Specimen measurement device and specimen measurement method

Abstract

To provide a specimen measurement device and a specimen measurement method that readily confirms the suitability of a sample as platelet-rich plasma.SOLUTION: A specimen measurement device 1 comprises a test section 13 for measuring optical information of platelet-rich plasma and platelet-poor plasma prepared from a blood specimen, a control sections 210 and 213 for acquiring information regarding platelet aggregation of the blood specimen based on the optical information of the platelet-rich plasma and platelet-poor plasma, and a display 4 for displaying information regarding platelet aggregation. The control sections 210 and 213 acquire evaluation information regarding the suitability of the platelet-rich plasma as a sample based on the measurement results of the platelet-rich plasma by the test section 13, and make the display 4 display the information.SELECTED DRAWING: Figure 15

Description

[Technical Field]

[0001] The present invention relates to a specimen measurement device and a specimen measurement method, and more particularly to a specimen measurement device and a specimen measurement method for measuring the platelet aggregation of a blood specimen. [Background technology]

[0002] Conventionally, platelet aggregation testing has been performed using a blood coagulation testing device. To measure platelet aggregation, a whole blood sample collected from a patient is centrifuged in two ways to prepare a platelet-rich plasma (PRP) sample containing many platelets and a platelet-poor plasma (PPP) sample containing substantially no platelets. The platelet aggregation is calculated based on optical information obtained by measuring the platelet-poor plasma sample and optical information obtained by measuring a platelet-rich plasma sample to which a reagent that induces platelet aggregation has been added. However, when the platelet count in the platelet-rich plasma sample is low (150 × 10 9 / L), there is a risk that accurate results will not be obtained. [Prior art documents] [Non-patent literature]

[0003] [Non-Patent Document 1] International Society on Thrombosis and Haemostasis (ISTH) guidelines: "Recommendations for the standardization of light transmission aggregometry: a consensus of the working party from the platelet physiology subcommittee of SSC / ISTH." Journal of Thrombosis and Haemostasis, 11: 1183-1189, 2013 Summary of the Invention [Problem to be solved by the invention]

[0004] For accurate measurement of platelet aggregation, a platelet count of 150 x 10 9 It is desirable to use a platelet-rich plasma sample with a platelet count of 1 / L or more. For this reason, the platelet count of the prepared platelet-rich plasma sample was measured using a hemocytometer separate from the blood coagulation tester to confirm whether it was suitable for the platelet aggregation test. This confirmation process was time-consuming and laborious. [Means for solving the problem]

[0005] A specimen measurement device (1) according to one aspect of the present invention is a specimen measurement device (1) for measuring the platelet aggregation of a blood specimen, and comprises a measurement unit (13) that measures optical information of platelet-rich plasma and platelet-poor plasma prepared from the blood specimen, a control unit (3) that acquires information about the platelet aggregation of the blood specimen based on the optical information of the platelet-rich plasma and the platelet-poor plasma, and a display unit (4) that displays the information about the platelet aggregation, wherein the control unit (3) acquires evaluation information about the suitability of the platelet-rich plasma as a sample based on the measurement results of the platelet-rich plasma by the measurement unit (13), and causes the display unit (4) to display the information.

[0006] A specimen measurement method according to one aspect of the present invention is a specimen measurement method for measuring the platelet aggregation ability of a blood specimen, and is characterized by comprising the steps of acquiring optical information from platelet-poor plasma and platelet-rich plasma, acquiring information relating to the platelet aggregation ability of the blood specimen based on the optical information acquired from the platelet-poor plasma and the platelet-rich plasma, and acquiring evaluation information relating to the suitability of the platelet-rich plasma as a sample based on the optical information acquired from the platelet-rich plasma. [Effects of the Invention]

[0007] The specimen measurement device and specimen measurement method according to the present invention make it possible to easily determine the suitability of platelet-rich plasma as a specimen. [Brief explanation of the drawings]

[0008] [Figure 1] 1 is a diagram showing the appearance of a specimen measurement device according to an embodiment; [Figure 2] FIG. 2 is a plan view showing the configuration of the specimen measurement device. [Figure 3] FIG. 2 is a block diagram showing the configuration of the specimen measurement device. [Figure 4] FIG. 10 is a diagram illustrating an example of a main menu screen. [Figure 5] FIG. 10 is a diagram illustrating an example of an order screen. [Figure 6] FIG. 1 is a flow chart showing an example of a sample measurement method. [Figure 7] FIG. 1 is a flow chart showing an example of a sample measurement method. [Figure 8] FIG. 1 is a flow chart showing an example of a sample measurement method. [Figure 9] FIG. 10 is a diagram showing an example of a setting screen relating to sample compatibility evaluation. [Figure 10] FIG. 1 shows the relationship between the initial absorbance of a platelet-rich plasma sample and the platelet count. [Figure 11] FIG. 1 shows the distribution of initial absorbance of a platelet-rich plasma sample. [Figure 12] FIG. 10 is a diagram showing an example of a setting screen relating to sample compatibility evaluation. [Figure 13] FIG. 10 is a diagram showing an example of a setting screen relating to sample compatibility evaluation. [Figure 14] FIG. 10 is a diagram showing an example of a setting screen relating to sample compatibility evaluation. [Figure 15] FIG. 1 is a flow diagram showing an example of a sample measurement method including sample compatibility evaluation. [Figure 16] FIG. 1 shows the change over time in absorbance of a sample after addition of an elicitor. [Figure 17] FIG. 1 is a flow diagram showing an example of a sample measurement method including sample compatibility evaluation. [Figure 18] FIG. 1 is a flow diagram showing an example of a sample measurement method including sample compatibility evaluation. [Figure 19] FIG. 10 is a diagram showing an example of a display screen of measurement results. [Figure 20]FIG. 10 is a diagram showing an example of a display screen of measurement results. DETAILED DESCRIPTION OF THE INVENTION

[0009] Hereinafter, embodiments of the specimen measurement device and specimen measurement method according to the present invention will be described in detail with reference to the drawings. The embodiments described below are merely examples, and the present invention is not limited to the following embodiments. Furthermore, the present invention includes configurations that selectively combine the respective components of the multiple embodiments and modified examples described below.

[0010] FIG. 1 is a perspective view showing the appearance of a specimen measurement device 1, which is an example of an embodiment. As shown in FIG. 1, the specimen measurement device 1 includes a housing 10 having a substantially rectangular parallelepiped outer shape. The specimen measurement device 1 is a blood coagulation measurement device configured to be able to measure the platelet aggregation of a blood sample. The housing 10 includes a front cover 10a that can be opened and closed. The front cover 10a slides or rotates up and down, and opening the front cover 10a allows the inside of the device to be exposed. The specimen measurement device 1 also includes a transport unit 102 for transporting the specimen, and a measurement start button 30.

[0011] The transport unit 102 is provided at the center in the height direction at the front of the sample measurement device 1. The transport unit 102 has a rack mounting unit 102a where the sample rack 105 is placed, and a rack recovery unit 102b where the sample rack 105 is transported from inside the housing 10 after measurement. The sample rack 105 holds a plurality of sample containers 104 containing samples. As will be described in detail later, when the sample measurement operation is started, the sample rack 105 placed in the rack mounting unit 102a is transported into the housing 10, and after the sample measurement is completed, it is transported from inside the housing 10 to the rack recovery unit 102b.

[0012] The measurement start button 30 is provided above the rack mounting section 102a at the front of the sample measurement device 1. When the operator places a sample rack 105 holding sample containers 104 on the rack mounting section 102a and then operates the measurement start button 30, the sample rack 105 is transported into the housing 10 and sample measurement begins. When manually entering sample information such as the sample identification number (sample ID) and measurement items, the sample information is entered on the order screen 700 (see Figure 5 described below) and then the measurement start button 30 is operated.

[0013] The specimen measurement device 1 further includes an analyzer 3 and a display 4. The analyzer 3 is a computer that analyzes the results of measurements performed in the device main body 2, and is communicatively connected to the device main body 2. In this embodiment, the device main body 2 is a unit in which measurement of the optical information of the specimen is performed, and refers to the parts other than the analyzer 3 and the display 4. In the example shown in FIG. 1, the display 4 is attached to the side of the housing 10, and the analyzer 3 is housed in a side rack 10b attached to the rear of the display 4.

[0014] The analysis device 3 may be communicably connected to a host computer in which sample information such as sample ID and measurement items is registered. The display 4 is a display unit that displays information related to platelet aggregation. The display 4 is a touch panel display that also functions as an input unit. The display 4 is connected to the analysis device 3 and communicably connected to the device main body 1 via the analysis device 3. For example, an operation signal from the display 4, which is a touch panel, is transmitted to the device main body 2 via the analysis device 3. The functions of the analysis device 3 may be built into the device main body 2, or the display 4 may be integrated into the device main body 2.

[0015] The specimen measurement device 1 is a device that analyzes blood coagulation function using, for example, the coagulation method, synthetic substrate method, immunoturbidimetry, and agglutination method, but below, the configuration and method for measuring platelet aggregation (aggregation method) will be described in detail.

[0016] FIG. 2 is a plan view showing the internal structure of specimen measurement device 1. As shown in FIG. 2, specimen measurement device 1 includes a diluted reagent preparation unit 11 that automatically prepares a diluted reagent solution containing a reagent, a measurement sample preparation unit 12 that prepares a measurement sample, and a measurement unit 13 that performs optical measurement of the measurement sample. The diluted reagent solution is prepared by mixing a reagent that induces platelet aggregation in the sample with a diluent such as physiological saline. The measurement sample is prepared, for example, by mixing the diluted reagent solution prepared by diluted reagent preparation unit 11 with a specimen. The specimens used in measuring platelet aggregation are platelet-rich plasma (PRP) specimens and platelet-poor plasma (PPP) specimens. Measurement unit 13 measures optical information of the PRP specimen and PPP specimen prepared from a blood specimen.

[0017] PRP and PPP samples are prepared by performing two types of centrifugation on whole blood samples collected from patients. A PRP sample is, for example, the supernatant obtained by centrifuging blood containing an anticoagulant such as sodium citrate at 200 × g for 10 minutes, where × g is a unit of centrifugal force. A PPP sample is, for example, the supernatant obtained by centrifuging blood containing an anticoagulant at 200 × g for 10 minutes and then centrifuging it again at 1500 × g for 15 minutes. A sample container 104 containing a PRP sample and a sample container 104 containing a PPP sample are paired and arranged in a sample rack 105.

[0018] The reagent contains a substance that induces platelet aggregation (inducer). Examples of inducing agents include adenosine diphosphate (ADP), collagen, epinephrine, arachidonic acid, ristocetin, and protease-activated receptor 1-activating peptide (PAR1-AP). Levohem ADP (registered trademark) can be used for ADP. Levohem Collagen (registered trademark) can be used for collagen. Levohem Epinephrine (registered trademark) can be used for epinephrine. Levohem Arachidonic Acid (registered trademark) can be used for arachidonic acid. Levohem Ristocetin (registered trademark) can be used for ristocetin.

[0019] The reagent containing the elicitor is dispensed only into the container containing the PRP sample. As will be described in detail below, the measurement sample preparation unit 12 dispenses a diluted reagent solution containing the reagent prepared by the diluted reagent solution preparation unit 11 into the reaction container 108 containing the PRP sample, and dispenses a diluent into the reaction container 108 containing the PPP sample. Furthermore, in order to promote the reaction between the elicitor and the platelets in the sample and to ensure uniformity of the reaction, the measurement sample preparation unit 12 heats the reaction container 108 containing the PRP sample to a predetermined temperature before dispensing the diluted reagent solution. Note that the reaction container 108 containing the PPP sample is not heated. Furthermore, an evaluation of suitability as a measurement sample (sample suitability evaluation) is performed on the measurement sample containing the PRP sample.

[0020] The diluted reagent liquid preparation unit 11 has a reagent preparation table 180. The reagent preparation table 180 is a circular table. A plurality of container racks 100, 300 are arranged around the periphery of the reagent preparation table 180. Reagent containers 90 containing solutions containing reagents, diluent containers 50 containing diluents, and diluted reagent containers 60 are arranged in the container racks 100, 300. The arrangement of the reagent containers 90, diluent containers 50, and diluted reagent containers 60 in the container racks 100, 300, and the arrangement of the container racks 100, 300 on the reagent preparation table 180 is performed by an operator with the front cover 10a open to expose the inside of the device.

[0021] The reagent preparation table 180 includes a first table 181 that is circular in plan view and a second table 182 that is annular in plan view and is provided on the outer periphery of the first table 181. In the example shown in FIG. 1 , four container racks 100 are arranged circumferentially on the first table 181. Three large container racks 300 are arranged circumferentially on the second table 182. The first table 181 and the second table 182 can be independently rotated circumferentially around a rotation axis 183 by a rotation mechanism equipped with an electric motor, and the rotation can move the reagent container 90, the diluent container 50, and the diluted reagent container 60 to their respective predetermined positions.

[0022] The diluted reagent preparation unit 11 includes a reagent information reading unit 184 that reads information attached to each of the reagent containers 90, diluent containers 50, diluted reagent containers 60, and container racks 100, 300. For example, this information is attached to each container and rack as a barcode, and the reagent information reading unit 184 includes a barcode reader. The first table 181 and the second table 182 can move the container racks 100, 300 and each container held in the racks to a reading position opposite the reagent information reading unit 184. By reading the information with the reagent information reading unit 184, the positions of the reagent containers 90, diluent containers 50, and diluted reagent containers 60 on the reagent preparation table 180 can be identified.

[0023] The information assigned to the reagent container 90 includes, for example, the identification number (ID) of the reagent container 90, the name of the reagent, the type of the reagent, the concentration of the reagent, the lot number, the expiration date, etc. The information assigned to the diluent container 50 includes, for example, the identification number (ID) of the diluent container 50, the name of the diluent, the type of the diluent, the lot number, the expiration date, etc. The information assigned to the diluted reagent container 60 includes, for example, the identification number (ID) of the diluted reagent container 60, etc. The information assigned to the container racks 100, 300 includes, for example, the identification number (ID) of the container racks 100, 300, etc.

[0024] The diluted reagent liquid preparation unit 11 includes first dispensing units 150a and 150b. Each of the first dispensing units 150a and 150b has a dispensing arm that rotatably holds a dispensing aspirating tube 153. The aspirating tube 153 is connected to a pump and is configured to aspirate and dispense a predetermined amount of fluid. The first dispensing units 150a and 150b move the aspirating tube 153 over the diluent container 50 to aspirate a predetermined amount of diluent from the diluent container 50 and dispense the predetermined amount of diluent into the diluted reagent liquid container 60. The first dispensing units 150a and 150b also move the aspirating tube 153 over the reagent container 90 to aspirate a predetermined amount of reagent from the reagent container 90 and dispense the predetermined amount of reagent into the diluted reagent liquid container 60. As a result, the reagent and the diluent are mixed in the diluted reagent liquid container 60, and a diluted reagent liquid containing the reagent is prepared.

[0025] As described above, the sample measurement device 1 includes a transport unit 102 including a rack mounting unit 102a and a rack recovery unit 102b. The transport unit 102 transports a sample rack 105 placed on the rack mounting unit 102a by an operator into the interior of the housing 10, and places the sample containers 104 held in the sample rack 105 at predetermined sample aspiration positions 501 and 502. The transport unit 102 also includes a sample information reading unit 103 that is placed on the transport path of the sample rack 105. The sample information reading unit 103 includes a barcode reader.

[0026] A label recording sample information, such as a barcode, is affixed to the sample container 104. Sample information includes, for example, sample ID, sample type, sample provider, and measurement items. Sample type information includes whether the sample is a PRP sample or a PPP sample. If the sample information is registered in the host computer, the operator does not need to input the sample information on the order screen 700; they simply place the sample rack 105 on the rack placement section 102a of the transport section 102 and operate the measurement start button 30. In this case, the sample information reading section 103 reads the barcode of the sample container 104 held in the sample rack 105, queries the host computer for information necessary for measurement, and automatically registers the measurement order.

[0027] The measurement sample preparation unit 12 has a turntable 160 that transports the reaction vessel 108. The turntable 160 is arranged outside the reagent preparation table 180. The turntable 160 has a ring shape in a plan view and can rotate in a circumferential direction. The turntable 160 has a plurality of holding holes 161 arranged along the circumferential direction. One reaction vessel 108 can be placed in each of the holding holes 161. A PRP specimen and a diluted reagent solution prepared by the diluted reagent solution preparation unit 11 are dispensed into the reaction vessel 108, and a measurement sample is prepared in the reaction vessel 108. The reaction vessel 108 is, for example, a cuvette. A stirring bar is placed in the reaction vessel 108 beforehand.

[0028] The sample is dispensed into the reaction container 108 by first dispensing units 150a and 150b of the diluted reagent solution preparation unit 11. The first dispensing unit 150a moves the suction tube 153 to aspirate a predetermined amount of sample from the sample container 104 placed at the sample suction position 501 of the transport unit 102. The first dispensing unit 150b moves the suction tube 153 to aspirate a predetermined amount of sample from the sample container 104 placed at the sample suction position 502 of the transport unit 102. After aspirating the sample, the first dispensing units 150a and 150b dispense the sample into the reaction container 108 placed at the sample dispensing positions 503 and 504 on the turntable 160.

[0029] The measurement sample preparation unit 12 has a gripping mechanism 170 that can transport the reaction vessel 108, and a heating table 190 that holds and heats the reaction vessel 108. The gripping mechanism 170 grips and transports the reaction vessel 108, removes the reaction vessel 108 containing the PRP sample from the holding hole 161 of the turntable 160, and places it on the heating table 190. The gripping mechanism 170 also places the reaction vessel 108 containing the PPP sample at the reagent dispensing position 508.

[0030] The heating table 190 is a circular table with a built-in heater, and includes a plurality of holding holes 191 for holding a plurality of reaction vessels 108 containing PRP samples, respectively, and a gripping mechanism 192 for gripping and transporting the reaction vessels 108. A plurality of holding holes 191 are arranged along the circumferential direction of the heating table 190. The heating table 190 is rotatable in the circumferential direction, and transports the reaction vessels 108 arranged in the plurality of holding holes 191 in the circumferential direction by rotation while heating the reaction vessels 108 to a predetermined temperature using the heater. The gripping mechanism 192 removes the reaction vessel 108 from the holding hole 191 and places the reaction vessel 108 at one of the reagent dispensing positions 507 and 508.

[0031] The measurement sample preparation unit 12 includes second dispensing units 120a and 120b. Each of the second dispensing units 120a and 120b includes an aspirating tube 121 for dispensing. The second dispensing units 120a and 120b move their aspirating tubes 121 to a diluted reagent container 60 positioned at a predetermined reagent aspirating position 505 or 506 on the reagent preparation table 180 and aspirate a predetermined amount of diluted reagent from the diluted reagent container 60. The second dispensing units 120a and 120b then move to a reaction vessel 108 positioned at a reagent dispensing position 507 or 508 and dispense a predetermined amount of diluted reagent into the reaction vessel 108 containing the PRP sample. The diluted reagent and the PRP sample are mixed in the reaction vessel 108, preparing a measurement sample containing a reagent at a predetermined concentration. The diluent is dispensed into the reaction vessel 108 containing the PPP sample at the reagent dispensing position 508.

[0032] The measurement sample preparation unit 12 further has a gripping mechanism 175 for transporting the reaction container 108. The gripping mechanism 175 has a movement mechanism in each of three orthogonal axial directions, X, Y, and Z, and grips and transports the reaction container 108. The gripping mechanism 175 transports the reaction container 108 containing the measurement sample from the reagent dispensing positions 507, 508 to the container placement unit 131 of the measurement unit 13. The gripping mechanism 175 also transports the reaction container 108 that has been measured from the container placement unit 131 to the waste outlet 106.

[0033] The measurement unit 13 measures the absorbance or transmittance of the measurement sample. The measurement unit 13 has a container placement unit 131 for placing a reaction container 108 containing the measurement sample, a light sending unit 132 for irradiating the reaction container 108 with light for signal detection, and a light receiving unit 133 arranged opposite the light sending unit 132 across the reaction container 108. The container placement unit 131 is equipped with a stirring mechanism that rotates a stirring bar in the reaction container 108. The measurement unit 13 is provided with a plurality of container placement units 131. In this case, the measurement samples in a plurality of reaction containers 108 can be measured simultaneously.

[0034] The measurement unit 13 measures changes over time in absorbance or transmittance during the process of an aggregation reaction of platelets and the like in the measurement sample in the reaction container 108 placed in the container placement unit 131. The light sending unit 132 irradiates light onto the measurement sample in the reaction container 108 placed in the container placement unit 131. The light sending unit 132 includes a light source such as a light emitting diode or a halogen lamp. The light receiving unit 133 receives transmitted light or scattered light of the light irradiated onto the measurement sample in the reaction container 108, and outputs an electrical signal according to the amount of received light. The light receiving unit 133 includes a photoelectric conversion element that converts the received light into an electrical signal and outputs it, and transmits this electrical signal to the analysis device 3.

[0035] The analyzer 3 analyzes the platelet aggregation ability of the sample based on the electrical signal output from the light-receiving unit 133, i.e., the measurement results of the optical information of the sample acquired by the measurement unit 13. The analyzer 3 creates a reaction curve such as that shown in FIG. 19 (described later) based on, for example, the absorbance or transmittance of the measurement sample, and calculates vWF:RCo (von Willebrand factor ristocetin cofactor) activity, adenosine diphosphate (ADP) maximum aggregation rate, collagen maximum aggregation rate, epinephrine maximum aggregation rate, arachidonic acid maximum aggregation rate, ristocetin maximum aggregation rate, and protease-activated receptor 1-activating peptide (PAR1-AP) maximum aggregation rate. The analyzer 3 also evaluates sample suitability based on the measurement results of the PRP sample.

[0036] Fig. 3 is a block diagram showing the configuration of the device main body 2 and the analysis device 3. As shown in Fig. 3, the device main body 2 includes a communication unit 209, and the analysis device 3 includes a communication unit 212. The device main body 2 and the analysis device 3 transmit and receive information via the communication units 209 and 212. The control unit 210 includes a processor such as a CPU (Central Processing Unit) or an FPGA (Field-Programmable Gate Array), and a storage device such as a ROM (Read Only Memory), RAM (Random Access Memory), or a hard disk.

[0037] The processor of the control unit 210 executes a control program stored in the storage device to control each component of the device main body 2 via the I / O board 211. The control unit 210 controls, for example, the dispensing operation of the second dispensing unit 120, the dispensing operation of the first dispensing units 150a and 150b, the operation of the reagent preparation table 180, the operation of each table and each gripping mechanism, the operation of the measurement unit 13, and the like.

[0038] The analyzer 3 includes a control unit 213 including a processor such as a CPU and storage devices such as a ROM, a RAM, and a hard disk. In this embodiment, the control unit 213 of the analyzer 3 analyzes the platelet aggregation of the specimen and also analyzes the suitability of a measurement specimen containing a PRP specimen as a specimen based on an electrical signal output from the light receiving unit 133 of the apparatus main body 2. A display 4 is connected to the analyzer 3, and analysis results by the analyzer 3, such as the platelet aggregation measurement results and sample suitability evaluation results shown in Figures 19 and 20 (described below), are displayed on the display 4.

[0039] 3 shows an example having two control units 210, 213, but the number of control units is not particularly limited. One control unit may control the device main body 2 and the analysis device 3, or three or more control units may control the device main body 2 and the analysis device 3. The location of the control units is also not particularly limited, and they may be located in only one of the device main body 2 or the analysis device 3. As described above, the functions of the analysis device 3 may be built into the device main body 2.

[0040] 4 shows a main menu screen 600. FIG. 5 shows an order screen 700 relating to the measurement of platelet aggregation. The main menu screen 600 and the order screen 700 are displayed on the display 4.

[0041] 4, the main menu screen 600 includes a toolbar 610 containing buttons for main functions, a status display area 620 containing indicators showing information such as the status of the device, the status of the host computer, and the remaining amounts of reagents and consumables, and a menu icon display area 630. The toolbar 610 includes a maintenance button 611 that is operated when performing maintenance and inspection of the device, a shutdown button 612 that is operated when shutting down the device, and an order button 613 that displays the order screen 700.

[0042] Menu icon display area 630 displays a plurality of buttons (icons) for performing various operations and displaying information, and may display the same buttons as those included in toolbar 610. Menu icon display area 630 includes a reagent consumables button 631, a calibration curve button 632, a QC chart button 633, a maintenance button 634, an error history button 635, a settings button 636, a shutdown button 637, etc. Settings button 636 is a button that displays a settings screen for measurement sample compatibility evaluation (see FIG. 9 described below), and is operated when performing sample compatibility evaluation.

[0043] As shown in FIG. 5, the order screen 700 includes an order registration section 701 for registering sample information such as the sample ID and measurement items, and a measurement type selection section 702 for displaying the currently selected measurement type. If the sample information is not registered in the host computer, the operator must enter the sample information required for the measurement into the order registration section 701. The operator also selects the measurement type using the measurement type selection section 702. The measurement type selection section 702 is provided with a pull-down button, which functions as a measurement type selection button. In FIG. 5, the words "Platelet Aggregation Order" are displayed in the measurement type selection section 702, indicating that platelet aggregation measurement has been selected as the measurement type.

[0044] The order registration unit 701 is displayed in a table format into which sample information can be entered. In platelet aggregation measurement, a PRP sample and a PPP sample are paired and placed on the sample rack 105, and the paired PRP and PPP samples are managed using the same sample ID. The order registration unit 701 displays multiple measurement items. The operator can select the desired measurement items for each sample from the table in the order registration unit 701, and the selected measurement items are registered as an order. When sample compatibility assessment is performed prior to platelet aggregation measurement, order registration is also performed based on the information read by the sample information reading unit 103 or based on the information entered on the order screen 700.

[0045] Hereinafter, the method for measuring platelet aggregation will be described with reference to FIGS.

[0046] 6, the method for measuring platelet aggregation includes the steps of registering a measurement order (step S10), preparing a measurement sample and measuring optical information (steps S11 and S12), and analyzing and outputting the measurement results (steps S13 and S14). In step S10, the control unit 210 controls the specimen information reading unit 103 to read the barcode on the specimen container 104, and queries the host computer for information necessary for the measurement to register the order. If specimen information is not registered in the host computer, the control unit 210 registers the order based on the information entered on the order screen 700.

[0047] In step S11, the control unit 210 controls the diluted reagent solution preparation unit 11 and the measurement sample preparation unit 12 to prepare a measurement sample containing a PPP specimen, and controls the measurement unit 13 to measure optical information of the measurement sample. In addition, in step S12, the control unit 210 controls the diluted reagent solution preparation unit 11 and the measurement sample preparation unit 12 to prepare a measurement sample containing a PRP specimen, and controls the measurement unit 13 to measure optical information of the measurement sample. Details of steps S11 and S12 will be described later, but in this embodiment, absorbance is measured as optical information.

[0048] In step S13, the control unit 210 transmits the measurement data acquired in steps S11 and S12 to the control unit 213 of the analysis device 3, and the control unit 213 analyzes the measurement data. For example, for a PRP sample, the control unit 213 calculates the change in the aggregation rate of the PRP sample over time, assuming that the initial absorbance immediately after adding the diluted reagent solution to the PRP sample represents an aggregation rate of 0% and the absorbance of the PPP sample represents an aggregation rate of 100%, and creates a reaction curve (aggregation waveform obtained by converting absorbance into aggregation rate) such as those shown in Figures 19 and 20 described below. The control unit 213 also calculates the maximum aggregation rate from the maximum change in absorbance associated with the platelet aggregation reaction.

[0049] In step S14, the control unit 213 of the analysis device 3 displays the platelet aggregation measurement results, such as the reaction curve and maximum aggregation rate, on the display 4. As will be described in detail later, the measurement result display screen may display the evaluation results of the sample suitability of the PRP specimen together with the platelet aggregation measurement results.

[0050] Fig. 7 is a flow diagram showing an example of the method for measuring a PPP sample in step S11 of Fig. 6. As shown in Fig. 7, in step S111, the control unit 210 controls the first dispensing unit 150a of the diluted reagent liquid preparation unit 11 to aspirate a predetermined amount of PPP sample from the sample container 104 containing the PPP sample and dispense it into the reaction container 108. In step S112, the control unit 210 controls the second dispensing unit 120a of the measurement sample preparation unit 12 to aspirate a predetermined amount of diluent from the diluent container 50 and dispense it into the reaction container 108, thereby preparing a measurement sample containing the PPP sample.

[0051] In step S113, the control unit 210 controls the gripping mechanism 175 of the measurement sample preparation unit 12 to transfer the reaction container 108 containing the diluted PPP sample to the measurement unit 13, and controls the measurement unit 13 to measure the absorbance of the PPP sample for a predetermined period of time.

[0052] Figure 8 is a flow diagram showing an example of the method for measuring a PRP specimen in step S12 of Figure 6. As shown in Figure 8, in step S121, control unit 210 controls first dispensing unit 150a to aspirate a predetermined amount of PRP specimen from specimen container 104 containing the PRP specimen and dispense it into reaction vessel 108 in which a stirring bar has been placed beforehand. In step S122, control unit 210 controls gripping mechanism 170 of measurement specimen preparing unit 12 to transfer reaction vessel 108 containing the PRP specimen onto heating table 190 and heat it at a predetermined temperature for a predetermined time.

[0053] In step S123, the control unit 210 controls the second dispensing unit 120a to aspirate a predetermined amount of diluted reagent liquid from the diluted reagent liquid container 60 and dispense it into the reaction container 108 containing the PRP sample, thereby preparing a measurement sample containing the PRP sample. The control unit 210 dispenses a predetermined reagent at a predetermined concentration based on the measurement items registered in the order, and prepares one or more types of measurement samples for one PRP sample. In step S124, the control unit 210 controls the gripping mechanism 175 to transfer the reaction container 108 containing the measurement sample to the container placement unit 131 of the measurement unit 13, and rotates the stir bar in the reaction container 108 to stir the measurement sample.

[0054] In step S125, the control unit 210 controls the measurement unit 13 to measure the absorbance of the measurement sample containing a reagent of a predetermined concentration and a PRP specimen for a predetermined time while stirring the measurement sample. Note that if multiple measurement items with different reagent types and concentrations are registered for one PRP specimen, steps S121 to S125 are repeated according to the number of measurement items. Preparation and measurement of measurement samples corresponding to multiple measurement items can be performed simultaneously in parallel.

[0055] Hereinafter, the function of evaluating the suitability of a PRP specimen as a measurement sample will be described in detail with reference to FIGS.

[0056] 9 is a diagram showing an example of a setting screen related to the conformity evaluation of a sample. As shown in FIG. 9, the setting screen 800 includes a list display area 801 that displays multiple measurement items, and a parameter registration section 802 for confirming, setting, changing, etc., the conditions for each measurement item. The setting screen 800 is a screen for confirming, setting, changing, etc., the conditions for each measurement item of the platelet aggregation of a sample, and it is also possible to register new measurement items and delete registered measurement items on the setting screen 800. The setting screen 800 is also used to set information necessary for the evaluation when conducting conformity evaluation of a measurement sample including a PRP sample.

[0057] The setting screen 800 is displayed on the display 4 by operating the setting button 636 on the main menu screen 600. In the list display area 801, multiple measurement items are displayed lined up vertically on the screen. In the specimen measurement device 1, multiple items with different types and concentrations of inducers are generally registered as measurement items for platelet aggregation. In the setting screen 800, by selecting a measurement item (type and concentration of inducer) in the list display area 801, the selected measurement item is displayed in the parameter registration section 802. The parameter registration section 802 has an edit button 803. By operating the edit button 803, the operator can set or change the conditions of the selected measurement item.

[0058] Specimen measurement device 1 obtains evaluation information regarding the suitability of a PRP specimen as a specimen based on the measurement results of a measurement sample containing a PRP specimen by measurement unit 13, and displays this information on display 4, which is a display unit. If the platelet count in a PRP specimen is low, there is a risk that accurate results will not be obtained in measuring platelet aggregation. For this reason, the platelet count in a PRP specimen has traditionally been measured separately using a hemocytometer to confirm whether the specimen is suitable for measuring platelet aggregation. Specimen measurement device 1 makes it easy to determine the suitability of a PRP specimen as a specimen, and since platelet aggregation can also be measured following the suitability determination, usability is greatly improved and the reliability of the measurement results is also improved.

[0059] The optical information of the PRP specimen required to obtain evaluation information on specimen suitability is absorbance or transmittance. Since specimen measurement device 1 is equipped with measurement unit 13 that measures the absorbance or transmittance of a specimen containing a PRP specimen, the absorbance or transmittance obtained by measurement unit 13 can be used as evaluation information on specimen suitability. In this embodiment, the absorbance of a specimen containing a PRP specimen is measured by the function of control unit 210 of device main body 2. Then, the measurement results are analyzed by the function of control unit 213 of analysis device 3, and evaluation information on the suitability as a measurement specimen is obtained.

[0060] In the example shown in FIG. 9, "ADP2.0_m," "ADP2.0_s," and "ADP2.0_e" are displayed in the parameter registration section 802, with "ADP2.0_s" selected. Operating the edit button 803 while "ADP2.0_s" is selected allows the conditions for "ADP2.0_s" to be set or changed. In "ADP2.0_s," "ADP" represents the type of inducer, "2.0" represents the inducer concentration, and "s" represents the initial absorbance. The initial absorbance refers to the absorbance immediately after (for example, within 10 seconds, as described in detail below) adding the inducer to the PRP sample, i.e., before platelet aggregation is detected.

[0061] As will be described in detail later, the suitability of a measurement sample containing a PRP sample is evaluated, for example, using the initial absorbance of the measurement sample containing a PRP sample. Therefore, when evaluating sample suitability, conditions related to the initial absorbance are set on a setting screen 800. Because the initial absorbance does not vary significantly depending on the measurement item (type and concentration of elicitor), conditions related to the initial absorbance may be set for each measurement item, or may be set as conditions common to all measurement items. When the edit button 803 is operated with "ADP2.0_s" selected, for example, a setting screen 810 for the evaluation reference value of the initial absorbance (see FIG. 12 described below) is displayed.

[0062] FIG. 10 shows the relationship between the initial absorbance ([PRP_s]) of a measurement sample containing a PRP specimen and the platelet count (PLT). FIG. 11 shows the distribution of initial absorbance of a sample containing a PRP specimen. As will be described in detail later, the data shown in FIGS. 10 and 11 indicate that the absorbance (initial absorbance) of a sample containing a PRP specimen acquired by the measurement unit 13 can be used as evaluation information for sample suitability. The initial absorbance of a sample containing a PRP specimen is the absorbance acquired by the measurement unit 13, and is the absorbance in the initial state after the addition of an inducer to the PRP specimen and before platelet aggregation is detected by the measurement unit 13, as described above.

[0063] The initial absorbance was measured at a wavelength of 660 nm using a blood coagulation analyzer (Sysmex Corporation's fully automated blood coagulation analyzer CS5100). The platelet count was measured using a blood cell counter (Sysmex Corporation's multi-parameter automated blood analyzer XS-1000i). Figure 10 shows the lower limit of the platelet count recommended by the ISTH guidelines (15 × 10 4 / μL).

[0064] The PRP and PPP samples used to measure the data shown in Figure 10 were prepared from the blood of 70 healthy volunteers. The preparation method for each sample is as follows. (1) Blood was collected from healthy volunteers using 3.2% sodium citrate-containing blood collection tubes (Venoject RRtubes (registered trademark) manufactured by Terumo Corporation). (2) Two blood samples were placed in 10 mL centrifuge tubes (sterilized round-bottomed tubes manufactured by Eiken Chemical Co., Ltd.) and centrifuged at 200 × g for 10 minutes using a high-speed refrigerated centrifuge (Model 7000 manufactured by Kubota Shoji Co., Ltd.). A portion of the supernatant was collected and used as a PRP sample. (3) The remaining supernatant was centrifuged at 1500 × g for another 15 minutes, and the supernatant was collected and used as the PPP sample.

[0065] Figure 10(a) shows the relationship between the initial absorbance [PRP_s] of a sample containing a PRP specimen and the platelet count (PLT). Figure 10(b) shows the relationship between the initial absorbance [PPP_s] of a sample containing a PPP specimen (PRP_s) subtracted from [PRP_s] (PRP_s - PPP_s), and the platelet count (PLT). Because PRP and PPP specimens contain components other than platelets, such as lipids, proteins, and amino acids, the influence of these components was eliminated by calculating [PRP_s] - [PPP_s]. As shown in Figure 10, a positive correlation was observed between the initial absorbance and the platelet count in both cases, suggesting that the suitability of a PRP specimen for platelet aggregation assays can be determined based on the initial absorbance of PRP without measuring the platelet count. By setting a reference value and comparing the initial absorbance of PRP to that reference value, the suitability of the specimen for assay can be determined.

[0066] The regression equation for determining the platelet count from the initial absorbance is as follows: As will be described in detail later, either of the following regression equations 1 and 2 can be used to evaluate sample suitability. Formula 1: PLT=[PRP_s] / 5.71-336.92 / 5.71 Formula 2: PLT=[PRP_s]-[PPP_s] / 5.70-317.48 / 5.70

[0067] Figure 11(a) shows the distribution of [PRP_s], and Figure 11(b) shows the distribution of [PRP_s]-[PPP_s]. The PRP and PPP samples used to measure the data shown in Figure 11 were prepared from the blood of 130 healthy volunteers. The preparation method for each sample was as described above. Figure 11 also shows the upper and lower limits of the 95% confidence interval.

[0068] The 95% confidence interval for the [PRP_s] distribution shown in Figure 11(a) was 419 to 828 mOD (optical density), and the 95% confidence interval for the [PRP_s]-[PPP_s] distribution shown in Figure 11(b) was 401 to 787 mOD. The platelet count calculated by substituting the lower limit of the 95% confidence interval for the initial absorbance distribution into the regression equation was nearly consistent with the recommended lower limit for platelet count in the ISTH guidelines. This demonstrates that the initial absorbance of the sample acquired by the measurement unit 13 can be used as evaluation information for sample suitability.

[0069] The control unit 213 of the analyzer 3 compares the initial absorbance of the PRP sample measured by the measurement unit 13 with a reference value to obtain information for evaluating the suitability of the PRP sample as a specimen. The reference value is set, for example, in the range of 400 to 440 mOD. The value set in the range of 400 to 440 mOD is the lower reference value (lower limit), which corresponds to the recommended lower limit of platelet count in the ISTH guidelines, as described above. Therefore, by using this lower limit, it is possible to evaluate the sample based on the recommended lower limit in the ISTH guidelines. The value of [PRP_s] - [PPP_s] may also be used to evaluate the sample suitability. In this case, the lower limit is set, for example, in the range of 380 to 420 mOD.

[0070] The control unit 213 outputs error information if the initial absorbance of the PRP sample is below the reference value. The error information is evaluation information indicating that the PRP sample used is not suitable as a sample. Details of the error information will be described later. An upper reference value (upper limit) may also be set for evaluating sample suitability. The upper limit is set, for example, in the range of 800 to 840 mOD based on the results of the above-mentioned study. The value of [PRP_s] - [PPP_s] may also be used for evaluating sample suitability. In this case, the upper limit is set, for example, in the range of 760 to 800 mOD.

[0071] The control unit 213 may compare the platelet count with a reference value to obtain evaluation information regarding the sample suitability of the PRP sample. If the platelet count of the PRP sample is below the reference value, the control unit 213 outputs error information. The platelet count of the PRP sample is calculated based on the initial absorbance of the PRP sample measured by the measurement unit 13, specifically using the above-mentioned regression formula 1. In this case, the recommended lower limit value of the ISTH guidelines can be used as the lower limit value. Furthermore, an upper limit value for the platelet count may be further set based on the above-mentioned regression formula 2.

[0072] FIG. 12 is a diagram showing a setting screen 810, which is an example of a screen for setting a reference value for sample suitability evaluation. As shown in FIG. 12, the setting screen 810 includes a selection button 811 for selecting whether or not to evaluate sample suitability based on the initial absorbance of a PRP sample, and a reference value input section 812 for inputting a reference value required for the evaluation. The selection button 811 includes a check box. When the operator checks the check box of the selection button 811, the evaluation of sample suitability based on the initial absorbance is enabled. In other words, the evaluation of sample suitability is executed. Furthermore, when the check box of the selection button 811 is checked, it becomes possible to input a reference value into the reference value input section 812.

[0073] The reference value input unit 812 includes two input units into which upper and lower limit reference values ​​can be input. Since the setting screen 810 sets evaluation conditions based on the initial absorbance of the PRP sample, the reference value of the initial absorbance is input into the reference value input unit 812. In the example shown in FIG. 12, an initial absorbance of "410" is input as the lower limit value and "850" as the upper limit value. The reference value may be an arbitrary value input by the operator, or may be selectable from predetermined values. Alternatively, only the selection button 811 may be displayed on the setting screen, and the reference value may be a fixed value registered in advance.

[0074] The setting screen 810 further includes a selection button 813 for selecting whether or not to inquire about continuing the measurement based on the evaluation information of the sample suitability. The selection button 813 includes a check box. When the operator checks the check box of the selection button 813, an inquiry about whether or not to continue the subsequent measurement is executed based on the evaluation information of the sample suitability. The information inquiring about whether or not to continue the measurement is displayed on the display 4 together with the button for selecting whether or not to continue the measurement.

[0075] If the evaluation result of sample suitability is positive, i.e., if the initial absorbance of the PRP sample is within the upper and lower limit reference value range entered in the reference value input section 812, the control section 210 of the device main body 2 continues the measurement of platelet aggregation without executing the inquiry even if the check box of the selection button 813 is checked. From the viewpoint of improving usability, it is preferable to automatically continue the measurement if the evaluation result of sample suitability is within the reference value range. Note that if the check box of the selection button 813 is not checked, the measurement of platelet aggregation is continued to the end regardless of the evaluation result.

[0076] When evaluation information indicating that the PRP sample is not suitable as a specimen is acquired, the control unit 210 causes the display 4 to display information for confirming whether the operator wishes to continue the measurement. In this case, the operator can determine whether to continue the measurement based on the information. In other words, when the evaluation result of sample suitability is negative, a query is made as to whether the subsequent measurement should be continued. As a specific example, when the initial absorbance of the PRP sample is below the lower limit input in the reference value input unit 812, the display 4 displays this information and a query as to whether the measurement should be continued.

[0077] Based on the measurement results of the PRP sample or the evaluation information on sample suitability, the control unit 210 may determine whether to prepare a measurement sample by adding a reagent containing an elicitor to the PRP sample, or may determine whether to continue measuring the absorbance of the measurement sample to which the reagent containing an elicitor has been added. When making the former determination, the measurement sample is prepared by adding a reagent containing an elicitor to the PRP sample after the sample suitability evaluation. On the other hand, when making the latter determination, the measurement of the optical information of the PRP sample to obtain evaluation information is performed within a predetermined time after adding the reagent containing the elicitor to the PRP sample, i.e., after preparing the measurement sample.

[0078] FIG. 13 is a diagram showing a setting screen 820, which is another example of a screen for setting a reference value for sample suitability evaluation. As shown in FIG. 13, the setting screen 820 includes a selection button 821 for selecting whether or not to evaluate sample suitability based on the platelet count of a PRP sample, and a reference value input section 822 for inputting a reference value required for the evaluation. The selection button 821 includes a check box. When the operator checks the check box of the selection button 821, the evaluation of sample suitability based on the platelet count is enabled. Furthermore, when the check box of the selection button 821 is checked, it becomes possible to input a reference value into the reference value input section 822.

[0079] The reference value input section 822 includes two input sections that allow input of upper and lower limit reference values, similar to the case of the setting screen 810. Since the setting screen 820 is used to set evaluation conditions based on the platelet count of the PRP sample, the reference value of the platelet count is input into the reference value input section 822. In the example shown in FIG. 13, "15×10" is input as the lower limit. 4 / μL, and the upper limit is 80 × 10 4 The platelet count of " / μL" is input. The reference value may be an arbitrary value that the operator can input, or may be selected from predetermined values. Alternatively, only the selection button 821 is displayed on the setting screen, and the reference value may be a fixed value that is registered in advance.

[0080] The reference value input unit 822 may further display a regression equation for calculating the platelet count from the initial absorbance of the PRP sample. The operator may be able to select the regression equation from among pre-registered equations. Similarly to the setting screen 810, the setting screen 820 may also include a selection button 813 for selecting whether or not to inquire about continuing the measurement based on the evaluation information of the sample suitability. When the evaluation conditions are set based on the setting screen 820, the control unit 213 estimates the platelet count from the initial absorbance of the PRP sample and acquires evaluation information based on the platelet count. Specifically, the platelet count is calculated from the initial absorbance of the PRP sample using the above-described regression equation 1 or 2, and the calculated platelet count is compared with the reference value input to the reference value input unit 822 to evaluate the sample suitability.

[0081] FIG. 14 shows a setting screen 830, which is another example of a screen for setting a reference value for sample suitability evaluation. As shown in FIG. 14, the setting screen 830 includes both a selection button 811 for selecting whether to evaluate sample suitability based on the initial absorbance of the PRP sample and a selection button 821 for selecting whether to evaluate sample suitability based on the platelet count of the PRP sample. In this case, the operator can select whether to perform the evaluation using the initial absorbance or the platelet count. The setting screen 830 also displays a reference value input section 812 in which the reference value for initial absorbance is input, a reference value input section 822 in which the reference value for platelet count is input, and a selection button 813 for selecting whether to inquire about continuing the measurement.

[0082] Fig. 15 is a flow diagram showing an example of a sample measurement method including sample compatibility assessment. Although not shown in Fig. 15, the sample measurement method including sample compatibility assessment includes a step of preparing a PPP sample and a PRP sample prepared from a blood sample.

[0083] In the example shown in Figure 15, a PPP sample and a PRP sample are measured in the same manner as in a normal platelet aggregation measurement, and the sample suitability of the PRP sample is evaluated. In this case, the measurement operation of the PPP sample (step S22) is the same as the method shown in Figure 7. Furthermore, the measurement operation of the PRP sample (step S23) is the same as the method shown in Figure 8. When the measurement of the PRP sample in step S23 is completed, the platelet aggregation measurement result and the sample suitability evaluation result are displayed on the display 4.

[0084] As shown in Fig. 15, when a compatibility assessment of a measurement sample containing a PRP specimen is performed, the control unit 210 sets information necessary for the assessment (step S20). The conditions for the compatibility assessment are set based on an operator's operation. For example, when a check box of a selection button 811 on a setting screen 810 shown in Fig. 12 is checked, the control units 210, 213 evaluate the sample compatibility based on the initial absorbance. When the setting screen 820 shown in Fig. 13 is applied, the control units 210, 213 evaluate the sample compatibility based on the platelet count when a check box of a selection button 821 on the setting screen 820 is checked.

[0085] The control unit 210 sets the reference values ​​input in the reference value input section 812 of the setting screen 810 as the judgment criteria for the sample suitability evaluation. Specifically, the control unit 210 sets the lower and upper limits of the initial absorbance as the reference values. When based on an input in the reference value input section 822 of the setting screen 820, the control unit 210 sets the lower and upper limits of the platelet count as the reference values. The reference values ​​may be pre-registered values ​​or may be automatically set by a function of the control unit 210.

[0086] In step S21, the control unit 210 controls the sample information reading unit 103 to read the barcode of the sample container 104. If the sample information is registered in the host computer, the control unit 210 queries the host computer for information necessary for measurement and automatically registers the sample information. For example, when a sample rack 105 holding sample containers 104 is placed on the rack mounting unit 102a and the measurement start button 30 is operated, the sample rack 105 is transported into the housing 10, sample measurement is initiated, and measurement order registration is executed. Note that step S21 is the same as step S10 in FIG. 6.

[0087] The control unit 210 prepares a sample containing a PPP sample and performs absorbance measurement (step S22: acquire first optical information), and then prepares a sample containing a PRP sample and performs absorbance measurement (step S23: acquire second optical information). Each measurement sample is prepared by dispensing each sample from a sample container 104 in a sample rack 105 placed on the rack mounting unit 102a. When measuring platelet aggregation, the sample rack 105 holds sample containers 104 containing PPP samples and PRP samples with the same sample ID, i.e., from the same donor.

[0088] When the measurement of the PRP sample is completed, the control unit 213 acquires evaluation information regarding the suitability of the PRP sample as a sample based on the absorbance of the PRP sample (step S24). Specifically, the initial absorbance of the PRP sample measured by the measurement unit 13, or the platelet count calculated from the initial absorbance, is compared with a reference value to evaluate the suitability of the PRP sample as a sample. In the example shown in FIG. 15, since the measurement of the PRP sample is completed in step S23, the control unit 213 analyzes the platelet aggregation ability regardless of the evaluation result of the sample suitability (step S25). The order of steps S24 and S25 is not particularly limited, and the order may be reversed.

[0089] The control unit 213 outputs the evaluation result of sample suitability to the display 4 (step S26). The evaluation result of sample suitability is output together with the measurement result of platelet aggregation. As will be described in detail later, the evaluation result of sample suitability and the measurement result of platelet aggregation are displayed on the same screen. If the initial absorbance of the PRP sample measured by the measurement unit 13 or the platelet count calculated from the initial absorbance falls below a lower limit reference value, the control unit 213 outputs error information indicating that the PRP sample used is not suitable as a sample.

[0090] 15, as described above, after measuring platelet aggregation, evaluation information on sample suitability is obtained using the optical information of the PRP sample, which is the measurement result. In this case, the control unit 210 measures the absorbance of the PRP sample to obtain the evaluation information within a predetermined time after adding a reagent containing an elicitor to the PRP sample. The predetermined time is set to, for example, 2 to 10 seconds after adding the reagent containing the elicitor.

[0091] Figure 16 shows the change in absorbance of a PRP sample over time after the addition of a reagent containing an initiator. As shown in Figure 16, the addition of an initiator to a PRP sample causes a decrease in absorbance as the platelet aggregation reaction progresses, but the decrease in absorbance due to the aggregation reaction is not detected until a predetermined time T2 has elapsed since the addition of the initiator. Therefore, by using the initial absorbance within the predetermined time T2 after the addition of the initiator, it is possible to appropriately evaluate the sample suitability of a PRP sample to which an initiator has been added. The predetermined time T2, during which the absorbance shows little change, varies depending on the type of initiator, but is, for example, 4 to 10 seconds.

[0092] In this embodiment, a reagent containing an elicitor is dispensed into a reaction vessel 108 containing a PRP specimen to prepare a measurement sample, and then the reaction vessel 108 is immediately transferred to the measurement unit 13. Therefore, in order to eliminate the influence of shock during transfer on the measurement, it is preferable that the measurement of the initial absorbance for obtaining evaluation information on sample suitability be performed a predetermined time T1 after the reaction vessel 108 is transferred to the measurement unit 13. An example of the predetermined time T1 is 0.5 to 2 seconds. Therefore, the control unit 210 measures the initial absorbance within a time period of 2 to 10 seconds after adding the reagent containing the elicitor to the PRP specimen.

[0093] The initial absorbance is calculated, for example, by monitoring the absorbance for a predetermined time period from T1 to T2 and linearly approximating the change. By substituting 0 for the time in the linear approximation formula, the initial absorbance can be calculated using this formula. In this case, the influence of variations in the measured values ​​can be suppressed, further improving the reliability of the evaluation results. Alternatively, the absorbance at the predetermined time period T1 can be defined as the initial absorbance.

[0094] The control unit 210 may measure the absorbance of the PRP sample to obtain evaluation information on sample suitability after preparing a measurement sample by adding a reagent containing an elicitor to the PRP sample and before starting to stir the measurement sample. The measurement unit 13 includes a stirring mechanism that rotates a stirrer in the reaction vessel 108, and absorbance measurements are performed while the stirrer is rotating. However, because rotating the stirrer promotes the agglutination reaction, absorbance measurements for reagent suitability evaluation may be performed before starting to stir the measurement sample. For example, the control unit 210 measures the initial absorbance of the PRP sample to obtain evaluation information within a predetermined time after adding a reagent containing an elicitor to the PRP sample and before starting to stir.

[0095] The control unit 213 compares the optical information of the PRP sample with a reference value to obtain evaluation information on sample suitability. The evaluation information may include information that prompts the blood cell counter to measure the platelet count. The evaluation information may also include information on the suitability of centrifugation conditions when preparing a PRP sample from a blood sample. The control unit 213 may further estimate the possibility of other diseases based on the measurement results or evaluation information of the PRP sample and display information on the other diseases on the display 4. Information on the other diseases may be output as part of the evaluation information on sample suitability.

[0096] If the initial absorbance or platelet count is below the lower limit reference value or exceeds the upper limit reference value, the control unit 213 outputs error information indicating that the PRP specimen used is not suitable as a sample as evaluation information. The error information may include information prompting the measurement of the platelet count using a blood cell counter, such as text information such as "The platelet count may be outside the recommended measurement range. Please measure the platelet count using a blood cell counter," or an error code indicating such information.

[0097] The error information may include information regarding the appropriateness of the centrifugation conditions when preparing a PRP sample from a blood sample, such as text information such as "The platelet count may be outside the recommended measurement range. Please check the centrifugation conditions during sample preparation." or an error code indicating the information. The main cause of platelet counts falling outside the recommended measurement range during PRP sample preparation is centrifugation conditions. Therefore, providing information about centrifugation conditions can encourage users to check the centrifugation conditions and prepare samples under appropriate conditions.

[0098] Figure 17 is a flow chart showing another example of a sample measurement method including sample suitability evaluation. The example shown in Figure 17 is similar to the example shown in Figure 15 in that after adding a reagent containing an elicitor to a PRP sample, absorbance measurement is performed within a predetermined time to evaluate sample suitability. However, the example shown in Figure 17 differs from the example shown in Figure 15 in that, if evaluation information indicating that the PRP sample is not suitable as a sample is obtained, information is output to confirm to the operator whether or not to continue the measurement. Furthermore, in the example shown in Figure 17, absorbance measurement of the PPP sample is performed after evaluation of sample suitability.

[0099] As shown in Fig. 17, the control unit 210 sets information necessary for evaluating sample suitability (step S30). Step S30 is similar to step S20 in Fig. 15. Furthermore, when the measurement start button 30 is operated and the sample rack 105 is transported into the housing 10, the control unit 210 controls the sample information reading unit 103 to read the barcode on the sample container 104 and register the measurement order (step S31). Step S31 is similar to step S21 in Fig. 6 and step S21 in Fig. 15.

[0100] The control unit 210 dispenses a predetermined amount of the PRP specimen from the specimen container 104 containing the PRP specimen into the reaction vessel 108, and transfers the reaction vessel 108 onto the heating table 190 to heat it at a predetermined temperature for a predetermined time (step S32). Step S32 is the same as steps S121 and S122 in FIG. 8. The control unit 210 dispenses a diluted reagent solution containing an elicitor into the reaction vessel 108 containing the PRP specimen, and prepares a measurement specimen containing the PRP specimen (step S33). If multiple measurement items are registered in an order for one PRP specimen, measurement specimens in the number corresponding to the number of measurement items are prepared.

[0101] The control unit 210 measures the initial absorbance of the sample containing the PRP sample (step S34). The sample absorbance measurement is performed while the stirrer in the reaction vessel 108 is rotating to stir the sample, but the initial absorbance for sample suitability evaluation may be measured within a predetermined time after the addition of the reagent containing the elicitor without stirring the sample. Next, the control unit 213 evaluates the sample suitability of the PRP sample based on the measurement data from step S34 (step S35). If the initial absorbance or platelet count is below the lower limit reference value or exceeds the upper limit reference value, the control unit 213 outputs error information indicating that the PRP sample used is not suitable as a sample.

[0102] When evaluation information indicating that the PRP specimen is not suitable as a sample is acquired, the control unit 213 displays information on the display 4 to confirm the operator's intention to continue the measurement, and determines whether or not to continue the measurement (steps S36 and S37). The control units 210 and 213 may automatically stop the measurement when the initial absorbance or platelet count of the PRP specimen falls below the lower limit reference value or exceeds the upper limit reference value (No in step S37), but preferably provide the operator with information to confirm their intention to continue the measurement.

[0103] If the evaluation result of sample suitability in step S35 is positive, i.e., if the initial absorbance or platelet count of the PRP sample is within the upper and lower limit reference value ranges, it is preferable that the control units 210, 213 automatically continue the measurement (Yes in step S37). In this case, from the viewpoint of improving usability, it is preferable to omit the confirmation with the operator in step S36.

[0104] In this embodiment, if the evaluation result of sample suitability is negative, i.e., if the initial absorbance or platelet count of the PRP sample is below the lower limit reference value or above the upper limit reference value, information for confirming whether to continue the measurement is displayed on the display 4. As a specific example, along with error information indicating that the PRP sample is unsuitable as a sample, text information such as "Do you want to continue the measurement?" or an error code indicating this information is displayed along with a button for selecting whether to continue the measurement. For example, if the control units 210, 213 receive an operation signal to continue the measurement, they continue the absorbance measurement of the measurement sample containing the PRP sample (Yes in step S37, step S38), and if they do not receive an operation signal to continue the measurement, they stop the measurement (No in step S37).

[0105] In step S38, the control unit 210 performs absorbance measurement of the sample containing the PRP sample, and then performs absorbance measurement of the sample containing the PPP sample (step S39). If the measurement sample was not stirred in step S34, stirring of the sample is started and absorbance measurement is performed in step S38. After the absorbance measurement of the PPP sample is completed, the control unit 213 analyzes platelet aggregation (step S40) and displays the platelet aggregation measurement results together with the evaluation results of sample suitability on the display 4 (step S41). If the measurement was aborted in step S37, the control unit 213 displays only the evaluation results of sample suitability on the display 4 in step S41.

[0106] Figure 18 is a flow chart showing another example of a sample measurement method including sample suitability evaluation. The example shown in Figure 18 is similar to the example shown in Figure 17 in that, when evaluation information indicating that the PRP sample is unsuitable as a sample is acquired, information is output to confirm the operator's intention to continue measurement. However, it differs from the example shown in Figure 17 in that absorbance measurement is performed to evaluate sample suitability before adding a reagent containing an elicitor to the PRP sample. In the example shown in Figure 18, a measurement sample containing an elicitor has not been prepared at the time the evaluation information on reagent suitability is acquired, so the control units 210 and 213 can determine whether to prepare a measurement sample based on the evaluation information on sample suitability.

[0107] As shown in Fig. 18, the control unit 210 sets information necessary for evaluating the compatibility of measurement samples containing PRP samples (step S50). When the measurement start button 30 is operated and a sample rack 105 is transported into the device, the control unit 210 controls the sample information reading unit 103 to read the barcode of the sample container 104 and registers a measurement order (step S51). Thereafter, a predetermined amount of PRP sample is dispensed from the sample container 104 containing the PRP sample into a reaction container 108 (step S52). Steps S50 to S52 are the same as steps S30 to S32 in Fig. 17. However, the reaction container 108 does not need to be heated in step S52.

[0108] The control unit 210 measures the initial absorbance of the PRP sample (step S53: acquiring third optical information) and evaluates the sample suitability of the PRP sample based on the measurement results (step S54). If the initial absorbance or platelet count is below the lower limit reference value or exceeds the upper limit reference value, the control unit 213 outputs error information indicating that the PRP sample used is not suitable as a sample.

[0109] When evaluation information indicating that the PRP specimen is not suitable as a sample is acquired, the control unit 213 displays information for confirming whether or not to continue the measurement on the display 4 and determines whether or not to continue the measurement (steps S55 and S56). When the initial absorbance or platelet count of the PRP specimen falls below a lower limit reference value or exceeds an upper limit reference value, the control unit 213 interrupts the series of measurements and confirms whether or not to continue the measurement. The control unit 213 may automatically stop the measurement (No in step S56), but preferably provides the operator with information for confirming whether or not to continue the measurement.

[0110] If the evaluation result of sample suitability is negative, for example, along with error information indicating that the PRP specimen is not suitable as a sample, text information such as "Do you want to prepare a measurement specimen and continue the measurement?" or an error code indicating such information is displayed along with a button to select whether to continue the measurement. If the control units 210, 213 receive an operation signal to continue the measurement, they continue the measurement of platelet aggregation (Yes in step S56), and if they do not receive an operation signal to continue the measurement, they stop the measurement (No in step S56).

[0111] If the measurement is continued in step S56, the control unit 210 prepares a measurement sample containing a PRP specimen in step S57 and measures the absorbance of the measurement sample (step S58: acquire second optical information). Thereafter, the control unit 210 measures the absorbance of a sample containing a PPP specimen (step S59: acquire first optical information). That is, in the method illustrated in FIG. 18 , third optical information for evaluating sample suitability is acquired from the PRP specimen before acquiring the second optical information. Here, the second optical information is information measured after a predetermined time has passed since the addition of a reagent that induces platelet aggregation to the platelet-rich plasma, and the reaction has progressed sufficiently, and the third optical information is information measured within a predetermined time since the addition of the reagent that induces platelet aggregation to the platelet-rich plasma.

[0112] When the absorbance measurement of the PPP sample is completed, the control unit 213 analyzes the platelet aggregation ability (step S60) and causes the measurement result of the platelet aggregation ability to be displayed on the display 4 together with the evaluation result of the sample suitability (step S61). If the measurement is stopped in step S56, the control unit 213 causes only the evaluation result of the sample suitability to be displayed on the display 4 in step S61.

[0113] 19 and 20 show result display screens 900 and 910, respectively, which are examples of display screens for measurement results. The result display screen 900 shown in FIG. 19 includes a reaction curve display area 901 that displays a reaction curve (agglutination waveform) in which absorbance is converted into an agglutination rate. The result display screen 910 shown in FIG. 20 similarly includes a reaction curve display area 911 that displays a reaction curve. The result display screen 900 is a screen that displays details of the results of a measurement item selected using a measurement item tab 902, whereas the result display screen 910 is a screen that simultaneously displays the results of multiple measurement items. Either the result display screen 900 or 910 can be displayed on the display 4, and the screen can be switched based on the operator's selection.

[0114] 19, the measurement item "ADP 1.0%" is selected, and the measurement results for that measurement item are displayed. The result display screen 900 displays a reaction curve when ADP is added to a PRP sample, and the detailed information display area 903 displays a value of 300 mOD as the initial absorbance "Abs PRP_s" of the sample containing the PRP sample, and the error information display area 904 displays an error code. In other words, the result display screen 900 displays information regarding platelet aggregation and evaluation information regarding the sample suitability of the PRP sample.

[0115] The reference value for the lower limit of the initial absorbance of a sample containing a PRP sample is set to, for example, 410 mOD. In this case, the initial absorbance of 300 mOD is below the lower limit, and error information indicating that the PRP sample used is not suitable as a sample, i.e., abnormal, is displayed as evaluation information for sample suitability. In the example shown in FIG. 19, the error code displayed in the error information display area 904 corresponds to this error information. In addition to the error code, the error information display area 904 may also display text indicating the nature of the error, such as "PLT number low." "PLT number low" indicates that the platelet count in the sample is low.

[0116] The result display screen 910 further includes a result list display area 912. The reaction curve display area 911 and result list display area 912 of the result display screen 910 display the results of multiple measurement items, making it easy to compare the measurement results. Since the initial absorbance of a sample containing a PRP specimen does not vary significantly depending on the type of inducer, as long as the PRP specimen is the same, the initial absorbance displayed in the result list display area 912 of FIG. 20 is a similar value that is lower than the lower limit reference value. Although the result display screen 910 does not display an error code like the one displayed on the result display screen 900, the result display screen 910 may also display error information that clearly indicates that the PRP specimen used is not suitable as a sample.

[0117] Display 4 may display, as sample suitability evaluation information, information that clearly indicates that the PRP sample used is appropriate (normal) as a sample, along with the initial absorbance or platelet count value when the initial absorbance of the PRP sample or the platelet count calculated from the regression equation is within the reference value range. Alternatively, if the sample is normal, only the initial absorbance or platelet count value may be displayed, and only if the sample is abnormal, error information that clearly indicates that the sample is abnormal may be displayed along with the initial absorbance or platelet count value.

[0118] The sample suitability evaluation information for a PRP sample whose initial absorbance or platelet count is outside the reference range may include, as described above, information encouraging measurement of the platelet count using a hemocytometer, or information regarding the appropriateness of the centrifugation conditions used to prepare the PRP sample from the blood sample. The result display screen may also display both types of information. For example, text such as "The platelet count may be outside the recommended measurement range. Please measure the platelet count using a hemocytometer. Also, the centrifugation conditions used to prepare the sample may not be appropriate. Please check the centrifugation conditions" or an error code indicating the information may be displayed.

[0119] If the initial absorbance or platelet count of the PRP sample is outside the reference range, the information displayed on the result display screen may include information about other diseases that can be inferred from the initial absorbance or platelet count of the measured PRP sample. For example, if the platelet count in the PRP sample is low and below the lower limit of the reference range, Bernard-Soulier syndrome may be the cause, so text information such as "The platelet count may be outside the recommended measurement range. Bernard-Soulier syndrome is suspected," or a code indicating such information, may be displayed on the result display screen.

[0120] As described above, the specimen measurement device 1 and specimen measurement method having the above configuration make it possible to easily determine the suitability of a PRP specimen as a sample. [Explanation of symbols]

[0121] 1. Sample measurement device 2. Device body 3 Analysis device 4. Display 10. Cabinet 10a Front cover 10b Side Rack 11 Diluted reagent solution preparation section 12 Measurement sample preparation section 13 Measuring part 30 Measurement start button 50 Diluent Container 60 Diluted Reagent Container 90 Reagent containers 100, 300 container racks 102 Conveying section 102a Rack mounting section 102b Rack collection section 103 Sample information reading unit 104 Sample container 105 sample racks 106 Disposal outlet 108 Reaction vessel 120a, 120b Second dispensing section 150a, 150b First dispensing section 121, 152 Suction tube 131 Container placement section 132 Light transmitting unit 133 Light receiving part 160 Rotating Table 161, 191 holding hole 170, 175, 192 gripping mechanism 180 Reagent Preparation Table 181 Table 1 182 Table 2 183 Rotation axis 184 Reagent information reading unit 190 Heating Table 209, 212 Communications Department 210, 213 Control section 211 I / O board 501, 502 Sample aspiration positions 503, 504 Sample dispensing position 505, 506 Reagent aspiration positions 507, 508 Reagent dispensing positions 600 Menu Screen 610 Toolbar 611, 634 Maintenance button 612, 637 Shutdown button 613 Order Button 620 Status display area 630 Menu icon display area 631 Reagent consumables button 632 Calibration curve button 633 QC Chart Button 633 635 Error history button 636 Settings button 700 Order Screen 701 Order Registration Department 702 Measurement type selection section 800, 810, 820, 830 setting screen 801 List display area 802 Parameter Registration Section 803 Edit button 811, 813, 821 selection buttons 812, 822 Reference value input section 900, 910 Result display screen 901, 911 response curve display area 902 Measurement Item Tab 903, 912 detailed information display area 904 Error information display area

Claims

1. A specimen measurement device for measuring platelet aggregation of a blood specimen, comprising: a measuring unit that measures optical information of platelet-rich plasma and platelet-poor plasma prepared from the blood sample; a control unit that acquires information about the platelet aggregation ability of the blood sample based on optical information of the platelet-rich plasma and the platelet-poor plasma; a display unit that displays information about the platelet aggregation activity; Equipped with The control unit obtains evaluation information regarding the suitability of the platelet-rich plasma as a sample based on the measurement results of the platelet-rich plasma by the measurement unit, and displays the information on the display unit.

2. The specimen measurement device according to claim 1 , wherein the optical information of the platelet-rich plasma used to obtain the evaluation information is absorbance or transmittance.

3. 3. The specimen measurement device according to claim 1, wherein the measurement of the optical information of the platelet-rich plasma to obtain the evaluation information is performed within a predetermined time after adding a reagent that induces platelet aggregation to the platelet-rich plasma.

4. The specimen measurement device according to claim 3 , wherein the predetermined time is set to a time of 2 seconds or more and 10 seconds or less after the addition of the reagent.

5. 3. The specimen measurement device according to claim 1, wherein the measurement of the optical information of the platelet-rich plasma to obtain the evaluation information is performed after preparing a measurement sample by adding a reagent that induces platelet aggregation to the platelet-rich plasma, and before starting to stir the measurement sample.

6. 3. The specimen measurement device according to claim 1, wherein the measurement of the optical information of the platelet-rich plasma to obtain the evaluation information is performed before adding a reagent that induces platelet aggregation to the platelet-rich plasma.

7. The specimen measurement device according to claim 1 , wherein the control unit compares optical information of the platelet-rich plasma with a reference value to obtain the evaluation information.

8. The specimen measurement device according to claim 1 , wherein the evaluation information includes information regarding the suitability of centrifugation conditions when preparing the platelet-rich plasma from the blood specimen.

9. The specimen measurement device according to claim 1 , wherein the evaluation information includes information prompting a blood cell counter to measure the platelet count.

10. The specimen measurement device according to claim 1 , wherein the control unit estimates a platelet count from a measurement result of the platelet-rich plasma, and acquires the evaluation information based on the platelet count.

11. The specimen measurement device according to claim 10 , wherein the control unit acquires the evaluation information by comparing the platelet count with a reference value.

12. The specimen measurement device according to claim 1 or 2, wherein the control unit further estimates the possibility of other diseases based on the platelet-rich plasma measurement results or the evaluation information, and causes the display unit to display information about the other diseases.

13. The specimen measurement device according to claim 1 or 2, wherein the control unit determines whether to prepare a measurement sample by adding a reagent that induces platelet aggregation to the platelet-rich plasma based on the measurement results of the platelet-rich plasma or the evaluation information.

14. The specimen measurement device according to claim 1 or 2, wherein the control unit determines whether or not to measure optical information of a measurement sample prepared by adding a reagent that induces platelet aggregation to the platelet-rich plasma based on the measurement results of the platelet-rich plasma or the evaluation information.

15. The specimen measurement device of claim 1 or 2, wherein the control unit causes the display unit to display information for confirming the intention to continue measurement when evaluation information indicating that the platelet-rich plasma is not suitable as a sample is obtained.

16. A sample measurement method for measuring platelet aggregation of a blood sample, comprising: acquiring optical information of the platelet-poor plasma and the platelet-rich plasma; obtaining information regarding the platelet aggregation ability of the blood sample based on optical information obtained from the platelet-poor plasma and the platelet-rich plasma; obtaining evaluation information regarding the suitability of the platelet-rich plasma as a sample based on optical information obtained from the platelet-rich plasma; A method for measuring a specimen, comprising:

17. The sample measurement method according to claim 16, further comprising the step of preparing the platelet-poor plasma and the platelet-rich plasma from the blood sample.

18. displaying information about the platelet aggregation activity; displaying the evaluation information; The method for measuring a specimen according to claim 16 or 17, further comprising:

19. The specimen measurement method according to claim 16 or 17, wherein the optical information of the platelet-rich plasma used to obtain the evaluation information is absorbance or transmittance.

20. The method further comprises the step of preparing a measurement sample by adding a reagent that induces platelet aggregation to the platelet-rich plasma, 18. The specimen measurement method according to claim 16, wherein the step of acquiring optical information of the platelet-rich plasma to obtain the evaluation information is performed within a predetermined time after the step of preparing the measurement sample.

21. The specimen measurement method according to claim 20 , wherein the predetermined time is set to a time of 2 seconds or more and 10 seconds or less after the addition of the reagent.

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