Automatic analysis device
The automatic analyzer achieves space savings and cost reductions by using a single stirring rod with controlled operations to prevent reagent contamination, ensuring accurate analysis of multiple types of reagents.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- HITACHI HIGH TECH CORP
- Filing Date
- 2023-11-30
- Publication Date
- 2026-07-23
AI Technical Summary
Hospitals and similar facilities face challenges in achieving space savings and cost reductions in automatic analyzers while maintaining analysis accuracy, particularly due to the potential for reagent contamination and mixing when using a single stirring rod for multiple types of reagents.
The automatic analyzer employs a first and second analysis unit with different measurement principles, a reagent storage unit, a stirring unit with a single stirring rod, and a control unit that manages the stirring operations to ensure multiple types of reagents are stirred without contamination, using a controlled sequence to minimize accuracy loss.
This approach allows for space savings and cost reductions while maintaining analytical accuracy by effectively stirring multiple reagents with a single stirring rod, preventing cross-contamination and improving measurement precision.
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Abstract
Description
Technical Field
[0001] The present invention relates to an automatic analyzer.
Background Art
[0002] An automatic analyzer reacts a blood, urine, or other biological sample (specimen) with an analytical reagent that specifically reacts with a measurement target component in the sample, and quantitatively detects the complex generated by this reaction, thereby automatically performing the process from measurement of the measurement target component to output of the result.
[0003] As a technique related to an automatic analyzer, a technique of stirring a first reagent not containing magnetic particles and a second reagent containing magnetic particles using respective stirring rods is disclosed (see Patent Document 1).
Prior Art Documents
Patent Documents
[0004]
Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0005] Hospitals and the like using automatic analyzers have demands for space saving and cost reduction. For example, by suppressing the number of stirring rods for reagents to one and commonly using a plurality of types of reagents, space saving can be achieved by reducing the stirring rods and drive mechanisms, and cost reduction can be achieved by reducing the number of parts. On the other hand, when there is one stirring rod for the reagent, there is concern about contamination of the stirring rod resulting in mixing of components between a plurality of reagents and a decrease in analysis accuracy due to reagent mixing.
[0006] The present invention has been made in view of the above, and an object thereof is to provide an automatic analyzer capable of achieving space saving and cost reduction by suppressing a decrease in analysis accuracy and stirring a plurality of types of reagents with one stirring rod. [Means for solving the problem]
[0007] The present invention includes several means for solving the above problems, but to give one example, it comprises a first analysis unit that performs analysis on a first group of analysis items, a second analysis unit that performs analysis on a second group of analysis items using a different measurement principle than the first analysis unit, a reagent storage unit that stores at least one first reagent container containing reagents used for analysis in the first analysis unit and at least one second reagent container containing reagents used for analysis in the second analysis unit, a stirring unit having a stirring rod for stirring the solutions in the first and second reagent containers, and a control unit that controls the operation of the stirring unit, wherein the control unit controls the operation of the stirring unit to stir the solutions in the second reagent containers after stirring the solutions in all of the first reagent containers in the reagent storage unit has been completed. [Effects of the Invention]
[0008] According to the present invention, by stirring multiple types of reagents with a single stirring rod while suppressing a decrease in analytical accuracy, it is possible to save space and reduce costs. [Brief explanation of the drawing]
[0009] [Figure 1] A schematic diagram showing the overall configuration of the automated analyzer. [Figure 2] A functional block diagram illustrating the schematic configuration of the analysis section of an automated analyzer. [Figure 3] A schematic diagram showing the main components of the stirring section, washing section, and reagent storage section. [Figure 4] A schematic diagram illustrating the stirring and washing operations. [Figure 5] A schematic diagram illustrating the stirring and washing operations. [Figure 6] A schematic diagram illustrating the stirring and washing operations. [Figure 7] A schematic diagram illustrating the stirring and washing operations. [Figure 8] A schematic diagram illustrating the stirring and washing operations. [Figure 9] A diagram schematically showing the states of the stirring operation and the cleaning operation. [Figure 10] A diagram schematically showing the state in which a reagent container is stored in the reagent storage unit. [Figure 11] A diagram showing the relationship between the operations of the reagent storage unit and the reading unit and the information stored in the storage unit. [Figure 12] A diagram showing the relationship between the reagent storage unit, the stirring unit, the cleaning unit and the control unit. [Figure 13] A flowchart showing the processing content of the determination process of the stirring number, stirring speed, stirring operation and cleaning operation schedule in the control unit. [Figure 14] A diagram showing an example of a correspondence table defining the relationship between the liquid volume and the stirring speed. [Figure 15] A diagram schematically showing the states of the special cleaning operation and the water exchange operation. [Figure 16] A diagram schematically showing the states of the special cleaning operation and the water exchange operation [Figure 17] A diagram schematically showing the states of the special cleaning operation and the water exchange operation. [Figure 18] A diagram schematically showing the states of the special cleaning operation and the water exchange operation. [Figure 19] A diagram schematically showing the states of the special cleaning operation and the water exchange operation.
Embodiments for Carrying Out the Invention
[0010] Hereinafter, embodiments of the present invention will be described with reference to the drawings. In this embodiment, a composite automatic analyzer that performs biochemical analysis and immunoassay will be exemplified and described. However, the present invention can be applied to any automatic analyzer that performs measurement using a plurality of types of reagents with different principles.
[0011] FIG. 1 is a diagram schematically showing the overall configuration of the automatic analyzer according to this embodiment.
[0012] In FIG. 1, the automatic analyzer 100 is a small-sized composite device capable of analyzing biochemical items and immune items, which analyzes specific components contained in specimens such as blood and urine provided by patients. It is roughly composed of a specimen storage unit 101, a reagent storage unit 102, reagent containers 103, a reading unit 104, a cleaning unit 105, a stirring unit 106, an analysis unit 107, a control unit 108, an input / output unit 109, and a storage unit 110.
[0013] In the specimen storage unit 101, a plurality of specimen containers for storing biological specimens such as blood and urine are placed. Although not shown in the figure, the specimen storage unit 101 is, for example, of a disk type in which a plurality of specimen containers are arranged and placed on a specimen disk capable of intermittent rotation clockwise and counterclockwise, or of a rack type in which specimen containers are held in a transportable rack and the rack is transported.
[0014] The reagent storage unit 102 is a disk-type storage unit in which a plurality of reagent containers 103 are arranged in the circumferential direction on a reagent disk capable of intermittent rotation clockwise and counterclockwise, and a plurality of reagent containers 103 corresponding to the analysis items of the automatic analyzer 100 are placed. The reagent containers 103 belong to biochemical items or immune items.
[0015] The reading unit 104 is a device that reads a reagent code for identifying the reagent container 103, reads the reagent codes written in each of the plurality of reagent containers 103, and transmits them to the control unit 108 (see FIGS. 11 and later). By rotating the reagent storage unit 102, the reagent container 103 that is the reading target of the reagent code is transported to the reading position by the reading unit 104.
[0016] The stirring unit 106 is a device that stirs the reagent filled in the reagent container 103 placed in the reagent storage unit 102. The stirring is performed by inserting a stirring rod having a paddle at the tip into the reagent container 103 and rotating it (see FIGS. 5, 9, 16, and later). By rotating the reagent storage unit 102, the reagent container 103 that is the stirring target of the stored reagent is transported to the stirring position by the stirring unit 106.
[0017] The cleaning unit 105 is a device that cleans the mechanism of the stirring unit 106 that has come into contact with the reagent after the reagent in the reagent container 103 has been stirred, using cleaning water. The stirring unit 106 is cleaned by rotating the stirring rod and paddle in the stored cleaning water (see Figures 7, 18, etc. below).
[0018] The analysis unit 107 is a device that dispenses a sample and reagents corresponding to the analytical items, and measures predetermined components based on their reaction (see Figure 2, etc., later).
[0019] The control unit 108 is a device that controls the overall operation of the automatic analyzer 100. It acquires corresponding information from the storage unit 110 based on signals (reagent codes) transmitted from the reading unit 104, controls the mechanical operation of each part of the automatic analyzer 100, and performs calculations on the analysis data obtained from the measurement.
[0020] The input / output unit 109 is a device that allows the operator to input data and operation commands necessary for analysis, and to display analysis results, and is composed of, for example, a mouse, keyboard, touch panel, and liquid crystal display.
[0021] The memory unit 110 stores reagent information, analysis parameters, analysis item requests, analysis results, etc., and is composed of internal / external memory such as an HDD (Hard Disk Drive) or SSD (Solid State Drive).
[0022] Figure 2 is a functional block diagram that schematically shows the configuration of the analysis section of the automated analyzer.
[0023] In Figure 2, the analysis unit 107 includes two analysis units with different measurement principles: a biochemical analysis unit 201 (first analysis unit) that analyzes biochemical items based on absorbance measurement, and an immunoassay unit 202 biochemical analysis unit (second analysis unit) that analyzes immunoassay items based on chemiluminescence (including electrochemiluminescence).
[0024] The biochemical analysis unit 201 consists of a biochemical dispensing unit 203, a biochemical reaction unit 204, a biochemical measurement unit 205, and a biochemical washing unit 221, and performs analysis using reagents related to biochemical parameters.
[0025] The biochemical reaction unit 204 is equipped with multiple reaction vessels for reacting the sample with reagents. The biochemical reaction unit 204 is, for example, a disk-type device capable of intermittent rotation in both clockwise and counterclockwise directions, with multiple reaction vessels arranged circumferentially. The biochemical reaction unit 204 maintains the reaction solution in the reaction vessels at an appropriate reaction temperature (e.g., 37°C).
[0026] The biochemical dispensing unit 203 is a device that, via an operating unit (not shown), accesses the sample storage unit 101, reagent storage unit 102, biochemical reaction unit 204, and biochemical washing unit 221 to dispense samples and reagents. The biochemical dispensing unit 203 aspirates a predetermined amount of sample from the sample container placed in the sample storage unit 101, aspirates a predetermined amount of reagent for a biochemical item from the reagent container 103 in the reagent storage unit 102, and discharges the sample and reagent into the reaction vessel placed in the biochemical reaction unit 204. The biochemical dispensing unit 203 may also be equipped with a function to agitate the reaction solution, which is a mixture of the sample and reagent. Specifically, for example, the biochemical dispensing unit 203 may have a function to agitate the reaction solution by repeatedly aspirating and discharging the reaction solution using a pipetting action, or a function to agitate the reaction solution by providing liquid flow to the reaction solution using another mechanism such as a stirring rod or ultrasonic waves.
[0027] The biochemical measurement unit 205 includes a light source 223 and a spectrophotometer 224. The light source 223 irradiates light onto the reaction solution in the reaction vessel on the biochemical reaction unit 204. The spectrophotometer 224 calculates absorbance by measuring the luminosity at wavelengths set for each test item of light irradiated from the light source 223 and transmitted through the reaction solution. If the reagent contains latex particles, the scattering intensity of the agglutination formed between the sample and the latex particles is measured as absorbance.
[0028] The biochemical washing unit 221 is a device for washing the biochemical dispensing unit 203 after the dispensing of samples and reagents into reaction vessels has been completed. The biochemical washing unit 221 may also be used to wash multiple reaction vessels after the measurement by the spectrophotometer 224 has been completed.
[0029] The immunoassay unit 202 consists of an immunodispensing unit 206, an immunoreaction unit 207, an immunoassay unit 208, and an immunowashing unit 222, and performs analysis using reagents related to the immunoassay parameters.
[0030] The immunoassay unit 207 is equipped with multiple reaction vessels for reacting the sample with reagents. The immunoassay unit 207 is, for example, a disk-type device capable of intermittent rotation in both clockwise and counterclockwise directions, with multiple reaction vessels arranged circumferentially. The immunoassay unit 207 maintains the reaction solution in the reaction vessels at an appropriate reaction temperature (e.g., 37°C). Although not specifically shown in the figures, a configuration may be provided in which a reaction unit having the functions of both the biochemical reaction unit 204 and the immunoassay unit 207 is shared between the biochemical analysis unit 201 and the immunoanalysis unit 202.
[0031] The immunodispensing unit 206 is a device that, via an operating unit (not shown), accesses the sample storage unit 101, reagent storage unit 102, immunoreaction unit 207, and immunowashing unit 222 to dispense samples and reagents. The immunodispensing unit 206 aspirates a predetermined amount of sample from the sample container placed in the sample storage unit 101, aspirates a predetermined amount of reagent for the immunoassay item from the reagent container 103 in the reagent storage unit 102, and discharges the sample and reagent into the reaction vessel placed in the immunoreaction unit 207. The immunodispensing unit 206 may also be equipped with a function to agitate the reaction solution, which is a mixture of the sample and reagent. Specifically, for example, the immunodispensing unit 206 may have a function to agitate the reaction solution by repeatedly aspirating and discharging the reaction solution using a pipetting action, or a function to agitate the reaction solution by rotating the reaction vessel on its axis to create a vortex or other liquid flow in the reaction solution.
[0032] The immunoassay unit 208 consists of a suction nozzle 209, an immunoassay cell 210, and a photomultiplier tube 211. The reagent for the immunoassay item contains magnetic particles, and the magnetic particles in the reaction solution form a complex with the target substance (target molecule) and a luminescent label through an antigen-antibody reaction. The immunoassay unit 208 quantitatively measures the target substance by measuring the complex of magnetic particles, the target substance, and the luminescent label.
[0033] The suction nozzle 209 aspirates the reaction solution from the reaction vessel in the immunoreaction unit 207 and introduces it into the immunocell 210.
[0034] The immunotherapy cell 210 is equipped with electrodes for measurement. The complex of the target substance (target molecule), magnetic particles, and luminescent label introduced into the immunotherapy cell is captured on the electrodes by the magnetic force of a magnet (not shown) built into the immunotherapy cell 210. In the immunotherapy cell 210, a voltage is applied to the electrodes to capture the complex on the electrodes, and the intensity of the electrochemiluminescence light emitted by the luminescent label of the complex is measured by a photomultiplier tube 211. In this embodiment, the use of electrochemiluminescence is illustrated as an example, but other methods such as chemiluminescence, in which a luminescence reaction is induced by a trigger reagent, may also be used.
[0035] Figure 3 is a schematic diagram showing the configuration of the main components of the stirring section, washing section, and reagent storage section, and depicts the standby state.
[0036] As shown in Figure 3, the stirring section 106 is generally composed of a stirring rod 301, a motor 302, a shaft 303, and an arm 304.
[0037] The shaft 303 is a hollow member extending vertically, with an arm 304 provided at its upper end. The shaft 303 has a vertical movement mechanism and a pivot mechanism (not shown), which allow the arm 304 to move vertically and pivot.
[0038] The arm 304 is a hollow member that extends horizontally, and one end is connected to and supported by the upper end of the shaft 303. A rod-shaped stirring rod 301 is attached to the other end of the arm 304, which is different from the end where it connects to the shaft 303, and extends downward from the arm 304.
[0039] The tip (lower end) of the stirring rod 301 is equipped with a paddle for stirring the reagent in the reagent container 103. The reagent is stirred by rotating the stirring rod 301 around its axis using the motor 302 while the tip of the stirring rod 301 is immersed in the reagent. The stirring rod 301 (paddle) can also be cleaned by rotating the stirring rod 301 around its axis using the motor 302 while the tip of the stirring rod 301 is immersed in a cleaning liquid (also called cleaning solution).
[0040] The stirring unit 106 moves the stirring rod 301 to the stirring position of the reagent in the reagent container 103 or to the washing position for washing by the washing tank 305 by the vertical movement and rotation of the arm 304 by the shaft 303, and the stirring rod 301 is rotated by the motor 302 to stir the reagent and wash the stirring rod 301. For example, if the reagent in the reagent container 103 contains particles, stirring by the stirring rod 301 dissociates the aggregated particles and homogenizes them.
[0041] The cleaning unit 105 is generally composed of a cleaning tank 305, a water supply nozzle 306, a water supply pump 307, a tube 308, a water receiver 309, a drain port 310, and a drain hole 311.
[0042] The cleaning tank 305 is a tank that stores water as a liquid (cleaning solution) for cleaning the stirring rod 301 (and paddle). A portion of the inner wall separating it from the adjacent water receiver 309 is formed to be lower than the rest of the wall. When the amount of water in the cleaning tank 305 exceeds a certain amount, the excess water overflows and is discharged into the water receiver 309.
[0043] The water supply pump 307 supplies water into the washing tank 305 via the tube 308 and water supply nozzle 306 based on a control signal from the control unit 108.
[0044] The water receiver 309 is a tank where water overflowing from the washing tank 305 is collected, and the water that flows into the water receiver 309 is discharged from the drain port 310 at the bottom.
[0045] The drain hole 311 is a hole structure provided at the bottom of the cleaning tank 305 and is controlled by an electromagnetic valve. When the electromagnetic valve is opened based on a control signal from the control unit 108, the water stored in the cleaning tank 305 is discharged from the drain hole 311. To drain all the water stored in the cleaning tank 305, the electromagnetic valve of the drain hole 311 can be opened for a sufficient amount of time to discharge all the water accumulated in the cleaning tank 305.
[0046] Figures 4 to 9 schematically illustrate the stirring and washing operations of the reagents in the stirring section, washing section, and reagent storage section. Note that some reference numerals have been omitted in Figures 4 to 9 for simplicity of illustration.
[0047] In this embodiment, the reagent stirring operation is performed during reagent setup and during the analytical operation. The stirring operation during reagent setup is performed once for each reagent for biochemical and immunoassay items to prevent nonspecific aggregation of particles contained in the reagent. On the other hand, during the analytical operation, the stirring operation and washing operation are performed once immediately before each reagent dispensing, but only for the immunoassay items.
[0048] As shown in Figure 3, in the standby state of the stirring and washing sections, the stirring rod 301 stops at a position higher than the inner wall of the washing tank 305 because the shaft 303 is at its upper limit.
[0049] Once the reagent information reading unit 104 has finished reading all reagent containers 103 installed in the reagent storage unit 102, water 312 is then filled to the maximum amount in the washing tank 305 via the water supply pump 307, tube 308, and water supply nozzle 306, as shown in Figure 4. The maximum amount of water 312 is determined by the control unit 108 based on water volume information previously recorded in the storage unit 110.
[0050] When the washing tank 305 is filled with water 312, the reagent storage unit 102 is then rotated according to the stirring number 412 (see Figure 12 below) determined by the control unit 108, as shown in Figure 5, and the reagent container to be stirred (here, referred to as reagent container 313 to distinguish it from other reagent containers) is moved to a position (stirring position) where the stirring rod 301 of the stirring unit 106 can access the reagent. Specifically, the stirring rod 301 moves directly above the reagent container 313 by the rotation of the arm 304 of the stirring unit 106, and the stirring rod 301 is inserted into the reagent container 313 by the descent of the arm 304 by the shaft 303. The stirring rod 301 moves down a fixed amount to near the bottom of the reagent container 313 and then stops, and the stirring rod 301 is rotated by the motor 302 according to the stirring speed 413 (see Figure 12 below) determined by the control unit 108, and the reagent in the reagent container 313 is stirred.
[0051] Once the stirring of the reagent in the reagent container 313 is complete, the stirring rod 301 is then raised to a position higher than the reagent liquid surface by the upward movement of the arm 304 by the shaft 303, as shown in Figure 6, and then stopped. At this time, the reagent adhering to the stirring rod 301 is accumulated at the tip of the stirring rod 301 by gravity. At this point, the stirring rod is rotated again by the motor 302, causing the reagent accumulated at the tip of the stirring rod 301 to be scattered into the reagent container 313.
[0052] Next, as shown in Figure 7, the stirring rod 301 is moved to a position higher than the reagent container 313 by the upward movement of the shaft 303 and stopped, and the stirring rod 301 is moved directly above the washing tank 305 by the rotational movement of the arm 304. After that, the stirring rod 301 is inserted into the washing tank 305 by the downward movement of the shaft 303, and is lowered by a fixed amount to near the bottom and stopped. After that, the stirring rod 301 is rotated by the motor 302 according to the stirring speed 413 (see Figure 12 below) determined by the control unit 108. While the stirring rod 301 is rotating by the motor 302, the reagent storage unit 102 is rotated, and the next reagent container 314 is moved to the stirring position according to the stirring number 412 (see Figure 12 below) determined by the control unit 108.
[0053] Next, as shown in Figure 8, the stirring rod 301 is raised to a position higher than the water surface in the cleaning tank 305 by the upward movement of the arm 304 by the shaft 303 and then stopped. At this time, the water (cleaning liquid) adhering to the stirring rod 301 is collected at the tip of the stirring rod 301 by gravity. At this point, the stirring rod 301 is rotated again by the motor 302, causing the water collected at the tip of the stirring rod 301 to be scattered into the cleaning tank 305. Simultaneously with the rotation of the stirring rod 301, a fixed amount of water 312 is supplied to the cleaning tank 305 from the water supply pump 307 via the tube 308 and water supply nozzle 306. The same amount of water 312 as supplied overflows from the upper end of the inner wall of the cleaning tank 305 into the water receiver 309 and is discharged from the drain port 310. This replaces the water 312 in the cleaning tank 305.
[0054] Once the water 312 in the washing tank 305 is replaced, the stirring rod 301 then stirs the reagent in the next reagent container 314 according to the stirring number 412 (see Figure 12 later) determined by the control unit 108, as shown in Figure 9. This is the same operation as in Figure 5.
[0055] Here, we will explain the process flow for the stirring and washing operations.
[0056] Figure 10 schematically shows how reagent containers are stored in the reagent storage section. Figure 11 shows the relationship between the operation of the reagent storage section and the reading section and the information stored in the memory section, and Figure 12 shows the relationship between the reagent storage section, the stirring section and the washing section and the control section.
[0057] During the stirring operation of the reagent container 103 stored in the reagent storage unit 102 and the cleaning operation of the stirring unit, the control unit 108 determines the stirring number 412 and stirring speed 413 from the reagent code 403 read by the reading unit 104, and controls the stirring operation by the stirring unit 106 and the cleaning operation by the cleaning unit 105 to be executed.
[0058] As shown in Figure 10, the reagent storage unit 102 randomly contains a group of reagent containers 103 belonging to biochemical items (referred to as reagent container group 401 to distinguish them from other reagent containers) and a group of reagent containers 103 belonging to immunological items (referred to as reagent container group 402 to distinguish them from other reagent containers).
[0059] As shown in Figure 11, the reagent storage unit 102 rotates with the reagent container groups 401 and 402 stored in it, and the reagent code 403 of the reagent container 103 of the installed reagent container groups 401 and 402 is read by the reading unit 104 and sent to the control unit 108. The control unit 108 receives the signal of the reagent code 403 read by the reading unit 104, queries the reagent information 404 stored in the storage unit 110 in advance for information on the reagent corresponding to the received reagent code 403, and obtains the corresponding information.
[0060] The reagent code 403 is a number assigned to each type of reagent contained in the reagent container 103, and the reagent information 404 links the reagent code 403 with information related to each reagent and stores it in the storage unit 110. Specifically, the reagent information 404 records the reagent code 403, the analysis item 408, the reading history 409, the particle size 410, and the filling amount 411.
[0061] Analysis item 408 indicates either a biochemical item or an analytical item that can be measured by the automated analyzer 100. In Figure 11, if the reagent container group 401 belonging to the biochemical item or the reagent container group 402 belonging to the immunoassay item is not installed, it is indicated as "-" with no information.
[0062] The reading history 409 shows the date and time of previous readings of the reagent code 403 of the reagent container 103, which is the target of the reading, by the automated analyzer 100 or another automated analyzer. In Figure 11, if the code has never been read (there is no reading history), it is indicated as "-" with no information.
[0063] The particle size 410 indicates the diameter of the particles contained in the reagent. If the reagent contains multiple types of particles with different particle sizes, the diameter of the main component particle is indicated. In Figure 11, if the reagent contains no particles, it is indicated as "-" to show no information.
[0064] The filling volume 411 indicates the volume of reagents filled into reagent container 103 of reagent container groups 401 and 402.
[0065] As shown in Figure 12, the control unit 108 determines the stirring number 412, stirring speed 413, and schedules for stirring and washing operations corresponding to the reagent based on the reagent information 404 in the storage unit 110.
[0066] Figure 13 is a flowchart showing the processing steps involved in determining the stirring number, stirring speed, and the schedules for the stirring and washing operations in the control unit.
[0067] In Figure 13, after the control unit 108 has finished reading the reagent code 403 via the reading unit 104 (step S100) and acquiring the reagent information 404 based on the reagent code 403 (step S1102), it performs a process to determine whether stirring is necessary for all reagents (hereinafter referred to as the stirring necessity determination process) (steps S200 to S200E).
[0068] In the stirring requirement determination process, it is first determined whether there is a history of reagent code reading (step S210), whether it has been less than 7 days since the last reading (step S220), and whether the reagent does not contain particles (step S230). If the result of any of the determinations in steps S210 to S230 is YES, the reagent is determined to be a reagent that does not require stirring (see reagent 407 in Figure 12) (step S211), and the stirring requirement determination process is terminated (step S200E).
[0069] Furthermore, if all the results of steps S210 to S230 are NO, the reagent is determined to be a reagent to be stirred (see reagents 405 and 406 to be stirred in Figure 12) (step S240), and is classified into either the "biochemical items" reagent 405 or the "immunological items" reagent 406 group according to the analytical items (step S250), and the stirring necessity determination process is terminated (step S200E).
[0070] Once the stirring requirement determination process is complete, the next step is to determine whether or not there are any reagents 405 and 406 to be stirred (step S300). If the determination result is YES, i.e., if there are no reagents to be stirred, the stirring operation is deemed unnecessary (step S301), and the process is terminated.
[0071] Furthermore, if the result of the determination in step S300 is NO, that is, if there is one or more reagents 405 and 406 to be stirred, the stirring number 412 is assigned to each of the biochemical item group and the immunoassay item group (steps S310, S311, S312, S320).
[0072] In step S320, the stirring number 412 is assigned as follows. Specifically, stirring number 412 is first assigned to the reagents with the smallest particle size 410. If multiple types of particle sizes 410 are stored in the reagent information 404 of the memory unit 110, the particle size of the main particle contained in the reagent is referenced.
[0073] Furthermore, if there are reagents with the same particle size 410, then the reagent codes 403 are assigned to the reagents in descending order of size, starting with the smallest reagent code 403, and the stirring number 412 is assigned to each reagent.
[0074] Furthermore, if there are reagents with the same reagent code 403, the reading unit 104 then assigns stirring number 412 to the reagents in order of their reading history 409, starting with the oldest reagent.
[0075] In this way, by processing in steps S100 to S320, the randomly placed reagents are grouped into biochemical items and immunological items, and a stirring number 412 is assigned to each, thereby suppressing contamination of the stirring rod 301 by biochemical reagents into immunological reagents and vice versa.
[0076] Furthermore, in the biochemical measurement unit 205, when measuring particle scattering, the larger the particle size 410, the greater the noise influence on wavelengths other than the one to be measured. Therefore, by stirring the smaller particle sizes 410 first, it is possible to prevent larger particle sizes 410 reagents from mixing with smaller particle sizes 410 reagents within the same analytical item, thereby improving the accuracy of the measurement.
[0077] After the processing in step S320 is completed and stirring number 412 is assigned, the stirring speed 413 is then determined based on the liquid volume of the reagent information (step S320). Figure 14 shows an example of a correspondence table that defines the relationship between liquid volume and stirring speed. The correspondence table is predetermined and stored in the storage unit 110, etc. The stirring speed 413 is the number of rotations of the stirring rod 301 per unit time. In this embodiment, as shown in Figure 14, by changing the stirring speed 413 according to the liquid volume, splashing of the liquid can be prevented and the efficiency of stirring can be improved. In this embodiment, a stirring operation in which the stirring speed is changed according to the liquid volume has been described as an example, but it is not limited to this, and for example, the stirring operation may be configured to change according to the number of days elapsed since the last reading of the reagent code reading history. Specifically, it is conceivable to shorten the stirring time or slow down the paddle rotation speed according to the number of days elapsed since the last reading of the reagent code.
[0078] Next, it is determined whether or not there are any reagents to be stirred for the immunoassay items (step S340). If the result is YES, that is, if there are no reagents to be stirred for the immunoassay items and only reagents to be stirred for the biochemistry items, all of the reagents for the biochemistry items are stirred according to stirring number 412 (step S341), a special washing operation is performed (step S342), the water in the washing tank 305 is completely replaced (step S343), and the process is completed. Here, the special washing operation is a washing operation to remove protein contamination such as antibodies that have been modified on the surface of the latex particles attached to the stirring rod 301. In addition, the complete replacement of the water in the washing tank 305 in step S343 is an operation to remove contamination originating from latex particles remaining in the water.
[0079] Furthermore, if the result of step S340 is NO, that is, if there are reagents to be stirred for the immunoassay items, then it is determined whether or not there are reagents to be stirred for the biochemical items (step S350). If the result of step S350 is YES, that is, if there are no reagents to be stirred for the biochemical items and only reagents to be stirred for the immunoassay items, then all the reagents for the immunoassay items are stirred according to stirring number 412 (step S351), and the process is terminated.
[0080] Furthermore, if the result of step S350 is NO, that is, if there are reagents to be stirred for both biochemical items and immunoassay items, then all of the reagents for the biochemical items are stirred according to stirring number 412 (step S360), a special washing operation is performed (step S370), the water in the washing tank 305 is completely replaced (step S380), all of the reagents for the immunoassay items are stirred according to stirring number 412 (step S390), and the process is terminated.
[0081] Figures 15 to 19 schematically illustrate the special cleaning operation and water exchange operation in the cleaning unit. Note that some reference numerals have been omitted in Figures 15 to 19 for simplicity of illustration.
[0082] The special cleaning operation (see steps S342 and S370 in Figure 13) and the complete replacement of the cleaning tank water (see steps S342 and S380 in Figure 13) are performed within the specified time allocated for the stirring operation.
[0083] After stirring of all reagents belonging to the biochemistry category (see steps S341 and S360 in Figure 13) is complete, as shown in Figure 15, the reagent storage unit 102 rotates, moving the detergent container 701 to a position accessible to the stirring rod 301 of the stirring unit 106. The detergent contained in the detergent container 701 is determined according to the material of the stirring rod 301 and the components of the reagents used; for example, a buffer solution with pH adjusted using sodium hydroxide or hydrochloric acid is conceivable.
[0084] Once the movement of the detergent container 701 is complete, as shown in Figure 16, the stirring rod 301 is moved directly above the detergent container 701 by the rotation of the arm 304 by the shaft 303 of the stirring unit 106, and the stirring rod 301 is inserted into the detergent container 701 by the downward movement of the arm 304 by the shaft 303. Then, according to the stirring speed 412 determined by the control unit 108, the stirring rod 301 is rotated by the motor 302 and the stirring rod 301 is washed with the solution in the detergent container 701. The stirring rod 301 is lowered by a fixed amount to near the bottom of the detergent container 701 and then stopped.
[0085] Next, as shown in Figure 17, the stirring rod 301 is raised to a position higher than the detergent liquid level in the detergent container 701 by the upward movement of the arm 304 by the shaft 303 and then stopped. At this time, the detergent adhering to the stirring rod 301 is accumulated at the tip of the stirring rod 301 by gravity. Then, the stirring rod 301 is rotated again by the motor 302, causing the detergent accumulated at the tip of the stirring rod 301 to be scattered into the detergent container 701.
[0086] Next, as shown in Figure 18, the stirring rod 301 is raised to a position higher than the detergent container 701 by the upward movement of the arm 304 by the shaft 303 and then stopped. The stirring rod 301 is then moved directly above the washing tank 305 by the rotation of the arm 304 by the shaft 303. In this state, the stirring rod 301 is inserted into the water of the washing tank 305 by the downward movement of the arm 304 by the shaft 303. At this time, the stirring rod 301 is lowered by a fixed amount to near the bottom of the washing tank 305 and stopped. After that, the stirring rod 301 is rotated by the motor 302 according to the stirring speed determined by the control unit 108. While the stirring rod 301 is rotating by the motor 302, the reagent storage unit 102 rotates, and the reagent containers 103 of the reagent container group 402 belonging to the immunoassay item determined according to stirring number 412 are moved to the stirring position. Furthermore, the water 312 in the washing tank 305 becomes contaminated water contaminated with reagents, latex particles, proteins that modify the latex surface, and detergents.
[0087] Next, as shown in Figure 19, the contaminated water in the washing tank 305 is completely discharged from the drain hole 311 under the control of the control unit 108.
[0088] After all the contaminated water has been discharged, the washing tank 305 is filled to its maximum capacity with water 312 from the water supply pump 307 via the tube 308 and water supply nozzle 306, thereby completely replacing the water in the washing tank 305.
[0089] In this embodiment, configured as described above, space savings and cost reductions can be achieved by stirring multiple types of reagents with a single stirring rod while suppressing a decrease in analytical accuracy.
[0090] <Note> It should be noted that the present invention is not limited to the embodiments described above, and includes various modifications and combinations that do not depart from the spirit of the invention. Furthermore, the present invention is not limited to having all the configurations described in the embodiments described above, and includes configurations in which some of the configurations are omitted. In addition, some or all of the above configurations, functions, etc. may be realized by designing, for example, an integrated circuit. Furthermore, each of the above configurations, functions, etc. may be realized in software by having a processor interpret and execute a program that realizes each function. [Explanation of symbols]
[0091] 100...Automatic analyzer, 101...Sample storage unit, 102...Reagent storage unit, 103...Reagent container, 104...Reading unit, 105...Washing unit, 106...Agitation unit, 107...Analysis unit, 108...Control unit, 109...Input / output unit, 110...Storage unit, 201...Biochemical analysis unit, 202...Immunoanalysis unit, 203...Biochemical dispensing unit, 204...Biochemical reaction unit, 205...Biochemical measurement unit, 206...Immunodispensing unit, 207...Immunoreaction unit, 208...Immunoassay unit, 209...Aspiration nozzle, 210...Immunocell, 211...Photomultiplier tube, 221...Biochemical washing unit, 222...Immunowashing unit, 223...Light source, 224...Spectrophotometer 301…Meter, 302…Stirring rod, 303…Motor, 304…Arm, 305…Washing tank, 306…Water supply nozzle, 307…Water supply pump, 308…Tube, 310…Drain port, 311…Drain hole, 312…Water, 313…Reagent container, 314…Reagent container, 401…Group of reagent containers, 402…Group of reagent containers, 403…Reagent code, 404…Reagent information, 405…Reagent to be stirred, 406…Reagent to be stirred, 407…Reagent not to be stirred, 408…Analysis item, 409…Reading history, 410…Particle size, 411…Filling amount, 412…Stirring speed, 413…Stirring speed, 701…Detergent container
Claims
1. The first analysis department conducts analysis related to the first set of analysis items, A second analysis unit performs analysis of the second group of analysis items using a measurement principle different from that of the first analysis unit, A reagent storage unit that stores at least one first reagent container containing reagents used for analysis in the first analysis unit, and at least one second reagent container containing reagents used for analysis in the second analysis unit, A stirring unit having a stirring rod for stirring the solutions in the first reagent container and the second reagent container, The system includes a control unit that controls the operation of the stirring section, The automatic analyzer is characterized in that the control unit controls the operation of the stirring unit so that it stirs the solution in the second reagent container after it has finished stirring the solutions in all of the first reagent containers in the reagent storage unit.
2. In the automated analyzer according to claim 1, The aforementioned first group of analytical items are biochemical analytical items, An automated analyzer characterized in that the second group of analytical parameters is an immunoassay parameter.
3. In the automated analyzer according to claim 1, The system further comprises a washing tank for containing a liquid for washing the stirring rod, An automated analyzer characterized in that the control unit controls the operation of the stirring unit and the washing tank so as to wash the stirring rod in the washing tank after the stirring of the solutions in all the first reagent containers in the reagent storage unit is complete, and before stirring the solutions in the second reagent containers.
4. In the automated analyzer according to claim 3, The automatic analyzer is characterized in that the control unit controls the washing tank to replace all the liquid used to wash the stirring rod after the stirring of all the solutions in the first reagent containers of the reagent storage unit has been completed, and before the stirring of the solutions in the second reagent containers.
5. In the automated analyzer according to claim 1, The control unit controls the stirring section to stir the reagent in order of increasing particle size of the beads contained in the reagent.
6. In the automated analyzer according to claim 1, The control unit controls the stirring section, which controls the rotation speed of the stirring rod according to the volume of the reagent.
7. In the automated analyzer according to claim 1, The reagent storage section further includes a reading unit for reading information about the reagents contained in the reagent containers stored in the reagent storage section, The control unit is characterized by determining whether the reagent container is the first reagent container or the second reagent container according to the information read by the reading unit.