Automated analysis device and reagent registration method for same
The automated analyzer addresses the issue of reagent waste by prioritizing used reagents over new ones through a reagent management system, enhancing reagent utilization efficiency.
Patent Information
- Application Number
- PCT/JP2025/000660
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-01-18
- Filing Date
- 2025-01-10
- Publication Date
- 2025-07-24
AI Technical Summary
Existing automated analyzers do not effectively manage the use of reagent containers, leading to potential waste due to users accidentally opening new reagents when used reagents are available, making it difficult to utilize all reagents before expiration.
An automated analyzer with a reagent holding unit, reading unit, storage unit, and control unit that prioritizes the use of used reagent containers over new ones by identifying and managing reagent information through identifiers, ensuring efficient reagent utilization.
The system encourages the use of used reagents, reducing waste and optimizing reagent consumption by guiding users to prioritize used containers, thereby extending their use until expiration.
Smart Images

Figure JP2025000660_24072025_PF_FP_ABST
Abstract
Description
Automatic analyzer and reagent registration method therefor
[0001] The present invention relates to an automatic analyzer and a reagent registration method therefor.
[0002] Patent Document 1 discloses an automatic analyzer in which a partially used reagent bottle that has been set in a certain analytical unit and used for analysis is temporarily stored in a refrigerator or the like at the end of work hours, and then the reagent bottle is reliably reset in the same analytical unit when use is resumed, thereby ensuring the reliability of data obtained during analysis and preventing waste of reagents and standard solutions.
[0003] Japanese Patent Application Laid-Open No. 2002-48800
[0004] Patent Document 1 does not take into consideration the case where, in addition to the partially used reagent container (reagent bottle) that has been temporarily set aside, there is another unopened reagent container stored that contains the same type of reagent as the reagent contained in the reagent container. As a result, there is a possibility that a user may unintentionally open a new reagent container even though a partially used reagent container exists. As the number of opened reagent containers increases, it becomes difficult to use up all the reagent before the expiration date, leading to reagent waste.
[0005] An object of the present invention is to provide an automatic analyzer that encourages users to use partially used reagent containers and improves the efficiency of reagent utilization.
[0006] In order to solve the above-mentioned problems, the automatic analyzer of the present invention comprises a reagent holding unit that holds a plurality of reagent containers that contain reagents; a reading unit that reads reagent information including the type of reagent from identifiers attached to the reagent containers; a memory unit that stores the reagent information of the partially used reagent containers; and a control unit that, when the reagent information is read from the identifier attached to the unopened reagent container, determines by referring to the memory unit whether or not there are partially used reagent containers that contain the same type of reagent as the reagent contained in the unopened reagent containers, and if there are partially used reagent containers that contain the same type of reagent, the control unit performs control to guide the partially used reagent containers to be used preferentially over the unopened reagent containers.
[0007] According to the present invention, it is possible to provide an automatic analyzer that encourages users to use partially used reagent containers and improves the efficiency of reagent use.
[0008] 1 is a front view showing an outline of an automatic analyzer and a storage cabinet; a top view of an analysis unit; a perspective view showing the configuration of a reagent container; a flowchart showing the processing of the automatic analyzer and the actions of a user when installing a reagent container; an example of a list screen of half-used reagents according to Example 1; a diagram showing a state in which a pull-down menu for narrowing down reagents is displayed on the list screen of half-used reagents; a diagram showing a state in which reagents have been narrowed down on the list screen of half-used reagents; an example of a reagent reading screen; an example of a reagent registration confirmation screen according to Example 1; an example of a screen recommending the registration of spare reagents; an example of a list screen of half-used reagents according to Example 2; an example of a reagent registration confirmation screen according to Example 2.
[0009] Hereinafter, an embodiment of the present invention will be described with reference to the drawings.
[0010] An automatic analyzer according to a first embodiment will be described with reference to FIGS. 1 to 10. FIG.
[0011] 1 is a front view showing an outline of an automatic analyzer and a storage cabinet. The automatic analyzer 1 includes a tag reader 13 (reading unit), an analysis unit 11, an output unit 12, an input unit 16, a memory unit 14, and a control unit 15. The storage cabinets 17a and 17b store reagent containers used in the automatic analyzer 1.
[0012] The tag reader 13 reads an IC tag (hereinafter simply referred to as a tag), which is an identifier attached to a reagent container. If the identifier attached to the reagent container is an RFID tag or a two-dimensional barcode other than an IC tag, a device capable of reading the identifier is used as the reading unit. The analysis unit 11 analyzes the components of a specimen (a biological sample such as blood or urine), and details will be described later using FIG. 2 . The output unit 12 is, for example, a display, and displays screens showing the status of the automated analyzer 1, analysis items, analysis results, advice and warnings for the user, etc. The input unit 16 is, for example, a keyboard or mouse, and accepts inputs from the user when setting or selecting specific items. The output unit 12 and the input unit 16 may be integrated into one unit, such as a touch panel. The memory unit 14 stores operation sequences, analysis results, reagent information (e.g., whether or not a partially used reagent, as described below, is present), etc., and is implemented as a storage device such as a HDD. The control unit 15 is connected to the aforementioned components that make up the automatic analyzer 1, controls the operation of each component, and displays a screen on the output unit 12, and is composed of, for example, a CPC or an MPU.
[0013] The storage cabinets 17a and 17b have a refrigeration function. Here, the description will be given assuming that the automated analyzer 1 of this embodiment does not have a function for refrigerating reagents after shutdown. Therefore, when the automated analyzer 1 is shut down, the user must remove the reagent containers from the automated analyzer 1 and transfer them to the storage cabinets 17a and 17b. Furthermore, when the user attempts to shut down the automated analyzer 1, it is desirable that a display or sound be output from the output unit 12 urging the user to remove the reagent containers. Note that although two storage cabinets 17a and 17b are shown in FIG. 1, the number of storage cabinets is not limited to this.
[0014] 2 is a top view of the analysis unit 11. The analysis unit 11 includes a reagent sample disk 21 (SR disk), a reaction disk (incubator) 27, a barcode reader 24, a dispensing mechanism 26, and a spectrophotometer 29.
[0015] The reagent and sample disk 21 has a reagent holding section 25 that holds a plurality of reagent containers 22 containing reagents, and a sample holding section 28 that holds a plurality of sample containers 23 containing samples, and is rotated by a drive mechanism (not shown). The reagent holding section 25 is provided on the inner diameter side of the reagent and sample disk 21, and the sample holding section 28 is provided on the outer diameter side of the reagent and sample disk 21. Furthermore, the sample holding section 28 can be transported independently of the reagent holding section 25.
[0016] The reaction disk 27 has a plurality of reaction vessels 30 mounted thereon in a circumferential arrangement and is rotated by a drive mechanism (not shown). The barcode reader 24 is disposed around the periphery of the reagent / sample disk 21 and reads the barcodes attached to the sample vessels 23.
[0017] The dispensing mechanism 26 is provided between the reagent / sample disk 21 and the reaction disk 27 and is capable of rotation and vertical movement. When dispensing a reagent, the dispensing mechanism 26 aspirates the reagent from a reagent container 22 located at the reagent aspirating position on the reagent / sample disk 21 and dispenses the aspirated reagent into a reaction container 30 located at the dispensing position on the reaction disk 27. When dispensing a sample, the dispensing mechanism 26 aspirates the sample from a sample container 23 located at the sample aspirating position on the reagent / sample disk 21 and dispenses the aspirated sample into a reaction container 30 located at the dispensing position on the reaction disk 27.
[0018] The spectrophotometer 29 is disposed around the reaction disk 27 and performs measurements for biochemical testing. The spectrophotometer 29 is equipped with a light source and a detector (not shown), and measures the absorbance of the reaction solution by irradiating a reaction solution containing a mixture of a reagent and a sample with the light source, dispersing and detecting the transmitted light. The measurement results of the spectrophotometer 29 are sent to the control unit 15, which calculates the component concentrations of the sample based on the measurement results. Note that instead of or in addition to the spectrophotometer 29, a detector that uses a photomultiplier tube to detect the amount of luminescence resulting from the luminescence reaction of a labeling substance contained in the reaction solution that has been reacted for a predetermined time on the reaction disk 27 may be provided as a detection mechanism for immunoassays.
[0019] FIG. 3 is a perspective view showing the configuration of a reagent container. As shown in FIG. 3, the reagent container 22 has a rectangular parallelepiped shape, and its top surface has multiple openings 31 protruding upward to allow the dispensing mechanism 26 to access the reagent. A tag 32 is attached to one of its short sides. The tag 32 records reagent information, including the type of reagent contained in the reagent container 22. The reagent information includes, for example, the type of reagent, lot number, individual identification number, remaining amount of reagent, number of tests, start date and time of use of the reagent container, expiration date of the reagent, etc. Note that the identifier attached to the reagent container 22 may be an RFID tag, a two-dimensional barcode, etc., as described above.
[0020] 4 is a flowchart showing the processing of the automatic analyzer and the actions of the user when installing a reagent container. In FIG. 4, steps S404 and S410 are actions of the user, and the other steps are processing of the automatic analyzer 1 (controller 15).
[0021] When a user uses a new reagent, the user registers the reagent in the automated analyzer 1. Here, it is assumed that the user will open the reagent container themselves after registering the reagent and before placing it in the reagent holding unit 25, but the reagent container may be opened automatically by the automated analyzer or before registering the reagent. The automated analyzer's processing for reagent registration is started when the user performs a predetermined operation on the input unit 16 while viewing a predetermined screen displayed on the output unit 12. When the reagent registration process starts, the control unit 15 refers to the memory unit 14 and determines whether or not there is a partially used reagent (opened reagent container), regardless of whether the reagent has already been placed in the reagent holding unit 25 or is stored in the storage cabinet 17 (step S401).
[0022] If it is determined that a half-used reagent is present, the control unit 15 causes the output unit 12 to display a list screen of half-used reagents (step S402). FIG. 5 illustrates an example of the list screen of half-used reagents according to Example 1. As shown in FIG. 5 , the list screen of half-used reagents includes a reagent selection tab 51 for narrowing down the search by reagent, a lot number 54 identifying each reagent container, a rack number 55 identifying each rack on which the reagent container is placed, a remaining amount of reagent 56, a registration date 57 of the reagent, an expiration date 58, whether the reagent is installed in the reagent storage unit 59, a next button 52 for transitioning to the next screen (the reagent reading screen in FIG. 8 ), and a print button 53 for printing the screen. When the user taps the reagent selection tab 51 using the input unit 16, a pull-down menu of candidate reagents for narrowing down the search is displayed, as shown in FIG. 6 . When the user selects a specific reagent, only the narrowed-down list of half-used reagents is displayed, as shown in FIG. 7 .
[0023] When the Next button 52 in FIGS. 5 to 7 is tapped or when it is determined in step S401 that there is no half-used reagent, the control unit 15 causes the output unit 12 to display a reagent reading screen (step S403). FIG. 8 is an example of the reagent reading screen. As shown in FIG. 8 , the reagent reading screen includes a message 84 prompting the user to bring the reagent container closer to the tag reader to read the reagent information, a read execution button 81, a cancel button 82 for canceling the reagent registration process, and a back button 83 for transitioning to the previous screen. The user then taps the read execution button 81 and brings the reagent container closer to the tag reader to cause the tag reader to read the reagent information on the tag (step S404). The user may remove the reagent container from the storage either after tapping the read execution button 81 or before tapping the read execution button 81.
[0024] Next, the control unit 15 determines whether the reagent is new, i.e., whether the reagent container is unopened, based on the read reagent information (step S405). If the reagent is determined to be new, the control unit 15 determines whether there is a half-used reagent of the same type by referring to the storage unit 14 (step S406). If there is no half-used reagent of the same type, the control unit 15 registers the reagent and stores the reagent information of the reagent in the storage unit 14 (step S407).
[0025] On the other hand, if a half-used reagent of the same type is found in step S406, the control unit 15 determines whether the reagent container containing the half-used reagent has already been installed in the reagent storage unit 25 (step S408). Whether the half-used reagent has already been installed is determined by, for example, whether the tag 32 of the opened reagent container has been read by the tag reader 13, whether the user has input that the reagent has been installed, or whether the tag 32 of the reagent container on the reagent storage unit 25 has been automatically read by a tag reader separately provided on the reagent sample disk 21. If it is determined in step S408 that the half-used reagent has already been installed, the control unit 15 registers the reagent and stores the reagent information of the reagent in the memory unit 14 without displaying on the output unit 12 that a half-used reagent of the same type exists (step S407). This is because if the half-used reagent has already been installed in the reagent storage unit 25, it is considered that the user, despite being aware of the existence of the half-used reagent, still wishes to register a new reagent.
[0026] Furthermore, if it is determined in step S408 that a half-used reagent has not been installed, the control unit 15 causes the output unit 12 to display a registration confirmation screen (step S409). FIG. 9 is an example of the reagent registration confirmation screen according to Example 1. As shown in FIG. 9, the registration confirmation screen displays a message 94 informing the user that a half-used reagent container containing the same type of reagent exists and prompting confirmation of reagent registration, along with information about the half-used reagent (lot number 54, etc.). The registration confirmation screen also includes an execute reagent registration button 91, a cancel button 92 for canceling the reagent registration process, and a print button 93 for printing the screen. After checking the registration confirmation screen, the user determines whether or not to register the new reagent that has been read (step S410).
[0027] If the user overlooks a partially used reagent of the same type on the screen displayed in step S402, the user taps the cancel button 92 to cancel the registration of the new reagent and remove the partially used reagent (opened reagent container) from the storage and place it in the reagent holding unit 25. This prevents the user from unintentionally opening a new reagent container even though a partially used reagent container is present in the storage, thereby increasing the number of opened reagent containers. As a result, it becomes easier to effectively use each reagent until its expiration date, leading to savings in reagent consumption. On the other hand, if the user knows that a partially used reagent exists in the storage but still wishes to use an unopened reagent container, the user taps the execute button 91 to instruct the registration of a new reagent. In this case, the control unit 15 registers the new reagent and stores the reagent information of the reagent in the memory unit 14 (step S407).
[0028] If the reagent is not new in step S405, i.e., if the reagent is determined to be a partially used reagent, the control unit 15 determines whether the remaining amount of reagent in the reagent container whose tag was read is equal to or greater than a predetermined value (step S411). If the remaining amount of reagent is equal to or greater than the predetermined value, the user places the reagent container in the reagent storage unit 25 as is, since there is a sufficient amount remaining for the analysis. On the other hand, if the remaining amount of reagent is less than the predetermined value, there is a possibility that the reagent will run out during the analysis, so the control unit 15 displays a screen recommending the registration of a spare reagent on the output unit 12 (step S412). FIG. 10 is an example of the screen recommending the registration of a spare reagent. As shown in FIG. 10, the screen recommending the registration 102 urges the user to register an unopened reagent container containing the same type of reagent as the partially used reagent whose tag was read as a spare reagent and place it in the reagent storage unit 25, along with information about the partially used reagent (e.g., lot number 54). The screen recommending the registration also includes an end button 101. When the end button 101 is tapped, the control unit 15 ends the processing.
[0029] 5 to 7, the user is notified of information about the partially used reagent before the tag is read. Therefore, if there is a partially used reagent that is the same as the reagent contained in the unopened reagent container that the user is attempting to register, the user can be made aware of this at an early stage before the tag is read. As a result, it is possible to prevent the user from having to take the unopened reagent container out of the storage cabinet and bring it close to the tag reader even though the used reagent is present.
[0030] An automatic analyzer according to Example 2 will be described with reference to Figures 11 and 12. Example 2 differs from Example 1 in that the list screen of half-used reagents also displays information identifying a repository that stores opened reagent containers containing half-used reagents. Note that the configuration of the automatic analyzer according to Example 2 and the processing performed when installing reagent containers are the same as those of Example 1.
[0031] Fig. 11 is an example of a list screen of half-used reagents according to Example 2, and corresponds to Fig. 5 of Example 1. Fig. 12 is an example of a reagent registration confirmation screen according to Example 2, and corresponds to Fig. 9 of Example 1. As shown in Figs. 11 and 12 , by also displaying the reagent storage cabinet number 111 as the storage location of the half-used reagent, the user can easily search for the reagent container even when there are multiple storage cabinets that are storage locations. The storage locations of half-used reagents are stored in the memory unit 14, and may be determined in advance by the user for each reagent, or may be input by the user when registering the reagent.
[0032] The present invention is not limited to the above-described embodiments and includes various modifications. Furthermore, in each embodiment, the automated analyzer does not have a refrigeration function, so after shutting down the automated analyzer, the user must store partially used reagents in a storage cabinet. However, even if the automated analyzer has a refrigeration function, partially used reagents must be stored in a storage cabinet if there is no free storage space in the automated analyzer. Therefore, the present invention is also effective for automated analyzers with a refrigeration function. Furthermore, in each embodiment, when an unopened reagent container is read by the tag reader, if there is a partially used reagent container containing the same type of reagent, the control unit 15 causes the output unit 12 to output a message to that effect. However, because the presence or absence of an unopened reagent container can be determined in step S401, the control unit 15 may lead to the partially used reagent container being used preferentially by not registering the unopened reagent container without outputting a message to the output unit 12 indicating the presence of a partially used reagent container.
[0033] 1...automatic analyzer, 11...analysis unit, 12...output unit, 13...tag reader, 14...storage unit, 15...control unit, 16...input unit, 17a, 17b...storage cabinet, 21...reagent sample disk, 22...reagent container, 23...sample container, 24...barcode reader, 25...reagent holding unit, 26...dispensing mechanism, 27...reaction disk, 28...sample holding unit, 29...spectrophotometer, 30...reaction container, 31...opening, 32...tag, 51...sample Drug selection tab, 52...Next button, 53...Print button, 54...Lot number, 55...Rack number, 56...Remaining amount, 57...Registration date, 58...Expiration date, 59...Installation status, 81...Execute button, 82...Cancel button, 83...Back button, 84...Message, 91...Execute button, 92...Cancel button, 93...Print button, 94...Message, 101...Exit button, 102...Advice, 111...Reagent storage number
Claims
1. A reagent holding unit that holds a plurality of reagent containers for storing reagents, a reading unit that reads reagent information including the type of reagent from an identifier attached to the reagent container, a storage unit that stores the reagent information of the reagent container in use, and a control unit that determines the presence or absence of a reagent container in use that stores the same type of reagent as the reagent stored in the unopened reagent container by referring to the storage unit when the reagent information is read from the identifier attached to the unopened reagent container. The control unit performs control to guide the reagent container in use to be preferentially used over the unopened reagent container when there is a reagent container in use that stores the same type of reagent. An automatic analyzer.
2. The automatic analyzer according to claim 1, further comprising an output unit that outputs that fact when there is a reagent container in use that stores the same type of reagent.
3. The automatic analyzer according to claim 2, wherein when there is a reagent container in use, the control unit causes the output unit to display a list screen of the reagent containers in use and then causes the output unit to display a reading screen that prompts the user to read the reagent information. An automatic analyzer.
4. The automatic analyzer according to claim 3, wherein the list screen includes information for identifying the storage cabinet for storing the reagent containers in use.
5. The automatic analyzer according to claim 2, wherein even when there is a reagent container in use that stores the same type of reagent, when the reagent container is already installed in the reagent holding unit, the output unit does not output that fact.
6. The automatic analyzer according to claim 1, wherein when there is no reagent container in use that stores the same type of reagent, the control unit stores the reagent information read from the identifier in the storage unit.
7. The automatic analyzer according to claim 6, further comprising an input unit that receives an input from the user. Even when there is a reagent container in use that stores the same type of reagent, when the input unit receives an input from the user instructing the use of the unopened reagent container, the control unit stores the reagent information read from the identifier in the storage unit.
8. The automatic analyzer according to claim 2, wherein the reagent information is read from the identifier attached to the reagent container of the partially used container, and when the remaining amount of the reagent in the reagent container is less than a predetermined value, the control unit causes the output unit to output advice for prompting the user to install an unopened reagent container containing the same type of reagent as the reagent. Automatic analyzer.
9. The automatic analyzer according to claim 1, which does not have a function of keeping the reagent cold after shutdown. Automatic analyzer.
10. A step in which a reading unit reads reagent information including the type of reagent from an identifier attached to an unopened reagent container containing the reagent; a step in which a control unit determines the presence or absence of a partially used reagent container containing the same type of reagent as the reagent contained in the unopened reagent container; and a step in which, when there is a partially used reagent container containing the same type of reagent, the control unit performs control to guide the partially used reagent container to be preferentially used over the unopened reagent container. A method for registering reagents in an automatic analyzer.
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