Automated analyzer
By using the method of multiple analytical units and control units to jointly control the stirring action in the automatic analysis device, the reagent mixing problem caused by a single stirring rod is solved, and the maintenance of analysis accuracy is achieved, space saving and cost reduction of the device is achieved.
Patent Information
- Application Number
- CN202380081990.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-12-23
- Filing Date
- 2023-11-30
- Publication Date
- 2025-07-04
AI Technical Summary
When using a single stirrer, the existing automatic analysis device has the problem of the mixing of components between reagents resulting in reduced analysis accuracy, and it is difficult to achieve space saving and cost reduction.
The automatic analysis device with the first and second analytical parts is adopted, and the analysis is performed using different measurement principles, and the operation of the stirring part is controlled by the control part, so that the stirring of the second reagent container is performed after the stirring of all the first reagent containers is completed.
While suppressing the reduction of analysis accuracy, agitating multiple reagents through a single stirring rod is achieved, achieving the effect of space saving and cost reduction.
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Figure CN120265990A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to an automatic analysis device. Background Art
[0002] An automatic analysis device reacts blood, urine, other biological specimens (samples) with an analysis reagent that specifically reacts with a component to be measured in the specimen, quantitatively detects the complex generated by this reaction, and thus automatically performs measurement of the component to be measured and output of the result.
[0003] As a technique related to an automatic analysis device, a technique of stirring a first reagent not containing magnetic particles and a second reagent containing magnetic particles using respective stirring rods has been disclosed (see Patent Document 1).
[0004] Prior Art Documents
[0005] Patent Documents
[0006] Patent Document 1: Japanese Unexamined Patent Application Publication No. 2013 - 250276 Summary of the Invention
[0007] Problems to be Solved by the Invention
[0008] Hospitals and the like using an automatic analysis device have expectations for space saving and cost reduction. For example, it is required to control the number of stirring rods for reagents to 1 and commonly use them for multiple reagents, thereby achieving space saving due to reduction of stirring rods and drive mechanisms and cost reduction due to reduction of the number of components. On the other hand, when the number of stirring rods for reagents is 1, there is a concern about mixing of components between multiple reagents caused by contamination of the stirring rod and reduction of analysis accuracy caused by mixing of reagents.
[0009] The present invention has been completed in view of the above circumstances, and an object thereof is to provide an automatic analysis device that can suppress reduction of analysis accuracy and can achieve space saving and cost reduction by using 1 stirring rod to stir multiple reagents.
[0010] Means for Solving the Problems
[0011] The present application includes multiple methods for solving the above problems. If one example is cited, it includes: a first analysis unit that analyzes a first analysis item group, a second analysis unit that analyzes a second analysis item group based on a measurement principle different from that of the first analysis unit, a reagent storage unit that stores at least one first reagent container containing a reagent for analysis in the first analysis unit and at least one second reagent container containing a reagent for analysis in the second analysis unit, a stirring unit having a stirrer for stirring the solutions in the first reagent container and the second reagent container, and a control unit that controls the operation of the stirring unit. The control unit controls the operation of the stirring unit such that after stirring the solutions in all the first reagent containers in the reagent storage unit is completed, the solutions in the second reagent container are stirred.
[0012] Advantages of the Invention
[0013] According to the present invention, by stirring multiple reagents with one stirrer while suppressing a decrease in analysis accuracy, space saving and cost reduction can be achieved. BRIEF DESCRIPTION OF THE DRAWINGS
[0014] Figure 1 It is a diagram schematically showing the overall configuration of an automatic analysis device.
[0015] Figure 2 It is a functional block diagram schematically showing the configuration of the analysis unit of the automatic analysis device.
[0016] Figure 3 It is a diagram schematically showing the main part configuration of the stirring unit, cleaning unit, and reagent storage unit.
[0017] Figure 4 It is a diagram schematically showing the states of the stirring operation and the cleaning operation.
[0018] Figure 5 It is a diagram schematically showing the states of the stirring operation and the cleaning operation.
[0019] Figure 6 It is a diagram schematically showing the states of the stirring operation and the cleaning operation.
[0020] Figure 7 It is a diagram schematically showing the states of the stirring operation and the cleaning operation.
[0021] Figure 8 It is a diagram schematically showing the states of the stirring operation and the cleaning operation.
[0022] Figure 9 It is a diagram schematically showing the states of the stirring operation and the cleaning operation.
[0023] Figure 10A diagram schematically showing the state where reagent containers are stored in a reagent storage unit.
[0024] 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.
[0025] Figure 12 A diagram showing the relationship between the reagent storage unit, the stirring unit, and the cleaning unit and the control unit.
[0026] Figure 13 A flowchart showing the processing content of the determination process of the schedule of the stirring number, stirring speed, stirring operation, and cleaning operation in the control unit.
[0027] Figure 14 A diagram showing an example of a correspondence table determining the relationship between the liquid volume and the stirring speed.
[0028] Figure 15 A diagram schematically showing the state of a special cleaning operation and a water replacement operation.
[0029] Figure 16 A diagram schematically showing the state of a special cleaning operation and a water replacement operation.
[0030] Figure 17 A diagram schematically showing the state of a special cleaning operation and a water replacement operation.
[0031] Figure 18 A diagram schematically showing the state of a special cleaning operation and a water replacement operation.
[0032] Figure 19 A diagram schematically showing the state of a special cleaning operation and a water replacement operation. Detailed Embodiments
[0033] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. It should be noted that in the present embodiment, a composite automatic analyzer for performing biochemical analysis and immunoassay is exemplified for description, but as long as it is an automatic analyzer that uses a plurality of reagents with different principles for measurement, the present invention can be applied.
[0034] Figure 1 A diagram schematically showing the overall configuration of the automatic analyzer of the present embodiment.
[0035] In Figure 1Among them, the automatic analysis device 100 is a composite and small-sized device that analyzes specific components contained in specimens such as blood and urine provided by patients and can analyze biochemical items and immunological items. 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.
[0036] In the specimen storage unit 101, a plurality of specimen containers containing biological specimens such as blood and urine are placed. It should be noted that 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 that can rotate intermittently in the clockwise and counterclockwise directions, or a support type in which the specimen containers are held on a transferable support and the support is transferred, etc.
[0037] The reagent storage unit 102 is a disk-type storage unit in which a plurality of reagent containers 103 are arranged and placed circumferentially on a reagent disk that can rotate intermittently in the clockwise and counterclockwise directions. A plurality of reagent containers 103 corresponding to the analysis items of the automatic analysis device 100 are placed. The reagent containers 103 belong to biochemical items or immunological items.
[0038] The reading unit 104 is a device that reads the reagent codes used to identify the reagent containers 103, reads the reagent codes written in each of the plurality of reagent containers 103, and sends them to the control unit 108 (refer to the following Figure 11 etc.). By rotating the reagent storage unit 102, the reagent container 103 that is the object of reading the reagent code is transported to the reading position of the reading unit 104.
[0039] 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 reagent is stirred by inserting a stirring rod with a blade at the front end into the reagent container 103 and rotating it (refer to the following Figure 5 、 Figure 9 、 Figure 16 etc.). By rotating the reagent storage unit 102, the reagent container 103 containing the reagent to be stirred is transported to the stirring position of the stirring unit 106.
[0040] The cleaning unit 105 is a device that cleans the mechanism that comes into contact with the reagent in the stirring unit 106 after stirring the reagent in the reagent container 103 using cleaning water. The stirring unit 106 is cleaned by rotating the stirring rod and the blade in the stored cleaning water (refer to the following Figure 7 、 Figure 18 etc.).
[0041] The analysis unit 107 is a device that dispenses a sample and a reagent corresponding to an analysis item and measures a predetermined component based on their reaction (refer to Figure 2 etc.).
[0042] The control unit 108 is a device that controls the overall operation of the automatic analyzer 100, obtains corresponding information from the storage unit 110 based on signals (reagent codes, etc.) sent from the reading unit 104, controls the mechanical operations of each part of the automatic analyzer 100, and performs operations on the analysis data obtained by measurement, etc.
[0043] The input / output unit 109 is a device that inputs data, operation instructions, etc. required for an operator to perform an analysis and displays the analysis results, etc. For example, it is composed of a mouse, a keyboard, a touch panel, a liquid crystal display, etc.
[0044] The storage unit 110 stores reagent information, analysis parameters, analysis item commissions, analysis results, etc. For example, it is composed of internal / external memories such as HDD (Hard Disk Drive) and SSD (Solid State Drive).
[0045] Figure 2 is a functional block diagram schematically showing the configuration of the analysis unit of the automatic analyzer.
[0046] In Figure 2 , as an analysis unit with different measurement principles, the analysis unit 107 has a biochemical analysis unit 201 (first analysis unit) that analyzes biochemical items based on absorbance measurement and an immunoassay analysis unit 202 (second analysis unit) that analyzes immunoassay items based on chemiluminescence (including electrochemiluminescence).
[0047] The biochemical analysis unit 201 is composed of a biochemical dispensing unit 203, a biochemical reaction unit 204, a biochemical measurement unit 205, and a biochemical cleaning unit 221, and performs analysis using reagents related to biochemical items.
[0048] In the biochemical reaction unit 204, a plurality of reaction vessels for reacting a sample with a reagent are placed. The biochemical reaction unit 204 is, for example, a disk-shaped device that can rotate intermittently in the clockwise and counterclockwise directions, and a plurality of reaction vessels are arranged and placed along the circumferential direction. In the biochemical reaction unit 204, the reaction solution in the reaction vessel is kept at an appropriate reaction temperature (for example, 37°C).
[0049] The biochemical dispensing unit 203 is a device that accesses the specimen storage unit 101, the reagent storage unit 102, the biochemical reaction unit 204, and the biochemical cleaning unit 221 through an unillustrated actuating unit to perform the dispensing of specimens, reagents, etc. The biochemical dispensing unit 203 aspirates a predetermined amount of the specimen from the specimen container placed on the specimen storage unit 101, aspirates a predetermined amount of the reagent for the biochemical item from the reagent container 103 in the reagent storage unit 102, and discharges the specimen and the reagent into the reaction container placed on the biochemical reaction unit 204. It should be noted that the biochemical dispensing unit 203 may also have the function of stirring the reaction solution, which is a mixed solution of the specimen and the reagent. Specifically, for example, a function of stirring the reaction solution by repeatedly performing pipetting operations of aspirating and discharging the reaction solution in the biochemical dispensing unit 203 can be considered, or a function of imparting liquid flow to the reaction solution by other mechanisms such as a stirring rod or ultrasonic waves to stir the reaction solution, etc.
[0050] 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 container on the biochemical reaction unit 204. The spectrophotometer 224 calculates the absorbance by measuring the light intensity at wavelengths set for each test item of the light irradiated from the light source 223 and transmitted through the reaction solution. When the reagent contains latex particles, the scattering intensity of the aggregate formed by the specimen and the latex particles is measured as the absorbance.
[0051] The biochemical cleaning unit 221 is a device for cleaning the biochemical dispensing unit 203 after the dispensing of the specimen and the reagent into the reaction container. It should be noted that the biochemical cleaning unit 221 may also clean a plurality of reaction containers after the measurement by the spectrophotometer 224.
[0052] The immunoassay unit 202 is composed of an immunodispensing unit 206, an immunoreaction unit 207, an immunoassay unit 208, and an immunocleaning unit 222, and performs analysis using reagents related to immunoassay items.
[0053] In the immunoreaction unit 207, a plurality of reaction containers for reacting the specimen with the reagent are placed. The immunoreaction unit 207 is, for example, a disk-shaped device capable of intermittently rotating clockwise and counterclockwise, and a plurality of reaction containers are arranged and placed along the circumferential direction. In the immunoreaction unit 207, the reaction solution in the reaction container is maintained at an appropriate reaction temperature (for example, 37°C). It should be noted that although not particularly illustrated, it may also be configured to have a reaction unit that has the functions of both the biochemical reaction unit 204 and the immunoreaction unit 207 through sharing in the biochemical analysis unit 201 and the immunoassay unit 202.
[0054] The immuno-dispensing unit 206 is a device that accesses the sample storage unit 101, the reagent storage unit 102, the immuno-reaction unit 207, and the immuno-washing unit 222 through an unillustrated actuating unit to perform the dispensing of samples, reagents, etc. The immuno-dispensing unit 206 aspirates a predetermined amount of the sample from the sample container placed in the sample storage unit 101, aspirates a predetermined amount of the reagent for the immunoassay item from the reagent container 103 in the reagent storage unit 102, and discharges the sample and the reagent into the reaction container placed in the immuno-reaction unit 207. It should be noted that the immuno-dispensing unit 206 may also have the function of stirring the reaction solution that is the mixed solution of the sample and the reagent. Specifically, for example, a function of stirring the reaction solution by repeatedly performing pipetting operations of aspirating and discharging the reaction solution in the immuno-dispensing unit 206, or a vortex stirring function of causing the reaction solution to generate a vortex and other liquid flows by rotating the reaction container around its axis to stir the reaction solution, etc. can be considered.
[0055] The immunoassay unit 208 is composed of a suction nozzle 209, an immuno-sample 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 substance to be measured (target molecule) and the luminescent label through an antigen-antibody reaction. The immunoassay unit 208 quantitatively measures the substance to be measured by measuring the complex of the magnetic particles, the substance to be measured, and the luminescent label.
[0056] The suction nozzle 209 aspirates the reaction solution in the reaction container located in the immuno-reaction unit 207 and introduces it into the interior of the immuno-sample cell 210.
[0057] An electrode for measurement is provided inside the immuno-sample cell 210, and the complex of the substance to be measured (target molecule), the magnetic particles, and the luminescent label in the reaction solution introduced into the immuno-sample cell is captured on the electrode by the magnetic force of an unillustrated magnet built into the immuno-sample cell 210. In the immuno-sample cell 210, a voltage is applied to the electrode to apply a voltage to the complex captured on the electrode, and the photomultiplier tube 211 measures the light intensity of the electrochemiluminescence emitted by the luminescent label of the complex. It should be noted that in this embodiment, the case of using the electrochemiluminescence method is illustrated, but for example, a method such as the chemiluminescence method in which a luminescence reaction is triggered by a reagent can also be used.
[0058] Figure 3 It is a diagram schematically showing the main components of the extraction stirring unit, the washing unit, and the reagent storage unit, and is a diagram showing the standby state.
[0059] As Figure 3 shown, the stirring unit 106 is roughly composed of a stirring rod 301, a motor 302, a shaft 303, and an arm 304.
[0060] The shaft 303 is a hollow member extending in the vertical direction, and an arm 304 is provided at the upper end. The shaft 303 has an up-and-down movement mechanism and a rotation mechanism (not shown), and can perform the up-and-down movement and rotation of the arm 304.
[0061] The arm 304 is a hollow member extending in the horizontal direction, and one end is connected to the upper end of the shaft 303 and supported. In addition, a rod-shaped stirring rod 301 extending downward from the arm 304 is installed at the end (the other end) of the arm 304 different from the connection part with the shaft 303.
[0062] At the front end (lower end) of the stirring rod 301, a paddle for stirring the reagent in the reagent container 103 is provided. The stirring rod 301 is rotated around the axis by the motor 302 in a state where the front end of the stirring rod 301 is immersed in the reagent, thereby stirring the reagent. In addition, in a state where the front end of the stirring rod 301 is immersed in the cleaning liquid (also called the cleaning solution), the stirring rod 301 is rotated around the axis by the motor 302, thereby enabling the cleaning of the stirring rod 301 (paddle).
[0063] The stirring unit 106 moves the stirring rod 301 to the stirring position of the reagent in the reagent container 103 and the cleaning position for cleaning based on the up-and-down movement and rotation of the arm 304 of the shaft 303, and stirs the reagent and cleans the stirring rod 301 by rotating the stirring rod 301 based on the motor 302. For example, when particles are contained in the reagent in the reagent container 103, the aggregation of the particles is dissociated and homogenized by stirring with the stirring rod 301.
[0064] The cleaning unit 105 is roughly composed of a cleaning tank 305, a water supply nozzle 306, a water supply pump 307, a pipe 308, a water receiving part 309, a drain port 310, and a drain hole 311.
[0065] The cleaning tank 305 is a tank part for storing water as a liquid (cleaning solution) for cleaning the stirring rod 301 (and the paddle). A part of the inner wall separating the adjacent water receiving part 309 is formed lower than the other parts. When the water in the cleaning tank 305 exceeds a certain amount, the excess water overflows and is discharged into the water receiving part 309.
[0066] The water supply pump 307 supplies water into the cleaning tank 305 via the pipe 308 and the water supply nozzle 306 based on a control signal from the control unit 108.
[0067] The water receiving part 309 is a tank part for accumulating the water overflowing from the cleaning tank 305, and the water flowing into the water receiving part 309 is discharged from the drain port 310 located at the bottom.
[0068] The drain hole 311 is a hole structure provided at the bottom of the cleaning tank 305 and controlled to open and close based on a solenoid valve. By opening the solenoid valve 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. When all the water stored in the cleaning tank 305 is to be discharged, by opening the solenoid valve of the drain hole 311 for a sufficient time, all the water accumulated in the cleaning tank 305 can be discharged.
[0069] Figures 4 - 9 It is a diagram schematically showing the stirring operation and cleaning operation conditions of the reagents in the stirring unit, cleaning unit, and reagent storage unit. It should be noted that in Figures 4 - 9 In order to simplify the illustration, some symbols are appropriately omitted.
[0070] The stirring operation of the reagent in this embodiment is an operation performed during reagent setting and analysis operation. In order to prevent non-specific aggregation of particles contained in the reagent, the stirring operation during reagent setting is performed once for each reagent of biochemical items and immunoassay items. On the other hand, the stirring operation during the analysis operation is only performed once for the reagent of the immunoassay item before each reagent dispensing, along with the cleaning operation.
[0071] As Figure 3 shown, in the standby state of the stirring unit and the cleaning unit, since the shaft 303 is at the upper limit point, the stirring rod 301 stops at a position higher than the inner wall of the cleaning tank 305.
[0072] When the reading unit 104 finishes reading the reagent information of all the reagent containers 103 set in the reagent storage unit 102, then, as Figure 4 shown, water 312 is filled into the cleaning tank 305 from the water supply pump 307 via the pipe 308 and the water supply nozzle 306 until the maximum amount. The maximum amount of water 312 is determined by the control unit 108 based on the water amount information pre-recorded in the storage unit 110.
[0073] When filling water 312 into the cleaning tank 305, then, as Figure 5 shown, according to the stirring number 412 determined by the control unit 108 (refer to the following Figure 12)Rotate the reagent storage unit 102 so that the reagent container to be the object of the stirring operation (here, the reagent container 313 is set distinctively from other reagent containers) moves to a position where the stirring rod 301 of the stirring unit 106 can approach the reagent (stirring position). Specifically, through the rotation operation of the arm 304 of the stirring unit 106, the stirring rod 301 moves above the reagent container 313, and the arm 304 is lowered by the shaft 303, and the stirring rod 301 is inserted into the reagent container 313. After the stirring rod 301 descends to near the bottom of the reagent container 313 with a fixed moving amount and stops, according to the stirring speed 413 determined by the control unit 108 (refer to the following Figure 12 ), rotate the stirring rod 301 by the motor 302 to stir the reagent in the reagent container 313.
[0074] When the stirring of the reagent in the reagent container 313 is completed, then, as Figure 6 shown, raise the arm 304 by the shaft 303 to raise the stirring rod 301 to a position higher than the reagent liquid level and stop. At this time, the reagent adhering to the stirring rod 301 accumulates at the front end of the stirring rod 301 due to gravity. Here, rotate the stirring rod again by the motor 302, whereby the reagent accumulated at the front end of the stirring rod 301 scatters into the reagent container 313.
[0075] Next, as Figure 7 shown, move the stirring rod 301 to a position higher than the reagent container 313 by raising the shaft 303 and stop, and move the stirring rod 301 above the cleaning tank 305 by the rotation operation of the arm 304. After that, lower the stirring rod 301 into the cleaning tank 305 by lowering the shaft 303, lower it to near the bottom with a fixed moving amount and stop. After that, according to the stirring speed 413 determined by the control unit 108 (refer to the following Figure 12 ), rotate the stirring rod 301 by the motor 302. During the rotation of the stirring rod 301 based on the motor 302, the reagent storage unit 102 rotates, and according to the stirring number 412 determined by the control unit 108 (refer to the following Figure 12 ), the next reagent container 314 moves to the stirring position.
[0076] Next, as Figure 8As shown, the arm 304 is raised by the shaft 303, and the stirring rod 301 is raised to a position higher than the water surface in the cleaning tank 305 and stopped. At this time, the water (cleaning liquid) adhering to the stirring rod 301 accumulates at the front end of the stirring rod 301 due to gravity. Here, by rotating the stirring rod 301 again using the motor 302, the water accumulated at the front end of the stirring rod 301 scatters in the cleaning tank 305. In addition, when a certain amount of water 312 is supplied to the cleaning tank 305 from the water supply pump 307 via the pipe 308 and the water supply nozzle 306 while the stirring rod 301 is rotating, an amount of water 312 equal to the supplied water overflows from the upper end of the inner wall of the cleaning tank 305 to the water receiving part 309 and is discharged from the drain port 310. Thus, the water 312 in the cleaning tank 305 is replaced.
[0077] After the water 312 in the cleaning tank 305 is replaced, next, as Figure 9 shown, according to the stirring number 412 determined by the control unit 108 (refer to the following Figure 12 ), the stirring rod 301 performs stirring on the reagent in the next reagent container 314. This is the same as the operation of Figure 5 .
[0078] Here, the processing flow of the stirring operation and the cleaning operation will be described.
[0079] Figure 10 It is a diagram schematically showing the state in which reagent containers are stored in the reagent storage unit. In addition, Figure 11 is 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 is a diagram showing the relationship between the reagent storage unit, the stirring unit, the cleaning unit, and the control unit.
[0080] In the stirring operation of the reagent in 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 the stirring speed 413 according to the reagent code 403 read by the reading unit 104, and controls to execute the stirring operation of the stirring unit 106 and the cleaning operation of the cleaning unit 105.
[0081] As Figure 10 shown, a set of reagent containers 103 belonging to the biochemical item (set as the reagent container group 401 to be distinguished from other reagent containers) and a set of reagent containers 103 belonging to the immune item (set as the reagent container group 402 to be distinguished from other reagent containers) are randomly arranged in the reagent storage unit 102.
[0082] As Figure 11As shown, with the reagent container groups 401 and 402 stored in the reagent storage unit, the reagent storage unit 102 rotates and moves, and the reagent codes 403 of the reagent containers 103 of the set reagent container groups 401 and 402 are 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 pre-stored in the storage unit 110 for the information of the reagent corresponding to the received reagent code 403, and obtains the corresponding information.
[0083] The reagent code 403 is a number determined for each type of reagent contained in the reagent container 103. In the reagent information 404, the reagent code 403 and the information related to each reagent are stored in the storage unit 110 in an associated manner. Specifically, as the reagent information 404, the reagent code 403, the analysis item 408, the reading history 409, the particle size 410, and the filling amount 411 are recorded.
[0084] The analysis item 408 shows any one of the biochemical items and the analysis items as the items that can be measured by the automatic analyzer 100. It should be noted that in Figure 11 in the case where the reagent container group 401 belonging to the biochemical item or the reagent container group 402 belonging to the immunoassay item is not set, it is represented as "-" as no information.
[0085] The reading history 409 represents the history of the reagent code 403 of the reagent container 103 to be read being read by this automatic analyzer 100 or other automatic analyzers in the past as the date and time. It should be noted that in Figure 11 in the case where it has not been read (no reading history), it is represented as "-" as no information.
[0086] The particle size 410 represents the diameter of the particles contained in the reagent. Additionally, in the case where the reagent contains multiple types of particles with different particle sizes, it represents the diameter of the particles that are the main component. It should be noted that in Figure 11 in the case where the reagent does not contain particles, it is represented as "-" as no information.
[0087] The filling amount 411 represents the capacity of the reagent filled in the reagent containers 103 of the reagent container groups 401 and 402.
[0088] As Figure 12 shown, in the control unit 108, based on the reagent information 404 in the storage unit 110, the stirring number 412, the stirring speed 413, the stirring operation, and the schedule of the cleaning operation corresponding to the reagent are determined.
[0089] Figure 13It is a flowchart showing the processing content of the determination process of the stirring number, stirring speed, and the schedule of the stirring operation and cleaning operation in the control unit.
[0090] In Figure 13 this, after the control unit 108 finishes 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 the process of determining whether stirring is required for all reagents (hereinafter referred to as the whether-stirring-is-required determination process) (steps S200 to S200E).
[0091] In the whether-stirring-is-required determination process, first, it determines whether there is a reagent code reading history (step S210), whether it is within 7 days since the last reading (step S220), and whether the reagent does not contain particles (step S230). If the determination result of any of steps S210 to S230 is "yes", the reagent is determined to be a non-stirring target reagent (refer to Figure 12 the non-stirring target reagent 407) (step S211), and the whether-stirring-is-required determination process ends (step S200E).
[0092] In addition, if the determination results of all of steps S210 to S230 are "no", the reagent is determined to be a stirring target reagent (refer to Figure 12 the stirring target reagents 405, 406) (step S240), and it is classified into the group of stirring target reagents 405 for "biochemical items" or the group of stirring target reagents 406 for "immunological items" according to the analysis item (step S250), and the whether-stirring-is-required determination process ends (step S200E).
[0093] When the whether-stirring-is-required determination process ends, then it determines whether there are no stirring target reagents 405, 406 (step S300). If the determination result is "yes", that is, when there are no stirring target reagents, the stirring operation is not required (step S301), and the process ends.
[0094] In addition, when the determination result in step S300 is "no", that is, when there is one or more stirring target reagents 405, 406, the process of assigning the stirring number 412 is performed for the biochemical item group and the immunological item group respectively (steps S310, S311, S312, S320).
[0095] In the process of step S320, the stirring number 412 is assigned as follows. Specifically, first, the stirring number 412 is assigned in order from the reagent with a small particle size 410. When there are multiple particle sizes 410 stored in the reagent information 404 in the storage unit 110, refer to the particle size of the main particles contained in the reagent.
[0096] In addition, in the case where there are reagents with the same particle size 410, then, starting from the reagent with the smaller reagent code 403, stirring numbers 412 are sequentially assigned.
[0097] Furthermore, in the case where there are reagents with the same reagent code 403, then, in the reading unit 104, starting from the reagent with an older reading history 409 of the reagent code 403, stirring numbers 412 are sequentially assigned.
[0098] In this way, through the processing of steps S100 to S320, the randomly arranged reagents are grouped into biochemical items and immunoassay items, and stirring numbers 412 are respectively assigned, thereby being able to suppress the mixing of biochemical reagents into immunoassay reagents and the mixing of immunoassay reagents into biochemical reagents caused by the contamination of the stirring rod 301.
[0099] In addition, in the biochemical measurement unit 205, when measuring particle scattering, the larger the particle size 410, the greater the influence on the noise other than the wavelength to be measured. Therefore, by starting stirring from the reagent with a smaller particle size 410, it is possible to prevent the reagent with a larger particle size 410 from mixing into the reagent with a smaller particle size 410 in the same analysis item, and the measurement accuracy can be improved.
[0100] When the processing of step S320 ends and the stirring number 412 is assigned, then, based on the liquid volume of the reagent information, the stirring speed 413 is determined (step S320). Figure 14 FIG. is an example of a correspondence table showing the relationship between the determined liquid volume and the stirring speed. The correspondence table is determined and stored in advance in the storage unit 110 or the like. The stirring speed 413 is the rotation speed of the stirring rod 301 per unit time. In the present embodiment, as Figure 14 shown, by changing the stirring speed 413 according to the liquid volume, it is possible to prevent the scattering of the liquid and improve the stirring efficiency. It should be noted that in the present embodiment, an example of the stirring operation of changing the stirring speed according to the liquid volume is illustrated, but it is not limited thereto. For example, it may be configured to change the stirring operation according to the number of days elapsed since the last reading of the reading history of the reagent code. Specifically, it is considered to shorten the stirring time or slow down the blade rotation speed according to the number of days elapsed since the last reading of the reagent code.
[0101] Next, it is determined whether there is no reagent to be stirred for the immunoassay item (step S340). When the determination result is "yes", that is, when there is no reagent to be stirred for the immunoassay item and only the reagent to be stirred for the biochemical assay item, all the reagents for the biochemical assay item are stirred according to the stirring number 412 (step S341), a special cleaning operation is performed (step S342), all the water in the cleaning tank 305 is replaced (step S343), and the process ends. Here, the special cleaning operation refers to a cleaning operation for removing protein contaminants such as antibodies modified on the surface of the latex particles attached to the stirring rod 301. In addition, the complete replacement of the water in the cleaning tank 305 in step S343 is an operation for eliminating contamination from the latex particles remaining in the water.
[0102] In addition, when the determination result in step S340 is "no", that is, when there is a reagent to be stirred for the immunoassay item, next, it is determined whether there is no reagent to be stirred for the biochemical assay item (step S350). When the determination result in step S350 is "yes", that is, when there is no reagent to be stirred for the biochemical assay item and only the reagent to be stirred for the immunoassay item, all the reagents for the immunoassay item are stirred according to the stirring number 412 (step S351), and the process ends.
[0103] In addition, when the determination result in step S350 is "no", that is, when there are both a reagent to be stirred for the biochemical assay item and a reagent to be stirred for the immunoassay item, all the reagents for the biochemical assay item are stirred according to the stirring number 412 (step S360), a special cleaning operation is performed (step S370), all the water in the cleaning tank 305 is replaced (step S380), all the reagents for the immunoassay item are stirred according to the stirring number 412 (step S390), and the process ends.
[0104] Figures 15 - 19 is a diagram schematically showing the state of the special cleaning operation and the water replacement operation in the cleaning unit. It should be noted that in Figures 15 - 19 For the sake of simplicity of the illustration, some symbols are appropriately omitted.
[0105] Special cleaning operation (refer to Figure 13 steps S342, S370) and the complete replacement of the cleaning tank water (refer to Figure 13 steps S342, S380) are performed within the specified time allocated for the stirring operation.
[0106] After the stirring of all the reagents to be stirred belonging to the biochemical assay item (refer to Figure 13 steps S341, S360) is completed, as Figure 15As shown, by rotating the reagent storage unit 102, the detergent container 701 is moved to a position where the stirring rod 301 of the stirring unit 106 can approach. The detergent stored in the detergent container 701 is determined according to the raw material of the stirring rod 301 and the components of the reagents used. For example, a buffer solution with its pH adjusted using sodium hydroxide and hydrochloric acid is envisioned.
[0107] When the movement of the detergent container 701 is completed, as Figure 16 shown, the arm 304 is rotated by the shaft 303 of the stirring unit 106 to move the stirring rod 301 above the detergent container 701, and the arm 304 is lowered by the shaft 303 to insert the stirring rod 301 into the detergent container 701. Then, at the stirring speed 412 determined by the control unit 108, the stirring rod 301 is rotated by the motor 302 to clean the stirring rod 301 with the solution in the detergent container 701. It should be noted that the stirring rod 301 descends by a fixed amount to near the bottom of the detergent container 701 and stops.
[0108] Next, as Figure 17 shown, the arm 304 is raised by the shaft 303 to raise the stirring rod 301 to a position higher than the liquid level of the detergent in the detergent container 701 and stop. At this time, the detergent adhering to the stirring rod 301 accumulates at the front end of the stirring rod 301 due to gravity. Here, by rotating the stirring rod 301 again using the motor 302, the detergent accumulated at the front end of the stirring rod 301 scatters in the detergent container 701.
[0109] Next, as Figure 18 shown, the arm 304 is raised by the shaft 303 to raise the stirring rod 301 to a position higher than the detergent container 701 and stop, and the arm 304 is rotated by the shaft 303 to move the stirring rod 301 above the cleaning tank 305. In this state, the arm 304 is lowered by the shaft 303 to insert the stirring rod 301 into the water in the cleaning tank 305. At this time, the stirring rod 301 descends by a fixed amount to near the bottom of the cleaning tank 305 and stops. After that, at the stirring speed determined by the control unit 108, the stirring rod 301 is rotated by the motor 302. During the rotation of the stirring rod 301 by the motor 302, the reagent storage unit 102 rotates, and the reagent container 103 of the reagent container group 402 belonging to the immunoassay item determined according to the stirring number 412 is moved to the stirring position. It should be noted that the water 312 in the cleaning tank 305 becomes contaminated water contaminated by reagents, latex particles, proteins modifying the latex surface, detergents, etc.
[0110] Next, as Figure 19 shown, all the contaminated water in the cleaning tank 305 is drained through the drain hole 311 under the control of the control unit 108.
[0111] After all the contaminated water has been discharged, water 312 is filled from the water supply pump 307 via the pipe 308 and the water supply nozzle 306 into the cleaning tank 305 up to the maximum amount, thereby replacing all the water in the cleaning tank 305.
[0112] In the present embodiment configured as described above, by stirring a plurality of reagents with one stirring rod while suppressing a decrease in analysis accuracy, it is possible to achieve space saving and cost reduction.
[0113] <Supplementary Note>
[0114] It should be noted that the present invention is not limited to the above-described embodiment, and includes various modifications and combinations within the scope not departing from its gist. In addition, the present invention is not limited to having all the configurations described in the above embodiment, and also includes configurations in which a part of the configuration is deleted. In addition, the above-described respective configurations, functions, etc. can also be implemented by, for example, designing a part or all of them in an integrated circuit. In addition, the above-described respective configurations, functions, etc. can also be implemented by software by a processor interpreting and executing a program that realizes each function.
[0115] Explanation of Reference Numerals
[0116] 100... Automatic analysis device, 101... Specimen storage unit, 102... Reagent storage unit, 103... Reagent container, 104... Reading unit, 105... Cleaning unit, 106... Stirring unit, 107... Analysis unit, 108... Control unit, 109... Input / output unit, 110... Storage unit, 201... Biochemical analysis unit, 202... Immunoassay unit, 203... Biochemical dispensing unit, 204... Biochemical reaction unit, 205... Biochemical measurement unit, 206... Immunoassay dispensing unit, 207... Immune reaction unit, 208... Immunoassay measurement unit, 209... Aspiration nozzle, 210... Immune sample cell, 211... Photomultiplier tube, 221... Biochemical cleaning unit, 222... Immunoassay cleaning unit, 223... Light source, 224... Spectrophotometer, 301... Stirring rod, 302... Motor, 303... Shaft, 304... Arm, 305... Cleaning tank, 306... Water supply nozzle, 307... Water supply pump, 308 ··· Pipe, 310... Drain port, 311... Drain hole, 312... Water, 313... Reagent container, 314... Reagent container, 401... Reagent container group, 402... Reagent container group, 403... Reagent code, 404... Reagent information, 405... Stirring target reagent, 406... Stirring target reagent, 407... Non-stirring target reagent, 408... Analysis item, 409... Reading history, 410... Particle size, 411... Filling amount, 412... Stirring speed, 413... Stirring speed, 701... Detergent container.
Claims
1. An automatic analysis device, characterized in that, Comprising: A first analysis unit that performs analysis on a first set of analysis items; A second analysis unit that performs analysis on a second set 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 and at least one second reagent container, where the first reagent container contains a reagent for analysis in the first analysis unit and the second reagent container contains a reagent 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; And A control unit that controls the operation of the stirring unit, The control unit controls the operation of the stirring unit such that after stirring the solutions in all of the first reagent containers in the reagent storage unit is completed, stirring of the solution in the second reagent container is performed.
2. The automatic analysis device according to claim 1, wherein The first set of analysis items is biochemical analysis items, The second set of analysis items is immunoassay analysis items.
3. The automatic analysis device according to claim 1, wherein The automatic analysis device further comprises a cleaning tank that contains a liquid for cleaning the stirring rod, The control unit controls the operations of the stirring unit and the cleaning tank such that after stirring the solutions in all of the first reagent containers in the reagent storage unit is completed and before stirring the solution in the second reagent container, the stirring rod is cleaned in the cleaning tank.
4. The automatic analysis device according to claim 3, wherein The control unit controls the cleaning tank such that after stirring the solutions in all of the first reagent containers in the reagent storage unit is completed and before stirring the solution in the second reagent container, all of the liquid for cleaning the stirring rod is replaced.
5. The automatic analysis device according to claim 1, wherein The control unit controls the stirring unit to perform stirring in ascending order of the particle size of the particles contained in the reagent.
6. The automatic analysis device according to claim 1, wherein The control unit controls the stirring unit, and the stirring unit controls the rotation speed of the stirring rod according to the liquid volume of the reagent.
7. The automatic analysis device according to claim 1, wherein The automatic analysis device further comprises a reading unit that reads information on the reagent contained in the reagent container stored in the reagent storage unit, The control unit determines which of the first reagent container and the second reagent container the reagent container is based on the information read by the reading unit.
Citation Information
Patent Citations
Specimen analyzer and specimen analysis method
JP2013250276A