Calibration curve display method and analyzer

Abstract

To provide a calibration curve display method and an analyzer, with which it is possible to efficiently confirm a calibration curve and confirm accuracy management results using the calibration curve.SOLUTION: A calibration curve display method pertaining to the present invention includes: measuring a standard sample that contains a component of known concentration and is used for creating a calibration curve and creating a calibration curve 91 before approval, on the basis of the obtained measurement result and the known concentration of the component contained in the standard sample; measuring an accuracy management sample that contains a component of known concentration and converting concentration of the obtained measurement result using the calibration curve 91 before approval, thereby acquiring an accuracy management result 88 related to the component concentration contained in the accuracy management sample; and displaying a screen 801 that includes the calibration curve 91 before approval and the accuracy management result 88.SELECTED DRAWING: Figure 14

Description

[Technical field]

[0001] The present invention relates to a method for displaying a calibration curve and an analytical device. [Background technology]

[0002] In the field of clinical testing, there are known sample analyzers that measure the concentration of a specific substance contained in a sample such as plasma, serum, or urine. In such sample analyzers, a calibration curve is used to convert data representing the characteristics of the sample into a concentration. For example, a blood coagulation analyzer that analyzes blood coagulation ability measures the coagulation time that represents the coagulation characteristics of the plasma sample, and calculates the concentration of fibrinogen, coagulation factors, and the like contained in the sample by applying the coagulation time to the calibration curve.

[0003] Patent Document 1 discloses an automatic analyzer capable of measuring a standard sample containing a component of known concentration and creating a calibration curve based on the relationship between the measured value and the known concentration value. The automatic analyzer of Patent Document 1 can measure a patient sample and a quality control sample and calculate concentration data using the calibration curve. The automatic analyzer of Patent Document 1 can display a quality control screen on which concentration data obtained by measuring the quality control sample is plotted in time series. An operator can check whether the automatic analyzer is performing an analysis with good accuracy by comparing the concentration data obtained by measuring the quality control sample with the average value and SD value displayed on the quality control screen. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] International Publication WO2016 / 140017 Summary of the Invention [Problem to be solved by the invention]

[0005] In order to use a calibration curve created based on the measurement results of a standard sample in the measurement of a sample, the validity of the calibration curve must be confirmed and approved as a calibration curve that can be used in the measurement of a sample. When confirming the validity of a calibration curve, the operator checks the linearity of the calibration curve and the measurement results of the measured standard sample. Furthermore, to confirm that the concentration conversion is being performed properly using the calibration curve, a test measurement of a quality control sample may be performed, and the concentration value obtained by applying the measurement results to the calibration curve may be compared with the displayed value of the quality control sample to confirm that the calibration curve is producing proper analytical results. Once it is confirmed that the concentration value of the quality control sample is proper, the operator approves the calibration curve.

[0006] However, conventional automatic analyzers, including the one described in Patent Document 1, had separate screens for displaying the calibration curve and the quality control results, so users had to go back and forth between the two screens to check the calibration curve and the analysis results of the quality control sample.

[0007] The present invention has been made in consideration of the above-mentioned circumstances, and its purpose is to provide a calibration curve display method and an analytical device that enable efficient confirmation of the calibration curve and confirmation of the results of quality control using the calibration curve. [Means for solving the problem]

[0008] As a result of various investigations, the present inventors have found that the above object can be achieved by the present invention described below.

[0009] A method for displaying a calibration curve according to one embodiment of the present invention includes measuring a standard sample for creating a calibration curve, the standard sample containing a component of known concentration, creating a pre-approval calibration curve based on the obtained measurement results and the known concentrations of the components contained in the standard sample, measuring a quality control sample containing a component of known concentration, and converting the obtained measurement results into concentrations using the pre-approval calibration curve to obtain quality control results regarding the concentrations of the components contained in the quality control sample, and displaying a screen including the pre-approval calibration curve and the quality control results obtained based on the pre-approval calibration curve.

[0010] According to this aspect, since the pre-approval calibration curve and the quality control results are included on the same screen, the operator does not need to switch screens to check the validity of the pre-approval calibration curve based on the quality control results. As a result, it is possible to simplify and streamline the work of checking the validity of the calibration curve.

[0011] In another aspect, the screen includes a button for accepting an operation to approve the calibration curve. According to this aspect, after confirming the validity of the calibration curve, the calibration curve can be approved without switching the screen.

[0012] In another aspect, when an operation to approve the calibration curve is accepted, the calibration curve displayed on the screen before approval is registered as the calibration curve to be used for measuring the sample. According to this aspect, it becomes possible to measure the sample using the approved calibration curve.

[0013] In another aspect, the screen further includes attribute information of the calibration curve before approval. According to this aspect, it is possible to confirm the attribute information of the calibration curve and then confirm the validity of the calibration curve without switching the screen.

[0014] In another aspect, the quality control results and the attribute information are displayed in a switchable manner in response to an operation by an operator. According to this aspect, it is possible to provide information useful for checking the calibration curve on a single screen while increasing the display area of ​​each piece of information displayed on the screen.

[0015] In another aspect, the screen includes an upper limit and a lower limit for the quality control result. According to this aspect, it is possible to easily check whether the quality control result is within an acceptable range.

[0016] In another aspect, the screen includes a target value of the quality control result. According to this aspect, it is possible to easily check how much the quality control result deviates from the target value.

[0017] In another aspect, the screen includes a time series display of multiple quality control results obtained in the past in addition to the quality control results. According to this aspect, it is possible to easily check whether the quality control results obtained using the pre-approval calibration curve have continuity with respect to the trend of quality control results obtained using the calibration curve obtained using the past calibration curve.

[0018] In another aspect, the screen includes a graph of the pre-approved calibration curve and quality control results plotted on the graph. According to this aspect, the quality control results obtained using the pre-approved calibration curve can be confirmed on the graph, so that information for confirming the validity of the calibration curve can be collected in one place. Effect of the Invention

[0019] According to the present invention, it is possible to facilitate and increase the efficiency of the work of checking a calibration curve and checking the results of quality control using the calibration curve. [Brief description of the drawings]

[0020] [Figure 1] 1 is a perspective view showing a schematic external configuration of a sample analyzer according to an embodiment of the present invention; [Diagram 2] FIG. 2 is a top view showing a schematic configuration of a measurement unit and a transport unit. [Diagram 3] FIG. 2 is a cross-sectional view illustrating a schematic configuration of a detection unit. [Figure 4] FIG. 2 is a block diagram showing a configuration of a measurement unit. [Diagram 5] 1 is a block diagram showing a simplified configuration of a sample analyzer. [Figure 6] FIG. 2 is a diagram showing an example of a coagulation curve. [Figure 7] FIG. 13 is a diagram showing an example of a calibration curve. [Figure 8] 4 is a flowchart showing the operation flow of the sample analyzer. [Figure 9] 10 is a flowchart showing the flow of a sample measurement and analysis process. [Figure 10] 13 is a flowchart showing an operation flow of a measurement unit. [Figure 11] 1 is a flowchart showing a procedure for creating a calibration curve. [Figure 12] 1 is a flowchart showing the flow of calibration curve confirmation QC. [Figure 13] FIG. 13 is a diagram showing an example of a calibration curve screen before calibration curve confirmation QC. [Figure 14] FIG. 13 is a diagram showing a first example of a calibration curve screen. [Figure 15] FIG. 13 is a diagram showing a second example of a calibration curve screen. [Figure 16] FIG. 13 is a diagram showing a third example of a calibration curve screen. [Figure 17] FIG. 13 is a diagram showing a fourth example of a calibration curve screen. [Figure 18] FIG. 13 is a diagram showing an example in which a calibration curve and QC results are displayed in separate windows. [Figure 19] FIG. 1 shows an example of calibration curves and QC results displayed on separate computer screens. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. In the drawings, the same reference numerals are used to denote the same configuration, and the description thereof will be omitted as appropriate.

[0022] FIG. 1 is a perspective view showing a schematic external configuration of a sample analyzer 1 according to an embodiment of the present invention. The hardware configuration of the sample analyzer 1 of this embodiment is disclosed in detail in U.S. Patent Publication No. 2018-0267069, the entire disclosure of which is incorporated herein by reference. In this specification, the device configuration will be described focusing on the parts related to the present invention. The sample analyzer 1 includes a measurement unit 2, a transport unit 3, and an analysis unit 4. The sample analyzer 1 is a blood coagulation analyzer that analyzes the coagulation ability of blood as a sample. In this specification, the front, back, left, right, top, and bottom directions are defined by the directions of the arrows shown in FIG. 1.

[0023] 2 is a top view that diagrammatically illustrates the configurations of the measurement unit 2 and the transport unit 3. The transport unit 3 is disposed in front of the measurement unit 2.

[0024] The transport unit 3 includes a rack setting unit 11, a rack transport unit 12, and a rack recovery unit 13. The rack setting unit 11 is an area for arranging a sample rack 15, in which one or more sample containers 14 to be analyzed are set, in the sample analyzer 1. In the rack setting unit 11, an operator sets the sample rack 15, in which the sample containers 14 containing samples are placed.

[0025] The rack transport unit 12 is disposed between the rack setting unit 11 and the rack collection unit 13 .

[0026] The rack recovery unit 13 is an area for recovering and storing the sample racks 15 after sample collection has been completed and transported by the rack transport unit 12. The rack recovery unit 13 is disposed downstream of the rack transport unit 12.

[0027] The transport unit 3 transports the sample rack 15 arranged in the rack setting unit 11 to the rack transport unit 12, and sequentially positions each sample container 14 at the sample aspiration position 16. The sample dispensing unit 18 collects samples by aspiration from the sample containers 14 positioned at the sample aspiration position 16. When the transport unit 3 completes collection of samples from one or more sample containers 14 for which an operator has instructed measurement among the sample containers 14 set in the sample rack 15, it transports the sample rack 15 to the rack recovery unit 13 for recovery and deposit.

[0028] The measurement unit 2 prepares a measurement sample by mixing a reagent with the sample collected at the sample suction position 16, and measures the prepared measurement sample. The measurement unit 2 includes a sample dispensing unit 18, a reaction vessel holding unit 22, a reagent storage unit 23, a reagent dispensing unit 27-1, a reagent dispensing unit 27-2, a heating unit 30, a sample measurement unit 34, and a sample information reading unit 17.

[0029] The reagent storage section 23 stores a reagent used in preparing a measurement sample. Specifically, the reagent storage section 23 is a disk-shaped member in a plan view, in which a plurality of reagent holding holes 25 for holding reagent containers containing the reagent are formed at predetermined intervals in the circumferential direction. In the example shown in Fig. 2, the plurality of reagent holding holes 25 aligned in the circumferential direction are formed in three radial rows. The reagent storage section 23 is configured to be rotatable in the circumferential direction around its center as an axis. The reagent stored in the reagent storage section 23 is a reagent for measuring prothrombin time, a reagent for measuring fibrinogen, or the like.

[0030] The reaction vessel holder 22 holds a reaction vessel 26 for preparing a measurement sample by reacting a specimen with a reagent. The reaction vessel holder 22 is an annular member in a plan view, in which a plurality of holding holes 24 for holding the reaction vessels 26 are formed at predetermined intervals in the circumferential direction. The reaction vessel holder 22 is configured to be rotatable in the circumferential direction around its center as an axis.

[0031] The specimen dispensing unit 18 collects a specimen by aspirating it from the specimen container 14 positioned at the specimen suction position 16, and discharges the collected specimen into the reaction container 26 in the reaction container holding unit 22. Specifically, the specimen dispensing unit 18 includes a specimen suction nozzle 19 for aspirating the specimen from the specimen container 14, an arm 20 which is a rod-shaped member having the specimen suction nozzle 19 with its suction port facing downward attached to one end thereof, and a drive mechanism 21 attached to the other end of the arm 20. The drive mechanism 21 can drive the arm 20 in the vertical direction and in the circumferential direction around the other end of the arm 20 as an axis. The specimen dispensing unit 18 is disposed between the specimen suction position 16 and the reaction container holding unit 22 so as to collect a specimen at the specimen suction position 16 and discharge the collected specimen into the reaction container 26 in the reaction container holding unit 22.

[0032] A diluent holding hole 38 for holding a diluent container containing a predetermined diluent is formed between the specimen suction position 16 and the reaction container holding section 22. The specimen dispensing section 18 is capable of aspirating diluent from the diluent container held in the diluent holding hole 38 and dispensing it into the reaction container 26. This allows the specimen dispensing section 18 to dispense a standard sample and a diluent into the reaction container in the calibration curve creation process described below, and to prepare a plurality of measurement samples with different dilution ratios based on the standard sample.

[0033] The heating unit 30 is disposed adjacent to the reaction vessel holding unit 22 and to the right rear thereof. The heating unit 30 heats the specimen contained in the reaction vessel 26 to a predetermined temperature (e.g., 37°C) according to the measurement. The heating unit 30 includes a heating and holding unit 31 and a transfer unit 33. The heating and holding unit 31 is a disk-shaped unit in a plan view, with a plurality of holding holes 32 for holding the reaction vessel 26 formed at a predetermined interval in the circumferential direction on the periphery. The heating and holding unit 31 is configured to be rotatable around its center as an axis. The heating and holding unit 31 includes a horizontal arm 33-1 that can be extended in the horizontal direction, a vessel catcher 33-2 provided at the tip of the horizontal arm 33-1, and a rotation mechanism 33-3 that rotates the horizontal arm 33-1 around its base end as an axis. The transfer unit 33 rotates and extends the horizontal arm 33-1 using the rotation mechanism 33-3, thereby capturing the reaction vessel 26 held in the reaction vessel holding unit 22 with the vessel catcher 33-2, and transfers it to the heating and holding unit 31 by shortening the horizontal arm 33-1. The transfer unit 33 also rotates and extends the horizontal arm 33-1 using the rotation mechanism 33-3, thereby transferring the reaction vessel 26 held by the vessel catcher 33-2 to a position 28-1-1 directly below the reagent aspirating nozzle 28-1 of the reagent dispensing unit 27-1 and a position 28-2-1 directly below the reagent aspirating nozzle 28-2 of the reagent dispensing unit 27-2.

[0034] The reagent dispensing section 27-1 is provided above the reagent storage section 23, the reaction vessel holding section 22, and the heating section 30. The reagent dispensing section 27-1 collects a predetermined amount of the reagent stored in the reagent storage section 23 by aspirating it, and discharges the collected reagent into the reaction vessel 26 transferred to a position 28-1-1 directly below the reagent aspirating nozzle 28-1. This mixes the specimen and the reagent to prepare a sample. The reagent dispensing section 27-1 includes a reagent aspirating nozzle 28-1 that aspirates the reagent from the reagent vessel held in the reagent holding hole 25, and a guide 29-1 that is a rod-shaped member to which the reagent aspirating nozzle 28-1 with its aspirating port facing downward is attached. The reagent aspirating nozzle 28-1 can be moved horizontally between one end and the other end of the guide 29-1 by a stepping motor 29A (see FIG. 4). Furthermore, reagent aspirating nozzle 28-1 can be moved up and down by stepping motor 29B (see FIG. 4). One end of guide 29-1 is located above reagent storage section 23, and the other end is located near heating section 30. Reagent dispensing section 27-1 is disposed such that guide 29-1 spans from near the center to the periphery of disc-shaped reagent storage section 23 so that reagent can be collected from reagent storage section 23. For this reason, reagent dispensing section 27-1 overlaps with reaction vessel holding section 22 and reagent storage section 23 in plan view, and therefore reagent dispensing section 27-1 is indicated by dashed lines in FIG. 2. The same applies to reagent dispensing section 27-2.

[0035] Similarly, the reagent dispensing section 27-2 collects a predetermined amount of the activation reagent stored in the reagent storage section 23 for starting the clotting reaction by aspirating it, and then discharges the collected activation reagent into the reaction vessel 26 transferred from the heating section 30 to a position 28-2-1 directly below the reagent aspirating nozzle 28-2 of the reagent dispensing section 27-2 by the transfer section 37. This causes the sample and the activation reagent to be mixed together and starts the clotting reaction. The reagent dispensing section 27-2 includes a reagent aspirating nozzle 28-2 for aspirating the reagent from the reagent vessel held in the reagent holding hole 25, and a guide 29-2, which is a rod-shaped member to which the reagent aspirating nozzle 28-2 is attached with its aspirating port facing downward. The reagent aspirating nozzle 28-2 includes a liquid level sensor (not shown). The reagent aspirating nozzle 28-2 can be moved horizontally between one end and the other end of the guide 29-2 by a stepping motor 29A (see FIG. 4). Furthermore, reagent aspirating nozzle 28-2 can be moved up and down by stepping motor 29B (see FIG. 4). One end of guide 29-2 is located above reagent storage section 23, and the other end is located near heating section 30 and sample measurement section 34. Reagent dispensing section 27-2 is disposed such that guide 29-2 spans from near the center to the periphery of disc-shaped reagent storage section 23 so that reagent can be collected from reagent storage section 23.

[0036] The sample measurement unit 34 is disposed adjacent to and behind the heating unit 30. The sample measurement unit 34 irradiates light onto the sample contained in the reaction vessel 26, detects an optical signal, and outputs a digital signal according to the light intensity. The sample measurement unit 34 includes a sample holding plate 35, a transfer unit 37, and a detection unit 39 (see FIG. 4). The sample holding plate 35 is a box-shaped member in which a plurality of sample holding holes 36 for holding the reaction vessels 26 are formed at predetermined intervals. The transfer unit 37 includes a horizontal arm 37-1 that can be extended in the horizontal direction, a vessel catcher 37-2 provided at the tip of the horizontal arm 37-1, and a slide mechanism 37-3 that slides the horizontal arm 37-1 in the left-right direction. The transfer section 37 transfers the reaction container 26 held in the holding hole 32 of the heating and holding section 31 of the heating section 30 to the sample holding hole 36 of the sample holding plate 35 via position 28-2-1 directly below the reagent suction nozzle 28-2 of the reagent dispensing section 27-2.

[0037] As shown in Figure 3, the detection unit 39 has a light source unit 39A that irradiates light onto the sample contained in the reaction vessel 26 held in each sample holding hole 36, and a light receiving unit 39B that receives light that has passed through the sample and converts an analog electrical signal corresponding to the intensity of the received light into a digital signal and outputs it.

[0038] Returning to Fig. 2, the specimen information reading unit 17 is a device that reads specimen information from a specimen information member that stores the specimen information. The specimen information reading unit 17 is disposed at a position facing the rack transport unit 12 so that it can read the specimen information from the specimen information member attached to the specimen container 14 being transported by the rack transport unit 12. The specimen information member is a label on which a machine-readable code recording the specimen information is printed, and the specimen information reading unit 17 is configured with a code reader. The machine-readable code is a one-dimensional barcode, and the specimen information reading unit 17 is a barcode reader.

[0039] Fig. 4 is a block diagram showing the configuration of the measurement unit 2. The measurement unit 2 includes a control unit 41, a storage unit 42, a communication unit 43, and, as shown in Fig. 2, a specimen dispensing unit 18, a reaction vessel holding unit 22, transfer units 33, 37, a heating unit 30, a reagent storage unit 23, a specimen information reading unit 17, a reagent dispensing unit 27, and a detection unit 39.

[0040] The control unit 41 is a circuit for controlling the operation of each part of the measurement unit 2 and the transport unit 3 according to each function. The control unit 41 is configured to include, for example, a CPU and its peripheral circuits.

[0041] The storage unit 42 includes a hard disk for storing various programs and various data for the control unit 41 to control each part of the measurement unit 2 and the transport unit 3.

[0042] The communication unit 43 is a circuit that inputs and outputs data to and from an external device under the control of the control unit 41. The communication unit 43 is configured to include an interface circuit that uses any communication standard, such as Ethernet and IEEE1394.

[0043] 5 is a block diagram showing a simplified configuration of the analysis unit 4. The analysis unit 4 includes a control unit 51, a storage unit 52, a display unit 53, an input unit 54, and a communication unit 55.

[0044] The control unit 51 is a circuit for controlling the operation of each part of the analysis unit 4 according to its function. The control unit 51 is configured to include, for example, a CPU and its peripheral circuits.

[0045] The storage unit 52 is a circuit that stores various programs 60 and various data, etc. The storage unit 52 includes a hard disk device, similar to the storage unit 42. The storage unit 52 stores the programs 60.

[0046] The program 60 includes a control program, an analysis processing program, a calibration curve processing program, and a quality control program. The control program is a program for controlling each part (memory unit 52, display unit 53, input unit 54, and communication unit 55) of the analysis unit 4 according to the function of each part. The analysis processing program is a program for executing predetermined processes related to sample measurement (setting of reagents, setting of calibration curves, analysis of measurement results, etc.). The calibration curve processing program is a program for executing predetermined processes related to standard sample measurement (creation and display of calibration curves, etc.). The quality control program is a program for executing predetermined processes related to quality control sample measurement (setting of execution conditions, display of measurement results, etc.).

[0047] The display unit 53 is a display equipped with a computer screen such as a liquid crystal display or an organic EL display. The display unit 53 is equipped with a touch panel, and may be integrated with an input unit 54 described below. The display unit 53 is connected to the control unit 51 via an HDMI or RGB cable. The display unit 53 displays image data of various screens input from the control unit 51 on the computer screen.

[0048] Input unit 54 is a device that inputs various commands, such as a command to create a calibration curve, and various data necessary for operating sample analyzer 1, to sample analyzer 1. Input unit 54 is configured with a keyboard, a pointing device including a mouse or a touch panel, and a plurality of input switches to which predetermined functions are assigned.

[0049] The communication unit 55 is a circuit that inputs and outputs data to and from external devices including the communication unit 43 of the measurement unit 2 under the control of the control unit 51. The communication unit 55 is configured to include an interface circuit using any communication standard such as Ethernet and IEEE1394.

[0050] <Operation of Sample Analyzer 1> Next, the operational flow of the sample analyzer 1 will be described with reference to the flowchart in Figure 8. The processing in Figure 8 is realized by the control unit 51 of the analysis unit 4 executing a program 60 stored in the storage unit 52.

[0051] In step S1, the control unit 51 executes a calibration curve creation process for creating a calibration curve. Details of the calibration curve creation will be described later with reference to FIG. 11. In step S2, the control unit 51 applies the measurement results obtained by measuring a quality control sample to the calibration curve to obtain the analysis results of the quality control sample (referred to as QC results) so that the operator can confirm the validity of the calibration curve created in step S1, and displays a calibration curve confirmation screen including the QC results and the calibration curve. Details of the calibration curve confirmation QC will be described later with reference to FIG. 12. In step S3, the control unit 51 approves (validates) the calibration curve in response to an operation from the operator. In step S4, the control unit 51 measures and analyzes the sample using the validated calibration curve.

[0052] <Sample measurement processing> The specimen measurement and analysis process in step S4 will be described with reference to Figures 2 to 7, 9 and 10. Figure 9 is a flow chart showing details of the specimen measurement and analysis process. The operator sets specimen containers 14 containing specimens in rack 15, and sets rack 15 in rack setting unit 11. When the operator operates input unit 54 to instruct the start of measurement, in step S10, control unit 51 determines that the measurement start instruction has been received (YES in S10). If the measurement start instruction has not been received (NO in S10), control unit 51 returns the process to the main routine in Figure 8.

[0053] In step S11, the control unit 51 that has received the measurement start instruction transmits a sample measurement command to the control unit 41 of the measurement unit 2.

[0054] FIG. 10 is a flowchart showing the operation flow of the control unit 41 of the measurement unit 2. In step S131, the control unit 41 judges whether or not a measurement command has been received from the control unit 51 of the analysis unit 4. If a measurement command has not been received (NO in S131), the control unit 41 repeats the process of step S131. When the control unit 41 receives a sample measurement command (YES in S131), in step S132, the control unit 41 controls each unit so that the measurement unit 2 operates as described below, thereby mixing the sample and the reagent to prepare a measurement sample, and measuring the measurement sample. The rack setting unit 11 positions the rack 15 set in the rack setting unit 11 on the rack transport unit 12. The rack transport unit 12 positions the sample container 14 set in the rack 15 at the sample suction position 16. The sample dispensing unit 18 collects a predetermined amount of sample from the sample container 14 at the sample suction position 16 by suctioning it with the sample suction nozzle 19, and discharges the sample into the reaction container 26 held in the holding hole 24 of the reaction container holding unit 22. This causes the sample in the sample container 14 to be dispensed into the reaction container 26. Once the sample has been dispensed into the reaction container 26, the reaction container holding section 22 rotates, and the reaction container 26 is transferred to the vicinity of the heating section 30. The transfer section 33 of the heating section 30 transfers the reaction container 26 from the holding hole 24 of the reaction container holding section 22 to the holding hole 32 of the heating section 30. The heating section 30 heats the reaction container 26. The reagent dispensing section 27-1 collects a predetermined amount of a predetermined reagent from the reagent storage section 23 by aspirating it with the reagent aspirating nozzle 28-1. The transfer section 33 transfers the reaction container 26 from the heating and holding section 31 to a position 28-1-1 directly below the movement path of the reagent aspirating nozzle 28-1. The reagent dispensing unit 27-1 moves the reagent aspirating nozzle 28-1 above the reaction vessel 26 and dispenses the reagent from the reagent aspirating nozzle 28-1 into the reaction vessel 26. This causes the reagent to be dispensed into the reaction vessel 26, and the sample and the reagent are mixed to prepare a measurement sample. The transfer unit 33 transfers the reaction vessel 26 into which the reagent has been dispensed to the holding hole 32 of the heating unit 30. Next, the heating and holding unit 31 of the heating unit 30 rotates to position the reaction vessel 26 near the sample measurement unit 34. The transfer unit 37 of the sample measurement unit 34 transfers the reaction vessel 26 from the heating and holding unit 31 to a position 28-2-1 directly below the movement path of the reagent aspirating nozzle 28-2.The reagent dispensing unit 27-2 moves the reagent aspirating nozzle 28-2 and dispenses the activation reagent from the reagent aspirating nozzle 28-2 into the reaction vessel 26. The transport unit 33 transports the reaction vessel 26 into which the activation reagent has been dispensed, to the sample holding hole 36 of the sample measurement unit 34.

[0055] The light source 39A of the sample measurement section 34 irradiates light onto the sample contained in the reaction vessel 26 transferred to the sample holding hole 36. The light receiving section 39B receives the light that has passed through the sample, converts an analog electrical signal corresponding to the intensity of the received light into a digital signal, and outputs the digital signal. The light irradiation by the light source 39A and the light reception by the light receiving section 39B continue for a predetermined period of time, and the digital signal output from the light receiving section 39B is stored in the memory section 42 as time-series measurement data that indicates the change over time in the amount of transmitted light.

[0056] In step S133, the control unit 41 transmits the measurement data (time series data of the amount of transmitted light output from the light receiving unit 39B) stored in the memory unit 42 to the control unit 51 of the analysis unit 4 via the communication unit 43. After transmitting the measurement data to the control unit 51 of the analysis unit 4, the control unit 41 of the measurement unit 2 returns the process to S131.

[0057] Returning to FIG. 9, in step S12, the control unit 51 of the analysis unit 4 receives the measurement data transmitted from the measurement unit 2 via the communication unit 55, and stores the received measurement data in the memory unit 52.

[0058] In step S13, the control unit 51 of the analysis unit 4 calculates the clotting time of the sample based on the received measurement data. FIG. 6 shows a typical clotting curve used to calculate the clotting time. The vertical axis in the graph of FIG. 6 represents the magnitude of the digital signal output from the light receiving unit 39B, that is, the amount of transmitted light. The horizontal axis in the graph of FIG. 6 represents the elapsed time since the light receiving unit 39B starts receiving light. FIG. 6 shows a percentage detection method as an example of a method for calculating the clotting time. The percentage detection method is a method in which the amount of transmitted light that is the baseline L1 before the progress of the clotting reaction is confirmed is set to 0%, the amount of transmitted light (L2) at the coagulation reaction stopping point is set to 100%, and the time at which the amount of transmitted light reaches the coagulation detection% is calculated as the clotting time. The coagulation detection% is set as a value of a predetermined percentage of the interval between the amount of transmitted light at the baseline L1 and the amount of transmitted light at the coagulation reaction stopping point. The coagulation detection% is used to search for a coagulation point at which the amount of transmitted light has changed by a predetermined percentage (coagulation detection%) from the baseline L1. The coagulation detection % is set to a value greater than 0 and less than 100. The coagulation detection % is set to, for example, 50%. The control unit 51 calculates the elapsed time when the coagulation detection % reaches 50% as the coagulation time. The control unit 51 stores the calculated coagulation time in the memory unit 52.

[0059] 9 again, next, in step S14, the control unit 51 of the analysis unit 4 applies the calculated coagulation time to the approved calibration curve stored in the memory unit 52, and converts it into the concentration of a predetermined component contained in the sample. The calibration curve is created and approved in advance prior to the measurement of the sample, and is stored in the memory unit 52.

[0060] FIG. 7 shows an example of a calibration curve. The vertical axis in the graph of FIG. 7 represents the clotting time, the horizontal axis represents the concentration of antithrombin (AT), which is an example of a predetermined component, and the line α is the calibration curve. The calibration curve is given as an approximation equation that represents the relationship between the clotting time as a measurement result obtained by measuring a sample and the concentration of a target component. Therefore, if the clotting time is obtained by measuring a sample, the concentration of the component corresponding to the clotting time can be obtained by applying the clotting time to the calibration curve.

[0061] 9 again, in step S15, control unit 51 displays on display unit 53 the clotting time as the measurement result and the converted concentration value as the analysis result obtained in step S12.

[0062] <Calibration curve creation process> The calibration curve creation process in step S1 of FIG. 8 will be described with reference to FIG. 11. A standard sample with a known concentration of a target component is used to create the calibration curve. The standard sample is a sample containing a component with a known concentration, and commercially available standard human plasma is preferably used. Prior to measuring the standard sample, the operator inputs the name and lot number of the standard sample, the measurement item, the reagent lot set, the number of measurements of the standard sample, and the target concentration to the analysis unit 4 via the input unit 54. Next, the operator sets a container containing the standard sample in the rack 15 instead of the specimen container 14, and sets the rack 15 in the rack setting unit 11 of the measurement unit 2. The operator inputs an instruction to create a calibration curve via the input unit 54.

[0063] In step S100, the control unit 51 determines whether or not an instruction to create a calibration curve has been received. If an instruction has not been received (NO in S100), the control unit 51 returns the process to the main routine of Fig. 8. If an instruction has been received (YES in S100), the control unit 51 in step S101 transmits a standard sample measurement command to the measurement unit 2 to dilute the standard sample, mix it with a reagent to prepare a measurement sample, and measure the measurement sample.

[0064] The operation of the measurement unit 2 upon receiving a measurement command for a standard sample is the same as that described with reference to Fig. 10, except that a standard sample is measured instead of a specimen. Upon receiving the measurement command, the control unit 41 of the measurement unit 2 controls the rack set unit 11 to position the rack 15 on the rack transport unit 12. The control unit 41 drives the rack transport unit 12 to position the container containing the standard sample set on the rack 15 at the specimen aspiration position 16.

[0065] The control unit 41 drives the specimen dispensing unit 18 to aspirate and collect a predetermined amount of standard sample from a container at the specimen suction position 16 using the specimen suction nozzle 19, and dispenses the standard sample into the reaction container 26 held in the holding hole 24 of the reaction container holding unit 22. Since it is necessary to measure a plurality of samples in which the standard sample is diluted to different concentrations in order to create a calibration curve, the standard sample is dispensed into the same number of reaction containers 26 as the number of measurements of the standard sample input by the operator prior to the measurement.

[0066] The control unit 41 controls the specimen dispensing unit 18 to aspirate the diluent from the diluent container held in the diluent holding hole 38 and discharge it into the reaction container 26 into which the standard specimen has been dispensed. The amount of diluent to be dispensed is determined by the control unit 51 based on the known concentration of the component to be measured contained in the standard specimen and the target concentration input by the operator. Specifically, the memory unit 52 of the analysis unit 4 stores the concentration of the component contained in the standard specimen in association with the lot number. The control unit 51 calculates the amount of diluent required to make the known concentration stored in the memory unit 52 the target concentration input by the operator, and causes the specimen dispensing unit 18 to dispense the required amount of diluent. This allows a plurality of standard specimens diluted to different concentrations to be prepared.

[0067] Thereafter, in the same procedure as in the specimen measurement process described above, reagent dispensing unit 27-1 dispenses reagent into reaction vessel 26 to prepare a measurement sample, the measurement sample is heated by heating unit 30, and the measurement sample is measured by detection unit 39. Control unit 41 stores the measurement data obtained by the measurement in memory unit 42 and transmits it to control unit 51 of analysis unit 4.

[0068] In step S102, the control unit 51 of the analysis unit 4 receives the measurement data transmitted from the measurement unit 2 via the communication unit 55, and stores the received measurement data in the memory unit 52.

[0069] In step S103, the control unit 51 calculates the clotting time for each of the plurality of standard samples based on the measurement data, and stores the calculated clotting time in the memory unit 52 as the measurement result.

[0070] In step 104, the control unit 51 plots multiple points (P1, P2, P3) on a graph where the clotting time obtained by measuring the standard sample intersects with the target concentration of the standard substance (i.e., the component concentration in the diluted standard sample), as shown in Fig. 7, creates an approximation line based on these plots as a calibration curve α, and stores this together with the calibration curve information in the memory unit 52. The calibration curve information includes the date and time when the calibration curve was created, information on the standard substance used to create the calibration curve (calibrator name, lot number, expiration date), information on the reagent lot set used to create the calibration curve, and the measurement conditions and measurement results for the standard substance.

[0071] In step S105, control unit 51 displays the calibration curve stored in storage unit 52 on display unit 53. Fig. 13 shows a calibration curve screen 80 displayed on display unit 53. As shown in Fig. 13, calibration curve screen 80 displays a graph display area 85 in which a calibration curve 91 is displayed in a graph, and a calibration curve information area 86 in which information related to the calibration curve is displayed.

[0072] The control unit 51 creates a graph of the target calibration curve 91 based on the calibration curve data read from the storage unit 52, and places the graph in a graph display area 85 in the calibration curve screen 80, as shown in Fig. 13. The horizontal axis (X axis) of the graph represents concentration, and the vertical axis (Y axis) represents coagulation time (measurement result). In addition to a straight line or curve representing the calibration curve 91, the graph also plots and displays point data of a plurality of measurement samples corresponding to a plurality of standard samples with different concentrations measured when the calibration curve was created.

[0073] The control unit 51 displays the calibration curve information read from the storage unit 52 in the calibration curve information area 86 in the calibration curve screen 80. As shown in FIG. 13, the area 86 includes an area 86A that displays attribute information of the calibration curve, and an area 86B that displays the measurement results of the standard sample used to create the calibration curve. The attribute information of the calibration curve displayed in the area 86A includes the calibration curve ID, creator information, expiration date of the calibration curve, creation date and time of the calibration curve, information of the standard sample used to create the calibration curve, and information of the reagent lot used to create the calibration curve. The area 86B includes the measurement results (clotting time) at multiple measurement points and the component concentrations after dilution of the standard sample. Note that, in the example of FIG. 13, an example is shown in which attribute information is displayed in the area 86A for an unvalidated calibration curve immediately after creation, but the information in the area 86A may be masked until the calibration curve is validated, and only the information of the measurement results may be displayed in the area 86B.

[0074] The calibration curve screen 80 includes a status area 82 that displays the status of the calibration curve. Fig. 13 is an example of a screen displaying a calibration curve before approval, and "Not Validated" is displayed in the status area 82, indicating that the calibration curve has not been approved. When the calibration curve 91 is approved, "Validated" is displayed in the status area 82.

[0075] 13, the operator confirms the validity of the calibration curve 91 by, for example, verifying the shape and linearity of the graph of the calibration curve 91 displayed in area 85 and the validity of the numerical values ​​of the measurement results displayed in area 86. If the operator determines that the calibration curve 91 can be used for measuring a sample, the operator can operate a validate button 90 displayed at the top of the screen to validate the unapproved calibration curve 91. On the other hand, if the operator wants to measure a quality control sample before validation and confirm the validity of the calibration curve 91 based on the measurement results of the quality control sample, the operator can perform a calibration curve confirmation QC, which will be described later.

[0076] If the validity of the calibration curve 91 cannot be confirmed, for example, if the shape of the calibration curve is not appropriate, the operator can operate the correction button 95 to correct the measurement points of the calibration curve 91. The correction of the calibration curve is disclosed in U.S. Patent Publication No. 2020-0103428, the entire disclosure of which is incorporated herein by reference.

[0077] <Standard curve confirmation QC processing> FIG. 12 is a flow chart of the calibration curve confirmation QC process executed in step S2 of FIG. 8. In the calibration curve confirmation QC, a quality control sample is used. The quality control sample is a specimen containing a known concentration of a component to be analyzed, and in this embodiment, it is a control plasma in which the amount of a component related to blood coagulation is adjusted. Coagutrol N manufactured by Sysmex Corporation is preferably used as the control plasma. For the quality control sample, a target value, an upper limit value, and a lower limit value are set by the manufacturer for each lot of the quality control sample, and the accuracy of the measurement and analysis by the sample analyzer 1 can be verified by comparing the results obtained by measuring and analyzing the quality control sample with the above values.

[0078] When performing calibration curve confirmation QC, the operator inputs the name and lot number of the quality control sample, the measurement item, and the reagent lot set of the quality control sample into the analysis unit 4 via the input unit 54 prior to measuring the quality control sample. The operator sets a container containing the quality control sample in place of the specimen container 14 in the rack 15, sets the rack 15 in the rack setting unit 11, and issues an instruction via the input unit 54 to perform the calibration curve confirmation QC.

[0079] In step S111, the control unit 51 judges whether or not an instruction to execute a calibration curve confirmation QC has been received from the operator via the input unit 54. If an instruction has been received (YES in S111), the control unit 51 transmits a measurement command for the quality control sample to the control unit 41 of the measurement unit 2 in step S112. Upon receiving the measurement command, the control unit 41 of the measurement unit 2 executes the measurement of the quality control sample in the same manner as the procedure described with reference to FIG. 10. Upon completion of the measurement, the measurement data of the quality control sample is sent from the measurement unit 2 to the control unit 51 of the analysis unit 4. In step S113, the control unit 51 receives the measurement data of the quality control sample and stores it in the memory unit 52. In step S114, the control unit 51 calculates the coagulation time, which is the measurement result, based on the measurement data of the quality control sample, and stores it in the memory unit 52.

[0080] In step S115, the control unit 51 generates an analysis result by applying the QC result (clotting time of the quality control sample) to the unapproved calibration curve 91 and converting it into a concentration. The control unit 51 stores the generated analysis result in the memory unit 52.

[0081] In step S116, control unit 51 displays calibration curve screen 801 including the result of the calibration curve confirmation QC on display unit 53. Note that, although an example is shown here in which calibration curve screen 801 is automatically displayed on display unit 53 immediately after step S115, a configuration in which the screen transitions to the calibration curve screen in response to an instruction from an operator may also be used.

[0082] FIG. 14 is a diagram of a calibration curve screen 801 displayed after the calibration curve confirmation QC is performed. As shown in FIG. 14, in the calibration curve screen 801 after the calibration curve confirmation QC is performed, in addition to the calibration curve information area 86, a QC result area 88 in which the analysis result by the calibration curve confirmation QC is displayed is displayed. The area 88 includes (1) clotting time, (2) analysis result, (3) upper limit value, (4) target value, and (5) lower limit value. The clotting time is a clotting time calculated based on the measurement data obtained by measuring the quality control sample in the measurement unit 2. The analysis result is a concentration conversion value obtained by applying the clotting time of the quality control sample to the target calibration curve 91, and in the example of FIG. 14, it is a fibrinogen concentration. The upper limit value, the target value, and the lower limit value are a target value (known concentration) of a predetermined component contained in the quality control sample, which is associated with the lot number of the quality control sample and stored in advance in the memory unit 52, and an upper limit value and a lower limit value that determine an allowable range based on the target value.

[0083] The operator can determine whether or not the target calibration curve can be validated by referring to the graph of the calibration curve 91 displayed simultaneously on the screen and the QC results displayed in the area 88. Specifically, the operator checks whether the linearity of the calibration curve 91 is sufficient and whether each point of the calibration curve 91 is not shifted based on the shape of the graph of the calibration curve 91. Furthermore, the operator checks whether the value of the analysis result is within the allowable range defined by the upper and lower limits of the quality control sample based on the calibration curve confirmation QC displayed in the area 88. In the example of FIG. 14, the analysis result of the low concentration quality control sample (Citrol 1) is 82.6 mg / dL, which is within the allowable range between the upper limit of 120.4 mg / dL and the lower limit of 58.8 mg / dL. The analysis result of the high concentration quality control sample (COAG N) is 191.2 mg / dL, which is within the allowable range between the upper limit of 265.7 mg / dL and the lower limit of 110.1 mg / dL. Therefore, by checking the information in region 88, the operator can confirm that the calibration curve 91 is performing the concentration conversion appropriately. If the analysis result in region 88 is outside the allowable range, the screen shown in FIG. 14 may display that the QC result is outside the allowable range. For example, the analysis result may be displayed in a different color, such as red. In yet another example, an alert message such as "QC result is outside the allowable range" may be displayed, or letters or symbols may be displayed indicating that the QC result is outside the allowable range.

[0084] The operator can not only determine whether the QC results are within the acceptable range, but also compare the analysis results of the quality control sample with the target value and decide whether to validate or not based on the size of the deviation.

[0085] The operator may not only compare the analysis result with the upper limit, lower limit, and target value, but also determine whether the calibration curve confirmation QC itself was performed appropriately. In the example of FIG. 14, the clotting time, which is the measurement result of the quality control sample, is also displayed in the area 88. The clotting time is the measurement result of the quality control sample before it is applied to the target calibration curve 91, and if the clotting time value is not appropriate, the analysis result based on it may not be an appropriate value. In the example of FIG. 14, in addition to the analysis result of the quality control sample, the clotting time before the measurement result of the quality control sample is applied to the calibration curve is also displayed at the same time, so that the operator can determine whether the measurement result of the quality control sample itself is reliable and then determine the validity of the calibration curve 91.

[0086] <Validate> 8 again, in step S3, when the operator validates the target calibration curve, the operator operates the validate button 90 displayed on the calibration curve screen 801 via the input unit 54. When the control unit 51 accepts the operation of the validate button 90 on the screen of FIG. 14, the control unit 51 adds a flag indicating that the target calibration curve has been validated to the data of the target calibration curve, and stores the information of the target calibration curve in the storage unit 52. In addition, the control unit 51 changes "Not Validated" in the status display area on the screen of FIG. 14 to "Validated." When the calibration curve is validated, if a measurement of the same item is subsequently performed using the reagent lot set registered together with the calibration curve information, the measurement result (clotting time) is converted to an analysis result using the validated calibration curve.

[0087] As described above, in this embodiment, the graph of the calibration curve 91, the measurement result 86B of the standard sample, and the calibration curve confirmation QC result are displayed on the same screen 801, so that the calibration curve 91 and the calibration curve confirmation QC result can be confirmed on the same screen. Furthermore, the work of validating the calibration curve 91 can also be completed within the calibration curve screen 801. After confirming the calibration curve 91, the operator does not need to go back and forth between the screens, such as opening another screen from the calibration curve screen 801 to confirm the QC result, for example, a QC chart screen, and then opening the calibration curve screen 801 again to validate the calibration curve 91. Therefore, the work of verifying the validity of the calibration curve 91 based on the QC result can be efficiently performed.

[0088] <Variation 1> FIG. 15 is a diagram showing a second example of the calibration curve screen 80. In the example shown in FIG. 14, an area 86 displaying calibration curve information and an area 88 displaying calibration curve confirmation QC results are displayed side by side on one screen. However, as shown in FIG. 15, the areas 86 and 88 may be displayed so as to overlap with each other, and one of them may be selectively displayed in front in response to an operation on the screen. Alternatively, a button for switching the display between the areas 86 and 88 may be arranged on the screen. Alternatively, the areas 86 and 88 may be switched in response to receiving an operation of a predetermined key (e.g., Tab key) on the keyboard. By configuring the areas 86 and 88 to be selectively displayed in this way, it is possible to increase the amount of information that can be displayed in each area, and to increase the visibility of the display by enlarging the information displayed in each area.

[0089] FIG. 16 is a diagram showing a third example of the calibration curve screen 80. In this example, a QC chart 92 is arranged instead of the area 88 shown in FIG. 14. In the case where multiple QC sample measurements have been performed in the past for the same reagent lot set and the same measurement item as the target calibration curve, the QC chart 92 chronologically arranges multiple QC results 921 corresponding to the multiple QC sample measurements and the calibration curve confirmation QC result 922. In the QC chart 92, the vertical axis indicates the analysis result (fibrinogen concentration in the example of FIG. 16), and the horizontal axis indicates the time series. The QC chart shows newer data toward the right, and the data of the calibration curve confirmation QC 922 is plotted on the rightmost side. In the QC chart 92, the upper limit (UL) and lower limit (LL) of the quality control sample and a line representing the target value are displayed at the center of the vertical axis. Next to the QC chart 92, an area 93 is arranged in which the result of the calibration curve confirmation QC using the target calibration curve is displayed. Area 93 displays (1) the analysis results from the calibration curve confirmation QC (fibrinogen concentration of the quality control sample in the example of FIG. 16), (2) the measurement date and time, (3) the number of N of the QC results of the controlled object plotted on the QC chart, (4) the average value of the QC results, (5) the standard deviation, and (6) the coefficient of variation. In addition, if calibration curve confirmation QC of multiple quality control samples has been performed for the target calibration curve 91, a scroll bar 94 is displayed next to the QC chart, and the QC charts of other quality control samples can be displayed by operating scroll bar 94.

[0090] In the example shown in FIG. 16, the result 922 of the calibration curve confirmation QC is displayed together with the upper limit, lower limit, and target value, so that the operator can visually understand whether the result of the calibration curve confirmation QC is within the tolerance defined by the upper and lower limits, or whether the deviation from the target value is within the tolerance. Furthermore, by arranging it in chronological order with the QC result 921 based on the past calibration curve, the operator can check whether the result of the current calibration curve confirmation QC is significantly different from the QC result using the past calibration curve. Even if the QC result using the target calibration curve is within the tolerance defined by the upper and lower limits, if the QC result using the target calibration curve shows a trend that is significantly different from the QC result using the past calibration curve, the continuity of the analysis results may be lost. Therefore, displaying the QC result based on the past calibration curve and the QC result based on the target calibration curve side by side as in FIG. 16 is useful for the operator to determine whether the calibration curve needs to be corrected and whether the calibration curve can be validated. In addition, by also displaying statistical information such as the average value and standard deviation of past QC results, the operator can compare past QC results based on statistical information as well as visual information.

[0091] 17 is a diagram showing a fourth example of the calibration curve screen 80. In this example, instead of displaying the calibration curve confirmation QC result area 88, a plurality of point data corresponding to the calibration curve confirmation QC result is plotted on a graph as points 95 and 96 in the graph display area 85. Point 95 is point data of the analysis result corresponding to a low concentration QC sample, and point 96 is point data of the analysis result corresponding to a high concentration QC sample. In this example, the operator can simultaneously refer to the graph of the calibration curve 91, the calibration curve information, and the QC result.

[0092] In the example of Figure 17, if the calibration curve confirmation QC result is outside the tolerance range of the corresponding quality control sample, the data plot is highlighted. The highlighting can be done, for example, by changing the color of the plot or displaying an exclamation mark. This allows the operator to not only see the calibration curve confirmation QC result simultaneously with the graph, but also to judge whether the calibration curve confirmation QC result is appropriate.

[0093] According to the sample analyzer 1 and the calibration curve display method of this embodiment, the calibration curve screen 80 displayed on the display unit 53 includes the calibration curve and the QC result on the same screen, so that the operator does not need to switch screens to check this information. As a result, it is possible to facilitate and streamline the checking of the calibration curve when checking the validity of the calibration curve.

[0094] In addition, since the calibration curve screen 80 in Figures 14 to 17 includes a validate button 90 for accepting an operation to approve the calibration curve, the operator can approve the calibration curve after confirming the validity of the calibration curve without having to move from the calibration curve screen 80 to another screen.

[0095] Furthermore, since the calibration curve screen 80 in Figures 14 to 17 includes attribute information of the calibration curve in addition to the calibration curve confirmation QC results, even if the operator wants to check attribute information of the calibration curve to confirm the validity of the calibration curve, such as the expiration date of the standard sample or the point data of the standard sample, the operator can check the information without moving screens.

[0096] Furthermore, according to the calibration curve screen 80 shown in FIG. 15, the calibration curve confirmation QC results and calibration curve attribute information are displayed in a switchable manner in response to the operator's operation, so that the display area of ​​each data item displayed on the screen can be increased, improving visibility.

[0097] Furthermore, since the calibration curve screen 80 in FIGS. 14 to 17 includes upper and lower limit values ​​for the calibration curve confirmation QC result, the operator can easily check whether the calibration curve confirmation QC result is within the allowable range.

[0098] Furthermore, since the calibration curve screen 80 in FIGS. 14 to 17 includes a target value for the calibration curve confirmation QC result, the operator can easily check how far the calibration curve confirmation QC result is from the target value.

[0099] Furthermore, the calibration curve screen 80 in FIG. 16 includes, in addition to the calibration curve confirmation QC results, a chronological display of multiple quality control results obtained in the past, allowing the operator to check the continuity of the data with the past QC results and confirm the validity of the calibration curve.

[0100] Furthermore, since the calibration curve screen 80 in FIG. 17 includes a graph of the calibration curve 91 and quality control results plotted on the graph, the operator can confirm the results of the calibration curve confirmation QC on the graph.

[0101] In order to express the present invention, the present invention has been described adequately and sufficiently through the embodiments with reference to the drawings in the above description, but it should be recognized that those skilled in the art can easily change and / or improve the above-mentioned embodiments. Therefore, unless the changes or improvements made by those skilled in the art are at a level that departs from the scope of the claims described in the claims, the changes or improvements are interpreted as being included in the scope of the claims.

[0102] In the above embodiment, an example in which the calibration curve and the calibration curve confirmation QC results are displayed in the calibration curve screen 801 has been shown, but the "screen including the calibration curve and the quality control results" in the present invention is not limited to this example, and is included in the category of the "screen" of the present invention as long as it can be displayed simultaneously on the same or multiple computer screens. FIG. 18 is a diagram showing another example of the display. As shown in FIG. 18, the screen 801A displaying the calibration curve 91 and the screen 801B displaying the calibration curve confirmation QC results may be divided into separate windows and displayed simultaneously within the computer screen (displayable area) of the display unit 53. Even with this display configuration, the operator can check the calibration curve 91 and the calibration curve confirmation QC results simultaneously. In this case, a QC result display button 803 may be provided in the window 801A displaying the calibration curve, and the window 801 may be popped up in response to the button 803 being operated. FIG. 19 is a diagram showing yet another example of the display. As shown in FIG. 19, a plurality of display units 53A, 53B may be provided in the sample analyzer 1, and an image 801A of the calibration curve 91 and an image 801B of the calibration curve confirmation QC results may be displayed simultaneously on each computer screen.

[0103] Although a blood coagulation analyzer has been exemplified in the above embodiment, the present invention may be applied to other sample analyzers that use a calibration curve, such as an immunoanalyzer, a biochemical analyzer, a nucleic acid analyzer, etc. For example, when the present invention is applied to an immunoanalyzer, the measurement unit sends a digital conversion value of the light intensity corresponding to the amount of antigen / antibody contained in a standard sample in which the concentration of a predetermined antigen / antibody is known to the analysis unit, and the analysis unit creates a calibration curve with two axes representing the digital conversion value of the light intensity and the known concentration of the antigen / antibody.

[0104] In the above embodiment, the analysis unit 4 and the measurement unit 2 are provided with individual control units 51, 41. This is not limiting, and the control units 51, 41 may be configured as a single common control unit (CPU). The same applies to the storage units 52, 42 and the communication units 55, 43. The analysis unit 4 may also be configured by a notebook or desktop computer externally connected to the sample analyzer 1.

[0105] In the above embodiment, an example was shown in which the display unit 53 was provided in the analysis unit 4, which is a separate computer connected to the measurement unit 2, but the display unit 53 may be incorporated in the measurement unit 2. [Explanation of symbols]

[0106] 1. Sample analyzer 2 Measuring section 52 Storage section 53 Display section 80 Calibration curve screen 85 Graph display area 86 Calibration curve information area 86A,86B,88 area 91 Calibration curve 92 QC Chart 93,94 points

Claims

1. A blood coagulation analyzer comprising: a measurement unit that prepares a first measurement sample by mixing a specimen with a coagulation time measurement reagent and measures the prepared first measurement sample to generate first measurement data; a control unit that receives the first measurement data from the measurement unit, obtains a coagulation time of the sample based on the first measurement data, and obtains an analysis result regarding the component concentration of the sample by applying the coagulation time to a first calibration curve registered in advance in a storage unit; a display unit that displays the analysis results obtained by the control unit; and Equipped with the measurement unit prepares a plurality of second measurement samples by mixing each of a plurality of standard samples containing a component of a known concentration with the clotting time measurement reagent, measures the prepared plurality of second measurement samples to generate second measurement data, the control unit receives the second measurement data from the measurement unit, obtains the clotting time of each of the plurality of standard samples based on the second measurement data, and creates a second calibration curve before approval based on the clotting time and the component concentrations of the plurality of standard samples, the measurement unit mixes a quality control sample with the clotting time measurement reagent to prepare a third measurement sample, measures the prepared third measurement sample to generate third measurement data, the control unit receives the third measurement data from the measurement unit, obtains the clotting time of the quality control sample based on the third measurement data, and applies the clotting time to the second calibration curve to obtain component concentrations of the quality control sample, The control unit is (1) the second calibration curve; (2) a component concentration of the quality control sample obtained from the coagulation time of the quality control sample and the second calibration curve; and (3) Upper and lower limits for the component concentration, which are preset for each lot of the quality control sample; (4) a button for approving the second calibration curve; Displaying a screen including the above on the display unit, When the control unit receives an operation to approve the second calibration curve via the button, the control unit registers the second calibration curve in the memory unit as the first calibration curve.

2. The blood coagulation analyzer according to claim 1 , wherein the control unit registers in the storage unit a lot number of the coagulation time measuring reagent used to create the second calibration curve in association with the second calibration curve.

3. The blood coagulation analyzer according to claim 1 , wherein the memory unit stores a lot number of the quality control sample and the upper limit and the lower limit.

4. 4. The blood coagulation analyzer according to claim 1, wherein the screen further includes a target value for the component concentration that is preset for each lot of the quality control sample.

5. 5. The blood coagulation analyzer according to claim 1, wherein the screen further includes measurement results of a plurality of the standard samples used to create the second calibration curve.

6. the screen further includes a button for correcting the second calibration curve; The blood coagulation analyzer according to claim 1 , wherein the control unit accepts an operation to correct the second calibration curve via the button.

7. The blood coagulation analyzer according to claim 1 , wherein the screen further displays a plurality of component concentrations obtained in the past in chronological order.

8. The blood coagulation analyzer according to any one of claims 1 to 7, wherein the screen further includes a graph of the second calibration curve and component concentrations of the quality control sample plotted on the graph.

9. The blood coagulation analyzer according to any one of claims 1 to 8, wherein the measurement unit prepares a plurality of standard samples having different concentrations by diluting a standard sample at a plurality of dilution ratios, and measures the prepared plurality of standard samples.

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