Blood analysis device and blood analysis method

Abstract

The present invention provides a blood analysis device and a blood analysis method capable of smoothly inspecting blood preparations. The blood analysis device (10) includes a pipetting unit that pipettes a blood preparation, a sample preparation unit (33) that mixes a reagent with the blood preparation pipetted by the pipetting unit to prepare a measurement sample, a measurement unit (30a) that measures the measurement sample, and a mode selector that accepts an input of the type of the blood preparation to be pipetted by the pipetting unit among several types of blood preparations. Among them, the blood analysis device (10) prepares the measurement sample according to the type of the blood preparation received. Thus, when measuring a blood preparation, the operator does not need to perform complicated processes such as changing settings according to the type of the blood preparation, etc., so that the blood preparation can be smoothly inspected.

Description

[0001] This application is a divisional application of a Chinese invention patent application submitted by the same applicant, with the application number 201810910986.4, the application date August 10, 2018, and the title "Blood analysis device, blood analysis method, and program". Technical Field

[0002] The present invention relates to a blood analysis device and a blood analysis method. Background Art

[0003] A blood preparation refers to a pharmaceutical product containing human blood or substances obtained from human blood as an active ingredient. Known blood preparations include component preparations prepared by separating components such as red blood cells, platelets, or plasma from human whole blood or human blood, and currently, these component preparations are mainly used for blood transfusions. Component preparations are used as a method for supplementing blood components for patients undergoing various surgical procedures, as well as patients with blood diseases or cancer. When a component preparation is transfused to a patient, donor white blood cells remaining in the preparation can cause blood transfusion side effects such as fever and allergic reactions, and in severe cases, blood transfusion side effects such as acute lung injury. Therefore, in order to prevent blood transfusion side effects, leukocyte removal treatment is performed before storing the component preparation, and a sampling inspection of the number of white blood cells remaining in the component preparation and the number of red blood cells is carried out at a certain ratio before the preparation leaves the factory.

[0004] Such a sampling inspection can be carried out, for example, using the flow system (general flow cytometer) described in the following Patent Document 1.

[0005] Prior Art Documents

[0006] Patent Documents

[0007] Patent Document 1: Japanese Patent Publication No. 2011-521228. Summary of the Invention

[0008] Technical Problems to be Solved by the Invention

[0009] When inspecting a blood preparation using a general flow cytometer as described above, in order to measure the required items for the blood preparation measurement, the operator needs to perform complicated processes such as the following: preparing measurement specimens manually for each required item, and individually setting the sensitivity of the detection unit and the method for classifying blood cells, etc., and then performing the measurement.

[0010] In view of the related technical problems, an object of the present invention is to provide a blood analysis device, a blood analysis method, and a program that can smoothly inspect blood preparations.

[0011] Technical Solutions for Solving the Technical Problems

[0012] The first aspect of the present invention relates to a blood analysis device. The blood analysis device (10) according to this aspect includes a sample preparation unit (33) that mixes a reagent with a blood preparation to prepare a measurement sample, a measurement unit (30a) for measuring the measurement sample, and a measurement mode selector (600) that receives an input of the type of blood preparation to be measured among several types of blood preparations. The blood analysis device (10) prepares a measurement sample according to the type of blood preparation received.

[0013] A "blood preparation" is a component preparation obtained by separating components such as red blood cells, platelets, or plasma from human whole blood or human blood. Blood preparations include, for example, red blood cell preparations, plasma preparations, platelet preparations, etc. A "red blood cell preparation" refers to a blood preparation obtained by extracting red blood cell components from whole blood. A "plasma preparation" refers to a blood preparation obtained by extracting plasma components from whole blood. A "platelet preparation" refers to a blood preparation obtained by extracting platelet components from whole blood. The measurement mode selector is composed of buttons, physical button members, etc. displayed on the interface of the display unit. The measurement mode selector may also receive an input of the type of blood preparation from the barcode of the container storing the blood preparation.

[0014] In the blood analysis device according to this aspect, the operator can appropriately prepare a measurement sample according to the measurement target blood preparation only by inputting the type of blood preparation to be measured among several types of blood preparations. Thus, when measuring a blood preparation, the operator does not need to perform complicated procedures such as changing settings according to the type of blood preparation, etc., and can therefore smoothly examine the blood preparation. In addition, since the measurement sample is prepared according to the blood preparation, unnecessary reagent use can be prevented and the amount of reagent used can be suppressed.

[0015] In the blood analysis device (10) according to this aspect, the measurement mode selector (600) can at least selectively input a red blood cell preparation measurement mode for measuring a red blood cell preparation and a platelet preparation measurement mode for measuring a platelet preparation.

[0016] The blood analysis device (10) according to this aspect further includes a display unit (43), and the blood analysis device (10) can cause the display unit (43) to display a reception interface (600) for receiving the type of blood preparation.

[0017] The blood analysis device (10) according to this embodiment can output quality information corresponding to the type of blood preparation based on the measurement results of a measurement sample. The "quality information" includes information indicating whether the quality of the blood preparation is guaranteed in an either-or manner, the measurement results of the main components of the blood preparation, the count results of blood cells remaining in the blood preparation, and the like. The output of the quality information can be achieved, for example, by displaying the quality information on a display unit provided in the blood analysis device, sending the quality information to a device other than the blood analysis device, or outputting it through voice from a speaker provided in the blood analysis device. In this way, by outputting the quality information corresponding to the type of blood preparation, the operator can simply and accurately check the quality of the blood preparation.

[0018] At this time, the blood analysis device (10) according to this embodiment determines the suitability of the blood preparation based on the standard of blood components corresponding to the type of blood preparation received and the measurement results of the measurement sample prepared from the blood preparation.

[0019] The blood analysis device (10) according to this embodiment can output the standard of blood components corresponding to the type of blood preparation received and the measurement results of the measurement sample prepared from the blood preparation. In this way, the operator can judge the quality of the blood preparation by referring to the output standard and measurement results.

[0020] In the blood analysis device (10) according to this embodiment, several types of blood preparations include red blood cell preparations. The blood analysis device (10) according to this embodiment controls the measurement unit (30a) so that when a red blood cell preparation is received as the measurement object, the number of red blood cells in the red blood cell preparation is measured. In this way, the operator can measure the number of red blood cells in the red blood cell preparation just by outputting the red blood cell preparation.

[0021] In the blood analysis device (10) according to this embodiment, several types of blood preparations include red blood cell preparations. The blood analysis device (10) according to this embodiment controls the measurement unit (30a) so that when a red blood cell preparation is received as the measurement object, the number of white blood cells in the red blood cell preparation is measured. In this way, the operator can measure the number of white blood cells to be removed in the red blood cell preparation just by inputting the red blood cell preparation.

[0022] At this time, the blood analysis device (10) according to this embodiment can determine the suitability of the red blood cell preparation based on the standard of the white blood cell count and the measured white blood cell count.

[0023] In the blood analysis device (10) according to this embodiment, several types of blood preparations include platelet preparations. The blood analysis device (10) according to this embodiment controls the measurement unit (30a) to measure the number of platelets in the platelet preparation when the platelet preparation is received as the measurement object. In this way, the operator can measure the number of platelets in the platelet preparation only by inputting the platelet preparation.

[0024] In the blood analysis device (10) according to this embodiment, several types of blood preparations include platelet preparations. The blood analysis device (10) according to this embodiment controls the measurement unit (30a) to measure the number of white blood cells in the platelet preparation when the platelet preparation is received as the measurement object. In this way, the operator can measure the number of white blood cells that should be removed in the platelet preparation only by inputting the platelet preparation.

[0025] At this time, the blood analysis device (10) according to this embodiment can determine whether the platelet preparation is appropriate based on the reference of the white blood cell count and the measured white blood cell count.

[0026] In the blood analysis device (10) according to this embodiment, several types of blood preparations include platelet preparations. The blood analysis device (10) according to this embodiment controls the measurement unit (30a) to measure the number of red blood cells in the platelet preparation when the platelet preparation is received as the measurement object. In this way, the operator can measure the number of red blood cells that should be removed in the platelet preparation only by inputting the platelet preparation.

[0027] At this time, the blood analysis device (10) according to this embodiment can determine whether the platelet preparation is appropriate based on the reference of the red blood cell count and the measured red blood cell count.

[0028] The blood analysis device (10) according to this embodiment controls the measurement unit (30a) to measure the fluorescence intensity of the particles in the platelet preparation, and determines whether the platelet preparation is appropriate based on the number of particles with a fluorescence intensity less than that of platelets. The particles with a small fluorescence intensity in the platelet preparation correspond to deteriorated platelets. Therefore, it is possible to determine whether the platelet preparation is appropriate based on the number of particles with a fluorescence intensity less than that of platelets.

[0029] At this time, the blood analysis device (10) according to this embodiment can determine whether the platelet preparation is appropriate based on the reference of the number of particles with a small fluorescence intensity in the platelet preparation and the measured number of particles with a small fluorescence intensity in the platelet preparation.

[0030] In the blood analysis device (10) according to this embodiment, several types of blood preparations include a plasma preparation. The blood analysis device (10) according to this embodiment controls the measurement unit (30a) to measure the number of white blood cells in the plasma preparation when the plasma preparation is received as the measurement object. In this way, the operator can measure the number of white blood cells to be removed in the plasma preparation only by inputting the plasma preparation.

[0031] At this time, the blood analysis device (10) according to this embodiment can determine whether the plasma preparation is appropriate based on the reference of the white blood cell count and the measured white blood cell count.

[0032] In the blood analysis device (10) according to this embodiment, several types of blood preparations include a plasma preparation. The blood analysis device (10) according to this embodiment controls the measurement unit (30a) to measure the number of red blood cells in the plasma preparation when the plasma preparation is received as the measurement object. In this way, the operator can measure the number of red blood cells to be removed in the plasma preparation only by inputting the plasma preparation.

[0033] At this time, the blood analysis device (10) according to this embodiment can determine whether the plasma preparation is appropriate based on the reference of the red blood cell count and the measured red blood cell count.

[0034] The blood analysis device (10) according to this embodiment further includes a stirring unit (310) for stirring the blood preparation. The blood analysis device (10) according to this embodiment controls the stirring unit (310) to change the stirring intensity of the blood preparation according to the type of the received blood preparation.

[0035] The blood analysis device (10) according to this embodiment further includes a stirring unit (310) for stirring the blood preparation. Several types of blood preparations include a red blood cell preparation and a platelet preparation. The blood analysis device (10) according to this embodiment controls the stirring unit (310) so that the stirring intensity of the stirring unit (310) is stronger when the red blood cell preparation is received as the measurement object than when the platelet preparation is received as the measurement object.

[0036] The viscosity of the red blood cell preparation is higher than that of the platelet preparation. Therefore, if the red blood cell preparation is not sufficiently stirred, it is possible that the red blood cells in the red blood cell preparation will not be evenly mixed and the red blood cell preparation cannot be measured correctly. Therefore, by setting the stirring intensity for the red blood cell preparation to be greater than that of the platelet preparation, the measurement accuracy of the red blood cell preparation can be improved. In addition, if the platelet preparation is over-stirred, the number of white blood cells remaining in the platelet preparation sometimes becomes a pseudo-high value. Therefore, by setting the stirring intensity for the platelet preparation to be less than that of the red blood cell preparation, the number of white blood cells becoming a pseudo-high value can be suppressed.

[0037] The blood analysis device (10) according to this embodiment further includes a stirring unit (310) for stirring blood preparations. The several types of blood preparations include red blood cell preparations and plasma preparations. The blood analysis device (10) according to this embodiment controls the stirring unit (310) such that when the red blood cell preparation is received as the measurement object, the stirring intensity of the stirring unit (310) is stronger than when the plasma preparation is received as the measurement object.

[0038] The viscosity of the red blood cell preparation is higher than that of the plasma preparation. Therefore, if the red blood cell preparation is not sufficiently stirred, it is possible that the red blood cells in the red blood cell preparation will not be evenly mixed, and the red blood cell preparation cannot be accurately measured. Therefore, by setting the stirring intensity for the red blood cell preparation to be greater than that of the plasma preparation, the measurement accuracy of the red blood cell preparation can be improved. In addition, if the plasma preparation is over-stirred, the number of white blood cells remaining in the plasma preparation sometimes becomes a false high value. Therefore, by setting the stirring intensity for the plasma preparation to be less than that of the red blood cell preparation, the number of white blood cells becoming a false high value can be suppressed.

[0039] In the blood analysis device (10) according to this embodiment, the several types of blood preparations include red blood cell preparations and platelet preparations. The blood analysis device (10) according to this embodiment controls the measurement unit (30a) such that when the red blood cell preparation is received as the measurement object, the measurement sample is measured by the resistive detection unit (34), and when the platelet preparation is received as the measurement object, the measurement sample is measured by the optical detection unit (36).

[0040] In the blood analysis device (10) according to this embodiment, the several types of blood preparations include red blood cell preparations and platelet preparations. The blood analysis device (10) according to this embodiment controls the measurement unit (30a) such that when the platelet preparation is received as the measurement object, the detection sensitivity of the number of red blood cells is higher than when the red blood cell preparation is received as the measurement object. In this way, the number of red blood cells in the red blood cell preparation and the number of red blood cells remaining in the platelet preparation can be appropriately measured respectively.

[0041] At this time, the blood analysis device (10) according to this embodiment controls the sample preparation unit (33) such that when the platelet preparation is received as the measurement object, the platelet preparation and the reagent for measuring reticulocytes are mixed to prepare the measurement sample. In this way, the number of red blood cells remaining very little in the platelet preparation can be measured with high accuracy.

[0042] In the blood analysis device (10) according to this embodiment, several types of blood preparations include a red blood cell preparation and a plasma preparation. The blood analysis device (10) according to this embodiment controls the measurement unit (30a) so that when a red blood cell preparation is received as the measurement object, the measurement sample is measured by the resistive detection unit (34), and when a plasma preparation is received as the measurement object, the measurement sample is measured by the optical detection unit (36).

[0043] In the blood analysis device (10) according to this embodiment, several types of blood preparations include a red blood cell preparation and a plasma preparation. The blood analysis device (10) according to this embodiment controls the measurement unit (30a) so that when a plasma preparation is received as the measurement object, the detection sensitivity of the number of red blood cells is higher than when a red blood cell preparation is received as the measurement object. In this way, the number of red blood cells in the red blood cell preparation and the number of red blood cells remaining in the plasma preparation can be appropriately measured respectively.

[0044] At this time, the blood analysis device (10) according to this embodiment controls the sample preparation unit (33) so that when a plasma preparation is received as the measurement object, the plasma preparation and a reagent for measuring reticulocytes are mixed to prepare a measurement sample. In this way, the number of red blood cells remaining very little in the plasma preparation can be measured with high accuracy.

[0045] The blood analysis device (10) according to this embodiment can receive whole blood and use it as the measurement object, and it controls the measurement unit (30a) so that when whole blood is received as the measurement object, the number of white blood cells in the measurement sample is measured. In this way, the operator can analyze both the blood preparation and the whole blood with one blood analysis device, so there is no need to measure the blood preparation and the whole blood separately with several devices.

[0046] At this time, the blood analysis device (10) according to this embodiment controls the measurement unit (30a) so that when a blood preparation is received as the measurement object, the amount of the measurement sample measured in the measurement of the number of white blood cells is more than the amount of the measurement sample measured in the measurement of the number of white blood cells when whole blood is received as the measurement object.

[0047] The blood analysis device (10) according to this embodiment further includes a control unit (41), and the control unit (41) controls the sample preparation unit (33) so that a measurement sample is prepared according to the type of the received blood preparation.

[0048] The second embodiment of the present invention relates to a blood analysis method. In the blood analysis method according to this embodiment, the type of the blood preparation is received from several types of blood preparations and used as the measurement object, and a measurement sample is prepared according to the type of the received blood preparation, and the prepared measurement sample is analyzed.

[0049] The blood analysis method according to this embodiment can achieve the same effect as the first embodiment.

[0050] The third embodiment of the present invention relates to a program. The program (42a) according to this embodiment causes a computer to perform the following processes: a process of receiving the type of blood preparation from several types of blood preparations and setting it as a measurement object, a process of preparing a measurement sample according to the received type of blood preparation, and a process of analyzing the prepared measurement sample.

[0051] The program according to this embodiment can achieve the same effect as the first embodiment.

[0052] The fourth embodiment of the present invention relates to a blood analysis device. The blood analysis device (10) according to this embodiment includes a sample preparation unit (33) that mixes a reagent with a sample to prepare a measurement sample, a measurement unit (30a) for measuring the measurement sample, and a measurement mode selector that selectively receives a blood preparation and whole blood and sets them as measurement objects. The blood analysis device (10) prepares a measurement sample according to the received measurement object.

[0053] In the blood analysis device according to this embodiment, an operator can analyze both a blood preparation and whole blood with one blood analysis device, so there is no need to measure a blood preparation and whole blood separately with several devices.

[0054] Advantages of the Invention

[0055] The blood preparation can be smoothly inspected by the present invention. Brief Description of the Drawings

[0056] Figure 1 A structural block diagram of the blood analysis device according to Embodiment 1;

[0057] Figure 2 (a) An oblique view of the structure of the container according to Embodiment 1; Figure 2 (b) An oblique view of the structure of the rack according to Embodiment 1;

[0058] Figure 3 A schematic diagram of the structure of the transport unit and the measurement unit according to Embodiment 1;

[0059] Figure 4 (a) A schematic diagram of the stirring operation of the stirring unit on the container according to Embodiment 1; Figure 4 (b) A diagram of the number of times the stirring unit turns the container upside down according to Embodiment 1;

[0060] Figure 5 A diagram of the relationship between the reagent, the chamber, the measurement sample, and the measurement unit according to Embodiment 1;

[0061] Figure 6 (a) Schematic diagram of the structure of the resistive detection unit according to Embodiment 1; Figure 6 (b) Schematic diagram of the structure of the hemoglobin detection unit according to Embodiment 1; Figure 6 (c) Schematic diagram of the structure of the optical detection unit according to Embodiment 1;

[0062] Figure 7 Explanation diagram of the setting of the measurement mode in the blood analysis device according to Embodiment 1;

[0063] Figure 8 Flowchart of the process of receiving the input of the measurement mode and preparing the measurement sample according to the received measurement mode according to Embodiment 1;

[0064] Figure 9 (a) Diagram of the structure of the interface for changing the measurement object according to Embodiment 1; Figure 9 (b) Diagram of the structure of the reception interface for receiving the input of the setting of the blood preparation measurement mode according to Embodiment 1;

[0065] Figure 10 Flowchart of the control operation performed by the control unit corresponding to the blood preparation measurement mode according to Embodiment 1;

[0066] Figure 11 Detailed diagram of the setting of the measurement process according to Embodiment 1;

[0067] Figure 12 (a) Diagram of the measurement items obtained in the red blood cell preparation measurement mode according to Embodiment 1; Figure 12 (b) Diagram of the measurement items obtained in the red blood cell preparation + residual blood cell measurement mode according to Embodiment 1;

[0068] Figure 13 Diagram of the measurement items obtained in the plasma preparation measurement mode according to Embodiment 1;

[0069] Figure 14 (a) Diagram of the measurement items obtained in the platelet preparation measurement mode according to Embodiment 1; Figure 14 (b) Diagram of the measurement items obtained in the platelet preparation + residual blood cell measurement mode according to Embodiment 1;

[0070] Figure 15 (a) Flowchart of the process of judging the suitability of the blood preparation and outputting the result according to Embodiment 1; Figure 15 (b) Diagram of the judgment criteria used in the judgment of the suitability of the blood preparation;

[0071] Figure 16 (a) and (b) are PLT-F scatter plots referred to in the determination of the suitability of the blood preparation according to Embodiment 1;

[0072] Figure 17 It is a view showing an interface that displays a measurement result list and a judgment result based on the measurement result according to Embodiment 1;

[0073] Figure 18 Figure (a) is a view showing a display area of a judgment result when there is a problem in the suitability of the blood preparation according to Embodiment 1; Figure 18 Figures (b) and (c) are views showing a list of measurement results based on the measurement result according to Embodiment 1; Figure 18 Figure (d) is a view showing a list of measurement results related to deteriorated platelets according to Embodiment 1;

[0074] Figure 19 Figures (a) and (b) are views showing charts based on the measurement result according to Embodiment 1;

[0075] Figure 20 It is a view showing a chart based on the measurement result according to Embodiment 1;

[0076] Figure 21 Figure (a) is a flowchart of the setting of the measurement object at startup according to Embodiment 1; Figure 21 Figure (b) is a view showing an interface for changing the measurement object at startup according to Embodiment 1;

[0077] Figure 22 Figure (a) is a flowchart of the suitability judgment process, the misjudgment process of the blood preparation, and the result output process according to Embodiment 2; Figure 22 Figure (b) is a view showing the judgment criteria used in the misjudgment of the blood preparation;

[0078] Figure 23 Figures (a) to (c) are views showing areas for displaying information indicating that the blood preparation to be measured is another blood preparation according to Embodiment 2. Detailed implementation manners

[0079] <Embodiment 1>

[0080] The following Embodiment 1 is applicable to the present inventor in a blood analysis device for analyzing samples such as blood collected from a subject. In the blood analysis device of Embodiment 1, the measurement objects are mainly whole blood and blood preparations. The blood analysis device of Embodiment 1 can also measure body fluids and other samples other than whole blood, but for convenience, the following description will be made on the case where the measurement objects are whole blood and blood preparations.

[0081] When the measurement object is whole blood, one whole blood mode is set from several whole blood modes related to whole blood. When the measurement object is a blood preparation, one blood preparation measurement mode is set from several blood preparation measurement modes related to the blood preparation. Whole blood is measured in the whole blood mode, and the blood preparation is measured in the blood preparation measurement mode. Here, the blood preparation refers to a component preparation prepared by separating components such as red blood cells, platelets, or plasma from human whole blood or human blood. The types of blood preparations in Embodiment 1 are red blood cell preparations, plasma preparations, and platelet preparations. A red blood cell preparation refers to a blood preparation prepared by extracting red blood cell components from whole blood. A plasma preparation refers to a blood preparation prepared by extracting plasma components from whole blood. A platelet preparation refers to a blood preparation prepared by extracting platelet components from whole blood.

[0082] As Figure 1 shown, the blood analysis device 10 has a transport unit 20, a measurement unit 30, and a control unit 40.

[0083] The transport unit 20 can transport Figure 2 the rack 120 shown in (b). Several Figure 2 containers 110 shown in (a) are placed on the rack 120. The transport unit 20 supplies the container 110 placed on the rack 120 to the measurement unit 30 by transporting the rack 120. Thus, the operation of supplying the container 110 to the measurement unit 30 by transporting the rack 120 by the transport unit 20 is hereinafter referred to as the "sampler operation". The transport unit 20 is communicably connected to the control unit 40 and is controlled by the control unit 40. The structure of the transport unit 20 will be described later with reference to Figure 3 it.

[0084] As Figure 2 shown in (a), the container 110 has a body 111, a lid 112, and a barcode label 113. The body 111 is a tubular container made of translucent glass or synthetic resin, which houses a sample or a blood preparation. The lid 112 is made of rubber and seals the upper end opening of the body 111. The barcode label 113 is attached to the side of the body 111. A barcode indicating the sample ID or the blood preparation ID is printed on the barcode label 113. The sample ID is information that can individually identify the sample. The blood preparation ID is information that can individually identify the blood preparation.

[0085] As Figure 2 shown in (b), the rack 120 has 10 placement parts 121 and a barcode label 122. The placement parts 121 can vertically place the containers 110. The barcode label 122 is attached to the side of the rack 120. A barcode indicating the rack ID is printed on the barcode label 122. The rack ID is information that can individually identify the rack 120.

[0086] Return Figure 1, the measurement unit 30 includes a measurement control unit 31, a pipetting unit 32, a sample preparation unit 33, a measurement unit 30a, and a signal processing circuit 37.

[0087] The measurement control unit 31 is composed of, for example, a CPU, an MPU, etc. The measurement control unit 31 receives signals output from each part of the measurement unit 30 and controls each part of the measurement unit 30. The measurement control unit 31 communicates with the control unit 40. The measurement control unit 31 has a storage unit 31a. The storage unit 31a is composed of, for example, a ROM, a RAM, a hard disk, etc. The measurement control unit 31 performs various processes based on the programs stored in the storage unit 31a.

[0088] The pipetting unit 32 has Figure 3 the pipette 32a as shown. It pipettes samples and blood preparations from the container 110 supplied to the measurement unit 30 through the pipette 32a. In addition, the container 110 is manually supplied to the measurement unit 30 by the operator in addition to being supplied to the measurement unit 30 by the transport unit 20 during the above sampler operation. Hereinafter, the operation of directly supplying the container 110 to the measurement unit 30 by the operator is referred to as "manual operation". The operator can operate the menu displayed on the display unit 43, etc. to set the operation of supplying the container 110 to the measurement unit 30 as one of the sampler operation and the manual operation.

[0089] The sample preparation unit 33 is connected to several containers that respectively store several reagents for measurement. When performing sample measurement, the sample preparation unit 33 mixes reagents with the samples pipetted by the pipetting unit 32 to prepare measurement samples. When performing blood preparation measurement, the sample preparation unit 33 mixes reagents with the blood preparations pipetted by the pipetting unit 32 to prepare measurement samples. The sample preparation unit 33 prepares red blood cell count / platelet count measurement samples (resistive type), hemoglobin measurement samples, white blood cell count measurement samples, white blood cell differential measurement samples, reticulocyte count measurement samples, and platelet count measurement samples (optical type) by mixing certain reagents with samples or blood preparations. For convenience, hereinafter, the red blood cell count / platelet count measurement sample (resistive type) is referred to as the "RBC / PLT measurement sample". The reagents connected to the sample preparation unit 33 and the measurement samples prepared in the sample preparation unit 33 will be described later Figure 5 for explanation.

[0090] The measurement unit 30a measures the measurement samples prepared by the sample preparation unit 33. The measurement unit 30a has a resistive detection unit 34, a hemoglobin detection unit 35, and an optical detection unit 36, and these detection units are used to measure the above several measurement samples.

[0091] Specifically, the resistive detection unit 34 measures blood cells by the sheath flow DC detection method based on the RBC / PLT measurement sample. The hemoglobin detection unit 35 measures hemoglobin by the SLS-hemoglobin method based on the hemoglobin measurement sample. The optical detection unit 36 measures blood cells by flow cytometry based on the white blood cell count measurement sample, white blood cell differential measurement sample, reticulocyte count measurement sample, and platelet count measurement sample (optical). The structures of the resistive detection unit 34, hemoglobin detection unit 35, and optical detection unit 36 will be described later with reference to Figure 6 Figs. (a) to (c).

[0092] The signal processing circuit 37 extracts the waveform corresponding to the particle based on the detection signal output from the resistive detection unit 34, and calculates the peak value of the waveform for each particle. The signal processing circuit 37 calculates the hemoglobin concentration based on the detection signal output from the hemoglobin detection unit 35. The signal processing circuit 37 extracts the waveform corresponding to the particle based on the detection signal output from the optical detection unit 36, and calculates the peak value, width, area, etc. of the waveform for each particle. The signal processing circuit 37 performs the above signal processing on the detection signals output from the resistive detection unit 34, hemoglobin detection unit 35, and optical detection unit 36 to generate measurement data, and outputs the generated measurement data to the measurement control unit 31.

[0093] The measurement control unit 31 stores the measurement data output from the signal processing circuit 37 in the storage unit 31a. After the measurement of one sample or one blood preparation is completed, the measurement control unit 31 sends the measurement data stored in the storage unit 31a to the control unit 40.

[0094] The control unit 40 includes a control section 41, a storage section 42, and a display section 43.

[0095] The control section 41 is constituted by, for example, a CPU. The control section 41 receives the signals output from each part of the control unit 40 and controls each part of the control unit 40. The control section 41 communicates with the transport unit 20 to control the transport unit 20. The control section 41 communicates with the measurement control unit 31 of the measurement unit 30 to control each part of the measurement unit 30 through the measurement control unit 31. The control section 41 stores the measurement data received from the measurement unit 30 in the storage section 42. The control section 41 analyzes the sample using the measurement data based on the sample, obtains the result values of several measurement items and uses them as the measurement results. The control section 41 also performs analysis based on the blood preparation using the measurement data based on the blood preparation, obtains the result values of several measurement items and uses them as the measurement results.

[0096] The measurement unit 30 and the control unit 40 may also be formed integrally. At this time, for example, the measurement control unit 31 is omitted, and the control unit 41 controls each part of the measurement unit 30 and the control unit 40.

[0097] The storage unit 42 is constituted by, for example, a ROM, a RAM, a hard disk, etc. The control unit 41 performs various processes based on the program 42a stored in the storage unit 42. The processes of the control unit 41 described with reference to the flowchart described later are performed based on the program 42a. The program 42a is not limited to being pre-stored in the storage unit 42, and may also be copied or installed from a recording medium 42b via a reading device (not shown) provided in the control unit 40. The recording medium 42b is constituted by, for example, an optical disc such as a CD-ROM. The program 42a may also be copied or installed from another computer via a communication cable or the like.

[0098] The display unit 43 displays an image and accepts an input from an operator. The display unit 43 is constituted by, for example, a touch panel type display. The control unit 40 may also have a display unit for displaying an image and an input unit for accepting an input from an operator instead of the display unit 43.

[0099] Here, the control unit 41 performs measurement and analysis of a blood preparation in the blood preparation measurement mode by executing the program 42a. At this time, the control unit 41 accepts an input of one blood preparation measurement mode out of several blood preparation measurement modes related to the blood preparation from the operator via the display unit 43. The input of the blood preparation measurement mode is performed via the reception interface 600 described later with reference to Figure 9 (b). The blood preparation measurement mode will be described later with reference to Figure 7 Then, the control unit 41 controls the sample preparation unit 33 to prepare a measurement sample using a reagent corresponding to the blood preparation measurement mode, and controls the measurement unit 30a to measure the measurement sample according to the blood preparation measurement mode.

[0100] In this way, the operator can appropriately measure the measurement target blood preparation only by inputting one blood preparation measurement mode corresponding to the measurement to be performed among several blood preparation measurement modes. Thus, when the operator measures a blood preparation, there is no need to perform complicated procedures such as changing settings according to the blood preparation. Therefore, the blood preparation can be inspected smoothly. Since the measurement sample is prepared according to the blood preparation, useless reagent use can be prevented and the amount of reagent used can be suppressed.

[0101] Next, with reference to Figure 3 , the conveyance of the container 110 will be described.

[0102] The conveyance unit 20 includes a storage unit 210, a conveyance unit 220, a storage unit 230, and a barcode unit 240. The measurement unit 30 is at Figure 1In addition to the structure shown, there are also a stirring unit 310, a container transfer unit 320, and a barcode unit 330. As described above, the transport unit 20 is used during the sampler operation.

[0103] The storage unit 210 stores the unprocessed rack 120. The transport unit 220 picks up the rack 120 transported rearward in the storage unit 210 and transports the picked-up rack 120 to the left. The barcode unit 240 rotates the container 110 positioned at the reading position 221 on the transport unit 220 within the placement unit 121, and reads the sample ID or the formulation ID from the barcode label 113 of the container 110 through the barcode reader 241. The barcode unit 240 also reads the rack ID from the barcode label 122 of the rack 120 positioned at the reading position 221.

[0104] The stirring unit 310 has a pair of clamping parts 311 for clamping the container 110 in the front-rear direction. The stirring unit 310 clamps the container 110 positioned at the take-out position 222 on the transport unit 220 with the clamping parts 311. The stirring unit 310 moves the clamping parts 311 upward in a state where the container 110 is clamped by the clamping parts 311, thereby taking out the container 110 placed on the rack 120 from the placement unit 121. Then, the stirring unit 310 rotates the clamping parts 311 above the rack 120 to stir the sample or the blood formulation in the container 110.

[0105] As Figure 4 shown in (a), the clamping parts 311 are provided on the shaft 312 and the clamping parts 311 can rotate around the shaft 312 extending in the front-rear direction. The control unit 41 controls the stirring unit 310 via the measurement control unit 31 and causes the clamping parts 311 clamping the container 110 to rotate around the shaft 312. Thus, as Figure 4 shown by the dashed line in (a), the container 110 rotates and the sample or the blood formulation in the container 110 is stirred.

[0106] Here, when the control unit 41 stirs the liquid in the container 110 through the stirring unit 310, it changes the stirring intensity according to the type of the liquid in the container 110. Specifically, the stirring intensity is determined by the number of operations of the container 110 from the upright state through the inverted state and back to the upright state, that is, the number of inversion operations, as shown in Figure 4 (a). The stirring intensity is also determined by the angle to which the container 110 is tilted during the inversion operation and the time for which the container 110 waits in the inverted state during the inversion operation.

[0107] As Figure 4As shown in (b), when the liquid in the container 110 is whole blood or a red blood cell preparation, the control unit 41 performs 8 inversion operations. When the liquid in the container 110 is a plasma preparation or a platelet preparation, the control unit 41 performs 5 inversion operations. That is, the control unit 41 performs 8 inversion operations in the whole blood mode. The control unit 41 performs 8 inversion operations in the red blood cell preparation measurement mode and the red blood cell preparation + residual blood cell measurement mode. The control unit 41 performs 5 inversion operations in the plasma preparation measurement mode. The control unit 41 performs 5 inversion operations in the platelet preparation measurement mode and the platelet preparation + residual blood cell measurement mode. Each measurement mode will be described later Figure 7 Although the number of inversion times is 8 for both whole blood and red blood cell preparations, the inversion angle and the waiting time in the inversion state for red blood cell preparations are greater than those for whole blood, respectively.

[0108] In this way, the stirring intensity for red blood cell preparations is stronger than that for whole blood, plasma preparations, and platelet preparations. The stirring intensity for plasma preparations and platelet preparations is weaker than that for whole blood and red blood cell preparations.

[0109] Here, the viscosity of red blood cell preparations is higher than that of whole blood, plasma preparations, and platelet preparations. Therefore, if the stirring of red blood cell preparations is insufficient, it is possible that the red blood cells in the red blood cell preparations will not be evenly mixed, and the red blood cell preparations cannot be measured correctly. Therefore, by setting the stirring intensity for red blood cell preparations to be stronger than that for whole blood, plasma preparations, and platelet preparations, the measurement accuracy of red blood cell preparations can be improved. In addition, if plasma preparations and platelet preparations are over-stirred, due to the influence of human factors, the number of white blood cells remaining in these preparations sometimes becomes a false high value. Therefore, by setting the stirring intensity for plasma preparations and platelet preparations to be weaker than that for whole blood and red blood cell preparations, the number of white blood cells becoming a false high value can be suppressed.

[0110] Since the properties of blood preparations and whole blood are different as described above, by changing the number of inversion operations of the stirring unit 310 between the blood preparation measurement mode and the whole blood mode, blood preparations and whole blood can be measured with high accuracy respectively.

[0111] The stirring intensity is not limited to being defined by the number of inversion operations, the inversion angle, and the waiting time in the inversion state. For example, the stirring intensity can also be defined by the inversion speed during the inversion operation. In addition, it is not limited to Figure 4The stirring of the liquid in the container 110 shown in (a) is performed by rotating the container 110 about the axis 312 while being held by the holding portion 311. For example, the stirring of the liquid in the container 110 can also be performed by shaking the container 110 in the vertical or horizontal direction, or by shaking the rack 120 on which the container 110 is placed. At this time, the stirring intensity is defined by, for example, the number of times and the speed at which the container 110 is shaken.

[0112] Return Figure 3 , the container transfer unit 320 has a placement portion 321 capable of vertically placing the container 110 and a member for transferring the placement portion 321 in the front-rear direction. The container 110 taken out from the rack 120 and whose internal liquid has been stirred is placed on the placement portion 321 of the container transfer unit 320. The container 110 placed on the placement portion 321 is transferred backward due to the drive of the placement portion 321. The barcode unit 330 rotates the container 110 positioned at the reading position 322 within the placement portion 321, and reads the sample ID or the preparation ID from the barcode label 113 of the container 110 through the barcode reader 331. In this way, when the sampler is operating, if the barcode units 240 and 330 perform two readings in total, it is possible to prevent the wrong container 110 from being taken.

[0113] After the container 110 is positioned at the pipetting position 323, the sample preparation unit 33 causes the lower end of the pipette 32a to penetrate the lid portion 112 of the container 110, and pipettes the sample or blood preparation stored in the container 110 through the pipette 32a. The container 110 after pipetting is transferred forward by the drive of the placement portion 321. Then, the stirring unit 310 takes out the container 110 from the placement portion 321 and returns the taken-out container 110 to the original placement portion 121 of the rack 120.

[0114] After performing the take-out and pipetting operations on all the containers 110 placed on the rack 120, the rack 120 is transported to the left and positioned behind the storage unit 230. After that, the rack 120 is transported forward and stored in the storage unit 230.

[0115] During manual operation, the operator manually inverts the container 110 in advance to stir the liquid in the container 110. During manual operation, the placement portion 321 of the container transfer unit 320 is transferred to the front of the window 301 through the window 301 that can be opened and closed and is provided on the front side of the measurement unit 30. Then, the operator places the container 110 on the placement portion 321. After that, in the same manner as during the sampler operation, the barcode of the container 110 is read by the barcode unit 330 at the position 322, and the liquid in the container 110 is pipetted at the pipetting position 323. The container 110 after pipetting is transported forward by the placement portion 321 and positioned in front of the window 301. Then the operator takes out the container 110 from the placement portion 321.

[0116] Next, a description will be given of the reagents mixed in the specimen preparation unit 33, the measurement specimens prepared in the specimen preparation unit 33, and the detection unit that measures the measurement specimens with reference to Figure 5 .

[0117] The specimen preparation unit 33 has chambers 33a to 33d for mixing a sample or a blood preparation and a reagent. The sample or blood preparation aspirated by the aspiration unit 32 is supplied to the chambers 33a to 33d. Various reagents are also supplied to the chambers 33a to 33d.

[0118] Specifically, "cellpack DCL" and "sulfolyser" are supplied as reagents to chamber 33a. "lysercell WNR" and "Fluorocell WNR" are supplied as reagents to chamber 33b. "lysercell WDF" and "Fluorocell WDF" are supplied as reagents to chamber 33c. "cellpack DFL", "Fluorocell RET", and "Fluorocell PLT" are supplied as reagents to chamber 33d. These reagents are all manufactured by Sysmex Corporation. cellpack, sulfolyser, lysercell, Fluorocell, DCL, WNR, WDF, DFL, and RET are all registered trademarks.

[0119] In the following description, for convenience, "cellpack DCL", "lysercell WNR", "Fluorocell WNR", "lysercell WDF", "Fluorocell WDF", "cellpack DFL", "Fluorocell RET", and "Fluorocell PLT" will be referred to as "cellpack DCL", "lysercell WNR", "Fluorocell WNR", "lysercell WDF", "Fluorocell WDF", "cellpack DFL", "Fluorocell RET", and "Fluorocell PLT", respectively.

[0120] Chamber 33a mixes a sample or a blood preparation and cellpack DCL to prepare an RBC / PLT measurement specimen for measuring red blood cells and platelets. Chamber 33a mixes a sample or a blood preparation, cellpack DCL, and sulfolyser to prepare a hemoglobin measurement specimen for measuring hemoglobin concentration. Chamber 33b mixes a sample or a blood preparation, lysercell WNR, and Fluorocell WNR to prepare a white blood cell count measurement specimen for measuring white blood cells and for measuring basophils and nucleated red blood cells.

[0121] In chamber 33c, a mixed sample or blood preparation, lysercell WDF, and Fluorocell WDF are used to prepare a white blood cell differential assay sample for measuring neutrophils, lymphocytes, monocytes, eosinophils, and abnormal cells such as blast white blood cells and atypical lymphocytes. In chamber 33d, a mixed sample or blood preparation, cellpack DFL, and Fluorocell RET are used to prepare a reticulocyte count assay sample for measuring reticulocytes and immature red blood cells. In chamber 33d, a mixed sample or blood preparation, cellpack DFL, and Fluorocell PLT are used to prepare a platelet count assay sample (optical method) for measuring platelets.

[0122] Cellpack DCL is also used as a sheath fluid in the resistive detection unit 34 and the optical detection unit 36, and is also used to clean each chamber. Lysercell WNR is also used to clean the flow path in the measurement unit 30.

[0123] The resistive detection unit 34 measures the RBC / PLT assay sample. The hemoglobin detection unit 35 measures the hemoglobin assay sample. The optical detection unit 36 measures the white blood cell count assay sample, the white blood cell differential assay sample, the reticulocyte count assay sample, and the platelet count assay sample (optical method) respectively. Hereinafter, the measurements of the RBC / PLT assay sample, the hemoglobin assay sample, the white blood cell count assay sample, the white blood cell differential assay sample, the reticulocyte count assay sample, and the platelet count assay sample (optical method) are respectively referred to as "RBC / PLT measurement", "hemoglobin measurement", "white blood cell count measurement", "white blood cell differential measurement", "reticulocyte count measurement", and "platelet count (optical method)".

[0124] Next, with reference to Figure 6 (a) to (c), the structures of the resistive detection unit 34, the hemoglobin detection unit 35, and the optical detection unit 36 will be described.

[0125] As Figure 6 (a) shows, the flow chamber 34a of the resistive detection unit 34 has a sample nozzle 411, a chamber 412, a small hole 413, and a recovery tube 414.

[0126] The sample nozzle 411 sends the RBC / PLT measurement sample and the sheath fluid upward. The chamber 412 is in the shape of a cone that becomes narrower upward. The RBC / PLT measurement sample enters the recovery tube 414 through the small hole 413. The blood cells contained in the RBC / PLT measurement sample pass through the small hole 413 in a lined-up state. In the RBC / PLT measurement, a direct current is supplied between the electrodes of the small hole 413, and the change in the direct current resistance when the RBC / PLT measurement sample passes through the small hole 413 is detected. When the blood cells in the RBC / PLT measurement sample pass through the small hole 413, the direct current resistance increases, so the detection signal reflects the information of the blood cells passing through the small hole 413. The resistive detection unit 34 outputs the detection signal to the subsequent signal processing circuit 37.

[0127] As Figure 6 shown in (b), the hemoglobin detection unit 35 includes a cell 421, a light-emitting diode 422, and a light-receiving element 423.

[0128] The cell 421 is made of a plastic material with high light transmittance. The light-emitting diode 422 irradiates light with a wavelength at which the absorbance of SLS-hemoglobin is high to the cell 421. The light-receiving element 423 is disposed opposite to the light-emitting diode 422 with the cell 421 in between, and it receives the transmitted light that has passed through the cell 421. The hemoglobin measurement sample is supplied to the cell 421. With the hemoglobin measurement sample stored in the cell 421, the light-emitting diode 422 emits light, and the transmitted light is received by the light-receiving element 423. The light-receiving element 423 only receives the transmitted light that has not been absorbed by the hemoglobin measurement sample among the light from the light-emitting diode 422. The light-receiving element 423 detects the intensity of the transmitted light. This detection signal corresponds to the absorbance. The hemoglobin detection unit 35 outputs the detection signal to the subsequent signal processing circuit 37.

[0129] As Figure 6 shown in (c), the optical detection unit 36 includes a flow cell 431, a light source 432, a collimating lens 433, a condenser lens 434, a beam stopper 435, a light-receiving unit 436, a condenser lens 437, a dichroic mirror 438, a light-receiving unit 439, an optical filter 440, and a light-receiving unit 441.

[0130] The flow cell 431 supplies the white blood cell count measurement sample, the white blood cell differential measurement sample, the reticulocyte count measurement sample, and the platelet count measurement sample (optical type) and the sheath fluid together. The flow cell 431 is made of a light-transmissive material and is tubular. The particles contained in the measurement sample pass through the inside of the flow cell 431 in a lined-up state. The light source 432 is a semiconductor laser light source that emits laser light of a certain wavelength. The light emitted from the light source 432 excites the dye contained in the measurement sample, causing fluorescence in a certain wavelength band to be generated from the dye.

[0131] The collimating lens 433 and the condenser lens 434 collect the light emitted from the light source 432 and irradiate it onto the measurement sample flowing in the flow cell 431. After the light from the light source 432 irradiates the measurement sample, forward scattered light, side scattered light, and fluorescence are generated from the particles in the measurement sample. The forward scattered light reflects information related to the particle size, the side scattered light reflects the internal information of the particles, and the fluorescence reflects the degree of staining of the particles. Among the light irradiated onto the flow cell 431, the light that has not irradiated the particles and has passed through the flow cell 431 is blocked by the beam stopper 435. The light receiving unit 436 is constituted by, for example, a photodiode. The light receiving unit 436 receives the forward scattered light and outputs a detection signal corresponding to the received forward scattered light.

[0132] The condenser lens 437 collects the side scattered light and fluorescence generated laterally to the flow cell 431. The dichroic mirror 438 reflects the side scattered light collected by the condenser lens 437 and transmits the fluorescence collected by the condenser lens 437. The light receiving unit 439 is constituted by, for example, a photodiode. The light receiving unit 439 receives the side scattered light reflected by the dichroic mirror 438 and outputs a detection signal corresponding to the received side scattered light. The optical filter 440 transmits only the light in the wavelength band corresponding to the fluorescence received by the light receiving unit 441 among the light transmitted through the dichroic mirror 438. The light receiving unit 441 is constituted by, for example, an avalanche photodiode. The light receiving unit 441 receives the fluorescence transmitted through the optical filter 440 and outputs a detection signal corresponding to the received fluorescence. In this way, the optical detection unit 36 outputs the detection signals of the light receiving units 436, 439, and 441 to the subsequent signal processing circuit 37.

[0133] Next, with reference to Figure 7 , the measurement modes in the blood analysis device 10 will be described.

[0134] When the measurement object is whole blood, the blood analysis device 10 has several whole blood modes and uses them as measurement modes. The whole blood modes related to whole blood include "CBC mode", "CBC + DIFF mode", "CBC + DIFF + RET mode", "CBC + DIFF + RET + PLT - F mode", etc. In the CBC mode, RBC / PLT measurement, hemoglobin measurement, and white blood cell count measurement are performed. In the CBC + DIFF mode, in addition to the measurements in the CBC mode, white blood cell differential measurement is also performed. In the CBC + DIFF + RET mode, in addition to the measurements in the CBC + DIFF mode, reticulocyte count measurement is also performed. In the CBC + DIFF + RET + PLT - F mode, in addition to the measurements in the CBC + DIFF + RET mode, platelet count measurement (optical method) is also performed.

[0135] When whole blood is received and used as the measurement object, the control unit 41 measures the RBC / PLT measurement sample prepared from the whole blood through the resistive detection unit 34 to obtain the number of red blood cells, that is, RBC. Additionally, at this time, the control unit 41 measures the white blood cell count measurement sample prepared from the whole blood through the optical detection unit 36 to obtain the number of white blood cells, that is, WBC. In the whole blood mode without platelet count measurement (optical), the control unit 41 measures the RBC / PLT measurement sample prepared from the whole blood through the resistive detection unit 34 to obtain the number of platelets, that is, PLT. When in the whole blood mode including platelet count measurement (optical), the control unit 41 measures the platelet count measurement sample (optical) prepared from the whole blood through the optical detection unit 36 to obtain the number of platelets, that is, PLT.

[0136] When the measurement object is a blood preparation, the blood analysis device 10 has several blood preparation measurement modes and uses them as the measurement modes. The blood preparation measurement modes related to blood preparations include "red blood cell preparation measurement mode", "red blood cell preparation + residual blood cell measurement mode", "plasma preparation measurement mode", "platelet preparation measurement mode", "platelet preparation + residual blood cell measurement mode". In the red blood cell preparation measurement mode, RBC / PLT measurement and hemoglobin measurement are performed. In the red blood cell preparation + residual blood cell measurement mode, in addition to the measurements in the red blood cell preparation measurement mode, white blood cell differential count measurement is also performed. In the plasma preparation measurement mode, white blood cell differential count measurement and reticulocyte count measurement are performed. In the platelet preparation measurement mode, RBC / PLT measurement, hemoglobin measurement, and platelet count measurement (optical) are performed. In the platelet preparation + residual blood cell measurement mode, in addition to the measurements in the platelet preparation measurement mode, white blood cell differential count measurement and reticulocyte count measurement are also performed.

[0137] When red blood cell preparation is received and used as the measurement object, that is, when the red blood cell preparation measurement mode or the red blood cell preparation + residual blood cell measurement mode is specified, the control unit 41 measures the RBC / PLT measurement sample prepared from the red blood cell preparation through the resistive detection unit 34 to obtain the number of red blood cells, that is, RBC. When the red blood cell preparation + residual blood cell measurement mode is specified, the control unit 41 measures the white blood cell differential count measurement sample prepared from the red blood cell preparation through the optical detection unit 36 to obtain the number of white blood cells remaining in the red blood cell preparation, that is, WBC.

[0138] When a plasma preparation is received and used as the measurement target, that is, when the plasma preparation measurement mode is specified, the control unit 41 measures a white blood cell differential measurement sample prepared from the plasma preparation through the optical detection unit 36, and obtains the number of white blood cells remaining in the plasma preparation, that is, WBC. In addition, at this time, the control unit 41 measures a reticulocyte count measurement sample prepared from the plasma preparation through the optical detection unit 36, and obtains the number of red blood cells remaining in the plasma preparation, that is, RBC.

[0139] When a platelet preparation is received and used as the measurement target, that is, when the platelet preparation measurement mode or the platelet preparation + residual blood cell measurement mode is specified, the control unit 41 measures a platelet count measurement sample (optical type) prepared from the platelet preparation through the optical detection unit 36, and obtains the platelet count, that is, PLT. When the platelet preparation + residual blood cell measurement mode is specified, the control unit 41 measures a white blood cell differential measurement sample prepared from the platelet preparation through the optical detection unit 36, and obtains the number of white blood cells remaining in the platelet preparation, that is, WBC. In addition, at this time, the control unit 41 measures a reticulocyte count measurement sample prepared from the platelet preparation through the optical detection unit 36, and obtains the number of red blood cells remaining in the platelet preparation, that is, RBC.

[0140] The control unit 41 can set the measurement mode to the whole blood mode or the blood preparation measurement mode according to the operator's input. In this way, if the measurement mode can be switched between the whole blood mode and the blood preparation measurement mode, the operator does not need to use several devices to separately measure the blood preparation and the whole blood.

[0141] The measurement target of the blood analysis device 10 can also be only the blood preparation. That is, the blood analysis device 10 can also only have the blood preparation measurement mode. At this time, the blood analysis device 10 becomes a device that only measures and analyzes the blood preparation, and the measurement mode is always the blood preparation measurement mode.

[0142] Figure 8 It is a flowchart of the process of receiving the input of the measurement mode and preparing the measurement sample according to the received measurement mode.

[0143] In step S11, the control unit 41 receives either the blood preparation measurement mode or the whole blood mode via the Figure 9 interface 500 described later (a). That is, in step S11, the control unit 41 selectively receives the blood preparation and the whole blood and uses them as the measurement target. In step S12, the control unit 41 determines whether the measurement mode received in step S11 is the blood preparation measurement mode. When the received measurement mode is the blood preparation measurement mode, the control unit 41 advances the process to step S13, and when the received measurement mode is the whole blood mode, the control unit 41 advances the process to step S15.

[0144] In step S13, the control unit 41 refers to Figure 9 (b) The receiving interface 600 described later receives Figure 7 The control unit 41 is a blood product measurement mode selected from the red blood cell product measurement mode, the red blood cell product + residual blood cell measurement mode, the plasma product measurement mode, the platelet product measurement mode, and the platelet product + residual blood cell measurement mode. In step S14, the control unit 41 prepares a measurement sample according to the blood product measurement mode accepted in step S13 based on the blood product aspirated by the aspiration unit 32. The measurement sample is prepared according to the type of measurement performed in the accepted blood product measurement mode. Thereafter, the control unit 41 uses the measurement sample prepared in step S14 as shown in FIG. Figure 10 Assays and analyses were performed as described.

[0145] In step S15, the control unit 41 receives Figure 7 The control unit 41 selects a whole blood mode from the CBC mode, CBC+DIFF mode, CBC+DIFF+RET mode, and CBC+DIFF+RET+PLT-F mode shown in the figure. In step S16, the control unit 41 prepares the measurement sample according to the whole blood mode received in step S15 based on the whole blood aspirated by the aspirating unit 32. The measurement sample is prepared according to the type of measurement performed in the received whole blood mode. Thereafter, the control unit 41 performs measurement and analysis using the measurement sample prepared in step S16.

[0146] Figure 9 (a) is a diagram showing an interface 500 for changing a measurement target. The interface 500 is displayed on the display unit 43 when an operator operates a menu or the like displayed on the display unit 43 .

[0147] like Figure 9 As shown in (a), the interface 500 for changing the measurement object includes a button 511 for designating whole blood, a button 512 for designating a blood product, an OK button 521, and a cancel button 522. The operator can change the operated button to a selected state by operating the buttons 511 and 512. The operator can select any one of the buttons 511 and 512.

[0148] If the operator presses the OK button 521 after selecting the button 511, the control unit 41 closes the interface 500 and displays a message on the display unit 43 for changing the default value. Figure 7 The control unit 41 receives the input of the whole blood mode through the interface, and then controls the sample preparation unit 33 to mix the reagent with the whole blood in the container 110 to prepare the measurement sample, and controls the measurement unit 30a to measure the prepared measurement sample.

[0149] On the other hand, if the operator operates the OK button 521 after selecting the button 512, the control unit 41 closes the interface 500 and displays on the display unit 43 an acceptance interface 600 for setting one of the several blood product measurement modes shown in Figure 7 as the measurement mode. After the control unit 41 receives the input of the blood product measurement mode via the acceptance interface 600, it controls the sample preparation unit 33 to mix a reagent with the blood product in the container 110 to prepare a measurement sample, and controls the measurement unit 30a to measure the prepared measurement sample.

[0150] If the operator operates the cancel button 522, the control unit 41 discards the selection state of the buttons on the interface 500 and closes the interface 500.

[0151] Figure 9 FIG. (b) is a view of the acceptance interface 600 for receiving the input of the blood product measurement mode to set the blood product measurement mode.

[0152] The acceptance interface 600 has a button 610 for designating a red blood cell product, a button 611 for indicating the measurement of white blood cells remaining in the red blood cell product, a button 620 for specifying a plasma product, a button 630 for designating a platelet product, a button 631 for indicating the measurement of red blood cells and white blood cells remaining in the platelet product, an OK button 641, and a cancel button 642.

[0153] The operator can change the operated button to a selected state by operating the buttons 610, 611, 620, 630, 631. The operator can select any one of the buttons 610, 620, 630. The button 611 becomes selectable when the button 610 is selected. The button 631 becomes selectable when the button 630 is selected. In the Figure 9 state illustrated in FIG. (b), since the buttons 610, 630 are not selected, the buttons 611, 631 are in a non-selectable state.

[0154] If the operator operates the OK button 641 after only selecting the button 610, the control unit 41 sets the measurement mode to the red blood cell preparation measurement mode. If the operator operates the OK button 641 after selecting the buttons 610 and 611, the control unit 41 sets the measurement mode to the red blood cell preparation + residual blood cell measurement mode. If the operator operates the OK button 641 after selecting the button 620, the control unit 41 sets the measurement mode to the plasma preparation measurement mode. If the operator operates the OK button 641 after only selecting the button 630, the control unit 41 sets the measurement mode to the platelet preparation measurement mode. If the operator operates the OK button 641 after selecting the buttons 630 and 631, the control unit 41 sets the measurement mode to the platelet preparation + residual blood cell measurement mode. The control unit 41 stores the set blood preparation measurement mode in the storage unit 42.

[0155] If the operator operates the cancel button 642, the control unit 41 discards the selection state of the buttons on the reception interface 600 and closes the reception interface 600.

[0156] In this way, by providing the buttons 610, 611, 630, and 631 for selecting the blood preparation measurement mode, the operator can select the buttons 610 and 630 in the process of inspecting the components of the blood preparation, and select the buttons 611 and 631 in the process of inspecting the residual blood cells in the blood preparation, etc., so that the operator can select the usage mode corresponding to the usage method of the blood analysis device 10.

[0157] If the reception interface 600 is configured as above, the operator can set the red blood cell preparation measurement mode by selecting the button 610 and measure the red blood cells in the red blood cell preparation. The operator can set the red blood cell preparation + residual blood cell measurement mode by selecting the buttons 610 and 611 and measure the red blood cells in the red blood cell preparation and the white blood cells remaining in the red blood cell preparation. The operator can set the plasma preparation measurement mode by selecting the button 620 and measure the red blood cells and white blood cells remaining in the plasma preparation. The operator can set the platelet preparation measurement mode by selecting the button 630 and measure the platelets in the platelet preparation. The operator can select the platelet preparation + residual blood cell measurement mode by selecting the buttons 630 and 631 and measure the platelets in the platelet preparation, the red blood cells and white blood cells remaining in the platelet preparation. In this way, the operator can measure the blood cells that are the main components of the blood preparation and the residual blood cells that should be removed in the blood preparation only by operating the buttons to input the blood preparation measurement mode.

[0158] In the plasma preparation measurement mode and the platelet preparation + residual blood cell measurement mode, it is not necessary to measure both the residual red blood cells and the residual white blood cells, and either one of them can also be measured. In addition, in Figure 9In the acceptance interface 600 of (b), the button 611 may also be omitted, and buttons for selecting the red blood cell preparation mode + residual blood cell measurement mode may be configured. The button 631 may also be omitted, and buttons for selecting the platelet preparation mode + residual blood cell measurement mode may be configured. When setting the mode for measuring only residual blood cells in the red blood cell preparation and the mode for measuring only residual blood cells in the platelet preparation and using them as the blood preparation measurement mode, buttons corresponding to these modes may also be configured in the acceptance interface 600.

[0159] In addition, the control unit 41 may also accept the input of the blood preparation measurement mode through a physical button component corresponding to the blood preparation measurement mode instead of the acceptance interface 600. When the blood preparation ID read from the barcode of the container 110 includes the blood preparation measurement mode, the control unit 41 may also accept the input of the blood preparation measurement mode based on the read blood preparation ID.

[0160] When it is a sampler operation, after the operator sets the blood preparation measurement mode in the acceptance interface 600, the container 110 containing the type of blood preparation corresponding to the set blood preparation measurement mode is placed on the rack 120, and the rack 120 is set in the storage unit 210. Thus, as described with reference to Figure 3 the rack 120 is automatically transported, and the containers 110 placed on the rack 120 are sequentially supplied to the measurement unit 30 to measure the blood preparation in the container 110. On the other hand, when it is a manual operation, after the operator sets the blood preparation measurement mode in the acceptance interface 600, the container 110 containing the type of blood preparation corresponding to the set blood preparation measurement mode is stirred and then placed in the placement portion 321 of the container transfer portion 320. Thus, as described with reference to Figure 3 the container 110 is supplied to the measurement unit 30 to measure the blood preparation in the container 110.

[0161] The same applies when the whole blood mode is set. The container 110 containing whole blood is supplied to the measurement unit 30 by the rack 120 or the operator to measure the whole blood in the container 110.

[0162] Next, with reference to the Figure 10 flowchart, the control performed by the control unit 41 according to the blood preparation measurement mode set through the acceptance interface 600 will be described.

[0163] After setting through the Figure 9 acceptance interface 600 of (b), the container 110 is supplied to the measurement unit 30, the blood preparation is aspirated from the container 110 by the pipetting unit 32, and a measurement sample is prepared in the step S14 of Figure 8 to start the Figure 10 processing.

[0164] In steps S101 to S104, the control unit 41 reads out the blood preparation measurement mode set by the reception interface 600 of (b) from the storage unit 42, and advances the process to one of steps S105 to S109 according to the read blood preparation measurement mode. Specifically, when the read blood preparation measurement mode is the red blood cell preparation measurement mode, the red blood cell preparation + residual blood cell measurement mode, the plasma preparation measurement mode, the platelet preparation measurement mode, and the platelet preparation + residual blood cell measurement mode, the control unit 41 advances the process to steps S105, S106, S107, S108, and S109 respectively. Figure 9 When the blood preparation measurement mode is the red blood cell preparation measurement mode, in step S105, the control unit 41 performs an RBC / PLT measurement based on the RBC / PLT measurement sample and a hemoglobin measurement based on the hemoglobin measurement sample. When the blood preparation measurement mode is the red blood cell preparation + residual blood cell measurement mode, in step S106, the control unit 41 performs an RBC / PLT measurement based on the RBC / PLT measurement sample, a hemoglobin measurement based on the hemoglobin measurement sample, and a white blood cell classification measurement based on the white blood cell classification measurement sample.

[0165] When the blood preparation measurement mode is the plasma preparation measurement mode, in step S107, the control unit 41 performs a white blood cell classification measurement based on the white blood cell classification measurement sample and a reticulocyte count measurement based on the reticulocyte count measurement sample.

[0166] When the blood preparation measurement mode is the platelet preparation measurement mode, in step S108, the control unit 41 performs an RBC / PLT measurement based on the RBC / PLT measurement sample, a hemoglobin measurement based on the hemoglobin measurement sample, and a platelet count measurement (optical method) based on the platelet count measurement sample (optical method). When the blood preparation measurement mode is the platelet preparation + residual blood cell measurement mode, in step S109, the control unit 41 performs an RBC / PLT measurement based on the RBC / PLT measurement sample, a hemoglobin measurement based on the hemoglobin measurement sample, a white blood cell classification measurement based on the white blood cell classification measurement sample, a reticulocyte count measurement based on the reticulocyte count measurement sample, and a platelet count measurement (optical method) based on the platelet count measurement sample (optical method).

[0167] By performing one of the processes in steps S105 to S109, the control unit 41 obtains measurement data on the blood preparation to be measured. The content of the measurement process performed by the control unit 41 in steps S105 to S109 will be described later with reference to

[0168] For explanation. Figure 11 will be described.

[0169] After the measurement of the blood preparation is completed, in step S110, the control unit 41 analyzes the blood preparation using the measurement data of the blood preparation. In the analysis of step S110, the control unit 41 obtains the result values for each measurement item and uses them as the measurement results. The measurement items to be obtained vary depending on the blood preparation measurement mode. The measurement items to be obtained will be described later with reference to Figure 12 (a) to Figure 14 (b).

[0170] Figure 11 For Figure 10 the processing settings of steps S105 to S109, that is, the detailed diagram of the processing settings corresponding to the blood preparation measurement mode.

[0171] Figure 11 The first row of Figure 11 represents the measurement in the red blood cell preparation measurement mode in step S105. Figure 11 The second row of Figure 11 represents the measurement in the red blood cell preparation + residual blood cell measurement mode in step S106. Figure 11 The third row of Figure 10 represents the measurement in the plasma preparation measurement mode in step S107.

[0172] Here, the measurement of each blood preparation does not have to be carried out in the same way as the measurement of whole blood, but as Figure 11 shown, part of it is carried out differently from the measurement of whole blood.

[0173] Specifically, in the red blood cell preparation measurement mode, the RBC / PLT measurement and the hemoglobin measurement are carried out with the same settings as those for whole blood. In detail, in the RBC / PLT measurement and the hemoglobin measurement, the volume of the red blood cell preparation used is the same as the amount of whole blood used. Such "the same settings as those for whole blood" means that the measurement-related settings such as the volume of the blood preparation and the reagent used in the measurement are the same as those for whole blood. The stirring of the container 110 in the sampler operation is carried out as described with reference to Figure 4 (b). In the red blood cell preparation + residual blood cell measurement mode, the RBC / PLT measurement and the hemoglobin measurement are carried out in the same way as those for whole blood, and the white blood cell classification measurement is carried out under high-sensitivity settings. The high-sensitivity settings will be described later.

[0174] In the plasma preparation measurement mode, white blood cell differential count measurement and reticulocyte count measurement are performed under high-sensitivity settings. In the platelet preparation measurement mode, RBC / PLT measurement and hemoglobin measurement are performed under high-sensitivity settings, and platelet count measurement (optical method) is performed with the same settings as for whole blood. In the platelet preparation + residual blood cell measurement mode, RBC / PLT measurement, hemoglobin measurement, white blood cell differential count measurement, and reticulocyte count measurement are performed under high-sensitivity settings, and platelet count measurement (optical method) is performed with the same settings as for whole blood.

[0175] Here, compared with measuring whole blood under normal settings, blood cells can be measured with higher sensitivity when measuring blood preparations under high-sensitivity settings. Specifically, in white blood cell differential count measurement, the amount of blood preparation used under high-sensitivity settings is more than the amount of whole blood used when measuring whole blood under normal settings, and the amount of the white blood cell differential count measurement sample based on the blood preparation measured under high-sensitivity settings is also more than the amount of the white blood cell differential count measurement sample based on whole blood measured under normal settings. In reticulocyte count measurement, the amount of blood preparation used under high-sensitivity settings is more than the amount of whole blood used when measuring whole blood under normal settings, and the amount of the reticulocyte count measurement sample based on the blood preparation measured under high-sensitivity settings is also more than the amount of the reticulocyte count measurement sample based on whole blood measured under normal settings. In addition, compared with performing white blood cell differential count measurement and reticulocyte measurement based on whole blood under normal settings, when performing white blood cell differential count measurement and reticulocyte measurement based on blood preparations under high-sensitivity settings, the flow rate of the measurement sample flowing into the flow cell 431 is set faster, and the time for the measurement sample to flow into the flow cell 431 is set longer.

[0176] In addition, in RBC / PLT measurement, the amount of the RBC / PLT measurement sample based on the blood preparation measured under high-sensitivity settings is more than the amount of the RBC / PLT measurement sample based on whole blood measured under normal settings. In addition, compared with performing RBC / PLT measurement based on whole blood under normal settings, when performing RBC / PLT measurement based on blood preparations under high-sensitivity settings, the time for the measurement sample to flow into the flow cell 431 is set longer. In hemoglobin measurement, the amount of the measurement sample measured and the time for the measurement sample to flow are also increased under high-sensitivity settings. Compared with the case of measuring whole blood under normal settings, blood cells can be measured with higher sensitivity through high-sensitivity settings.

[0177] Thus, the control unit 41 controls the measurement conditions in the measurement unit 30a according to the blood preparation measurement mode. By controlling the measurement conditions according to the blood preparation measurement mode, measurements corresponding to the properties of the blood preparation and the like can be performed.

[0178] Figure 12 (a)~ Figure 14(b) is a diagram showing the measurement items obtained in five blood preparation measurement modes and the reagents used in the five blood preparation measurement modes. Figure 12 (a) to Figure 14 (b) correspond to the red blood cell preparation measurement mode, the red blood cell preparation + residual blood cell measurement mode, the plasma preparation measurement mode, the platelet preparation measurement mode, and the platelet preparation + residual blood cell measurement mode, respectively.

[0179] Figure 12 (a) to Figure 14 The upper table in (a) to (b) shows the measurement items obtained in the measurement of each blood preparation measurement mode and the measurement channels for obtaining the measurement items. Among the measurement items, "RBC", "PLT", and "WBC" are the number of red blood cells, platelets, and white blood cells per unit volume, respectively. Among the measurement items, "HGB" and "HCT" are the hemoglobin concentration and hematocrit, respectively. In addition, the measurement items in the upper table are measurement items with clinical significance. In each blood preparation measurement mode, it is also possible to obtain Figure 12 (a) to Figure 14 the result values of measurement items other than those shown in (b).

[0180] As Figure 12 (a) and (b) show, when it is a red blood cell preparation, the measurement result based on RBC / PLT measurement is used as the result value of the measurement item "RBC". As Figure 13 and Figure 14 (b) shows, when it is a plasma preparation and a platelet preparation, the measurement result based on the reticulocyte count measurement is used as the result value of the measurement item "RBC". In this way, the red blood cells in the red blood cell preparation and the red blood cells in other blood preparations remaining outside the red blood cell preparation can be appropriately measured by performing different measurements respectively.

[0181] As Figure 13 and Figure 14 (b) shows, when it is a plasma preparation and a platelet preparation, the measurement result based on the reticulocyte count measurement is used as the result value of the measurement item "RBC", rather than the measurement result based on RBC / PLT measurement. Only a very small amount of residual red blood cells exist in the blood preparation. Therefore, the accuracy of the result value of the measurement item "RBC" can be improved by performing the reticulocyte count measurement instead of the RBC / PLT measurement. That is, in the detection of the number of red blood cells, the reticulocyte count measurement is performed when it is a plasma preparation and a platelet preparation, and the RBC / PLT measurement is performed when it is a red blood cell preparation. Therefore, the sensitivity of detecting the number of red blood cells when it is a plasma preparation and a platelet preparation is improved compared with the sensitivity of detecting the number of red blood cells when it is a red blood cell preparation. Thus, the number of red blood cells remaining in the plasma preparation and the platelet preparation can be obtained with high accuracy.

[0182] In addition, white blood cells and red blood cells remaining in the blood preparation are obtained by performing white blood cell classification measurement and reticulocyte count measurement respectively under settings with higher sensitivity compared to the case of measuring whole blood under normal settings. Thus, it is possible to measure with high precision that only very few white blood cells and red blood cells remain in the plasma preparation and platelet preparation.

[0183] In Figure 12 (a) to Figure 14 (b), the table in the lower row indicates the types of reagents used to prepare the measurement sample when performing the measurement shown in the table in the upper row.

[0184] As Figures 11 to 14 (b) shows, the control unit 41 controls the types and numbers of measurement samples to be prepared and the types and numbers of reagents used in the measurement according to the blood preparation measurement mode. For example, in the process of the red blood cell preparation measurement mode, the control unit 41 prepares two types of measurement samples, namely the RBC / PLT measurement sample and the hemoglobin measurement sample, and uses two types of reagents, cellpack DCL and sulfolyser. In this way, if the measurement sample is prepared and the reagent is used according to the blood preparation measurement mode, the usage amount of the reagent can be more effectively suppressed.

[0185] Next, with reference to Figure 15 (a), the blood preparation appropriateness judgment process and the result output process performed by the control unit 41 will be described.

[0186] Figure 15 (a)'s process starts after the end of the process in Figure 10 . In step S201, the control unit 41 judges whether the blood preparation is appropriate based on the result value of the measurement item obtained in step S110 in Figure 10 , that is, the measurement result and Figure 15 (b)'s judgment criterion.

[0187] Figure 15 (b) is a diagram showing the criteria for blood components that the blood preparation should meet. The first to fifth rows are respectively the judgment criteria for the measurement results applicable to each blood preparation measurement mode. As shown in the first row, when it is the red blood cell preparation measurement mode, if the value of the measurement item "RBC" is within the normal range, it is judged that the quality of the red blood cell preparation "has no problem". As shown in the second row, when it is the red blood cell preparation + residual blood cell measurement mode, if the value of the measurement item "RBC" is within the normal range and the value of the measurement item "WBC" is below the threshold th1, it is judged that the quality of the red blood cell preparation "has no problem". The threshold th1 is set to, for example, 3 cells / μL.

[0188] As shown in the 3rd line, when in the plasma preparation measurement mode, if the value of the measurement item "WBC" is below the threshold th2 and the value of the measurement item "RBC" is below the threshold th3, it is judged that the quality of the plasma preparation "is okay". The thresholds th2 and th3 are set to 4 / μL and 1.2×10 4 / μL, respectively.

[0189] As shown in the 4th line, when in the platelet preparation measurement mode, if the value of the measurement item "PLT" is within the normal range and the number of particles of debris per unit volume is below the threshold th4, it is judged that the quality of the platelet preparation "is okay". As shown in the 5th line, when in the platelet preparation + residual blood cell measurement mode, if the value of the measurement item "PLT" is within the normal range, the value of the measurement item "WBC" is below the threshold th2, the value of the measurement item "RBC" is below the threshold th3, and the number of particles of debris per unit volume is below the threshold th4, it is judged that the quality of the platelet preparation "is okay". In each of the cases in the 1st to 5th lines, when the above judgment criteria are not met, it is judged that the quality of the blood preparation "is problematic".

[0190] The ranges of values for judging the values of the measurement items "RBC" and "PLT" as normal and the values of the thresholds th1, th2, th3, and th4 can be changed through a menu or the like displayed on the display unit 43. Thereby, it is possible to set judgment criteria corresponding to the purification process of the blood preparation, set judgment criteria corresponding to quality standards stipulated by countries and regions, etc. Therefore, the quality of the blood preparation can be appropriately judged.

[0191] In addition, in Figure 15 the blood preparation measurement modes shown in the 2nd to 5th lines of (b), it is judged whether all of several conditions are satisfied, but in the judgment of the appropriateness of each blood preparation measurement mode, it is also possible to judge whether at least one of several conditions is satisfied.

[0192] Figure 16 (a) and (b) are PLT - F scatter plots referred to in the judgment criteria for the platelet preparation measurement mode and the platelet preparation + residual blood cell measurement mode. In the PLT - F scatter plot, the horizontal axis and the vertical axis are the fluorescence intensity and the forward scatter light intensity obtained based on platelet number measurement (optical method), respectively. The fluorescence intensity is a value corresponding to the staining degree of the particles in the platelet preparation, and the forward scatter light intensity is a value corresponding to the size of the particles in the platelet preparation. In the PLT - F scatter plot, points of each particle are plotted based on the fluorescence intensity and the forward scatter light intensity obtained for each particle. In the PLT - F scatter plot, there are shown a platelet region representing the particle distribution corresponding to platelets and a debris region representing the particle distribution corresponding to debris generated due to deterioration of the platelet preparation. The debris region is a region where the fluorescence intensity of the particles is less than that of the platelets.

[0193] Figure 16 (a) is a PLT-F scatter plot obtained based on the measurement of a normal platelet preparation. Figure 16 (b) is a PLT-F scatter plot obtained based on the measurement of a deteriorated platelet preparation. Comparing Figure 16 (a) and (b), it can be seen that due to the deterioration of the platelet preparation, the number of particles in the debris area increases. From this, it can be known that the particles in the debris area, that is, the particles with a fluorescence intensity less than that of platelets, correspond to deteriorated platelets. Therefore, as Figure 15 shown by the judgment criteria in the 4th and 5th rows of (b), if the number of particles of debris is greater than a certain threshold th4, it can be known that the quality of the platelet preparation has deteriorated. Therefore, the control unit 41 obtains the number of particles of debris as the measurement result, and can judge the quality of the platelet preparation by comparing the obtained number of particles of debris, that is, the number of deteriorated platelets, with the judgment criteria.

[0194] When obtaining the number of particles of debris, the control unit 41 does not need to actually generate a PLT-F scatter plot to count the number of particles in the debris area, and it obtains the number of particles of debris through the same data processing as when generating the PLT-F scatter plot.

[0195] Return Figure 15 (a), in step S202, after the control unit 41 receives a display instruction from the operator, as Figures 17 to 20 shown, it outputs the measurement result and the judgment result to the display unit 43. In this way, Figure 15 the process of (a) ends.

[0196] Figure 17 is a view of the interface 700 displayed by the display unit 43.

[0197] The interface 700 has regions 701, 702, 703 and labels 710, 720, 730. The control unit 41 displays the type of blood preparation, the blood preparation ID, the date and time of measuring the blood preparation in the region 701. The control unit 41 displays the relevant judgment result of the suitability of the blood preparation carried out in Figure 15 step S201 of (a) in the region 702. That is, in the region 702, information indicating whether the quality of the blood preparation is guaranteed in an alternative manner is displayed. The control unit 41 displays the corresponding measurement result, chart, etc. in the region 703 according to one of the labels 710, 720, 730 being operated.

[0198] In Figure 17The measurement results such as those of the red blood cell preparation + residual blood cell measurement mode are shown in the example. The content of the displayed interface 700 shown in area 701 is based on the red blood cell preparation. "Pass" indicating that there is "no problem" with the quality of the blood preparation is displayed in area 702. When the quality is "no problem", the color within area 702 changes to green so that the normality can be visually grasped easily. On the other hand, when there is "a problem" with the quality of the blood preparation, "Fail" is displayed in area 702 as shown in Figure 18 Figure (a). At this time, the color within area 702 changes to red so that the abnormality can be visually grasped easily.

[0199] In this way, if the relevant judgment result of the appropriateness of the corresponding blood preparation is displayed in area 702, the operator can smoothly and accurately grasp the quality of the blood preparation.

[0200] If the label 710 is operated, a list 711 of the result values of the measurement items other than the measurement item of the residual blood cells and a list 712 of the measurement items of the residual blood cells are displayed within area 703. As shown in Figure 17 Figure, if the label 710 is operated for the measurement results of the red blood cell preparation + residual blood cell measurement mode, within area 703, corresponding to the upper table in Figure 12 Figure (b), a list 711 of the result values of the measurement items "RBC", "HCT", "HGB" and a list 712 of the result value of the measurement item "WBC" are displayed. When it is the red blood cell preparation measurement mode, the display of list 712 is omitted.

[0201] As shown in Figure 18 Figure (b), if the label 710 is operated for the measurement results of the plasma preparation measurement mode, within area 703, corresponding to the upper table in Figure 13 Figure, a list 712 of the result values of the measurement items "RBC", "WBC" is displayed. At this time, the display of list 711 is omitted.

[0202] As shown in Figure 18 Figure (c), if the label 710 is operated for the measurement results of the platelet preparation + residual blood cell measurement mode, within area 703, corresponding to the upper table in Figure 14 Figure (b), a list 711 of the result value of the measurement item "PLT" and a list 712 of the result values of the measurement items "RBC", "WBC" are displayed. In addition, when it is the platelet preparation measurement mode, the display of list 712 is omitted.

[0203] If the label 720 is operated, a list 721 of the result values of other measurement results is displayed within area 703. As shown in Figure 18As shown in (d), when the operation strip 720 is used for the measurement results of the platelet preparation measurement mode and the platelet preparation + residual blood cell measurement mode, a list 721 showing the number of particles in the fragment area, that is, the number of deteriorated platelets, is displayed in the area 703.

[0204] In this way, the relevant measurement results of red blood cells in the red blood cell preparation are displayed in the red blood cell preparation measurement mode, and the relevant measurement results of red blood cells in the red blood cell preparation and white blood cells remaining in the red blood cell preparation are displayed in the red blood cell preparation + residual blood cell measurement mode. Thus, the operator can confirm the quality of the red blood cell preparation. In the plasma preparation measurement mode, the relevant measurement results of red blood cells and white blood cells remaining in the plasma preparation are displayed. Thus, the operator can confirm the quality of the plasma preparation. In the platelet preparation measurement mode, the relevant measurement results of platelets and deteriorated platelets in the platelet preparation are displayed, and in the platelet preparation + residual blood cell measurement mode, the relevant measurement results of platelets and deteriorated platelets in the platelet preparation, red blood cells and white blood cells remaining in the platelet preparation are displayed. Thus, the operator can confirm the quality of the platelet preparation. As described above, the quality information is displayed on the display unit 43, so the operator can simply and accurately perform the quality inspection of the blood preparation.

[0205] In the area 703, Figure 15 As shown in (b), the reference of the blood component corresponding to the type of blood preparation can also be displayed together with the result value of the measurement item. By displaying the reference and the measurement result in this way, the operator can judge the quality of the blood preparation by referring to the displayed reference and measurement result.

[0206] When the strip 730 is operated, a bar chart and a scatter plot associated with the analysis process of step S110 of Figure 10 are displayed in the area 703. The control unit 41 can generate a bar chart and a scatter plot during the analysis process, or can generate a bar chart and a scatter plot at the time when the strip 730 is operated.

[0207] As Figure 19 shown in (a), when the strip 730 is operated for the measurement results of the red blood cell preparation + residual blood cell measurement mode, an RBC bar chart 731 and a PLT bar chart 732 generated in the RBC / PLT measurement and a WDF scatter plot 733 generated in the white blood cell classification measurement are displayed in the area 703. When it is the red blood cell preparation measurement mode, the display of the WDF scatter plot 733 is omitted.

[0208] As Figure 19 shown in (b), when the strip 730 is operated for the measurement results of the plasma preparation measurement mode, a WDF scatter plot 733 generated in the white blood cell classification measurement and a RET scatter plot 734 generated in the reticulocyte number measurement are displayed in the area 703.

[0209] As Figure 20 shown, regarding the operation label 730 of the measurement result of the platelet preparation + residual blood cell measurement mode, in region 703, an RBC histogram 731 and a PLT histogram 732 generated in the RBC / PLT measurement, a WDF scatter plot 733 generated in the white blood cell differential measurement, a RET scatter plot 734 generated in the reticulocyte count measurement, and a PLT-F scatter plot 735 generated in the platelet count (optical method) are displayed. When in the platelet preparation measurement mode, the display of the WDF scatter plot 733 and the RET scatter plot 734 is omitted.

[0210] As Figure 19 (a), (b) and Figure 20 shown, if the histograms and scatter plots generated in each measurement are displayed as quality information, the operator can further and detailedly grasp the quality of the blood preparation.

[0211] Instead of the operation of displaying the quality information on the display unit 43, the quality information of the list and chart can also be sent to a device other than the blood analysis device 10, and the quality information of the list can also be output as voice from the speaker provided in the blood analysis device 10. If the quality information is output in this way, the operator can perform the quality inspection of the blood preparation by confirming the output quality information.

[0212] Next, the setting of the measurement object at startup will be described with reference to Figure 21 the flowchart of (a).

[0213] Figure 21 The process of (a) starts with the operator operating the menu or the like displayed on the display unit 43 to input an instruction to start setting the measurement object at startup.

[0214] In step S301, the control unit 41 displays an interface 800 for setting the measurement object at startup on the display unit 43. As Figure 21 shown in (b), the interface 800 has a button 801 for designating whole blood as the measurement object, a button 802 for designating a blood preparation as the measurement object, an OK button 811, and a cancel button 812. The operator can select any one of the buttons 801 and 802. In step S302, the control unit 41 determines whether the OK button 811 has been operated.

[0215] If the operator operates the OK button 811 after selecting one of the buttons 801 and 802, in step S303, the control unit 41 stores the measurement object specified by the button 801 or the button 802 as the measurement object at startup in the storage unit 42. Then, the control unit 41 closes the interface 800. On the other hand, if the operator operates the cancel button 812, the control unit 41 does not execute step S303, discards the measurement object selected on the interface 800, and closes the interface 800.

[0216] When the blood analysis device 10 is started up, the control unit 41 sets the measurement object set as described above as the measurement object of the blood analysis device 10. Thus, when the blood analysis device 10 is mainly used for the measurement of whole blood, if the operator sets the measurement object at startup to whole blood in advance via the interface 800, after the blood analysis device 10 is started up, the effort of setting the measurement object to whole blood via the Figure 9 interface 500 of (a) can be omitted. Similarly, when the blood analysis device 10 is mainly used for the measurement of blood products, if the operator sets the measurement object at startup to blood products in advance via the interface 800, after the blood analysis device 10 is started up, the effort of setting the measurement object to blood products via the Figure 9 interface 500 of (a) can be omitted.

[0217] <Implementation Mode 2>

[0218] As Figure 22 shown in (a), in Implementation Mode 2, compared with Figure 15 (a), step S211 is added to the latter stage of step S201. In Figure 22 (a)'s step S202, the judgment result of the blood product error is also displayed according to the instruction from the operator. The structure and other processes of Implementation Mode 2 are the same as those of Implementation Mode 1.

[0219] As Figure 22 shown in (a), in step S211, the control unit 41 judges the error of the blood product based on the result value of the measurement item obtained in Figure 10 step S110, that is, the measurement result and Figure 22 the judgment criteria shown in (b).

[0220] Figure 22 (b)'s judgment criteria represent the blood component criteria satisfied by other blood products different from the target blood product. Figure 22 (b)'s first to third lines are respectively the judgment criteria for judging the possibility of judging three blood products as other products. As shown in the first line, when measuring a red blood cell product, the value of the measurement item "RBC" is less than 100 (10 4 / μL), or if the value of the measurement item "HGB" is less than 5 (g / dL), or if the value of the measurement item "HCT" is less than 20 (%), it is determined that the measured blood product is not a red blood cell product, but a plasma product or a platelet product. As shown in the second line, when measuring a plasma product, if the value of the measurement item "RBC" is greater than 50 (10 4 / μL), it is determined that the measured blood product is not a plasma product, but a red blood cell product. As shown in the third line, when measuring a platelet product, if the value of the measurement item "PLT" is less than 20 (10 4 / μL), it is determined that the measured blood product is not a platelet product, but a red blood cell product or a plasma product.

[0221] When measuring a plasma product, platelet count measurement (optical method) is not performed, so it is difficult to determine the presence or absence of platelets. However, when platelet count measurement (optical method) is also performed during the measurement of a plasma product, if the value of the measurement item "PLT" is greater than a certain value, it can also be determined that the measured blood product is not a plasma product, but a platelet product. Similarly, when platelet count measurement (optical method) is also performed during the measurement of a red blood cell product, if the value of the measurement item "PLT" is greater than a certain value, it can also be determined that the measured blood product is not a red blood cell product, but a platelet product. In the measurement of a platelet product, if the value of the measurement item "RBC" is greater than a certain value, it can also be determined that the measured blood product is not a platelet product, but a red blood cell product.

[0222] In step S202, the control unit 41 also displays the determination result of the blood product error in step S211 on the display unit 43 in addition to the same information as in the first embodiment. For example, when the control unit 41 receives an instruction to measure a red blood cell product, if it is determined in step S211 that the measured blood product is a plasma product or a platelet product, Figure 23 the area 704 shown in (a) is displayed within the interface 700. In Figure 23 the area 704 illustrated in (a), information indicating that the measured blood product is another blood product is displayed as "plasma product platelet product ".

[0223] In addition, when the control unit 41 receives an instruction to measure a plasma product and it is determined in step S211 that the measured blood product is a red blood cell product, Figure 23 the area 704 shown in (b) is displayed within the interface 700. Figure 23 In the area 704 illustrated in (b), information indicating that the measured blood product is another blood product is displayed as "red blood cell product ”. When the control unit 41 determines in step S211 that the measured blood preparation is a red blood cell preparation or a plasma preparation when receiving an instruction to measure a platelet preparation, Figure 23 the area 704 shown in (c) is displayed within the interface 700. Figure 23 In the area 704 illustrated in (c), as information indicating that the measured blood preparation is another blood preparation, “red blood cell preparation plasma preparation ” is displayed.

[0224] In this way, if information indicating that the measured blood preparation is another blood preparation is displayed on the display unit 43, the operator can smoothly grasp that Figure 9 in the reception interface 600 of (b), a different blood preparation measurement mode was erroneously selected, or a different type of blood preparation was erroneously stored in the container 110, etc.

[0225] Symbol Explanation

[0226] 10 Blood analysis device

[0227] 30a Measurement unit

[0228] 33 Specimen preparation unit

[0229] 34 Resistive detection unit

[0230] 36 Optical detection unit

[0231] 41 Control unit

[0232] 42a Program

[0233] 43 Display unit

[0234] 310 Stirring unit

[0235] 600 Reception interface

Claims

1. A blood analysis device, the blood analysis device comprises: a pipetting unit that pipettes a sample to be measured; herein, the sample includes whole blood collected from a subject and several blood preparations prepared by separating certain components from human whole blood, a specimen preparation unit that mixes the sample pipetted by the pipetting unit and a reagent to prepare a measurement specimen; herein, the specimen preparation unit can prepare the following measurement specimens: (i) a first measurement specimen prepared by using the sample and a diluent to at least detect red blood cells; (ii) a second measurement specimen prepared by using the sample and a hemoglobin measurement reagent to at least measure the hemoglobin concentration; (iii) a third measurement specimen prepared by using the sample and a first staining reagent to at least optically detect white blood cells; and (iv) a fourth measurement specimen prepared by using the sample and a second staining reagent to at least optically detect platelets; a resistive detection unit that detects blood cells based on the change in resistance when the blood cells pass through a micropore; a hemoglobin detection unit that irradiates light on the measurement specimen contained in a light-transmissive container and detects the light from the measurement specimen; an optical detection unit that has a light-transmissive flow cell, irradiates light on the blood cells flowing in the flow cell, and detects the scattered light and fluorescence generated from the blood cells; a mode selector for selecting a mode for measurement from several modes including a whole blood mode and several blood preparation modes; wherein, the blood analysis device can selectively perform measurement operations according to the selected mode, and the measurement operations include the following (1), (2), and (3): (1) A first measurement operation for whole blood cell count (CBC) and white blood cell classification including the following steps: (1a) Prepare the first measurement specimen by the specimen preparation unit, and measure the first measurement specimen by the resistive detection unit to obtain the number of red blood cells and the number of platelets, (1b) Prepare the second measurement specimen by the specimen preparation unit, and measure the second measurement specimen by the hemoglobin detection unit to obtain the hemoglobin concentration, (1c) Prepare the third measurement specimen by the specimen preparation unit, and measure the third measurement specimen by the optical detection unit to analyze white blood cells, (2) A second measurement operation for quality inspection of red blood cell preparations including the following steps: (2a) Prepare the first measurement specimen by the specimen preparation unit, and measure the first measurement specimen by the resistive detection unit to obtain the number of red blood cells, (2b) Prepare the third measurement specimen by the specimen preparation unit, and measure the third measurement specimen by the optical detection unit to detect residual white blood cells in the red blood cell preparation, (3) A third measurement operation for quality inspection of platelet preparations including the following steps: (3a) Prepare at least one of the first and fourth measurement specimens by the specimen preparation unit, and to obtain the number of platelets, measure the first measurement specimen by the resistive detection unit and / or measure the fourth measurement specimen by the optical detection unit, (3b) Prepare the third measurement sample through the sample preparation unit, and measure the third measurement sample through the optical detection unit to detect residual white blood cells in the platelet preparation.

2. The blood analysis device according to claim 1, wherein: The mode selection member selects a mode for measurement from several modes including the whole blood mode for aspirating the whole blood, the red blood cell preparation mode for aspirating the red blood cell preparation, and the platelet preparation mode for aspirating the platelet preparation.

3. The blood analysis device according to claim 1, wherein: It further includes a display unit, The blood analysis device causes the display unit to display an acceptance interface for accepting a mode for measurement.

4. The blood analysis device according to claim 1, wherein: Output quality information corresponding to the type of the blood preparation based on the measurement results obtained through the second or third measurement operation.

5. The blood analysis device according to claim 4, wherein: Judge whether the blood preparation is appropriate based on the standard of blood components corresponding to the type of the blood preparation and the measurement results obtained through the second or third measurement operation.

6. The blood analysis device according to claim 1, wherein: Output the standard of blood components corresponding to the type of the blood preparation and the measurement results obtained through the second or third measurement operation.

7. The blood analysis device according to claim 1, wherein: Judge whether the red blood cell preparation is appropriate based on the standard of the number of residual white blood cells and the number of residual white blood cells in the red blood cell preparation detected in the second measurement operation (2b).

8. The blood analysis device according to claim 1, wherein: Judge whether the platelet preparation is appropriate based on the standard of the number of residual white blood cells and the number of residual white blood cells in the platelet preparation detected in the third measurement operation (3b).

9. The blood analysis device according to claim 1, wherein: The sample preparation unit can also prepare the following measurement samples: (v) The fifth measurement sample prepared by using the sample and the third staining reagent for at least optically detecting red blood cells, The third measurement operation further includes the following steps: (3c) Prepare the fifth measurement sample through the sample preparation unit, and measure the fifth measurement sample through the optical detection unit to detect residual red blood cells in the platelet preparation.

10. The blood analysis device according to claim 9, wherein: Judge whether the platelet preparation is appropriate based on the standard of the number of residual red blood cells and the number of residual red blood cells in the platelet preparation detected in the third measurement operation (3c).

11. The blood analysis device according to claim 1, wherein: Judge whether the platelet preparation is appropriate based on the number of blood cells whose fluorescence intensity detected by the optical detection unit in the third measurement operation (3a) is less than the fluorescence intensity detected from platelets by the optical detection unit.

12. The blood analysis device according to claim 11, It is characterized in that: It is determined whether the platelet preparation is appropriate based on the reference of the number of particles with low fluorescence intensity in the platelet preparation and the number of blood cells with fluorescence intensity less than that of platelets.

13. The blood analysis device according to claim 1, It is characterized in that: The measurement operation further includes the following (4): (4) The 4th measurement operation for the quality inspection of the plasma preparation, including the following processes: (4a) The 3rd measurement sample is prepared by the sample preparation unit, and the 3rd measurement sample is measured by the optical detection unit to detect residual white blood cells in the plasma preparation.

14. The blood analysis device according to claim 13, It is characterized in that: It is determined whether the plasma preparation is appropriate based on the reference of the number of residual white blood cells and the number of residual white blood cells in the plasma preparation detected in the 4th measurement operation (4a).

15. The blood analysis device according to claim 1, It is characterized in that: The sample preparation unit can also prepare the following measurement samples: (v) The 5th measurement sample prepared by using the sample and the 3rd staining reagent for at least optically detecting red blood cells, The measurement operation further includes the following (4): (4) The 4th measurement operation for the quality inspection of the plasma preparation, including the following processes: (4b) The 5th measurement sample is prepared by the sample preparation unit, and the 5th measurement sample is measured by the optical detection unit to detect residual red blood cells in the plasma preparation.

16. The blood analysis device according to claim 15, It is characterized in that: It is determined whether the plasma preparation is appropriate based on the reference of the number of residual red blood cells and the number of residual red blood cells in the plasma preparation detected in the 4th measurement operation (4b).

17. The blood analysis device according to claim 1, It is characterized in that: It further includes a stirring unit for stirring the sample, wherein, Before preparing the measurement sample, the 1st, 2nd, and 3rd measurement operations further include a process of stirring the sample by the stirring unit, The blood analysis device controls the stirring unit so that the stirring intensity of the sample in the 2nd measurement operation and the 3rd measurement operation is different.

18. The blood analysis device according to claim 17, It is characterized in that: The blood analysis device controls the stirring unit so that the stirring intensity of the sample by the stirring unit in the 2nd measurement operation is stronger than that in the 3rd measurement operation.

19. The blood analysis device according to claim 1, It is characterized in that: The amount of the 3rd measurement sample measured by the optical detection unit in the 2nd measurement operation (2b) is more than the amount of the 3rd measurement sample measured by the optical detection unit in the 1st measurement operation (1c).

20. The blood analysis device according to claim 1, It is characterized in that: The amount of the third measurement sample measured by the optical detection unit in the third measurement operation (3b) is greater than the amount of the third measurement sample measured by the optical detection unit in the first measurement operation (1c).

21. The blood analysis device according to claim 1, wherein: it further includes a control unit that controls the pipetting unit, the sample preparation unit, the resistive detection unit, the hemoglobin detection unit, and the optical detection unit.

22. The blood analysis device according to any one of claims 1 to 21, wherein: the third measurement operation (3a) is a process of preparing the fourth measurement sample by the sample preparation unit and measuring the fourth measurement sample by the optical detection unit to obtain the platelet count.

23. A blood analysis method, comprising the following steps: selecting a mode for sample measurement from several modes including a whole blood mode and several blood preparation modes; here, the sample includes whole blood collected from a subject and several blood preparations prepared by separating certain components from human whole blood, selectively performing a measurement operation on the sample according to the selected mode; here, the measurement operation includes the following (1), (2), and (3) (1) The first measurement operation for complete blood count (CBC) and white blood cell classification of whole blood, including the following steps: (1a) Preparing the first measurement sample and measuring the first measurement sample by the resistive detection unit to obtain the red blood cell count and the platelet count. Here, the first measurement sample is prepared using the sample and a diluent, (1b) Preparing the second measurement sample and measuring the second measurement sample by the hemoglobin detection unit to obtain the hemoglobin concentration. Here, the second measurement sample is prepared using the sample and a hemoglobin measurement reagent, (1c) Preparing the third measurement sample and measuring the third measurement sample by the optical detection unit to analyze white blood cells. Here, the third measurement sample is prepared using the sample and a first staining reagent, (2) The second measurement operation for quality inspection of red blood cell preparations, including the following steps: (2a) Preparing the first measurement sample and measuring the first measurement sample by the resistive detection unit to obtain the red blood cell count, (2b) Preparing the third measurement sample and measuring the third measurement sample by the optical detection unit to detect residual white blood cells in the red blood cell preparation, (3) The third measurement operation for quality inspection of platelet preparations, including the following steps: (3a) Preparing at least one of the first and fourth measurement samples and measuring the first measurement sample by the resistive detection unit and / or measuring the fourth measurement sample by the optical detection unit to obtain the platelet count. Here, the fourth measurement sample is prepared using the sample and a second staining reagent, (3b) Preparing the third measurement sample and measuring the third measurement sample by the optical detection unit to detect residual white blood cells in the platelet preparation, Here, the resistive detection unit detects blood cells based on changes in resistance when blood cells pass through a micropore, the hemoglobin detection unit irradiates light to a measurement sample stored in a light-transmissive container, and detects the light from the measurement sample, and the optical detection unit has a light-transmissive flow cell, irradiates light to blood cells flowing in the flow cell, and detects scattered light and fluorescence generated from the blood cells.

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