JP2010078477A - Automatic analyzer and display method of analysis accuracy control - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To easily and rapidly specify the cause of a reduction of analysis accuracy without a need of complicated work. <P>SOLUTION: The display method of analysis accuracy control includes steps of: obtaining the analysis results concerning an accuracy control sample of a plurality of analysis items (step S161); deriving accuracy control values using thereof (step S162); generating a two dimensional graph 15 on which the accuracy control values are plotted (step S163); and displaying an accuracy control result confirmation screen (analysis result) 10 containing thereof (step S165). The status information controlled in a status control table 422 is also displayed on the status confirmation screen (all items) 20 (step S171). The accuracy control result confirmation screen (analysis result) 10 includes a screen switching button for the display instruction input of the status confirmation screen (all items) 20. The status confirmation screen (all items) 20 displays the status information by corresponding to the analysis items. <P>COPYRIGHT: (C)2010,JPO&amp;INPIT

Description

  The present invention relates to an automatic analyzer and an analysis accuracy management display method, for example, an automatic analysis device that performs biochemical analysis and immunological analysis, and an analysis accuracy management display method thereof.

  Usually, for example, an automatic analyzer that automatically performs biochemical analysis and immunological analysis requires a certain level of analysis accuracy in order to accurately diagnose a subject such as a human or animal. However, this analysis accuracy may be lowered due to, for example, a change in reagent state or apparatus state, or a measurement environment. For this reason, the user who uses the automatic analyzer is required to quickly identify the cause of the reduced analysis accuracy and improve it.

  For example, in Patent Document 1 shown below, the daily analysis accuracy management results are managed by the X-R control chart method, and when a change occurs in the reagent state, the apparatus state, etc. (hereinafter simply referred to as measurement conditions), An automatic analyzer that records contents as data together with date information is disclosed. In the case where a decrease in analysis accuracy is later found in this automatic analyzer, the user specifies the date on which the analysis accuracy has decreased from the X-R control chart, and from the contents of changes in measurement conditions recorded in association with this day It is possible to identify the cause of the reduced analysis accuracy.

  In Patent Document 2 shown below, an analysis process is performed on a quality control sample (hereinafter referred to as a quality control sample), and an analysis result obtained thereby does not satisfy a preset reference value. In some cases, an automatic analyzer is disclosed for easily performing remeasurement of calibration and remeasurement of a quality control sample.

JP-A-6-281656 JP 2007-78375 A

  Usually, in an analysis process using an automatic analyzer, an analysis process is performed on a quality control sample as a preliminary preparation, and the analysis result falls within a preset tolerance range of analysis accuracy (hereinafter simply referred to as an acceptable range). The routine work in the analysis process was started after it was confirmed that satisfactory analysis accuracy was obtained depending on whether it was included or not. Further, when the analysis result for the quality control sample is out of the allowable range, it is necessary to investigate the cause and to perform the routine work after improving the result.

  However, in Patent Document 1 described above, an event that causes a decrease in accuracy that occurs on the day when the analysis accuracy is reduced (a change in reagent state, apparatus state, etc.) can be specified, but there are a plurality of specified events. Since it is necessary to individually investigate which is the cause, it is impossible to quickly identify the cause of the actual decrease in analysis accuracy, and there is a problem that it takes time and effort.

  Furthermore, in the above-mentioned Patent Document 2, when the analysis result for the quality control sample does not satisfy the reference value, it is possible to recommend the calibration and the remeasurement for the quality control sample and allow the user to easily execute this. Since there is no configuration for investigating the cause of the decrease in analysis accuracy, the above-mentioned problems cannot be solved.

  Therefore, the present invention has been made in view of the above problems, and an automatic analyzer and an analysis that can easily and quickly specify the cause of a decrease in analysis accuracy without requiring complicated work. An object is to provide a quality control display method.

  In order to achieve this object, the automatic analyzer according to the present invention includes an analysis result acquisition means for acquiring an analysis result for an accuracy control sample for each of a plurality of analysis items, and an accuracy control value indicating the analysis accuracy for the analysis item. One or more for each analysis item, a quality control value deriving means for deriving the data using the analysis result, a graph generating means for generating a graph in which the quality control value is plotted, a graph display means for displaying the graph Status information management means for managing status information classified into items, and status display means for displaying status information associated with each of one or more analysis items, wherein the graph display means includes the status information A first screen switching button for inputting an information display instruction together with the graph; If the display instruction using the first screen switching button is input, and characterized by displaying in association with the status information to the analysis item.

  The automatic analyzer according to the present invention includes an analysis item selection means for selecting one or more analysis items corresponding to the quality control values plotted on the graph, and the status display means is selected by the analysis item selection means. The status information associated with the analyzed item is displayed.

  In the above-described automatic analyzer according to the present invention, the graph generation means is the graph in which the analysis accuracy tolerance is set for each analysis item, and the tolerances for all analysis items overlap each other. The quality control value is plotted on the graph set to be displayed in a region, and the status display means associates status information associated with the analysis item corresponding to the quality control value not included in the allowable range Is displayed.

  In the above-described automatic analyzer according to the present invention, the item includes at least one of analysis parameters, quality control sample information, calibration information, and sample information.

  In the above-described automatic analyzer according to the present invention, the status display means displays status information in which the accuracy management value of the corresponding analysis item is not included in the allowable range, and the accuracy management value of the corresponding analysis item is in the allowable range. It is characterized by being displayed with emphasis over the status information included in.

  In the above-described automatic analyzer according to the present invention, the status information displayed by the status display means includes a common item specifying means for specifying an item including status information having the same value between analysis items, and the common item specifying means includes: Common status display means for displaying status information belonging to the identified item, and the status display means for inputting a display instruction for status information belonging to an item including status information having the same value among the analysis items When the second screen switching button is displayed together with the status information and the common status display means receives a display instruction using the second screen switching button, the status information belonging to the item specified by the common item specifying means Is displayed.

  In the above-described automatic analyzer according to the present invention, the common status display means displays a third screen switching button for inputting a display instruction for causing the status display means to display the status information together with the status information, and the status The display means displays the status information when a display instruction is input using the third screen switching button.

  The analysis accuracy management display method according to the present invention includes an analysis result acquisition step for acquiring an analysis result for an accuracy control sample for each of a plurality of analysis items, and an accuracy control value indicating the analysis accuracy for the analysis item. Categorizing into one or more items for each analysis item, a quality control value deriving step derived using the method, a graph generation step for generating a graph in which the quality control values are plotted, a graph display step for displaying the graph A status information management step for managing the status information displayed, and a status display step for displaying the status information associated with each of the one or more analysis items, wherein the graph generation step includes a display instruction for the status information A first screen switching button for inputting the Status display step, if the display instruction using the first screen switching button is input, and characterized by displaying in association with the status information to the analysis item.

  The analysis accuracy management display method according to the present invention described above includes an analysis item selection step for selecting one or more analysis items corresponding to the accuracy control values plotted on the graph, and the status display step includes the analysis item selection step. The status information associated with the analysis item selected in is displayed.

  In the analysis accuracy management display method according to the present invention described above, the graph generation step is the graph in which the analysis accuracy tolerance range is set for each analysis item, and each tolerance range for all analysis items is mutually equal. The quality control value is plotted on the graph set to be displayed in the overlapping region, and the status display step is associated with the analysis item corresponding to the quality control value not included in the allowable range It is characterized by displaying status information.

  The analysis accuracy management display method according to the present invention described above is characterized in that the item includes at least one of an analysis parameter, accuracy control sample information, calibration information, and sample information.

  In the analysis accuracy management display method according to the present invention described above, the status display step includes status information in which the accuracy management value of the corresponding analysis item is not included in the allowable range, and the accuracy management value of the corresponding analysis item is the allowable value. It is characterized by being displayed with emphasis over the status information included in the range.

  The analysis accuracy management display method according to the present invention described above includes a common item specifying step for specifying an item including status information having an equal value between analysis items, among the status information displayed by the status display means, and the common item specifying A common status display step for displaying status information belonging to the item specified by the means, wherein the status display step inputs an instruction to display status information belonging to the item including status information having the same value among the analysis items A second screen switching button is displayed together with the status information, and the common status display step belongs to the item specified by the common item specifying means when a display instruction is input using the second screen switching button It is characterized by displaying status information.

  In the analysis accuracy management display method according to the present invention described above, the common status display step displays a third screen switching button for inputting a display instruction for displaying the status information together with the status information, and the status display step includes When the display instruction is input using the third screen switching button, the status information is displayed.

  According to the present invention, it is possible to display an accuracy management value indicating the analysis accuracy of each of a plurality of analysis items in one graph, and status information associated with one or more analysis items is displayed for each item. The display can be easily switched using the screen switching button displayed with the graph, reducing the analysis accuracy without requiring complicated work. Therefore, it is possible to realize an automatic analyzer and an analysis accuracy management display method that can easily and quickly identify the cause according to the status information displayed in association with the analysis item.

  Hereinafter, the best mode for carrying out the present invention will be described in detail with reference to the drawings. In addition, this invention is not limited by the following embodiment. Moreover, in the following description, each figure has shown only the shape, the magnitude | size, and positional relationship so that the content of this invention can be understood, Therefore, this invention was illustrated in each figure. It is not limited to only the shape, size, and positional relationship.

<Embodiment 1>
Hereinafter, an automatic analyzer 1000 according to Embodiment 1 of the present invention will be described in detail with reference to the drawings.

(Automatic analyzer)
FIG. 1 is a schematic diagram showing a schematic configuration of an automatic analyzer 1000 according to the present embodiment. As shown in FIG. 1, an automatic analyzer 1000 stocks a main unit 100 for automatically performing measurement on various analysis items, a sample supplied to the main unit 100, and a cuvette C described later. And a control terminal 400 for executing control of processes and operations for the main unit 100 and the subunit 300, analysis of input measurement results, and the like. The upper surface 100A of the main unit 100, which is an analysis execution surface, is appropriately covered with, for example, an openable / closable cover.

  As shown in FIG. 1, the subunit 300 includes, for example, a sample rack 301 that can hold one or more sample containers 302 in which a liquid sample is placed, and a rack that can store one or more sample racks 301. A set unit 310 and a rack collection unit 320 that can store one or more sample racks 301 holding sample containers 302 containing analyzed samples are mounted.

  In the above, the sample rack 301 stored in the rack set unit 310 is transported on the transport path 330 shown in FIG. 1 by a transport mechanism (not shown) mounted on the subunit 300, and then stored in the rack recovery unit 320. The At this time, the sample rack 301 is temporarily stopped at the sample collection position 114 on the transport path 330, and the sample is collected from the sample container 302 that is appropriately held using a sample dispensing unit 110 described later. However, the sample rack 301 holding the sample container 302 containing the sample that needs to be retested is once branched from the transport path 330 to the retest path 340, and the sample is separated again at the retest sample collection position 115. After that, it returns to the transport path 330 again and is accommodated in the rack collection unit 320.

  Similarly, as shown in FIG. 1, the main unit 100 includes, for example, a sample dispensing unit 110, a reaction tank 120, a sample probe cleaning unit 130, an interrupt sample unit 140, an electrolyte measurement unit 150, First stirring unit 160, first reagent dispensing unit 170, first reagent cold box 180, first reagent probe cleaning unit 190, light source lamp set 210 and light receiving unit 211, and second reagent dispensing unit 220 And the 2nd reagent cool box 230, the 2nd reagent probe washing | cleaning unit 240, the 2nd stirring unit 250, and the cuvette washing | cleaning unit 260 are mounted.

  Here, an example of the cuvette C used in the present embodiment will be described with reference to the drawings. 2A is a perspective view showing the shape of the cuvette C, and FIG. 2B is a perspective view showing the shape of a cuvette C2 that is a modification of the cuvette C. FIG. As shown in FIG. 2A, the cuvette C used in the present embodiment is a cylindrical container having an opening CA formed in the upper part. Such a cuvette C is formed using a transparent material such as hard glass, plastic, or quartz. At the time of measurement, the cuvette C side surface is irradiated with light having a predetermined wavelength output from the light source lamp set 210. The measurement for each analysis item is performed by receiving the light transmitted through the cuvette C by the light receiving unit 211 and measuring the light intensity. Further, as a modification of the cuvette C according to the present embodiment, for example, as shown in FIG. 2B, a substantially quadrangular prism shape in which the corner of the opening CA2 formed in the upper portion has a slightly rounded shape. The container. However, the present invention is not limited to these shapes and can be variously modified.

  As shown in FIG. 3, the cuvette C as described above is set in each of a plurality of cuvette holders 122 b arranged circumferentially along the inner periphery of the reaction tank 120. FIG. 3 is a top view showing a layout example of a plurality of cuvette holders 122b arranged in the reaction tank 120. FIG. Each cuvette holder 122 b is provided with a hole for transmitting light from the light source lamp set 210 to the light receiving unit 211. Here, a schematic configuration of the light source lamp set 210 and the light receiving unit 211 and the cuvette holder 122b disposed therebetween will be described with reference to FIG. 4 is a cross-sectional view showing a schematic configuration of the A-A ′ cross section of FIG. 3.

  As shown in FIG. 4, the cuvette holder 122 b is provided with holes 122 y and 122 z for transmitting light from the light source lamp set 210 to the light receiving unit 211. Light of a predetermined wavelength output from the light source lamp set 210 enters the reaction liquid LC in the cuvette C from the hole 122x provided in the outer wall 122e of the reaction tank 120 through the hole 122y of the cuvette holder 122b, and is appropriately absorbed. After being attenuated, the light is emitted to the light receiving unit 211 through the hole 122z of the cuvette holder 122b. Therefore, the absorbance by the reaction liquid LC is, for example, the intensity of light when light having a predetermined wavelength output from the light source lamp set 210 is transmitted through the empty cuvette C and the intensity of light detected by the light receiving unit 211. It can be obtained by comparison.

  Further, at each position (122, 124, 125, 128, etc.) shown in FIG. 1, the target cuvette C is arranged by the cuvette holder 122b in the reaction tank 120 orbiting around the rotation shaft 121. In the cuvette C in the reaction tank 120, the sample dispensed using the sample dispensing unit 110, the first reagent dispensed using the first reagent dispensing unit 170, and the second reagent dispensing. The second reagent collected using the injection unit 220 is appropriately dispensed. In the present embodiment, quality control samples are also dispensed as appropriate. Thereby, a liquid mixture (or reaction liquid) corresponding to one or more analysis items or analysis accuracy management purposes is generated in the cuvette C in the reaction tank 120.

  The sample dispensing unit 110 pivots or moves up and down around the pivot 112 to move to the sample collection position 114, the re-examination sample collection position 115, or the interrupted sample collection position 141, and at this position, a predetermined sample is obtained. A sample is aspirated from the container 302 to be collected. Further, the dispensed specimen is dispensed by discharging it into the target cuvette C in the reaction tank 120 at the specimen dispensing position 122. On the other hand, the first reagent dispensing unit 170 moves to the first reagent sorting position 183 by pivoting or moving up and down around the pivot 172, and at this position, the first reagent bottle in the first reagent cooler 180 is moved. The first reagent is aspirated from 182 and dispensed. Further, the dispensed first reagent is dispensed by being discharged into the target cuvette C in the reaction tank 120 at the first reagent dispensing position 124. Similarly, the second reagent dispensing unit 220 moves to the second reagent sorting position 233 by pivoting or moving up and down around the pivot 222, and at this position, the second reagent in the second reagent cooler 230 is moved. The second reagent is dispensed from the bottle 232. Further, the dispensed second reagent is dispensed to the target cuvette C in the reaction tank 120 at the second reagent dispensing position 125.

  The mixed liquid generated in the cuvette C is appropriately stirred using, for example, the first stirring unit 160 or the second stirring unit 250. Thereby, the reaction liquid LC is generated in the cuvette C. Thereafter, the cuvette C is disposed between the light source lamp set 210 and the light receiving unit 211, and the intensity of light transmitted through the cuvette C and the reaction liquid LC is measured using these. The obtained measurement results are output to the control terminal 400 connected via, for example, the interface (I / F) 290, and are analyzed appropriately by the control terminal 400.

  In FIG. 1, a sample probe cleaning unit 130 is a unit for preventing carry-over between samples, and appropriately cleans the sample probe 123 in the sample dispensing unit 110 after dispensing. Further, the first reagent probe cleaning unit 190 and the second reagent probe cleaning unit 240 respectively carry between the reagents via the first reagent probe 173 or the second reagent probe 223, between the quality control samples, or between these. It is a unit for preventing contamination due to over, and the first reagent probe 173 or the second reagent probe 223 in the first reagent dispensing unit 170 or the second reagent dispensing unit 220 after dispensing is appropriately washed.

  The cuvette cleaning unit 260 is a unit for cleaning and reusing the used cuvette C. The first reagent cold storage 180 is a cold storage for storing the first reagent in a temperature-controlled environment, and a plurality of first reagent bottles arranged circumferentially along the inside of the outer circumference circle. 182 is stored. At the first reagent sorting position 183, the first reagent bottle 182 containing the target first reagent is arranged by the first reagent cold box 180 orbiting around the rotation shaft 181. Similarly, the second reagent cold box 230 is a cold box for storing the second reagent in a temperature-controlled environment, and a plurality of second reagent bottles 232 arranged circumferentially along the outer circumference. Is stored. At the second reagent sorting position 233, the second reagent bottle 232 containing the target second reagent is arranged by the second reagent cool box 230 orbiting around the rotation shaft 231.

  In the present embodiment, the first reagent refrigerating machine 180 also stores a management sample bottle 502 for storing an accuracy control sample used for managing analysis accuracy in addition to the first reagent. Therefore, the first reagent dispensing unit 170 sucks the quality control sample from the management sample bottle 502 in the first reagent cooler 180 at the first reagent dispensing position 183 periodically or as needed. And the dispensed quality control sample is dispensed by discharging it into the target cuvette C in the reaction tank 120 at the first reagent dispensing position 124. However, the present invention is not limited to this. For example, a quality control sample is placed in the sample container 301 in the same manner as the sample, and the sample dispensing unit 110 dispenses the sample at the sample dispensing position 114 on the transport path 330. It may be configured to dispense into the target cuvette C at 122.

  Further, the first reagent cooler 180 and the second reagent cooler 230 have a barcode reader 184 or 234 for reading a barcode attached to the outside of the first reagent bottle 182 or the second reagent bottle 232, respectively. The first reagent or the second reagent stored in each of the first reagent bottle 182 and the second reagent bottle 232 is managed by reading information such as the status described in the barcode. Similarly, a barcode is also affixed to the outside of the management sample bottle 502, and the quality control sample stored in the management sample bottle 502 is managed by reading this using the barcode reader 184. The

  In addition, the interrupt sample unit 140 is a unit for interrupting a series of analysis processes for a plurality of samples set in the rack set unit 310 and setting a sample to be analyzed first. The electrolyte measurement unit 150 is a unit for measuring the electrolyte contained in the specimen as necessary.

  Each unit operates under the control of the control terminal 400 connected externally via an interface (I / F) 290 provided in the main unit 100, for example. The control terminal 400 includes, for example, an interface (I / F) 410 for connecting to the interface 290 of the main unit 100 via a predetermined line 430, an analysis unit 402 for analyzing an input measurement result, and a user Input unit 403 for inputting various instructions and commands, display unit 404 for displaying various measurement / analysis results, sample status, measurement / analysis progress, etc. to the user, various control programs and input A storage unit 405 for storing measurement results, generated analysis results, and the like, and a control unit 401 for controlling the above-described units and controlling each unit in the main unit 100 and the subunit 300 are included. The control terminal 400 is connected to an external storage unit 420 that stores various data such as programs describing various operations executed by the control terminal 400 and analysis results. However, the present invention is not limited to this, and the external storage unit 420 such as an internal hard disk drive may be replaced with an internal storage unit.

(Analysis accuracy management)
Further, in the present embodiment, in order to keep the accuracy of the analysis result by the automatic analyzer 1000 above a certain level and to enable the user to quickly cope with this when the analysis accuracy is reduced, An analysis accuracy management operation is executed periodically or as needed, and an event that causes a decrease in analysis accuracy is recorded as data (status information) together with date and time information on the occurrence of the event.

  Events that cause a decrease in analysis accuracy include various parameters for analysis processing (hereinafter referred to as analysis parameters), accuracy control samples used for accuracy control, and various conditions when calibration is performed (hereinafter simply referred to as analysis parameters). (Referred to as calibration conditions) and changes in reagents used for analysis. In the following description, these events are collectively referred to as status change. However, the present embodiment is not limited to this, and all events that can be considered as factors that cause a decrease in analysis accuracy, such as changes in the measurement environment, can be targeted for this embodiment.

  Further, in the present embodiment, status information is classified into a plurality of items and managed in accordance with the location related to the status information, the attribute or type of the element, and the like. For example, the analysis parameter is managed as status information belonging to the item “analysis parameter”. In addition, various information related to the quality control sample (hereinafter referred to as quality control sample information) is managed as status information belonging to the item “quality control sample information”. Furthermore, various pieces of information relating to calibration are managed as status information belonging to the item “calibration information”. Furthermore, various information related to the reagent is managed as status information belonging to the item “reagent information”. Thus, by classifying and managing status information into a plurality of items, it is possible to more easily identify the cause (status change) that has reduced the analysis accuracy.

  In the present embodiment, status information classified and managed for each item as described above is further classified and managed for each analysis item. As a result, it is possible to easily identify which analysis item is affected by the status change.

  Further, in the present embodiment, the recorded status information is presented to the user as necessary, so that the user can easily identify the cause of the reduced analysis accuracy without requiring complicated work. Make it possible. Furthermore, presenting the recorded status information to the user as needed can also prompt the user to manage the device status, so that the maintenance and improvement of analysis accuracy can be more reliably realized. It becomes possible.

  In the present embodiment, for example, a case where an operation for managing analysis accuracy (analysis accuracy management operation) is executed when the automatic analyzer 1000 is started up will be described as an example. However, the present invention is not limited to this. For example, every time a predetermined number of samples are analyzed, the analysis accuracy management operation for all items to be analyzed (hereinafter simply referred to as analysis items) is executed. In addition, it is possible to classify the analysis items into several categories, and to perform various modifications such as configuring the analysis accuracy management operation periodically or as needed for each category. .

  In the present embodiment, an analysis process is performed on a plurality of types of quality control samples for each analysis item, and a value indicating the analysis accuracy of the automatic analyzer 1000 based on the analysis result obtained (the following accuracy) Equivalent to the control value). Further, the derived accuracy management value is graphed and presented to the user, thereby allowing the user to manage the analysis accuracy of the automatic analyzer 1000 regarding each analysis item. In the following, two types of quality control samples 1 (first quality control sample) and quality control sample 2 (second quality control sample) having different concentrations are used as a plurality of types of quality control samples. However, the present invention is not limited to this, and can be variously modified such as three or more types of quality control samples having different concentrations, three or more types of quality control samples having different components, and the same type of quality control samples. .

  Furthermore, in the present embodiment, the management target value is set for the quality control value derived from the analysis result obtained using a quality control sample for a certain analysis item. The management target value is a target value of an accuracy management value derived from an analysis result obtained when an analysis item is analyzed using a certain management reagent in the automatic analyzer 1000, and is used for managing analysis accuracy. This is the reference value.

  This control target value is determined, for example, as an accuracy control value obtained by analyzing with an automatic analyzer determined as a standard device, an average value of a plurality of accuracy control values obtained with this device, or a standard method From the quality control value derived from the result obtained by the measurement method, the analysis item and / or the characteristic characteristic of the apparatus can be set.

  In this embodiment, the control target value set for the combination of the analysis item and the quality control sample is used as a reference, and a range of a width determined in advance from this value (corresponding to a quality control allowable range described later). And let the user manage the analysis accuracy based on whether or not the analysis result is included in this range. Note that the accuracy control tolerance range is, for example, ± 2σ (σ is a standard deviation), ± 3σ, or the deviation rate (%) from the management target value that is the target value, and the reproducibility and analysis results of the automatic analyzer 1000 Can be set in consideration of the analysis item and / or the characteristic of the apparatus.

Overall Operation Next, the overall operation from the start to the end of the automatic analyzer 1000 according to this embodiment will be described in detail with reference to the drawings. FIG. 5 is a flowchart showing an outline of the overall operation of the automatic analyzer 1000 according to this embodiment. The automatic analyzer 1000 realizes each step and / or means described later by the control unit 401 in the control terminal 400 shown in FIG. 1 operating by controlling each unit of the main unit 100 and each unit of the control terminal 400. Therefore, the following description will be given focusing on the operation of the control unit 401.

  As shown in FIG. 5, when the automatic analyzer 1000 is activated, the control unit 401 first determines whether there is a status change of the automatic analyzer 1000 (step S101). This can be realized, for example, by detecting that a change in the analysis parameter is input by the user using the input unit 403 of the control terminal 400, for example, for a change in the analysis parameter. Further, for the change of the quality control sample, for example, it is attached to the control sample bottle 502 using the barcode reader 184 or 234 provided in the first reagent cool box 180 or the second reagent cool box 230 described above. A method of detecting a change in the quality control sample when the barcode is read and determining whether or not this is different from the previously read information, or a user inputs switching of the quality control sample using the input unit 403 It can be realized by using various configurations such as a method for detecting this. Furthermore, regarding the change in calibration conditions, for the sample (calibrator) used for calibration, the barcode attached to the bottle is read using the barcode reader 184 or 234 described above, It can be realized by a method of determining whether or not the read information is different and detecting a change of the calibrator when they are different, and various execution conditions in the calibration can be executed by the user using the input unit 403. This can be realized by a method of detecting that a change in conditions has been input. Furthermore, with respect to the change of the reagent, as with the quality control sample, for example, the first reagent is stored using the barcode reader 184 or 234 provided in the first reagent cool box 180 or the second reagent cool box 230 described above. A method of detecting a change in a reagent when a barcode attached to the bottle 182 or the second reagent bottle 232 is read, and determining whether or not this is different from the previously read information, It can be realized using various configurations such as a method of detecting that the switching of the first or second reagent is input using 403.

  If there is a status change as a result of the determination in step S101 (Yes in step S101), the control unit 401 executes a process of recording this status change as data (status information update process) (step S102), and then The process proceeds to step S103. Details of the status information update process shown in step S102 will be described in detail later with reference to FIG. On the other hand, if the result of determination in step S101 is that there is no status change (No in step S101), the control unit 401 proceeds directly to step S103.

  In step S103, the control unit 401 executes an initiation process for setting the automatic analyzer 1000 into a measurable state. This initiation process includes various preparation / input processes such as cleaning the cuvette C and various probes, stabilizing the temperature of the reaction tank 120, and setting or changing analysis parameters used in the subsequent analysis process.

  When the initiation process of the automatic analyzer 1000 is completed, the control unit 401 next determines whether or not the user has input an instruction to end the automatic analyzer 1000 using the input unit 403, a power switch, or the like (step S104). . When the end instruction is input (Yes in step S104), the control unit 401 ends the process. On the other hand, if no termination instruction has been input (No in step S104), the control unit 401 determines whether there is a status change of the automatic analyzer 1000 (step S105) as in step S101. . This step is mainly intended to determine whether or not a setting change that causes a status change has been made in the initiation process. If the result of this determination is that there is a status change (Yes in step S105), the control unit 401 returns to step S102 and executes status information update processing. On the other hand, if the result of determination in step S105 is that there is no status change (No in step S105), then the control unit 401 has received an instruction to start an analysis operation (analysis start instruction) from the input unit 403. Is determined (step S106). Note that various settings such as analysis parameters used in the analysis process are input from the input unit 403 by the user in the initiation process of step S103 as described above.

  As a result of the determination in step S106, when an analysis start instruction is input (Yes in step S106), the control unit 401 executes a series of analysis processes for one or more samples accommodated in the subunit 300 in FIG. (Step S107), and then returns to Step S104. On the other hand, if the result of determination in step S106 is that an analysis start instruction has not been input (No in step S106), the control unit 401 returns to step S104 and repeatedly executes the same determination.

  As described above, a series of overall operations from the start to the end of the automatic analyzer 1000 according to the present embodiment are executed.

.. Status Information Update Process Next, the status information update process shown in step S102 of FIG. 5 will be described in detail with reference to the drawings. FIG. 6 is a flowchart showing an outline of status information update processing according to this embodiment.

  As shown in FIG. 6, in the status information update process, the control unit 401 first determines which item (analysis parameter, quality control sample, calibration condition, reagent, etc.) the status change detected in step S101 in FIG. Is identified (step S111). In this description, an item in which a status change has occurred is referred to as a change item. Next, the control unit 401 acquires status information after the change relating to the specified change item (step S112). A specific example of status information will be described in the description of the status management table 422 described later.

  After specifying the change item and acquiring the changed status information, the control unit 401 next specifies all the analysis items related to the change item (step S113). For example, if the analysis parameter is changed, it can be obtained by specifying which analysis item is used in the analysis parameter.

  Next, the control unit 401 updates the status information associated with the analysis item identified in the status management table 422 with the status information acquired in step S112 (step S114), and then returns to the overall operation of FIG. . Thereby, the status information of the automatic analyzer 1000 managed in the status management table 422 is updated to the latest information.

.. Status Management Table Here, the status management table 422 according to the present embodiment will be described in detail with reference to the drawings. FIG. 7 is a diagram showing a configuration example of the status management table 422 according to the present embodiment. As shown in FIG. 7, the status management table 422 is status information management means for managing status information classified into one or more items for each analysis item, and includes analysis parameters, quality control sample information, calibration information, and the like. Status information classified into each item of reagent information is managed in association with an analysis item (item name). However, the items and the like are not limited to those shown in FIG.

  In the present embodiment, the analysis parameters are various settings necessary for executing the analysis process. For example, the amount of the sample or the first / second reagent dispensed in one measurement is determined. Sample dispensing volume, first reagent dispensing volume, second reagent dispensing volume, main wavelength and sub-wavelength of light used for absorbance measurement, analytical method / slope specifying the analytical method and slope used for it And a measurement point for setting the measurement timing.

  The quality control sample information is information about a sample used in the analysis for managing the analysis accuracy. For example, the quality control sample name that is the name of the quality control sample, its lot number, and this quality control sample. And a lot change date which is information on the date and time when

  Furthermore, the calibration information refers to the calibrator name that is the name of the sample (calibrator) to be used for calibration, the lot number, the calibration execution date that is information on the date and time when the calibration was performed, and the calibrator switched. A lot change date that is date and time information.

  Furthermore, the reagent information includes a lot number of the first and second reagents used in the analysis process and a lot switching date that is information on the date and time when the reagent is switched.

  The status management table 422 for managing the status information is stored in, for example, the external storage unit 420 shown in FIG. 1, and is referred to by the control unit 401 as necessary.

.. Initiation Process Next, the initiation process shown in step S103 of FIG. 5 will be described in detail with reference to the drawings. FIG. 8 is a flowchart showing a schematic flow of the initiation process of the automatic analyzer 1000 according to the present embodiment.

  As shown in FIG. 8, in the initiation process according to the present embodiment, first, as described above, the control unit 401 cleans the cuvette C and various probes, stabilizes the temperature of the reaction tank 120, and performs step S107 described later. Various preparation / input processes such as setting or changing analysis parameters used in the analysis process are executed (step S121).

  Next, the control unit 401 executes management analysis processing (step S122) and accuracy management result display processing (step S123) as analysis accuracy management operations. The management analysis process and the accuracy management result display process according to this embodiment will be described in detail later.

  Next, the control unit 401 determines whether or not the analysis accuracy of the automatic analyzer 1000 is normal as a result of the analysis accuracy management operation (step S124). This is realized, for example, by determining whether or not the accuracy management value of each analysis item obtained in the accuracy management result display processing described later is included in the accuracy management allowable range set in advance for each analysis item. can do.

  As a result of the determination in step S124, when the analysis accuracy is normal (Yes in step S124), the control unit 401 returns to the overall operation illustrated in FIG. On the other hand, when the analysis accuracy is not normal (No in step S124), the control unit 401 requests the user to improve the abnormal part based on each screen presented to the user in the accuracy management result display process in step S123 (step S125). ). Thereafter, when the fact that the abnormal part has been improved is input from the user using the input unit 403 (Yes in step S126), the control unit 401 returns to step S121 and repeats the subsequent operations.

... Analysis accuracy management operation Next, the analysis accuracy management operation according to the present embodiment will be described in detail with reference to the drawings. In the analysis accuracy management operation according to the present embodiment, as described above, the management analysis process (step S122) using the accuracy control samples 1 and 2 for measuring the analysis accuracy and the analysis result obtained by this management analysis process are used. A quality control result display process (step S123) for displaying to the user as the quality control result is executed. In the following description, for the sake of simplification, the case where only the first reagent stored in the first reagent cooler 180 is used will be described as an example. However, the present invention is not limited to this, and the second reagent is appropriately used. A second reagent or the like stored in the cool box 230 may be used. Further, in the following description, for the sake of simplicity, the type of the first reagent is not distinguished, but this does not mean that the same type of first reagent is used for all analysis items. That is, in the present invention, different types of first reagents are appropriately used depending on the analysis item.

... Management Analysis Process First, the management analysis process shown in step S122 of FIG. 8 will be described in detail. FIG. 9 is a flowchart showing the flow of management analysis processing according to this embodiment. However, for the sake of simplification of explanation, an example will be given below in which the first reagent is reacted with each of the quality control samples 1 and 2 and the absorbance of the reaction liquid LC obtained thereby is measured to obtain the analysis result. I will explain.

  In the management analysis process according to the present embodiment, as shown in FIG. 9, the control unit 401 first selects one of one or more analysis items and sets this as a target analysis item (step S131). .

  When the target analysis item is selected in step S131, in the management analysis process, first, the analysis process for the quality control sample 1 out of a plurality of types (2 types in this example) of the quality control samples 1 and 2 is executed. Therefore, the control unit 401 rotates the first reagent cooler 180 around the rotation shaft 181 so that the control sample bottle in which the quality control sample 1 corresponding to the target analysis item is stored at the first reagent sorting position 183. 502 is arranged (step S132).

  Next, the control unit 401 controls the driving mechanism (not shown) to pivot and move the first reagent dispensing unit 170 up and down, thereby moving the tip of the first reagent probe 173 in the first reagent dispensing unit 170 to the first position. The quality control sample 1 is aspirated from the control sample bottle 502 by inserting it into the control sample bottle 502 located at the one reagent sorting position 183 and controlling a valve and a syringe (not shown) in this state (step S133). . Thereby, the quality control sample 1 is dispensed by the first reagent dispensing unit 170.

  Next, the control unit 401 arranges a predetermined cuvette (hereinafter, this cuvette is referred to as a target cuvette) C at the first reagent dispensing position 124 by rotating the reaction tank 120 around the rotation shaft 121 (step S134). .

  Next, the control unit 401 controls the drive mechanism (not shown) to pivot and move the first reagent dispensing unit 170 up and down to move the first reagent probe 173 onto the first reagent dispensing position 124, By controlling a valve and a syringe (not shown) in this state, the quality control sample 1 that has been collected is discharged into the target cuvette C disposed at the first reagent dispensing position 124 (step S135). Thereby, the quality control sample 1 is dispensed into the target cuvette C. The control unit 401 stores information about which quality control sample is dispensed into which cuvette C, for example, in the storage unit 405 (see FIG. 1).

  Next, the control unit 401 controls a driving mechanism (not shown) to pivot and move the first reagent dispensing unit 170 up and down, so that the first reagent probe 173 of the first reagent dispensing unit 170 is moved to the first reagent. The first reagent probe 173 is cleaned by moving to the probe cleaning unit 190 and appropriately driving the first reagent dispensing unit 170 and the first reagent probe cleaning unit 190 in this state (step S136).

  In addition, the control unit 401 rotates the first reagent cooler 180 around the rotation shaft 181 to store the first reagent corresponding to the target analysis item at the first reagent sorting position 183. Are arranged (step S137).

  Next, the control unit 401 controls the driving mechanism (not shown) to pivot and move the first reagent dispensing unit 170 up and down, thereby moving the tip of the first reagent probe 173 in the first reagent dispensing unit 170 to the first position. The first reagent is dispensed from the first reagent bottle 182 by being inserted into the first reagent bottle 182 located at the one reagent dispensing position 183 and controlling a valve and a syringe (not shown) in this state (step) S138). As a result, the first reagent is dispensed by the first reagent dispensing unit 170.

  Next, the controller 401 arranges the target cuvette C into which the quality control sample 1 has been dispensed at the first reagent dispensing position 124 by rotating the reaction tank 120 around the rotation shaft 121 (step S139).

  Next, the control unit 401 controls the driving mechanism (not shown) to pivot and move the first reagent dispensing unit 170 up and down to move the first reagent probe 173 onto the first reagent dispensing position 183, By controlling a valve and a syringe (not shown) in this state, the first reagent that has been dispensed is discharged into the target cuvette C disposed at the first reagent dispensing position 183 (step S140). Thereby, the first reagent is dispensed into the target cuvette C, and a mixed liquid composed of the quality control sample 1 and the first reagent is generated in the target cuvette C.

  Next, the control unit 401 controls a driving mechanism (not shown) to pivot and move the first reagent dispensing unit 170 up and down, so that the first reagent probe 173 of the first reagent dispensing unit 170 is moved to the first reagent. The first reagent probe 173 is washed by moving to the probe washing unit 190 and appropriately driving the first reagent dispensing unit 170 and the first reagent probe washing unit 190 in this state (step S141).

  In addition, the control unit 401 makes the target cuvette C into which the quality control sample 1 and the first reagent have been dispensed be disposed in the vicinity of the first stirring unit 160 by rotating the reaction tank 120 around the rotation shaft 121. While arrange | positioning in the 1st stirring position of illustration, the liquid mixture in the object cuvette C is stirred by controlling the 1st stirring unit 160 (step S142). As a result, a reaction liquid LC including the quality control sample 1 and the first reagent is generated in the target cuvette C. The first stirring unit 160 includes a stirring rod for stirring the liquid in the cuvette C, and the mixed liquid in the target cuvette C is stirred using this.

  Next, the control unit 401 drives the first stirring unit 160 and the cleaning unit provided therein, thereby cleaning the stirring rod used for stirring the mixed liquid in the target cuvette C (step S143).

  Further, the control unit 401 rotates the reaction tank 120 around the rotation shaft 121 to place the target cuvette C at a measurement position (not shown) between the light source lamp set 210 and the light receiving unit 211 (step S144). .

  Next, the control unit 401 outputs light of a predetermined wavelength to the light source lamp set 210 in a state where the target cuvette C is disposed between the light source lamp set 210 and the light receiving unit 211, and the target cuvette C and the reaction liquid LC are output. By allowing the light receiving unit 211 to receive the transmitted light, the intensity of the light transmitted through the reaction liquid LC in the target cuvette C is measured (step S145). The measurement result acquired by the light receiving unit 211 is input to the control unit 401.

  Next, the control unit 401 inputs the measurement result to the analysis unit 402 shown in FIG. 2, and causes the analysis unit 402 to perform analysis using the measurement result, so that the reaction liquid LC generated in the target cuvette C can be obtained. Analysis is performed (step S146). Specifically, the absorbance of the reaction liquid LC is calculated from the intensity ratio of the light transmitted through the cuvette C and the reaction liquid LC to the intensity of the light transmitted through the empty cuvette C. In addition, the control unit 401 stores the absorbance obtained in the analysis unit 402, various parameters when this analysis is performed, and the like in the external storage unit 420 as an analysis result (step S147). In the external storage unit 420, as shown in FIG. 10, the date and time (measurement date and time) when the management analysis process of step S122 is executed, the analysis item (item name) to be analyzed, and the quality control sample used are associated with each other. Detailed analysis results such as absorbance and display value are managed in the analysis result accumulation table 421. In the analysis result accumulation table 421, analysis results obtained by past management analysis processing are also accumulated.

  When the measurement for the quality control sample 1 is executed as described above, the control unit 401 next determines whether or not the measurement for the quality control sample 2 corresponding to the analysis item selected as the target has been executed (step). S148). As a result of this determination, when the measurement of the quality control sample 2 has not been executed (No in step S148), the control unit 401 causes the first reagent cooler 180 to circulate around the rotation shaft 181 as in step S132. Thus, the management sample bottle 502 in which the quality control sample 2 corresponding to the target analysis item is stored is arranged at the first reagent sorting position 183 (step S149). Thereafter, the control unit 401 generates the reaction liquid LC composed of the quality control sample 2 and the first reagent in the target cuvette C different from the above by executing the operation described using steps S133 to S147. The intensity of the light transmitted through is measured, and the result obtained by analyzing the measurement result in the analysis unit 402 is stored in the external storage unit 420.

  Further, as a result of the determination in step S148, when the measurement for the quality control sample 2 corresponding to the analysis item selected as the target has been executed (Yes in step S148), the control unit 401 has not executed the measurement. It is determined whether another analysis item exists (step S150).

  As a result of the determination in step S150, when there is another analysis item for which measurement has not been performed (Yes in step S150), the control unit 401 selects one of the other analysis items for which measurement has not been performed, Is the target analysis item (step S151). Thereafter, the control unit 401 executes the operation described using steps S132 to S150, thereby performing the analysis using the quality control samples 1 and 2 selected as the target analysis item and the first reagent corresponding to the analysis item. Execute. Note that the analysis result obtained in the analysis unit 402 is stored in the external storage unit 420. Further, as a result of the determination in step S150, if there is no other analysis item for which measurement has not been performed (No in step S150), the control unit 401 ends the analysis management process in step S122 and performs the initiation process illustrated in FIG. Return.

.... Quality control result display Next, in describing the quality control result display process shown in step S123 of FIG. 8, the screen displayed to the user in the quality control result display process according to the present embodiment will be described first. To do.

  In the present embodiment, for example, an accuracy management result confirmation screen (analysis result) 10 (see FIG. 11) is displayed on the display unit 404 as a screen for presenting the results of the analysis accuracy management processing to the user. A status confirmation screen (all items) 20 (see FIG. 12) and a status confirmation screen (common items) 30 (see FIG. 13) are displayed on the display unit 404 as screens for presenting the status to the user.

・ ・ ・ ・ ・ Quality control result confirmation screen (analysis result)
Here, the quality control result confirmation screen (analysis result) 10 (first screen) will be described in detail with reference to FIG. FIG. 11 is a screen diagram showing an example of the quality control result confirmation screen (analysis result) 10 according to the present embodiment. As shown in FIG. 11, an accuracy management result confirmation screen (analysis result) 10 is plotted with an operation area 11 for inputting various operations such as screen switching and graph switching, and an accuracy management value obtained from the analysis result. A display area 12 for displaying the displayed graph.

  In the display area 12, the date and time (measurement date and time) 13 when the management analysis process shown in FIG. 9 is performed and the two-dimensional graph 15 in which the accuracy management values are two-dimensionally plotted as described above are displayed.

  The accuracy management value is a numerical value derived by substituting various parameters such as absorbance included in the analysis result in the analysis result accumulation table 421 shown in FIG. 10 into a predetermined function. In this derivation, weighting is performed according to the degree of contribution of each parameter to the analysis accuracy and the characteristic difference of each automatic analyzer 1000, and so on, based on empirical rules obtained in past experiments and operations, etc. Possible functions should be used.

  Further, the two-dimensional graph 15 includes an area (accuracy management allowable range 15a) indicating that the analysis accuracy estimated from the accuracy control value is within a range allowable for performing a normal analysis (hereinafter referred to as an allowable range). , Other regions, that is, regions indicating a range in which analysis accuracy is not allowable (regions other than the accuracy management allowable range 15a in the two-dimensional graph 15: accuracy management non-permissible range).

  In the two-dimensional graph 15, the horizontal axis indicates the analysis result of the quality control sample 1, for example, and the vertical axis indicates the analysis result of the quality control sample 2, for example. Therefore, each plot 16 or 16a drawn on this plot indicates both the analysis result of the quality control sample 1 and the analysis result of the quality control sample 2 for one analysis item. In the present embodiment, when the analysis results of both the quality control samples 1 and 2 for a certain analysis item are within the allowable range, the plot 16 indicating the measurement result for this analysis item is acceptable for the quality control in the two-dimensional graph 15. It is drawn in the range 15a. On the other hand, when the analysis result of at least one of the quality control samples 1 and 2 is outside the allowable range, the plot 16a indicating the measurement result for this analysis item is drawn outside the quality control allowable range 15a.

  Furthermore, plots 16 and / or 16a indicating analysis results for all analysis items are drawn on the two-dimensional graph 15. Therefore, according to the present embodiment, it is possible to check the analysis accuracy for a plurality of analysis items at a time.

  As described above, in the present embodiment, the analysis results for a plurality of quality control samples (1, 2) relating to the same analysis item are displayed in one graph (two-dimensional graph 15), so that the analysis results can be easily displayed to the user. It is possible to realize a confirmation screen (accuracy management result confirmation screen (analysis result) 10) that can be visually confirmed to confirm analysis accuracy. However, the present invention is not limited to this, and can be modified in any way as long as it is displayed so that at least the accuracy of the analysis is acceptable and that which is not acceptable can be visually confirmed.

  In the two-dimensional graph 15, each line passing through the center of each of the vertical axis and the horizontal axis represents a management target value for each analysis item. Further, in the two-dimensional graph 15, the vertical axis and horizontal axis ranges are set so that the accuracy control allowable ranges 15a for all the analysis items are overlapped with each other. Thereby, since the user only has to determine whether or not the accuracy management value of each analysis item is out of the common accuracy management allowable range 15a, it is possible to further easily confirm the analysis accuracy by visual recognition. Become. Since the display range of the two-dimensional graph 15 is determined based on the accuracy control allowable range 15a for each analysis item, an accuracy control value that is not included in the display range of the two-dimensional graph 15 may be derived. is there. In such a case, the quality control value is plotted, for example, on the outer edge of the two-dimensional graph 15 or on the inner side of the quality control unacceptable range slightly smaller than the outer edge.

  Further, the control terminal 400 according to the present embodiment is configured by a PC (Personal Computer) equipped with a GUI (Graphical User Interface) function using a mouse or the like, for example. Therefore, in the present embodiment, when the pointer 17 is placed on any of the plots 16 or 16a, information for specifying an analysis item corresponding to the plot 16 or 16a, for example, an item name, a popup 18 or the like is configured. May be used.

  In addition, in the present embodiment, the plot 16a (first mark) outside the quality control allowable range 15a is emphasized using, for example, a color or a size different from the plot 16 (second mark) within the quality control allowable range 15a. It may be displayed or blinked. Further, information (for example, item name) for specifying an analysis item for the plot 16a may be displayed using the pop-up 18a or the like regardless of the position of the pointer 17. As a result, it is possible to alert the user about an analysis item that deviates from the preset accuracy control allowable range 15a.

  On the other hand, in the operation area 11, an operation button group 11 a including one or more operation buttons for allowing the user to input an operation for displaying past analysis results on the two-dimensional graph 15, and a screen displayed on the display unit 404 are automatically displayed. One or more screen switching buttons (“all item display” button: first screen switching button) for allowing the user to input an operation for switching to a screen (status confirmation screen (all items) 20) for displaying the status of the analyzer 1000 Including a screen switching button group 11b. By incorporating such various buttons in the screen, it is possible to smoothly perform the screen switching operation, so that it is possible to facilitate the operation of confirming the analysis accuracy.

  For example, when the user selects any one of the operation buttons in the operation button group 11a using the input unit 403, the control unit 401 acquires the analysis result for the past stored in the external storage unit 420, and uses this Then, the quality control result confirmation screen (analysis result) 10 is generated and displayed on the display unit 404. In addition, the control unit 401 generates and displays an accuracy management result confirmation screen (analysis result) 10 of an analysis result for a certain past, and then acquires an analysis result for the past after a certain period of time. It is also possible to generate and display a quality control result confirmation screen (analysis result) 10.

  When the user selects the “display all items” button in the screen switching button group 11 b using the input unit 403, the control unit 401 stores, for example, an accuracy management value from the status management table 422 stored in the external storage unit 420. Status information regarding all analysis items not included in the accuracy management allowable range 15 a is acquired, and a status confirmation screen (all items) 20 described later is generated using the status information, and displayed on the display unit 404. Further, for example, when the user selects the “display all items” button in a state where one or more plots 16 and / or 16 a are selected using the input unit 403, it corresponds to the selected plots 16 and / or 16 a, respectively. A status confirmation screen (all items) 20 for the analysis items may be generated and displayed. An example of the status confirmation screen (all items) 20 will be described in detail later with reference to FIG.

・ ・ ・ ・ ・ Status confirmation screen (all items)
Next, an example of the status confirmation screen (all items) 20 will be described in detail with reference to the drawings. FIG. 12 is a screen diagram showing an example of the status confirmation screen (all items) 20 according to the present embodiment. As shown in FIG. 12, the status confirmation screen (all items) 20 includes an operation area 11 for inputting various operations such as screen switching, and all analysis items or selections outside the accuracy control allowable range 15a. A status display area 22 for displaying status information for all analysis items.

  In the status display area 22, a date and time (measurement date and time) 13 when the management analysis process shown in FIG. 9 is performed, and a status presentation area 22a that presents the corresponding analysis item and status information are displayed. The status presentation area 22a is not limited to the table shown in FIG. 12, but may be any method as long as the status information managed in the status management table 422 in FIG. Can also be changed. The status presentation area 22a is provided with a scroll bar 22s for allowing the user to input an instruction to scroll the display area of the status display area 22a up and down or left and right.

  By visually confirming the status information presented as described above, in this embodiment, it is possible to easily confirm in which item the factor that has reduced the analysis accuracy exists. It is possible to easily identify the cause of the reduced analysis accuracy without requiring complicated work.

  On the other hand, in the operation area 11, a screen switching button (“analysis result display” button) for allowing the user to input an operation for switching the screen displayed on the display unit 404 to the quality control result confirmation screen (analysis result) 10 in FIG. And a screen switching button group 11b including a screen switching button (“common item display” button: second screen switching button) for switching to the status confirmation screen (common item) 30 shown in FIG.

  Here, when the user selects the “display common item” button in the screen switching button group 11 b using the input unit 403, the control unit 401 acquires the status confirmation screen (all items) 20 from the status management table 422. Among the status information, the status information for the item having the same value in all the analysis items is specified, and a status confirmation screen (common item) 30 to be described later is generated using the status information and displayed on the display unit 404. An example of the status confirmation screen (common item) 30 will be described in detail later with reference to FIG.

・ ・ ・ ・ ・ Status confirmation screen (common items)
Next, an example of the status confirmation screen (common item) 30 will be described in detail with reference to the drawings. FIG. 13 is a screen diagram showing an example of a status confirmation screen (common item) 30 according to the present embodiment. As shown in FIG. 13, the status confirmation screen (common item) 30 includes an operation area 11 for inputting various operations such as screen switching, and status information acquired in the generation of the status confirmation screen (all items) 20. And a status display area 32 for displaying status information for items whose values are common among all the analysis items.

  In the status display area 32, a date and time (measurement date and time) 13 when the management analysis process shown in FIG. 9 is performed, and a status presentation area 32a that presents the corresponding analysis items and status information common to them are displayed. . The status presentation area 32a may be provided with a scroll bar for allowing the user to input an instruction to scroll the display area of the status display area 32a up and down or left and right.

  As described above, by displaying a screen that presents only common status information, it is possible to easily visually identify which item was a factor that reduces analysis accuracy.

  On the other hand, in the operation area 11, a screen switching button (“analysis result display” button) for allowing the user to input an operation for switching the screen displayed on the display unit 404 to the quality control result confirmation screen (analysis result) 10 in FIG. And a screen switching button group 11b including a screen switching button (“all item display” button: third screen switching button) for switching to the status confirmation screen (all items) 20 shown in FIG.

... Quality control result display processing Next, the quality control result display processing shown in step S123 of Fig. 8 will be described in detail. FIG. 14 is a flowchart showing a flow of quality control result display processing according to the present embodiment. However, in the following description, for the sake of simplification, description will be given focusing on the operation when any one of the screen switching buttons in the screen switching button group 11b of each screen (10, 20, 30) is selected. .

  In the quality control result display process according to the present embodiment, as shown in FIG. 14, the control unit 401 first displays the latest analysis results on the quality control samples 1 and 2 obtained by the management analysis process shown in FIG. Acquired from the external storage unit 420 (step S161) (analysis result acquisition means / step), and calculates a quality control value for each combination of the analysis item and the quality control sample using a predetermined function from the acquired analysis result (step) S162) (Accuracy management value deriving means / step).

  Next, the control unit 401 generates a two-dimensional graph 15 in which the calculated quality control value is plotted (step S163) (graph generation means / step), and this is the source file of the quality control result confirmation screen (analysis result) 10 As a result, the quality control result confirmation screen (analysis result) 10 as shown in FIG. 11 is generated (step S164). Also, the control unit 401 displays the generated quality control result confirmation screen (analysis result) 10 on the display unit 404 in the control terminal 400 (step S165) (graph display means / step). In this embodiment, the template of the source file of each screen (see FIGS. 11 to 13) including the quality control result confirmation screen (analysis result) 10 is, for example, HTML (HyperText Markup Language) format or XML (Extensible Markup). (Language) format and the like, which are appropriately read from the external storage unit 420, for example. Therefore, for example, the control unit 401 reads out the source file from the external storage unit 420 and incorporates a link to the generated two-dimensional graph 15 (see FIG. 11) at a predetermined location thereof, so that each screen (10, 20, 30 etc.) is generated.

  Next, the control unit 401 determines whether or not an instruction to end the quality control result display process (hereinafter referred to as a display end instruction) has been input from the user (step S166). For example, this can be realized by the control unit 401 determining whether or not the user has pressed the escape (Esc) key on the keyboard of the input unit 403. When a display end instruction is input (Yes in step S166), the control unit 401 ends the quality control result display process and returns to the initiation process illustrated in FIG.

  On the other hand, when the display end instruction has not been input (No in step S166), the control unit 401 next selects any screen switching button in the screen switching button group 11b of the currently displayed screen (10, 20, 30). Is clicked (selected) by operating the pointer 17 using the input unit 403. In this determination, the control unit 401 first determines whether or not the “analysis result display” button, which is a screen switching button, has been clicked (step S167). The “analysis result display” button is a screen switching button for the user to input an instruction to display the quality control result confirmation screen (analysis result) 10 shown in FIG. 11 on the display unit 404.

  When the “analysis result display” button is clicked (Yes in step S167), the control unit 401 returns to step S161 to generate and display the quality control result confirmation screen (analysis result) 10 (steps S161 to S165). After that, the determination in step S166 is executed.

  On the other hand, when the “analysis result display” button has not been clicked (No in step S167), the control unit 401 next determines whether or not the “display all items” button has been clicked (step S168). The “display all items” button is a screen switching button for the user to input an instruction to display the status confirmation screen (all items) 20 shown in FIG.

  When the “display all items” button is clicked (Yes in step S168), the control unit 401 selects the plot 16 selected by the user from the status information managed in the status management table 422 of the external storage unit 420, and Status information associated with an analysis item corresponding to 16a or an analysis item out of the quality control allowable range 15a in the two-dimensional graph 15 is acquired (step S169), and the acquired status information is applied to the table. By incorporating this into the source file of the status confirmation screen (all items) 20, a status confirmation screen (all items) 20 as shown in FIG. 12 is generated (step S170). Also, the control unit 401 displays the generated status confirmation screen (all items) on the display unit 404 in the control terminal 400 (step S171) (status display means / step). Thereafter, the control unit 401 returns to Step S166. The selection of the plots 16 and / or 16a associated with the analysis items to be displayed on the status confirmation screen (all items) 20 is performed by the user operating the pointer 17 from the input unit 403 to select one or more plots 16 and 16a. It is possible to configure to click each of 16a (analysis item selection means / step).

  On the other hand, when the “display all items” button has not been clicked (No in step S168), the control unit 401 next determines whether or not the “display common items” button has been clicked (step S172). The “common item display” button is a screen switching button for the user to input an instruction to display the status confirmation screen (common item) 30 shown in FIG. 13 on the display unit 404. In this description, for the sake of simplicity, the “display common item” button is not included in the quality control result confirmation screen (analysis result) 10. However, the present invention is not limited to this and may be included.

  When the “display common item” button is clicked as a result of the determination in step S172 (Yes in step S172), the control unit 401 has a common value for each item in the status information acquired from the status management table 422 in step S169. The status information to be identified is identified (step S173) (common item identifying means / step), and the identified status information is applied to the table and incorporated into the source file of the status confirmation screen (common item) 30, as shown in FIG. Such a status confirmation screen (common item) 30 is generated (step S174). Further, the control unit 401 displays the generated status confirmation screen (common item) 30 on the display unit 404 of the control terminal 400 (step S175) (common status display means / step). Thereafter, the control unit 401 returns to Step S166.

  With the configuration and operation as described above, in this embodiment, an accuracy management value indicating analysis accuracy for a plurality of accuracy control samples acquired for each of a plurality of analysis items is drawn and displayed on one two-dimensional graph 15. Therefore, it is possible to easily confirm the analysis accuracy of the plurality of management reagents for each of the plurality of analysis items by visual recognition without requiring a complicated operation such as switching the screen. In addition, it is possible to allow the user to easily check the status information of the analysis items that are out of the accuracy management allowable range 15a, that is, the items related to the analysis items with the unacceptable accuracy in the analysis processing, on the status confirmation screen (all items) 20. Therefore, the user can easily identify the cause of the reduced analysis accuracy without requiring a complicated operation. Furthermore, in the present embodiment, it is possible to selectively display status information regarding items common to one or more analysis items that are out of the accuracy control allowable range 15 a using the status confirmation screen (common items) 30. Therefore, it becomes possible to make the user specify the cause of the reduced analysis accuracy more easily.

(Modification)
FIG. 15 shows a modification of the status confirmation screen (all items) 20 according to this embodiment. As shown in FIG. 15, in the status confirmation screen (all items) 20A, status information 22H for items whose values are common in all the analysis items among the status information acquired in the generation of the status confirmation screen (all items) 20A. Is displayed in highlights, bold, or highlighted colors. For example, the control unit 401 identifies status information having a common value for each item from the status information acquired from the status management table 422 in step S169 of FIG. 14, for example, and the status confirmation screen in which this is highlighted in step S170 (All items) It is realizable by comprising so that 20A may be produced | generated.

  As described above, by highlighting the common status information, it is possible to easily identify visually which item was a factor that reduces the analysis accuracy.

<Embodiment 2>
Next, an automatic analyzer according to Embodiment 2 of the present invention will be described in detail. The configuration and operation of the automatic analyzer according to this embodiment are the same as those of the automatic analyzer 1000 according to Embodiment 1 of the present invention. Therefore, in this Embodiment, the detailed description is abbreviate | omitted by quoting this. However, in the automatic analyzer according to the present embodiment, the quality control result confirmation screen (analysis result) 10 shown in FIG. 11 is replaced with a quality management result confirmation screen (analysis result) 40 shown in FIG.

... Quality control result confirmation screen (analysis result)
As shown in FIG. 16, the quality control result confirmation screen (analysis result) 40 according to the present embodiment plots an operation area 11 for inputting various operations such as screen switching and graph switching, and analysis results. A display area 42 for displaying the graph.

  The display area 42 displays the date and time (measurement date and time) 13 when the management analysis process similar to the management analysis process shown in FIG. 9 is performed, and a graph 45 on which the analysis result obtained by the management analysis process is plotted. Is done.

  The graph 45 includes an accuracy management allowable range 45a that is an area between the lower limit 45LL and the upper limit 45UL, and an area outside the accuracy management allowable range 45a. The graph 45 is a two-dimensional graph in which the vertical axis indicates a value obtained as an analysis result, and the horizontal axis indicates any one of a plurality of analysis items. Therefore, in the graph 45, analysis results for a plurality of analysis items are displayed in parallel in the horizontal direction. Adjacent analysis items are arranged at a predetermined interval.

  In the graph 45, the analysis results of the quality control sample 1 and the quality control sample 2 are drawn in separate plots 46, 46a, 47 or 47a for each analysis item. For example, the plots 46 and 46a indicating the analysis results for the quality control sample 1 are expressed by shapes or colors different from the plots 47 and 47a indicating the analysis results for the quality control sample 2.

  Further, in the present embodiment, when the analysis result of the quality control sample 1 for a certain analysis item is within the allowable range, the plot 46 indicating the analysis result for this analysis item is within the quality control allowable range 45a in the graph 45. When the analysis result of the quality control sample 2 with respect to a certain analysis item is within the allowable range, the plot 47 indicating the analysis result with respect to this analysis item is drawn within the quality control allowable range 45a in the graph 45. On the other hand, when the analysis result of the quality control sample 1 is outside the allowable range, the plot 46a indicating the analysis result for the analysis item is drawn outside the quality control allowable range 15a, and the analysis result of the quality control sample 2 is also within the allowable range. If it is outside, the plot 47a indicating the analysis result for this analysis item is drawn outside the quality control allowable range 45a.

  Further, plots 46, 46a, 47 and / or 47a indicating the analysis results for all analysis items are drawn on the graph 45. Therefore, according to the present embodiment, it is possible to confirm the analysis accuracy for a plurality of analysis items with one graph (graph 45).

  As described above, in this embodiment, the analysis results for a plurality of quality control samples related to the same analysis item are displayed in one graph (graph 45), so that the user can easily visually check the analysis results and confirm the analysis accuracy. This makes it possible to realize a confirmation screen (accuracy management result confirmation screen (analysis result) 40).

  In the graph 45, each line passing through the center of each of the vertical axis and the horizontal axis represents a management target value for each analysis item. Furthermore, the vertical axis range is set in the graph 45 so that the accuracy control allowable range 45a for all analysis items is displayed in a band-like region having the same width in the vertical axis direction. Thereby, the user only has to determine whether or not the accuracy management value of each analysis item is out of the band-shaped accuracy management allowable range 45a extending in the horizontal direction that is the arrangement direction of the analysis items. Confirmation of analysis accuracy can be facilitated.

  The display area 42 is provided with a scroll bar 42 s for allowing the user to input an instruction to scroll the display area 42 left and right. As a result, analysis results for analysis items that cannot be displayed at once can be incorporated into one graph. Note that the scrolling direction is not limited to left and right, but may be up and down. In this case, the graph 45 has a plurality of levels in the vertical direction. However, the present invention is not limited to this, and for example, the analysis result for all the analysis items may be displayed at a time by appropriately reducing the interval between the analysis items arranged in the horizontal direction in the graph 45. .

  In the present embodiment, the plots 46a and 47a outside the quality control allowable range 45a are highlighted or blinked using, for example, a color or size different from the plots 46 and 47 within the quality control allowable range 45a. You may do it. Further, when the user selects any plot 46, 46a, 47 or 47a in the graph 45 using the input unit 403, or an item name drawn at the bottom of the graph 45, the selected item is selected in the present embodiment. You may comprise so that the detail of the analysis result about the analysis item corresponding to a plot or an item name may be displayed. Since the quality control result confirmation screen (individual) 20 for displaying the details is the same as the screen described with reference to FIG. 9 in the first embodiment of the present invention, detailed description thereof is omitted here.

  On the other hand, the operation area 11 displays an operation button group 11a and a screen switching button group 11b as in the first embodiment of the present invention.

  With the configuration and operation as described above, in the present embodiment, as in the first embodiment of the present invention, the accuracy control value indicating the analysis accuracy of the plurality of accuracy control samples acquired for each of the plurality of analysis items is 1 Since it is possible to draw and display on one graph 45, it is easy to visually recognize the analysis accuracy of a plurality of management reagents for each of a plurality of analysis items without requiring a complicated operation such as switching screens. It becomes possible to confirm.

  In addition, since the operation | movement etc. in the case of displaying the status information about the analysis item out of the quality control allowable range 45a or the analysis item selected by the user are the same as those of the embodiment of the present invention, the detailed explanation is given here. Is omitted.

  Further, the above embodiment is merely an example for carrying out the present invention, and the present invention is not limited to these, and various modifications according to specifications and the like are within the scope of the present invention. It is obvious from the above description that various other embodiments are possible within the scope of the present invention.

  Further, the above embodiment is merely an example for carrying out the present invention, and the present invention is not limited to these, and various modifications according to specifications and the like are within the scope of the present invention. It is obvious from the above description that various other embodiments are possible within the scope of the present invention.

It is a schematic diagram which shows schematic structure of the automatic analyzer by Embodiment 1 or 2 of this invention. It is a perspective view which shows schematic structure of the cuvette used in Embodiment 1 or 2 of this invention. It is a perspective view which shows the modification of the cuvette shown to FIG. 2A. It is a top view which shows schematic structure of the cuvette holder in the reaction tank by Embodiment 1 or 2 of this invention. It is sectional drawing which shows schematic structure of the A-A 'cross section of FIG. It is a flowchart which shows the outline of the whole operation | movement of the automatic analyzer by Embodiment 1 or 2 of this invention. It is a flowchart which shows the outline of the status information update process by Embodiment 1 or 2 of this invention. It is a figure which shows the structural example of the status management table by Embodiment 1 or 2 of this invention. It is a flowchart which shows the schematic flow of the initialization process of the automatic analyzer by Embodiment 1 or 2 of this invention. It is a flowchart which shows the flow of the management analysis process by Embodiment 1 or 2 of this invention. It is a figure which shows the structural example of the analysis result accumulation | storage table by Embodiment 1 or 2 of this invention. It is a screen figure which shows an example of the quality control result confirmation screen (analysis result) by Embodiment 1 of this invention. It is a screen figure which shows an example of the status confirmation screen (all items) by Embodiment 1 or 2 of this invention. It is a screen figure which shows an example of the status confirmation screen (common item) by Embodiment 1 or 2 of this invention. It is a flowchart which shows the flow of the quality control result display process by Embodiment 1 or 2 of this invention. It is a screen figure which shows the modification of the status confirmation screen (all items) by Embodiment 1 of this invention. It is a screen figure which shows an example of the quality control result confirmation screen (analysis result) by Embodiment 2 of this invention.

Explanation of symbols

1000 Automatic analyzer 10, 40 Quality control result confirmation screen (analysis result)
11 Operation area 11a Operation button group 11b Screen switching button group 12, 42 Display area 13 Measurement date and time 15 Two-dimensional graph 15a, 45a Accuracy control allowable range 16, 16a, 46, 46a, 47, 47a Plot 17 Pointer 18, 18a Pop-up 20 , 20A Status confirmation screen (all items)
22, 32 Status display area 22H Status information 22a, 32a Status presentation area 22s, 42s Scroll bar 30 Status confirmation screen (common items)
45 Graph 45LL Lower limit 45UL Upper limit 100 Main unit 110 Sample dispensing unit 120 Reaction tank 121 Rotating shaft 124 First reagent dispensing position 160 First stirring unit 170 First reagent dispensing unit 173 First reagent probe 180 First reagent cold storage 181 Rotating shaft 182 First reagent bottle 183 First reagent sorting position 184, 234 Bar code reader 190 First reagent probe cleaning unit 210 Light source lamp set 211 Light receiving unit 230 Second reagent cooler 232 Second reagent bottle 300 Sub unit 400 Control terminal 401 Control unit 402 Analysis unit 403 Input unit 404 Display unit 405 Storage unit 420 External storage unit 421 Analysis result accumulation table 422 Status management table 502 Control sample bottle C Cuvette LC Reaction solution

Claims (14)

An analysis result acquisition means for acquiring an analysis result of a quality control sample for each of a plurality of analysis items;
An accuracy management value deriving means for deriving an accuracy management value indicating the analysis accuracy of the analysis item using the analysis result;
Graph generating means for generating a graph in which a plurality of quality control values corresponding to the plurality of analysis items are plotted;
Graph display means for displaying the graph;
Status information management means for managing status information classified into one or more items for each analysis item;
Status display means for displaying status information associated with each of the one or more analysis items;
With
The graph display means displays a first screen switching button for inputting an instruction to display the status information together with the graph,
The status display means displays the status information in association with the analysis item when a display instruction is input using the first screen switching button. Analysis item selection means for selecting one or more analysis items corresponding to the quality control values plotted in the graph,
The automatic analysis apparatus according to claim 1, wherein the status display unit displays status information associated with the analysis item selected by the analysis item selection unit. The graph generating means is the graph in which an allowable range of the analysis accuracy is set for each analysis item, and is set so that each allowable range for all analysis items is displayed in an overlapping area. Plot the quality control value on the graph;
2. The automatic analyzer according to claim 1, wherein the status display means displays status information associated with an analysis item corresponding to a quality control value not included in the allowable range.   The automatic analysis apparatus according to claim 1, wherein the item includes at least one of an analysis parameter, quality control sample information, calibration information, and sample information.   The status display means emphasizes the status information in which the accuracy management value of the corresponding analysis item is not included in the allowable range more than the status information in which the accuracy management value of the corresponding analysis item is included in the allowable range. The automatic analyzer according to any one of claims 1 to 4, wherein the automatic analyzer is displayed. Of the status information displayed by the status display means, common item specifying means for specifying an item including status information whose value is equal between analysis items,
Common status display means for displaying status information belonging to the item specified by the common item specifying means;
With
The status display means displays a second screen switching button for inputting a display instruction of status information belonging to an item including status information having the same value among the analysis items together with the status information,
6. The common status display means displays status information belonging to the item specified by the common item specifying means when a display instruction is input using the second screen switching button. The automatic analyzer as described in any one of. The common status display means displays a third screen switching button for inputting a display instruction for causing the status display means to display the status information together with the status information,
7. The automatic analyzer according to claim 6, wherein the status display means displays the status information when a display instruction is input using the third screen switching button. An analysis result acquisition step for acquiring an analysis result of the quality control sample for each of a plurality of analysis items;
An accuracy management value deriving step for deriving an accuracy management value indicating the analysis accuracy of the analysis item using the analysis result;
A graph generation step of generating a graph in which a plurality of quality control values corresponding to the plurality of analysis items are plotted;
A graph display step for displaying the graph;
A status information management step for managing status information classified into one or more items for each analysis item;
A status display step for displaying status information associated with each of the one or more analysis items;
Including
The graph display step displays a first screen switching button for inputting a display instruction of the status information together with the graph,
In the status display step, when a display instruction is input using the first screen switching button, the status information is displayed in association with the analysis item. An analysis item selection step for selecting one or more analysis items corresponding to the quality control values plotted in the graph,
9. The analysis accuracy management display method according to claim 8, wherein the status display step displays status information associated with the analysis item selected in the analysis item selection step. The graph generation step is the graph in which the allowable range of the analysis accuracy is set for each analysis item, and is set so that the allowable ranges for all the analysis items are displayed in an overlapping area. Plot the quality control value on the graph;
9. The analysis accuracy management display method according to claim 8, wherein the status display step displays status information associated with an analysis item corresponding to an accuracy management value not included in the allowable range.   The analysis quality management display method according to any one of claims 8 to 10, wherein the item includes at least one of an analysis parameter, quality control sample information, calibration information, and sample information.   The status display step emphasizes the status information in which the accuracy management value of the corresponding analysis item is not included in the allowable range more than the status information in which the accuracy management value of the corresponding analysis item is included in the allowable range. 12. The analysis accuracy management display method according to claim 8, wherein the analysis accuracy management display method is displayed. Of the status information displayed by the status display means, a common item specifying step for specifying an item including status information whose value is equal between analysis items,
A common status display step for displaying status information belonging to the item specified by the common item specifying means;
Including
The status display step displays a second screen switching button for inputting a display instruction of status information belonging to an item including status information having the same value among the analysis items, together with the status information,
13. The common status display step displays status information belonging to an item specified by the common item specifying unit when a display instruction is input using the second screen switching button. The analysis accuracy management display method according to any one of the above. In the common status display step, a third screen switching button for inputting a display instruction for displaying the status information is displayed together with the status information.
14. The analysis accuracy management display method according to claim 13, wherein the status display step displays the status information when a display instruction is input using the third screen switching button.

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