Automatic analysis device and automatic analysis method

WO2025037494A1PCT designated stage expired Publication Date: 2025-02-20HITACHI HIGH TECH CORP
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Patent Information

Application Number
PCT/JP2024/024237
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-08-14
Filing Date
2024-07-04
Publication Date
2025-02-20

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Abstract

To enable analysis of a certain specimen that can be analyzed when a prescribed condition is met even if a setting for recovering a rack on which the specimen is mounted is effective when an abnormality that cannot be analyzed occurs in the specimen. An automatic analysis device according to the present disclosure performs preset control from among first control and second control. The first control is control for, when there is a dispensing abnormality of the specimen, continuing an analysis scheduled for another specimen in a rack on which a specimen container storing the specimen is mounted. The second control is control for, when there is a dispensing abnormality of the specimen, cancelling the analysis scheduled for another specimen in the rack on which the specimen container storing the specimen is mounted, and conveying the rack to a rack storage unit by a conveyance mechanism. When there is a dispensing abnormality of the specimen in a state in which the second control is set, the automatic analysis device performs the first control when the prescribed condition is met (refer to fig. 2).
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Description

Automatic analysis device and automatic analysis method

[0001] The present disclosure relates to an automatic analyzer and an automatic analysis method, for example, an automatic analyzer that performs quantitative and qualitative analysis of biological samples such as blood and urine, and more particularly to an automatic analyzer equipped with a transport device that transports sample containers to the analyzer.

[0002] Automated analyzers that automatically perform quantitative and qualitative analysis of biological samples such as blood and urine have become increasingly popular, particularly in large hospitals and clinical testing centers that need to process many patient samples in a short period of time. Various types of automated analyzers have been developed, ranging in size from large to medium to small, depending on their processing capacity. In the case of medium and large analyzers, multiple sample containers containing samples are held in holders called sample racks and transported to the analyzer via a transport line (transport device). Some analyzers can automatically output analysis results simply by having a laboratory technician insert a rack into the sample rack input port.

[0003] In this case, the automatic analyzer transports racks inserted into a sample rack inlet on a belt conveyor-like transport line, and during transport a barcode reader on the line identifies the rack type and the sample and performs analysis.

[0004] As mentioned above, in facilities where many patient samples are processed in one day, it is desirable for an automated analyzer to output analysis results as quickly as possible.

[0005] In order to output many analysis results, Patent Document 1 describes a means for identifying samples that require reanalysis due to an abnormality or samples that need to be collected for reanalysis, and for interrupting the analysis of the sample rack on which the sample is loaded and issuing an instruction to collect the sample.

[0006] JP 2016-14686 A

[0007] In the above-mentioned conventional device, if an abnormality occurs that makes analysis impossible, such as a lack of sample, the analysis of the rack on which the sample is loaded is interrupted and the rack is recovered, making it possible to quickly recover a specific sample without waiting for the completion of analysis of other samples loaded on that rack.

[0008] However, with the above method, the operator is unable to immediately remove the rack and samples collected by the device, and analyzable samples remain in the rack storage section without being analyzed, which is a problem.

[0009] The above problem is particularly significant in the case of urgent specimens for which rapid output of analytical results is required.

[0010] The present disclosure proposes a technology that enables the analysis of samples that can be analyzed if certain conditions are met when an abnormality occurs in a sample that makes it impossible to analyze, even if a setting to recover the rack on which the sample is loaded is enabled.

[0011] An example of an automatic analyzer according to the present disclosure is an automatic analyzer comprising: a transport mechanism that transports a rack carrying a plurality of specimen containers containing specimens to be analyzed to a dispensing mechanism; a dispensing mechanism that dispenses specimens loaded on the rack transported by the transport mechanism; a rack storage unit that stores the rack in a position from which the rack can be removed; and a control unit that performs a preset control of a first control or a second control, wherein the first control is a control that, when there is an abnormality in the dispensing of the specimen, continues the analysis planned for other specimens in the rack carrying the specimen container containing the specimen; the second control is a control that, when there is an abnormality in the dispensing of the specimen, cancels the analysis planned for other specimens in the rack carrying the specimen container containing the specimen and transports the rack to the rack storage unit by the transport mechanism; and when there is an abnormality in the dispensing of the specimen with the second control set, the control unit performs the first control if a predetermined condition is met.

[0012] An example of an automatic analysis method according to the present disclosure is an automatic analysis method using an automatic analyzer comprising: a transport mechanism that transports a rack carrying a plurality of specimen containers containing specimens to be analyzed to a dispensing mechanism; a dispensing mechanism that dispenses specimens loaded onto the rack transported by the transport mechanism; a rack storage unit that stores the rack in a position from which the rack can be removed; and a control unit that performs a preset control of a first control or a second control, wherein the first control is a control that, when there is an abnormality in the dispensing of the specimen, continues the analysis planned for other specimens in the rack carrying the specimen containers containing the specimen; and the second control is a control that, when there is an abnormality in the dispensing of the specimen, cancels the analysis planned for other specimens in the rack carrying the specimen containers containing the specimen and transports the rack to the rack storage unit by the transport mechanism; and the automatic analysis method includes the control unit performing the first control when there is an abnormality in the dispensing of the specimen and when a predetermined condition is met.

[0013] If an abnormality occurs that makes analysis impossible, even if the setting to recover the rack on which the sample is loaded is enabled, by making it possible to analyze analyzable samples if certain conditions are met, the time that analyzable samples remain in the rack storage section without being analyzed can be minimized.

[0014] It is a schematic diagram of the entire configuration of an automatic analyzer according to an embodiment of the present disclosure.It is a flowchart showing the flow of processing of an automatic analyzer according to an embodiment of the present disclosure.It is a configuration diagram of a GUI related to the operation of an automatic analyzer according to an embodiment of the present disclosure.

[0015] The configuration and operation of an automatic analyzer according to an embodiment of the present disclosure will be described below with reference to FIGS.

[0016] 1 is a schematic diagram of an entire configuration of an automatic analyzer according to an embodiment of the present disclosure. The automatic analyzer automatically analyzes (or measures; the same applies hereinafter) samples, and executes an automatic analysis method according to this embodiment.

[0017] The automatic analyzer of this embodiment comprises a sample rack input unit 1, an ID reading unit 2, a transport mechanism 3, a rack standby unit 4, an analysis module 5, a rack storage unit 6, and an overall management computer 7 (control unit).

[0018] The sample rack input unit 1 is a section where a plurality of sample racks, each holding a plurality of samples (specimens), are input. The analysis modules 5 are arranged along the transport mechanism 3.

[0019] The transport mechanism 3 transports a sample rack (rack) carrying a plurality of sample containers containing samples to be analyzed from the sample rack input unit 1 to the dispensing mechanism of the analysis module 5. The transport mechanism 3 also transports samples that have been analyzed in the analysis module 5 to the rack standby unit 4. The transport mechanism 3 also transports sample racks for which no analysis request has been made from the sample rack input unit 1 to the rack storage unit 6.

[0020] The rack standby unit 4 is installed in the transport mechanism 3 to which racks loaded with standard samples, quality control samples, general samples, etc. are transported. The rack standby unit 4 is a line mechanism that holds and waits for one or more sample racks (including, but not limited to, sample racks scheduled for analysis). The rack standby unit 4 can hold a rack loaded with any sample transported by the transport mechanism 3 for any period of time, and can supply the rack again to the analysis module 5 or the rack storage unit 6 at any timing.

[0021] The rack storage unit 6 stores the sample rack in a position where it can be removed.

[0022] The automatic analyzer is equipped with a sample rack input unit 1, an ID reader 2, a transport mechanism 3, a rack standby unit 4, an analysis module 5, and an overall management computer 7 that performs the necessary control over a rack storage unit 6. The automatic analyzer is also equipped with an operation unit 8 for inputting information and a display device 9 for displaying analysis results, etc., which are connected to the overall management computer 7.

[0023] Each sample held in a sample rack is associated with a sample ID indicating attribute information about the sample (reception number, patient name, requested analysis items, whether it is a trace sample, whether it is a general sample, whether it is an urgent sample, etc.). Furthermore, each sample rack is associated with a rack ID indicating rack identification information such as a rack number. The sample rack placed in the sample rack input unit 1 is transported by the transport mechanism 3, and when the sample rack moves to the transport mechanism 3, the sample ID and sample rack ID are read by the ID reading unit 2 and sent to the overall management computer 7.

[0024] The sample rack is then transported to the analysis module 5 via the rack standby unit 4. The analysis module 5 is equipped with a dispensing mechanism that dispenses samples loaded onto the sample rack transported by the transport mechanism 3.

[0025] During dispensing by the dispensing mechanism, a sample dispensing error may occur. When a sample dispensing error occurs, the overall management computer 7 can perform a preset control from the first control or the second control (details will be described later with reference to FIG. 2). Whether the first control or the second control is set can be stored in the storage device of the overall management computer 7 as rack collection request information, for example.

[0026] When a dispensing error occurs, the overall management computer 7 executes a rack transport scheduler program to function as a rack transport scheduler. The rack transport scheduler checks whether the first control or the second control is set by referring to information related to the samples loaded on the rack and rack retrieval request information stored in a storage device within the overall management computer 7, and continues or suspends sample analysis based on predetermined conditions, creates a rack retrieval schedule, and performs rack retrieval.

[0027] 2 is a flowchart showing the flow of processing performed by an automatic analyzer according to an embodiment of the present disclosure. This flowchart relates to an automatic analysis method according to this embodiment. The operation of the automatic analyzer will be described below with reference to FIG. 2.

[0028] In step 201, the overall control computer 7 receives an analysis start request from the operation unit 8 and display device 9, and instructs the analysis module 5 to start analysis, thereby putting the entire automatic analyzer into an analysis state.

[0029] In step 202 , the automatic analyzer reads the rack ID and sample ID of the rack using the ID reading unit 2 , and transports the rack into the rack waiting unit 4 .

[0030] In step 203 , the automatic analyzer transports the rack that has been transported into the rack standby section 4 into the analysis module 5 .

[0031] In step 204, the automated analyzer dispenses the samples held in the racks that have been carried into the analysis module. At this time, the sample dispensing can be performed based on the request information stored in the overall management computer 7. Step 204 and the subsequent processes are repeatedly executed for each sample to be dispensed.

[0032] In step 205, the overall management computer 7 determines whether a dispensing abnormality has occurred during sample dispensing. Dispensing abnormalities include sample clogging, empty sample suction, etc. The automated analyzer is equipped with a configuration for detecting such dispensing abnormalities. In particular, by determining sample clogging and empty sample suction as dispensing abnormalities, it is possible to appropriately detect abnormalities that require action.

[0033] 2 ends and the dispensing operation continues. If a dispensing abnormality has occurred, the process proceeds to step 206.

[0034] In step 206, the overall management computer 7 checks whether the first control or the second control is set. If the first control is set, the process proceeds to step 207. In principle, the first control cancels the analysis of only the sample in which a dispensing error occurred, while continuing the analysis of other samples. In other words, the first control is a control that, when a dispensing error occurs in a sample, continues the analysis of other samples scheduled for the sample rack containing the sample container containing the sample.

[0035] If the second control is set in step 206, the process proceeds to step 211. The second control is a control that, in principle, cancels the analysis of all samples in the sample rack. That is, in the case of a sample dispensing abnormality, the second control cancels the analysis scheduled for other samples in the sample rack containing the sample container containing the sample, and transports the sample rack to the rack storage unit 6 by the transport mechanism 3.

[0036] In step 207, the overall management computer 7 determines whether a sample dispensing error has occurred multiple times in succession (e.g., for multiple samples dispensed consecutively). If a sample dispensing error has not occurred multiple times in succession, the process proceeds to step 208.

[0037] In step 208, the overall management computer 7 executes the first control, i.e., cancels the analysis of the sample for which a dispensing error occurred, and continues dispensing of the undispensed samples.

[0038] In step 207, if a sample dispensing error occurs multiple times in succession, the process proceeds to step 211, where the flow transitions to the second control. In this way, the overall control computer 7 performs the second control when a sample dispensing error occurs multiple times in succession while the first control is set.

[0039] If dispensing abnormalities occur multiple times in succession, there is a high probability that dispensing abnormalities will also occur in other samples on the same sample rack. However, with the automatic analyzer of this embodiment, the analysis of other samples is canceled in such cases, thereby preventing frequent dispensing abnormalities.

[0040] In step 211, the overall management computer 7 determines whether the cause of the dispensing abnormality is a lack of sample. Note that the automatic analyzer is equipped with a configuration for identifying the cause of the dispensing abnormality, and such a configuration can be appropriately designed by a person skilled in the art based on known techniques, etc.

[0041] If the cause of the dispensing abnormality is a lack of sample, the process proceeds to step 209. If the cause of the dispensing abnormality is not a lack of sample, the process proceeds to step 212.

[0042] In step 209, the overall management computer 7 determines whether the sample for which a sample shortage has occurred is a trace sample. If it is a trace sample, the process proceeds to step 208, where the flow transitions to the first control flow. This transition may be performed particularly when the sample for which empty suction has occurred due to a sample shortage is a trace sample. That is, if a sample dispensing abnormality occurs while the second control is set, and the sample for which empty suction has occurred is a trace sample, the overall management computer 7 determines that the predetermined condition has been met and performs the first control.

[0043] By this branching process, analysis continues for other samples that are less likely to cause empty sampling, thereby preventing unnecessary cancellations.

[0044] In step 209, if the specimen for which a sample shortage has occurred is not a trace specimen, the process proceeds to step 212.

[0045] In step 212, the overall management computer 7 determines whether or not a predetermined time has elapsed since the last time the user operated the automated analyzer via the display device 9. If the predetermined time has elapsed, it determines that a predetermined condition has been met, and the process proceeds to step 208, where it transitions to the first control flow.

[0046] Generally, if a long time has passed since the user last operated the display device 9, the user is absent and it is often the case that immediate action cannot be taken even if the sample is collected by the second control. In such a case, the branching of step 212 gives priority to the analysis of samples that can be analyzed by the first control, allowing the analysis to be carried out efficiently.

[0047] In particular, the overall management computer 7 may store the time when the user operates the automatic analyzer via the display device 9. This configuration allows the determination in step 212 to be performed appropriately. In the example of Fig. 3 described below, this time is displayed as the operation time.

[0048] In step 212, if the predetermined time has not elapsed, the process proceeds to step 213.

[0049] In step 213, the overall management computer 7 determines whether or not a predetermined time has elapsed since the last time the transport mechanism 3 transported a sample rack to the dispensing mechanism of the analysis module 5. If the predetermined time has elapsed, the process proceeds to step 208, where the process transitions to the first control flow.

[0050] Generally, if a long time has passed since the last sample rack was transported, the user is absent and immediate action is often not possible even if samples are collected using the second control. In such cases, the branching of step 213 prioritizes the analysis of samples that can be analyzed using the first control, allowing for efficient analysis.

[0051] 1, the overall management computer 7 may store the time when the transport mechanism 3 transports the sample rack to the dispensing mechanism of the analysis module 5. With this configuration, the determination in step 213 can be performed appropriately.

[0052] In step 213, if the predetermined time has not elapsed, the process proceeds to step 214.

[0053] In step 214, the overall management computer 7 determines whether or not there is an undispensed micro-volume sample in the sample rack. If there is an undispensed micro-volume sample, the process proceeds to step 210. If there is no undispensed micro-volume sample, the process proceeds to step 215.

[0054] In step 210, the overall management computer 7 cancels the analysis of all samples held in the sample racks except for the trace samples, and continues the analysis of all trace samples.

[0055] Step 210 may be executed particularly when a sample is empty. That is, when a sample dispensing abnormality (e.g., empty aspiration) occurs while the second control is set, and there is an undispensed trace sample in the sample rack carrying the sample container containing the sample, the overall management computer 7 continues the analysis scheduled for the trace sample and cancels the analysis scheduled for samples other than the trace sample (this control can be considered different from the first control and the second control, but can also be considered included in the second control).

[0056] Generally, the amount of a sample may decrease over time due to evaporation. This effect is particularly significant for trace samples, so even if the sample is recovered using the second control, it may not be possible to perform an appropriate analysis. By branching at step 214, analysis is performed on the trace sample, preventing evaporation of the trace sample and allowing for efficient analysis.

[0057] In step 215, the overall management computer 7 executes a second control, i.e., cancels the analyses scheduled for other samples in the sample rack containing the sample container, and transports the sample rack from the rack standby unit 4 to the rack storage unit 6 by the transport mechanism 3. Here, by using the rack standby unit 4, the undispensed sample rack can be appropriately held and kept waiting.

[0058] Thus, according to the automatic analyzer and automatic analysis method of this embodiment, when a dispensing abnormality occurs, even if the second control setting for recovering the sample rack on which the sample is loaded is enabled, if certain conditions are met, it is possible to analyze analyzable samples, thereby minimizing the time that analyzable samples remain unanalyzed in the rack storage unit 6.

[0059] Next, the operation of the automatic analyzer by a user will be described with reference to Fig. 3. Fig. 3 is a diagram showing the configuration of a GUI related to the operation of the automatic analyzer according to this embodiment.

[0060] The GUI is displayed on, for example, a display device 9. The display device 9 is configured so that a user can operate the automatic analyzer by directly touching the display device 9. Such a configuration can be realized, for example, by using a known touch panel. Such a configuration allows intuitive operation, thereby increasing user convenience.

[0061] In the GUI, the user can configure automatic rack collection settings for general samples by operating the general sample selection button 301. For example, a GUI for selecting either first control or second control for general samples is displayed, and either first control or second control can be set via this.

[0062] Similarly, the user can set automatic rack collection for urgent samples by operating the urgent sample selection button 302. For example, a GUI for selecting either the first control or the second control for urgent samples is displayed, and either the first control or the second control can be set via this.

[0063] These settings may be individually selectable depending on the type of dispensing abnormality. For example, in an automatic analyzer, it is possible to selectively set in advance whether to perform the first control or the second control when a sample clog occurs, and similarly, it is possible to selectively set in advance whether to perform the first control or the second control when a sample is empty. This configuration allows for flexible settings depending on the type of dispensing abnormality.

[0064] 3, such settings can be made via a GUI. For example, the automated analyzer includes a GUI for setting whether the first control or the second control is to be performed when a sample clog occurs, and similarly, a GUI for setting whether the first control or the second control is to be performed when a sample is empty. This configuration allows for intuitive operation, thereby improving user convenience.

[0065] 3, the overall management computer 7 performs a preset control, either the first control or the second control, for each of multiple types of specimens (general specimens and urgent specimens). This configuration allows for flexible settings depending on the specimen type.

[0066] In the GUI, the user can input the start time of the time period for which the second control is to be set by operating the start time button 303. The overall management computer 7 accepts this input, sets the first control up to the start time, and sets the second control after the start time. This configuration makes it possible to specify in advance the automatic switching of the control content at a specific time, improving user convenience.

[0067] Similarly, in the GUI, the user can input the end time of the time period for which the second control is set by operating the end time button 304. The overall management computer 7 accepts this input, sets the second control until the end time, and sets the first control after the end time. This configuration makes it possible to specify in advance the automatic switching of the control content at a specific time, improving user convenience.

[0068] When the user operates the OK button 306 in the GUI, the overall management computer 7 stores the information that has been input via the GUI up to that point in a storage device within the overall management computer 7 .

[0069] When the user operates the cancel button 305 in the GUI, the overall management computer 7 does not store the contents that have been input via the GUI up to that point in the storage device of the overall management computer 7, and closes the GUI.

[0070] As described above, according to this embodiment, when a dispensing abnormality occurs, it is possible to interrupt the analysis of the sample rack and recover it, but if certain conditions are met, it is possible to prioritize the analysis of analyzable samples in the sample rack, making it possible to obtain analysis results quickly.

[0071] 1...Sample rack loading section 2...ID reading section 3...Transport mechanism 4...Rack standby section 5...Analysis module 6...Rack storage section 7...Overall management computer (control section) 8...Operation section 9...Display device 301...General sample selection button 302...Urgent sample selection button 303...Start time button 304...End time button 305...Cancel button 306...OK button

Claims

1. An automatic analyzer comprising: a transport mechanism that transports a rack carrying a plurality of specimen containers containing specimens to be analyzed to a dispensing mechanism; a dispensing mechanism that dispenses the specimens loaded onto the rack transported by the transport mechanism; a rack storage unit that stores the rack in a position from which it can be removed; and a control unit that performs a preset control of a first control or a second control, wherein the first control is a control for continuing an analysis planned for other specimens in the rack carrying the specimen containers containing the specimen when an abnormality in the dispensing of the specimen occurs; and the second control is a control for canceling an analysis planned for other specimens in the rack carrying the specimen containers containing the specimen when an abnormality in the dispensing of the specimen occurs, and transporting the rack to the rack storage unit by the transport mechanism, and the control unit performs the first control when a predetermined condition is met when an abnormality in the dispensing of the specimen occurs with the second control set.

2. The automatic analyzer according to claim 1, wherein the abnormality in dispensing includes a clogging of the specimen.

3. The automatic analyzer according to claim 1, wherein the abnormal dispensing includes empty aspirating of a sample.

4. The automatic analyzer according to claim 1, further comprising a display device, wherein the automatic analyzer is capable of operating the automatic analyzer by a user directly touching the display device.

5. An automatic analyzer according to claim 2, characterized in that it is possible to selectively set in advance whether to perform the first control or the second control when a sample clogging occurs.

6. An automatic analyzer according to claim 3, characterized in that it is possible to selectively set in advance whether to perform the first control or the second control when dry suction of a sample occurs.

7. The automatic analyzer according to claim 4, wherein said control unit stores the time when said user operates said automatic analyzer via said display device.

8. An automatic analyzer as described in claim 7, characterized in that the specified condition includes a predetermined time or more having passed since the last time the user operated the automatic analyzer via the display device.

9. An automatic analyzer as described in claim 1, wherein the predetermined condition includes a predetermined time or more having elapsed since the last time that the transport mechanism transported the rack to the dispensing mechanism.

10. An automatic analyzer according to claim 6, wherein the predetermined condition includes that the sample in which the dry suction has occurred is a trace amount of sample.

11. An automatic analyzer according to claim 1, characterized in that the control unit performs a second control when an abnormality in the dispensing of the sample occurs multiple times in succession while the first control is set.

12. An automatic analyzer according to claim 1, wherein the control unit, when an abnormality occurs in dispensing the sample while the second control is set, and when there is an undispensed trace sample in the rack carrying the sample container containing the sample, continues the analysis scheduled for the trace sample and cancels the analysis scheduled for samples other than the trace sample.

13. The automatic analyzer according to claim 1, wherein the control unit receives an input of a start time of the time period during which the second control is set.

14. The automatic analyzer according to claim 1, wherein the control unit receives an input of an end time of the time period during which the second control is set.

15. An automatic analysis method using an automatic analyzer comprising: a transport mechanism which transports a rack carrying a plurality of specimen containers containing specimens to be analyzed to a dispensing mechanism; a dispensing mechanism which dispenses the specimens carried in the rack transported by the transport mechanism; a rack storage unit which stores the rack in a position from which the rack can be removed; and a control unit which performs a preset control of a first control or a second control, wherein the first control is a control for continuing an analysis planned for other specimens in the rack carrying the specimen containers containing the specimen when an abnormality in dispensing of the specimen occurs; and the second control is a control for canceling an analysis planned for other specimens in the rack carrying the specimen containers containing the specimen when an abnormality in dispensing of the specimen occurs, and transporting the rack to the rack storage unit by the transport mechanism, wherein the automatic analysis method includes the control unit performing the first control when a predetermined condition is met when an abnormality in dispensing of the specimen occurs with the second control set.

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