation | movement of the automatic analyzer 10 of this embodiment is demonstrated with reference to FIGS. In this embodiment, a case will be described in which it is determined that the detected abnormality is caused by the apparatus.

  FIG. 11 is a flowchart illustrating an example of a process of displaying a list of graphs indicating reaction time courses on the display unit 42 when it is determined that the detected abnormality is caused by the apparatus.

  As shown in FIG. 11, after completion of the sample measurement, information on the reaction container 51 designated as abnormal is input to the classification processing unit 50. With this as a trigger, the reaction time course graph data is grouped and displayed on the display unit 42.

  First, preliminary measurement is performed on all items in the analysis unit 24, and the measurement result is transmitted to the data processing unit 30. The graph creation unit 32 processes the received measurement result of the preliminary measurement and creates graph data of the reaction time course (step S011).

  Based on the measurement results of the measurement of all items performed in this measurement, graph data of this reaction time course is created and stored in the data storage unit 33. In the preliminary measurement, the reagent blank measurement and the standard sample measurement are performed among those described above.

  Next, sample measurement is performed on all items in the analysis unit 24, and the measurement result is output to the data processing unit 30. The graph creation unit 32 processes the received measurement result of the sample measurement and creates graph data of the reaction time course (step S012).

  The graph data indicating the reaction time course is created over all items and stored in the data storage unit 33. During the sample measurement, the abnormal data detection unit 60 detects an abnormal reaction. Based on the detection of the abnormal data, the reaction vessel 51 suspected of being abnormal is designated.

  The designation of the reaction vessel 51 is performed, for example, by being identified by a barcode attached to the reaction vessel 51.

  The designation of the reaction vessel 51 suspected of being abnormal is transmitted to the graph classification unit 54 as an error signal. Upon receipt of the error signal, the graph classification unit 54 determines that there is a suspicion that there is an abnormality in the designated reaction vessel 51, and groups the measurement results of the measurements performed in the designated reaction vessel 51 under a predetermined condition ( Steps S013 to S015). In this grouping, for example, measurement results for the past 20 measurements retroactive from the current measurement are grouped.

  Next, graph data of the reaction time course is respectively created by the graph creation unit 32 from the grouped measurement results, and a plurality of created graph data is output to the display unit 42 to display the graph of the reaction time course. A list is displayed on the unit 42 (step S016).

  FIG. 12 shows a list of graphs showing reaction time courses. In this figure, a plurality of past measurement results in the reaction container 51 in which the specimen in which the error is detected is acquired and shown as a list of graphs.

  As shown in FIG. 12, when the sample measurement is completed, a graph list 74 is displayed on the display unit 42. The graph list 74 displays a plurality of graphs 73A to 73F arranged in a staggered pattern from left to right and from top to bottom. Also, check boxes 75A to 75F for selecting the graph are displayed in the vicinity of each graph.

  The graph list 74 includes buttons for instructing the analysis unit 24, the data processing unit 30, and the like as necessary. This button includes, for example, a reexamination button 76A for instructing reexamination of the selected item, a report button 76B for moving to the report creation screen, an export button 76C for outputting the measurement result of the selected item to the outside, and FIG. Examples include a result list button 76D for displaying a list of the analysis results shown, a display group button 76E for changing a display group to be displayed in the graph list, and the like.

  Graphs 73A to 73F are all graphs showing reaction time courses. The curve of the reaction time course shown in each graph is created based on the measurement results obtained using the same reaction vessel 51.

  The plurality of graphs 73A to 73F may be arranged with other parameters in order to narrow down the presence or absence of abnormality in the reaction vessel 51. This parameter is, for example, a specimen, an item, or the like. That is, the graphs 73 </ b> A to 73 </ b> F may be created based on measurement results measured using the same reaction container 51 in the same group of specimens and items.

  The plurality of graphs 73A to 73F are arranged in chronological order, with the graph 73A being the oldest measurement data and the graph 73F being the newest measurement data. That is, the plurality of graphs 73A to 73F are obtained by retroactively displaying five measurement graphs from the graph 73F created based on the measurement result in which the abnormality of the reaction vessel 51 is detected. In this case, a graph for five measurements is displayed retroactively, but for example, a graph for 20 measurements can be displayed retrospectively.

  When the curves of the reaction time courses shown in the graphs 73A to 73F are compared, the spike wave 120 is confirmed in the curves of the reaction time course shown in the graph 73C. Also in the graphs 73D, 73E, and 73F, the spike wave 120 is confirmed on the curve of the reaction time course shown in each graph.

  The spike wave 120 is a characteristic waveform generated in the reaction time course curve when the reaction vessel 51 is damaged. If the reaction vessel 51 has a flaw, the flaw causes scattering, reflection, etc., so that the light reaching the light receiving portion is attenuated and the absorbance shows a strong peak.

  The abnormal data detection unit 60 calculates the change rate or change value of the measurement data at every predetermined interval, and compares it with the value of the allowable range of change rate or change amount of the measurement data calculated at every predetermined interval. In this case, when the value is out of the allowable range, it is determined as abnormal data, and an abnormality is detected.

  In the graphs 73C, 73D, 73E, and 73F, the spike wave 120 was confirmed on the curve of the reaction time course shown in each graph. This means that the specified reaction vessel 51 is damaged at the time between the time when the measurement corresponding to the graph 73B is performed and the time when the measurement corresponding to the graph 73C is performed. Can do. Thereby, the timing at which an abnormality has occurred in the reaction vessel 51 can be known.

  This process can also be performed in the same manner when the time when there was an abnormal reaction is specified by the abnormal data detection unit 60. Specifically, the graph data of the reaction time course created based on the result of measurement performed for 10 minutes before and after the measurement result measured at this time is acquired. Further, these graph data are grouped and displayed on the display unit 42. Thereby, it is possible to easily confirm whether or not an abnormality has occurred in the reaction vessels 51 other than the specific reaction vessel 51. In other words, if an abnormality has occurred, it is possible to identify under what conditions it is occurring, which can be used for troubleshooting.

  Further, in the automatic analyzer of the first embodiment, the display group can be set to “reaction vessel” by pressing the display group button 36E of the graph list 43 displayed on the display unit 42. Therefore, the reaction vessel 51 suspected of being abnormal is specified, and graph data indicating the reaction time course corresponding to each measurement is created from the measurement results for the past 20 measurements of the reaction vessel 51. Based on these graph data, a graph of the reaction time course is displayed on the display unit 42 as a list. By comparing the curves of the reaction time courses for 20 measurements in time series, the timing at which an abnormality has occurred in the reaction vessel 51 can be known.

  Operations other than those described above of the automatic analyzer 10 of this embodiment can be performed in the same manner as the operations of the automatic analyzer of the first embodiment.

[Operation and effect of automatic analyzer]
The automatic analyzer according to this embodiment is configured in the same manner as the automatic analyzer according to the first embodiment, and further groups measurement results based on abnormality data originating from the apparatus. As a result, the same effect as the automatic analyzer of the first embodiment can be obtained, and the timing at which an abnormality has occurred in the apparatus can be known.

  In addition, since the measurement results are grouped based on the time when the abnormal data occurs, it is possible to easily check whether an abnormality has occurred other than a specific device. In other words, if an abnormality has occurred, it is possible to identify under what conditions it is occurring, which can be used for troubleshooting.

  Although several embodiments of the present invention have been described, these embodiments are presented by way of example and are not intended to limit the scope of the invention. These embodiments can be implemented in various other forms, and various omissions, replacements, and changes can be made without departing from the spirit of the invention. These embodiments and their modifications are included in the scope and gist of the invention, and are also included in the invention described in the claims and the equivalents thereof.

DESCRIPTION OF SYMBOLS 1 Reagent rack 2 1st reagent storage 3 2nd reagent storage 4 Reagent container 5 Reaction storage 6 Disc sampler 7 Sample dispensing probe 8 1st reagent dispensing probe 9 2nd reagent dispensing probe 10 Automatic analyzer 11 Agitation unit 12 Photometry Unit 13 Cleaning unit 14 Arm 24 Analysis unit 25 Analysis control unit 26 Mechanism unit 27 Control unit 30 Data processing unit 31 Calculation unit 32 Graph creation unit 33 Data storage unit 40 Output unit 41 Printing unit 42 Display unit 50 Classification processing unit 51 Reaction vessel 52 Search Unit 53 Classification Condition Storage Unit 54 Graph Classification Unit 55 Classification Graph Storage Unit 60 Abnormal Data Detection Unit 61 Sample Container 70 System Control Unit 80 Operation Unit 90 Storage Unit

Claims (5)

An analyzer that dispenses each liquid of the sample and reagent into a reaction vessel to generate a mixed solution, and measures the components of the mixed solution;
In response to the measurement result output from the analysis unit, the processing unit calculates the concentration of the specific substance in the mixed solution, and creates and processes reaction curve data based on the concentration; and
In response to the measurement result output from the analysis unit, an abnormality detection unit that detects the presence or absence of an abnormality,
In response to detection of an abnormality in the abnormality detection unit, a classification processing unit that groups the data of the reaction curve according to the type of the cause of the abnormality,
A display unit that displays a list of the graphs including the grouped reaction curves;
Comprising
Automatic analyzer. The reaction curve is a reaction time course showing a time series change of the concentration,
The automatic analyzer according to claim 1. The display unit receives the measurement result of the mixed liquid containing a patient sample as a sample, the test curve prepared and processed, and the sample to improve the measurement accuracy and measurement accuracy of the measurement result. The graph is displayed, superimposed on at least one preliminary measurement curve, which has been created and processed in response to the measurement result of the preliminary measurement measured prior to the measurement,
It is characterized by
The automatic analyzer according to claim 1 or 2. The processing unit creates the reaction curve data from the measurement results of the measurement of a plurality of items performed on the mixed solution, and the classification processing unit determines that the type of the abnormality factor is the mixed solution. Grouping the data of the reaction curves that have been created and processed based on all the measurement results of the measurement of a plurality of items performed on the mixed solution,
The automatic analyzer according to any one of claims 1 to 3, wherein: The processing unit creates the reaction curve from the measurement results of the measurement of a plurality of items performed on the mixed solution, respectively, and the classification processing unit causes the type of the abnormality factor to be attributed to the reaction container. Grouping the data of the prepared reaction curves based on the measurement results within a predetermined range among the plurality of measurements performed using the reaction container,
The automatic analyzer according to any one of claims 1 to 3, wherein:

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