Sample measuring device

Abstract

To provide a sample measuring device that can reduce the likelihood of overlooking platelet aggregation during platelet measurement. [Solution] The sample measuring device for measuring a blood sample taken from a subject includes an electrical detection unit 120 for detecting electrical signals corresponding to cells, an optical detection unit 110 for detecting optical signals corresponding to cells, a hemoglobin detection unit 130 for detecting optical signals corresponding to hemoglobin, a preparation unit 162, and an analysis unit that analyzes measurement data and provides analysis results. The preparation unit 162 prepares a measurement sample PAB for detecting platelet aggregation using the optical detection unit 110 in accordance with a measurement order that includes a measurement instruction for measurement item CBC or measurement item CBC, DIFF, and the analysis unit analyzes the measurement data obtained from the measurement of the measurement sample PAB and provides analysis results regarding platelet aggregation.

Description

Technical Field

[0001] The present invention relates to a specimen measuring device for measuring a specimen.

Background Art

[0002] Counting the number of platelets in a specimen is important in screening for hemostatic disorders and the like. However, if there are platelet abnormalities in the specimen, the counted value of platelets may become inaccurate. Therefore, evaluating the presence or absence of platelet abnormalities in the specimen is important for obtaining an accurate counted value of platelets. In Patent Document 1 shown below, as a method for detecting platelet abnormalities, the number of platelets is counted by a first measurement (Impedance method), and when the obtained counted value is lower than a threshold value, the number of platelets is counted by a second measurement (FCM method).

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] In the method described in Patent Document 1 above, for example, even if platelet abnormalities such as platelet aggregation occur in the specimen, it may happen that no abnormality is determined in the counted value of platelets in the first measurement. In this case, since the second measurement is not performed on the specimen for which the second measurement should be performed, an inaccurate platelet count based on the first measurement becomes the final platelet count. Therefore, in order to obtain an accurate counted value of platelets, it is necessary to reduce the oversight of platelet aggregation.

[0005] In view of such problems, an object of the present invention is to provide a specimen measuring device capable of reducing the oversight of platelet aggregation in the measurement of platelets.

Means for Solving the Problems

[0006] The present invention relates to a sample measuring device for measuring blood samples taken from a subject. The sample measuring device (1) of the present invention includes an electrical detection unit (120) for detecting electrical signals corresponding to cells contained in the blood sample, a first optical detection unit (110) for detecting optical signals corresponding to cells, a second optical detection unit (130) for detecting optical signals corresponding to hemoglobin contained in the blood sample, a preparation unit (162) for preparing a measurement sample for measurement by the electrical detection unit (120), the first optical detection unit (110), and the second optical detection unit (130), and an analysis unit (401) for analyzing measurement data obtained from the measurement of the measurement sample and providing analysis results. The preparation unit (162) prepares a sample for detecting platelet aggregation by the first optical detection unit (110) in accordance with a measurement order that includes a measurement instruction for (1) a first measurement item including red blood cell count, white blood cell count, hemoglobin level, hematocrit value, mean corpuscular volume, mean corpuscular hemoglobin level, mean corpuscular hemoglobin concentration, and platelet count, or (2) the first measurement item and a second measurement item related to the morphological classification of white blood cells by the first optical detection unit (110). The analysis unit (401) analyzes the measurement data obtained from the measurement of the sample for detecting platelet aggregation and provides analysis results regarding platelet aggregation.

[0007] According to the present invention, platelet aggregation is automatically detected by the first optical detection unit in response to a measurement order that includes a measurement instruction for a first measurement item, or for both the first and second measurement items, regardless of the measurement result of the platelet count. Therefore, the likelihood of overlooking platelet aggregation can be reduced. [Effects of the Invention]

[0008] According to the present invention, the risk of overlooking platelet aggregation during platelet measurement can be reduced. [Brief explanation of the drawing]

[0009] [Figure 1] Figure 1 is a perspective view showing an example of the configuration of a sample measuring device according to an embodiment. [Figure 2] Figure 2 is a block diagram showing the functional configuration of a measurement unit according to an embodiment. [Figure 3] Figure 3 shows an example of the configuration of an optical detection unit according to an embodiment. [Figure 4] Figure 4 shows representative values ​​(peak value, width, and area) of waveform data based on an optical signal detected by an optical detection unit according to an embodiment. [Figure 5] Figure 5 shows an example of the configuration of an electrical detection unit and a hemoglobin detection unit according to an embodiment. [Figure 6] Figure 6 is a block diagram showing a configuration according to an embodiment in which the measurement sample prepared in each chamber provided in the measurement unit is supplied to the optical detection unit, the electrical detection unit, and the hemoglobin detection unit. [Figure 7] Figure 7 is a schematic cross-sectional view showing the configuration of a suction tube according to an embodiment. [Figure 8] Figure 8 shows a configuration for aspirating and discharging a sample via a suction tube, according to an embodiment. [Figure 9] Figure 9 shows the configuration of a fluid circuit connected to a chamber, an electrical detection unit, and a hemoglobin detection unit, according to an embodiment. [Figure 10] Figure 10 shows the configuration of a fluid circuit connected to a chamber and an optical detection unit according to an embodiment. [Figure 11] Figure 11 is a block diagram showing the functional configuration of an analysis unit according to an embodiment. [Figure 12] Figure 12 is a diagram showing the relationship between the measurement mode and the sample to be measured according to this embodiment. [Figure 13] Figure 13 shows a histogram of RBC / PLT based on measurement data of a measurement sample RBC / PLT acquired using an electrical detection unit according to an embodiment. [Figure 14] Figure 14 shows a scattergram of the PAB based on measurement data of the measurement sample PAB acquired using an optical detection unit according to an embodiment. [Figure 15]FIG. 15 is a diagram for explaining verification performed by the inventors regarding the determination accuracy of platelet aggregation based on the scattergram PAB according to the embodiment. [Figure 16] FIG. 16 is a diagram showing the configuration of the analysis result list screen according to the embodiment. [Figure 17] FIG. 17 is a diagram showing the configuration of the analysis result display screen according to the embodiment. [Figure 18] FIG. 18 is a diagram illustrating an analysis result display screen based on the measurement mode CBC+DIFF according to the embodiment. [Figure 19] FIG. 19 is a diagram illustrating an analysis result display screen based on the measurement mode CBC+DIFF+RET+PLT-V according to the embodiment. [Figure 20] FIG. 20 is a diagram showing a time chart when the measurement mode CBC is set in the measurement order according to the embodiment. [Figure 21] FIG. 21 is a diagram showing a time chart when the measurement mode CBC+DIFF is set in the measurement order according to the embodiment. [Figure 22] FIG. 22 is a flowchart showing the processing performed by the control unit of the analysis unit according to the embodiment. [Figure 23] FIG. 23 is a diagram showing the scattergram PAB-2 generated based on the measurement data of the measurement sample PAB according to the modification example. [Figure 24] FIG. 24 is a diagram illustrating an analysis result display screen on which a message indicating that erythrocyte abnormality due to fragmented erythrocytes or microspherocytes has occurred is displayed according to the modification example.

MODE FOR CARRYING OUT THE INVENTION

[0010] FIG. 1 is a perspective view showing an example of the configuration of the specimen measuring device 1. In FIG. 1, the directions of up and down, left and right, front and back are shown.

[0011] The specimen measuring device 1 is a blood cell counter that measures blood cells such as white blood cells, red blood cells, and platelets contained in a specimen, and performs classification and / or counting of each blood cell. The specimen is a blood sample collected from a subject, for example, whole blood. The specimen measuring device 1 comprises a measuring unit 10, a transport unit 20, and an analysis unit 30.

[0012] The transport unit 20 is positioned in front of the measurement unit 10 and transports a sample rack R holding multiple sample containers T to the measurement unit 10. The measurement unit 10 takes a sample container T from the sample rack R, sets the removed sample container T in the sample setting unit 12, and transfers it to the sample aspiration position in the housing 11. The measurement unit 10 aspirates a sample from the sample container T positioned at the sample aspiration position and measures the blood cells contained in the sample. The measurement unit 10 returns the sample container T, after measurement is complete, to the sample rack R.

[0013] The analysis unit 30 performs an analysis, including classification and / or counting of blood cells, based on the measurement data acquired by the measurement unit 10, and generates analysis results. The analysis results include, for example, result values, graphs, charts, and flag information based on the analysis.

[0014] The analysis unit 30 includes a display unit 31 and an operation unit 32. The display unit 31 displays analysis results, etc., and is composed of, for example, a liquid crystal display or an organic EL display. The operation unit 32 receives operations from the operator and is composed of, for example, a mouse or keyboard. The display unit 31 and the operation unit 32 may be integrated, for example, as a touch panel display.

[0015] Figure 2 is a block diagram showing the functional configuration of the measurement unit 10.

[0016] The measurement unit 10 includes an optical detection unit 110, an electrical detection unit 120, a hemoglobin detection unit 130, analog processing units 141, 142, 143, A / D conversion units 151, 152, 153, a sample container transfer unit 161, a preparation unit 162, IF (interface) units 171, 172, and a communication unit 173.

[0017] The optical detection unit 110 detects optical signals corresponding to blood cells in the sample based on flow cytometry. The electrical detection unit 120 detects electrical signals corresponding to blood cells in the sample based on sheath flow DC detection. The hemoglobin detection unit 130 detects optical signals corresponding to the hemoglobin concentration of the sample based on SLS-hemoglobin detection. The configurations of the optical detection unit 110, the electrical detection unit 120, and the hemoglobin detection unit 130 will be described later with reference to Figures 3 and 5.

[0018] The analog processing units 141, 142, and 143 perform processing such as noise reduction and smoothing on the analog signals detected by the optical detection unit 110, the electrical detection unit 120, and the hemoglobin detection unit 130, respectively. The A / D conversion units 151, 152, and 153 convert the analog signals processed by the analog processing units 141, 142, and 143 into digital signals, respectively, and transmit the measurement data based on the converted digital signals to the analysis unit 30 via the IF unit 171 and the communication unit 173.

[0019] The sample container transfer unit 161 includes a mechanism for removing sample containers T from the sample rack R on the transfer unit 20, a sample setting unit 12 (see Figure 1), and a mechanism for transferring the sample setting unit 12 back and forth.

[0020] The preparation unit 162 aspirates a sample from the sample container T and prepares a measurement sample for measurement by the optical detection unit 110, the electrical detection unit 120, and the hemoglobin detection unit 130 based on the aspirated sample. The preparation unit 162 may also include a suction tube for aspirating a sample from the sample container T and a chamber for mixing the sample aspirated by the suction tube with reagents to prepare the measurement sample.

[0021] The preparation unit 162 includes, for example, a first chamber (e.g., chambers C11, C12, C22 described later) used for a first measurement item (e.g., CBC), a chamber (e.g., chamber C21 described later) used for a second measurement item (e.g., DIFF), and a third chamber (e.g., chamber C23 described later) used for a third measurement item other than the first and second measurement items (e.g., RET or PLT-V). The preparation unit 162 may prepare a measurement sample (measurement sample PAB described later) for detecting platelet aggregation using any of the first to third chambers. In other words, the preparation unit 162 may share any of the first to third chambers for preparing a measurement sample for detecting platelet aggregation. Preferably, the preparation unit 162 may prepare a measurement sample for detecting platelet aggregation using a chamber from the first to third chambers that is not used for measurement. For example, for a measurement order that includes a measurement instruction for a first measurement item but does not include a measurement instruction for a second measurement item, the preparation unit 162 may prepare a measurement sample for detecting platelet aggregation using the second or third chamber. Alternatively, for example, for a measurement order that includes a measurement instruction for a first measurement item, or for both the first and second measurement items, the preparation unit 162 may prepare a measurement sample for detecting platelet aggregation using the third chamber. Figure 6, described later, illustrates an example in which the third chamber is shared as the chamber for preparing the measurement sample for platelet aggregation. Instead of a shared chamber, the preparation unit 162 may be provided with a dedicated chamber for preparing the measurement sample for detecting platelet aggregation (measurement sample PAB, described later).

[0022] In one example, the preparation unit 162 includes a suction tube 301 as shown in Figure 6, a suction tube transfer unit for transferring the suction tube 301 within the housing 11, a flow path, syringe pump, valve, and mechanism for driving them as shown in Figure 8, a flow path, syringe pump, diaphragm pump, valve, and mechanism for driving them as shown in Figures 9 and 10, and chambers C11, C12, C21 to C23 as shown in Figures 9 and 10.

[0023] The communication unit 173 is configured, for example, with a connection terminal based on the USB standard, and communicates with the analysis unit 30. Each part of the measurement unit 10 is controlled by the analysis unit 30 via the IF units 171, 172 and the communication unit 173.

[0024] The optical detection unit 110 detects the optical signals of blood cells contained in the sample based on flow cytometry. The optical detection unit 110 mainly comprises a flow cell through which the sample containing blood cells flows, a light source that irradiates the sample flowing through the flow cell with light, and a light receiving unit that receives the light generated from the blood cells irradiated by the light in the flow cell. An example of such an optical detection unit 110 will be described with reference to Figure 3.

[0025] Figure 3 shows an example of the configuration of the optical detection unit 110. For convenience, the X, Y, and Z axes, which are orthogonal to each other, are indicated in Figure 3. The Z axis direction is the flow direction of the sample to be measured in the flow cell 211.

[0026] The optical detection unit 110 includes light sources 201 and 202, a dichroic mirror 203, a flow cell 211, a light receiving unit 221, a dichroic mirror 231, light receiving units 232 and 233, a dichroic mirror 241, and light receiving units 242 and 243.

[0027] Light sources 201 and 202 are, for example, semiconductor laser light sources. Light source 201 emits light with wavelength λ10 in the Y-axis direction, and light source 202 emits light with wavelength λ20 in the X-axis direction. Wavelength λ10 is, for example, in the blue-violet wavelength band, with a central wavelength of 315 nm to 490 nm. Wavelength λ20 is, for example, in the red wavelength band, with a central wavelength of 610 nm to 750 nm. The dichroic mirror 203 is configured to reflect light from light source 201 in the X-axis direction and transmit light from light source 202. The dichroic mirror 203 is positioned so that the light from light sources 201 and 202 overlaps and irradiates the flow channel 211a of the flow cell 211.

[0028] The sample to be measured, prepared by the preparation unit 162 and supplied to the optical detection unit 110, flows through the channel 211a of the flow cell 211. When blood cells in the sample to be measured flowing through channel 211a are irradiated with light of wavelength λ10 from the light source 201 and light of wavelength λ20 from the light source 202, forward scattered light, side scattered light, and fluorescence are generated from the irradiated blood cells. In one example, when a fluorescent dye used to stain blood cells is irradiated with light of wavelengths λ10 and λ20, light of wavelengths λ11 and λ21 are generated, respectively.

[0029] The light-receiving unit 221 receives forward-scattered light of wavelength λ20 based on light from the light source 202 and detects an optical signal corresponding to the received light intensity. The light-receiving unit 221 is, for example, a photodiode (PD). The forward-scattered light reflects the size of the blood cells. The larger the blood cell, the greater the forward-scattered light received by the light-receiving unit 221, and the smaller the blood cell, the smaller the forward-scattered light received by the light-receiving unit 221.

[0030] The dichroic mirror 231 is configured to reflect side-scattered light of wavelength λ10 based on light from the light source 201 and transmit fluorescence of wavelength λ11 based on light from the light source 201. The light-receiving unit 232 receives the side-scattered light of wavelength λ10 and detects an optical signal corresponding to the received light intensity. The light-receiving unit 232 is, for example, a photodiode (PD). The side-scattered light reflects the complexity inside the blood cell. For example, if the inside of a white blood cell contains many granules, the side-scattered light received by the light-receiving unit 232 will be large, and if there are fewer granules, the side-scattered light received by the light-receiving unit 232 will be small.

[0031] The light-receiving unit 233 receives fluorescence at wavelength λ11 and detects an optical signal corresponding to the received light intensity. The light-receiving unit 233 is, for example, a photomultiplier tube (PMT), an avalanche photodiode (APD), or a photodiode (PD). Fluorescence reflects the intensity of cell staining by the dye. For example, in the case of fluorescence generated from leukocytes stained with nucleic acid dyes, the fluorescence received by the light-receiving unit 233 increases when the leukocytes contain a lot of nucleic acid, and decreases when the amount of nucleic acid decreases.

[0032] The dichroic mirror 241 is configured to reflect side-scattered light of wavelength λ20 based on light from the light source 202 and transmit fluorescence of wavelength λ21 based on light from the light source 202. The light-receiving unit 242 receives the side-scattered light of wavelength λ20 and detects an optical signal corresponding to the light-receiving intensity. The light-receiving unit 242 is, for example, a photodiode (PD). The light-receiving unit 243 receives fluorescence of wavelength λ21 and detects an optical signal corresponding to the light-receiving intensity. The light-receiving unit 243 is, for example, a photomultiplier tube (PMT), an avalanche photodiode (APD), or a photodiode (PD).

[0033] The configuration of the optical detection unit 110 shown in Figure 3 is just one example, and other configurations may be adopted. For example, the optical detection unit 110 may not have multiple light sources emitting light of different wavelengths as shown in Figure 3, but may have a configuration that includes a single light source emitting light of a single wavelength. In this case, the optical detection unit 110 does not need to include a light source 201 emitting light of wavelength λ10. In this case, the light receiving unit 232 for receiving side-scattered light of wavelength λ10 and the light receiving unit 233 for receiving fluorescence of wavelength λ11 can also be omitted.

[0034] Figure 4 shows typical values ​​(peak value, width, and area) of waveform data based on the optical signal detected by the optical detection unit 110.

[0035] The analog processing unit 141 (see Figure 2) performs processing such as noise reduction and smoothing on the waveform analog optical signals detected by the light receiving units 221, 232, 233, 242, and 243. The A / D conversion unit 151 (see Figure 2) converts the waveform analog optical signals processed by the analog processing unit 141 into digital signals, and acquires waveform data based on the waveform digital optical signals, as shown in Figure 4. The waveform data is the portion of the digital optical signal that shows a value above a threshold, and can be considered as data corresponding to a single cell.

[0036] As shown in the upper, middle, and lower sections of Figure 4, the A / D conversion unit 151 calculates representative values ​​such as peak value, width, and area from each waveform data. The peak value is a representative value corresponding to the height of the waveform data, the width is a representative value corresponding to the width of the waveform data, and the area is a representative value corresponding to the area enclosed by the shape of the waveform data. Each representative value is a parameter that reflects the characteristics of the cell. The representative values ​​for each blood cell obtained by the A / D conversion unit 151 are transmitted to the analysis unit 30 as measurement data.

[0037] Figure 5 shows an example of the configuration of the electrical detection unit 120 and the hemoglobin detection unit 130.

[0038] The electrical detection unit 120 primarily comprises an aperture large enough to allow blood cells contained in the sample to pass through one by one, and electrodes for applying a voltage to the aperture. The electrical detection unit 120 applies a voltage between the electrodes of the aperture, passes the sample through the aperture, and detects an electrical signal corresponding to the change in DC resistance as the blood cells pass through the aperture. As shown in the upper part of Figure 5, in one example, the electrical detection unit 120 includes a chamber 121, a sample nozzle 122, an aperture 123, a chamber 124, and a recovery tube 125.

[0039] Chamber 121 houses a sample nozzle 122 and has a tapered shape that narrows towards the tip. The tip of chamber 121 is connected to chamber 124 via aperture 123. The sample nozzle 122 sends the sample supplied to the electrical detection unit 120 toward the recovery tube 125. Sheath fluid is supplied into chamber 121. The sample, encased in the sheath fluid, passes through aperture 123 to the recovery tube 125. The blood cells contained in the sample pass through aperture 123 in a single line. Electrodes are provided on aperture 123. A voltage is applied between the electrodes of aperture 123, and an electrical signal corresponding to the change in resistance as the blood cells contained in the sample pass through aperture 123 is detected. The change in resistance reflects the volume of blood cells passing through aperture 123. For example, if the blood cells are large, the change in resistance in aperture 123 will be large, and if the blood cells are small, the change in resistance will be small. The electrical detection unit 120 detects an electrical signal that reflects the volume of blood cells in this manner.

[0040] The chamber 124 may be supplied with sheath fluid so that it flows downwards over the outer region of the recovery tube 125. The sheath fluid flowing outside the recovery tube 125 reaches the lower end of the chamber 124 and then flows into the interior of the recovery tube 125. This prevents blood cells that have passed through the aperture 123 from returning to the aperture 123, thereby preventing false detection of blood cells.

[0041] The hemoglobin detection unit 130 optically measures the hemoglobin concentration in the blood. The hemoglobin detection unit 130 mainly comprises a cell that contains a measurement sample, which is a mixture of blood and a hemolytic agent that dissolves red blood cells and converts the dissolved hemoglobin into SLS-hemoglobin; a light source that irradiates the cell with light; and a light receiving unit that receives light from the irradiated measurement sample. As shown in the lower part of Figure 5, in one example, the hemoglobin detection unit 130 comprises a cell 131, a light source unit 132, and a light receiving unit 133.

[0042] Cell 131 is made of a translucent material and contains the sample to be measured supplied to the hemoglobin detection unit 130. The light source unit 132 irradiates cell 131 with light at a wavelength with high absorbance by SLS-hemoglobin, for example, 555 nm. The light receiving unit 133 is positioned opposite the light source unit 132, with cell 131 in between. The light receiving unit 133 receives transmitted light from the light source unit 132 that was not absorbed by the sample to be measured. The hemoglobin detection unit 130 detects an optical signal that reflects the absorbance based on the intensity of the transmitted light.

[0043] Figure 6 is a block diagram showing the configuration in which the measurement samples prepared in each chamber C11, C12, C21-C23 provided in the measurement unit 10 are supplied to the optical detection unit 110, the electrical detection unit 120, and the hemoglobin detection unit 130.

[0044] The sample aspirated from the sample container T by the suction tube 301 is distributed to the chambers C11, C12, and C21-C23 necessary for preparing the sample, based on the measurement order set for that sample. Chambers C11, C12, and C21-C23 are containers with open tops. The configuration of chambers C11, C12, and C21-C23 will be explained later with reference to Figures 9 and 10.

[0045] Chamber C11 is connected via a channel to a first reagent container containing the diluent RBC / PLT. The preparation unit 162 supplies the diluent RBC / PLT from the first reagent container to Chamber C11. In Chamber C11, the sample and the diluent RBC / PLT are mixed to prepare the measurement sample RBC / PLT. The diluent RBC / PLT is a reagent for diluting the sample to a state suitable for the measurement of red blood cells and platelets, and may be a buffer that disperses while maintaining the morphology of most of the red blood cells contained in the sample without hemolyzing them. The diluent RBC / PLT may have its pH and osmotic pressure adjusted so that red blood cells are not lysed, and may contain buffers or osmotic pressure adjusters. The diluent RBC / PLT may be a buffer that does not contain, or substantially does not contain, a surfactant that hemolyzes red blood cells. The diluent RBC / PLT is, for example, CellPak® DCL (manufactured by Sysmex Corporation). Chamber C11 is connected via a channel to the electrical detection unit 120. The preparation unit 162 supplies the measurement sample RBC / PLT to the electrical detection unit 120 via a flow path. The measurement sample RBC / PLT is measured by the electrical detection unit 120. The control unit 401 of the analysis unit 30 analyzes the measurement data of the measurement sample RBC / PLT and performs classification and counting of red blood cells, platelets, etc.

[0046] Chamber C12 is connected via a channel to a second reagent container containing the hemolytic reagent HGB. Chamber C12 is further connected via a channel to a third reagent container containing the diluent HGB. The preparation unit 162 supplies the hemolytic reagent HGB from the second reagent container to chamber C12 and supplies the diluent HGB from the third reagent container to chamber C12. In chamber C12, the sample, the hemolytic reagent HGB, and the diluent HGB are mixed to prepare the measurement sample HGB. The hemolytic reagent HGB may be a reagent for eluting hemoglobin from red blood cells and converting the eluted hemoglobin into SLS-hemoglobin. An example of the hemolytic reagent HGB is Sulfolyzer® (manufactured by Sysmex Corporation). The diluent HGB is a reagent for diluting the sample and may be the same reagent as the diluent RBC / PLT described above, or it may be a diluent specifically for hemoglobin measurement. The dilution reagent HGB is, for example, Cellpack® DCL (manufactured by Sysmex Corporation). Chamber C12 is connected to the hemoglobin detection unit 130 via a flow channel. The preparation unit 162 supplies the measurement sample HGB to the hemoglobin detection unit 130 via the flow channel. The measurement sample HGB is measured in the hemoglobin detection unit 130. The control unit 401 of the analysis unit 30 analyzes the measurement data of the measurement sample HGB and obtains hemoglobin levels, etc.

[0047] Chamber C21 is connected via a channel to a fourth reagent container containing the hemolytic reagent WDF. Chamber C21 is further connected via a channel to a fifth reagent container containing the staining reagent WDF. The preparation unit 162 supplies the hemolytic reagent WDF from the fourth reagent container to chamber C21 and supplies the staining reagent WDF from the fifth reagent container to chamber C21. In chamber C21, the sample, the hemolytic reagent WDF, and the staining reagent WDF are mixed to prepare the measurement sample WDF. The hemolytic reagent WDF is a reagent that lyses red blood cells and causes damage to the cell membrane of white blood cells to the extent that a fluorescent dye can penetrate it, and may contain a surfactant. The surfactant may be, for example, a nonionic surfactant. An example of the hemolytic reagent WDF is LyzaCell® WDF II (manufactured by Sysmex Corporation). The staining reagent WDF is a reagent containing a fluorescent dye for staining white blood cells for classification. The fluorescent dye contained in the staining reagent WDF is, for example, a cyanine-based fluorescent dye that can be excited by light of wavelength λ20 and can bind to nucleic acids. The staining reagent WDF is, for example, Fluorocell® WDF (manufactured by Sysmex Corporation). Chamber C21 is connected to the optical detection unit 110 via a channel. The preparation unit 162 supplies the measurement sample WDF to the optical detection unit 110 via the channel. The measurement sample WDF is measured by the optical detection unit 110. The control unit 401 of the analysis unit 30 analyzes the measurement data of the measurement sample WDF and the measurement data of the measurement sample WNR to classify and count leukocytes (e.g., neutrophils, lymphocytes, monocytes, eosinophils, basophils).

[0048] Chamber C22 is connected via a channel to a sixth reagent container containing the hemolytic reagent WNR. Chamber C22 is further connected via a channel to a seventh reagent container containing the staining reagent WNR. The preparation unit 162 supplies the hemolytic reagent WNR from the sixth reagent container to chamber C22 and supplies the staining reagent WNR from the seventh reagent container to chamber C22. In chamber C22, the sample, the hemolytic reagent WNR, and the staining reagent WNR are mixed to prepare the measurement sample WNR. The hemolytic reagent WNR is a reagent that lyses red blood cells and causes damage to the cell membrane of white blood cells to the extent that a fluorescent dye can penetrate it, and may contain a surfactant. The surfactant may be, for example, a nonionic surfactant. An example of the hemolytic reagent WNR is LyzaCell® WNR (manufactured by Sysmex Corporation). The staining reagent WNR is a reagent containing a fluorescent dye that stains white blood cells and nucleated red blood cells for the counting of white blood cells, basophils, and nucleated red blood cells. The fluorescent dye contained in the staining reagent WNR is, for example, a fluorescent dye that can be excited by light of wavelength λ20 and can bind to nucleic acids. The staining reagent WNR is, for example, Fluorocell® WNR (manufactured by Sysmex Corporation). Chamber C22 is connected to the optical detection unit 110 via a channel. The preparation unit 162 supplies the measurement sample WNR to the optical detection unit 110 via the channel. The measurement sample WNR is measured by the optical detection unit 110. The control unit 401 of the analysis unit 30 analyzes the measurement data of the measurement sample WNR and performs classification and counting of leukocytes, basophils, nucleated erythrocytes, etc.

[0049] Chamber C23 is connected via a channel to the eighth reagent container containing the diluent RET. Chamber C23 is further connected via a channel to the ninth reagent container containing the staining reagent RET. The preparation unit 162 supplies the diluent RET from the eighth reagent container to chamber C23 and supplies the staining reagent RET from the ninth reagent container to chamber C23. In chamber C23, the sample, the diluent RET, and the staining reagent RET are mixed to prepare the measurement sample RET. The diluent RET is a reagent for diluting the sample in a state suitable for measuring reticulocytes, and may be a buffer that disperses most of the red blood cells in the sample while maintaining their shape without hemolysis. The diluent RET may have its pH and osmotic pressure adjusted so that red blood cells do not dissolve, and may contain buffers or osmotic pressure adjusters. The diluent RET may be a buffer that does not contain, or substantially does not contain, a surfactant that hemolyzes red blood cells. An example of the diluent RET is Cellpack® DFL (manufactured by Sysmex Corporation). The staining reagent RET is a reagent containing a staining dye that stains nucleic acids contained in reticulocytes, for example, Fluorocell® RET (manufactured by Sysmex Corporation). Chamber C23 is connected to the optical detection unit 110 via a flow channel. The preparation unit 162 supplies the measurement sample RET to the optical detection unit 110 via the flow channel. The measurement sample RET is measured by the optical detection unit 110. The control unit 401 of the analysis unit 30 analyzes the measurement data of the measurement sample RET and performs classification and counting of reticulocytes, etc.

[0050] Chamber C23 is connected via a channel to a 10th reagent container containing diluent PLT-V. Chamber C23 is further connected via a channel to an 11th reagent container containing staining reagent PLT-V. The preparation unit 162 supplies diluent PLT-V from the 10th reagent container to chamber C23 and supplies staining reagent PLT-V from the 11th reagent container to chamber C23. In chamber C23, the sample, diluent PLT-V, and staining reagent PLT-V are mixed to prepare the measurement sample PLT-V. Diluent PLT-V is a reagent for diluting the sample in a state suitable for optical measurement of platelets, and may be a buffer that disperses most of the red blood cells contained in the sample while maintaining their shape without hemolysis. Diluent PLT-V may have its pH and osmotic pressure adjusted so that red blood cells are not dissolved, and may contain buffers or osmotic pressure adjusters. Diluent PLT-V may be a buffer that does not contain, or substantially does not contain, a surfactant that hemolyzes red blood cells. The dilution reagent PLT-V may be the same reagent as the dilution reagent RET, or it may be a special reagent for optically measuring platelets. Dilution reagent PLT-V is, for example, Cellpack® DFL (manufactured by Sysmex Corporation). Staining reagent PLT-V is a reagent containing a staining dye for specifically staining platelets, and is, for example, Fluorocell® PLT (manufactured by Sysmex Corporation). The preparation unit 162 supplies the measurement sample PLT-V to the optical detection unit 110 via a flow channel. The measurement sample PLT-V is measured by the optical detection unit 110. The control unit 401 of the analysis unit 30 analyzes the measurement data of the measurement sample PLT-V and performs classification and counting of platelets, etc.

[0051] Furthermore, chamber C23 is connected via a flow path to a 12th reagent container containing the diluent PAB. The preparation unit 162 supplies the diluent PAB from the 12th reagent container to chamber C23. In chamber C23, the sample and the diluent PAB are mixed to prepare the measurement sample PAB. The diluent PAB is a reagent for diluting the sample without dissolving aggregated platelets, and may be a buffer that disperses most of the red blood cells contained in the sample while maintaining their shape without hemolysis. The diluent PAB may have its pH and osmotic pressure adjusted so that red blood cells are not dissolved, and may contain buffers or osmotic pressure adjusters. The diluent PAB may be a buffer that does not contain, or substantially does not contain, a surfactant that hemolyzes red blood cells. The diluent PAB may be the same as any of the diluent RBC / PLT, diluent HGB, diluent PLT-V, or diluent RET, as long as it is a diluent that does not dissolve aggregated platelets, or it may be a dedicated diluent. In a preferred embodiment, the diluent PAB may be the same as the diluent RBC / PLT, for example, CellPak® DCL (manufactured by Sysmex Corporation). The preparation unit 162 supplies the measurement sample PAB to the optical detection unit 110 via a flow channel. The measurement sample PAB is measured by the optical detection unit 110. The control unit 401 of the analysis unit 30 analyzes the measurement data of the measurement sample PAB and determines whether or not platelet aggregation is present.

[0052] In the configuration example shown in Figure 6, chamber C23 is shared for the preparation of the three types of measurement samples, RET, PLT-V, and PAB, as described above. When multiple measurement samples are prepared for a single sample, they are prepared sequentially with staggered timings. In another embodiment, if only the first measurement item is to be measured, the measurement sample WDF is not prepared, and therefore chamber C21, which is not used for measurement, may be used as the chamber for preparing the measurement sample PAB.

[0053] Figure 7 is a schematic cross-sectional view showing the configuration of the suction tube 301.

[0054] The lower end 301a of the suction tube 301 has a cylindrical shape in which the lower end is notched by a surface that is inclined with respect to the horizontal plane. A channel 301b through which the sample passes is formed inside the suction tube 301. The channel 301b is formed along the vertical direction in which the suction tube 301 extends and is open to the outside from the side of the suction tube 301 at the lower end 301a.

[0055] The amount of sample aspirated from the sample container T by the suction tube 301 is constant regardless of the measurement order set for the sample. When a certain amount of sample is aspirated from the sample container T by the suction tube 301, the flow path 301b is filled with the sample, as shown in Figure 7. The sample that fills the flow path 301b is discharged sequentially into a predetermined chamber from the lower end 301a side. This discharge operation is performed continuously in response to a single aspiration of sample from the sample container T.

[0056] Specifically, a predetermined amount of sample located at the bottom of the flow path 301b is discharged into chamber C11 as a preparatory operation for discharge by the suction tube 301. The sample discharged into chamber C11 as a preparatory operation is then discarded via a disposal flow path described later.

[0057] Next, a predetermined amount of sample located above the sample for preparation in channel 301b is discharged into chamber C12 for the preparation of the measurement sample HGB. Next, a predetermined amount of sample located above the sample for the measurement sample HGB in channel 301b is discharged into chamber C11 for the preparation of the measurement sample RBC / PLT. Next, a predetermined amount of sample located above the sample for the measurement sample RBC / PLT in channel 301b is discharged into chamber C21 for the preparation of the measurement sample WDF. Next, a predetermined amount of sample located above the sample for the measurement sample WDF in channel 301b is discharged into chamber C23 for the preparation of the measurement sample PAB.

[0058] Next, a predetermined amount of sample located above the sample for measurement sample PAB in channel 301b is discharged into chamber C22 for the preparation of measurement sample WNR. Subsequently, a predetermined amount of sample located above the sample for measurement sample WNR in channel 301b is discharged into chamber C23 for the preparation of measurement sample RET. Subsequently, a predetermined amount of sample located above the sample for measurement sample RET in channel 301b is discharged into chamber C23 for the preparation of measurement sample PLT-V.

[0059] In the dispensing operation described above, the amount of sample dispensed into each chamber is determined to a predetermined amount in accordance with the preparation operation and the preparation of each measurement sample. The amount of sample used to prepare the measurement sample PAB may be less than the amount of sample used to prepare the measurement sample for measuring white blood cell count or white blood cell classification, i.e., the measurement sample WNR or measurement sample WDF. For example, the amount of sample used to prepare the measurement sample PAB is 5 μL. For example, the amount of sample used to prepare the measurement sample WNR is 17 μL. For example, the amount of sample used to prepare the WDF is 17 μL. By reducing the amount of sample used to prepare the measurement sample PAB, the amount of sample aspirated from the sample container T can be reduced, thereby reducing the minimum sample volume required for measurement, and increasing the possibility of measurement with, for example, pediatric blood or small blood volumes.

[0060] Furthermore, samples corresponding to measurement samples that do not require preparation are discarded without being used for the preparation of the measurement samples. For example, if the preparation of the measurement sample RET is not required, the sample for the measurement sample RET is discharged from the lower end 301a of the suction tube 301 with the tip of the suction tube 301 positioned at the height of the washer 302 (see Figure 8) and collected by the washer 302. Unnecessary samples in the suction tube 301 may also be disposed of by discharging them into an empty chamber and having them discharged from that chamber, without using the washer 302.

[0061] As shown in Figure 7, the reason why the dispensing order to each chamber is predetermined is that when a sample is aspirated into the suction tube 301, a concentration gradient is created in the vertical direction in the flow path 301b of the suction tube 301. Since the amount of sample aspirated into the suction tube 301 is constant, if the dispensing order to each chamber is not changed, the concentration of the sample dispensed into each chamber can be set to be nearly constant for each measurement. This suppresses variability in measurement data based on concentration gradients.

[0062] Figure 8 shows the configuration for aspirating and discharging a sample via the suction tube 301.

[0063] The specimen container T comprises a body T1 having an opening at its upper end and capable of containing a specimen, and a lid T2 for sealing the upper end of the body T1. The specimen container T is, for example, an EDTA blood collection tube containing EDTA as an anticoagulant. The suction tube 301 is transported by the suction tube transport unit, so that its lower end 301a punctures the lid T2 from above and is inserted into the body T1. In this state, the specimen is aspirated from inside the specimen container T. The suction tube 301 is also transported by the suction tube transport unit, so that its lower end 301a is inserted into the chambers C11, C12, C21-C23. In this state, the specimen in the suction tube 301 is discharged into the chambers.

[0064] The upper end of the suction tube 301 is connected to the syringe pump 311 via a flow path, and a valve 312 is located in this flow path. The syringe pump 311 is equipped with a piston and a motor and is configured to apply a predetermined pressure to the flow path, thereby aspirating a predetermined amount of sample from the sample container T via the suction tube 301 and discharging a predetermined amount of the aspirated sample via the suction tube 301.

[0065] The sample aspirated by the suction tube 301 is dispensed into at least one of the chambers C11, C12, C21-C23, based on the measurement order set for the sample. In each chamber, the sample is mixed with a predetermined liquid reagent to prepare the measurement sample. Once the dispensing of the sample is complete, the sample remaining in the suction tube 301 is discarded. For sample disposal, for example, the syringe pump 311 may draw in the sample remaining in the suction tube 301 and discard it via the valve 313. Alternatively, the remaining sample may be discarded through the washer 302.

[0066] When cleaning the flow path 301b (see Figure 7) of the suction tube 301, the lower end 301a (see Figure 7) of the suction tube 301 is positioned inside the washer 302. In this state, the syringe pump 311 transfers the cleaning fluid supplied to the syringe pump 311 to the suction tube 301. The cleaning fluid transferred to the suction tube 301 is discharged from the opening at the lower end 301a and discarded through the washer 302. When cleaning the outer surface of the suction tube 301, the suction tube 301 is moved vertically relative to the washer 302. At this time, the cleaning fluid supplied to the washer 302 hits the outer surface of the suction tube 301 and is discarded through the washer 302. In this way, the inside and outside of the suction tube 301 are cleaned.

[0067] For example, the dilution reagent RBC / PLT may be used as the cleaning solution for cleaning the suction tube 301. Also, for example, the dilution reagent RBC / PLT may be used as the cleaning solution for cleaning the chamber, flow path, and detection unit, as well as as the sheath liquid supplied to the detection unit and flow path, as will be explained with reference to Figures 9 and 10.

[0068] Figures 7 and 8 illustrate a so-called pipetting method, in which a suction tube 301 is inserted into each chamber and a predetermined amount of sample is dispensed to quantitatively distribute the sample to each of the chambers C11, C12, C21, C22, and C23. The method of distributing the sample to multiple chambers is not limited to the pipetting method; for example, a sampling valve method may also be used. In the sampling valve method, the sample aspirated from the sample container T is introduced into a predetermined volume flow path provided in a rotary valve, the rotary valve is rotated to quantify the sample, and the quantified sample is delivered to the chambers via the flow path. With the sampling valve method, it is not necessary to distribute the sample to each chamber sequentially, and it is possible to achieve the entire process from sample quantification to distribution in a short time.

[0069] Figure 9 shows the configuration of the fluid circuit connected to chambers C11 and C12, the electrical detection unit 120, and the hemoglobin detection unit 130.

[0070] Chambers C11 and C12 are containers with open tops. The sample aspirated from the sample container T by the suction tube 301 is discharged into the chambers C11 and C12 through the opening at the top. Each chamber C11 and C12 also includes an inlet 321 for supplying reagents, an outlet 322 for discharging the measurement sample prepared in the chamber, and a waste port 323 for discarding the liquid inside the chamber. Chamber C22 further includes an inlet 324 for supplying reagents.

[0071] Chamber C11 is supplied with the diluent RBC / PLT via inlet 321. In chamber C11, the sample and the diluent RBC / PLT are mixed to prepare the measurement sample RBC / PLT. Chamber C12 is supplied with the hemolytic reagent HGB via inlet 324 and the diluent HGB via inlet 321. In chamber C12, the sample, the hemolytic reagent HGB, and the diluent HGB are mixed to prepare the measurement sample HGB.

[0072] The outlet 322 of chamber C11 is connected to the flow path 341 via valve 331. The syringe pump 342, valve 343, and electric detection unit 120 are connected to the flow path 341. The outlet 322 of chamber C12 is connected to the hemoglobin detection unit 130 via valve 333. The hemoglobin detection unit 130 is connected to the flow path 344 via valve 334. Valves 343 and 345 are connected to the flow path 344. The diaphragm pump 346 is connected to the flow path 344 via valve 345. Valve 347 is connected to the flow path between valve 345 and the diaphragm pump 346. The waste ports 323 of chambers C11 and C12 are connected to the waste flow paths via valves 332 and 335, respectively.

[0073] Once the preparation of the RBC / PLT sample in chamber C11 is complete, the diaphragm pump 346 draws the RBC / PLT sample from chamber C11 into the flow path 341. The syringe pump 342 supplies the RBC / PLT sample stored in the flow path 341, along with the sheath fluid, to the electrical detection unit 120. The syringe pump 342 is configured to transfer a predetermined amount of the RBC / PLT sample stored in the flow path 341 to the electrical detection unit 120 by applying a predetermined pressure to the flow path 341.

[0074] The electrical detection unit 120 flows the measurement sample RBC / PLT and sheath fluid through the aperture 123 (see Figure 5) and applies a voltage to the aperture 123. The electrical detection unit 120 detects electrical signals corresponding to red blood cells and platelets in the measurement sample RBC / PLT flowing through the aperture 123. The measurement sample RBC / PLT that has passed through the aperture 123 of the electrical detection unit 120 is collected through the recovery tube 125 and discarded.

[0075] When the required amount of measurement sample RBC / PLT is supplied from chamber C11, cleaning solution is supplied to chamber C11, and chamber C11 is cleaned. The cleaning solution in chamber C11 is discarded through the waste port 323 and discharged into the flow path 341 via the outlet 322. The cleaning solution discharged into the flow path 341 is discarded through the valve 347. In addition, the cleaning solution discharged into the flow path 341 is also supplied to the electrical detection unit 120, and the inside of the electrical detection unit 120 is cleaned.

[0076] Once the preparation of the HGB sample in chamber C12 is complete, the HGB sample is supplied to the hemoglobin detection unit 130 via valve 333 and placed in cell 131 (see Figure 5). Light is shone onto the HGB sample in cell 131, and the transmitted light is received. An optical signal corresponding to the absorbance is detected based on the transmitted light intensity. The hemoglobin detection unit 130 detects an optical signal corresponding to the amount of hemoglobin based on the HGB sample using the SLS-hemoglobin method. The HGB sample used for measurement in the hemoglobin detection unit 130 is discarded.

[0077] Once the measurement of the HGB sample by the hemoglobin detection unit 130 is complete, a washing solution is supplied to the chamber C12, and the chamber C12 is washed. The washing solution in the chamber C12 is discarded through the waste port 323 and discharged to the hemoglobin detection unit 130 through the outlet 322. The washing solution discharged to the hemoglobin detection unit 130 washes the inside of the hemoglobin detection unit 130 and is discharged into the flow path 344. The washing solution discharged into the flow path 344 is discarded through the valve 347.

[0078] Figure 10 shows the configuration of the fluid circuit connected to chambers C21 to C23 and the optical detection unit 110.

[0079] Chambers C21 to C23 may have the same shape as chamber C11 shown in Figure 9. The sample aspirated from the sample container T by the suction tube 301 is discharged into the chambers C21 to C23 through the openings at the upper ends.

[0080] Chamber C21 is supplied with hemolytic reagent WDF and staining reagent WDF via inlet 321. In chamber C21, the sample, hemolytic reagent WDF, and staining reagent WDF are mixed to prepare the measurement sample WDF. Chamber C22 is supplied with hemolytic reagent WNR and staining reagent WNR via inlet 321. In chamber C22, the sample, hemolytic reagent WNR, and staining reagent WNR are mixed to prepare the measurement sample WNR.

[0081] Dilution reagent RET and staining reagent RET are supplied to chamber C23 via inlet 321. In chamber C23, the sample, dilution reagent RET, and staining reagent RET are mixed to prepare the measurement sample RET. Dilution reagent PLT-V and staining reagent PLT-V are also supplied to chamber C23 via inlet 321. In chamber C23, the sample, dilution reagent PLT-V, and staining reagent PLT-V are mixed to prepare the measurement sample PLT-V. Dilution reagent PAB is also supplied to chamber C23 via inlet 321. In chamber C23, the sample and dilution reagent PAB are mixed to prepare the measurement sample PAB.

[0082] The outlets 322 of chambers C21 to C23 are each connected to a flow path 361 via valves 351. A syringe pump 362, a valve 363, and an optical detection unit 110 are connected to the flow path 361. A diaphragm pump 364 is connected to the flow path 361 via valve 363. A valve 365 is connected to the flow path between valve 363 and the diaphragm pump 364. The waste ports 323 of chambers C21 to C23 are each connected to the waste flow path via valves 352.

[0083] Once the preparation of the measurement sample is complete in each chamber C21 to C23, the diaphragm pump 364 draws the prepared measurement sample from the corresponding chamber into the flow path 361. The syringe pump 362 supplies the measurement sample stored in the flow path 361 to the optical detection unit 110. The syringe pump 362 is configured to transfer a predetermined amount of the measurement sample stored in the flow path 361 to the optical detection unit 110 by applying a predetermined pressure to the flow path 361.

[0084] The optical detection unit 110 flows the sample to be measured and the sheath fluid into the flow cell 211 (see Figure 3) and detects the optical signal corresponding to the cells in the sample to be measured based on the flow cytometry method.

[0085] The optical detection unit 110 measures the WDF of the sample and detects optical signals corresponding to leukocytes, etc., in the WDF of the sample. The optical detection unit 110 measures the WNR of the sample and detects optical signals corresponding to leukocytes, basophils, nucleated red blood cells, etc., in the WNR of the sample. The optical detection unit 110 measures the RET of the sample and detects optical signals corresponding to reticulocytes, etc., in the RET of the sample. The optical detection unit 110 measures the PLT-V of the sample and detects optical signals corresponding to platelets, etc., in the PLT-V of the sample. The optical detection unit 110 measures the PAB of the sample and detects optical signals corresponding to aggregated platelets, etc., in the PAB of the sample. The optical detection unit 110 measures each sample individually. Samples that have passed through the flow cell 211 of the optical detection unit 110 are discarded.

[0086] Once measurement by the optical detection unit 110 is completed for one sample, cleaning solution is supplied to the chamber in which the sample was prepared. The cleaning solution in the chamber is then discarded through the waste port 323 and valve 352, and also discharged into the flow path 361 via the outlet 322. The cleaning solution discharged into the flow path 361 is then discarded through valve 365.

[0087] Figure 11 is a block diagram showing the functional configuration of the analysis unit 30.

[0088] The analysis unit 30 comprises a control unit 401, a storage unit 402, and a communication unit 403. The analysis unit 30 also includes a display unit 31 and an operation unit 32 as shown in Figure 1.

[0089] The control unit 401 is composed of, for example, a CPU. The control unit 401 performs sample analysis and controls the measurement unit 10 and the transport unit 20 by executing a computer program stored in the storage unit 402. The storage unit 402 is composed of, for example, an HDD or SSD. The storage unit 402 stores a measurement order set for each sample, measurement data received from the measurement unit 10, analysis results based on the measurement data, and a program for controlling the analysis unit 30, the measurement unit 10, and the transport unit 20.

[0090] The communication unit 403 is configured with connection terminals based on the USB standard and communicates with the measurement unit 10 and the transport unit 20 via a cable based on the USB standard. The control unit 401 receives measurement data acquired by the measurement unit 10 via the communication unit 403.

[0091] Figure 12 shows the relationship between the measurement mode and the sample being measured.

[0092] The sample measuring device 1 determines the measurement mode according to the measurement parameters included in the measurement order. The sample measuring device 1 is configured to measure samples using, for example, the following eight measurement modes.

[0093] (1) CBC (2) CBC + DIFF (3) CBC+RET (4) CBC+DIFF+RET (5) CBC+PLT-V (6) CBC+DIFF+PLT-V (7) CBC+RET+PLT-V (8) CBC+DIFF+RET+PLT-V

[0094] Each of the measurement modes (1) to (8) above includes one or more measurement items from CBC, DIFF, RET, and PLT-V, and at least one measurement item, CBC. The measurement order includes the measurement parameters to be performed on the sample (e.g., WBC: white blood cell count, PLT: platelet count, etc.). The measurement mode is determined according to the measurement parameters included in the measurement order.

[0095] For example, the measurement parameters corresponding to the measurement item CBC (Complete Blood Count) include red blood cell count (RBC), white blood cell count (WBC), hemoglobin level (HGB), hematocrit value (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and platelet count (PLT). The measurement parameters corresponding to the measurement item CBC may further include nucleated red blood cell count (NRBC#), nucleated red blood cell percentage (NRBC%), basophil count (BASO#), and basophil percentage (BASO%).

[0096] Red blood cell count (RBC), platelet count (PLT), and hematocrit value (HCT) are determined based on the electrical signals obtained by the electrical detection unit 120 measuring the RBC / PLT of the sample. White blood cell count (WBC) is determined based on the optical signals obtained by the optical detection unit 110 measuring the WNR of the sample. Hemoglobin level (HGB) is determined based on the optical signals obtained by the hemoglobin detection unit 130 measuring the HGB of the sample. Mean corpuscular volume (MCV) is determined from the red blood cell count (RBC) and hematocrit value (HCT). Mean corpuscular hemoglobin (MCH) is determined from the red blood cell count (RBC) and hemoglobin level (HGB). Mean corpuscular hemoglobin concentration (MCHC) is determined from the hematocrit value (HCT) and hemoglobin level (HGB).

[0097] The measurement parameters corresponding to the measurement item DIFF include neutrophil count (NEUT#), lymphocyte count (LYMPH#), monocyte count (MONO#), eosinophil count (EO#), neutrophil ratio (NEUT%), lymphocyte ratio (LYMPH%), monocyte ratio (MONO%), and eosinophil ratio (EO%). In the measurement item DIFF, the measurement sample WDF is measured by the optical detection unit 110, classifying white blood cells into multiple subgroups (neutrophils, lymphocytes, monocytes, eosinophils), and each classified subgroup is counted. As described above, if the measurement item CBC includes basophil count (BASO#) as a measurement parameter, white blood cells may be classified into five subgroups (neutrophils, lymphocytes, monocytes, eosinophils, basophils) based on the measurement data of the measurement items CBC and DIFF, and each of the five classified subgroups may be counted.

[0098] The measurement parameters corresponding to the measurement item RET include the reticulocyte count (RET#). The measurement parameters corresponding to the measurement item RET may further include the reticulocyte percentage (RET%), low fluorescence reticulocyte percentage (LFR), medium fluorescence reticulocyte percentage (MFR), and high fluorescence reticulocyte percentage (HFR). In the measurement item RET, the measurement sample RET is measured by the optical detection unit 110, thereby classifying mature red blood cells and reticulocytes, and the classified reticulocytes are counted. The measurement parameters corresponding to the measurement item RET may further include the platelet count (PLT#) obtained by optically measuring the platelet count.

[0099] The measurement parameters corresponding to the measurement item PLT-V include platelet count (PLT). The measurement parameters corresponding to the measurement item PLT-V may further include immature platelet ratio (IPF) and immature platelet count (IPF#). In the measurement item PLT-V, the platelets are classified by the measurement of the PLT-V sample by the optical detection unit 110, and the classified platelets are counted.

[0100] If the measurement order includes only measurement parameters related to the measurement item CBC, the sample measuring device 1 determines the measurement mode to CBC. In measurement mode CBC, the sample measuring device 1 prepares the measurement samples RBC / PLT, HGB, WNR, and PAB as shown in Figure 12.

[0101] If the measurement parameters included in the measurement order are measurement parameters related to the measurement items CBC and DIFF, the sample measuring device 1 determines the measurement mode to CBC+DIFF. In the measurement mode CBC+DIFF, the sample measuring device 1 prepares the measurement samples RBC / PLT, HGB, WNR, WDF, and PAB as shown in Figure 12.

[0102] If the measurement parameters included in the measurement order are measurement parameters related to the measurement items CBC and RET, the sample measuring device 1 determines the measurement mode to CBC+RET. In the measurement mode CBC+RET, the sample measuring device 1 prepares the measurement samples RBC / PLT, HGB, WNR, and RET as shown in Figure 12.

[0103] If the measurement parameters included in the measurement order are measurement parameters related to the measurement items CBC, DIFF, and RET, the sample measuring device 1 determines the measurement mode to CBC+DIFF+RET. In the measurement mode CBC+DIFF+RET, the sample measuring device 1 prepares the measurement samples RBC / PLT, HGB, WNR, WDF, and RET as shown in Figure 12.

[0104] If the measurement parameters included in the measurement order are measurement parameters related to the measurement items CBC and PLT-V, the sample measuring device 1 determines the measurement mode to CBC+PLT-V. In the measurement mode CBC+PLT-V, the sample measuring device 1 prepares the measurement samples RBC / PLT, HGB, WNR, and PLT-V as shown in Figure 12.

[0105] If the measurement parameters included in the measurement order are measurement parameters related to the measurement items CBC, DIFF, and PLT-V, the sample measuring device 1 determines the measurement mode to CBC+DIFF+PLT-V. In the measurement mode CBC+DIFF+PLT-V, the sample measuring device 1 prepares the measurement samples RBC / PLT, HGB, WNR, WDF, and PLT-V as shown in Figure 12.

[0106] If the measurement parameters included in the measurement order are measurement parameters related to the measurement items CBC, RET, and PLT-V, the sample measuring device 1 determines the measurement mode to CBC+RET+PLT-V. In the measurement mode CBC+RET+PLT-V, the sample measuring device 1 prepares the measurement samples RBC / PLT, HGB, WNR, RET, and PLT-V as shown in Figure 12.

[0107] If the measurement parameters included in the measurement order are measurement parameters for the measurement items CBC, DIFF, RET, and PLT-V, the sample measuring device 1 determines the measurement mode to CBC+DIFF+RET+PLT-V. In the measurement mode CBC+DIFF+RET+PLT-V, the sample measuring device 1 prepares the measurement samples RBC / PLT, HGB, WNR, WDF, RET, and PLT-V as shown in Figure 12.

[0108] The sample measuring device 1 supplies the prepared sample to the optical detection unit 110, the electrical detection unit 120, and the hemoglobin detection unit 130 in each measurement mode, and measures each sample.

[0109] Next, referring to Figure 13, we will explain the analysis based on the measurement data of the RBC / PLT sample acquired using the electrical detection unit 120.

[0110] The control unit 401 of the analysis unit 30 generates the RBC / PLT histogram shown in Figure 13 based on the measurement data obtained from the measurement of the RBC / PLT sample. In the RBC / PLT histogram, the horizontal axis represents the value corresponding to the cell size, and the vertical axis represents the frequency (number).

[0111] Generally, red blood cells are larger than platelets. The diameter of red blood cells in healthy blood is 7 μm to 8 μm, while the diameter of platelets is 2 μm to 4 μm. Therefore, as shown in the upper part of Figure 13, in healthy individuals, the peaks corresponding to the red blood cell population and the peaks corresponding to the platelet population appear clearly separated in the particle size distribution. By utilizing this difference in size, the control unit 401 of the analysis unit 30 can count red blood cells and platelets in the blood. For example, the control unit 401 of the analysis unit 30 sets a threshold Sth for cell size between the red blood cell peak and the platelet peak, counting cells smaller than the threshold Sth as platelets and cells larger than or equal to the threshold Sth as red blood cells.

[0112] When platelet aggregation occurs in the RBC / PLT sample, the aggregated platelets are larger in size and therefore not included in the platelet population. As shown in the lower part of Figure 13, the number of cells in the region corresponding to the platelets may decrease. Therefore, for example, by comparing the platelet count with a threshold and performing a remeasurement by the optical detection unit 110 when the platelet count falls below the threshold, it is possible to detect that platelet aggregation has occurred. Patent Document 1 proposes a method for detecting platelet aggregation by triggering a remeasurement by the optical detection unit based on such an abnormality in the platelet count.

[0113] However, even if platelet aggregation occurs, the platelet count may not fall below the threshold. In this case, there may be a certain number of cells in the region corresponding to platelets, and re-measurement may not be performed. Therefore, platelet aggregation may be overlooked in Patent Document 1.

[0114] In contrast, in this embodiment, in the measurement mode CBC or measurement mode CBC+DIFF, where the platelet count is measured as a measurement parameter, the measurement sample PAB is automatically measured by the optical detection unit 110 without depending on the platelet count result, and platelet aggregation is detected based on the obtained measurement data. Therefore, the sample measurement device 1 of this embodiment can reduce the chances of overlooking platelet aggregation.

[0115] Next, with reference to Figure 14, an example of an analysis method based on measurement data of the measurement sample PAB acquired using the optical detection unit 110 will be described. The upper part of Figure 14 shows a scattergram PAB in which platelet aggregation was determined not to have occurred, and the lower part of Figure 14 shows a scattergram PAB in which platelet aggregation was determined to have occurred. In the following, for the sake of explanation, an example will be described in which the control unit 401 plots cells on the scattergram and counts the cells by gating, but cells plotted at a specific gate may also be counted by calculation.

[0116] The control unit 401 of the analysis unit 30 generates a scattergram PAB shown in Figure 14 based on the measurement data obtained from the measurement of the measurement sample PAB. In the scattergram PAB, the horizontal axis corresponds to the width (R-FSC_W) of the waveform data acquired based on the forward scattered light generated by the light of wavelength λ20 (red wavelength band) emitted from the light source 202, and the vertical axis corresponds to the peak value (R-FSC_P) of the waveform data acquired based on the forward scattered light generated by the light of wavelength λ20 (red wavelength band) emitted from the light source 202.

[0117] The control unit 401 plots cells on a scattergram consisting of a vertical axis and a horizontal axis as described above, using measurement data based on the measured sample PAB, and generates a scattergram PAB. The control unit 401 analyzes the scattergram PAB to detect platelet aggregation. The methods exemplified in (1) to (3) below may be used to detect platelet aggregation.

[0118] (1) Detection based on platelet aggregation ratio This method detects platelet aggregation by determining the ratio of aggregated platelets to non-aggregated platelets based on the number of aggregated and non-aggregated platelets plotted on the scattergram PAB. For example, the control unit 401 sets two regions on the scattergram PAB, as shown by the dashed lines: (B11) where non-aggregated platelets are distributed, and (B12) where aggregated platelets are distributed. Aggregated platelets have a larger surface area and length than non-aggregated platelets. Therefore, aggregated and non-aggregated platelets can be distinguished by the forward scattered light peak value, which is a representative value reflecting the surface area of ​​the cell, and the width of the forward scattered light waveform data, which is a representative value reflecting the length of the cell. Thus, aggregated platelets can be detected by setting regions B11 and B12 as shown in Figure 14.

[0119] These two regions B11 and B12 are predetermined regions common to all samples. However, these two regions B11 and B12 may be set variably for each sample based on the centroid position of the plot within the initial region.

[0120] As shown by the dashed lines, the scattergram PAB contains regions where cells suspected to be red blood cells (B13), fragmented red blood cells (B14), and microcytic red blood cells are distributed. Red blood cells are larger than platelets and are therefore distributed in the upper right of the scattergram PAB. Fragmented red blood cells and microcytic red blood cells are smaller than normal red blood cells but slightly larger than platelets, and have a narrower particle width, so they are distributed near the upper left of regions B11 and B12, as shown in Figure 14. Thus, in the scattergram PAB, the distribution regions of normal red blood cells, fragmented red blood cells, and microcytic red blood cells are separated from the distribution regions of non-aggregated and aggregated platelets. Therefore, by defining regions B11 and B12 as shown in Figure 14, non-aggregated and aggregated platelets can be classified separately from red blood cells, fragmented red blood cells, and microcytic red blood cells.

[0121] The control unit 401 obtains the number of cells in regions B11 and B12, respectively, in the scattergram PAB. The control unit 401 obtains the aggregated platelet ratio by dividing the number of cells in region B12 by the number of cells in region B11. The control unit 401 compares the aggregated platelet ratio with a predetermined threshold and determines that platelet aggregation has occurred if the aggregated platelet ratio is higher than the predetermined threshold. Figure 14 shows an example in which the number of cells plotted in region B11 of the scattergram PAB with R-FSC_W and R-FSC_P as two axes is used as the number of non-aggregated platelets, but the number of cells identified using other representative values ​​may also be used as the number of non-aggregated platelets. For example, the number of non-aggregated platelets may be determined in a scattergram with forward scattered light intensity (R-FSC_P) and side scattered light intensity (R-SSC_P) as two axes.

[0122] (2) Detection based on the number of platelet aggregates Platelet aggregation may be detected based solely on the number of aggregated platelets, without using the number of non-aggregated platelets. For example, the control unit 401 may determine that platelet aggregation has occurred in the target sample if the number of aggregated platelets obtained based on the scattergram PAB is above a predetermined threshold. In this case, the control unit 401 may set only region B12 and not region B11.

[0123] (3) Detection based on the extent of distribution of platelet populations Platelet aggregation may be detected based on the extent of the distribution of the platelet population without distinguishing between non-aggregated and aggregated platelets. For example, the control unit 401 creates a particle size distribution of R-FSC_W with the width of the waveform data of forward scattered light as the axis for the platelet population included in regions B11 and B12 of the scattergram PAB. In such a particle size distribution, it becomes a normal distribution with a peak on the lower side of R-FSC_W. When platelet aggregation occurs, aggregated platelets appear on the higher side of R-FSC_W, so when the above particle size distribution is drawn, the distribution tends to spread on the higher side. A parameter that reflects this spread of distribution may be obtained, and it may be determined that platelet aggregation has occurred if the parameter is greater than a threshold. As a parameter that reflects the spread of distribution, for example, the half-width at half the height of the peak of the particle size distribution or the standard deviation may be used.

[0124] Next, referring to Figure 15, we will explain the verification conducted by the inventors regarding the accuracy of platelet aggregation determination based on the scattergram PAB.

[0125] In this study, 19 blood samples were used. A medical technologist prepared smears from the 19 blood samples and visually examined each smear to determine whether or not platelet aggregation was present in each sample. As a result, 6 samples were determined to have platelet aggregation by visual inspection, i.e., positive samples, and 13 samples were determined not to have platelet aggregation by visual inspection, i.e., negative samples.

[0126] The inventors used these 19 samples and had the sample measuring device 1 perform a scattergram PAB analysis. Platelet aggregation was determined to have occurred when the number of cells in region B12 was above a predetermined threshold. The results of the platelet aggregation determination are shown in Figure 15.

[0127] The number of true positives, false positives, true negatives, and false negatives were 6, 1, 12, and 0, respectively. The sensitivity was 100.0%, and the specificity was 92.3%. The 100% sensitivity indicates that the analysis method of this embodiment using scattergram PAB can achieve platelet aggregation detection with minimal missed detections.

[0128] The measurement of the PAB sample may be configured to be performed automatically in all measurement modes that include the measurement item CBC, or the measurement items CBC and DIFF. For example, since all eight measurement modes described above include the measurement item CBC, the system may be configured to automatically prepare and measure the PAB sample regardless of which of the eight measurement modes is selected. However, in a preferred example, if the measurement item includes the measurement of platelets by the optical detection unit 110, the measurement of the PAB sample may be omitted. For example, in measurement modes that include the measurement item RET or PLT-V, the PAB sample does not need to be measured. In this case, a scattergram similar to the PAB scattergram is generated based on the RET and PLT-V samples, and platelet aggregation is determined using this scattergram.

[0129] When a measurement sample RET is prepared according to the measurement item RET, or when a measurement sample PLT-V is prepared according to the measurement item PLT-V, the control unit 401 of the analysis unit 30 generates a scattergram with R-FSC_W on the horizontal axis and R-FSC_P on the vertical axis based on the prepared measurement sample RET or measurement sample PLT-V. The control unit 401 then determines platelet aggregation in the same manner as in Figure 14. If both measurement samples RET and PLT-V are prepared, the control unit 401 determines platelet aggregation based on the measurement sample PLT-V.

[0130] Thus, when the measurement mode includes the measurement item RET or PLT-V, platelet aggregation can be determined using the measurement sample RET or measurement sample PLT-V instead of the measurement sample PAB. This is because, since hemolytic reagents are not used in the preparation of the measurement samples RET and PLT-V, platelets are not dissolved, and it is possible to classify aggregated platelets using a scattergram on the same axis as the scattergram PAB.

[0131] Figure 16 shows the configuration of the analysis results list screen 500.

[0132] When the control unit 401 receives a display instruction for the analysis results list screen 500, it displays the analysis results list screen 500 on the display unit 31 and performs processing according to the operator's operation on the analysis results list screen 500.

[0133] The analysis results list screen 500 comprises a list area 501 and a detail area 502.

[0134] Each row in the list area 501 indicates the measurement performed during a single sample aspiration. The list area 501 has multiple items, including a sample ID that identifies the sample, the measurement type (described later), the measurement date and time, and the result value for each measurement parameter.

[0135] The measurement type can be one of the following values: "Initial", "Repeat", "Rerun", or "Reflex". "Initial" indicates that the sample measuring device 1 is performing the first measurement (initial test) on the sample with the sample ID included in the measurement order. "Repeat" indicates that the measurement was performed again on the same sample if an error occurred during the "Initial" measurement. "Rerun" indicates that the measurement was performed again on the same sample using the same measurement mode as the Initial measurement if the result of the "Initial" measurement matched a predetermined Rerun rule. "Reflex" indicates that the measurement was performed again on the same sample using a different measurement mode than the Initial measurement (reflex measurement) if the result of the "Initial" measurement matched a predetermined Reflex rule.

[0136] In the list area 501 illustrated in Figure 16, the sample IDs in the second and third rows are both "0002," the measurement type in the second row is "Initial," and the measurement type in the third row is "Reflex." Therefore, it can be seen that the Reflex measurement in the third row was performed using a different measurement mode than the initial measurement indicated in the second row.

[0137] When an operator performs a predetermined operation (e.g., click) on a row in the list area 501, the row becomes selected, as indicated by the diagonal lines in Figure 16. The detail area 502 displays the details of the result values ​​for each measurement parameter obtained from the measurement of the row selected in the list area 501. Furthermore, when an operator performs a predetermined operation (e.g., double-click) on a row in the list area 501, even more detailed analysis results corresponding to that row are displayed on the analysis result display screen 600 shown in Figure 16.

[0138] Figure 17 shows the configuration of the analysis results display screen 600.

[0139] When the control unit 401 receives a display instruction for the analysis results display screen 600, it displays the analysis results display screen 600 on the display unit 31 and processes the data according to the operator's operation on the analysis results display screen 600. The content displayed on the analysis results display screen 600 is based on the analysis results for one row of the list area 501 shown in Figure 16.

[0140] As shown in Figure 17, the analysis results display screen 600 includes an analysis information display area 601, a result value display area 610, a graph display area 620, and a flag display area 630.

[0141] The analysis information display area 601 displays the sample ID and measurement mode. The result value display area 610 displays lists corresponding to the measurement items CBC, DIFF, RET, and PLT-V. Each list displays the result values ​​of the measurement parameters included in each measurement item. The graph display area 620 displays the scattergram WDF based on the measurement sample WDF, the scattergram WNR based on the measurement sample WNR, the scattergram RET based on the measurement sample RET, the scattergram PLT-V based on the measurement sample PLT-V, the histogram RBC based on the measurement sample RBC / PLT, and the histogram PLT based on the measurement sample RBC / PLT. The histograms RBC and PLT are generated based on the histogram RBC / PLT exemplified in Figure 13. The flag display area 630 includes areas for displaying information about white blood cells, areas for displaying information about red blood cells, and areas for displaying information about platelets.

[0142] Figure 18 is an example of the analysis result display screen 600 based on the measurement mode CBC+DIFF, and Figure 19 is an example of the analysis result display screen 600 based on the measurement mode CBC+DIFF+RET+PLT-V.

[0143] In the analysis results display screen 600 of Figure 18, since the measurement mode for the analysis is CBC+DIFF, the result value display area 610 displays the result values ​​of the measurement parameters included in the measurement items CBC and DIFF, and the graph display area 620 displays the scattergram WDF, WNR and histogram RBC, PLT. In this case, the result value of platelet count (PLT) in the measurement item CBC in the result value display area 610 displays the platelet count obtained based on the measurement sample RBC / PLT.

[0144] In the example shown in Figure 18, the number of aggregated platelets in the scattergram PAB (see Figure 14) based on the measured sample PAB was above a predetermined threshold, so the message "PLT Clumps?" indicating the presence of aggregated platelets is displayed in the area of ​​the flag display area 630 that displays information about platelets.

[0145] Furthermore, since the measurement corresponding to the analysis result was a first measurement, button 641, indicating that it is a first measurement, is displayed in a selected state on the analysis result display screen 600. In Figure 18, the selected state of button 641 is indicated by halftone dots for convenience. In addition, since there is a Reflex measurement corresponding to the analysis result, button 642 for displaying the analysis result of the Reflex measurement corresponding to the analysis result is displayed on the analysis result display screen 600. By operating button 642, the operator can display the analysis result of the Reflex measurement on the analysis result display screen 600.

[0146] In the analysis results display screen 600 of Figure 19, since the measurement mode for the analysis is CBC+DIFF+RET+PLT-V, the result value display area 610 displays the result values ​​of the measurement parameters included in the measurement items CBC, DIFF, RET, and PLT-V, and the graph display area 620 displays the scattergrams WDF, WNR, RET, PLT-V and the histograms RBC and PLT. In this case, the result value of platelet count (PLT) in the measurement item CBC in the result value display area 610 displays the platelet count obtained based on the measurement sample PLT-V.

[0147] In the example shown in Figure 19, the measurement data based on the measurement sample PLT-V is plotted on a scattergram with axes similar to those of the scattergram PAB (see Figure 14). Based on this scattergram, the number of aggregated platelets is above a predetermined threshold, and therefore the message "PLT Clumps?" indicating that aggregated platelets have occurred is displayed in the area of ​​the flag display area 630 that displays information about platelets.

[0148] Furthermore, since the measurement corresponding to the analysis result is a Reflex measurement, button 642, which indicates that it is a Reflex measurement, is displayed in a selected state on the analysis result display screen 600. In Figure 19, the selected state of button 642 is indicated by halftone dots for convenience. By operating button 641, the operator can display the corresponding initial analysis result on the analysis result display screen 600.

[0149] Next, with reference to Figures 20 and 21, we will describe the time charts for sample dispensing, sample preparation, and measurement based on the measurement order.

[0150] In the time charts shown in Figures 20 and 21, the rightward direction indicates the passage of time, and the time span between two adjacent vertical lines is 1 second. For convenience, the horizontal axis in Figures 20 and 21 shows the elapsed time in seconds. The control unit 401 of the analysis unit 30 controls the dispensing of samples in each chamber, the preparation of measurement samples, and the measurement by each detection unit, as shown in the time charts. The control unit 401 executes one operation sequence for each measurement order. The operation sequence specifies the order and timing of operation for each part of the measurement unit 10, chambers C11, C12, C21-C23, optical detection unit 110, electrical detection unit 120, hemoglobin detection unit 130, and components such as valves and pumps included in the fluid circuit. When the control unit 401 executes the operation sequence, for example, the valves and pumps are controlled so that they open at a predetermined timing, and then the pumps are driven after a predetermined time.

[0151] In Figures 20 and 21, the rectangular labels indicate the duration of the steps included in the operation sequence. Specifically, the left and right ends of the rectangular labels related to dispensing indicate the timing for starting the discharge of the sample into the chamber and the timing for ending the dispensing of the sample into the chamber, respectively. The left and right ends of the rectangular labels related to preparation indicate the timing for starting the mixing of reagents into the chamber and the timing for starting the transfer of the measurement sample from the chamber after the reaction is complete, respectively. The left and right ends of the rectangular labels related to measurement indicate the timing for starting the signal acquisition process in the corresponding detection unit and the timing for ending the signal acquisition process, respectively.

[0152] Figures 20 and 21 show rectangular labels related to the cleaning, charging, and pre-measurement operations for the RBC / PLT sample. In the "RBC / PLT cleaning" step, the path through which the RBC / PLT sample is transported to the electrical detection unit 120 (e.g., the flow path 341 in Figure 9) and the electrical detection unit 120 are cleaned. In the "RBC / PLT charging" step, the RBC / PLT sample in chamber C11 is charged into the flow path 341. In the "RBC / PLT pre-measurement operations" step, the electrical detection unit 120 is cleaned and sheath fluid is flowed into the electrical detection unit 120.

[0153] In the preparation of each measurement sample (RBC / PLT, PAB, HGB, WDF, WNR, RET, PLT-V), the type of reagent, the amount of reagent, and the amount of sample used are individually set to ensure that the measurement is appropriate for each sample. Furthermore, in the measurement of each measurement sample (WDF, WNR, RET, PLT-V), the amount and flow rate of the sample flowed through the optical detection unit 110, and the time for which the sample is flowed through the optical detection unit 110 are individually set to ensure that the measurement is appropriate for each sample.

[0154] As shown in Figure 20, when the measurement mode CBC is set, the sample aspirated by the suction tube 301 is sequentially dispensed into chambers C12, C11, C23, and C22 for preparing the measurement samples HGB, RBC / PLT, PAB, and WNR, respectively. Then, in each chamber, the preparation of the measurement samples HGB, RBC / PLT, PAB, and WNR is started in order, and the measurement of the measurement samples HGB, PAB, RBC / PLT, and WNR is started in order.

[0155] As shown in Figure 20, the preparation of the measurement sample PAB begins at approximately 9 seconds in the time chart. The measurement of RBCs / PLTs to determine the platelet count begins at approximately 18 seconds in the time chart. In other words, the preparation of the measurement sample PAB begins before the platelet count measurement is completed. By starting the preparation of the measurement sample PAB before the completion of the platelet count measurement, the waiting time is reduced compared to the configuration where the preparation of the measurement sample PAB begins after waiting for the platelet count measurement results, and platelet aggregation can be detected while maintaining processing capacity.

[0156] As shown in Figure 21, when the measurement mode CBC+DIFF is set, the sample aspirated by the suction tube 301 is sequentially dispensed into chambers C12, C11, C21, C23, and C22 for preparing the measurement samples HGB, RBC / PLT, WDF, PAB, and WNR, respectively. Then, in each chamber, the preparation of the measurement samples HGB, RBC / PLT, WDF, PAB, and WNR is started in order, and the measurement of the measurement samples HGB, PAB, RBC / PLT, WNR, and WNR is started in order.

[0157] As shown in Figure 21, even when the measurement mode CBC+DIFF is set, the preparation of the measurement sample PAB is started before the measurement of the platelet count is completed, similar to Figure 20. Furthermore, the measurement for platelet aggregation detection by the optical detection unit 110 is performed before the measurement for leukocyte classification by the optical detection unit 110. The measurement sample WDF for leukocyte classification classifies leukocytes based on subtle differences in the amount of nucleic acid inside the cells, so it is necessary to allow sufficient penetration of the fluorescent dye into the cells, and thus a long reaction time is required. In contrast, the measurement sample PAB for detecting platelet aggregation can be prepared simply by diluting blood with a diluent, so the reaction time is short. Therefore, by measuring the measurement sample PAB with the optical detection unit 110 before the measurement sample WDF, the waiting time is shortened compared to waiting for the preparation of the measurement sample WDF to be completed before measurement, and platelet aggregation detection becomes possible while maintaining processing capacity.

[0158] The measurement of the PAB sample shown in Figures 20 and 21 may be set to be completed in a shorter time than the measurement of other samples using the optical detection unit 110 (e.g., WDF, RET, PLT-V). For example, the time it takes to flow the PAB sample through the flow cell 211 (see Figure 3) (1.5 seconds) may be shorter than the time it takes to flow the PLT-V sample through the flow cell 211 (16.1 seconds). Preferably, the average flow velocity when flowing the PAB sample through the flow cell 211 (10.6 m) may be faster than the flow velocity when flowing the PLT-V sample through the flow cell 211 (4.9 m).

[0159] Thus, the reason why the average flow rate can be increased is that the light detected from the measurement sample PAB is forward scattered light, and since the amount of light that can be received is larger compared to weak light such as fluorescence, a sufficiently sensitive signal can be obtained even at a high flow rate. Automatically measuring the measurement sample PAB in measurement mode CBC or measurement mode CBC+DIFF increases the possibility of detecting platelet aggregation, but it increases the number of measurement samples to be prepared and reduces the available time of the optical detection unit 110, so simply adding measurement sample PAB may extend the turnaround time (TAT). By completing the measurement of measurement sample PAB in a short time, a significant increase in TAT can be avoided.

[0160] Figure 22 is a flowchart showing the processing performed by the control unit 401 of the analysis unit 30.

[0161] When the control unit 401 receives a measurement start instruction, in step S1 it reads out the measurement order stored in the storage unit 402 based on the sample ID.

[0162] For example, when the control unit 401 receives a measurement start instruction, it controls the transport unit 20 to transport the sample rack R to a position where the sample container T can be retrieved by the sample container transport unit 161. The transport unit 20 is equipped with a reader that reads a machine-readable code (e.g., a barcode) attached to the sample container T mounted on the transported sample rack R. The machine-readable code stores information about the sample ID. When the machine-readable code of the sample container T is read by the reader from the transported sample rack R, the sample ID is input to the control unit 401. The control unit 401 refers to the storage unit 402 and reads out the measurement order corresponding to the acquired sample ID.

[0163] In step S2, the control unit 401 performs a measurement determination process based on the measurement order read in step S1.

[0164] For example, the control unit 401 determines the measurement mode based on the measurement parameters included in the measurement order, and determines the measurement samples that need to be prepared in accordance with the measurement mode by referring to a table that defines the relationship between the measurement mode and the measurement sample as illustrated in Figure 12. At this time, the control unit 401 determines at least the measurement sample PAB as the measurement sample that needs to be prepared, according to the measurement order for the initial inspection, that is, the measurement order in which "Initial" is set as the measurement type.

[0165] In step S3, the control unit 401 controls the measurement unit 10 to aspirate a sample from the sample container T. In step S4, the control unit 401 uses the aspirated sample to prepare a measurement sample corresponding to the measurement mode determined in step S2, and controls the measurement unit 10 to measure the prepared measurement sample. As a result, measurement data is acquired according to the measurement performed. In step S5, the control unit 401 performs analysis based on the measurement data and generates analysis results. In step S6, the control unit 401 performs platelet aggregation determination processing based on the measurement data and adds the determination result to the analysis results.

[0166] In steps S7 and S8, the control unit 401 determines whether the measurement performed in step S4 matches the retest rule. If the retest rule is met, the control unit 401 performs either (1) Repeat or Rerun, which repeats the measurement using the same measurement mode on the same sample, or (2) Reflex, which performs the measurement using a measurement mode with added measurement items on the same sample, depending on the matched rule.

[0167] In step S7, the control unit 401 determines whether the Repeat or Rerun rule is met. If an error occurs in the initial measurement performed in step S4, the control unit 401 determines that the Repeat rule is met (S7: YES) and executes Repeat. If no error occurs but the measurement result meets a predetermined condition (for example, if the low reliability flag is set), the control unit 401 determines that the Rerun rule is met (S7: YES) and executes Rerun. In Repeat or Rerun, the measurement is performed using the same measurement mode as the initial measurement, so the process returns to step S3.

[0168] If the determination in step S7 is NO, in step S8, the control unit 401 determines whether the Reflex rule is met. If the initial measurement result performed in step S4 meets predetermined conditions, the control unit 401 determines that the Reflex rule is met (step S8: YES). The Reflex rule may include, for example, a rule to perform measurement using measurement mode CBC+DIFF+PLT-V when the number of platelets included in the analysis result is above or below a predetermined threshold, or when the analysis result includes platelet aggregation.

[0169] If the analysis result matches the Reflex rule (S8: YES), the control unit 401 returns the process to step S2 and executes the process from step S2 onward in a new measurement mode determined based on the Reflex rule. If the analysis result does not match the Reflex rule (S8: NO), the control unit 401 provides the analysis result in step S9 and terminates the process.

[0170] As an example of providing analysis results, the control unit 401 may display an analysis result display screen 600, such as that shown in Figure 18 or Figure 19, on the display unit 31, which is generated based on the target analysis results. The analysis result display screen 600 may be displayed in response to a display instruction from the operator, or it may be displayed automatically when the measurement is completed. As another example of providing analysis results, the control unit 401 may return the analysis result data to the sender of the measurement order. For example, if the measurement order was sent from a host computer, the control unit 401 may return the analysis result data, such as that shown in Figure 18 or Figure 19, along with the sample ID, to the host computer.

[0171] The analysis results provided in step S9 include the platelet aggregation determination results obtained in step S6. If multiple measurements (e.g., Initial measurement and Reflex measurement) are performed for a measurement order, multiple determination results regarding platelet aggregation may be obtained. Several possible embodiments for providing the analysis results in this case are exemplified below.

[0172] If multiple results regarding platelet aggregation are obtained from multiple measurements, each result may be provided. For example, if a Reflex measurement is performed in addition to the Initial measurement, both the platelet aggregation result from the Initial measurement and the platelet aggregation result from the Reflex measurement may be provided as analysis results. For example, as illustrated in Figures 18 and 19, if platelet aggregation is determined to be present in both the Initial measurement (CBC+DIFF) and the Reflex measurement (CBC+DIFF+RET+PLT-V), "PLT Clumps?" will be displayed on the analysis result display screen 600 for the Initial measurement, and "PLT Clumps?" will also be displayed on the analysis result display screen 600 for the Reflex measurement.

[0173] If multiple results regarding platelet aggregation are obtained from multiple measurements, only one of the results may be provided. For example, only the platelet aggregation result included in the analysis results of the last measurement performed among multiple measurements may be provided. For example, if a Reflex measurement is performed after an Initial measurement, the platelet aggregation result from the last Reflex measurement will be provided. The platelet aggregation result from the Initial measurement will not be provided. In this case, for example, if platelet aggregation is determined to be present in both the Initial measurement (CBC+DIFF) and the Reflex measurement (CBC+DIFF+RET+PLT-V), "PLT Clumps?" will not be displayed on the Initial measurement analysis result display screen 600, but only on the Reflex measurement analysis result display screen 600. On the other hand, if platelet aggregation is determined to be present in the Initial measurement but not in the Reflex measurement, "PLT Clumps?" will not be displayed on either the Initial measurement analysis result display screen 600 or the Reflex measurement analysis result display screen 600.

[0174] <Effects of the specimen measuring device according to this embodiment> The sample measuring device 1 for measuring blood samples collected from a subject includes an electrical detection unit 120 for detecting electrical signals corresponding to cells contained in the blood sample, an optical detection unit 110 (first optical detection unit) for detecting optical signals corresponding to cells, a hemoglobin detection unit 130 (second optical detection unit) for detecting optical signals corresponding to hemoglobin contained in the blood sample, a preparation unit 162 for preparing measurement samples RBC / PLT, HGB, WDF, WNR, RET, PLT-V, and PAB for measurement by the electrical detection unit 120, the optical detection unit 110 (first optical detection unit), and the hemoglobin detection unit 130 (second optical detection unit), and a control unit 401 (analysis unit) for analyzing measurement data obtained from the measurement of the measurement samples and providing analysis results. The preparation unit 162 prepares a measurement sample PAB for detecting platelet aggregation using the optical detection unit 110 (first optical detection unit) in response to a measurement order that includes a measurement instruction for (1) a first measurement item including red blood cell count, white blood cell count, hemoglobin level, hematocrit value, mean corpuscular volume, mean corpuscular hemoglobin level, mean corpuscular hemoglobin concentration, and platelet count, or (2) the first measurement item and a second measurement item related to the morphological classification of white blood cells by the optical detection unit 110 (first optical detection unit). The control unit 401 (analysis unit) analyzes the measurement data obtained from the measurement of the measurement sample PAB for detecting platelet aggregation and provides analysis results regarding platelet aggregation.

[0175] In this configuration, a measurement sample PAB for detecting platelet aggregation is automatically prepared and analytical results regarding platelet aggregation are provided, regardless of the platelet count result, in response to a measurement order that includes the measurement instructions for the first measurement item, or the first and second measurement items. Because analytical results regarding plasma aggregation are provided independently of the platelet count result, it is possible to reduce the chances of missing samples where the platelet count is lower than it should be due to platelet aggregation, for example, and to reduce the possibility of reporting inaccurate platelet counts.

[0176] Furthermore, in blood sample measurement, generally, the first measurement item, or the first and second measurement items, are measured for all blood samples. According to this embodiment, since analytical results regarding platelet aggregation are provided for substantially all blood samples, the presence or absence of platelet aggregation can be determined earlier, for example, compared to when additional measurements are performed to detect platelet aggregation in response to the initial measurement. As a result, even if re-collection of blood is necessary for the subject, re-collection can be performed quickly, thus enabling smooth testing of the subject.

[0177] Furthermore, since the first measurement item includes measurement parameters related to platelet count, the result values ​​of the measurement parameters related to platelet aggregation can be used to evaluate the platelet count obtained according to the measurement instructions for the first measurement item. This allows for smooth evaluation of the platelet count without wasting the analytical results related to platelet aggregation.

[0178] The first measurement item corresponds to the Complete Blood Count (CBC), and the second measurement item relates to multiple morphological classifications of white blood cells.

[0179] In this configuration, the first measurement item corresponds to the measurement item CBC, and the second measurement item corresponds to the measurement item DIFF. The measurement instruction for measurement mode CBC or measurement mode CBC+DIFF is typically applied to substantially all blood samples in the measurement of blood samples. Therefore, analytical results regarding platelet aggregation can be provided for substantially all blood samples.

[0180] The preparation method for measuring RBC / PLT, HGB, WDF, and WNR for (1) the first measurement item, or (2) the first and second measurement items, by the preparation unit 162, and the preparation method for measuring PAB for detecting platelet aggregation by the preparation unit 162 are different from each other.

[0181] In this configuration, the preparation of the former measurement samples RBC / PLT, HGB, WDF, and WNR is different from the preparation of the latter measurement sample PAB, for example, in terms of the type of reagent, the amount of reagent, and the amount of blood sample used. In other words, the preparation methods for the two are different. This allows the preparation method for the measurement sample PAB for detecting platelet aggregation to be set separately from other preparation methods, so that the type of reagent, the amount of reagent, and the amount of blood sample used can be precisely set when preparing the measurement sample PAB for detecting platelet aggregation. Therefore, when preparing the measurement sample PAB for detecting platelet aggregation, for example, the cost of reagents can be reduced and the measurement sample PAB can be prepared efficiently.

[0182] The measurement method for the measurement sample WDF and WNR for (1) the first measurement item, or (2) the first measurement item and the second measurement item, using the optical detection unit 110 (first optical detection unit), and the measurement method for the measurement sample PAB for detecting platelet aggregation using the optical detection unit 110 (first optical detection unit) are different from each other.

[0183] In this configuration, the measurement of the former sample WDF and WNR, and the measurement of the latter sample PAB, do not match, for example, the amount and flow rate of the sample flowed through the optical detection unit 110, or the time the sample is flowed through the optical detection unit 110. In other words, the two measurement methods are different. As a result, the measurement method for the sample PAB used to detect platelet aggregation can be set separately from other measurement methods, allowing for precise setting of the amount and flow rate of the sample PAB, the time the sample PAB is flowed, etc., when measuring the sample PAB used to detect platelet aggregation. Therefore, the sample PAB used to detect platelet aggregation can be measured efficiently.

[0184] The optical detection unit 110 (first optical detection unit) is used for both measuring the WDF of the measurement sample for the second measurement item and measuring the PAB of the measurement sample for detecting platelet aggregation.

[0185] With this configuration, the measurement of the second measurement item and the measurement for detecting platelet aggregation are performed by a common optical detection unit 110, eliminating the need for separate optical detection units for these measurements. Therefore, the size of the sample measuring device 1 can be kept down.

[0186] As shown in Figures 20 and 21, the optical detection unit 110 (first optical detection unit) measures the measurement sample WDF for measuring the second measurement item and the measurement sample PAB for detecting platelet aggregation at different timings.

[0187] With this configuration, each sample can be smoothly measured using a single optical detection unit 110.

[0188] The preparation unit 162 is equipped with a suction tube 301 that punctures the lid of the sample container T (container) containing the blood sample and aspirates the blood sample, and aspirates a blood sample for preparing measurement samples RBC / PLT, HGB, WDF, and WNR for (1) the first measurement item, or (2) the first measurement item and the second measurement item, and a blood sample for preparing the measurement sample PAB for detecting platelet aggregation, from the sample container T (container) in a single puncture.

[0189] This configuration allows for efficient blood sample aspiration because the blood samples needed to prepare each measurement sample are not aspirated separately.

[0190] The preparation unit 162 aspirates blood samples necessary for preparing the measurement samples RBC / PLT, HGB, and WNR for the first measurement item, blood samples necessary for preparing the measurement sample WDF for the second measurement item, and blood samples necessary for preparing the measurement sample PAB for detecting platelet aggregation, and distributes them into different chambers C11, C12, and C21-C23.

[0191] With this configuration, the blood samples required to prepare each measurement sample are prepared in separate chambers, allowing each measurement sample to be prepared in parallel.

[0192] Regardless of the analysis results of the first measurement item, the preparation unit 162 aspirates the blood sample necessary for detecting platelet aggregation and distributes it to chamber C23.

[0193] This configuration allows for earlier preparation of the PAB (platelet aggregation detection sample) compared to a system where the blood sample necessary for detecting platelet aggregation is aspirated and dispensed after the analysis results for the first measurement item have been generated.

[0194] The preparation unit 162 includes (1) a chamber C11 (first chamber) connected to the electrical detection unit 120 for mixing a blood sample and the diluent RBC / PLT to prepare a measurement sample RBC / PLT for measuring the first measurement item; (2) a chamber C21 (second chamber) connected to the optical detection unit 110 (first optical detection unit) for mixing a blood sample, the staining reagent WDF, and the hemolytic reagent WDF to prepare a measurement sample WDF for measuring the second measurement item; and (3) a chamber C23 (third chamber) connected to the optical detection unit 110 (first optical detection unit) for mixing a blood sample and the staining reagent RET to prepare measurement samples RET and PLT-V for measuring the third measurement item related to the classification of reticulocytes or platelets. The preparation unit prepares a measurement sample PAB for detecting platelet aggregation using chamber C23 (third chamber) in accordance with a measurement order that includes measurement instructions for the first and second measurement items but does not include a measurement instruction for the third measurement item.

[0195] With this configuration, if a measurement order is set that does not include instructions for measuring the third measurement item, chamber C23 will not be used for measuring the third measurement item. Therefore, when a measurement order is set that includes instructions for measuring the first and second measurement items but does not include instructions for measuring the third measurement item, chamber C23 can be used to prepare the measurement sample PAB for detecting platelet aggregation, and the measurement sample PAB for detecting platelet aggregation can be prepared in parallel with other measurement samples. This shortens the turnaround time (TAT) of the sample measuring device 1.

[0196] The preparation unit 162 shares at least one of several types of reagents used to prepare measurement samples RBC / PLT, HGB, WDF, WNR, RET, and PLT-V for the measurement of a first measurement item, a second measurement item, and other measurement items different from both the first and second measurement items, for the preparation of the measurement sample PAB for detecting platelet aggregation. Specifically, the shared reagent is a diluent used in the electrical detection unit 120 and the hemoglobin detection unit 130.

[0197] This configuration eliminates the need to prepare a dedicated reagent for the platelet aggregation sample (PAB), thus reducing reagent costs.

[0198] The number of reagents used to prepare the measurement sample PAB for detecting platelet aggregation is less than the number of reagents used to prepare the measurement sample for the first measurement item, the second measurement item, and any one of the first or second measurement items. In the above embodiment, the number of reagents used to prepare the measurement sample PAB is 1, whereas the number of reagents used to prepare other measurement samples WNR, WDF, PLT-V, and RET, which are measured by the optical detection unit 110, is 2 or more.

[0199] This configuration reduces the number of reagents used to prepare the PAB (platelet aggregation) sample for detection, thereby lowering reagent costs.

[0200] The preparation unit 162 prepares a measurement sample PAB for detecting platelet aggregation without using a hemolytic reagent.

[0201] This configuration prevents the dissolution of aggregated platelets and allows for accurate detection of platelet aggregation.

[0202] The preparation unit 162 prepares a measurement sample PAB for detecting platelet aggregation by mixing the blood sample with the diluent reagent PAB.

[0203] This configuration allows for the easy preparation of PAB (platelet aggregation) samples for detecting platelet aggregation.

[0204] The preparation unit 162 prepares a measurement sample PAB for detecting platelet aggregation by mixing the blood sample with the dilution reagent used in the electrical detection unit 120.

[0205] With this configuration, the measurement sample PAB for detecting platelet aggregation is prepared using the dilution reagent used in the electrical detection unit 120, thus reducing the cost of reagents.

[0206] The preparation unit 162 prepares a measurement sample WDF for measuring the second measurement item by mixing a hemolytic reagent WDF for lysing red blood cells in a blood sample, a staining reagent WDF for staining white blood cells, and the blood sample, and prepares a measurement sample PAB for detecting platelet aggregation without using the hemolytic reagent WDF.

[0207] With this configuration, the preparation of the measurement sample PAB for detecting platelet aggregation does not require the use of the hemolytic reagent WDF compared to the preparation of the measurement sample WDF for measuring the second measurement item, thus reducing reagent costs. Furthermore, interference from hemolyzed red blood cells etc. generated by the hemolytic reagent WDF with the detection of aggregated platelets can be suppressed.

[0208] The preparation unit 162 prepares a measurement sample WDF for measuring the second measurement item by mixing a hemolytic reagent WDF for lysing red blood cells in the blood sample, a staining reagent WDF for staining white blood cells, and the blood sample, and prepares a measurement sample PAB for detecting platelet aggregation without using the staining reagent WDF.

[0209] With this configuration, the preparation of the measurement sample PAB for detecting platelet aggregation does not require the use of the staining reagent WDF compared to the preparation of the measurement sample WDF for measuring the second measurement item, thus reducing the cost of reagents.

[0210] The preparation unit 162 prepares a measurement sample WDF for measuring the second measurement item by mixing a hemolytic reagent WDF for lysing red blood cells in the blood sample, a staining reagent WDF for staining white blood cells, and the blood sample. It also prepares a measurement sample PAB for detecting platelet aggregation without using the staining reagent WDF. The control unit 401 (analysis unit) analyzes the presence or absence of platelet aggregation based on the peak value and width of the waveform data of forward scattered light from the measurement data obtained by the optical detection unit 110 (first optical detection unit) of the measurement sample PAB for detecting platelet aggregation.

[0211] In this configuration, since the staining reagent WDF is not used in the preparation of the measurement sample PAB for detecting platelet aggregation, the fluorescence signal from the staining reagent is not used. Instead, based on the peak value and width of the waveform data obtained from each particle in the measurement sample PAB by the forward scattered light of the optical detection unit 110, particles corresponding to platelet aggregation can be accurately fractionated from other particles. This allows for accurate analysis of the presence or absence of platelet aggregation in blood samples.

[0212] As shown in Figures 20 and 21, the optical detection unit 110 (first optical detection unit) measures the measurement sample PAB for detecting platelet aggregation before the measurement sample WDF for measuring the second measurement item. Furthermore, the time required to prepare the measurement sample PAB for detecting platelet aggregation by the preparation unit 162 is shorter than the time required to prepare the measurement sample WDF for measuring the second measurement item.

[0213] With this configuration, the measurement sample PAB for detecting platelet aggregation, which is prepared before the measurement sample WDF for measuring the second measurement item, is measured first by the optical detection unit 110, thereby shortening the total time required for the preparation and measurement of these two measurement samples.

[0214] As shown in Figures 20 and 21, the timing for preparing the WDF measurement sample for measuring the second measurement item and the timing for preparing the PAB measurement sample for detecting platelet aggregation overlap, at least in part.

[0215] This configuration allows for an improvement in the turn-to-attach (TAT) of the sample measuring device 1 by overlapping the preparation timings of the measurement samples WDF and PAB at least partially.

[0216] As shown in Figures 20 and 21, the time it takes for the optical detection unit 110 (first optical detection unit) to measure the measurement sample PAB for detecting platelet aggregation is shorter than the time it takes for the optical detection unit 110 (first optical detection unit) to measure the measurement sample WDF for measuring the second measurement item.

[0217] With this configuration, the time required to measure the PAB of the measurement sample for detecting platelet aggregation is short, so even if the PAB of the measurement sample for detecting platelet aggregation is measured for virtually all blood samples, the deterioration of the TAT of the sample measuring device 1 can be suppressed.

[0218] The control unit 401 (analysis unit) analyzes the number of platelets based on the measurement data obtained by the electrical detection unit 120 measuring the measurement sample RBC / PLT for the measurement of the first measurement item, and analyzes the presence or absence of platelet aggregation based on the measurement data obtained by the optical detection unit 110 (first optical detection unit) measuring the measurement sample PAB for detecting platelet aggregation.

[0219] With this configuration, the results of the analysis on the presence or absence of platelet aggregation can be used to evaluate the platelet count obtained based on the measurement of the first measurement item.

[0220] The preparation of the measurement sample PAB for detecting platelet aggregation by the preparation unit 162 and the measurement of the measurement sample PAB by the optical detection unit 110 (first optical detection unit) are performed regardless of the platelet count analysis results.

[0221] With this configuration, the preparation and measurement of the platelet aggregation-related sample PAB is performed regardless of the platelet count analysis results, thus enabling the provision of platelet aggregation analysis results for virtually all blood samples. Furthermore, it is possible to rapidly generate analysis results for the presence or absence of platelet aggregation without waiting for the platelet count analysis.

[0222] As shown in the flag display area 630 of Figure 18, the control unit 401 (analysis unit) provides information regarding the reliability of the platelet count included in the analysis result when platelet aggregation is detected.

[0223] This configuration allows for smooth evaluation of the platelet count obtained based on the measurement of the first measurement item by referring to information regarding the reliability of the platelet count.

[0224] In response to an initial test order for a blood sample, the preparation unit 162 prepares a measurement sample PAB for detecting platelet aggregation, and the optical detection unit 110 (first optical detection unit) measures the measurement sample PAB.

[0225] With this configuration, the preparation and measurement of the PAB (platelet aggregation) sample for detecting platelet aggregation are performed during the initial examination of the blood sample, thus ensuring that analytical results regarding platelet aggregation are reliably provided for virtually all blood samples.

[0226] The preparation unit 162 prepares a sample for detecting platelet aggregation in response to a measurement order that includes (1) a first measurement item, or (2) a first measurement item and a second measurement item, but does not include a measurement item different from the first and second measurement items.

[0227] For example, by analyzing the measurement data obtained from both the measurement of stained reticulocytes using the optical detection unit 110 (measurement of measurement sample RET) and the measurement of stained platelets using the optical detection unit 110 (measurement of measurement sample PLT-V), analytical results regarding platelet aggregation can be generated. Therefore, with the above configuration, when the measurement instructions do not include measurement items different from the first and second measurement items, the preparation of the measurement sample PAB for detecting platelet aggregation can be prevented from being wasted.

[0228] The preparation unit 162 is connected to the electrical detection unit 120 and includes chamber C11 (first chamber) for preparing measurement sample RBC / PLT (first measurement sample) used for electrical measurement of red blood cell count and platelet count by mixing blood sample and diluent RBC / PLT; chamber C22 (second chamber) for preparing measurement sample WNR (second measurement sample) used for optical measurement of white blood cell count by mixing blood sample, staining reagent WNR and hemolysis reagent WNR; and chamber C22 (second chamber) for preparing measurement sample HGB used for optical measurement of hemoglobin amount by mixing blood sample, diluent HGB and hemolysis reagent HGB. The system includes a chamber C12 (third chamber) for preparing GB (third measurement sample), a chamber C21 (fourth chamber) connected to the optical detection unit 110 (first optical detection unit) for preparing measurement sample WDF (fourth measurement sample) used for optical measurement of leukocyte classification by mixing a blood sample, staining reagent WDF and hemolysis reagent WDF, and a chamber C23 (fifth chamber) connected to the optical detection unit 110 (first optical detection unit) for preparing measurement sample RET or measurement sample PLT-V (fifth measurement sample) used for optical measurement of reticulocyte count or platelet count by mixing a blood sample, staining reagent RET, PLT-V and diluent reagent RET, PLT-V. The preparation unit 162 prepares the first to fifth measurement samples in chambers C11, C22, C12, C21, and C23 (chambers 1 to 5) according to a measurement order that includes measurement instructions for (1) a first measurement item including red blood cell count, white blood cell count, hemoglobin level, hematocrit value, mean corpuscular volume, mean corpuscular hemoglobin level, mean corpuscular hemoglobin concentration, and platelet count, (2) a second measurement item relating to the morphological classification of white blood cells, and (3) a third measurement item relating to the classification of reticulocytes or platelets. In response to a measurement order that includes measurement instructions for the first measurement item, or the first and second measurement items, but does not include measurement instructions for the third measurement item, it prepares a measurement sample PAB (sixth measurement sample) for detecting platelet aggregation in chamber C23 (chamber 5). The control unit 401 (analysis unit) analyzes the measurement data obtained from the measurement of the measurement sample PAB (sixth measurement sample) and provides analysis results regarding platelet aggregation.

[0229] With this configuration, in the case of a measurement order that includes the first measurement item, or the first and second measurement items, but does not include the third measurement item, the measurement sample PAB for detecting platelet aggregation is prepared in chamber C23. This allows for the preparation of the measurement sample PAB using chamber C23 effectively, even in the case of a measurement order that does not include the third measurement item.

[0230] <Example of changes> In the above embodiment, when the measurement of the sample PAB was performed, platelet aggregation was determined using the scattergram PAB shown in Figure 14. However, fragmented red blood cells and microcytic red blood cells may also be determined using the measurement data of the sample PAB.

[0231] Figure 23 shows the scattergram PAB-2 generated based on the measurement data of the sample PAB.

[0232] In the scattergram PAB-2, the horizontal axis corresponds to the peak value (R-SSC_P) of the waveform data acquired based on the side-scattered light produced by the light of wavelength λ20 (red wavelength band) emitted from light source 202, and the vertical axis corresponds to the peak value (R-FSC_P) of the waveform data acquired based on the forward-scattered light produced by the light of wavelength λ20 (red wavelength band) emitted from light source 202.

[0233] The control unit 401 plots cells on a scattergram consisting of the vertical and horizontal axes as described above, using measurement data based on the measurement sample PAB, and generates a scattergram PAB-2. Then, the control unit 401 sets a region (B21) in the scattergram PAB-2 where fragmented red blood cells and microcytic red blood cells are distributed, as shown by the dashed line. Region B21 is a predetermined region common to all samples. However, region B21 may be set variably for each sample based on the centroid position of the plot within the initial region.

[0234] Furthermore, as indicated by the dashed lines, the scattergram PAB-2 contains regions where normal red blood cells (B22) and platelets (B23) are distributed. Normal red blood cells are larger than platelets and generally larger than fragmented red blood cells and microcytic red blood cells, so they are distributed in the upper right of the scattergram PAB-2. Platelets are smaller than normal red blood cells and generally smaller than fragmented red blood cells and microcytic red blood cells, so they are distributed in the lower left of the scattergram PAB-2. Thus, in the scattergram PAB-2, the regions of normal red blood cells and platelets are generally far from the distribution regions of fragmented red blood cells and microcytic red blood cells. As a result, by defining region B21 as shown in Figure 23, fragmented red blood cells and microcytic red blood cells can be classified to some extent, distinguishing them from normal red blood cells and platelets.

[0235] The control unit 401 counts the cells in region B21 of the scattergram PAB-2 to obtain the number of fragmented red blood cells and microcytic red blood cells. The control unit 401 also obtains the ratio of fragmented red blood cells to microcytic red blood cells by dividing the number of cells in region B21 by the number of cells in region B22.

[0236] The control unit 401 determines that fragmented red blood cells or microcytic red blood cells are present in the target sample if the number of fragmented red blood cells and microcytic red blood cells obtained based on the scattergram PAB-2 is above a predetermined threshold. The upper part of Figure 23 shows a scattergram PAB-2 in which fragmented red blood cells and microcytic red blood cells are determined not to be present, and the lower part of Figure 23 shows a scattergram PAB-2 in which fragmented red blood cells or microcytic red blood cells are determined to be present.

[0237] Furthermore, the control unit 401 may determine that fragmented red blood cells or microcytic red blood cells are present in the target sample if the ratio of fragmented red blood cells and microcytic red blood cells obtained based on the scattergram PAB-2 is greater than a predetermined threshold.

[0238] The analysis using the scattergram PAB-2 shown in Figure 23 is performed in response to the measurement of the sample PAB. That is, if the control unit 401 of the analysis unit 30 decides to measure the sample PAB in step S2 of Figure 22, it performs the analysis using the scattergram PAB-2 in step S5 of Figure 22 based on the measurement data of the sample PAB. If the control unit 401 determines that fragmented red blood cells or microcytic red blood cells are present based on the analysis using the scattergram PAB-2, it displays the message "PLT low reliability," indicating that an abnormality in red blood cells due to fragmented red blood cells or microcytic red blood cells has occurred, in the area that displays information about platelets in the flag display area 630 of the analysis result display screen 600, as shown in Figure 24.

[0239] As shown in Figure 24, if a message indicating an erythrocyte abnormality due to fragmented red blood cells or microcytic red blood cells is displayed in the flag display area 630, it is possible that the platelets detected based on the measured sample RBC / PLT may contain fragmented red blood cells or microcytic red blood cells. Therefore, the operator can understand that the platelet count (PLT) in the result value display area 610 obtained based on the measured sample RBC / PLT may contain fragmented red blood cells or microcytic red blood cells, and that the platelet count (PLT) may be inaccurate.

[0240] Furthermore, the control unit 401 performs separate determinations for platelet aggregation and for fragmented red blood cells and microcytic red blood cells based on the measurement data of the sample PAB. Therefore, if it determines that platelet aggregation is present and fragmented red blood cells or microcytic red blood cells are present, it displays "PLT Clumps?" and "PLT low reliability" in the flag display area 630 of Figure 24.

[0241] <Effects of the modified sample measuring device> The preparation unit 162 prepares the measurement sample RBC / PLT (first measurement sample) for measuring red blood cells and platelets by mixing the blood sample and the diluent RBC / PLT; the measurement sample WNR (second measurement sample) for measuring white blood cells by mixing the blood sample, the staining reagent WNR and the hemolysis reagent WNR; the measurement sample HGB (third measurement sample) for measuring hemoglobin levels by mixing the blood sample, the diluent HGB and the hemolysis reagent HGB; and the measurement sample PAB (fourth measurement sample) for detecting red blood cell abnormalities caused by fragmented red blood cells or microcytic red blood cells by mixing the blood sample and the diluent PAB.

[0242] The control unit 401 (analysis unit) analyzes the measurement data obtained by measuring the measurement sample RBC / PLT (first measurement sample) with the electrical detection unit 120 to obtain the red blood cell count and platelet count, analyzes the measurement data obtained by measuring the measurement sample WNR (second measurement sample) with the optical detection unit 110 (first optical detection unit) to obtain the white blood cell count, analyzes the measurement data obtained by measuring the measurement sample HGB (third measurement sample) with the hemoglobin detection unit 130 (second optical detection unit) to obtain the hemoglobin amount, and analyzes the measurement data obtained by measuring the measurement sample PAB (fourth measurement sample) with the optical detection unit 110 (first optical detection unit) to detect red blood cell abnormalities due to fragmented red blood cells or microcytic red blood cells.

[0243] This configuration allows for the detection of red blood cell count, platelet count, white blood cell count, and hemoglobin level, as well as red blood cell abnormalities caused by fragmented red blood cells or microcytic red blood cells. This makes it possible to diagnose blood samples from various perspectives. Furthermore, if a blood sample contains fragmented red blood cells or microcytic red blood cells, the reliability of the platelet count obtained by measuring the RBC / PLT sample with the electrical detection unit 120 may decrease. However, with the above configuration, since red blood cell abnormalities caused by fragmented red blood cells or microcytic red blood cells can be detected, the reliability of the platelet count can be ensured.

[0244] The control unit 401 (analysis unit) analyzes the measurement data obtained by measuring the measurement sample PAB (fourth measurement sample) with the optical detection unit 110 (first optical detection unit) and further detects platelet aggregation.

[0245] This configuration allows for the detection of platelet aggregation in addition to red blood cell abnormalities caused by fragmented red blood cells or microcytic red blood cells, enabling the diagnosis of blood samples from a wider range of perspectives.

[0246] The control unit 401 (analysis unit) analyzes the measurement data obtained by measuring the measurement sample PAB (fourth measurement sample) with the optical detection unit 110 (first optical detection unit) to distinguish and detect red blood cell abnormalities caused by fragmented red blood cells or microcytic red blood cells from platelet aggregation.

[0247] This configuration allows for the distinct detection of red blood cell abnormalities caused by fragmented red blood cells or microcytic red blood cells, and platelet aggregation. This enables the diagnosis of blood samples from a variety of perspectives based on the detection results of both red blood cell abnormalities and platelet aggregation.

[0248] The preparation unit 162, in accordance with a measurement order that includes measurement instructions for (1) a first measurement item including red blood cell count, white blood cell count, hemoglobin level, hematocrit value, mean corpuscular volume, mean corpuscular hemoglobin level, mean corpuscular hemoglobin concentration, and platelet count, (2) a second measurement item related to the morphological classification of white blood cells, and (3) a third measurement item related to the classification of reticulocytes or platelets, prepares the measurement sample RBC / PLT (first measurement sample) in chambers C11, C22, C12, C21, C23 (chambers 1 to 5). The following samples are prepared: (1), measurement sample WNR (2nd measurement sample), measurement sample HGB (3rd measurement sample), measurement sample WDF (4th measurement sample), measurement sample RET, or measurement sample PLT-V (5th measurement sample). In accordance with a measurement order that includes the measurement instructions for the 1st measurement item, or the 1st and 2nd measurement items, but does not include the measurement instructions for the 3rd measurement item, the measurement sample PAB (6th measurement sample) is prepared in chamber C23 (5th chamber) for detecting red blood cell abnormalities caused by fragmented red blood cells or microcytic red blood cells. The control unit 401 (analysis unit) analyzes the measurement data obtained from the measurement of the measurement sample PAB (6th measurement sample) and provides analysis results regarding red blood cell abnormalities caused by fragmented red blood cells or microcytic red blood cells.

[0249] Typically, when measuring blood samples, instructions for measuring the first measurement item, or the first and second measurement items, are given for all blood samples. When such standard measurement instructions are given, the above configuration prepares a sample for detecting red blood cell abnormalities caused by fragmented red blood cells or microcytic red blood cells, and provides analytical results regarding red blood cell abnormalities caused by fragmented red blood cells or microcytic red blood cells. Therefore, analytical results regarding red blood cell abnormalities caused by fragmented red blood cells or microcytic red blood cells can be provided for substantially all blood samples.

[0250] Furthermore, in the case of a measurement order that includes the first measurement item, or the first and second measurement items, but does not include the third measurement item, the PAB sample for detecting red blood cell abnormalities due to fragmented red blood cells or microcytic red blood cells is prepared in chamber C23. This allows for the preparation of the PAB sample using chamber C23 in the case of a measurement order that does not include the third measurement item.

[0251] <Other examples of changes> In the above embodiments and modified examples, in the measurement and analysis corresponding to the measurement item DIFF, white blood cells were classified into four subgroups (neutrophils, lymphocytes, monocytes, and eosinophils). However, the invention is not limited to this, and white blood cells may be classified into five subgroups (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), or into two or three subgroups.

[0252] In the above embodiments and modified examples, when platelet aggregation is determined based on the measurement data of any of the measurement samples PAB, RET, or PLT-V, the scattergram used to determine platelet aggregation, the number of non-aggregated platelets, the number of aggregated platelets, and the aggregated platelet ratio may be displayed on the analysis result display screen 600. Also, in the above modified example, when red blood cell abnormalities due to fragmented red blood cells or microcytic red blood cells are determined based on the measurement data of the measurement sample PAB, the scattergram PAB-2 and the number of fragmented red blood cells and microcytic red blood cells may be displayed on the analysis result display screen 600.

[0253] In the above embodiments and modified examples, when it is determined that platelet aggregation has occurred, information indicating that platelet aggregation has occurred is displayed in the flag display area 630. However, when it is determined that platelet aggregation has not occurred, information indicating that platelet aggregation has not occurred may also be displayed in the flag display area 630.

[0254] In the above embodiments and modifications, when platelet aggregation is detected, a string indicating that platelet aggregation has occurred is displayed. However, the invention is not limited to this; an image or sound indicating that platelet aggregation has occurred may be output, or data corresponding to the string may be transmitted to another device.

[0255] In the above example of modification, if it is determined that an abnormality in red blood cells caused by fragmented red blood cells or microcytic red blood cells has occurred, information indicating that the reliability of the platelet count is low is displayed in the flag display area 630. However, if it is determined that no abnormality in red blood cells caused by fragmented red blood cells or microcytic red blood cells has occurred, information indicating that there is no problem with the reliability of the platelet count may also be displayed in the flag display area 630.

[0256] In the above example of modification, a string indicating low reliability of the platelet count was displayed when it was determined that an abnormality in red blood cells due to fragmented red blood cells or microcytic red blood cells had occurred. However, the system is not limited to this; an image or sound indicating low reliability of the platelet count may be output, and data corresponding to the string may be transmitted to another device.

[0257] In the above embodiments and modifications, the sample aspirated from the sample container T by the suction tube 301 was distributed to each chamber by being discharged from the suction tube 301. However, the invention is not limited to this, and the sample aspirated by the suction tube 301 may also be distributed to each chamber by being transferred to each chamber via a flow path.

[0258] In the above embodiments and modifications, the light-receiving unit 221 of the optical detection unit 110 receives forward-scattered light with a wavelength of λ20 (red wavelength band) and detects an optical signal corresponding to the received intensity of the forward-scattered light with wavelength λ20. However, instead, it may receive forward-scattered light with a wavelength of λ10 (blue-violet wavelength band) and detect an optical signal corresponding to the received intensity of the forward-scattered light with wavelength λ10. Furthermore, the optical detection unit 110 may be equipped with both a light-receiving unit for receiving forward-scattered light with wavelength λ10 and a light-receiving unit for receiving forward-scattered light with wavelength λ20.

[0259] In the above embodiments and modifications, both axes of the scattergram PAB were axes based on forward scattered light with a wavelength of λ20 (red wavelength band), but one or both axes of the scattergram PAB may be axes based on forward scattered light with a wavelength of λ10 (blue-violet wavelength band).

[0260] In the above embodiments and modified examples, the measurement order was stored in the storage unit 402 of the analysis unit 30, but it is not limited to this, and may also be stored in a host computer installed outside the sample measuring device 1. In this case, when the control unit 401 receives a measurement start instruction, in step S1 of Figure 22, it receives a measurement order from the host computer based on the sample ID included in the start instruction.

[0261] In the above embodiments and modified examples, the control unit 401 of the analysis unit 30 controlled the measurement unit 10 and generated analysis results by analyzing the measurement data. However, the analysis unit 30 is not limited to this, and may also be provided with a separate control unit for controlling the measurement unit 10 and an analysis unit for generating analysis results by analyzing the measurement data.

[0262] In the above embodiments and modifications, the measurement unit 10 and the analysis unit 30 may be integrated. In this case, a touch panel display capable of inputting and displaying information may be provided on the front of the housing of the integrated device. Alternatively, the measurement unit 10, the transport unit 20, and the analysis unit 30 may be integrated.

[0263] <Note> In another view, the present invention relates to a sample measuring device for measuring a blood sample taken from a subject. The sample measuring device (1) of the present invention includes an electrical detection unit (120) for detecting electrical signals corresponding to cells contained in a blood sample, a first optical detection unit (110) for detecting optical signals corresponding to cells, a second optical detection unit (130) for detecting optical signals corresponding to hemoglobin contained in a blood sample, a preparation unit (162) for preparing a sample for measurement by the electrical detection unit (120), the first optical detection unit (110), and the second optical detection unit (130), and an analysis unit (401) for analyzing measurement data obtained from the measurement of the sample and providing analysis results. The preparation unit (162) prepares a first measurement sample for measuring red blood cells and platelets by mixing a blood sample and diluent; a second measurement sample for measuring white blood cells by mixing a blood sample, staining reagent and hemolysis reagent; a third measurement sample for measuring hemoglobin levels by mixing a blood sample, diluent and hemolysis reagent; and a fourth measurement sample for detecting red blood cell abnormalities due to fragmented red blood cells or microcytic red blood cells by mixing a blood sample and diluent reagent. The analysis unit (401) analyzes the measurement data obtained by measuring the first sample with the electrical detection unit (120) to obtain the red blood cell count and platelet count, analyzes the measurement data obtained by measuring the second sample with the first optical detection unit (110) to obtain the white blood cell count, analyzes the measurement data obtained by measuring the third sample with the second optical detection unit (130) to obtain the hemoglobin level, and analyzes the measurement data obtained by measuring the fourth sample with the first optical detection unit (110) to detect red blood cell abnormalities caused by fragmented red blood cells or microcytic red blood cells.

[0264] According to the present invention, it is possible to detect red blood cell count, platelet count, white blood cell count, and hemoglobin level, as well as red blood cell abnormalities caused by fragmented red blood cells or microcytic red blood cells. This makes it possible to diagnose blood samples from various perspectives. Furthermore, if a blood sample contains fragmented red blood cells or microcytic red blood cells, the reliability of the platelet count obtained by measuring the first measurement sample with an electrical detection unit may decrease. In contrast, according to the present invention, since red blood cell abnormalities caused by fragmented red blood cells or microcytic red blood cells can be detected, the reliability of the platelet count can be ensured.

[0265] Embodiments of the present invention can be modified in various ways as appropriate within the scope of the technical idea set forth in the claims. [Explanation of symbols]

[0266] 1. Sample measuring device 110 Optical detection unit (first optical detection unit) 120 Electrical detection unit 130 Hemoglobin detection unit (second optical detection unit) 162 Preparation Department 301 Suction tube 401 Control Unit (Analysis Unit) T Specimen container (container) T2 lid

Claims

1. A specimen measuring device for measuring blood samples collected from a subject, An electrical detection unit for detecting electrical signals corresponding to cells contained in the blood sample, A first optical detection unit for detecting an optical signal corresponding to the aforementioned cell, A second optical detection unit for detecting an optical signal corresponding to the hemoglobin contained in the blood sample, The electrical detection unit, the first optical detection unit, and the preparation unit for preparing a sample for measurement by the second optical detection unit, Includes an analysis unit that analyzes measurement data obtained by measuring the aforementioned sample and provides analysis results, The preparation unit is (1) First measurement items including red blood cell count, white blood cell count, hemoglobin level, hematocrit value, mean corpuscular volume, mean corpuscular hemoglobin level, mean corpuscular hemoglobin concentration, and platelet count, or (2) The first measurement item and the second measurement item relating to the morphological classification of leukocytes by the first optical detection unit, In response to a measurement order that includes a measurement instruction, the first optical detection unit prepares the measurement sample for detecting platelet aggregation. The analysis unit analyzes the measurement data obtained by measuring the measurement sample for detecting platelet aggregation and provides the analysis results regarding platelet aggregation. Sample measuring device.

2. The first measurement item is a measurement item corresponding to CBC (Complete Blood Count). A specimen measuring device according to claim 1.

3. The second measurement item is a measurement item related to multiple morphological classifications of white blood cells. A specimen measuring device according to claim 1.

4. The method for preparing the measurement sample by the preparation unit for measuring (1) the first measurement item, or (2) the first measurement item and the second measurement item, and the method for preparing the measurement sample by the preparation unit for detecting platelet aggregation are different from each other. A specimen measuring device according to claim 1.

5. The first optical detection unit is used for measuring the measurement sample for measuring the second measurement item and for measuring the measurement sample for detecting platelet aggregation. A specimen measuring device according to claim 1.

6. The first optical detection unit measures the measurement sample for measuring the second measurement item and the measurement sample for detecting platelet aggregation at different timings. A specimen measuring device according to claim 1.

7. The preparation unit is The system includes a suction tube for puncturing the lid of the container holding the blood sample and aspirating the blood sample, (1) The blood sample for preparing the measurement sample for the first measurement item, or (2) the first measurement item and the second measurement item, and the blood sample for preparing the measurement sample for detecting platelet aggregation, are aspirated from the container in a single puncture. A specimen measuring device according to claim 1.

8. The preparation unit is At least one of several types of reagents for preparing the measurement sample for measuring the first measurement item, the second measurement item, and other measurement items different from both the first and second measurement items is shared for preparing the measurement sample for detecting platelet aggregation. A specimen measuring device according to claim 1.

9. The preparation unit prepares the measurement sample for detecting platelet aggregation without using a hemolytic reagent. A specimen measuring device according to claim 1.

10. The preparation unit prepares the measurement sample for detecting platelet aggregation by mixing the blood sample and the diluent. A specimen measuring device according to claim 1.

11. The preparation unit is A hemolytic reagent for lysing red blood cells in the blood sample, a staining reagent for staining white blood cells, and the blood sample are mixed to prepare the measurement sample for measuring the second measurement item. Without using the hemolytic reagent, the measurement sample for detecting platelet aggregation is prepared. A specimen measuring device according to claim 1.

12. The preparation unit is A hemolytic reagent for lysing red blood cells in the blood sample, a staining reagent for staining white blood cells, and the blood sample are mixed to prepare the measurement sample for measuring the second measurement item. Without using the aforementioned staining reagent, the measurement sample for detecting platelet aggregation is prepared. A specimen measuring device according to claim 1.

13. The preparation unit is A hemolytic reagent for lysing red blood cells in the blood sample, a staining reagent for staining white blood cells, and the blood sample are mixed to prepare the measurement sample for measuring the second measurement item. Without using the aforementioned staining reagent, the measurement sample for detecting platelet aggregation is prepared, The aforementioned analysis unit is Based on the peak value and width of the forward-scattered light waveform data obtained from the measurement data of the measurement sample by the first optical detection unit for detecting platelet aggregation, the presence or absence of platelet aggregation is analyzed. A specimen measuring device according to claim 1.

14. The timing for preparing the measurement sample for measuring the second measurement item and the timing for preparing the measurement sample for detecting platelet aggregation overlap with each other in at least part of the same time. A specimen measuring device according to claim 1.

15. The time it takes for the first optical detection unit to measure the sample for detecting platelet aggregation is shorter than the time it takes for the first optical detection unit to measure the sample for measuring the second measurement item. A specimen measuring device according to claim 1.

16. The aforementioned analysis unit is Based on the measurement data obtained by the electrical detection unit measuring the measurement sample for the measurement of the first measurement item, the platelet count is analyzed. Based on the measurement data obtained by the first optical detection unit measuring the measurement sample for detecting platelet aggregation, the presence or absence of platelet aggregation is analyzed. A specimen measuring device according to claim 1.

17. The preparation of the measurement sample for detecting platelet aggregation by the preparation unit and the measurement of the measurement sample by the first optical detection unit are performed regardless of the platelet count analysis results. A specimen measuring device according to claim 1.

18. The analysis unit, upon detection of platelet aggregation, provides information regarding the reliability of the platelet count included in the analysis results. A specimen measuring device according to claim 1.

19. In accordance with the measurement order for the initial test of the blood sample, the preparation unit prepares the measurement sample for detecting platelet aggregation, and the first optical detection unit measures the measurement sample. A specimen measuring device according to claim 1.

20. The preparation unit prepares the measurement sample for detecting platelet aggregation in accordance with the measurement order, which includes a measurement instruction for (1) the first measurement item, or (2) the first measurement item and the second measurement item, and does not include a measurement instruction for a measurement item different from the first measurement item and the second measurement item. A specimen measuring device according to claim 1.

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