JP6752089B2 - Automatic analyzer - Google Patents

Description

The present invention relates to an automatic analyzer that performs qualitative and quantitative analysis of biological samples such as blood and urine, and a control method thereof.

An automatic analyzer that performs quantitative and qualitative analysis of specific components contained in a sample by adding multiple types of reagents loaded in advance to a biological sample such as blood or urine has high reproducibility of measurement results and measurement. In addition to having the feature of being able to speed up the process, it is also possible to improve the analysis processing capacity and respond to the diversification of measurement items by connecting multiple analysis units via the sample transfer line. The introduction is being promoted mainly in large hospitals and clinical testing centers.

As a technique related to the setting of such an automatic analyzer, for example, in Patent Document 1 (Japanese Unexamined Patent Publication No. 8-338884), a sample and a reagent are separated into a reaction vessel arranged on a reaction vessel at the time of sample analysis work. In an automatic analyzer that pours, measures the contents of the reaction vessel, and cleans the reaction vessel after measuring the contents, a process of storing a processing list including each processing unit of cleaning the reaction vessel and cleaning the dispensing probe. A preparation consisting of a list storage means, a screen display means for displaying a screen of a process list including each of the above process units read from the process list storage means, and a process unit selected from the process list on the screen. Preparation for storing the operation The operation storage means, the time setting column storage means for storing the column for reserving the day when the power of the analyzer is turned on, and the column for reserving the time and minute when the power is turned on, and the time When the reserved time storage means for storing the day and hour and minute set via the screen read from the setting field storage means to the screen display means and the set time and minute on the set day are reached, a sample is obtained. An automatic analyzer including a control means for causing the analyzer to perform a preparatory operation composed of the selected processing units before starting analysis work is disclosed.

Japanese Unexamined Patent Publication No. 8-338884

By the way, in an automatic analyzer, a user may set and edit measurement items and parameters related to a system for the purpose of maintenance, evaluation of reagents, confirmation of validity of measurement results, and the like. On the other hand, setting / editing parameters during sample measurement may affect the measurement results of measurement items during measurement, so setting / editing parameters during sample measurement may be restricted. There are many. Therefore, when setting / editing parameters, the user can set / edit the parameters of the automatic analyzer by waiting until the measurement item being measured is completed or interrupting the measurement item being measured. It will be necessary to shift to a state where it is possible (hereinafter referred to as a standby state).

However, when the operator needs to wait until the automatic analyzer goes into the standby state when setting / editing the parameters, the work efficiency may decrease. In addition, since the parameters are set and edited in the standby state, the sample cannot be measured, and there is a concern that the work efficiency may be further reduced. In particular, in large hospitals and clinical laboratory centers, the number of samples to be analyzed is large, so the automatic analyzer may be operated for 24 hours, and the operator may wait until the standby state is reached, or the parameters may be stopped in the standby state. It is considered that the influence of setting / editing of is large.

The present invention has been made in view of the above, and an object of the present invention is to provide an automatic analyzer capable of suppressing a decrease in work efficiency due to parameter setting / editing and a control method thereof.

In order to achieve the above object, the present invention is a reaction in which a reagent disk on which a plurality of reagent containers containing a reagent used for sample analysis are mounted and a plurality of reaction vessels for reacting the sample and the reagent are arranged. A disk, a sample dispensing mechanism for dispensing the sample into the reaction vessel of the reaction disk, a reagent dispensing mechanism for dispensing the reagent into the reaction vessel of the reaction disk, and the sample of the reaction vessel. The operator sets and edits the measurement unit that measures the reaction solution of the reagent and the parameters used for the analysis process that analyzes the sample by a series of processes from the dispensing of the sample and the reagent to the analysis of the measurement result. And a control unit that executes the analysis process using the parameters, and if the parameters are set / edited during the standby state, which is a state in which the analysis process is not performed, the parameters are set. Is stored in the first storage unit, and the analysis process is executed using the parameters stored in the first storage unit. If the parameters are set / edited during the analysis process, the parameters are executed. Is stored in the second storage unit, and when the state in which the analysis process is being executed transitions to the standby state, the parameters stored in the second storage unit are stored in the first storage unit. It is assumed that the control unit is provided.

According to the present invention, it is possible to suppress a decrease in work efficiency due to parameter setting / editing.

It is a figure which shows schematic the whole structure of the automatic analyzer which concerns on one Embodiment. It is a functional block diagram which shows typically the function of the control device. It is a figure which shows the parameter setting screen. It is a flowchart which shows the process in the control part at the time of pressing a registration button. It is a flowchart which shows the process in the control part at the time of pressing a start button. It is a flowchart which shows the process in the control part at the time of transition of the operation state of an automatic analyzer. It is a flowchart which shows the process in the control part at the time of starting of an automatic analyzer. It is a figure which shows an example of the operation of an automatic analyzer.

An embodiment of the present invention will be described with reference to the drawings.

FIG. 1 is a diagram schematically showing an overall configuration of an automatic analyzer according to the present embodiment.

In FIG. 1, the automatic analyzer 100 accommodates a biological sample such as blood or urine to be analyzed, a quality control sample, a sample for calibration, or the like (hereinafter, these are collectively referred to as a sample). The sample container loading section 110 into which the sample container rack 102 on which the above (for example, five) sample containers 101 is mounted is charged, and one or more (for example, three) that perform an analysis process on the sample contained in the sample container 101. ), The sample container storage unit 112 that stores the sample container rack 102 on which the sample container 101 that has been processed by the automatic analyzer 100 is mounted, the sample container charging unit 110, the analysis unit 111, and the sample. A control device that controls the operation of the entire automatic analyzer 100 by being connected to each configuration of the automatic analyzer 100 via a network cable and a hub 113, and a transfer line 103 that conveys the sample container rack 102 between the container storage portions 112. It is roughly configured from 114.

The control device 114 is connected to the host system 116 via the network, and is connected to the remote system 117 via the public line 115. When the operator makes an analysis request from the input unit 114b (described later) of the control device 114 or the host system 116, the information related to the analysis request is transmitted to each analysis unit 111 via the network, and the analysis unit 111 analyzes the information. The result is transmitted to the controller 114 (and, if necessary, the host system 116). The remote system 117 stores information such as parameters, which are analysis condition information regarding reagents used for analysis processing in the automatic analyzer 100, and distributes the parameters in response to a request from the control device 114. The delivered parameters are stored in the control device 114 and transmitted to each analysis unit 111 when the sample analysis process is executed.

The analysis unit 111 is a reaction in which a reagent disk 104 on which a plurality of reagent containers 104a containing reagents used for sample analysis are mounted and a plurality of reaction vessels 105a for mixing and reacting the sample and the reagent are arranged. The disk 105, the sample dispensing mechanism 106 that dispenses the sample of the sample container 101 conveyed by the transfer line 103 into the reaction container 105a of the reaction disk 105, and the reagent of the reagent container 104a of the reagent disk 104 are divided into the reaction container 105a. The reagent dispensing mechanism 107 to be injected and the mixed solution (reaction solution) of the sample and the reagent dispensed into the reaction vessel 105a are irradiated with the light from the light source 108a, and the transmitted light and the scattered light are detected by the detector 108b. This is roughly composed of a measuring unit 108 for measuring the reaction solution.

FIG. 2 is a functional block diagram schematically showing the functions of the control device.

In FIG. 2, the control device 114 includes a display unit 114a, an input unit 114b, a control unit 114c, and a storage unit 114d.

The input unit 114b is for inputting various information and operation instructions by the operator, and is, for example, a mouse, a keyboard, or the like.

The display unit 114a displays various setting screens, operation screens, various information, analysis results, etc., and can be operated by the input unit 114b as a graphic user interface (GUI).

The input unit 114b and the display unit 114a constitute a setting unit for the operator to set and edit parameters used in the analysis process for analyzing the sample by a series of processes from the dispensing of the sample and the reagent to the analysis of the measurement result. doing.

The storage unit 114d stores parameters used in the analysis process, various settings, reagent information, analysis results, and the like, and is stored in the first storage unit 124 and the first storage unit 124 for storing the parameters used in the analysis process. It has a second storage unit 134 that temporarily stores the parameters before being stored as a temporary file. The details of the storage of the first and second storage units 124 and 134 will be described later.

The control unit 114c controls the operation of the entire automatic analysis device 100 by controlling each configuration of the control device 114, and executes the analysis process using the parameters stored in the first storage unit 124.

In the automatic analyzer 100, in the standby state in which the analysis process is not performed, the sample to be analyzed is charged into the sample container charging unit 110 and the start of the analysis process is instructed (in other words, the display unit 114a displays the sample). When the start button (not shown) is pressed by the operation of the input unit 114b), the analysis process is immediately started, and when the analysis process of the corresponding sample is completed, the sample is transported to the sample container storage unit 112 and put into the standby state. Transition. In addition, when another sample to be analyzed is input during the analysis process and the start button is pressed, the start of the analysis process of the corresponding sample is reserved, and the analysis process of the sample being analyzed is completed. Later, the analysis processing of other samples is continuously started without transitioning to the standby state, and the transition to the standby state is performed after the analysis processing of all the samples reserved for the start of the analysis processing is completed.

Here, the setting / editing process for setting / editing the parameters used in the analysis process will be described.

In the setting / editing process of the present embodiment, when the operator sets / edits the parameters in the setting unit and the application is instructed, the parameters set / edited according to the operating state of the automatic analyzer 100 at that time. It changes the handling.

FIG. 3 is a diagram showing a parameter setting screen.

In FIG. 3, the parameter setting screen 301 is displayed on the display unit 114a, and is a parameter input unit that inputs parameters by directly inputting parameters or selectively inputting parameters to be read from the remote system 117. 302, an application time setting unit 303 for setting the application time of the parameter input to the parameter input unit 302, a registration button 304 for registering and validating the setting contents of the parameter input unit 302 and the application time setting unit 303, and a parameter. It has a close button 305 that discards and cancels the input content of the setting screen 301. In FIG. 3, the parameter input unit 302 only needs to be able to directly input various parameters required for the analysis process or selectively input various parameters, and details thereof will be omitted.

The application time setting unit 303 does not set the application time of the parameter input to the parameter input unit 302, but sets it to be applied when the registration button 304 is pressed. The non-setting selection unit 303a and the parameter input to the parameter input unit 302. It has a date designation unit 303b that specifies the date of application of. Only one of the non-setting selection unit 303a and the date designation unit 303b can be selected. In the date designation unit 303b, the time when the parameter is to be applied (for example, year / month / day) can be input, and the parameter is input when the specified date is reached or when the specified date has passed. Applies.

Subsequently, the processing of the control device 114 when the registration button 304 is pressed on the parameter setting screen 301 will be described.

FIG. 4 is a flowchart showing a process in the control unit when the registration button is pressed.

In FIG. 4, when the registration button 304 is pressed, the control unit 114c determines whether the non-setting selection unit 303a or the date designation unit 303b is selected by the application time setting unit 303 (step S401), and there is no setting. When it is determined that the selection unit 303a has been selected, it is determined whether or not the automatic analyzer 100 is in the standby state in which the analysis process is not being performed (step S402). If the determination result in step S402 is YES, the parameters set / edited by inputting to the parameter input unit 302 of the parameter setting screen 301 are stored (stored) in the first storage unit 124 (step S403) and processed. To finish.

If the determination result in step S402 is NO, whether or not there is a temporary file in the second storage unit 134 (whether the parameter is temporarily stored) and the number of temporary files start the analysis process. It is determined whether or not it is the same as the number of times the start button is pressed (steps S404 and S405), and if the determination results of both steps S404 and S405 are YES, the parameter input unit 302 of the parameter setting screen 301 The existing temporary file stored in the second storage unit 134 is overwritten with the parameters set / edited by inputting to (step S406), and the process ends. If the determination result of at least one of steps S404 and S405 is NO, the parameter set / edited by inputting to the parameter input unit 302 of the parameter setting screen 301 is newly temporarily stored in the second storage unit 134. Save as a file (step S407) and end the process.

Further, in step S401, when it is determined that the date designation unit 303b is selected, it is determined whether or not there is a temporary file in the second storage unit 134 (whether the parameter is temporarily stored) (step S408). ), If the determination result is YES, the parameters set / edited by inputting to the parameter input unit 302 of the parameter setting screen 301 are overwritten and saved in the existing temporary file stored in the second storage unit 134. (Step S409) If the determination result is NO, the file is saved as a new temporary file in the second storage unit 134 (step S410), and the process ends.

FIG. 5 is a flowchart showing a process in the control unit when the start button is pressed.

In FIG. 5, when the start button is pressed, the control unit 114c determines whether or not the start of the analysis process is a transition from the standby state (step S501), and if the determination result is YES, the first The parameter is read from the storage unit 124 of the above and acquired (step S502). If the determination result in step S501 is NO, it is determined whether or not there is a temporary file in the second storage unit 134 (step S503), and if the determination result is YES, the latest temporary file is determined. The parameter is read and acquired (step S504), and when the determination result is NO, the parameter is read and acquired from the first storage unit 124 (step S505).

After acquiring the parameters in any of steps S502, S504, and S505, perform a parameter check to check whether the acquired parameters are consistent or whether they are abnormal parameters due to reasons such as editing. Then, it is determined whether or not the check result is normal (step S506), and if the determination result is YES, the analysis process is started using the acquired parameters (step S507), and the process is terminated. If the determination result in step S506 is NO, a caution screen indicating that the parameter is in an abnormal state is displayed on the display unit 114a to notify the operator (step S508), and the analysis process is stopped. (The analysis process is not started) (step S509), the process is terminated.

FIG. 6 is a flowchart showing processing in the control unit at the time of transition of the operating state of the automatic analyzer.

In FIG. 6, when the operating state of the automatic analyzer 100 transitions, the control unit 114c determines whether or not the transition to the standby state (step S601), and if the determination result is NO, the process ends. If the determination result in step S601 is YES, the application time setting unit 303 determines which of the non-setting selection unit 303a and the date designation unit 303b is selected (step S602), and the non-setting selection unit 303a is determined. When it is determined that is selected, the latest parameter of the temporary file stored in the second storage unit 134 is stored in the first storage unit 124 (step S603), and the second storage unit 134 is stored. All temporary files stored in (step S604) are deleted, and the process ends. If it is determined in step S602 that the date designation unit 303b has been selected, the latest temporary file stored in the second storage unit 134 is retained, and the other temporary files are deleted (step). S605), the process is terminated.

FIG. 7 is a flowchart showing a process in the control unit when the automatic analyzer is started.

In FIG. 7, when the automatic analyzer 100 is activated, the control unit 114c first determines whether the application time setting unit 303 selects the non-setting selection unit 303a or the date designation unit 303b (step S701). When it is determined that the non-setting selection unit 303a is selected, the start-up process for starting the automatic analyzer 100 is started (step S605), and the process is ended.

If it is determined in step S701 that the date designation unit 303b has been selected, it is determined whether the current date is the date specified by the date designation unit 303b, or whether it is after the specified date. If at least one of the determination results of (steps S702 and 703), steps S702, and S703 is YES, the latest parameter of the temporary file stored in the second storage unit 134 is stored in the first storage unit. It is stored in the unit 124 (step S704), all the temporary files stored in the second storage unit 134 are deleted (step S705), and the activation process for activating the automatic analyzer 100 is started (step S605). End the process. If the determination results in both steps S702 and S703 are NO, the start-up process for starting the automatic analyzer 100 is started (step S605), and the process ends.

The operation of the automatic analyzer of the present embodiment configured as described above will be described.

FIG. 8 is a diagram showing an example of the operation of the automatic analyzer.

FIG. 8 illustrates a case where the start button is pressed in the standby state while the non-setting selection unit 303a is selected by the application time setting unit 303.

In FIG. 8, when the start button is pressed by the setting unit (display unit 114a, input unit 114b) (step S801), the control unit 114c reads out the parameters from the first storage unit 124 and acquires them (step S802). ), The acquired parameter is transmitted to the analysis unit 111 (step S803). At this time, the analysis unit 111 starts the analysis process.

Next, when the operator sets / edits the parameters in the setting unit (step S804), since the state of the automatic analyzer 100 is in the analysis process, the set / edited parameters are stored in the first storage unit 124 instead of the first storage unit 124. It is stored as a temporary file (No. 1) in the storage unit 134 of No. 2 (step S805). When the start button is pressed again in this state (step S806), the parameters of the latest temporary file (No. 1) are acquired from the second storage unit 134 (step S807). After that, the result of the analysis process started by pressing the start button in step S801 (using the parameters of step S802) is output from the analysis unit 111 to the control device 114 (step S808). At this time, the control device 114 transmits the parameter acquired in step S807 to the analysis unit as a parameter used in the analysis process started by pressing the start button in step S806 (step S809).

Next, when the operator sets / edits the parameters again in the setting unit (step S810), the state of the automatic analyzer 100 is in the process of analysis, so the parameters set / edited are not stored in the first storage unit 124. It is stored as a temporary file (No. 2) in the second storage unit 134 (step S811). At this time, the temporary file (No. 1) is also stored in the second storage unit 134, but the illustration is omitted. When the start button is pressed again in this state (step S812), the parameters of the latest temporary file (No. 2) are acquired from the second storage unit 134 (step S813). After that, the result of the analysis process started by pressing the start button in step S806 (using the parameters of step S807) is output from the analysis unit 111 to the control device 114 (step S814). At this time, the control device 114 transmits the parameter acquired in step S813 to the analysis unit as a parameter used in the analysis process started by pressing the start button in step S812 (step S815).

After that, the result of the analysis process started by pressing the start button in step S812 (using the parameters of step S813) is output from the analysis unit 111 to the control device 114 (step S816), and then the state transitions to the standby state. At this time, the latest temporary file (No. 2) of the second storage unit 134 is stored in the first storage unit 124 (step S817), and all the parameters (temporary file) stored in the second storage unit 134 are stored. No. 1 and No. 2) are deleted (step S818).

The effects of the present embodiment configured as described above will be described.

In the automatic analyzer, the user may set and edit measurement items and parameters related to the system for the purpose of maintenance, evaluation of reagents, confirmation of validity of measurement results, and the like. On the other hand, setting / editing parameters during sample measurement may affect the measurement results of measurement items during measurement, so setting / editing parameters during sample measurement may be restricted. There are many. Therefore, when setting / editing parameters, the user can set / edit the parameters of the automatic analyzer by waiting until the measurement item being measured is completed or interrupting the measurement item being measured. It becomes necessary to shift to a possible state (standby state). However, when the operator needs to wait until the automatic analyzer goes into the standby state when setting / editing the parameters, the work efficiency may decrease. In addition, since the parameters are set and edited in the standby state, the sample cannot be measured, and there is a concern that the work efficiency may be further reduced. In particular, in large hospitals and clinical laboratory centers, the number of samples to be analyzed is large, so the automatic analyzer may be operated for 24 hours, and the operator may wait until the standby state is reached, or the parameters may be stopped in the standby state. It is considered that the influence of setting / editing of is large.

On the other hand, in the present embodiment, when a parameter used for the analysis process is set / edited during the standby state in which the analysis process is not performed, the parameter is stored in the first storage unit 124. At the same time, the analysis process is executed using the parameters stored in the first storage unit 124, and when the parameters are set / edited during the analysis process, the parameters are stored in the second storage unit 134 and the analysis process is performed. When the state in which is being executed is changed to the standby state, the parameters stored in the second storage unit 134 are stored in the first storage unit 124, so that the work involved in setting / editing the parameters is performed. The decrease in efficiency can be suppressed.

The present invention is not limited to the above-described embodiments, and includes various modifications. For example, the above-described embodiment has been described in detail in order to explain the present invention in an easy-to-understand manner, and is not necessarily limited to the one including all the described configurations. Further, each of the above configurations, functions and the like may be realized by designing a part or all of them by, for example, an integrated circuit. Further, the above-described respective configurations, functions and the like may be realized by software by a processor interpreting and executing a program that realizes each function.

100 Automatic analyzer 101 Sample container 102 Sample container rack 103 Transfer line 104 Reagent disk 104a Reagent container 105 Reaction disk 105a Reaction container 106 Sample dispensing mechanism 107 Reagent dispensing mechanism 108 Measuring unit 108a Light source 108b Detector 110 Sample container loading unit 111 Analysis unit 112 Sample container storage unit 113 Hub 114 Control device 114a Display unit 114b Input unit 114c Control unit 114d Storage unit 115 Public line 116 Upper host system 117 Remote system 124 First storage unit 134 Second storage unit 301 Parameter setting screen 302 Parameter input unit 303 Applicable time setting unit 303a No setting selection unit 303b Date specification unit 304 Registration button 305 Close button

Claims (6)

A reagent disc on which multiple reagent containers containing reagents used for sample analysis are mounted, and
A reaction disk in which a plurality of reaction vessels for reacting the sample and the reagent are arranged, and
A sample dispensing mechanism for dispensing the sample into the reaction vessel of the reaction disk,
A reagent dispensing mechanism for dispensing the reagent into the reaction vessel of the reaction disk,
A measuring unit for measuring the reaction solution of the sample and the reagent in the reaction vessel,
A setting unit for the operator to set and edit parameters used in the analysis process for analyzing the sample by a series of processes from the dispensing of the sample and the reagent to the analysis of the measurement result.
A control unit that executes the analysis process using the parameters.
When the parameter is set / edited and applied during the standby state in which the analysis process is not performed, the applied parameter is stored in the first storage unit.
When the start of the analysis process is instructed during the standby state, the analysis process is executed using the parameters stored in the first storage unit.
When the parameter is set / edited and applied during the analysis process, the applied parameter is stored in the second storage unit, and the state in which the analysis process is executed is changed to the standby state. An automatic analyzer comprising a control unit that stores the parameters stored in the second storage unit in the first storage unit when a transition occurs. A reagent disc on which multiple reagent containers containing reagents used for sample analysis are mounted, and
A reaction disk in which a plurality of reaction vessels for reacting the sample and the reagent are arranged, and
A sample dispensing mechanism for dispensing the sample into the reaction vessel of the reaction disk,
A reagent dispensing mechanism for dispensing the reagent into the reaction vessel of the reaction disk,
A measuring unit for measuring the reaction solution of the sample and the reagent in the reaction vessel,
A setting unit for the operator to set and edit parameters used in the analysis process for analyzing the sample by a series of processes from the dispensing of the sample and the reagent to the analysis of the measurement result.
A first storage unit that stores the parameters set / edited and applied during the standby state, which is a state in which the analysis process is not performed, and
A second storage unit you temporarily storing the parameter set and edited during the analysis process,
When said start of the analysis process in the standby state is instructed, and a control unit which performs an analysis process for analyzing the sample using the parameters stored in the first storage unit,
When the control unit transitions from the state in which the analysis process is being executed to the standby state, the control unit reads out the parameters stored in the second storage unit and stores them in the first storage unit. An automatic analyzer featuring. In the automatic analyzer according to claim 1 or 2.
An automatic analyzer characterized in that when the parameter stored in the second storage unit is stored in the first storage unit, the parameter stored in the second storage unit is deleted. In the automatic analyzer according to claim 1 or 2.
When the control unit is instructed to start the analysis process of another sample during the analysis process of the sample using the parameter stored in the first storage unit, the control unit stores the sample in the second storage unit. An automatic analyzer characterized in that the analysis process of the other sample is continuously executed after the end of the analysis process of the previous sample using the parameters. In the automatic analyzer according to claim 1 or 2.
The setting unit includes an application time setting unit capable of setting a time when the parameter input by the operator is applied at a time other than the time of input.
The control unit is an automatic analyzer characterized in that the parameters input to the setting unit are handled as if they were set and edited at a time set by the application time setting unit. A reagent disk on which a plurality of reagent containers containing reagents used for sample analysis are mounted, a reaction disk on which a plurality of reaction containers for reacting the sample and the reagent are arranged, and the reaction container of the reaction disk are described. A sample dispensing mechanism for dispensing a sample, a reagent dispensing mechanism for dispensing the reagent into the reaction vessel of the reaction disk, and a measuring unit for measuring the sample of the reaction vessel and the reaction solution of the reagent. It is a control method of the automatic analyzer provided.
A procedure for the operator to set and edit parameters used in the analysis process for analyzing the sample by a series of processes from the dispensing of the sample and the reagent to the analysis of the measurement result.
When the parameter is set / edited and applied during the standby state in which the analysis process is not performed, the procedure for storing the applied parameter in the first storage unit and the procedure for storing the applied parameter in the first storage unit.
When the start of the analysis process is instructed during the standby state, the procedure of executing the analysis process using the parameter stored in the first storage unit and the procedure of executing the analysis process.
When the parameter is set / edited and applied during the analysis process, the procedure for storing the applied parameter in the second storage unit and the procedure for storing the applied parameter in the second storage unit.
When transitioning from the state in which the analysis process is being executed to the standby state, it is characterized by having a procedure of storing the parameters stored in the second storage unit in the first storage unit. How to control the automatic analyzer.

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