Automated Analysis System

Abstract

This automatic analysis system comprises: an analysis unit (10) capable of selectively executing a general sample analysis or an accuracy management analysis; a display input unit (30); a time setting storage unit (40) in which setting relating to the execution time for the accuracy management analysis is stored; a display control unit (50) that displays a postponement instruction key on the display input unit at a prescribed timing earlier than the execution time determined on the basis of the setting stored in the time setting storage unit; and a postponement control unit (60) that postpones the execution time on the basis of prescribed operation having been performed on the postponement instruction key. Accordingly, it is possible to perform appropriate analysis management according to a situation in an automatic analysis device that performs an accuracy management analysis at the preset time.

Description

[Technical Field]

[0001] The present invention relates to an automatic analysis system capable of analyzing a plurality of samples continuously and automatically. [Background technology]

[0002] Conventionally, automated analyzers have been known that automatically perform quantitative analysis of specific components contained in samples such as blood and urine. In such automated analyzers, a mixed solution containing a sample and a reagent corresponding to the specific component (hereinafter referred to as the test component) is irradiated with light, and the absorbance and turbidity (scattered light intensity, transmitted light intensity) of the mixed solution are measured. If the test component is contained in the sample, the test component reacts with the reagent, causing the absorbance or turbidity of the mixed solution to change depending on the concentration of the test component. Therefore, by creating a calibration curve showing the relationship between the concentration of the test component and the absorbance or turbidity, the concentration of the test component in the sample can be calculated based on the calibration curve.

[0003] In an automated analyzer, quality control analysis is usually performed before starting analysis, such as when the power is turned on, or after a predetermined time has elapsed since the start of analysis, or after analyzing a predetermined number of samples. In quality control analysis, the above-mentioned measurements are performed on a quality control sample containing a test item component of a known concentration to determine the concentration of the test item component, and the quality control of the quantitative analysis is performed by checking whether the concentration is within a specified range (see, for example, Patent Document 1). [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2010-151707 Summary of the Invention [Problem to be solved by the invention]

[0005] When quality control analysis is performed at preset times during analysis, such as after a specified time has elapsed or after a specified number of samples have been analyzed, depending on the device settings, restrictions may be imposed so that subsequent sample analysis (hereinafter referred to as general sample analysis) cannot be performed unless quality control analysis is performed. If restrictions are imposed, for example, when there are samples for which the analysis results need to be reported urgently, or when there are many unanalyzed samples and general sample analysis is delayed, it is inconvenient that analysis cannot be continued.

[0006] In addition, based on the results of previous quality control analyses and general sample analyses, it may be determined that there is no problem even if quality control analyses are not performed immediately. When there are only a few unanalyzed samples remaining, it may be more convenient to continue with general sample analyses without performing quality control analyses.

[0007] The present invention has been made in consideration of the above-mentioned problems, and aims to enable appropriate analysis management according to the situation in an automatic analyzer that performs quality control analysis at predetermined times. [Means for solving the problem]

[0008] In order to solve the above problems, an automatic analysis system according to a first aspect of the present invention comprises: an analysis unit capable of selectively performing general sample analysis and quality control analysis; a display input unit; a timing setting storage unit that stores settings regarding the timing of performing the quality control analysis; a display control unit that displays a postponement instruction key on the display input unit at a predetermined timing before the execution time determined based on the setting stored in the time setting storage unit; The apparatus further includes a postponement control unit that postpones the execution time based on a predetermined operation performed on the postponement instruction key.

[0009] A display processing device for an automatic analysis system according to a second aspect of the present invention, which is made to solve the above problems, comprises: A display processing device for an automatic analysis system having an analysis unit that can selectively perform general sample analysis and quality control analysis, a display input unit; a timing setting storage unit that stores settings regarding the timing of performing the quality control analysis; a display control unit that displays a postponement instruction key on the display input unit at a predetermined timing before the execution time determined based on the setting stored in the time setting storage unit; The apparatus further includes a postponement control unit that postpones the execution time based on a predetermined operation performed on the postponement instruction key. [Effects of the Invention]

[0010] According to the present invention, the user can postpone the timing of quality control analysis with a simple operation, and can perform appropriate analysis management according to the analysis situation. [Brief explanation of the drawings]

[0011] [Figure 1] 1 is a configuration diagram showing an outline of an automatic analysis system according to one embodiment of the present invention. [Figure 2] FIG. 10 shows an example of a screen on which a postponement instruction key is displayed in the embodiment. [Figure 3] FIG. 10 shows an example of a screen on which analysis results are displayed in the embodiment. [Figure 4] 10 is a flowchart showing a processing procedure of a display control unit in the embodiment. [Figure 5] 10 is a flowchart showing the procedure of processing by a postponement control unit in the embodiment. [Figure 6] 10 is a flowchart showing the processing procedure of the quantification unit in the embodiment. [Figure 7] 10 is a flowchart showing a processing procedure of an output unit in the embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0012] An embodiment of an automated analysis system according to the present invention will be described below with reference to the drawings. The automated analysis system according to the present invention is an analysis system that can be used with an apparatus capable of automatically and continuously analyzing multiple samples, such as an automated biochemistry analyzer, an automated immunological analyzer, or an automated blood coagulation analyzer. In this embodiment, quality control analysis is not performed automatically, but is instead performed by a user performing a predetermined operation.

[0013] 1 is a schematic diagram showing the configuration of an automatic analysis system 1. The automatic analysis system 1 includes an analysis device 10 (analysis unit in the present invention) that analyzes samples, and a display processing device 20 that displays information related to the analysis device 10.

[0014] The analytical device 10 is configured to perform predetermined measurements on a general sample as a specimen and a quality control sample containing test item components at known concentrations. In this embodiment, the analytical device 10 is equipped with a light source and a photodetector. The analytical device 10 irradiates a mixed solution containing a sample and a reagent corresponding to the test item components with light from the light source, and measures changes in the amount of light (absorbance or turbidity) detected by the photodetector. The analytical device 10 can analyze multiple test item components for a single specimen. For example, a single specimen is dispensed into multiple containers, each of which is mixed with a reagent corresponding to the test item component, and the above-described measurements are performed on the mixed solution. The analytical device 10 according to this embodiment is configured so that subsequent general sample analysis is disabled unless the quality control analysis is performed properly.

[0015] The display processing device 20 includes a display input unit 30, a timing setting storage unit 40, a display control unit 50, and a postponement control unit 60. The actual entity of the display processing device 20 is, for example, a general-purpose personal computer (PC), and the functions of each component (the display input unit 30, the timing setting storage unit 40, the display control unit 50, the postponement control unit 60, and the quantification unit 70, storage unit 80, and output unit 90, which will be described later) can be realized by running dedicated control and processing software installed on the PC. The display processing device 20 is connected to the analysis device 10 via a network cable or wireless LAN.

[0016] The display input unit 30 is composed of a display such as a liquid crystal display, and an operation input unit such as a mouse, touch panel, numeric keypad, etc. The display input unit 30 displays multiple screens containing various information such as the analysis conditions, analysis progress, and analysis results of the analyzer 10, and the screens can be switched by selecting keys or tabs drawn on the screen with the mouse, touch panel, etc.

[0017] The timing setting memory unit 40 stores settings related to the timing of quality control analysis. The timing of quality control analysis may be set based on a date and time, or based on the interval (execution interval) between consecutive quality control analyses. The starting date and time may be, for example, the date and time when the analyzer 10 is powered on, the date and time when the analysis operation begins, the date and time when the quality control analysis is performed, etc. The interval may be a time interval, such as every two hours, or a sample number interval, such as every 50 samples. Alternatively, the interval may be set based on both time and the number of samples, and the size of each interval may vary. Reagents used in quality control analysis have recommended intervals for quality control analysis set according to their stability. Therefore, when a user sets the interval on a setting screen (not shown) displayed on the display / input unit 30 according to the analysis status while referring to the recommended interval, the execution time may be set accordingly and stored in the timing setting memory unit 40. The recommended intervals for each type of reagent may be stored in advance in the timing setting memory unit 40 (or another memory unit), and when the type of reagent or test item is selected, the timing for performing the quality control analysis may be set accordingly and stored in the timing setting memory unit 40.

[0018] The display control unit 50 monitors the elapsed time from the starting date and time or the number of general samples measured by the analyzer 10, and displays a postponement instruction key on the display input unit 30 to postpone the execution of the quality control analysis at a predetermined timing before the execution of the next quality control analysis. Note that "display" includes enabling an already displayed key from an inoperable state to an operable state. The timing for displaying the postponement instruction key may be immediately before the execution of the next quality control analysis, but it is preferable to display it when approximately 50% to 90% of the interval from the starting date and time to the execution of the next quality control analysis has elapsed.

[0019] FIG. 2 shows an example of a screen of the display / input unit 30 on which a postponement instruction key is displayed. In FIG. 2, the postponement instruction key A is displayed on a screen showing the implementation status of quality control analysis for each test item (hereinafter referred to as status information). The status information may be, for example, "QC Good" (QC stands for Quality Control) if the concentration of the test item component in the quality control sample is within the specified range as a result of the quality control analysis; "QC Abnormal" if the concentration is not within the specified range; "QC Failed" if the quality control analysis was not performed properly; or "No QC" if quality control analysis was not performed during the general sample analysis, or a corresponding icon. In FIG. 2, each cell in Table C corresponds to a test item, allowing the user to check the status information for each test item. For example, the cell in the first row from the top and first column from the left in Table C (item a) displays "QC Good," indicating that the quality control analysis for item a was performed normally and that quality control is in good condition. The box in the first row from the top, third column from the left in Table C (item c) displays "No QC," indicating that no quality control analysis will be performed during the analysis for item c. Figure 2 shows the state when item b is selected.

[0020] The display control unit 50 not only displays the postponement instruction key A at a predetermined timing before the execution time of the quality control analysis, but also updates the status information displayed on the display input unit 30 at that timing or when the execution time of the quality control analysis has passed. For example, at a predetermined timing before the execution time of the quality control analysis, the status information is updated to "QC preparation," and when the execution time of the quality control analysis has passed, the status information is updated to "QC exceeded." The postponement instruction key A is displayed only while the status information is "QC preparation," and when the status information changes to "QC exceeded," the postponement instruction key A is erased from the display input unit 30. In addition, as described below, the postponement instruction key A is also erased when a predetermined operation is performed on the postponement instruction key A. Note that "erasing" includes disabling a displayed key from an operable state to an inoperable state.

[0021] The postponement control unit 60 changes the settings stored in the timing setting memory unit 40 and postpones the execution time of the quality control analysis based on a predetermined operation performed on the postponement instruction key A (for example, an input operation such as the user clicking the postponement instruction key with a mouse on the display input unit 30). For example, the postponement control unit 60 postpones the execution time by adding the interval from the execution time of the postponed quality control analysis to the execution time of the next scheduled quality control analysis, or by skipping the execution time of the quality control analysis to be postponed. Furthermore, based on the predetermined operation performed on the postponement instruction key A, the postponement control unit 60 updates the status information, for example, to "QC postponed," and displays the postponement cancel key B indicated by the dotted line in FIG. 2 on the display input unit 30. At this time, the postponement instruction key A is erased. The postponement cancel key B is also erased when the postponed quality control analysis is executed. If the postponement process by the postponement control unit 60 continues, the reliability of quality control will decrease, so the process of displaying the postponement instruction key A in the display control unit 50 is not performed for the execution time of the quality control analysis after the postponement.

[0022] The display processing device 20 according to this embodiment further includes a quantification unit 70, a storage unit 80, and an output unit 90. The quantification unit 70 calculates the concentration of the test item component in the general sample based on a calibration curve created in advance from measurement data related to the light intensity measured by the analysis device 10. The calculation results are then stored in the storage unit 80. At this time, a flag is attached to the calculation results of the general sample analyzed during the period in which the quality control analysis was postponed (the period from the time when the quality control analysis was previously scheduled to be performed but was not performed due to the postponement until the time when the quality control analysis was performed after the postponement). This allows the calculation results of the general sample analyzed during the period in which the quality control analysis was postponed to be distinguished from the calculation results of the general sample analyzed outside that period.

[0023] The output unit 90 reads out the concentration results calculated by the quantification unit 70 from the storage unit 80 and outputs them by displaying them on the display / input unit 30 or printing them out on paper. At this time, calculation results with flags attached are output so that they can be distinguished from other calculation results by adding, for example, an underscore, a mark, or a comment, or by using a bold font. In Figure 3, the concentration value for item a is underscored.

[0024] An example of the operation of the automated analysis system according to this embodiment will be described with reference to the flowcharts of Figures 4 to 7. Figures 4 to 7 are flowcharts showing the processing procedures of the display control unit 50, the postponement control unit 60, the quantification unit 70, and the output unit 90, respectively. In this embodiment, when the analysis device 10 is started, a first quality control analysis is performed, and the flowcharts of Figures 4 to 7 start from the date and time when the first quality control analysis is completed. Hereinafter, quality control analysis will be abbreviated as QC.

[0025] 4, in step S101, the display control unit 50 determines whether the latest (next scheduled) QC execution time has passed. The QC execution time is set in advance by settings stored in the time setting storage unit 40. If the latest QC execution time has not passed, the process proceeds to step S102, and if the latest QC execution time has passed, the process proceeds to step S107.

[0026] If it is determined in step S101 that the latest QC execution time has not passed, the display control unit 50 determines in step S102 whether a predetermined time before the QC execution time has passed. If the predetermined time has passed, the process proceeds to step S103. If the predetermined time has not passed, the process returns to step S101.

[0027] In step S103, the display control unit 50 determines whether or not the status information needs to be updated (whether or not the status information is "QC good"). If an update is necessary, the display control unit 50 updates the status information to "QC ready" in step S104. If an update is not necessary (if the status information has already been updated to "QC ready"), the process returns to step S101.

[0028] After updating the status information in step S104, in step S105 the display control unit 50 determines whether the execution time of the latest QC is the execution time after postponement. If the execution time of the latest QC is not the execution time after postponement, in step S106 the display control unit 50 causes the display input unit 30 to display (enable) postponement instruction key A. Thereafter, the process returns to step S101. If the execution time of the latest QC is the execution time after postponement, the process returns to step S101 without performing step S106. This prevents the execution time of the postponed QC from being postponed again.

[0029] If it is determined in step S101 that the time for performing the latest QC has passed, the display control unit 50 determines in step S107 whether or not it is necessary to update the status information (whether or not the status information is "QC preparation"). If it is necessary to update the status information, the display control unit 50 updates the status information to "QC exceeded" in step S108 and erases the postponement instruction key from the display input unit 30. Thereafter, the process returns to step S101. If it is not necessary to update the status information (if the status information has already been updated to "QC exceeded"), the process returns directly to step S101.

[0030] The above process is repeatedly executed during system operation, thereby managing the timing of QC execution. If the user performs a predetermined operation (for example, by placing a QC sample in the analyzer 10 and inputting an instruction to perform QC to the analyzer 10) and QC is performed normally, and there are no problems with the results, the status information is reset to "QC good," the QC execution timing is updated to the next QC execution timing, and the operations of steps S101 to S108 are repeated.

[0031] After the postponement instruction key is displayed in step S106, if a predetermined operation is performed on the postponement instruction key, processing is performed by the postponement control unit 60. As shown in FIG. 5, in step S201, the postponement control unit 60 determines whether a predetermined operation has been performed on the postponement instruction key displayed on the display input unit 30. If the predetermined operation has not been performed, the process returns to step S201. If the predetermined operation has been performed, the postponement control unit 60 updates the status information to "QC postponed" in step S202, and postpones the execution time of the next scheduled QC to the execution time of the QC after that in step S203. In addition, in step S204, the postponement instruction key is erased (disabled) and a postponement cancel key is displayed on the display input unit 30. The order of steps S202, S203, and S204 does not matter, and they may be performed simultaneously. Thereafter, in step S205, the postponement control unit 60 erases the postponement cancel key when the postponed QC is performed. After step S205, the process returns to step S201, and the subsequent processes are repeated during the analysis.

[0032] According to the above process, a postponement instruction key is displayed on the display input unit 30 at a predetermined timing before the QC execution time, allowing the user to postpone the QC execution time depending on the usage status of the device. Furthermore, the status information displayed on the display input unit 30 is updated to "QC preparation" or "QC exceeded" at a predetermined timing, urging the user to prepare for or execute QC. Furthermore, the status information is updated to "QC postponed" based on a predetermined operation performed on the postponement instruction key, allowing the user to easily confirm that QC is being postponed. Furthermore, a postponement cancel key is displayed when a predetermined operation is performed on the postponement instruction key, allowing the user to cancel the postponement.

[0033] 6, the quantification unit 70 determines in step S301 whether or not a quantification request has been received from the analyzer 10. If no quantification request has been received, the process returns to step S301. If a quantification request has been received, the quantification unit 70 calculates the concentration of the test item component in the general sample based on a calibration curve created in advance from the measurement data measured by the analyzer 10 in step S302. Next, in step S303, the quantification unit 70 determines whether or not the general sample whose concentration has been calculated was analyzed within a period during which the QC execution time was postponed (i.e., from the time when the QC execution time was previously set but was not performed due to the postponement to the time when the QC execution time was postponed). If the general sample was analyzed within a period during which the QC execution time was postponed, the quantification unit 70 attaches a flag to the calculation result calculated in step S302 and stores the result in the memory unit 80 in step S304. If the general sample was not analyzed within the period for which QC execution was postponed, in step S305, the quantification unit 70 stores the calculation result calculated in step S302 without attaching a flag in the storage unit 80. After steps S304 and S305, the process returns to step S301, and the subsequent processes are repeated.

[0034] Furthermore, as shown in FIG. 7, the output unit 90 determines in step S401 whether or not there is an output request. If there is no output request, the process returns to step S401. If there is an output request, the output unit 90 reads out the calculation result stored by the quantification unit 70 from the memory unit 80 in step S402. Next, in step S403, the output unit 90 determines whether or not a flag is attached to the calculation result. If a flag is attached to the calculation result, the output unit 90 displays the calculation result on the display input unit 30 with a mark such as an underscore, a mark, or a comment attached in step S404. If a flag is not attached to the calculation result, the output unit 90 displays the calculation result as is on the display input unit 30 in step S405. After steps S404 and S405, the process returns to step S401, and the subsequent processes are repeated.

[0035] According to the above process, the results of quantitative analysis can be output separately for samples analyzed while the execution time of QC was postponed and samples analyzed at other times.

[0036] (Variation) The above describes specific examples of the form for carrying out the present invention, but the present invention is not limited to the above-described embodiments, and appropriate modifications are permitted within the scope of the spirit of the present invention.

[0037] In the above embodiment, when the timing of the quality control analysis is postponed, the timing is postponed until the next execution time, and the postponed execution time is not repeatedly postponed. However, the longest postponement time may be set to the next execution time, and the postponement may be repeated little by little during that time.

[0038] In the above embodiment, when the status information is updated, a pop-up screen may be displayed at the time of update so that the user can easily recognize it, or a sound or a lamp may be used to notify the user.

[0039] In the above embodiment, the timing of the quality control analysis is postponed by performing a specified operation on the postponement instruction key displayed on the display input unit 30. However, it is also possible to have a configuration in which a button or the like other than the display input unit 30 is enabled based on the status information displayed on the display unit being updated to "QC preparation", and the timing of the quality control analysis is postponed by pressing that button.

[0040] [Aspect] It will be apparent to those skilled in the art that the above-described exemplary embodiments are examples of the following aspects.

[0041] (Item 1) An automated analysis system according to one aspect of the present invention comprises: an analysis unit capable of selectively performing general sample analysis and quality control analysis; a display input unit; a timing setting storage unit that stores settings regarding the timing of performing the quality control analysis; a display control unit that displays a postponement instruction key on the display input unit at a predetermined timing before the execution time determined based on the setting stored in the time setting storage unit; The apparatus further includes a postponement control unit that postpones the execution time based on a predetermined operation performed on the postponement instruction key.

[0042] This enables appropriate analysis management according to the situation in an automatic analyzer that performs quality control analysis at a preset time.

[0043] (2) The automatic analysis system according to the first aspect of the present invention comprises: moreover, a storage unit for storing the results; The result stored in the storage unit is executed within the period for which the execution time is postponed. execution And Taichi The results of general sample analysis and those outside the above period execution And Taichi The apparatus may also be provided with an output section that outputs the results of the general sample analysis separately from the results of the analysis of the sample.

[0044] This makes it easy to determine which of the analysis results are from samples analyzed during the postponement of the quality control analysis. If there is a problem with the quality control analysis after the postponement, it is only necessary to check the results of the samples analyzed during the postponement, making the confirmation process easier.

[0045] (Item 3) The automatic analysis system according to item 1 or 2, the display input unit displays identification information that identifies the analysis status of the quality control analysis, The postponement control unit may set the identification information to "postponed" based on a predetermined operation being performed on the postponement instruction key.

[0046] This makes it easier for the user to recognize that the timing of quality control analysis has been postponed.

[0047] (4) The automatic analysis system according to the first or second aspect of the present invention comprises: The postponement control unit may display a postponement cancel key on the display input unit based on a predetermined operation being performed on the postponement instruction key.

[0048] This allows the user to cancel the postponement of quality control analysis at their discretion while the postponement is in progress.

[0049] (Item 5) Automated Analysis According to an Aspect of the Present Invention system The display processing device for A display processing device for an automatic analysis system having an analysis unit that can selectively perform general sample analysis and quality control analysis, a display input unit; a timing setting storage unit that stores settings regarding the timing of performing the quality control analysis; a display control unit that displays a postponement instruction key on the display input unit at a predetermined timing before the execution time determined based on the setting stored in the time setting storage unit; The apparatus further includes a postponement control unit that postpones the execution time based on a predetermined operation performed on the postponement instruction key.

[0050] This enables appropriate analysis management according to the situation in an automatic analyzer that performs quality control analysis at a preset time. [Explanation of symbols]

[0051] 10…Analyzer 20...Display processing device 30...Display input section 40...Time setting memory section 50...Display control unit 60... Postponement control unit 70...Quantitative part 80...Storage section 90...Output section

Claims

1. an analysis unit capable of selectively performing general sample analysis and quality control analysis; a display input unit; a timing setting storage unit that stores settings regarding the timing of performing the quality control analysis; a display control unit that displays a postponement instruction key on the display input unit at a predetermined timing before the execution time determined based on the setting stored in the time setting storage unit; a postponement control unit that postpones the execution time based on a predetermined operation performed on the postponement instruction key; An automated analysis system comprising:

2. The automated analysis system according to claim 1, further comprising: a storage unit for storing the results; an output unit that outputs the results stored in the storage unit by distinguishing between the results of the general sample analysis performed within the period for which the execution time was postponed and the results of the general sample analysis performed outside the period; An automated analysis system comprising:

3. The automated analysis system according to claim 1, the display input unit displays identification information that identifies the analysis status of the quality control analysis, The postponement control unit sets the identification information to "postponed" based on a predetermined operation being performed on the postponement instruction key.

4. The automated analysis system according to claim 1, The postponement control unit displays a postponement cancel key on the display input unit based on a predetermined operation being performed on the postponement instruction key.

5. A display processing device for an automatic analysis system having an analysis unit that can selectively perform general sample analysis and quality control analysis, a display input unit; a timing setting storage unit that stores settings regarding the timing of performing the quality control analysis; a display control unit that displays a postponement instruction key on the display input unit at a predetermined timing before the execution time determined based on the setting stored in the time setting storage unit; a postponement control unit that postpones the execution time based on a predetermined operation performed on the postponement instruction key; A display processing device comprising:

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