Measuring device
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- SYSMEX CORP
- Filing Date
- 2025-01-24
- Publication Date
- 2026-08-05
AI Technical Summary
【0006】 本発明によれば、第1容器または第2容器の交換中であっても、測定ユニットへの試薬供給を継続するため、装置の処理能力が高くなり試薬の消費量が増加した場合であっても、測定装置を止めずに測定を継続することができる。
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Figure 2026126984000001_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a measuring device.
Background Art
[0002] Patent Document 1 discloses a system that supplies reagents from a reagent station equipped with a container for storing reagents to a plurality of reagent consumption stations. A buffer chamber for storing the reagents supplied from the reagent station toward the reagent consumption stations is provided between the reagent station and the reagent consumption stations. Since the reagents are stored in the buffer chamber, the supply of reagents to the reagent consumption stations can be continued even if the remaining amount of reagents in the container of the reagent station is insufficient.
Prior Art Documents
Patent Documents
[0003]
Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0004] When the processing capacity of the reagent consumption stations is improved, the amount of reagent consumed per unit time at the reagent consumption stations increases. Since the system of Patent Document 1 supplies reagents from the reagent station to a plurality of reagent consumption stations, when the processing capacity of each reagent consumption station is improved, even if there is a buffer chamber, the amount of reagent that can be supplied may become insufficient for the processing capacity of the plurality of reagent consumption stations. Patent Document 1 does not consider such problems.
Means for Solving the Problems
[0005] The measuring device according to the present invention comprises a reagent storage section capable of accommodating a first container for accommodating a diluent for diluting a blood sample and a second container for accommodating a hemolytic agent for lysing red blood cells contained in the blood sample; a transport unit disposed above the reagent storage section and comprising a first region and a second region on which the blood sample is placed, for transporting the placed blood sample; a measuring unit for measuring the blood sample transported from the first region and discharging the measured blood sample into the second region; a supply unit for supplying the diluent and hemolytic agent to the measuring unit; and a control unit for controlling the transport unit, the measuring unit and the supply unit, wherein the measuring unit comprises a third container capable of accommodating a staining solution for staining the blood sample and a first chamber for mixing the diluent supplied from the first container and the blood sample to prepare a first sample. The apparatus comprises a second chamber for preparing a second sample by mixing the hemolytic agent supplied from the second container with the blood sample and the staining solution, and a measurement unit including an electrical signal measurement unit for measuring the electrical signal of the first sample and an optical signal measurement unit for measuring the optical signal of the second sample. The apparatus is capable of acquiring the electrical and optical signals of 300 to 500 samples per hour for a measurement order of (1) a first measurement item including red blood cell count, white blood cell count, hemoglobin amount, hematocrit value, mean corpuscular volume, mean corpuscular hemoglobin amount, mean corpuscular hemoglobin concentration and platelet count, and (2) a second measurement item for classifying white blood cells into five categories. The apparatus acquires measurement results based on the obtained electrical and optical signals. The supply unit continues to supply the diluent while the first container is being replaced and continues to supply the hemolytic agent while the second container is being replaced. [Effects of the Invention]
[0006] According to the present invention, even when the first or second container is being replaced, the supply of reagents to the measurement unit is continued. Therefore, even if the processing capacity of the device increases and the amount of reagent consumed increases, the measurement can be continued without stopping the measuring device. [Brief explanation of the drawing]
[0007] [Figure 1]Figure 1 is a schematic front view showing the external appearance of the measuring device according to Embodiment 1. [Figure 2] Figure 2 is a plan view showing the configuration of the transport unit according to Embodiment 1. [Figure 3] Figure 3 is a schematic plan view showing the configuration of the measurement unit according to Embodiment 1. [Figure 4] Figure 4 is a perspective view showing an example of the configuration of the reagent storage section according to Embodiment 1. [Figure 5] Figure 5 shows an example configuration according to Embodiment 1, in which the first container or the second container is connected to the supply unit. [Figure 6] Figure 6 is a perspective view showing the configuration of the staining solution container according to Embodiment 1. [Figure 7] Figure 7 is a schematic diagram showing the configuration of the supply unit according to Embodiment 1. [Figure 8] Figure 8 is a schematic diagram showing the configuration in which staining solution is supplied from the third container to each chamber according to Embodiment 1. [Figure 9] Figure 9 is a table showing an example of the types of reagents used by the measuring device according to Embodiment 1, the capacity of each container, and the number of tests that can be measured. [Figure 10] Figure 10 is a block diagram showing the configuration according to Embodiment 1, in which the measurement samples prepared in each chamber are supplied to the measurement unit. [Figure 11] Figure 11 is a schematic diagram showing the configuration of a fluid circuit including a chamber and an optical measuring unit according to Embodiment 1. [Figure 12] Figure 12 is a schematic diagram showing the configuration of the chamber, HGB chamber, electrical measuring unit, and fluid circuit connected to the HGB measuring unit according to Embodiment 1. [Figure 13] Figure 13 shows the configuration of the flow cell 65 of the optical measuring unit 381 according to Embodiment 1. [Figure 14] Figure 14 is a schematic diagram showing the configuration of the chamber, HGB chamber, electrical measuring unit, and fluid circuit connected to the HGB measuring unit according to Embodiment 1. [Figure 15]FIG. 15 is a block diagram showing the functional configuration of the measurement unit according to Embodiment 1. [Figure 16] FIG. 16 is a block diagram showing the functional configurations of the conveyance unit and the analysis unit according to Embodiment 1. [Figure 17] FIG. 17 is a time chart of measurements by the measurement unit according to Embodiment 1. [Figure 18] FIG. 18 is a flowchart regarding the supply of a diluent by the measuring device. [Figure 19] FIG. 19 is a diagram showing an example of the screen display of the replacement alarm according to Embodiment 1. [Figure 20] FIG. 20 is an output example of the replacement alarm by notification to the mobile terminal according to Embodiment 1. [Figure 21] FIG. 21 is an example of a reagent information screen according to Embodiment 1. [Figure 22] FIG. 22 is a flowchart showing an example of the supply of a staining solution according to a modified example in Embodiment 1. [Figure 23] FIG. 23 is a diagram showing the configuration of the supply unit according to Embodiment 2. [Figure 24] FIG. 24 is an example of a reagent information screen according to Embodiment 2. [Figure 25] FIG. 25 is a diagram showing an example of identification information attached to a container housed in the reagent storage unit according to Embodiment 2. [[ID=3l]] [Figure 26] FIG. 26 is a flowchart regarding the automatic switching of reagents according to Embodiment 24. [Figure 27] FIG. 27 is a schematic diagram showing the configuration of the reagent supply unit according to Embodiment 3. [Figure 28] FIG. 28 is a flowchart showing an example of the supply of a diluent according to Embodiment 3. [Figure 29] FIG. 29 is a schematic diagram showing the configuration of the reagent supply unit according to Embodiment 4. [Figure 30] FIG. 30 is a schematic diagram showing the configuration of the reagent supply unit according to Embodiment 5. [Figure 31]Figure 31 shows a modified version of the reagent information screen. [Modes for carrying out the invention]
[0008] The measuring device of Embodiment 1 is a measuring device that measures blood samples using a diluent and a hemolytic agent. The diluent is contained in the first container, and the hemolytic agent is contained in the second container. The measuring unit performs measurements by receiving the diluent and hemolytic agent from the first and second containers. The processing speed of the measuring unit is, for example, 300 to 500 samples per hour. This measuring unit achieves continuous loading by having reserve tanks for both the first and second containers, and by continuing to supply the diluent or hemolytic agent from the respective reserve tanks even while the first or second container is being replaced. In the second embodiment, the measuring device has a first container and a fourth container for containing the diluent, which are switchably connected, and a second container and a fifth container for containing the hemolytic agent, which are switchably connected. Continuous loading is achieved by continuing to supply the diluent from the fourth container when it becomes impossible to supply the diluent from the first container, and by continuing to supply the hemolytic agent from the fifth container when it becomes impossible to supply the hemolytic agent from the second container. The measuring device of Embodiment 3 is a measuring device that includes a reserve tank, which is part of the measuring device of Embodiment 1, and a switching function, which is part of the measuring device of Embodiment 2. The measuring device of Embodiment 4 achieves continuous loading by diluting the concentrated diluent contained in the first container to a predetermined ratio and supplying it to the measuring unit, and by continuing to supply the diluent from the dilution tank even while the first container is being replaced. The measuring device of Embodiment 5 is a measuring device that, in addition to the dilution tank provided in the measuring device of Embodiment 4, is equipped with a function for switching between concentrated and diluted reagents.
[0009] <Embodiment 1> Figure 1 is a schematic front view showing an example of the configuration of the measuring device 1.
[0010] The measuring device 1 includes, for example, a measuring unit 10, a transport unit 30, a supply unit 40, a reagent storage unit 50, and a control unit 200.
[0011] The measuring device 1 is, for example, a device for measuring blood samples. The measuring device 1 is, for example, a blood cell counter that counts the blood cells contained in whole blood by measuring whole blood. The measuring device 1 is, for example, connected to a host computer HC and measures samples based on measurement orders entered into the host computer HC. Measurement orders may be entered directly into the measuring device 1. The measuring device 1 may also obtain measurement orders from a computer other than the host computer HC. A measurement order includes, for example, (1) a first set of measurement items including red blood cell count, white blood cell count, hemoglobin level, hematocrit value, mean corpuscular volume, mean corpuscular hemoglobin level, mean corpuscular hemoglobin concentration, and platelet count, and (2) measurement instructions for a second set of measurement items that classify white blood cells into five categories. The measuring device 1 can measure, for example, 300 to 500 samples per hour for the measurement orders of the first set of measurement items and the second set of measurement items.
[0012] In the measuring device 1 illustrated in Figure 1, the relationship between the reagent supply unit 40, which is the reagent source, and the measuring unit 10, which is the reagent recipient, is one-to-one, rather than one-to-many. The measuring device 1 can achieve a predetermined processing capacity (in this embodiment, processing 300 to 500 samples per hour) in a standalone manner. The supply unit 40 can perform continuous loading of reagents within the measuring device 1, which processes samples at a predetermined processing capacity in a standalone manner. The supply unit 40 is used exclusively for the corresponding measuring unit 10 and supplies reagents exclusively to the corresponding measuring unit 10. With this configuration of the measuring device 1, it becomes easy to design a supply unit 40 that can continuously supply reagents according to the processing capacity of the measuring unit 10 that consumes the reagents. When expanding the system, for example, multiple measuring devices 1 are installed, and each measuring device 1 is connected by a transport system capable of transporting samples and racks containing samples. Even if multiple measuring devices 1 are installed due to system expansion, continuous loading of reagents can be performed within each measuring device 1. In other words, each of the multiple measuring devices 1 is a module in system expansion. The system is expanded by combining the measuring devices 1 as modules. Therefore, even if the system is expanded, the reagent supply capacity of the supply unit 40 only needs to be designed based on the processing capacity of each individual measuring device 1, and continuous loading of reagents can be designed independently of the processing capacity of the entire expanded system.
[0013] The measurement unit 10 includes, for example, a first measurement unit 11 and a second measurement unit 12. The measurement unit 10 may consist of either the first measurement unit 11 or the second measurement unit 12 alone. For example, the two measurement units are arranged adjacent to each other. The first measurement unit 11 and the second measurement unit 12 can perform sample measurements in parallel. For example, when sample (A) and sample (B) are supplied to the measurement device 1, the first measurement unit 11 can measure sample (A), and in parallel, the second measurement unit 12 can measure sample (B). This operation improves the overall processing capacity of the measurement device 1. The transport unit 30 distributes multiple samples to the first measurement unit 11 and the second measurement unit 12, for example, by transporting a rack R holding sample containers 110. The measurement unit 10 and the transport unit 30 are mounted on a wagon 60.
[0014] The reagent storage section 50 is located inside the wagon 60. The reagent storage section 50 houses a first container 700 containing a diluent and a second container 800 containing a hemolytic agent.
[0015] The supply unit 40 is housed inside the wagon 60. The supply unit 40 supplies diluent from the first container 700 housed in the reagent storage unit 50 to the measurement unit 10, and supplies hemolytic agent from the second container 800 to the measurement unit 10. The measurement unit 10 aspirates the sample contained in the sample container 110 transported by the transport unit 30. The measurement unit 10 mixes the aspirated sample with the reagents to prepare a measurement sample, and measures the prepared measurement sample. The reagents mixed with the sample are the diluent and hemolytic agent supplied by the supply unit 40, and the staining solution contained in the third container 900 set in the measurement unit 10.
[0016] A display 70 is connected to the measurement unit 10, for example. The display 70 is connected to the measurement unit 10 via a movable arm, for example. The display 70 displays an operation screen as an interface for operating the measurement device 1, or displays the analysis results obtained when the measurement device 1 measures a sample.
[0017] The control unit 200 controls the operation of each part (including the measurement unit 10, transport unit 30, and supply unit 40) so that the measuring device 1 can measure a sample, analyzes the measurement data obtained when the measurement unit 10 measures the sample to generate analysis results, and provides the generated analysis results.
[0018] Figure 2 is a plan view showing an example of the configuration of the transport unit 30. The transport unit 30 comprises a first region 31 on which a rack R holding samples before measurement by the measurement unit 10 is placed, and a second region 32 on which a rack R on which samples after measurement is placed is placed.
[0019] The first area 31 comprises a first table 311 and a second table 312. The first table 311 supports the placed rack R and transports the rack R in the Y1 direction. The rack R, transported to the position shown in A in Figure 2, is transported in the X1 direction to the second table 312. The second table 312 transports the rack R received from the first table 311 in the Y2 direction. The rack R, transported to the position shown in B in Figure 2, is further transported in the Y2 direction to the conveyor 33.
[0020] The conveyor 33 transports the rack R in the X2 direction and supplies the sample containers 110 mounted on the rack R to the access position P1 of the first measurement unit 11 and the access position P2 of the second measurement unit 12, thereby supplying the sample containers 110 to either the first measurement unit 11 or the second measurement unit 12. The first measurement unit 11 accesses the sample container 110 located at position P1 and aspirates the sample contained in the sample container 110. The second measurement unit 12 accesses the sample container 110 located at position P2 and aspirates the sample contained in the sample container 110. After supplying the sample containers 110 to either the first measurement unit 11 or the second measurement unit 12, the conveyor 33 transports the rack R in the X2 direction. The conveyor 33 transports the rack R to a position adjacent to the second region 32 (the position shown as C in Figure 2).
[0021] The second area 32 comprises a third table 321 and a fourth table 322. The third table 321 receives racks R moved from the conveyor 33 and transports them in the Y1 direction. Once transported to the position indicated by D in Figure 2, the racks R are transported in the X1 direction to the fourth table 322. The fourth table 322 transports the racks R received from the third table 321 in the Y2 direction. As a result, racks R that have been supplied to the measuring unit 10 are arranged on the fourth table 322 from the rear (Y2 direction side). The racks R arranged on the fourth table 322 are then removed by the user.
[0022] The transport unit 30 is equipped with a reading unit 34 located adjacent to the conveyor 33. The reading unit 34 is a code reader that reads machine-readable codes attached to the sample containers 110 held in the rack R. By reading the codes, the reading unit 34 obtains the sample ID of the sample contained in the sample container 110.
[0023] Figure 3 is a schematic plan view showing an example configuration of the measurement unit 10.
[0024] The measuring unit 10 includes a gripping mechanism 310, a stirring mechanism 320, a container transfer mechanism 330, a dispensing mechanism 350, an RBC / PLT chamber C11, an HGB chamber C12, and a chamber heating unit 400.
[0025] The gripping mechanism 310 includes a pair of gripping pieces 313 for gripping the sample container 110 from the front and rear directions, a mechanism for moving the pair of gripping pieces 313 toward and toward each other, and a mechanism for moving the pair of gripping pieces 313 in the vertical direction. The gripping mechanism 310 is positioned above the access position P1 on the conveyor 33 (see Figure 2). Figure 3 illustrates the first measurement unit 11, and the gripping mechanism 310 of the second measurement unit 12 is positioned above the access position P2. An opening 314a is formed on the lower surface of the housing 314 so that the pair of gripping pieces 313 can move vertically relative to the lower surface of the housing 314.
[0026] The gripping mechanism 310 uses a pair of gripping pieces 313 to grip the sample container 110 positioned at the removal position P1, and moves the pair of gripping pieces 313 upward to remove the sample container 110 from the rack R and position it above the access position P1.
[0027] The stirring mechanism 320 includes a holding part 323, a sliding part 324, and a mechanism for driving the holding part 323 and the sliding part 324. The holding part 323 includes a holding member 323a having a hole formed therein that can hold the sample container 110, and a rotating shaft 323c extending in the front-rear direction. The sliding part 324 supports the lower part of the holding part 323 and is configured to be movable in the left-right direction. The holding part 323 is configured to be rotatable around the rotating shaft 323c.
[0028] The sample container 110 is stirred as follows: The gripping mechanism 310 grasps the sample container 110 at the removal position P1, removes it from the rack R, and moves it upward. The stirring mechanism 320 moves the slide part 324 to the left, positioning the holding member 323a below the lifted sample container 110. In this state, the gripping mechanism 310 moves the gripped sample container 110 downward, setting the sample container 110 in the holding member 323a. The gripping mechanism 310 releases the gripped sample container 110. The stirring mechanism 320 moves the slide part 324 to the right, positioning the sample container 110 held in the holding member 323a in the stirring position. When the stirring mechanism 320 rotates the holding part 323 around the rotation axis 323c, the sample container 110 held in the holding member 323a is inverted upside down. When the stirring mechanism 320 reverses the rotation of the holding part 323, the sample container 110 is returned to its original orientation. By repeating this forward and reverse rotation, the sample container 110 is rotated and stirred multiple times, and the sample is stirred.
[0029] The container transfer mechanism 330 includes a holding member 331 having a hole formed therein that can hold the sample container 110, a plate member 332 that supports the holding member 331 and extends in the front-rear direction, and a mechanism for moving the plate member 332 in the front-rear direction.
[0030] When the stirring of the sample container 110 by the stirring mechanism 320 is complete, the stirring mechanism 320 repositions the sample container 110, held by the holding member 323a, above the removal position P1. The gripping mechanism 310 grasps the sample container 110 held by the holding member 323a and removes it upward. In this state, the stirring mechanism 320 retracts the holding part 323 and the sliding part 324 to the right. The container transfer mechanism 330 positions the holding member 331 below the sample container 110. The gripping mechanism 310 sets the sample container 110 into the holding member 331 by transferring the gripped sample container 110 downward. The gripping mechanism 310 releases the gripped sample container 110.
[0031] When the sample container 110 is set in the holding member 331, the container transfer mechanism 330 moves backward, and the sample container 110 is positioned for aspiration by the dispensing mechanism 350.
[0032] The dispensing mechanism 350 includes a rigid suction tube 351 extending in the vertical direction and a transfer unit 353 that moves the suction tube 351 in the vertical and horizontal directions. The tip of the suction tube 351 is sharply formed so that it can puncture the lid that closes the upper opening of the specimen container 110.
[0033] When the sample container 110 is positioned in the aspiration position, the dispensing mechanism 350 drives the transfer unit 353 to move the suction tube 351 downward, and the tip of the suction tube 351 punctures the lid of the sample container 110. The tip of the suction tube 351 is positioned a predetermined distance above the inner bottom of the sample container 110, and in this state, the dispensing mechanism 350 aspirates the sample from the sample container 110 via the suction tube 351.
[0034] The chamber heating unit 400 includes chambers C21 to C24. Each chamber is located adjacent to another. The detailed configuration of the chamber heating unit 400 will be described later.
[0035] The dispensing mechanism 350 dispenses the sample aspirated at the aspiration position P4 via the aspiration tube 351 into at least one of the chambers C11, C12, and C21-C24, according to the measurement order. In each chamber C11, C12, and C21-C24, the sample and reagents are mixed to prepare the measurement sample.
[0036] Once the sample has been aspirated into the sample container 110, the container transfer mechanism 330 positions the sample container 110, held by the holding member 331, above the removal position P1, and the gripping mechanism 310 grasps the sample container 110 from the holding member 331 and lifts it upward. In this state, the container transfer mechanism 330 retracts the holding member 331 to the rear. The gripping mechanism 310 returns the grasped sample container 110 to its original hole in the rack R.
[0037] Thus, the measurement unit 10 is equipped with a gripping mechanism 310 for removing the sample container 110, which has been transported by the transport unit 30, from the rack R, and a stirring mechanism 320 for stirring the removed sample container 110, as separate mechanisms. This allows the gripping mechanism 310 to remove the sample container 110 from or return it to the rack R, and the stirring mechanism 320 to stir the sample container 110, to be performed in parallel. This configuration enhances the processing capacity of the measurement unit 10.
[0038] Figure 4 is a perspective view showing an example of the configuration of the reagent storage unit 50. As shown in Figure 4, the wagon 60 is equipped with an opening / closing section 61 on its front. The opening / closing section 61 is a door that can be pulled forward. By opening the opening / closing section 61, the user can access the reagent storage unit 50. The reagent storage unit 50 is equipped with a plurality of drawers 52. One or more reagent containers are placed in the drawers 52. When the user wants to change a reagent, for example, they can pull out the drawer 52 on which the target reagent container is placed, as shown in Figure 4. In the example in Figure 4, the first container 700 for the diluent is placed in the left drawer 52, and the second container 800 for the hemolytic agent is placed in the right drawer 52. The wagon 60 and the reagent storage unit 50 are used exclusively for the measurement unit 10 installed on the top surface of the wagon 60. The wagon 60 and reagent storage unit 50 exclusively supply reagents from the installed reagent containers to the measurement unit 10 installed on the top surface of the wagon 60.
[0039] Figure 5 shows an example configuration in which a first container 700 or a second container 800 is connected to the supply unit 40. Although Figure 4 illustrates the first container 700, the connection to the supply unit 40 with the second container 800 is the same. The supply unit 40 includes a tube 51 that is inserted into the container and delivers the reagent inside the container. The tube comprises a first tube 51a that is inserted into the container, a second tube 51b connected to the first tube 51a, and a connector 53 provided between the first tube 51a and the second tube 51b.
[0040] The first container 700 includes an outer box 58. The top of the outer box 58 is provided with a mouth 54 which forms an opening into which the first tube 51a is inserted. The mouth 54 has a screw-type cylinder that can be opened and closed by a screw cap. The mouth 54 is closed with the screw cap when the first container 700 is in circulation, and when in use the screw cap is removed and the mouth 54 is opened, the first tube 51a is inserted through the mouth 54. The connector 53 has the shape of a screw cap, and the first tube 51a is supported so that it hangs down from the center of the cap. By fitting the connector 53 into the mouth 54, the tip of the first tube 51a is fixed in contact with the inner bottom of the first container 700.
[0041] The first tube 51a is connected to the second tube 51b via a connector 53. The second tube 51b is connected to the reserve tank RT of the supply unit 40, which will be described later. The reserve tank RT is depressurized by the negative pressure generated by the pump 57. When the reserve tank RT is depressurized, the diluent in the first container 700 is drawn out from the tip of the first tube 51a. In this way, the supply unit 40 supplies the diluent contained in the first container 700 to the reserve tank RT by operating the pump 57 via the measurement control unit 852 (see Figure 16). The second container 800 has the same configuration as the first container 700, and the hemolytic agent in the second container 800 is supplied to the reserve tank RT via the first tube 51a and the second tube 51b.
[0042] Figure 6 is a perspective view showing an example configuration of the staining solution storage section 112. The measuring unit 10 is equipped with an openable / closable section 111 on its front. The openable / closable section 111 is part of the front cover of the measuring unit 10 and can be opened by pushing it upwards. When the openable / closable section 111 is opened, the staining solution storage section 112 is exposed. The staining solution storage section 112 can accommodate a third container containing the staining solution. The third container is, for example, a container molded from plastic. The third container may also be a pouch container made of aluminum, polypropylene, PET (polyethylene terephthalate), or the like.
[0043] Figure 7 is a schematic diagram showing an example of the configuration of the supply unit 40. The measuring device 1 uses five types of reagents, including two types of diluents and three types of hemolytic agents. The diluents include diluent A, which dilutes blood for the measurement of red blood cells and / or platelets by the electrometric measuring unit 382, and diluent B, which dilutes blood for the measurement of red blood cells and / or platelets by the optical measuring unit 381. The hemolytic agents include hemolytic agent A, which is used for white blood cell classification by the optical measuring unit 381, hemolytic agent B, which is used for white blood cell counting by the optical measuring unit 381, and hemolytic agent C, which is used for hemoglobin measurement by the HGB measuring unit 383. Diluents A and B are contained in first containers 700 and 701, respectively. Hemolytic agents A, B, and C are contained in second containers 800, 801, and 802, respectively. The reagent storage section 50 houses these five containers, and each container is connected to the supply section 40 via a tube 51.
[0044] The supply unit 40 includes, for example, five reserve tanks RT. A first container 700 containing diluent A is connected to the measurement unit 10 via a reserve tank. A first container 701 containing diluent B is connected to the measurement unit 10 via a reserve tank RT2. A second container 800 containing hemolytic agent A is connected to the measurement unit 10 via a reserve tank RT3. A second container 801 containing hemolytic agent B is connected to the measurement unit 10 via a reserve tank RT4. A second container 802 containing hemolytic agent C is connected to the measurement unit 10 via a reserve tank RT5. The flow paths from each container and reserve tank to the measurement unit 10 are used exclusively for the measurement unit 10 corresponding to the supply unit 40. The supply unit 40 exclusively supplies reagents to the corresponding measurement unit 10 via the flow paths from each container and reserve tank to the measurement unit 10.
[0045] The first container 700 and the first reserve tank RT1 are connected via a tube as described with reference to Figure 5. The first reserve tank RT1 and the measurement unit 10 are connected via a tube, and the diluent is supplied to the measurement unit 10 by drawing the diluent from the bottom of the first reserve tank RT1. The other first containers 701 and second containers 800-802 are connected in the same way as their corresponding reserve tanks RT.
[0046] Each of the reserve tanks RT1 to RT5 is equipped with a float sensor FS. The float sensor FS detects the remaining amount of reagent in each reserve tank. For example, when the float sensor FS of reserve tank RT1 detects a decrease in the reagent level, the supply unit 40 drives the pump 57 via the measurement control unit 852 (see Figure 16) to supply the diluent A contained in the first container 700 to reserve tank RT1. Similarly, for the other reserve tanks, reagent is replenished from the corresponding container to the reserve tank RT based on the signal from the float sensor FS.
[0047] The supply unit 40 includes, for example, a bubble sensor BS installed in the flow path connecting each container to the reserve tank RT. The bubble sensor BS detects bubbles that enter the flow path when the pump 57 draws up reagent after the reagent in the container has been consumed and the container is out of reagent. The bubble sensor BS detects bubbles, indicating that the corresponding container is out of reagent.
[0048] Figure 8 is a schematic diagram showing an example configuration in which staining solution is supplied to each chamber from a third container set in the staining solution storage section 112. The measuring device 1 uses four types of staining solutions. The staining solutions include staining solution A used for leukocyte classification, staining solution B used for leukocyte counting, staining solution C used for reticulocyte measurement, and staining solution D used for optical measurement of platelets. Staining solutions A to D are contained in third containers 900, 901, 902, and 903, respectively. The third container is a cartridge-type container made of, for example, resin, and is inserted from the front into a plurality of partitioned holders provided in the staining solution storage section 112. The third container is loaded into the measuring device 1 by inserting a suction tube 55 into the inside of the third container inserted into the holder.
[0049] A third container 900 containing staining solution A is connected to chambers C21 and C22. The measuring unit 10 draws staining solution A through a suction tube 55 inserted into the third container 900 and supplies staining solution A to chambers C21 and C22 via a liquid supply tube 56. A third container 901 containing staining solution B is connected to chamber C23. A third container 902 containing staining solution C and a third container 903 containing staining solution D are connected to chamber C24. Staining solutions B to D are also supplied to their corresponding chambers in the same way as staining solution A.
[0050] Figure 9 is a table showing an example of the types of reagents used by the measuring device 1, the capacity of each container, and the number of tests that can be measured. The first container for Diluent A contains 10 L of Diluent A. The number of tests that can be measured using 10 L of Diluent A is 500. The first container for Diluent B contains 10 L of Diluent B. The number of tests that can be measured using 10 L of Diluent B is 500. The second container for Hemolytic Agent A contains 5 L of Hemolytic Agent A. The number of tests that can be measured using 5 L of Hemolytic Agent A is 3500. The second container for Hemolytic Agent B contains 5 L of Hemolytic Agent B. The number of tests that can be measured using 5 L of Hemolytic Agent B is 3500. The second container for Hemolytic Agent C contains 5 L of Hemolytic Agent C. The number of tests that can be measured using 5 L of Hemolytic Agent C is 3500. The third container for staining solution A contains 300 mL of staining solution A. 15,000 tests can be measured using 300 mL of staining solution A. The third container for staining solution B contains 300 mL of staining solution B. 15,000 tests can be measured using 300 mL of staining solution B. The third container for staining solution C contains 300 mL of staining solution C. 15,000 tests can be measured using 300 mL of staining solution C. The third container for staining solution D contains 300 mL of staining solution D. 15,000 tests can be measured using 300 mL of staining solution D.
[0051] The volumes of each reagent shown in Figure 9 are examples and can be changed as appropriate. For example, if the amount of diluents A and B contained in the first container is 6L, 300 tests can be measured. If the amount of diluents A and B contained in the first container is 30L, 1500 tests can be measured. If the number of measurable tests falls below 300, a measuring device with a processing capacity of 300 samples per hour will not last for one hour; therefore, it is preferable that the first container contains an amount of diluent equivalent to at least one hour of processing capacity. On the other hand, if the capacity of the first container is increased to reduce the frequency of replacement, the container becomes heavy, increasing the physical burden on the user associated with reagent replacement; therefore, it is preferable that the amount of diluent contained in the first container be 30L (approximately 30kg) or less. Accordingly, it is preferable that the amounts of diluents A and B contained in the first container correspond to a number of measurable tests between 300 and 1500.
[0052] Similarly, the amounts of hemolytic agents A, B, and C contained in the second container may correspond to a number of tests between 2100 and 7000. For example, if the amount of hemolytic agents A, B, and C is 3L, 2100 tests can be measured. If the amount of hemolytic agents A, B, and C contained in the second container is, for example, 20L, 7000 tests can be measured. The amounts of staining solutions A, B, C, and D contained in the third container may correspond to a number of tests between 5000 and 30000. For example, if the amount of staining solutions A, B, C, and D is 100mL, 5000 tests can be measured. If the amount of staining solutions A, B, C, and D is 600mL, 30000 tests can be measured.
[0053] As illustrated in Figure 9, the number of measurable samples for staining solutions A, B, C, and D contained in the third container is greater than the number of measurable samples for diluents A and B contained in the first container. Furthermore, the number of measurable samples for staining solutions A, B, C, and D contained in the third container is greater than the number of measurable samples for hemolytic agents A, B, and C contained in the second container. The amount of diluent contained in the first container and the hemolytic agent contained in the second container used per measurement is greater than that of the staining solution. Therefore, although the volume of diluent and hemolytic agent is greater than that of the staining solution, the number of measurable tests per container of diluent and hemolytic agent is less than that of the staining solution. Consequently, the replacement frequency of the first and second containers is greater than that of the staining solution container. The amount of staining solution contained in the third container used per measurement is less than that of the diluent and hemolytic agent. Therefore, although the volume of the staining solution is less than that of the diluent and hemolytic agent, the number of measurable tests per container of staining solution is greater than that of the diluent and hemolytic agent. The third container is replaced less frequently than the first and second containers. For this reason, continuous loading is achieved by providing a reserve tank for the diluent and hemolytic agent, which are replaced frequently, while the measurement unit can be miniaturized by not providing a reserve tank for the staining solution, which is replaced less frequently.
[0054] The capacities of the first reserve tanks 710 and 711 may be smaller than those of the first containers 700 and 701. The capacity of the first reserve tank may be determined based on the number of samples that can be measured using the diluent contained in the first reserve tank, the amount of time for which the diluent can be continuously supplied to the first reserve tank, or the capacity relationship with the first container. If the capacity is determined based on the number of samples that can be measured using the diluent contained in the first reserve tank, for example, it may be an amount that can measure 300 samples, an amount that can measure 200 samples, an amount that can measure 100 samples, an amount that can measure 50 samples, or an amount that can measure 20 samples. If the diluent is determined based on the time it can be continuously supplied, for example, if the measurement unit measures 300 samples using 6 L of diluent per hour, the amount could be 6 L, which is the amount that can be supplied for 1 hour; 3 L, which is the amount that can be supplied for 30 minutes; 1.5 L, which is the amount that can be supplied for 15 minutes; or 0.5 L, which is the amount that can be supplied for 5 minutes. If the amount is determined based on the relationship with the capacity of the first container, for example, it could be 9 L, which is 90% of the diluent capacity of the first container; 8 L, which is 80%; 7 L, which is 70%; 6 L, which is 60%; 5 L, which is 50%; 4 L, which is 40%; 3 L, which is 30%; 2 L, which is 20%; or 1 L, which is 10%. The capacity of the second reserve tank may be determined in the same way as the first reserve tank.
[0055] Figure 10 is a block diagram showing an example configuration in which measurement samples prepared in each chamber C11, C12, C21-C24 provided in the measurement unit 10 are supplied to the optical measurement unit 381, the electrical measurement unit 382, and the HGB measurement unit 383.
[0056] The operation described with reference to Figure 10 is performed by the measurement control unit 852 (see Figure 16) of the control unit 200, which controls the dispensing mechanism 350, the preparation of the measurement samples in each chamber C11, C12, C21-C24, and the measurements performed by each measurement unit 381-383.
[0057] Chamber C11 is a chamber for preparing samples for the measurement of red blood cells and platelets by the electrical measurement unit 382. Diluent A, contained in the first container 700, is supplied to Chamber C11 via the reserve tank RT1 (see Figure 8). Diluent A and the sample are mixed to prepare the RBC / PLT measurement sample. The RBC / PLT measurement sample prepared in Chamber C11 is measured by the electrical measurement unit 382. The electrical measurement unit 382 acquires electrical signals corresponding to red blood cells and platelets. The analysis unit 851 of the control unit 200 (see Figure 16) analyzes the measurement results of the RBC / PLT measurement sample and acquires the red blood cell count, platelet count, etc.
[0058] Chamber C12 is a chamber for preparing a sample for hemoglobin concentration measurement in the HGB measurement unit 383. Hemolytic agent C, contained in the second container 802, is supplied to Chamber C11 via the reserve tank RT5 (see Figure 8). The hemolytic agent C and the sample are mixed to prepare the HGB measurement sample. The HGB measurement sample prepared in Chamber C12 is measured in the HGB measurement unit 383. The HGB measurement unit 383 acquires absorbance corresponding to the hemoglobin concentration. The analysis unit 851 of the control unit 200 analyzes the absorbance and acquires the hemoglobin concentration, etc.
[0059] Chamber C21 is a chamber for preparing samples for leukocyte classification by the optical measurement unit 381. Hemolytic agent A, contained in the second container 800, is supplied to Chamber C21 via the reserve tank RT3 (see Figure 8), and then staining solution A, contained in the third container 900, is supplied. Hemolytic agent A, staining solution A, and the sample are mixed to prepare the WDF measurement sample. The WDF measurement sample prepared in Chamber C21 is measured by the optical measurement unit 381. The optical measurement unit 381 acquires optical signals corresponding to leukocytes. The analysis unit 851 of the control unit 200 analyzes the measurement results of the WDF measurement sample prepared in WDF Chamber C21 and performs classification of leukocytes (e.g., five classifications: neutrophils, lymphocytes, monocytes, eosinophils, and basophils). Chamber C22 has the same function as Chamber C21.
[0060] Chamber C23 is a chamber for preparing a sample for leukocyte counting by the optical measurement unit 381. Hemolytic agent B, contained in the second container 801, is supplied to Chamber C23 via the reserve tank RT4 (see Figure 8), and then staining solution B, contained in the third container 901, is supplied. The hemolytic agent B, staining solution B, and the sample are mixed to prepare the WNR measurement sample. The WNR measurement sample prepared in Chamber C23 is measured by the optical measurement unit 381. The optical measurement unit 381 acquires an optical signal corresponding to leukocytes. The analysis unit 851 of the control unit 200 analyzes the measurement results of the WNR measurement sample and obtains the leukocyte count.
[0061] Chamber C24 is a chamber for preparing samples for reticulocyte measurement by the optical measurement unit 381 and for optical measurement of platelets. Diluent B, contained in the first container 701, is supplied to Chamber C24 via the reserve tank RT2 (see Figure 8). Staining solution C is further supplied to Chamber C24 from the third container 902, and staining solution D is supplied from the third container 903. Diluent B, staining solution C, and the sample are mixed to prepare the RET measurement sample used for reticulocyte measurement. The RET measurement sample prepared in Chamber C24 is measured by the optical measurement unit 381. The optical measurement unit 381 acquires optical signals corresponding to reticulocytes. The analysis unit 851 of the control unit 200 analyzes the measurement results of the RET measurement sample and classifies the reticulocytes.
[0062] In chamber C24, diluent B, staining solution D, and the sample are mixed to prepare a PLT-F measurement sample used for optical measurement of platelets. The PLT-F measurement sample prepared in chamber C24 is measured in the optical measurement unit 381. The optical measurement unit 381 acquires an optical signal corresponding to platelets. The analysis unit 851 of the control unit 200 analyzes the measurement results of the PLT-F measurement sample and obtains the platelet count.
[0063] Figure 11 is a schematic diagram showing an example of the configuration of a fluid circuit including chambers C21 to C24 and an optical measuring unit 381.
[0064] Chambers C21 to C24 have similar configurations to each other. Each of chambers C21 to C24 includes an inlet 361 through which reagents and washing solutions are supplied, an outlet 362 through which the measurement sample prepared in the chamber is discharged, and a waste port 363 through which the liquid in the chamber is discharged.
[0065] Chamber C21 is supplied with hemolytic agent A, staining solution A, and washing solution via inlet 361. Chamber C22 is supplied with hemolytic agent A, staining solution A, and washing solution via inlet 361, similar to chamber C21. Chamber C23 is supplied with hemolytic agent B, staining solution B, and washing solution via inlet 361. Chamber C24 is supplied with diluent B, staining solution C, staining solution D, and washing solution.
[0066] The outlets 362 of chambers C21 to C24 are connected to flow path 651 via valves 611, 621, 631, and 641, respectively. A syringe pump 652, valves 653 and 654, and an optical measuring unit 381 are connected to flow path 651. A diaphragm pump 655 is connected to flow path 651 via valve 653. The waste ports 363 of chambers C21 to C24 are connected to waste flow path via valves 612, 622, 632, and 642, respectively.
[0067] Once the preparation of the measurement sample is complete in each chamber shown in Figure 11, the diaphragm pump 655 draws the prepared measurement sample from the corresponding chamber into the flow path 651. The syringe pump 652 supplies the measurement sample stored in the flow path 651 to the optical measurement unit 381. The syringe pump 652 is configured to transfer a predetermined amount of the measurement sample stored in the flow path 651 to the optical measurement unit 381 by applying a predetermined pressure to the flow path 651.
[0068] The optical measurement unit 381 flows the sample and sheath fluid supplied from the flow channel 651 into the flow cell 65 (see Figure 13) and outputs an optical signal corresponding to the blood cells in the sample based on the flow cytometry method. The sample that has passed through the optical measurement unit 381 is discarded. When the measurement by the optical measurement unit 381 is completed for one sample, washing solution is supplied to the chamber in which the sample was prepared. The washing solution in the chamber is discharged into the flow channel 651 via the outlet 362 and also discarded via the waste port 363. The washing solution discharged into the flow channel 651 is discarded via valve 654 by syringe pump 652 and diaphragm pump 655.
[0069] Figure 12 is a schematic diagram showing an example of the configuration of a fluid circuit connected to chamber C11, HGB chamber C12, electrical measuring unit 382, and HGB measuring unit 383.
[0070] Chambers C11 and C12 have the same configuration as chambers C21 to C24 described above. Each of chambers C11 and C12 is equipped with an inlet 361 through which reagents and washing solution are supplied, an outlet 362 through which the measurement sample prepared in the chamber is discharged, and a waste port 363 through which the liquid in the chamber is discharged.
[0071] Diluent A and washing solution are supplied to chamber C11 via inlet 361. Hemolytic agent C is supplied to HGB chamber C12 via inlet 361.
[0072] The outlet 362 of chamber C11 is connected to the flow path 681 via valve 661. The syringe pump 682, valve 683, and electric measuring unit 382 are connected to the flow path 681. The outlet 362 of chamber C12 is connected to the HGB measuring unit 383 via valve 671. The HGB measuring unit 383 is connected to the flow path 684 via valve 672. Valves 683, 685, and 686 are connected to the flow path 684. The diaphragm pump 687 is connected to the flow path 684 via valve 685. The waste ports 363 of chambers C11 and C12 are connected to the waste flow paths via valves 662 and 672, respectively.
[0073] Once the preparation of the RBC / PLT measurement sample is complete in chamber C11, the diaphragm pump 687 draws the RBC / PLT measurement sample from chamber C11 into the channel 681. The syringe pump 682 supplies the RBC / PLT measurement sample stored in the channel 681 to the electrical measurement unit 382. The syringe pump 682 is configured to transfer a predetermined amount of the measurement sample stored in the channel 681 to the electrical measurement unit 382 by applying a predetermined pressure to the channel 681.
[0074] The electrical measurement unit 382 flows the RBC / PLT measurement sample and sheath fluid supplied from the flow path 681 into the flow cell 66 (see Figure 14) and outputs an electrical signal corresponding to the blood cells in the RBC / PLT measurement sample based on the sheath flow DC detection method. The RBC / PLT measurement sample that has passed through the electrical measurement unit 382 is discarded. When the measurement of the RBC / PLT measurement sample by the electrical measurement unit 382 is completed, washing fluid is supplied to the chamber C11. The washing fluid in the chamber C11 is discharged to the flow path 681 via the outlet 362 and also discarded via the waste port 363. The washing fluid discharged to the flow path 681 is discarded via valve 686 by syringe pump 682 and diaphragm pump 687.
[0075] Once the preparation of the HGB measurement sample is complete in chamber C12, the HGB measurement sample is supplied to the HGB measurement unit 383 via valve 671. The HGB measurement unit 383 outputs absorbance corresponding to the hemoglobin concentration. The HGB measurement sample used for measurement in the HGB measurement unit 383 is discarded. Once the measurement of the HGB measurement sample by the HGB measurement unit 383 is complete, washing solution is supplied to chamber C12. The washing solution in chamber C12 is discharged to the HGB measurement unit 383 via outlet 362 and also discarded via waste port 363. The washing solution discharged to the HGB measurement unit 383 passes through the inside of the HGB measurement unit 383 and is discharged into the flow path 684. The washing solution discharged into the flow path 684 is discarded via valve 686 by syringe pump 682 and diaphragm pump 687.
[0076] Figure 13 shows the configuration of the flow cell 65 of the optical measuring unit 381.
[0077] As shown in Figure 13, the flow cell 65 of the optical measuring unit 381 is equipped with a sheath liquid supply port 41, a sample nozzle 42, a pore section 43, and a waste port 44.
[0078] The sheath fluid supply port 41 supplies sheath fluid into the flow cell 65. The sample nozzle 42 sends the sample upward within the flow cell 65. The sample, enveloped in sheath fluid, proceeds through the channel 43a formed in the pore section 43 to the waste port 44. The blood cells contained in the sample pass through the channel 43a in a line. Laser light of a predetermined wavelength is irradiated into the channel 43a. When laser light is irradiated onto the sample passing through the channel 43a, forward scattered light, side scattered light, and fluorescence are generated from the blood cells in the sample. The light-receiving section of the optical measurement unit 381 outputs optical signals corresponding to the intensity of the forward scattered light, side scattered light, and fluorescence. The intensity of the forward scattered light reflects information about the size of the blood cells, the intensity of the side scattered light reflects internal information of the blood cells, and the intensity of the fluorescence reflects the degree of staining of the blood cells. When cleaning the optical measurement unit 381, cleaning fluid is supplied to the sheath fluid supply port 41 and the sample nozzle 42.
[0079] Furthermore, the optical signal can be any signal obtained as an optical response by irradiating blood cells with light. The optical signal is not limited to signals based on light scattering and fluorescence as described above; for example, it may also be a signal based on light absorption or a signal based on transmitted light.
[0080] Figure 14 shows the configuration of the flow cell 66 of the electrical measuring unit 382 and the configuration of the HGB measuring unit 383.
[0081] As shown on the left side of Figure 14, the flow cell 66 of the electrical measuring unit 382 comprises a sample nozzle 151, a chamber 152, an aperture 153, a recovery tube 154, and a chamber 155.
[0082] The sample nozzle 151 delivers the sample upward. The chamber 152 has a tapered shape that narrows as it goes upward. Sheath fluid is supplied into the chamber 152. The sample, encased in the sheath fluid, passes through the aperture 153 to the recovery tube 154. The blood cells contained in the sample pass through the aperture 153 in a single line. Electrodes are provided in the aperture 153. A direct current is supplied between the electrodes of the aperture 153, and an electrical signal corresponding to the change in DC resistance as the sample passes through the aperture 153 is detected. The RBC / PLT diluent used to prepare the RBC / PLT sample is conductive because it contains electrolytes. As a result, the DC resistance increases as the blood cells in the RBC / PLT sample pass through the aperture 153, and the electrical signal reflects information about the blood cells passing through the aperture 153.
[0083] Sheath fluid is supplied to chamber 155 so that it flows downwards over the outer region of the recovery tube 154. The sheath fluid flowing outside the recovery tube 154 reaches the lower end of chamber 155 and then flows into the interior of the recovery tube 154. This prevents blood cells that have passed through aperture 153 from returning to aperture 153, thereby preventing false detection of blood cells. During cleaning of the electrical measurement unit 382, cleaning fluid is supplied to the sample nozzle 151 and chambers 152 and 155.
[0084] As shown on the right side of Figure 14, the HGB measuring unit 383 comprises a cell 383a, a light source unit 383b, and a light receiving unit 383c.
[0085] Cell 383a is made of a highly translucent plastic material. The light source unit 383b irradiates cell 383a with light of a wavelength that has a high absorption rate due to SLS-hemoglobin. The light receiving unit 383c is positioned opposite the light source unit 383b, with cell 383a in between, and receives the transmitted light that has passed through cell 383a.
[0086] The HGB measurement sample is placed in cell 383a. In this state, the light source unit 383b emits light, and the light receiving unit 383c receives the transmitted light. Since cell 383a is made of a highly translucent material, the light receiving unit 383c receives only the transmitted light from the light source unit 383b that was not absorbed by the HGB measurement sample. The light receiving unit 383c detects a signal corresponding to the intensity of the transmitted light. This signal corresponds to the absorbance.
[0087] Figure 15 is a block diagram showing an example configuration of the measurement unit 10.
[0088] The measurement unit 10 includes an optical measurement unit 381, an electrical measurement unit 382, an HGB measurement unit 383, analog processing units 813, 814, 815, A / D conversion units 821, 822, 823, IF (interface) units 390, 391, a communication unit 803, a transport unit 30, a supply unit 40, and a liquid transport unit 90.
[0089] The analog processing units 813, 814, and 815 perform processing such as noise reduction and smoothing on the analog signals output from the optical measurement unit 381, the electrical measurement unit 382, and the HGB measurement unit 383, respectively. The A / D conversion units 821, 822, and 823 convert the analog signals processed by the analog processing units 813, 814, and 815 into digital signals, respectively, and transmit the measurement results to the control unit 200 via the IF unit 390 and the communication unit 803. The communication unit 803 is configured with connection terminals based on the USB standard and communicates with the control unit 200.
[0090] The liquid transfer unit 90 includes a mechanism for driving a syringe pump, a diaphragm pump, and a valve for transferring liquid in the flow path shown in Figures 11 and 12. The mechanism unit 80 includes a gripping mechanism 310 (see Figure 3) for removing the sample container 110 from the rack R, a stirring mechanism 320 (see Figure 3) for stirring the sample container 110, and a dispensing mechanism 350 for moving the suction tube 351 for aspirating the sample from the sample container 110 and dispensing it into each chamber. Each part of the measurement unit 10 is controlled by the control unit 200 via the IF unit 391 and the communication unit 803.
[0091] Figure 16 is a block diagram showing an example configuration of the transport unit 30 and the control unit 200.
[0092] The transport unit 30 comprises a mechanism unit 251 and a communication unit 252.
[0093] The mechanism unit 251 includes a mechanism for moving the rack R within the first area 31, a mechanism for moving the rack R within the second area 32, and a mechanism for driving the conveyor 33. The communication unit 252 is composed of connection terminals based on the USB standard and communicates with the control unit 200.
[0094] The control unit 200 includes a control unit 850, a storage unit 861, a display unit 853, an input unit 854, and communication units 862 and 863.
[0095] The control unit 850 is composed of, for example, a CPU. The control unit 850 has the functions of an analysis unit 851 that performs sample analysis by executing a computer program stored in the storage unit 861, and a measurement control unit 852 that controls the measurement unit 10. The storage unit 861 is composed of, for example, an SSD, HDD, RAM, etc. The storage unit 861 stores the measurement results received from the measurement unit 10, a program for controlling the control unit 200, and a program for realizing the functions of the analysis unit 851 and the measurement control unit 852. The storage unit 861 also stores a reagent information database containing reagent information for various reagents that are managed exclusively by the measurement device 1.
[0096] The display unit 853 is composed of, for example, a liquid crystal display or an organic EL display. The input unit 854 is composed of, for example, a mouse or a keyboard. The display unit 853 and the input unit 854 may be configured as an integrated unit, or they may be composed of, for example, a touch panel display.
[0097] The communication unit 862 is configured with connection terminals based on the USB standard and communicates with the communication unit 803 of the measurement unit 10 and the communication unit 252 of the transport unit 30 via a USB standard cable. The measurement control unit 852 controls each part of the transport unit 30 via the communication unit 862 and receives the sample ID read by the reading unit 34 of the transport unit 30.
[0098] The communication unit 863 is composed of connection terminals based on the Ethernet standard and communicates with a host computer outside the measuring device 1 via an Ethernet standard cable. When the measurement control unit 852 receives the sample ID read by the reading unit 34 of the transport unit 30, it queries the host computer via the communication unit 863 for the measurement order corresponding to the sample ID. The measurement control unit 852 receives the measurement order corresponding to the sample ID from the host computer. The received measurement order for each sample is stored in the storage unit 861. The measurement control unit 852 can also accept measurement orders from an operator via the input unit 854.
[0099] The measuring device 1 determines the measurement mode according to the measurement items included in the measurement order. The measuring device 1 is configured to measure samples using, for example, the following eight measurement modes. (1) CBC (2) CBC + DIFF (3) CBC+RET (4) CBC+DIFF+RET (5) CBC+PLT-F (6) CBC+DIFF+PLT-F (7) CBC+RET+PLT-F (8) CBC+DIFF+RET+PLT-F
[0100] The measurement items included in the measurement order are, for example, the following: • Measurement items corresponding to CBC (Details will be described later, but these are multiple measurement items including red blood cell count (RBC), etc.) • Measurement items corresponding to DIFF (details will be described later, but these include multiple measurement items such as neutrophil count (NEUT#) and lymphocyte count (LYMPH#)). • Measurement items corresponding to RET (Details will be described later, but these include measurement items such as reticulocyte count) • Measurement items corresponding to PLT-F (details will be described later, but these include measurement items such as platelet count)
[0101] CBC stands for Complete Blood Count. The eight measurement items corresponding to CBC are red blood cell count (RBC), white blood cell count (WBC), hemoglobin level (HGB), hematocrit value (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MFCH), mean corpuscular hemoglobin concentration (MCHC), and platelet count (PLT). The measurement items corresponding to CBC may also include nucleated red blood cell count (NRBC#), nucleated red blood cell percentage (NRBC%), basophil count (BASO#), and basophil percentage (BASO%). Red blood cell count (RBC), platelet count (PLT), and hematocrit value (HCT) are determined based on the electrical signal obtained by the electrical measurement unit 382 measuring the RBC / PLT of the measurement sample. White blood cell count (WBC) is determined based on the optical signal obtained by the optical measurement unit 381 measuring the WNR of the measurement sample. Hemoglobin (HGB) is determined based on the optical signal obtained by the HGB measurement unit 383 measuring the HGB of the sample. Mean corpuscular volume (MCV) is determined from the red blood cell count (RBC) and hematocrit value (HCT). Mean corpuscular hemoglobin (MCH) is determined from the red blood cell count (RBC) and hemoglobin (HGB). Mean corpuscular hemoglobin concentration (MCHC) is determined from the hematocrit value (HCT) and hemoglobin (HGB).
[0102] The measurement items corresponding to DIFF include, for example, neutrophil count (NEUT#), lymphocyte count (LYMPH#), monocyte count (MONO#), eosinophil count (EO#), neutrophil percentage (NEUT%), lymphocyte percentage (LYMPH%), monocyte percentage (MONO%), and eosinophil percentage (EO%). The measurement items corresponding to DIFF are determined by the measurement of the sample WDF by the optical measurement unit 381, which classifies the white blood cells into multiple subpopulations (neutrophils, lymphocytes, monocytes, eosinophils), and each of the classified subpopulations is counted. As mentioned above, if CBC includes basophil count (BASO#) as a measurement parameter, the white blood cells may be classified into five subpopulations (neutrophils, lymphocytes, monocytes, eosinophils, basophils) based on the measurement data of CBC and DIFF, and each of the five classified subpopulations may be counted.
[0103] An example of a measurement item corresponding to RET is the reticulocyte count (RET#). The measurement items corresponding to RET may further include the reticulocyte percentage (RET%), low fluorescence reticulocyte percentage (LFR), medium fluorescence reticulocyte percentage (MFR), and high fluorescence reticulocyte percentage (HFR). In the measurement items corresponding to RET, the RET of the measurement sample is measured by the optical measurement unit 381, which classifies mature red blood cells from reticulocytes, and the classified reticulocytes are counted. The measurement items corresponding to RET may further include the platelet count (PLT#), obtained by optically measuring the platelet count, as a parameter.
[0104] The measurement item corresponding to PLT-F is platelet count (PLT). The measurement items corresponding to PLT-F may further include immature platelet ratio (IPF) and immature platelet count (IPF#). The measurement item corresponding to PLT-F is determined by the optical measurement unit 381, which classifies the platelets and counts the classified platelets.
[0105] If the measurement order includes only measurement items corresponding to CBC, the measurement control unit 852 determines the measurement mode to CBC. In CBC mode, the measurement control unit 852 controls the measurement unit 10 to prepare RBC / PLT measurement samples, HGB measurement samples, and WNR measurement samples.
[0106] If the measurement items included in the measurement order are measurement items corresponding to CBC and DIFF, the measurement control unit 852 determines the measurement mode to CBC+DIFF. In CBC+DIFF mode, the measurement control unit 852 controls the measurement unit 10 to prepare RBC / PLT measurement samples, HGB measurement samples, WNR measurement samples, and WDF measurement samples.
[0107] If the measurement items included in the measurement order correspond to CBC and RET, the measurement control unit 852 determines the measurement mode to CBC+RET. In CBC+RET mode, the measurement control unit 852 controls the measurement unit 10 to prepare RBC / PLT measurement samples, HGB measurement samples, WNR measurement samples, and RET measurement samples.
[0108] If the measurement items included in the measurement order correspond to CBC, DIFF, and RET, the measurement control unit 852 determines the measurement mode to CBC+DIFF+RET. In CBC+DIFF+RET mode, the measurement control unit 852 controls the measurement unit 10 to prepare RBC / PLT measurement samples, HGB measurement samples, WNR measurement samples, WDF measurement samples, and RET measurement samples.
[0109] If the measurement items included in the measurement order correspond to CBC and PLT-F, the measurement control unit 852 determines the measurement mode to CBC+PLT-F. In CBC+PLT-F mode, the measurement control unit 852 controls the measurement unit 10 to prepare RBC / PLT measurement samples, HGB measurement samples, WNR measurement samples, and PLT-F measurement samples.
[0110] If the measurement items included in the measurement order correspond to CBC, DIFF, and PLT-F, the measurement control unit 852 determines the measurement mode to CBC+DIFF+PLT-F. In CBC+DIFF+PLT-F mode, the measurement control unit 852 controls the measurement unit 10 to prepare the measurement samples RBC / PLT, HGB, WNR, WDF, and PLT-F.
[0111] If the measurement items included in the measurement order correspond to CBC, RET, and PLT-F, the measurement control unit 852 determines the measurement mode to CBC+RET+PLT-F. In CBC+RET+PLT-F mode, the measurement control unit 852 controls the measurement unit 10 to prepare RBC / PLT measurement samples, HGB measurement samples, WNR measurement samples, RET, and PLT-F.
[0112] If the measurement items included in the measurement order correspond to CBC, DIFF, RET, and PLT-F, the measurement control unit 852 determines the measurement mode to CBC+DIFF+RET+PLT-F. In CBC+DIFF+RET+PLT-F mode, the measurement control unit 852 controls the measurement unit 10 to prepare the measurement samples RBC / PLT, HGB, WNR, WDF, RET, and PLT-F.
[0113] The measurement unit 10 supplies the prepared measurement samples in each measurement mode to the optical measurement unit 381, the electrical measurement unit 382, and the HGB measurement unit 383, measures each measurement sample, and transmits the measurement data obtained from each measurement sample to the control unit 200. The control unit 850 of the control unit 200 stores the acquired measurement data in the storage unit 861.
[0114] The analysis unit 851 analyzes the measurement data of RBC / PLT measurement samples and obtains the number of red blood cells, platelet count, and mean corpuscular volume (MCV) as analysis results. Mean corpuscular volume is a measurement value related to the volume of red blood cells. The analysis unit 851 analyzes the measurement data of HGB measurement samples and obtains the hemoglobin concentration as analysis results. Based on the measurement data of WDF measurement samples, the analysis unit 851 classifies the blood cells in the sample into neutrophils, lymphocytes, monocytes, eosinophils, etc., and analyzes the measurement data of WNR measurement samples to classify the blood cells in the sample into basophils, etc. Based on the classification results of WDF measurement samples and WNR measurement samples, the analysis unit 851 classifies the blood cells in the sample into neutrophils, lymphocytes, monocytes, eosinophils, and basophils, and obtains the number and / or ratio of neutrophils, lymphocytes, monocytes, eosinophils, and basophils as analysis results. Analysis unit 851 analyzes the measurement data of WNR measurement samples to classify the blood cells in the sample into white blood cells, nucleated red blood cells, etc., and obtains the white blood cell count and nucleated red blood cell count as analysis results. Analysis unit 851 analyzes the measurement data of RET measurement samples to classify the blood cells in the sample into reticulocytes, etc., and obtains the reticulocyte count, etc. as analysis results. Analysis unit 851 analyzes the measurement data of PLT-F measurement samples to classify the blood cells in the sample into platelets, etc., and obtains the platelet count, etc. as classification results.
[0115] Figure 17 is a time chart of measurements by the first measurement unit 11. The first measurement unit 11 is configured to overlap parts of the measurement sequences of two samples so that it can measure with a processing capacity of 150 samples / hour in CBC+DIFF mode, for example. The second measurement unit 12 is configured similarly to the first measurement unit 11, for example. In this configuration example, the measurement unit 10 is configured to measure with a processing capacity of 300 samples / hour in CBC+DIFF mode. The time chart of two samples measured consecutively will be explained with reference to Figure 17.
[0116] In the time chart shown in Figure 17, the rightward direction indicates the passage of time, and the time interval between two adjacent vertical lines is 2 seconds. The measurement control unit 852 controls the preparation of the measurement sample in each chamber and the measurement by each measurement unit, as shown in the following time chart. The measurement control unit 852 executes one operation sequence for each sample. The operation sequence specifies the order and timing of operation for each part of the measurement unit 10, namely the sample preparation unit (i.e., chambers C11, C12, C21~C24), each measurement unit 381~383, and components such as valves and pumps included in the fluid circuit. When the measurement control unit 852 executes the operation sequence, the valves and pumps are controlled, for example, so that the valves open at a predetermined timing, and the pumps are driven after a predetermined time. As will be explained in detail below, by starting the operation sequence at a predetermined timing, the measurement control unit 852 partially overlaps the preparation of the WDF measurement sample and the measurement by the optical measurement unit for two consecutive samples.
[0117] In Figure 17, the rectangular labels indicate the duration of the steps included in the operation sequence. For the preparation rectangular label, the left end indicates the timing to start mixing the reagents into the chamber, and the right end indicates the timing to start transferring the measurement sample from the chamber after the reaction is complete. For the measurement rectangular label, the left end indicates the timing to start the signal acquisition process in the corresponding detection unit, and the right end indicates the timing to end the signal acquisition process.
[0118] As shown in Figure 17, when the CBC+DIFF mode is set in response to a measurement order, the following steps are executed in order: "HGB preparation" for preparing an HGB sample, "RBC preparation" for preparing an RBC / PLT sample, "WDF preparation" for preparing a WDF sample, and "WDF preparation" for preparing a WNR sample. These steps are executed as follows: First, the sample aspirated by the suction tube 301 is dispensed sequentially into chambers C12, C11, C21, and C22. The reagents predetermined for preparing each sample, namely the diluent, hemolytic agent, and staining solution, are supplied to each chamber by the liquid transfer unit 90. The sample and reagent are mixed in each chamber, and the measurement sample is prepared after a predetermined reaction time has elapsed.
[0119] Once the preparation of the measurement sample in each chamber is complete, the measurement sample is transferred from each chamber to the corresponding measurement unit, where the measurement is performed. The transfer of the measurement sample and the measurement by each measurement unit are carried out, for example, as follows.
[0120] Once the HGB preparation process is complete, valve 671 in the flow path between chamber C12 and HGB measurement unit 383 is opened, and a predetermined amount of HGB measurement sample is transferred to the HGB measurement unit 383. In the "HGB measurement" process, the transferred HGB sample is measured by the HGB measurement unit 383.
[0121] Once the RBC preparation process is complete, the diaphragm pump 687 draws the RBC / PLT sample from chamber C11, and the syringe pump 682 transfers the RBC sample to the electrical measurement unit 382. In the "RBC measurement" process, the transferred RBC / PLT sample is measured by the electrical measurement unit 382.
[0122] Once the WDF preparation process is complete, the diaphragm pump 655 draws the WDF measurement sample from chamber C21, and the syringe pump 652 transfers the WDF measurement sample to the optical measurement unit 381. In the "WDF measurement" process, the transferred WDF sample is measured by the optical measurement unit 381.
[0123] Once the WNR preparation process is complete, the diaphragm pump 655 draws the WNR measurement sample from chamber C23, and the syringe pump 652 transfers the WNR measurement sample to the optical measurement unit 381. In the "WNR measurement" process, the transferred WNR sample is measured by the optical measurement unit 381.
[0124] In this manner, the CBC+DIFF measurement of the first sample is performed. If the second sample following the first sample is also measured in CBC+DIFF mode, the HGB preparation / measurement, RBC preparation / measurement, WDF preparation / measurement, and WNR preparation / measurement are performed for the second sample in the same way as for the first sample. The preparation time and measurement time for each sample are the same for the first and second samples, but the chamber used for WDF preparation is different. If the WDF sample of the first sample is prepared in chamber C21, the WDF sample of the second sample that follows will be prepared in chamber C22. In other words, when measurements are performed consecutively in CBC+DIFF mode, the two chambers C21 and C22 are used alternately.
[0125] When performing WDF measurements on multiple samples consecutively, the periods from WDF preparation to WDF measurement for the first and second samples overlap at least partially, as shown by the hatching in Figure 16. In the example in Figure 16, the WDF preparation of the second sample overlaps with the WDF measurement of the first sample. More specifically, the WDF preparation of the second sample is started between the WDF preparation and WDF measurement of the first sample. With this configuration, the WDF preparation of the second sample can be started without waiting for the completion of the WDF measurement of the first sample, thereby significantly improving the processing capacity of the measurement unit 10.
[0126] Figure 18 is a flowchart illustrating the supply of diluent by the measuring device 1. Referring to Figure 18, the continuous loading function of the measuring device 1 using the reserve tank RT will be explained. Figure 18 illustrates the flow of supplying diluent from the first container 700 as an example, but the supply of hemolytic agent from the second container 800 is performed using the same flow. Furthermore, the following explanation describes an example where diluent A is supplied via reserve tank RT1, but other reagents (diluent B, hemolytic agents A-C) are also supplied via their respective reserve tanks RT2-RT5.
[0127] <Step S1: Supply of Diluent> In step S1, the measurement control unit 852 controls the supply unit 40 to continue supplying the diluent from the first container 700 to the measurement unit 10 until the remaining amount of diluent in the first container 700 falls below a predetermined amount. The supply of the diluent to the measurement unit 10 includes, for example, supplying the diluent A from the first container 700 containing the diluent A to the chamber C11 for the preparation of the RBC sample in the chamber C11 described above. If the diluent A is used as a cleaning solution for cleaning each of the chambers C11, C12, C21 to C24, the supply of the diluent in step S1 may also include supplying the diluent A as a cleaning solution to each chamber.
[0128] The control of the supply unit 40 by the measurement control unit 852 is performed, for example, as follows:
[0129] (1) Fill the reserve tank The measurement control unit 852 drives a pump 57 connected to the first container 700 containing the diluent A to store a predetermined amount of diluent A in the reserve tank RT1. For example, the reserve tank RT1 is equipped with a float sensor FS as described with reference to Figure 7, and the measurement control unit 852 is configured to detect the water level of the diluent A based on the signal from the float sensor FS. The measurement control unit 852 fills the reserve tank RT1 with diluent A until the water level reaches a predetermined upper limit position as detected by the float sensor FS.
[0130] (2) Supply to the measuring unit 10 The measurement control unit 852 controls the supply unit 40 to supply diluent A from the reserve tank RT1 to the measurement unit 10 in accordance with the measurement operation performed by the measurement unit 10. For example, referring to the time chart shown in Figure 17, in the "RBC preparation" step, a predetermined amount of diluent A stored in the reserve tank RT1 is supplied to the chamber C11, and the sample aspirated from the sample container 110 is mixed with the predetermined amount of diluent A. The supply unit 40 includes a quantification unit that includes a valve and a pump for quantifying and drawing in diluent A from the reserve tank RT1 and sending it to the chamber connected to the reserve tank RT1. The measurement control unit 852 controls the quantification unit of the supply unit 40 to quantify the diluent A and send it to the chamber C11.
[0131] (3) Refilling the reserve tank When diluent is supplied from the reserve tank RT1 to the measurement unit 10, the remaining amount of diluent A in the reserve tank RT1 decreases, and the water level of diluent A drops accordingly. When the measurement control unit 852 detects, based on the signal from the float sensor FS, that the remaining amount of diluent A in the reserve tank RT1 has decreased to a predetermined replenishment level (for example, 80% of the maximum level), it drives the pump 57 again to supply diluent A from the first container 700 to the reserve tank RT1 until the water level of diluent A reaches a predetermined upper limit. In this way, diluent A is replenished as needed so that a certain amount of diluent A is stored in the reserve tank RT1, for example, an amount between the maximum level (100%) and the replenishment level (80%). Note that although (2) and (3) are described here as being executed in order, (2) and (3) may be executed simultaneously. In other words, when the pump 57 is driven while the diluent A is being drawn out from the bottom of the reserve tank RT1 in response to the measurement operation by the measurement unit 10, the diluent A is replenished from the first container 700 into the reserve tank RT1 while the diluent A is being supplied from the reserve tank RT1.
[0132] (4) Detection of remaining amount of diluent As the supply from the reserve tank RT1 to the measurement unit 10 is repeated, the amount of diluent A in the first container 700 decreases, and eventually the remaining amount of diluent A in the first container 700 falls below a predetermined amount. The predetermined amount is, for example, the amount that cannot be further aspirated by the tube inserted into the container, i.e., the dead volume remaining in the container. The supply unit 40 is equipped with a sensor that detects the remaining amount in the first container 700 that contains the diluent A. In the example in Figure 7, the supply unit 40 is equipped with a bubble sensor BS in the flow path connecting the reserve tank RT1 and the first container 700. The bubble sensor BS detects bubbles that have entered the flow path when the diluent A has run out of reagent and is aspirated through the first tube 51a inserted into the first container 700. The measurement control unit 852 detects that the remaining amount in the first container 700 has fallen below a predetermined amount based on the signal from the bubble sensor BS. When the measurement control unit 852 detects that the remaining amount is below a predetermined amount, the process proceeds to step S2.
[0133] In the above example, a bubble sensor is used to detect the remaining amount in the first container 700, but the remaining amount may be detected by other methods. For example, a float sensor may be provided on the first tube 51a inserted into the first container 700 to detect the remaining amount from the water level in the first container 700. Alternatively, the remaining amount may be detected based on the number of tests performed using the diluent in the first container 700. For example, the remaining amount may be detected by subtracting the number of tests performed using diluent A from the number of measurable tests when unused.
[0134] <Step S2: Output of replacement alarm> In step S2, the measurement control unit 852 outputs a replacement alarm. The replacement alarm only needs to prompt the user of the measuring device 1 to replace the first container 700, and the output format can take various forms. Possible output formats include (1) screen display, (2) voice message, and (3) notification to a mobile terminal. Examples of each output format are described below.
[0135] An example of the screen display for the replacement alarm will be explained with reference to Figure 19. The replacement alarm is displayed on the display by the control unit 200, for example. The control unit 200 manages the remaining amount of reagent in cooperation with the supply unit 40. The control unit 200 manages the remaining amount of reagent based on the one-to-one relationship between the supply unit 40 and the corresponding measurement unit 10. The control unit 200 manages the remaining amount of reagent related to the supply unit 40 as the remaining amount of reagent used exclusively for the corresponding measurement unit 10. In the screen illustrated in Figure 19, the control unit 200 manages the remaining amount of reagent in each container corresponding to the supply unit 40 based on the amount of reagent supplied exclusively to the measurement unit 10 corresponding to the supply unit 40. Figure 19 shows an example of screen D1 displayed on the display 70. Screen D1 comprises a first area D100 and a second area D200 as its main display areas. The first area D100 displays, for example, icons for the user to give instructions to the control unit 200, and the analysis results of the sample generated by the control unit 200. The second area D200 displays the status of the measurement unit 10. For example, if an error occurs in the measurement unit 10, a notification that an error has occurred will be displayed in the second area D200. In Figure 19, as an example of the output of a replacement alarm, message D201 is displayed, indicating that reagent replacement is necessary as an example of an error that occurred in the measurement unit 10. The user can recognize that reagent replacement is necessary in the measurement unit 10 by checking the display in the second area D200. In Figure 19, the replacement alarm is displayed in the form of a message, but it may be output in other formats. For example, an icon representing the status of the measurement unit 10 by color may be displayed, and the color of the icon may change to indicate that the reagent is running out. For example, the icon may be displayed in green when there is no abnormality in the measurement unit 10, and in red when the reagent runs out.
[0136] In the screen shown in Figure 19, when the user selects the second area D200 with the pointing device, the reagent information window D300 is displayed. In the example screen shown in Figure 19, the reagent information window D300 is overlaid on the first display area 100, but the information in the reagent information window D300 may be displayed in the first display area 100. The reagent information window D300 includes an area D301 that displays information about reagents contained in the first measurement unit 11, an area D302 that displays information about reagents contained in the second measurement unit 20, and an area D303 that displays information about reagents contained in the reagent storage section 50.
[0137] Area D301 displays multiple reagent volume gauges indicating the remaining amounts of various staining solutions set in the reagent placement section 23 of the first measurement unit 11. For example, in the example in Figure 19, four reagent volume gauges corresponding to staining solutions A, B, C, and D are displayed from left to right. The graphic for each reagent volume gauge includes a rectangular frame and a gauge within the frame that represents the remaining amount of the staining solution. The gauge displays the remaining amount of each staining solution as a height. For example, the gauge represents the height of the remaining amount of staining solution when the amount of staining solution contained in the unused third container is set to 100%. By displaying the remaining amount of staining solution in a graph in this way, the user can visually grasp the remaining amount of each reagent. In addition, by displaying the remaining amounts of multiple staining solutions contained in the first measurement unit 11 on a single screen, the user can view the remaining amounts of multiple reagent staining solutions at a glance.
[0138] Area D302 displays multiple reagent volume gauges indicating the remaining amounts of various staining solutions set in the reagent placement section 23 of the second measurement unit 20. The configuration of area D302 is the same as that of area D301.
[0139] Area D303 displays multiple reagent volume gauges that show the remaining amounts of various types of reagents stored in the reagent storage section 50. In the example in Figure 19, five reagent volume gauges are displayed from left to right, corresponding to Diluent A, Diluent B, Hemolytic Agent A, Hemolytic Agent B, and Hemolytic Agent C. In the example in Figure 19, the number of uses for Diluent A and Hemolytic Agent C is zero, and the gauges corresponding to each reagent are represented by a height of zero.
[0140] As illustrated in Figure 19, in addition to the reagent volume gauge, the remaining amount of each reagent may be displayed in text. The remaining amount may be displayed as, for example, "250 / 500," indicating that the current amount is 250 tests out of a remaining amount of 500 tests when unused, or as the number of remaining uses, such as "100 tests remaining." By checking the number of remaining uses, the user can understand how many measurements are possible before the reagent runs out. The number of remaining uses is just one example of a display format; for example, the remaining amount of the reagent may be displayed by volume, such as "50 ml remaining," or the remaining amount may be displayed qualitatively in multiple stages (e.g., 5 stages). As shown in Figure 19, in addition to the remaining amount information of various reagents, the reagent lot number (LOT) and expiration date (EXP) may also be displayed.
[0141] The reagent level gauges for Diluent A and Hemolytic Agent C are displayed with an icon D304 indicating that reagent replacement is necessary. By checking the reagent level gauge, the user can identify which reagent is running low. The addition of icon D304 to the gauge also highlights the reagent that is running low (Diluent A and Hemolytic Agent C in the example in Figure 19) to distinguish it from other reagents. This highlighting makes it easier for the user to recognize which reagent needs to be replaced. The highlighting is not limited to the display of icon D304. For example, the gauge for the reagent that is running low and needs to be replaced may be displayed in a first color (e.g., red) for a warning, and the gauges for other reagents that are not running low may be displayed in a second color (e.g., blue). The above is an example of outputting a replacement alarm via screen display.
[0142] The output of the replacement alarm via voice message is performed, for example, when the measurement control unit 852 detects that the reagent for diluent A in the first container 700 has run out, by outputting a voice message such as "Please replace the reagent container for diluent A" from a speaker (not shown).
[0143] Figure 20 shows an example of an output of a replacement alarm via notification to a mobile terminal. The mobile terminal 1000 is a portable electronic device such as a smartphone, tablet computer, or laptop computer. In the example in Figure 20, the mobile terminal 1000 is a smartphone. The mobile terminal 1000 is connected to the internet via a mobile communication network such as 5G. The mobile terminal 1000 has an application program installed that assists in the operation of the measuring device 1. The mobile terminal 1000 can communicate with a cloud server that collects and provides data from the measuring device 1. The communication unit 863 of the control unit 200 is also connected to the internet and can communicate with the aforementioned cloud server. When the measurement control unit 852 of the measuring device 1 detects that the diluent A has run out of reagent, it sends data to the cloud server indicating that the diluent A has run out of reagent, associated with the device ID of the measuring device 1. Upon receiving this data, the cloud server generates a message indicating that the diluent A has run out of reagent and sends a push notification to the mobile terminal 1000. When the application on the mobile terminal 1000 receives a push notification, it displays a message on its display indicating that the diluent A has run out of reagent. Figure 20 shows an example where the mobile terminal 1000, upon receiving a push notification, displays a message indicating that the diluent A has run out of reagent. In this way, by displaying a replacement alarm on the mobile terminal 1000 in addition to or as an alternative to the display on the display 70 of the measuring device 1, the user can be aware of the reagent running out and promptly start replacing the reagent, even if the user is away from the measuring device 1. Furthermore, by displaying the message via push notification, the user can recognize the replacement alarm without opening the application.
[0144] The mobile terminal 1000 may display reagent remaining amount information of the measurement unit 10 in response to the user's operation of the application. The right side of Figure 20 shows an example of an application screen. Application screen D101 includes, for example, the ID of the data-linked measurement unit 10 and reagent information for the measurement unit 10. In the example of Figure 20, the remaining amounts of multiple reagents set in the measurement device 1 are displayed by reagent amount gauges, similar to the reagent information displayed on the reagent information screen shown in Figure 18. In the example of Figure 20, only the remaining amounts of some of the multiple reagents set in the measurement device 1 are displayed to fit the screen size of the mobile terminal 1000. The user can scroll the screen to display the remaining amounts of other reagents. In the example of Figure 20, five reagent amount gauges corresponding to diluent A, diluent B, hemolytic agent A, hemolytic agent B, and hemolytic agent C are displayed from top to bottom. Unlike the screen in Figure 18, the layout of the example screen in Figure 20 shows the reagent volume gauges arranged vertically to match the screen size of a smartphone, with the rightmost part of each gauge corresponding to 100% remaining and the leftmost part to 0%.
[0145] In the example screen in Figure 20, similar to Figure 18, the state where diluent A and hemolytic agent C are out of reagents is shown. The reagent volume gauges for diluent A and hemolytic agent C are marked with icon D120, indicating that reagent replacement is necessary. The user can recognize the reagent that needs to be replaced by icon D120. In addition to sending a notification that the reagent is out of stock to the mobile terminal 1000, the remaining reagent levels in the measuring device 1 can be checked from the mobile terminal 1000. This eliminates the need for the user to return to the measuring device 1 just to check the reagent levels, even if they are in a remote location after receiving the replacement alarm notification. When reagent replacement is necessary, it is preferable for the user to not only transport the reagent that needs to be replaced from the storage space to the measuring device 1, but also other types of reagents that are about to run out, thereby eliminating the need to travel between the measuring device 1 and the storage space. Therefore, by allowing the remaining levels of reagents other than the one that has run out to be checked in the application, the work involved in reagent replacement can be made more efficient.
[0146] <Step S3: Supply from the reserve tank> Referring again to Figure 18, in step S3, the measurement control unit 852 stops supplying diluent A from the first container 700 and supplies diluent from the reserve tank RT1 to the measurement unit 10. In step S3, as in step S1, diluent A stored in the reserve tank RT1 is supplied to the measurement unit 10 in accordance with the consumption of diluent A in the measurement unit 10. At the time of step S3, the amount of diluent in the first container 700 is below a predetermined amount, and the remaining amount of diluent A in the reserve tank RT1 is at the replenishment level (e.g., 80%). The measurement control unit 852 controls the supply unit 40 to continue supplying diluent A stored in the reserve tank RT1 to the measurement unit 10 without newly drawing diluent A from the first container 700.
[0147] The supply unit 40 continues to supply diluent A even while the user is performing the replacement of the first container 700 after receiving a replacement alarm. The replacement of the first container 700 is performed, for example, as follows: The user opens the opening / closing unit 61 (see Figure 4) to expose the reagent storage unit 50 and pulls out the drawer 52 on which the first container 700 is placed. The second tube 51b extending from the reserve tank RT1 of the supply unit 40 is long enough so that it does not come off the first container 700 even when the drawer 52 is pulled out forward while the tube 51 remains connected to the first container 700. The user removes the empty first container 700, which has run out of reagent, from the drawer and places a new first container 700 on the drawer 52. The user removes the connector 53 from the empty first container 700, pulls out the first tube 51a, inserts the first tube 51a into the new first container 700, and attaches the connector 53. The user returns the drawer 52 containing the new first container 700 and closes the opening / closing section 61. In this way, the container that has run out of reagent is replaced with a new one.
[0148] The supply unit 40 continues to supply the diluent from the reserve tank RT even when the opening / closing unit 61 is opened to replace the first container 700 containing the diluent. The same applies to the hemolytic agent; the supply unit 40 continues to supply the hemolytic agent from the reserve tank RT even when the opening / closing unit 61 is opened to replace the second container 800 containing the hemolytic agent.
[0149] Furthermore, the supply unit 40 continues to supply the diluent from the reserve tank RT even when the first tube 51a is withdrawn from the first container 700 containing the diluent. The same applies to the hemolytic agent; the supply unit 40 continues to supply the hemolytic agent from the reserve tank RT even when the opening / closing unit 61 is opened to replace the second container 800 containing the hemolytic agent.
[0150] <Step S4: Decision on reagent replacement> In step S4, the measurement control unit 852 determines whether the reagent that has run out has been replaced. In determining whether the reagent has been replaced, (1) for example, it may recognize that new reagent information has been entered, or (2) the measurement control unit 852 may automatically recognize that the reagent has been replaced based on the signal from the sensor.
[0151] As an example of (1) above, the measurement control unit 852 may recognize reagent replacement when reagent information of the same type as the reagent subject to the replacement alarm is input. For example, when a replacement alarm for diluent A is output, the measurement control unit 852 may determine that the reagent has been replaced when the user inputs reagent information for a new first container 700 containing diluent A. Reagent information can be input to the control unit 200 by having a machine-readable code printed on the outside of the first container 700 read by a reader (not shown), such as a handheld code reader. The machine-readable code includes reagent information such as the type code of the reagent contained in the container (codes distinguishing diluent A, diluent B, and hemolytic agents A-C), expiration date, and lot number. The reagent information is input to the measurement control unit 852 by decoding the reagent information from the code read by the code reader. Alternatively, the reagent information may be input to the control unit 200 by the user operating a keyboard or touch panel. If the type code included in the input reagent information matches the type of reagent for which a replacement alarm has been output, the measurement control unit 852 determines YES in step S4 and proceeds to step S7.
[0152] As another example of (1) above, the measurement control unit 852 may recognize that a reagent has been replaced by accepting an operation to cancel the replacement alarm. For example, when replacement alarm D304 corresponding to diluent A is selected in the example screen of Figure 19, the measurement control unit 852 displays the dialog box D330 illustrated in Figure 21A. The dialog box D330 displays the message "Replace diluent A and select the complete button." When the user replaces diluent A and selects the complete button, the measurement control unit 852 recognizes that the reagent has been replaced and proceeds to step S5. Alternatively, when replacement alarm D304 corresponding to diluent A is selected, the measurement control unit 852 may display the dialog box D331 illustrated in Figure 21B. The dialog box D330 displays the message "Replace diluent A and enter the reagent information for the new diluent A." The dialog box D331 further includes input fields for the lot number of the new diluent A and an expiration date. After the user replaces diluent A and enters the data for each field, and selects the "Register" button, the measurement control unit 852 recognizes that the reagent has been replaced and proceeds to step S7.
[0153] As an example of (2) above, the measurement control unit 852 may, for example, aspirate a reagent from a new first container 700 and recognize that the reagent has been replaced when no air bubbles are detected during aspiration.
[0154] <Step S5: Check reserve tank level> If it is determined in step S4 that the reagent has not been replaced, the measurement control unit 852 determines whether the remaining amount of diluent A in the reserve tank RT1 is equal to or greater than a predetermined amount. Whether or not it is equal to or greater than the predetermined amount is determined, for example, by whether or not the float sensor FS provided in the reserve tank RT1 has reached the lower limit level. If the float sensor FS has not reached the lower limit level, there is still an amount of diluent A equal to or greater than the predetermined amount remaining in the reserve tank RT1, so the measurement control unit 852 continues to supply diluent A to the measurement unit 10 and returns the process to the determination in step S4.
[0155] <Step S6: Stop the measurement unit 10> In step S5, if the measurement control unit 852 determines that the remaining amount in the reserve tank RT1 is not equal to or greater than a predetermined amount, it stops the measurement of new samples by the measurement unit 10. Stopping the measurement of new samples includes, for example, stopping the aspiration of the next sample that the aspiration tube 351 of the measurement unit 10 is scheduled to aspirate. In step S6, while the measurement of new samples is stopped, the processing of samples that have already been aspirated by the aspiration tube 351 and whose measurement has started continues. By continuing to measure aspirated samples, it is possible to avoid wasting aspirated samples. Here, the "determined amount" mentioned in step S5 is set to be at least more than the amount required to complete the measurement of aspirated samples. Furthermore, the "determined amount" is set to correspond to the maximum number of samples that the measurement unit 10 can measure in parallel. For example, as explained with reference to Figure 17, the first measurement unit 11 of this embodiment is configured to measure two samples in parallel, for example, to increase processing capacity. For example, the second measurement unit 12 is configured similarly. In this configuration example, the measurement unit 10 is configured to measure up to four samples in parallel. Therefore, in this configuration example, the "specified amount" is set to be greater than the amount required to complete the measurement of at least four samples. This makes it possible to maintain the processing capacity of the measurement unit 10 for as long as possible without wasting aspirated samples.
[0156] <Step S7: Reagent Information Registration / Alarm Cancellation> If the measurement control unit 852 determines that a reagent exchange has occurred in step S4, it updates the reagent information DB stored in the storage unit 861 based on the reagent information of the exchanged reagent. For example, if diluent A is exchanged, the remaining amount information, expiration date, and lot number of diluent A stored in the reagent information DB are updated based on the information of the new first container 700. The remaining amount information may be overwritten based on the input reagent information if the remaining amount information is stored in the input reagent information, or it may be reset to the initial remaining amount value in accordance with the reagent exchange if the input reagent information does not include the remaining amount information, and the expiration date and lot number are overwritten with the newly input information. Once the measurement control unit 852 registers the reagent information after the exchange, it cancels the exchange alarm output in step S2. Once the alarm is canceled, the measurement control unit 852 returns to step S1.
[0157] Figure 18 illustrates the flow of supplying the diluent from the first container 700 as an example, but the supply of the hemolytic agent from the second container 800 is performed using the same flow. Based on Figure 18, the hemolytic agent supply flow is explained as follows: In step S1, the supply unit 40 continues to supply the hemolytic agent from the second container 800 to the measurement unit 10 via the reserve tanks RT3-5 until the amount of hemolytic agent in the second container 800 falls below a predetermined remaining amount. (1) Filling the reserve tank with hemolytic agent, (2) Supplying the hemolytic agent to the measurement unit 10, (3) Replenishing the reserve tank with hemolytic agent, and (4) Detecting the remaining amount of hemolytic agent are as described in the example of diluent supply.
[0158] As hemolytic agent is supplied from reserve tanks RT3-5 to the measurement unit 10, replenishment from the second container 800 is repeated, causing the amount of hemolytic agent in the second container 800 to decrease until the remaining amount falls below a predetermined level. When the remaining amount of hemolytic agent in the second container 800 falls below a predetermined level, the measurement control unit 852 outputs a replacement alarm in step S2. In step S3, the supply unit 40 stops supplying hemolytic agent from the second container 800 and continues supplying hemolytic agent from reserve tanks RT3-5 to the measurement unit 10.
[0159] The supply unit 40 continues to supply the hemolytic agent even while the user is performing the replacement of the second container 800 after receiving a replacement alarm. The replacement of the second container 800 is performed in the same manner as the replacement of the first container.
[0160] The supply unit 40 continues to supply the hemolytic agent from the reserve tank RT even when the opening / closing unit 61 is opened to replace the second container 800 containing the hemolytic agent.
[0161] Furthermore, the supply unit 40 continues to supply the hemolytic agent from the reserve tank RT even when the first tube 51a is withdrawn from the second container 800 containing the hemolytic agent.
[0162] In step S4, the measurement control unit 852 determines whether the reagent that has run out has been replaced. If it determines that the reagent has not been replaced, in step S5, the measurement control unit 852 determines whether the remaining amount of hemolytic agent in the reserve tank RT is equal to or greater than a predetermined amount, and if a predetermined amount of hemolytic agent remains, it returns to the determination in step S4.
[0163] If, in step S5, the measurement control unit 852 determines that the remaining amount in the reserve tank RT1 is not equal to or greater than a predetermined amount, it stops the measurement of a new sample by the measurement unit 10.
[0164] If the measurement control unit 852 determines that a reagent exchange has occurred in step S4, it updates the reagent information DB stored in the storage unit 861 based on the reagent information of the exchanged reagent.
[0165] Figure 22A is a flowchart relating to the supply of staining solution by the measuring device 1. Below, the supply of staining solution A from staining solutions A to D will be explained as an example. In step S1, the measurement control unit 852 supplies staining solution from the third container 900 to the measurement unit 10 until the remaining amount of staining solution in the third container 900 falls below a predetermined amount. The determination in step S1 may also be made, for example, by whether the number of times the staining solution stored in the memory unit 861 can be used has reached a predetermined value (e.g., zero).
[0166] In step S2, the measurement control unit 852 outputs a staining solution replacement alarm when the remaining amount of diluent in the third container 900 falls below a predetermined amount. The method for outputting the replacement alarm is as described with reference to Figure 19.
[0167] In step S3, the measurement control unit 852 stops the measurement of new samples by the measurement unit 10. In step S3, while the measurement of new samples is stopped, the processing of samples that have already been aspirated by the suction tube 351 and whose measurement has started continues.
[0168] In step S4, the measurement control unit 852 determines whether the third container containing the staining solution has been replaced. The determination of whether the third container has been replaced may be made, for example, based on whether the reagent information for the third container has been registered, or whether the staining solution has been aspirated from the newly set third container without detecting any air bubbles, similar to the first container 700.
[0169] In step S5, the measurement control unit 852 registers the reagent information and cancels the replacement alarm. The registration of reagent information is the same as described in step S7 in Figure 18. Thus, unlike the example of supplying the diluent, the reserve tank RT1 is not used for supplying the staining solution, so when the staining solution in the third container runs out of reagent, the measurement of new samples in the measurement unit 10 stops.
[0170] Figure 22B is a flowchart showing an example of staining solution supply using a modified method. In Figure 22A, an exchange alarm is output and the measurement unit 10 stops measuring new samples when the remaining amount falls below a predetermined level. In other words, the exchange alarm is not output until the measurement of new samples is stopped. In contrast, in Figure 22, the remaining amount is monitored in stages at multiple levels, an exchange alarm is output when the remaining amount falls below the first level, and the measurement of new samples is stopped when the remaining amount falls below the second level. This will be explained in detail below.
[0171] In step S1, the measurement control unit 852 determines whether the remaining amount of staining solution in the third container is below the first level. The remaining amount at the first level is greater than the amount at the second level, which will be described later. For example, if the amount of staining solution in an unused third container is considered to be 100%, the amount of staining solution at the first level is 10%, and the amount of staining solution at the second level is 0%. When the amount of staining solution in the third container reaches the first level, the measurement control unit 852 outputs a replacement alarm in step S2. The method for outputting the replacement alarm is as described with reference to Figure 19. Even after outputting the replacement alarm, the measurement control unit 852 continues to supply staining solution from the third container in order to continue measuring a new sample.
[0172] In step S3, the measurement control unit 852 determines whether the amount of staining solution in the third container has reached the second level. In step S4, if the remaining amount has reached the second level, the measurement control unit 852 stops measuring the new sample. In steps S5 and S6, after the measurement of the new sample has stopped, if the third container is replaced, the measurement control unit 852 cancels the replacement alarm.
[0173] <Embodiment 2> Embodiment 2 will be described with reference to Figures 23 to 26. As mentioned above, Embodiment 2 differs from Embodiment 1 in that it achieves continuous loading of diluent and hemolytic agent by using a reserve tank RT, in that Embodiment 2 achieves continuous loading by implementing a function to automatically switch the reagent supply source. Specifically, the measuring device 1 in Embodiment 2 connects multiple containers containing the same type of reagent to the measuring unit, and when one container in use runs out of reagent, it automatically switches the supply source to a spare container. The measuring device 1 also supplies reagent from the spare container to the measuring unit while replacing the container that has run out of reagent.
[0174] Figure 23 shows an example of the configuration of the supply unit 40 according to Embodiment 2. In Figure 23, for the sake of simplicity, only the fluid circuit for supplying the diluent A to the measurement unit 10 from the supply unit 40 is shown. The reagent storage unit 50 of Embodiment 2 includes a first container 700 and a fourth container 702 as containers for storing the diluent A. The first container 700 is fluidically connected to the switching unit 510 via a bubble sensor BS. The fourth container 702 is fluidically connected to the switching unit 510 via a bubble sensor BS. As explained with reference to Figure 5, the first tube 51a extending from the switching unit 510 is inserted into the mouth of each container, thereby fluidly connecting each container 700, 701 to the switching unit 510.
[0175] The switching unit 510 is a fluid mechanism for switching the supply source of the diluent A supplied to the measuring unit 10 between the first container 700 and the fourth container 702, and includes, for example, a valve that switches between a first flow path connecting the first container 700 and the measuring unit 10 and a second flow path connecting the fourth container 702 and the measuring unit 10. The switching unit 510 switches between the first flow path and the second flow path by driving the valve under the control of the measuring control unit 852.
[0176] Figure 24 shows an example of the reagent information screen in Embodiment 2. Unlike the screen of Embodiment 1 illustrated in Figure 19, the reagent volume gauges for Diluent A, Diluent B, Hemolytic Agent A, Hemolytic Agent B, and Hemolytic Agent C are displayed as twin displays, each containing two gauges. Of the two gauges, one gauge corresponds to one reagent container, and the other gauge corresponds to the other reagent container. For example, in the reagent volume gauge for Diluent A, the left gauge corresponds to the first container 700, and the right gauge corresponds to the fourth container 702. In the example in Figure 24, of the two gauges for Diluent A, the left gauge is labeled "DA1" representing "Diluent A_1," and the right gauge is labeled "DA2" representing "Diluent A_2," so that the two are displayed separately.
[0177] Figure 25 shows an example of identification information attached to containers housed in the reagent storage section 50. As shown in Figure 25, the tube inserted into the first container 700 is fitted with a tag TG1 printed with identification information indicating that it corresponds to DA1, and the tube inserted into the fourth container 702 is fitted with a tag TG2 printed with identification information indicating that it corresponds to DA2. Since the amount of reagent remaining inside the first and fourth containers cannot be seen, it is impossible to tell which is the first container and which is the fourth container by appearance alone. For example, one can only identify which container has run out of reagent by lifting the box and checking its weight. By attaching tags as shown in Figure 25, the user can distinguish between the first container 700 and the fourth container 702 by appearance alone, reducing the effort required for reagent replacement.
[0178] Furthermore, as shown in Figure 25, the tags are printed with information identifying the type of reagent. In the example in Figure 25, the text printed on the tag is "DA," indicating that the reagent type is Diluent A. Similarly, for Diluent B, the tags are printed with "DB1" and "DB2." In the case of hemolytic agent A, as shown in Figure 25, the second container 800 containing hemolytic agent A has a tag TG3 attached with "HA1," representing "Hemolytic Agent A_1," printed on it. The fifth container 808 containing hemolytic agent A has a tag TG4 attached with "HA2," representing "Hemolytic Agent A_2," printed on it. Since the text printed on the tag is "HA," it indicates that the reagent type is hemolytic agent A. Users can recognize the type of reagent from the information printed on the tags. This prevents users from mixing up reagents. For example, this prevents unintended problems such as a user viewing the reagent information screen in Figure 24 mistakenly removing a tube from the second container 800, which corresponds to "HA1," when they should be replacing the fourth container 702, which corresponds to "DA2." Alternatively, if two tubes are removed from containers to replace two types of reagents at once, it becomes less likely that the tubes should be inserted into the wrong container.
[0179] Figure 25 shows an example of identifying reagent types by attaching tags with printed text to the tubes. The method of identifying reagent types is not limited to this; for example, the color of the tubes may differ depending on the type of reagent or the type of container into which they are inserted. For example, the tubes inserted into the container for diluent A may be blue, the tubes inserted into the container for diluent B may be green, and the tubes inserted into the container for hemolytic agent A may be purple. Alternatively, the shape of the connector 53 (see Figure 5) for attaching the tubes to the containers may differ for each type of container. For example, the connector 53 for the DA1 tube may be designed to engage only with the screw of the container for diluent A, and the connector 53 for the HA1 tube may be designed to engage only with the screw of the container for hemolytic agent A.
[0180] Figure 26 is a flowchart illustrating the automatic switching of reagents. Figure 26 uses the example of supplying diluent A from the first container 700 and the fourth container 702 to the measurement unit 10. The automatic switching function is the same for diluent B and hemolytic agents A to C, so their explanation is omitted. In the following explanation, we will assume that the first container 700 and the fourth container 702 are filled with the maximum amount of diluent A, and that the first container 700 is set to "in use".
[0181] In step S1, the measurement control unit 852 controls the switching unit 510 to connect a flow path for supplying the diluent A from the first container 700 to the measurement unit 10. In this state, the measurement control unit 852 controls the supply unit 40 to supply the diluent A from the first container 700 to the measurement unit 10 until the remaining amount of diluent A in the first container 700 falls below a predetermined amount. The determination of whether or not the amount has fallen below the predetermined amount is as explained in step S1 of Figure 18. When the diluent A is supplied from the first container 700 and the remaining amount of diluent A falls below a predetermined amount, the bubble sensor BS provided in conjunction with the first container 700 detects bubbles.
[0182] In step S2, the measurement control unit 852 outputs a replacement alarm corresponding to the first container 700. In the example reagent information screen in Figure 24, a "replace" icon is added to the reagent level gauge of DA1. This notifies the user that DA1 is out of reagent and needs to be replaced, prompting them to replace it. The method for outputting the replacement alarm is as described in Embodiment 1 with reference to Figure 18.
[0183] As shown in Figure 24, on the reagent information screen, an "In Use" icon is added to the gauge corresponding to the reagent container currently in use. In the example in Figure 24, the "In Use" icon is added to the DA1 gauge corresponding to the first container 700. Similarly, for other types of reagents, the "In Use" icon is added to the gauge corresponding to the container currently in use. By checking the "In Use" icon, users can understand which container is currently in use.
[0184] A "Replace" icon is added to the gauge corresponding to a container that has run out of reagent, prompting the user to replace the reagent. In the example in Figure 24, the "Replace" icon is added to the DA2 gauge corresponding to the fourth container 702. Similarly, for other types of reagents, the "In Use" icon is added to the gauge of the two gauges corresponding to the container that has run out of reagent. The user prepares the container corresponding to the reagent with the "Replace" icon and replaces the run-out first container 700 with a new container by reconnecting the tube.
[0185] After the measurement control unit 852 outputs a replacement alarm, in step S3, the measurement control unit 852 determines whether a spare container corresponding to the container that has run out of reagent is connected to the measurement unit 10. For example, if the first container 700 runs out of reagent, the measurement control unit 852 determines whether the fourth container 702 is connected as a spare container. The determination of whether a spare container is connected is made, for example, based on the remaining amount of the container set to "in use" and other containers containing the same type of reagent. For example, if the first container 700 (DA1) containing diluent A is in use, and the remaining amount of the fourth container 702 (DA2) containing diluent A is greater than zero, the measurement control unit 852 determines that there is a spare container. If the first container 700 (DA1) is in use and the remaining amount of the fourth container 702 (DA2) is zero, the measurement control unit 852 determines that there is no spare container. If it is determined that there is no spare container, in step S5, the measurement control unit 852 stops measuring the new sample.
[0186] If the measurement control unit 852 determines in step S3 that there is a spare container, in step S4 the measurement control unit 852 switches the supply source of diluent A from the first container 700 (DA1) to the fourth container 702 (DA2). For example, the measurement control unit 852 controls the valve included in the switching unit 510 to close the first flow path connecting the first container 700 and the measurement unit 10, and to open the second flow path connecting the fourth container 702 and the measurement unit 10. In this state, the measurement control unit 852 controls the supply unit 40 to supply diluent A from the fourth container 702. The measurement control unit 852 changes the status of the fourth container 702 to "In Use" instead of the first container 700. The measurement control unit 852 also adds an "In Use" icon to the reagent volume gauge for "DA2" on the reagent information screen.
[0187] In step S6, the measurement control unit 852 determines whether or not the reagent-depleted container has been replaced. Whether or not the container has been replaced is as explained in step S4 of Figure 18.
[0188] In step S7, the measurement control unit 852 identifies the type of reagent that has been replaced based on the reagent type information included in the input reagent information. The measurement control unit 852 overwrites the reagent information of the container that is not in the "in use" status among the two containers corresponding to the identified type of reagent with the newly input reagent information. For example, suppose the reagent in the first container 700 (DA1) is out of reagent and the status of the fourth container 702 (DA2) is "in use," and reagent information for the container containing diluent A is input. In this case, the measurement control unit 852 identifies the reagent information corresponding to the first container 700 (DA1) as the reagent information that should be automatically overwritten, and overwrites the reagent information of the first container 700 (DA1) with the newly input reagent information. The reagent information of the fourth container 702 (DA2) is maintained without being overwritten. In this way, the reagent information of the container in use is maintained, and the reagent information of the container that is not in use is automatically overwritten, so the user does not need to input which of the two containers' reagent information should be overwritten, thereby reducing the complexity of reagent replacement. Furthermore, problems caused by users accidentally overwriting reagent information in a container currently in use are avoided. Once the reagent information is registered, the measurement control unit 852 cancels the alarm and returns the process to step S1.
[0189] When the process returns to step S1, the container in use and the spare container are swapped from the previous turn. In other words, in the previous turn, the status of the first container 700 (DA1) was "in use" and the fourth container 702 (DA2) was the spare, but this time, the first container 700 (DA1) is the spare and the fourth container 702 (DA2) is in use. Therefore, in this turn, in step S1, the supply of diluent A will continue until the remaining amount in the fourth container 702 falls below a predetermined amount. The same applies to the processes from step S2 onward.
[0190] As explained with reference to Figure 26, in Embodiment 2, the measurement control unit 852 continues to supply diluent A until the remaining amount in the container being used falls below a predetermined amount, and then automatically switches the supply source of diluent A to the spare container. With this control, since the reagent in the other container is consumed only after one of the two containers runs out of reagent, the reagent in the other container is preserved without its amount being reduced until the reagent in the first container runs out. Since it becomes possible to replace the container that has run out of reagent while there is still a sufficient amount of reagent remaining in the other container, the time during which continuous loading is possible can be maximized, and the likelihood of continuing measurement without stopping the measurement unit 10 can be increased. This effect can be clearly seen when compared to, for example, the case where the reagents in the two containers are consumed simultaneously. Let's consider the case where the reagents in the two containers are consumed simultaneously, for example, a cycle of consuming a certain amount of reagent from container A, then a certain amount of reagent from container B, and repeating this cycle multiple times. In this configuration, reagent replacement does not occur until the total amount of reagent in both containers A and B is depleted, thus allowing for a longer interval between reagent replacements. However, if both containers A and B run out of reagent simultaneously, or if container B has almost no reagent left when container A runs out, there is insufficient time to replace the reagents without stopping the measurement unit 10. Therefore, the above-described embodiment 2 is advantageous in terms of achieving continuous loading.
[0191] <Embodiment 3> The measuring device of Embodiment 3 is a measuring device that includes the reserve tank of the measuring device of Embodiment 1 and the switching function of the measuring device of Embodiment 2. Figure 27 is a schematic diagram showing an example of the configuration of the supply unit 40 in Embodiment 3. The supply unit 40 of Embodiment 3 includes a reserve tank RT that is added between the switching unit 510 and the measuring unit 10 in the supply unit 40 of Embodiment 2.
[0192] The configuration of the reserve tank RT is the same as that described in Embodiment 1. The switching unit 510 includes a valve for switching the supply source of the diluent A between the first container 700 and the fourth container 702, as described in Embodiment 2. The switching unit 510 can switch between a first flow path through which the first container 700 and the reserve tank RT are fluidly connected, and a second flow path through which the fourth container 702 and the reserve tank RT are fluidly connected. The other configurations are the same as those described in Embodiments 1 and 2.
[0193] Figure 28 is a flowchart illustrating an example of diluent supply in Embodiment 3. Figure 25 describes an example in which diluent A is supplied from the first container 700 and the fourth container 702 to the measurement unit 10 via the reserve tank RT. The supply and automatic switching functions via the reserve tank RT are the same for diluent B and hemolytic agents A to C, so their explanation is omitted. In the following, we will assume that the first container 700 and the fourth container 702 are filled with the maximum amount of diluent A, and that the first container 700 is set to "in use".
[0194] In step S1, the measurement control unit 852 controls the supply unit 40 to supply the diluent A from the first container 700, which is in use, to the measurement unit 10 via the reserve tank RT until the remaining amount of diluent in the first container 700 falls below a predetermined amount.
[0195] In step S2, the measurement control unit 852 outputs a replacement alarm when the remaining amount in the first container 700 falls below a predetermined amount. The method for outputting the replacement alarm is as described in Embodiments 1 and 2.
[0196] In step S3, the measurement control unit 852 determines whether or not there is a spare container. The determination of whether or not there is a spare container is as described in the second embodiment. If it is determined that there is a spare container, in step S4, the measurement control unit 852 switches the supply source of the diluent A from the first container 700 that is in use to the spare fourth container 702.
[0197] In step S5, the measurement control unit 852 determines whether or not the reagent has been replaced. The determination of whether or not the reagent has been replaced is as described in Embodiment 2. If it determines that the reagent has been replaced, the measurement control unit 852 proceeds to step S6 and overwrites the reagent information corresponding to the first container 700 that has run out of reagent with the newly entered reagent information. The measurement control unit 852 cancels the replacement alarm and returns to step S1.
[0198] If it is determined in step S3 that there are no spare containers, the process proceeds to step S7. In step S7, the measurement control unit 852 stops supplying the diluent from the container to the reserve tank RT and continues supplying the diluent from the reserve tank RT.
[0199] In step S8, the measurement control unit 852 determines whether or not the reagent has been replaced. The determination of whether or not the reagent has been replaced is as described in Embodiment 2. In this case, there are two containers that have run out of reagent, but the decision of which container's reagent to replace can be made according to an arbitrary rule. For example, if both containers have run out of reagent, the system may prompt the user to replace the first container 700 (DA1) first, or the user may be allowed to choose whether to replace the first container 700 (DA1) or the fourth container 702 (DA2). If the system determines that the reagent has been replaced, the measurement control unit 852 proceeds to step S5 and overwrites the reagent information corresponding to the container that has run out of reagent with the newly entered reagent information.
[0200] If the measurement control unit 852 determines that the reagent has not been replaced, it determines in step S9 whether there is any remaining amount in the reserve tank RT. The method for checking the remaining amount in the reserve tank RT is as described in Embodiment 1. If it determines that there is still some remaining amount in the reserve tank RT, the measurement control unit 852 returns to step S8 and repeats the determination until the reagent is replaced or the reserve tank RT runs out of liquid. If it determines in step S9 that the reserve tank RT has run out of liquid, the measurement control unit 852 stops measuring the new sample.
[0201] According to Embodiment 3, by providing a reserve tank RT in addition to multiple containers containing the same type of reagent, it is possible to secure time for reagent replacement without stopping the measurement, and the continuous loading function can be further enhanced.
[0202] <Embodiment 4> Embodiment 4 will be described with reference to Figure 29. The measuring device 1 of Embodiment 4 comprises a tank T for containing water, a first container 700 for containing concentrated diluent, and a dilution tank DT. Embodiment 4 provides a continuous loading function by diluting the concentrated diluent A contained in the first container 700 to a predetermined ratio in the dilution tank DT and supplying it to the measuring unit 10, and by continuing to supply the diluent from the dilution tank DT even while the first container 700 is being replaced.
[0203] Figure 29 is a schematic diagram showing an example configuration of the supply unit 40 in Embodiment 4. For the sake of simplicity, Figure 29 only shows the fluid circuit of the supply unit 40 for supplying concentrated diluent A to the measurement unit 10. The reagent storage unit 50 includes a first container 700 as a container for storing concentrated diluent A. The supply unit 40 includes a dilution tank DT. The first container 700 is fluidly connected to the dilution tank DT via a bubble sensor BS. As explained with reference to Figure 5, the first container 700 and the dilution tank DT are fluidly connected by inserting a first tube 51a extending from the dilution tank DT into the mouth of the container. Although not shown in the figure, a reserve tank may be provided between the first container 700 and the dilution tank DT.
[0204] Tank T contains water. Tank T is fluidically connected to the dilution tank DT via a tube. The diluent is supplied to the dilution tank DT by drawing water from the bottom of Tank T. The water contained in Tank T may be water supplied from outside the measuring device, or water supplied via the water purification device 550 inside the measuring device.
[0205] The dilution tank DT is equipped with, for example, a float sensor FS. As described above, the float sensor FS detects the remaining amount of reagent in the reserve tank. For example, when the float sensor FS of the dilution tank DT detects a decrease in the remaining amount of reagent, the supply unit 40 drives the pump 57 via the measurement control unit 852 (see Figure 18) to supply a predetermined amount of concentrated diluent A contained in a predetermined amount of first container 700 and a predetermined amount of water to the dilution tank DT. In the dilution tank DT, the concentrated diluent A and water are mixed to prepare diluent A of the appropriate concentration. The dilution tank DT and the measurement unit 10 are connected via a tube. Diluent A is supplied to the measurement unit 10 by drawing diluent A from the bottom of the dilution tank DT in response to the measurement operation by the measurement unit 10.
[0206] <Embodiment 5> The measuring device of Embodiment 5 is a measuring device that, in addition to the dilution tank DT provided in the measuring device of Embodiment 4, is equipped with a function for switching between concentrated and diluted reagents. Figure 30 is a schematic diagram showing an example of the configuration of the supply unit 40 in Embodiment 5. The supply unit 40 of Embodiment 5 is equipped with a switching unit 510 and a fourth container 702 that can be switched between the first container 700 and the supply unit 40 of Embodiment 4.
[0207] The configuration of the dilution tank DT is the same as that described in Embodiment 4. The switching unit 510 includes a valve for switching the supply source of the concentrated diluent A between the first container 700 and the fourth container 702, as described in Embodiment 2. The switching unit 510 can switch between a first flow path through which the first container 700 and the dilution tank DT are fluidly connected, and a second flow path through which the fourth container 702 and the dilution tank DT are fluidly connected. The other configurations are the same as those described in Embodiments 2 and 4.
[0208] <Other configuration examples> Figure 31 shows a modified version of the reagent information screen in Embodiment 1. In Embodiment 1 described above, when the first container 700 and the second container 800 run out of reagent and the reagent supply source switches to the reserve tank, a replacement alarm D304 is displayed. In the modified version, in addition to or as an alternative to the display prompting replacement, the remaining amount in the reserve tank may be displayed. For example, in Figure 31, instead of the replacement alarm D304, a graphic D304a showing the remaining amount in the reserve tank is displayed. Graphic D304a displays, for example, that the reagent supply mode is reserve tank mode (meaning the supply source has switched to the reserve tank) and the remaining amount in the reserve tank is displayed in real time in the form of the number of measurable tests. With such a display, the user can understand that the reagent supply from the reserve tank is continuing. In addition, by knowing the remaining amount in the reserve tank, the user can know by when the reagent needs to be replaced so that measurements do not stop, and this can support the operation of the laboratory to realize continuous loading. Figure 31 shows an example of a screen displayed on the display 70, but the display screen of the mobile terminal illustrated in Figure 18 may similarly show that it is in reserve tank mode and the remaining amount in the reserve tank. [Explanation of Symbols]
[0209] 1. Measuring device 10 measuring units 11. First Measurement Unit 12. Second Measurement Unit 20 Staining solution storage section 30 Conveyor Units 31 First area 32 Second area 33 Conveyor 40 Supply section 50 Reagent storage section 52 drawers 53 Connectors 54 Mouth 51a First tube 51b Second tube 58 Outer box 60 Wagon 61 First opening / closing section 62 Second opening / closing section 65, 66 Flow Cells 70 displays 80 Mechanism 90 Liquid transfer section 110 sample containers 200 control units 251 Mechanism Department 252 Communications Department 301 Suction tube 310 Gripping mechanism 311 Table 1 312 Table 2 313 A pair of gripping pieces 314 cabinets 314a aperture 320 Stirring mechanism 321 Table 3 322 Table 4 323 Holding part 323a Retaining member 323b Rotation axis 324 Slide section 330 Container transfer mechanism 332 Plate members 350 Dispensing Mechanism 351 Suction tube 353 Transfer section 381 Optical measurement section 382 Electrical measuring unit 383 HGB measurement section 390, 391 IF section 400 Chamber Heating Unit 601, 682 Syringe pumps 655, 687 Diaphragm pumps 700, 701 1st container 702 4th container 710, 711 First Reserve Tank 800, 801, 802 2nd container 808 5th container 810, 811, 812 Second Reserve Tank 813, 814, 815 Analog Processing Unit 821, 822, 823 A / D conversion section 850 Control Unit 851 Analysis Department 852 Measurement Control Unit 853 Display section 854 Input section 803, 862, 863 Communications Department 900, 901, 902, 903 3rd container 1000 mobile devices C11 RBC / PLT Chamber C12 HGB Chamber C21, C22, C23, C24 Chambers HC Host Computer R Rack RT Reserve Tank
Claims
1. A reagent storage section capable of accommodating a first container for a diluent for diluting a blood sample, and a second container for a hemolytic agent for lysing the red blood cells contained in the blood sample, A transport unit is provided, which is positioned above the reagent storage section and comprises a first region and a second region on which the blood sample is placed, and which transports the placed blood sample. A measuring unit that measures the blood sample transported from the first region and discharges the measured blood sample to the second region, A supply unit for supplying the diluent and hemolytic agent to the measurement unit, The system comprises the transport unit, the measuring unit, and the control unit for controlling the supply unit, The aforementioned measuring unit is A third container capable of containing a staining solution for staining the blood sample, A first chamber for mixing the diluent supplied from the first container with the blood sample to prepare a first sample, A second chamber for preparing a second sample by mixing the hemolytic agent supplied from the second container, the blood sample, and the staining solution, The device includes a measuring unit that includes an electrical signal measuring unit for measuring the electrical signal of the first sample and an optical signal measuring unit for measuring the optical signal of the second sample, (1) First measurement items including red blood cell count, white blood cell count, hemoglobin level, hematocrit value, mean corpuscular volume, mean corpuscular hemoglobin level, mean corpuscular hemoglobin concentration, and platelet count, (2) Second measurement item that classifies white blood cells into five categories For a given measurement order, it is possible to acquire the electrical and optical signals of 300 to 500 samples per hour, and to obtain measurement results based on the acquired electrical and optical signals. The supply unit is a measuring device that continues to supply a diluent while the first container is being replaced, and continues to supply a hemolytic agent while the second container is being replaced.
2. The aforementioned supply unit is The supply of the diluent is continued when the amount of the diluent contained in the first container is below a predetermined first remaining amount. The measuring device according to claim 1, wherein the supply of the hemolytic agent is continued when the amount of the hemolytic agent contained in the second container is below a predetermined second remaining amount.
3. The aforementioned supply unit is The supply of the diluent is continued when the connection between the first container and the measuring unit is released when the remaining amount falls below a predetermined first level. The measuring device according to claim 1, wherein the supply of the hemolytic agent is continued when the connection between the second container and the measuring unit is released when the remaining amount falls below a predetermined second amount.
4. The reagent storage section is equipped with a drawer or door that can be opened and closed. The aforementioned supply unit is While the drawer or door is open for the replacement of the first container, the supply of the diluent is continued. The measuring device according to claim 1, wherein the supply of the hemolytic agent is continued when the drawer or door is open for the replacement of the second container.
5. The measuring apparatus according to claim 1, wherein the control unit controls the measuring unit to stop the preparation of the first sample and the second sample and the measurement by the measuring unit when the remaining amount of the staining solution in the third container is less than or equal to a predetermined amount.
6. The first container is capable of holding a first amount of the diluent, The third container is capable of holding a second amount of the staining solution, The measuring device according to claim 1, wherein the number of samples that the measuring unit can measure using the second amount of staining solution is greater than the number of samples that can be measured using the first amount of diluent contained in the first container.
7. The second container is capable of holding a third amount of the hemolytic agent, The measuring device according to claim 6, wherein the number of samples that the measuring unit can measure using the second amount of staining solution is greater than the number of samples that can be measured using the third amount of hemolytic agent contained in the second container.
8. The measuring apparatus according to claim 6, wherein the third container holds an amount of the staining solution that is sufficient to prepare the second sample for 5,000 to 30,000 specimens.
9. The measuring apparatus according to claim 8, wherein the first container holds an amount of the diluent that is sufficient to prepare the first sample and the second sample of 300 to 1500 specimens.
10. The measurement unit comprises a plurality of the third containers, The measuring apparatus according to claim 1, wherein a plurality of the third containers each contain the staining solution used for the first measurement item and the staining solution used for the second measurement item.
11. When a measurement order for the first measurement item is received, the supply unit supplies both the diluent contained in the first container and the hemolytic agent contained in the second container to the measurement unit. The measuring device according to claim 1, wherein even when there is a measurement order for the first measurement item and the second measurement item, both the diluent contained in the first container and the hemolytic agent contained in the second container are supplied to the measuring unit.
12. The measurement unit is equipped with a suction tube for aspirating the staining solution. The measuring device according to claim 1, wherein the control unit controls the measuring unit to stop the measurement when the suction tube is removed from the third container.
13. The system further comprises a first reserve tank for storing the diluent contained in the first container, The measuring device according to claim 1, wherein the supply unit supplies the diluent stored in the first reserve tank to the measuring unit when the supply of the diluent from the first container is stopped.
14. The measuring device according to claim 13, wherein the first reserve tank is capable of storing an amount of the diluent that is sufficient to measure substantially 200 blood samples based on the order for whole blood count and leukocyte counting.
15. The system further includes a second reserve tank for storing the hemolytic agent contained in the second container, The measuring apparatus according to claim 13, wherein the supply unit supplies the hemolytic agent stored in the second reserve tank to the measuring unit when the supply of the hemolytic agent from the second container is stopped.
16. The measuring device according to claim 13, wherein the amount of the diluent that can be stored in the first reserve tank is less than the amount of the diluent that can be contained in the first container.
17. The measuring device according to claim 13, wherein the amount of hemolytic agent that can be stored in the second reserve tank is less than the amount of hemolytic agent that can be contained in the second container.
18. The measurement unit is capable of measuring the sample using a diluent supplied from the first reserve tank. The measuring apparatus according to claim 13, wherein the supply unit supplies the diluent from the first container to the first reserve tank which is supplying the diluent to the measuring unit.
19. The measuring device according to claim 13, wherein the supply unit supplies the diluent from the first container to the first reserve tank in accordance with the amount of the diluent consumed in the first reserve tank.
20. The measuring device according to claim 13, wherein the control unit stops measuring a new sample when the amount of the diluent contained in the first container is less than or equal to a predetermined amount, and the amount of the diluent stored in the first reserve tank is less than or equal to a predetermined amount.
21. The control unit, (1) The number of measurements taken using the diluent in the first container, or (2) Signal from a sensor that detects the remaining amount in the first container The measuring device according to claim 20, which detects the remaining amount in the first container based on any of the following.
22. The reagent storage section is capable of further accommodating a fourth container for the diluent and a fifth container for the hemolytic agent. The aforementioned supply unit is When the supply of the diluent from the first container becomes impossible, the supply of the diluent from the fourth container is continued. The measuring device according to claim 1, wherein when the supply of the diluent from the second container becomes impossible, the supply of the hemolytic agent from the fifth container is continued.
23. The reagent storage section is capable of further accommodating a fourth container for the diluent, The aforementioned supply unit is When the remaining amount in the first container falls below a predetermined amount, the supply source of the diluent is automatically switched from the first container to the fourth container. The measuring device according to claim 1.
24. The reagent storage section is capable of further accommodating a fourth container for the diluent, The aforementioned supply unit is When the supply source for the diluent is the first container, the supply source for the diluent is automatically switched from the first container to the fourth container when the remaining amount in the first container falls below a predetermined amount. When the supply source for the diluent is the fourth container, the supply source for the diluent is automatically switched from the fourth container to the first container when the remaining amount in the fourth container falls below a predetermined amount. The measuring device according to claim 1.
25. A first tube inserted into the first container, The second container includes a second tube inserted into the second container, The first tube and the second tube are designed to identify the container into which they are to be inserted. The measuring device according to claim 1.
26. The reagent storage section is capable of further accommodating a fifth container for the hemolytic agent, The aforementioned supply unit is When the remaining amount in the second container falls below a predetermined amount, the supply source of the hemolytic agent is automatically switched from the second container to the fifth container. The measuring device according to claim 22.
27. It also includes a display unit, The measuring device according to claim 1, wherein the control unit causes the remaining amount of diluent in the first container and the remaining amount of hemolytic agent in the second container to be displayed on the display unit.
28. The measuring device according to claim 26, wherein the control unit causes the display unit to output a first alarm prompting the replacement of the first container when the remaining amount of the diluent contained in the first container is below a predetermined amount.
29. The measuring device according to claim 26, wherein the control unit causes the display unit to output a second alarm prompting replacement of the second container when the remaining amount of the hemolytic agent contained in the second container is below a predetermined amount.
30. The measuring device according to claim 1, wherein the control unit causes a terminal capable of communicating with the control unit to output a first alarm prompting the replacement of the first container.
31. The measuring device according to claim 1, wherein the control unit causes a terminal capable of communicating with the control unit to output a second alarm prompting the replacement of the second container.
32. The reagent storage section is capable of further accommodating a fourth container for the diluent, The aforementioned supply unit is When the supply of the diluent from the first container becomes impossible, the supply of the diluent from the fourth container is continued. The measuring device further includes a reading unit that reads reagent information from a reagent container. The measuring device according to claim 1, wherein the control unit overwrites the reagent information of the first container with the reagent information of the new container when the reading unit reads the reagent information of a new container containing the diluent.
33. The reagent storage section is capable of further accommodating a fifth container for the diluent, The aforementioned supply unit is When the supply of the diluent from the second container becomes impossible, the supply of the diluent from the fifth container is continued. The measuring device further includes a reading unit that reads reagent information from a reagent container. The measuring device according to claim 1, wherein the control unit overwrites the reagent information of the second container with the reagent information of the new container when the reading unit reads the reagent information of the new container.
34. The supply unit includes a dilution device that dilutes the diluent contained in the first container at a predetermined ratio, The measuring device according to claim 1, wherein the diluted solution, diluted to a predetermined ratio by the dilution device, is supplied to the measuring unit.
35. The dilution device mixes water supplied from outside the measuring device with the diluent supplied from the first container to dilute the diluent, The measuring apparatus according to claim 34, wherein the supply unit supplies the diluted solution to the measuring unit.
36. The reagent storage section is capable of further accommodating a fourth container for the diluent, The aforementioned supply unit is When the supply of the diluent from the first container becomes impossible, The diluent contained in the fourth container is diluted by the dilution device. The diluted solution, diluted to a predetermined ratio by the dilution device, is supplied to the measuring unit. The measuring device according to claim 34.
37. The reagent container is capable of containing 20 L of the diluent and 10 L of the hemolytic agent. The measurement unit includes a staining solution storage section, The measuring device according to claim 1, wherein the staining solution storage section is capable of storing 10 ml of the staining solution.
38. The supply unit supplies the diluent to the measuring unit, which is positioned above the reagent storage unit, so that the measuring unit uses the diluent contained in the first container exclusively. The measuring device according to claim 1.
39. The supply unit supplies the diluent to the measuring unit so that the measuring unit, which is positioned above the reagent storage unit, exclusively uses the hemolytic agent contained in the second container. The measuring device according to claim 1.
40. The supply unit is equipped with a channel for exclusively supplying the diluent contained in the first container to the measuring unit positioned above the reagent container. The measuring device according to claim 1.
41. The supply unit is equipped with a channel for exclusively supplying the hemolytic agent contained in the second container to the measurement unit positioned above the reagent storage unit. The measuring device according to claim 1.
42. The control unit manages the remaining amount of the diluent used exclusively by the measuring unit located above the reagent storage unit. The measuring device according to claim 1.
43. The control unit manages the remaining amount of the hemolytic agent used exclusively by the measuring unit located above the reagent storage unit. The measuring device according to claim 1.