Calibration curve setting method, sample analysis method and procedure, sample analysis device

Abstract

This invention provides a calibration curve setting method, sample analysis method and procedure, and sample analysis apparatus that simplify operation for operators in restoring a calibrated calibration curve to its original state. The calibration curve setting method of this invention includes: generating a first calibration curve based on measured values ​​obtained from a standard sample with a known concentration of a predetermined component; generating a second calibration curve by correcting the generated first calibration curve; displaying a screen supporting the operator in restoring the second calibration curve to the first calibration curve; receiving an instruction to restore the second calibration curve to the first calibration curve; and displaying the first calibration curve when the instruction is received.

Description

Technical Field

[0001] This invention relates to a calibration curve setting method, a sample analysis method, a calibration curve setting program, a sample analysis program, and a sample analysis device. Background Technology

[0002] In the field of clinical examination, sample analysis devices are known for analyzing the concentration of specific substances contained in samples such as plasma, serum, and urine. Such sample analysis devices receive light transmitted through or emitted from the sample and convert the measured value based on the light intensity into the concentration of a predetermined substance contained in the sample. A calibration curve representing the correspondence between the measured value based on the light intensity and the concentration of the substance is used in the concentration conversion. The calibration curve is generated by measuring multiple standard substances with known concentrations of the specific substance, each with a different concentration. Patent Document 1 describes the following key point: reagents are generally managed at 2–8°C on the device, but reagent degradation cannot be avoided, thus requiring calibration curve correction. To address this situation, Patent Document 1 discloses an automatic analysis device that displays the remaining time until calibration curve correction is performed on a CRT screen, reduces the remaining time accordingly with the elapsed time, and automatically performs calibration curve correction when the remaining time reaches zero.

[0003] Existing technical documents

[0004] Patent documents

[0005] Patent Document 1: Japanese Patent Application Publication No. 8-262028 Summary of the Invention

[0006] If the reagents used in the sample analysis device are changed, for example, if the types and manufacturing batches of the reagents before and after the change are the same, it is sometimes possible to use a calibration curve created for the reagents before the change for the reagents after the change. In this case, if the calibration curve has been corrected, and concentration conversion is performed on the device using the calibration curve corrected to suit the deteriorated reagents, an error will occur, so it is necessary to restore the calibration curve to its original state. However, Patent Document 1 does not describe restoring the calibration curve to its original state after correction.

[0007] The present invention was made in view of the above reasons, and its object is to provide a calibration curve setting method, a sample analysis method, a calibration curve setting program, a sample analysis program, and a sample analysis device that simplify the operation of the operator in restoring the calibrated calibration curve to the calibration curve before calibration.

[0008] The inventors have conducted various studies, and as a result, discovered that the above-mentioned objective is achieved through the following invention. Specifically, one aspect of the invention provides a calibration curve setting method comprising: generating a first calibration curve based on measured values ​​obtained from a standard sample with a known concentration of a predetermined component; generating a second calibration curve by correcting the generated first calibration curve; displaying a screen supporting the operator regarding restoring the second calibration curve to the first calibration curve; receiving an instruction to restore the second calibration curve to the first calibration curve; and displaying the first calibration curve when the instruction is received.

[0009] This sample analysis method features a screen that supports the operator in restoring the second calibration curve to the first calibration curve, thus simplifying the operation for operators who wish to restore the calibrated calibration curve to the uncalibrated calibration curve.

[0010] Another aspect of the present invention provides a calibration curve setting program that enables a computer to: generate a first calibration curve based on measured values ​​obtained from a standard sample with a known concentration of a predetermined component; generate a second calibration curve by correcting the generated first calibration curve; display a screen supporting the operator regarding restoring the second calibration curve to the first calibration curve; and receive instructions to restore the second calibration curve to the first calibration curve.

[0011] This calibration curve setting procedure enables the computer to display a screen supporting the operator on how to restore the second calibration curve to the first calibration curve, thus simplifying the operation for operators who want to restore the calibrated calibration curve to the original calibration curve.

[0012] Another aspect of the present invention provides a sample analysis apparatus comprising: a measuring unit for measuring a standard sample with a known concentration of a predetermined component; a control unit; and a display unit for displaying information. The control unit performs the following actions: generating a first calibration curve based on the measured values ​​obtained by measuring the standard sample with a known concentration of the predetermined component using the measuring unit; generating a second calibration curve by correcting the generated first calibration curve; displaying a screen on the display unit to support the operator regarding restoring the second calibration curve to the first calibration curve; receiving an instruction to restore the second calibration curve to the first calibration curve; and displaying the first calibration curve on the display unit when the instruction is received.

[0013] Such a sample analysis device uses the display unit to display a screen that supports the operator in restoring the second calibration curve to the first calibration curve, thus simplifying the operation for operators who want to restore the calibrated calibration curve to the uncalibrated calibration curve.

[0014] Another aspect of the present invention provides a sample analysis method comprising: preparing a first calibration curve using a standard substance for a reagent of a specific manufacturing batch number; generating an analysis result using measured values ​​obtained from measuring a sample with the aforementioned reagent and the first calibration curve; preparing a second calibration curve to correct for changes in the properties of the aforementioned reagent over time; providing an analysis result using measured values ​​obtained from measuring a sample with the aforementioned changes in properties over time and the second calibration curve; and providing an analysis result using measured values ​​obtained from measuring a sample with the replaced reagent and the first calibration curve when the manufacturing batch number of the replaced reagent is the same as the manufacturing batch number of the reagent before the replacement is replaced, and when the specific manufacturing batch of the reagent is replaced with a reagent of the same type.

[0015] This sample analysis method provides analytical results when the reagent in the specific manufacturing batch is replaced with a reagent of the same type, and the batch number of the replaced reagent is the same as the batch number of the reagent before replacement. It uses the measured value obtained by measuring the sample with the replaced reagent and the first calibration curve to provide analytical results. Therefore, it can be used to simplify the operation of the operator who restores the calibration curve after correction to the calibration curve before correction.

[0016] Another aspect of the present invention provides a sample analysis program that enables a computer to perform: for a reagent of a specific manufacturing batch number, using a standard substance to create a first calibration curve; using the measured values ​​obtained by measuring a sample with the aforementioned reagent and the aforementioned first calibration curve to generate an analysis result; to correct the aforementioned first calibration curve and create a second calibration curve in order to address changes in the properties of the aforementioned reagent over time; using the measured values ​​obtained by measuring a sample with the aforementioned changes in properties over time and the aforementioned second calibration curve to provide an analysis result; and when the reagent of the specific manufacturing batch is replaced with a reagent of the same type and the manufacturing batch number of the replaced reagent is the same as the manufacturing batch number of the reagent before the replacement, using the measured values ​​obtained by measuring a sample with the replaced reagent and the first calibration curve to provide an analysis result.

[0017] This sample analysis procedure provides analytical results using the measured values ​​obtained from measuring the sample with the replaced reagent and the first calibration curve, when the batch number of the replaced reagent is the same as that of the reagent before the replacement after the specific batch of the reagent is replaced with the same type of reagent. Therefore, it simplifies the operation for operators who want to restore the calibration curve after correction to the calibration curve before correction.

[0018] Another aspect of the present invention provides a sample analysis apparatus that uses a calibration curve to analyze a sample. The sample analysis apparatus includes: a measuring unit for measuring the sample and a standard sample with a known concentration of a predetermined component; and a control unit that performs the following actions: generating a first calibration curve using a standard substance for a reagent of a specific manufacturing batch number; generating an analytical result using the measured value obtained from measuring the sample with the aforementioned reagent and the first calibration curve; generating a second calibration curve to correct for changes in the properties of the aforementioned reagent over time; providing an analytical result using the measured value obtained from measuring the sample with the reagent that has undergone the aforementioned changes in properties over time and the second calibration curve; and providing an analytical result using the measured value obtained from measuring the sample with the replaced reagent and the first calibration curve when the manufacturing batch number of the replaced reagent is the same as the manufacturing batch number of the reagent before the replacement is replaced, after the reagent of the specific manufacturing batch has been replaced with a reagent of the same type.

[0019] When such a sample analysis device replaces the reagent of the specific manufacturing batch with a reagent of the same type, and the manufacturing batch number of the replacement reagent is the same as that of the reagent before replacement, it provides analysis results using the measured values ​​obtained by measuring the sample with the replacement reagent and the first calibration curve. Therefore, it can be used to simplify the operation of the operator in order to restore the calibration curve after correction to the calibration curve before correction.

[0020] The calibration curve setting method, sample analysis method, calibration curve setting program, sample analysis program, and sample analysis device of the present invention can simplify the operation for operators who want to restore the calibrated calibration curve to the calibration curve before calibration. Attached Figure Description

[0021] Figure 1 This is a perspective view schematically showing the external structure of the sample analysis device according to an embodiment of the present invention.

[0022] Figure 2A This is a top view schematically showing the structure of the measuring section and the conveying section.

[0023] Figure 2B This is a diagram schematically showing the structure of the sample measuring section.

[0024] Figure 3 This is a block diagram showing the structure of the measuring unit.

[0025] Figure 4 This is a block diagram showing the structure of the analysis unit.

[0026] Figure 5 This is a diagram showing the basic shape of the solidification curve used to calculate solidification time.

[0027] Figure 6A This is a graph showing an example of a calibration curve.

[0028] Figure 6B This is a graph showing an example of a calibration curve.

[0029] Figure 7A This is a flowchart showing the sample analysis process performed by the control unit of the measurement unit.

[0030] Figure 7B This is a flowchart showing the sample analysis processing performed by the control unit of the analysis department.

[0031] Figure 8A This is a flowchart illustrating the main process of monitoring reagent remaining quantity performed by the control unit of the measuring unit.

[0032] Figure 8B This is a flowchart illustrating the main process performed by the control unit of the analysis department to monitor the remaining reagent levels.

[0033] Figure 9A This is a flowchart illustrating the main processes involved in creating the calibration curve.

[0034] Figure 9B This is a flowchart illustrating the main processes involved in correcting the calibration curve.

[0035] Figure 10 This is a flowchart illustrating the main processes involved in the calibration curve swapping support process.

[0036] Figure 11 This is an example of a screen showing the reagent remaining amount reset.

[0037] Figure 12A This is an example of a query screen.

[0038] Figure 12B This is another example of a query screen.

[0039] Figure 13A This is an example of a calibration curve screen.

[0040] Figure 13B This is another example of a calibration curve display.

[0041] Figure 14 This is an example of a calibration curve screen showing the calibration curve before calibration.

[0042] Figure 15 This is an example of a calibration curve selection screen.

[0043] Figure 16This is a flowchart illustrating the main process of the calibration curve replacement support process for the modified example.

[0044] (Symbol Explanation)

[0045] 1: Sample analysis device; 2: Measurement unit; 3: Transport unit; 4: Analysis unit; 72: Calibration curve display query screen; 73: Calibration curve screen; 76: Calibration curve list screen. Detailed Implementation

[0046] Hereinafter, one embodiment of the present invention will be described with reference to the accompanying drawings. Furthermore, structures indicated by the same symbols in the various figures are identical structures, and their descriptions are omitted where appropriate.

[0047] Figure 1 This is a perspective view schematically showing the external structure of the sample analysis apparatus 1 according to an embodiment of the present invention. The hardware structure of the sample analysis apparatus 1 according to this embodiment is disclosed in detail in U.S. Patent Publication No. 2018-0267069, the entire contents of which are incorporated herein by reference. In this specification, the apparatus structure is described focusing on the parts relevant to the present invention. The sample analysis apparatus 1 includes a measuring unit 2, a conveying unit 3, and an analysis unit 4. The sample analysis apparatus 1 is a blood coagulation analysis apparatus for analyzing the coagulation ability of blood as a sample. In this specification, according to… Figure 1 The arrows shown define the directions: front, back, left, right, up, and down.

[0048] Figure 2A This is a top view schematically showing the structure of the measuring unit 2 and the conveying unit 3. The conveying unit 3 is located in front of the measuring unit 2.

[0049] The transport unit 3 includes a holder mounting unit 11, a holder transport unit 12, and a holder recovery unit 13. The holder mounting unit 11 is a region for arranging a sample holder 15, which holds one or more sample containers 14 that are the objects of analysis, in the sample analysis apparatus 1. The operator places the sample holder 15, which holds the sample containers 14 containing the samples, in the holder mounting unit 11.

[0050] The cage conveying section 12 is disposed between the cage setting section 11 and the cage retraction section 13.

[0051] The sample holder retrieval section 13 is the area for retrieving and placing the sample holder 15 that has been transported by the sample holder transport section 12 after sample extraction. The sample holder retrieval section 13 is located downstream of the sample holder transport section 12.

[0052] The transport unit 3 transports the sample holder 15, which is disposed in the holder setting unit 11, to the holder transport unit 12, and sequentially positions each sample container 14 at the sample aspiration position 16. The sample dispensing unit 18 extracts samples from the sample containers 14 positioned at the sample aspiration position 16 by aspiration. When the extraction of samples from all the sample containers 14 disposed in the sample holder 15 is completed, the transport unit 3 transports the sample holder 15 to the holder recycling unit 13 for recycling and placement.

[0053] The measuring unit 2 prepares a test sample by mixing the reagent with the sample extracted at the sample aspiration position 16, and measures the prepared test sample. The measuring unit 2 includes a sample dispensing unit 18, a reaction vessel holding unit 22, a reagent retention unit 23, a reagent dispensing unit 27-1, a reagent dispensing unit 27-2, a heating unit 30, a sample measuring unit 34, and a sample information reading unit 17.

[0054] The reagent retention section 23 stores reagents used for preparing and measuring samples. Specifically, the reagent retention section 23 is a plate-shaped component, viewed from above, formed at predetermined intervals in the circumferential direction, with multiple reagent holding holes 25 for holding the reagent container containing the reagents. Figure 2A In the example shown, the multiple reagent holding holes 25 arranged circumferentially are formed in three rows radially. The reagent retention section 23 is configured to rotate circumferentially around its center axis. The reagents retained in the reagent retention section 23 are reagents for prothrombin time assays or fibrinogen assays, etc.

[0055] The reagent information reading unit 81 is a device for reading reagent information from a reagent information component containing reagent information. The reagent information reading unit 81 is positioned facing the reagent storage unit 23 to enable reading reagent information from a reagent information component attached to the reagent container held in the reagent storage unit 23. Specifically, the reagent information component is a sticker printed with a barcode recording reagent information, and the reagent information reading unit 81 is configured to have a barcode reader. The barcode can be either a 1D barcode or a 2D barcode (a so-called QR code (registered trademark)). Alternatively, the reagent information component can be an RFID tag storing reagent information, and the reagent information reading unit 81 can be an RFID reader. The reagent information includes information indicating the type of reagent and information indicating the manufacturing batch of the reagent.

[0056] The reaction vessel holding part 22 holds the reaction vessel 26, which is used to prepare the test sample by reacting the sample with the reagent. The reaction vessel holding part 22 is a ring-shaped component in plan view, having a plurality of holding holes 24 for holding the reaction vessel 26 formed at predetermined intervals in the circumferential direction. The reaction vessel holding part 22 is configured to be rotatable in the circumferential direction with its center as an axis.

[0057] The sample dispensing unit 18 extracts a sample from the sample container 14 located at the sample aspiration position 16 and discharges the extracted sample into the reaction container 26 of the reaction container holding unit 22. Specifically, the sample dispensing unit 18 includes a sample aspiration nozzle 19 for aspirating a sample from the sample container 14, a rod-shaped member, i.e., an arm 20, with the sample aspiration nozzle 19-1 at one end facing downwards, and a drive mechanism 21 installed at 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 about the other end of the arm 20 as an axis. The sample dispensing unit 18 is disposed between the sample aspiration position 16 and the reaction container holding unit 22 so that a sample can be extracted at the sample aspiration position 16 and discharged into the reaction container 26 of the reaction container holding unit 22.

[0058] A diluent holding hole 38 is formed between the sample aspiration position 16 and the reaction vessel holding section 22. This diluent holding hole 38 is used to hold a diluent container containing a predetermined diluent. The sample dispensing section 18 can draw diluent from the diluent container held in the diluent holding hole 38 and dispense it into the reaction vessel 26. Thus, the sample dispensing section 18 can dispense standard samples and diluents into the reaction vessel during the calibration curve preparation process described later, and prepare multiple test samples with different dilution ratios according to the standard samples.

[0059] The heating unit 30 is disposed adjacent to the reaction vessel holding unit 22 on its right rear side. The heating unit 30 heats the sample contained in the reaction vessel 26 to a predetermined temperature (e.g., 37°C) corresponding to the measurement. The heating unit 30 includes a heating holding unit 31 and a transfer unit 33. The heating holding unit 31 is a plate-shaped unit in plan view, with a plurality of holding holes 32 for holding the reaction vessel 26 formed at predetermined intervals in the circumferential direction on its edge. The heating holding unit 31 is configured to be rotatable about its center axis. The heating holding unit 31 includes a horizontal arm 33-1 that can extend in the horizontal direction, a container catcher 33-2 provided at the front end of the horizontal arm 33-1, and a rotation mechanism 33-3 that rotates the horizontal arm 33-1 about its base axis. The transfer unit 33 rotates and extends the horizontal arm 33-1 using the rotating mechanism 33-3, thereby capturing the reaction vessel 26 held in the reaction vessel holding part 22 using the container trap 33-2. By shortening the horizontal arm 33-1, it is transferred to the heating holding part 31. In addition, the transfer unit 33 rotates and extends the horizontal arm 33-1 using the rotating mechanism 33-3, thereby transferring the reaction vessel 26 held by the container trap 33-2 to positions 28-1-1 directly below the reagent suction nozzle 28-1 of the reagent dispensing part 27-2 and 28-2-1 directly below the reagent suction nozzle 28-2 of the reagent dispensing part 27-2.

[0060] The reagent dispensing section 27-1 is positioned above the reagent storage section 23, the reaction vessel holding section 22, and the heating section 30. The reagent dispensing section 27-1 extracts a predetermined amount of reagent stored in the reagent storage section 23 and discharges the extracted reagent towards the reaction vessel 26, which is positioned at a position 28-1-1 directly below the reagent suction nozzle 28-1. This mixes the sample with the reagent to prepare a test sample. The reagent dispensing section 27-1 includes a reagent suction nozzle 28-1 that draws reagent from a reagent container held in the reagent holding hole 25, and a guide member 29-1 that serves as a rod-shaped component with the suction nozzle 28-1 facing downwards. The reagent suction nozzle 28-1 can be powered by a stepper motor 29A (see reference). Figure 3 The guide 29-1 moves horizontally between one end and the other. Additionally, the reagent suction nozzle 28-1 can be moved using a stepper motor 29B (see reference). Figure 3 It moves vertically. One end of the guide 29-1 is located above the reagent retention section 23, and the other end is located near the heating section 30. The reagent dispensing section 27-1 is arranged such that the guide 29-1 extends from near the center of the circular reagent retention section 23 to the edge, so that reagents can be extracted from the reagent retention section 23. Therefore, the reagent dispensing section 27-1 overlaps with the reaction vessel holding section 22 and the reagent retention section 23 when viewed from above, so that... Figure 2A The reagent dispensing section 27-1 is indicated by a dashed line. The same applies to reagent dispensing section 27-2.

[0061] Similarly, the reagent dispensing section 27-2 extracts a predetermined amount of activating reagent for initiating the coagulation reaction from the reagent retention section 23, and discharges the extracted activating reagent to the reaction vessel 26 located at position 28-2-1 directly below the reagent suction nozzle 28-2, which is transferred from the heating section 30 to the reagent dispensing section 27-2 by the transfer section 37. Thus, the sample mixes with the activating reagent, and the coagulation reaction begins. The reagent dispensing section 27-2 includes a reagent suction nozzle 28-2 for drawing reagent from a reagent container held in the reagent retention hole 25, and a guide member 29-2, which is a rod-shaped member on which the suction nozzle 28-2 is mounted with its suction port facing downwards. The reagent suction nozzle 28-2 includes a liquid level sensor 28A (see reference). Figure 3 The reagent suction nozzle 28-2 can be powered by a stepper motor 29A (see reference). Figure 3 The guide 29-2 moves horizontally between one end and the other. Additionally, the reagent suction nozzle 28-2 can be moved using a stepper motor 29B (see reference). Figure 3It moves in the vertical direction. One end of the guide 29-2 is located above the reagent retention section 23, and the other end is located near the heating section 30 and the sample measuring section 34. The reagent dispensing section 27-2 is configured such that the guide 29-2 is positioned from near the center of the circular reagent retention section 23 to the edge, so that the reagent can be extracted from the reagent retention section 23.

[0062] The sample measuring unit 34 is disposed adjacent to and behind the heating unit 30. The sample measuring unit 34 illuminates the sample contained in the reaction vessel 26 with light and detects the optical signal, outputting a digital signal corresponding to the light intensity. The sample measuring unit 34 includes a sample holding plate 35, a transfer unit 37, and a detection unit 39 (see reference 30). Figure 3 The sample holding plate 35 is a box-shaped component with multiple sample holding holes 36 for holding the reaction vessel 26 spaced at predetermined intervals. The transfer unit 37 includes a horizontal arm 37-1 that can extend in the horizontal direction, a container catcher 37-2 provided at the front end of the horizontal arm 37-1, and a sliding mechanism 37-3 that allows the horizontal arm 37-1 to slide in the left and right direction. The transfer unit 37 transfers the reaction vessel 26, which is held in the holding hole 32 of the heating holding part 31 of the heating part 30, to the sample holding hole 36 of the sample holding plate 35 via a position 28-2-1 directly below the reagent suction nozzle 28-2 of the reagent dispensing part 27-2.

[0063] Testing Department 39 Figure 2B As shown, each sample holding hole 36 has: a light source 39A, which irradiates the sample housed in the reaction vessel 26 held in the sample holding hole 36 with light; and a light receiving part 39B, which receives the light transmitted through the sample and converts the analog electrical signal corresponding to the light intensity into a digital signal and outputs it.

[0064] Return to Figure 2A The sample information reading unit 17 is a device for reading sample information from a sample information component that stores sample information. The sample information reading unit 17 is positioned facing the holder transport unit 12 so that it can read sample information from a sample information component attached to the sample container 14 transported by the holder transport unit 12. The sample information component is a label printed with a machine-readable code recording sample information, and the sample information reading unit 17 is configured to include a barcode reader. The machine-readable code is a 1D barcode, and the sample information reading unit 17 is a barcode reader.

[0065] Figure 3 This is a block diagram showing the structure of the measuring unit 2. The measuring unit 2 includes a control unit 41, a storage unit 42, a communication unit 43, and so on. Figure 2AThe sample dispensing section 18, reaction vessel holding section 22, transfer section 33, 37, heating section 30, reagent retention section 23, sample information reading section 17, reagent dispensing section 27, and detection section 39 are shown.

[0066] The control unit 41 is a circuit used to control the operation of each part of the measuring unit 2 and the conveying unit 3 according to their respective functions. The control unit 41 is configured, for example, to include a CPU and its peripheral circuitry.

[0067] The storage unit 42 includes a hard disk for storing various programs and data used by the control unit 41 to control the various parts of the measurement unit 2 and the transmission unit 3.

[0068] The communication unit 43 is a circuit that performs data input and output with external devices under the control of the control unit 41. The communication unit 43 is configured, for example, to have an interface circuit that uses any communication standard such as Ethernet (registered trademark) and IEEE 1394.

[0069] Figure 4 This is a simplified block diagram showing the structure 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.

[0070] The control unit 51 is a circuit used to control the operation of each part of the analysis unit 4 according to their respective functions. The control unit 51 is configured, for example, to include a CPU and its peripheral circuitry.

[0071] Storage unit 52 is a circuit that stores various programs 60 and various data. Storage unit 52, like storage unit 42, is configured to include a hard disk device. Program 60 is stored in storage unit 52.

[0072] Program 60 includes a control program, an analysis processing program, a calibration curve processing program, and an accuracy management program. The control program controls each part of the analysis unit 4 (storage unit 52, display unit 53, input unit 54, and communication unit 55) according to their respective functions. The analysis processing program performs predetermined processes related to sample measurement (reagent setting, calibration curve setting, and analysis of measurement results, etc.). The calibration curve processing program performs predetermined processes related to standard sample measurement (calibration curve creation and display, etc.). The accuracy management program performs predetermined processes related to accuracy management of sample measurement (setting execution conditions and displaying measurement results, etc.).

[0073] Display unit 53 is a touch panel type display equipped with a display device such as a liquid crystal display or an organic EL display.

[0074] The input unit 54 is a device that inputs various instructions, such as instructions for generating calibration curves, and various data required to operate the sample analysis device 1 into the sample analysis device 1. The input unit 54 is configured to include a keyboard, a pointing device including a mouse or touch panel, and multiple input switches assigned predetermined functions.

[0075] The communication unit 55 is a circuit that performs data input and output between the communication unit 43, which includes the measurement unit 2, and external devices under the control of the control unit 51. The communication unit 55 may be configured, for example, to have an interface circuit that uses any communication standard such as Ethernet (registered trademark) and IEEE 1394.

[0076] Reference Figures 2A to 4 The sample processing procedure is explained below. When performing a sample analysis, the sample dispensing unit 18 extracts a predetermined amount of sample from the sample container 14 located at the sample aspiration position 16 using the sample aspiration nozzle 19, and discharges the sample into the reaction container 26 held in the holding hole 24 of the reaction container holding unit 22. Thus, the sample in the sample container 14 is dispensed into the reaction container 26. When the sample is dispensed into the reaction container 26, the reaction container holding unit 22 rotates, and the reaction container 26 is moved to the vicinity of the heating unit 30. The transfer unit 33 of the heating unit 30 moves the reaction container 26 from the holding hole 24 of the reaction container holding unit 22 to the holding hole 32 of the heating unit 30. The heating unit 30 heats the reaction container 26. The reagent dispensing unit 27-1 extracts a predetermined amount of reagent from the reagent retention unit 23 using the reagent aspiration nozzle 28-1. The transfer unit 33 moves the reaction vessel 26 from the heating and holding unit 31 to a position 28-1-1 directly below the reagent suction nozzle 28-1. The reagent dispensing unit 27-1 moves the reagent suction nozzle 28-1 to this position 28-1-1, at which position 28-1-1, dispensing reagent from the reagent suction nozzle 28-1 into the reaction vessel 26. Thus, reagent is dispensed into the reaction vessel 26, and the sample and reagent are mixed, thereby preparing the sample. The transfer unit 33 moves the reagent-dispensed reaction vessel 26 to the holding hole 32 of the heating unit 30. Next, the heating and holding unit 31 of the heating unit 30 rotates, positioning the reaction vessel 26 near the sample measuring unit 34. The transfer unit 37 of the sample measuring unit 34 moves the reaction vessel 26 from the heating and holding unit 31 to a position 28-2-1 directly below the moving path of the reagent suction nozzle 28-2. Next, in order to initiate the solidification reaction, the reagent dispensing section 27-2 moves the reagent suction nozzle 28-2 to position 28-2-1, at which position 28-2-1 the activating reagent is discharged from the reagent suction nozzle 28-2 into the reaction vessel 26. The transfer section 37 transfers the reaction vessel 26 containing the activating reagent to the sample holding hole 36 of the sample measuring section 34.

[0077] The light source 39A of the sample measuring unit 34 illuminates the sample housed in the reaction vessel 26, which is transferred to the sample holding hole 36. The light receiving unit 39B receives the light transmitted through the sample and converts the analog electrical signal corresponding to the light intensity into a digital signal for output. The light irradiation by the light source 39A and the light receiving by the light receiving unit 39B are continued for a predetermined time, and the digital signal output from the light receiving unit 39B is stored in the storage unit 42 as time series data. The control unit 41 of the measuring unit 2 sends the time series data stored in the storage unit 42 to the control unit 51 of the analysis unit 4.

[0078] The control unit 51 of the analysis unit 4 calculates the solidification time of the sample based on the received time series data. Figure 5 The basic shape of the solidification curve used to calculate solidification time is shown. Figure 5 The vertical axis in the graph represents the magnitude of the digital signal output from the light-receiving part 39B, i.e., the amount of transmitted light. Figure 5 The horizontal axis in the graph represents the elapsed time since the light-receiving part 39B began to receive light. Figure 5 As an example of a method for calculating solidification time, the percentage detection method is shown. The percentage detection method is as follows: the transmitted light amount at a baseline L1 before the solidification reaction is confirmed is set to 0%, and the transmitted light amount at the point where the solidification reaction stops (L2) is set to 100%. The time it takes for the transmitted light amount to reach the solidification detection % is calculated as the solidification time. The solidification detection % is set to a predetermined proportion of the interval between the transmitted light amount at the baseline L1 and the transmitted light amount at the point where the solidification reaction stops. The solidification detection % is used to explore the solidification point where the transmitted light amount changes from the baseline L1 by a predetermined proportion (solidification detection %). The solidification detection % is set to a value greater than 0 and less than 100. For example, the solidification detection % is set to 50%. The control unit 51 calculates the elapsed time when the solidification detection % reaches 50%. This is the solidification time.

[0079] Next, the control unit 51 of the analysis unit 4 applies the calculated coagulation time to the calibration curve, converting it into the concentration of the predetermined component contained in the sample. The calibration curve is prepared in advance before the sample is measured. Figure 6 shows an example of a calibration curve. In the graph of Figure 6, the vertical axis represents the coagulation time, the horizontal axis represents the concentration of antithrombin (AT), which is an example of the predetermined component, and line α is the calibration curve. When the sample is measured and the coagulation time is calculated, the concentration on the calibration curve for that coagulation time is determined as the concentration of the predetermined component of the sample.

[0080] In the preparation of the calibration curve, a standard sample with a known concentration of a predetermined component is used. Instead of sample container 14, multiple containers holding the same standard sample are placed on sample holder 15, and the solidification time of the standard sample is calculated in the same order as the determination of the sample. However, in order to make the concentrations of the predetermined component different, the diluent in sample dispensing section 18 is not mixed with the diluent in diluent holding hole 38 for a portion of the standard sample, and the diluent is dispensed into reaction container 26 for a portion of the standard sample, so that the concentration of the predetermined component decreases. On the graph of Figure 6, multiple points (P1, P2, P3) are plotted where the solidification time obtained by measuring the standard sample intersects with the known concentration of the standard sample (in the case of diluted standard sample, the concentration corresponding to the dilution ratio), and the approximate line based on these plotted points is used as calibration curve α.

[0081] Next, use Figure 7A as well as Figure 7B This describes the sample analysis process performed by the control unit 41 of the measuring unit 2 and the control unit 51 of the analysis unit 4. (Figure 7 and...) Figure 7B The processes shown are repeated during the period when the sample analysis device 1 is started.

[0082] like Figure 7A As shown, in step S1, the control unit 41 performs a reagent remaining amount monitoring process to monitor the remaining amount of reagent contained in the reagent container 25. Details regarding the reagent remaining amount monitoring process will be described later.

[0083] In step S2, the control unit 41 performs a reagent replacement process. This process is performed when the operator inputs a reagent replacement instruction via the display unit 53 of the analysis unit 4. During this process, the reagent information reading unit 81 reads information indicating the type of reagent and information indicating the manufacturing batch of the reagent from the reagent information component attached to the reagent container 25, which is newly placed by the operator in the reagent holding hole 25, and stores it in the storage unit 42.

[0084] In step S3, the control unit 41 performs the sample measurement process. This process is performed when the operator inputs an instruction to measure the sample (the subject's sample or a standard sample) via the display unit 53 of the analysis unit 4. The operation of the measurement unit 2 based on the sample measurement process is as described above. Through this process, the measurement unit 2 and each part of the transport unit 3 operate to draw the sample or standard sample from the sample container 14, perform sample preparation, heating, and other processes, and the detection unit 34 outputs a digital signal corresponding to the amount of light received, which is stored in the storage unit 42.

[0085] In step S4, the control unit 41 performs communication processing. In this processing, information stored in step S2 indicating the type of reagent and the manufacturing batch of the reagent, as well as digital signals corresponding to the amount of light received stored in step S3, are sent to the communication unit 55 of the analysis unit 4.

[0086] like Figure 7B As shown, the control unit 51 performs a calibration curve generation process in step S5. In this process, the control unit 51 calculates the solidification time based on the digital signal obtained from the measurement unit 2 by measuring a standard sample, and generates a calibration curve based on the calculated solidification time and the known concentration of the standard sample. Figure 6A The calibration curve before correction is shown (e.g., calibration curve α). Details regarding the preparation of the calibration curve will be described later.

[0087] In step S6, the control unit 51 performs a calibration curve correction process. In this process, the control unit 51 corrects the calibration curve before correction and generates... Figure 6B The corrected calibration curves are shown below (e.g., calibration curve β, calibration curve γ, calibration curve θ). Details regarding the calibration curve correction process will be described later.

[0088] In step S7, the control unit 51 performs a reagent remaining quantity monitoring process to monitor the remaining amount of reagent contained in the reagent container 25. Details regarding the reagent remaining quantity monitoring process will be described later.

[0089] In step S8, the control unit 51 performs a calibration curve replacement process. The calibration curve replacement process will be described later.

[0090] In step S9, the control unit 51 performs analysis result provision processing. In this processing, the control unit 51 calculates the solidification time based on the digital signal corresponding to the amount of light received, sent from the measurement unit 2, and converts the solidification time into concentration using a calibration curve that has been set to be usable. The converted concentration is displayed on the display unit 53. The calibration curve used for concentration conversion is the uncorrected calibration curve when the calibration curve has not been corrected, and the corrected calibration curve when the calibration curve has been corrected.

[0091] In step S10, the control unit 51 performs communication processing. In this processing, the control unit 51 receives various information such as digital signals and reagent information sent from the measuring unit 2, and sends various information such as instructions input by the operator to the measuring unit 2.

[0092] Next, use Figure 8A as well as Figure 8B This describes the reagent remaining quantity monitoring process performed by the control unit 41 of the measuring unit 2 and the control unit 51 of the analysis unit 4.

[0093] In step S11, the control unit 41 performs reagent remaining quantity monitoring. In this process, the control unit 41 compares the liquid level sensor 28A of the reagent dispensing unit 27 (refer to...) Figure 3 The amount of drop of the suction nozzle when the liquid level of the reagent is detected and the threshold used to determine that the remaining amount of reagent is below a predetermined amount.

[0094] In step S12, the control unit 41 determines whether the remaining amount of reagent is lower than a predetermined amount based on the comparison result of step S11. If the remaining amount of reagent is lower than the predetermined amount (step S12: Yes), the control unit 41 notifies the control unit 51 of the analysis unit 4 of the situation in step S13. If the remaining amount of reagent is not lower than the predetermined amount (step S12: No), the process returns to the main routine shown in FIG7.

[0095] On the other hand, in step S15, the control unit 51 of the analysis unit 4 determines whether there is a notification from the control unit 41 of the measurement unit 2 that the remaining amount of reagent is low. If there is a notification (step S15: yes), the control unit 51 displays a reagent remaining amount reset screen on the display unit 52 in step S16 and resets the reagent remaining amount according to the operator's instructions. If there is no notification, the process returns to the main routine shown in FIG7.

[0096] Figure 11 An example of a reagent remaining quantity reset screen displayed in step S16 is shown. The reagent remaining quantity reset screen 71 includes a first message display area 711 that displays a message asking whether the remaining quantity needs to be reset, such as "Reset the remaining quantity. Is that okay?", a "Yes" button 712, and a "No" button 713. The "Yes" button 712 is used to input an instruction to reset the remaining quantity. The "No" button 713 is used to end the remaining quantity reset inquiry screen 71 without resetting the remaining quantity.

[0097] When the operator selects the "Yes" button 712, the control unit 51 resets the reagent remaining amount in step S16, that is, deletes the reagent remaining amount information stored in the storage unit 52, and displays an inquiry screen on the display unit 53 asking whether to display the calibration curve screen. In addition, the operator takes out a reagent container with a remaining amount lower than the predetermined amount from the reagent holding hole 25 of the reagent retention unit 23, and places a new reagent container of the same type in the same reagent holding hole.

[0098] Figure 12AAn example of an inquiry screen is shown. Inquiry screen 72 includes a second message display area 721 indicating that the reset of the remaining amount of reagent used for the measurement of the calibrated calibration curve has been completed, such as "The remaining amount of reagent used for the measurement of the calibrated calibration curve has been reset"; a third message display area 722 indicating that the calibration curve display is enabled, such as "Display calibration curve screen?"; a fourth message display area 723 indicating that the calibrated calibration curve can be restored to the calibration curve before calibration, such as "If you press the [Reset] button on the calibration curve screen, you can restore the calibration curve to its original state."; a "Yes" button 724; and a "No" button 725. The "Yes" button 724 is used to input an instruction to display the calibration curve. The "No" button 725 is used to end the display of inquiry screen 72.

[0099] Furthermore, if the calibration curve is not corrected, the control unit 51 will in step S16... Figure 12B The query screen shown is displayed on display unit 53. In this query screen, the calibration curve has not been corrected, so nothing is displayed in the 4th message display area 723.

[0100] Return to Figure 8B In step S17, the control unit 51 sets the calibration curve display flag to ON. The calibration curve is determined based on the state of the reagent, so if the reagent held in the reagent storage unit 23 is replaced, it needs to be remade. However, if the reagent before and after the replacement are from the same manufacturing batch, the same calibration curve can be used. On the other hand, even if the reagent before and after the replacement are from the same manufacturing batch, if the calibration curve is corrected after its creation due to the deterioration of the reagent before the replacement, it is still necessary to restore the corrected calibration curve to the original calibration curve.

[0101] Figure 9A as well as Figure 9B This is a flowchart illustrating the main processes involved in creating and correcting the calibration curve. (For example...) Figure 9AAs shown, in step S19, the control unit 51 of the analysis unit 4 determines whether the operator has received an instruction to create a calibration curve via the input unit 54. If the instruction has been received (step S19: Yes), the control unit 51 creates a calibration curve in step S20 based on a digital signal representing the time series of absorbance of the standard sample received from the control unit 41 of the measurement unit 2. The order of creating the calibration curve is as described above. The control unit 51 adds the type and batch information of the reagent used to measure the standard sample, read by the reagent information reading unit 81, a pre-calibration flag indicating that it is a calibration curve before calibration, and a usable flag indicating that it is a calibration curve that can be used to calculate concentration to the created calibration curve, and stores it together with the calibration curve in the storage unit 52. Thus, the uncalibrated calibration curve is set as a calibration curve that can be used to calculate concentration. If it is determined in step S19 that the instruction to create a calibration curve has not been received (step S19: No), the process returns to the main routine.

[0102] like Figure 9B As shown, in step S24, the control unit 51 of the analysis unit 4 determines whether the operator has received a calibration instruction for the calibration curve via the input unit 54. If the instruction has been received (step S24: yes), the control unit 51 calibrates the calibration curve in step S25, thereby generating a calibrated calibration curve and storing it in the storage unit 52. Figure 6B This illustrates an example of calibration curve correction. Figure 6B The example shown displays the calibration curve β after the first correction, which shifts the calibration curve α parallel to the direction of decreasing solidification time. Furthermore, with further correction to the calibration curve β, the calibration curve γ after the second correction is shown, and with further correction to the calibration curve γ, the calibration curve θ after the third correction is shown.

[0103] Additionally, in step S25, control unit 51 copies the reagent type and manufacturing batch information attached to the calibration curve before calibration and attaches it to the calibrated calibration curve obtained through calibration. Furthermore, control unit 51 adds a usability flag indicating that the calibration curve can be used for concentration calculation and a calibration flag indicating that it is a calibrated calibration curve to the calibrated calibration curve, and stores these together with the calibrated calibration curve in storage unit 52. Additionally, control unit 51 deletes the usability flag attached to the calibration curve before calibration created in step S20. However, the calibration curve before calibration, reagent information, and calibration flag stored in storage unit 52 are not deleted but retained. If it is determined in step S24 that the calibration curve calibration instruction has not been accepted (step S24: No), the process returns to the main routine.

[0104] Figure 10This is a flowchart illustrating the calibration curve switching process. In step S30, the control unit 51 determines whether the calibration curve screen display flag is set to "on". If the calibration curve screen display flag is set to "on" (step S30: Yes), the control unit 51 displays the calibration curve screen in step S31. If the calibration curve screen display flag is not set to "on" (step S30: No), the control unit 51 returns the process to the main routine.

[0105] Figure 13A An example of the calibration curve screen displayed in step S31 is shown (calibration curve screen (A)). The calibration curve screen 73 has an item information display area 731, a point information display area 732, a curve display area 733, an instruction area 734, and a calibration curve status display area 735.

[0106] The project information display area 731 is used to display calibration curve attribute information related to the calibration curve with the usability mark attached. In the project information display area 731, the calibration curve's validity period, calibration curve creation date and time, verification date and time (date and time with the usability mark attached), the name and manufacturing batch of the standard sample, and the manufacturing batch of the reagents used to create the calibration curve are displayed as calibration curve attribute information. The curve display area 733 is used to display the calibration curve. Figure 13A In the example shown, the calibration curve θ is displayed as the calibration curve after three corrections. The point information display area 732 is an area that displays the predetermined concentration at the calibration curve displayed in the curve display area 733 and the corresponding solidification time in numerical form.

[0107] The instruction area 734 is used to display instruction buttons corresponding to the instructions that can be executed in the calibration curve screen 73. In the instruction area 734, multiple instruction buttons are displayed, including a "Verify" button 7342, a "Reset" button 7343, and a "Select" button 7344. The "Verify" button 7342 is used to input an instruction to set the displayed calibration curve as a usable calibration curve. The "Reset" button 7343 is used to select and read the uncorrected calibration curve (the calibration curve created in step S20) stored in the storage unit 52 and display it in the curve display area 733. The "Select" button 7344 is used to switch to a screen that selects a usable calibration curve from multiple calibration curves created and stored in the storage unit 52. When the calibration curve set as usable is a corrected calibration curve (i.e., one with a corrected mark), the "Reset" button 7343 is set to read the uncorrected calibration curve stored in the storage unit 52 (the reset button is activated).

[0108] The calibration curve status display area 735 indicates whether the calibration curve displayed in the graph display area 733 has been set as a usable calibration curve, i.e., whether a usable indicator has been added to the calibration curve. If the calibration curve has been set as usable, "Validated" is displayed; if it has not been set as usable, "Not Validated" is displayed. Furthermore, if no calibration curve is displayed in the graph display area 733, "No Calibration Curve" is displayed. Additionally, if a calibration curve is displayed in the graph display area 733, but is determined to have been improperly created due to a measurement error during the determination of a standard sample, an "Error" indicating that the calibration curve cannot be set as usable (cannot be validated) is displayed.

[0109] Furthermore, if the calibration curve in step S31 is an uncorrected calibration curve, such as Figure 13B As shown, the display shows an uncorrected calibration curve (in...). Figure 13B In the example, the calibration curve screen 73 shows the calibration curve α. Additionally, on this calibration curve screen 73, the "Reset" button 7343 is grayed out, and the function of reading the calibration curve before calibration is disabled.

[0110] Return to Figure 10 In step S32, the control unit 51 determines whether the input to the "reset" button 7343 has been accepted. If the input has been accepted (step S32: Yes), the control unit 51 proceeds to step S33; if the input has not been accepted (step S32: No), the process proceeds to step S36. Furthermore, the operator can confirm the manufacturing batch of the reagent before replacement and the manufacturing batch of the reagent after replacement, and decide whether to select the "reset" button 7343 based on whether the two are the same.

[0111] In step S33, the control unit 51 performs the process of displaying the calibration curve before calibration in the graph display area 733. Since the calibration curve before calibration is marked with a pre-calibration flag, the control unit 51 selects the calibration curve with the pre-calibration flag and whose reagent type and manufacturing batch information are the same as the calibration curve after calibration as the calibration curve before calibration, reads it from the storage unit 52, and displays it on the display unit 53.

[0112] Figure 14 This shows an example of a calibration curve displaying the calibration curve before calibration. For example... Figure 14As shown, in the curve display area 733 of the calibration curve screen 73, in addition to displaying the calibration curve θ after three calibrations, the calibration curve α before calibration is also displayed. In the project information display area 731, in addition to displaying the information of the calibration curve θ, the calibration curve attribute information of the calibration curve α is also displayed. In the point information display area 732, in addition to displaying the information of the calibration curve θ, the solidification time and concentration of the calibration curve α are also displayed numerically. Regarding the display of the calibration curve status area 735, the calibration curve α has not been set to be usable at this time point (no usability flag is attached), so "Unverified" is displayed. The operator determines whether the calibration curve α can be set to be usable based on the various information displayed on the calibration curve screen 73. If it is determined that it can be set, the operator selects the "Verify" button 7342.

[0113] When the operator selects the "Verify" button 7342, the control unit 51 adds a usability flag to the calibration curve α in step S34, indicating that it is a calibration curve that can be used to calculate the concentration, and stores it in the storage unit 52 along with the calibration curve α. Additionally, the usability flag added to the previously used calibration curve θ is deleted.

[0114] Return to Figure 10 If the control unit 51 determines in step S32 that the input of the "Reset" button 7343 has not been accepted (step S31: No), then in step S36 it determines whether the input of the "Select" button 7344 has been accepted. If it determines that the input of the "Select" button 7344 has been accepted, then in step S37 the control unit 51 displays the calibration curve selection screen and accepts the selection of the calibration curve.

[0115] Figure 15 An example of a calibration curve selection screen is shown. This calibration curve selection screen displays in one view the calibration curve ID0000001, which was created for reagent batch group 505401, which is of the type PT and THS. The calibration curves ID0000002 to 0000004 were created by correcting the calibration curve.

[0116] The calibration curve selection screen 76 includes a calibration curve list display area 762 for displaying a calibration curve list 761, an "OK" button 764, and a "Cancel" button 765. The calibration curve list 761 includes a reagent batch group display column 7611 displaying the reagent group used to create the calibration curve, a verification date display column 7612 displaying the date the calibration curve was set as a usable calibration curve, a calibration curve ID display column 7613 displaying the calibration curve ID used to identify the calibration curve, and a calibration curve status display column 7614 indicating whether the calibration curve has been set as a usable calibration curve and whether the calibration curve is a calibrated calibration curve. In the calibration curve status display column 7614, if the calibration curve has been set as a usable calibration curve, "Verified" is displayed. Additionally, if the calibration curve is a calibrated calibration curve, "Corrected" is displayed. That is, in the calibration curve status display column 7614, historical information of the presence or absence of correction is displayed for each calibration curve represented by calibration curve IDs 0000001 to 0000004.

[0117] The rows of the calibration curve list 761 are configured to be selectable via the operation of the input unit 54 (in... Figure 15 In the example, the calibration curve ID0000001 is selected. The "OK" button 764 is used to input the information to display the calibration curve of the selected row. Figure 14 The button indicated in the curve display area 733 of the calibration curve screen 73 shown. The "Cancel" button 765 is a button used to input an instruction to end the display of the calibration curve selection screen 76 and display the original calibration curve screen 73.

[0118] When the operator selects the "OK" button 764, the control unit 51 ends the display of the calibration curve selection screen 76 in step S38, and adds the selected calibration curve to the curve display area 733. Figure 14 In the example, the calibration curve α) is displayed on the display unit 53.

[0119] When the operator selects the "Verify" button 7342 on the calibration curve screen 73, the control unit 51 adds a usable flag to the calibration curve α in step S39, indicating that it is a calibration curve that can be used to calculate concentration, and stores it in the storage unit 52 along with the calibration curve α. Additionally, calibration curves that were previously in use are deleted. Figure 14 In the example, the available flag is added to the calibration curve θ.

[0120] According to the sample analysis device 1 and calibration curve setting method of the above embodiments, as a screen for supporting the restoration (replacement) of the calibrated calibration curve (second calibration curve) to the calibration curve before calibration (first calibration curve) before calibration, a calibration curve screen 73 including a "reset" button 7343 and a calibration curve selection screen 76 including calibration history information are displayed, so the operator can easily restore to the calibration curve before calibration.

[0121] In addition, the operator can select the "Reset" button 7343 when the calibrated calibration curve is displayed, so it is easy to know when to restore the calibration curve to its original state.

[0122] In addition, when the operator selects the "Reset" button 7343, the calibration curve before and after calibration are displayed side by side, so it is easy to understand the extent to which the calibration curve changes by restoring to the calibration curve before calibration.

[0123] In addition, the operator can easily restore the original calibration curve by simply selecting the "Verify" button 7342, thus setting the displayed calibration curve before calibration to a usable calibration curve.

[0124] In addition, when the remaining amount of reagent used to measure the standard sample is lower than the predetermined amount, an inquiry screen 72 is displayed, which includes a message indicating that the calibration curve can be restored to the state before correction, and a calibration curve screen 73 is displayed, so that the operator can restore the calibration curve to the state before correction at an appropriate time.

[0125] In addition, the "Reset" button 7343 is enabled when the calibration curve is calibrated and disabled when the calibration curve is not calibrated, so the operator does not need to confirm whether the calibration curve has been calibrated.

[0126] Furthermore, according to the sample analysis device 1 and calibration curve setting method of the above embodiment, a calibration curve list 761 containing historical information on the calibration curves has been calibrated is displayed, so the operator can easily identify which calibration curve has not been calibrated. Additionally, an uncalibrated calibration curve can be selected from the calibration curve list 761 and displayed on the calibration curve screen 73, thus easily restoring the calibration curve to its original state.

[0127] To illustrate the invention, it has been adequately and sufficiently described above with reference to the accompanying drawings. However, it should be understood that modifications and / or improvements to the above-described embodiments can be readily made by those skilled in the art. Therefore, any modifications or improvements made by those skilled in the art that do not depart from the scope of the claims are construed as being included within the scope of the claims.

[0128] For example, in the above embodiment, as a screen for supporting the restoration of the calibrated calibration curve (second calibration curve) to the calibration curve before calibration (first calibration curve), a calibration curve screen 73 including a "reset" button 7343 and a calibration curve selection screen 76 including calibration history information are displayed, but it can also be configured to display only one of the screens.

[0129] For example, in the above embodiment, the control unit 51 does not delete the calibration curve before correction stored in the storage unit 52 in step S25, but it may also store the content of the correction performed in the storage unit 52 and delete the calibration curve before correction. In this case, when the calibration curve before correction is displayed on the calibration curve screen 73, the control unit 51 may also reproduce the calibration curve before correction based on the calibration curve after correction stored in the storage unit 52 and the correction content stored in the storage unit 52.

[0130] In addition, in the above embodiment, in step S20, a pre-calibration flag is affixed to the uncalibrated calibration curve, and in step S33, the calibration curve with the pre-calibration flag is selected and displayed on the calibration curve screen 73. However, it is also possible not to affix the pre-calibration flag, and instead select the calibration curve without the post-calibration flag as the uncalibrated calibration curve and display it on the calibration curve screen 73. Alternatively, it is also possible not to affix the pre-calibration flag and the post-calibration flag to the calibration curve, and instead select the calibration curve with the oldest date and time affixed with the usable flag as the pre-calibration calibration curve.

[0131] Furthermore, in the above embodiment, the calibrated calibration curve is displayed on the calibration curve screen 73 in step S31, but the calibration curve before calibration can also be displayed. That is, in the above embodiment, the calibration curve before calibration is displayed by selecting the "Reset" button 7343, but according to this modification, the calibration curve before calibration can also be displayed by selecting the "Yes" button 724 on the query screen 72. That is, according to this modification, the "Yes" button 724 on the query screen 72, like the "Reset" button 7343 in the above embodiment, serves to support restoring the calibrated calibration curve (second calibration curve) to the calibration curve before calibration (first calibration curve).

[0132] In addition, in the above embodiment, in step S33, the calibration curve before calibration and the calibration curve after calibration are displayed side by side on the calibration curve screen 73, but the calibration curve after calibration can also be deleted from the screen, and only the calibration curve before calibration is displayed.

[0133] In addition, in the above embodiment, by selecting the "Verify" button 7342, a usable mark is added to the calibration curve before calibration, but by selecting the "Reset" button 7343, the calibration curve before calibration is displayed and a usable mark is automatically added.

[0134] In addition, in the above embodiment, by displaying the inquiry screen 72 and selecting the "Yes" button 724, the calibration curve screen 73 can be displayed. However, the calibration curve screen 73 can also be displayed by selecting the "Yes" button 712 on the reagent remaining amount reset screen 71.

[0135] Furthermore, while the above embodiments describe a blood coagulation analysis apparatus, the present invention can also be applied to other sample analysis apparatuses that use calibration curves, such as immunoassay apparatuses, biochemical analysis apparatuses, and nucleic acid analysis apparatuses. For example, when the present invention is applied to an immunoassay apparatus, the measuring unit sends a digitally converted value of the light intensity corresponding to the amount of antigen / antibody contained in a standard sample with a known concentration of a predetermined antigen / antibody to the analyzing unit, and the analyzing unit generates a calibration curve with the digitally converted value of the light intensity and the known concentration of the antigen / antibody as the two axes.

[0136] In addition, in the above embodiment, the control unit of the measurement unit performs the measurement process of the sample and the standard sample, and the control unit of the analysis unit performs the process of generating and correcting the calibration curve, etc. However, these processes can also be performed by one control unit (one CPU and its peripheral circuits).

[0137] (Other variations)

[0138] Figure 16 This example illustrates another variation of the calibration curve replacement support process. This variation differs from the described embodiment in that the control unit 51 compares the manufacturing batch of the reagent in the reagent container before replacement with the manufacturing batch of the reagent in the reagent container after replacement.

[0139] In step S50, the control unit 51 determines whether the reagent has been replaced. Figure 8B The control unit 51 determines whether step S16 was performed and whether the calibration curve in use is a calibrated calibration curve, i.e., whether a calibrated flag was attached to the calibration curve in use. If the reagent was replaced and the calibration curve is a calibrated calibration curve (step S50: Yes), the control unit 51 compares the manufacturing batch of the reagent in the reagent container before replacement stored in the storage unit 52 with the manufacturing batch of the reagent in the reagent container after replacement read by the reagent information reading unit 81 in step S51. If the reagent was not replaced or the calibration curve is an uncalibrated calibration curve (step S50: No), the process returns to the main routine.

[0140] If the manufacturing batches being compared are identical (step S52: Yes), control unit 51 adds a usability flag to the calibration curve before calibration in step S53, and removes the usability flag added to the calibration curve after calibration in use. If the manufacturing batches being compared are identical (step S52: No), the process returns to the main routine.

[0141] In this modified example, when the calibration curve is corrected before reagent replacement, the corrected calibration curve is used to provide analytical results in step S9 shown in Figure 7 before reagent replacement. When the manufacturing batch of the reagent in the reagent container before replacement is the same as that in the reagent container after replacement, the corrected calibration curve automatically reverts to the original calibration curve, and the analytical results are provided using the original calibration curve in step S9. Thus, in this modified example, when the manufacturing batch of the reagent in the replacement reagent container is the same, the corrected calibration curve automatically reverts to the original calibration curve, so the operator does not need to verify the reagent manufacturing batch, simplifying the operation of restoring the corrected calibration curve to the original calibration curve.

[0142] Furthermore, in this modified example, if the manufacturing batches being compared are identical (step S52: Yes), Figure 13 or... can also be displayed. Figure 14 The calibration curve screen 73 shown displays the calibration curve before calibration based on the "Reset" button 7343 and / or confirms the calibration curve before calibration based on the "Verify" button 7342.

Claims

1. A calibration curve setting method of setting a calibration curve, comprising: creating a first calibration curve from a measurement value obtained from a standard sample whose concentration of a predetermined component is known; creating a second calibration curve by correcting the created first calibration curve; displaying a screen for assisting an operator in restoring the second calibration curve to the first calibration curve; accepting an instruction to restore the second calibration curve to the first calibration curve; and when the instruction is accepted, displaying the first calibration curve.

2. The calibration curve setting method according to claim 1, wherein the screen includes an instruction acceptance button for accepting the instruction from the operator to restore the second calibration curve to the first calibration curve, and the instruction is accepted via the instruction acceptance button.

3. The calibration curve setting method according to claim 2, wherein in the acceptance of the instruction via the instruction acceptance button, the instruction is accepted in a state where the second calibration curve is displayed.

4. The calibration curve setting method according to claim 2 or 3, wherein when a remaining amount of a reagent for measuring the standard sample is less than a predetermined amount, the operator is notified that the instruction can be accepted, and the screen including the instruction acceptance button is displayed.

5. The calibration curve setting method according to any one of claims 2 to 4, wherein the instruction acceptance button is activated when the second calibration curve is created, and is deactivated when the second calibration curve is not created. further comprising attaching a correction flag indicating whether or not correction is performed to the first calibration curve and / or the corrected first calibration curve, and when the instruction is accepted via the instruction acceptance button in the display of the first calibration curve, the first calibration curve is selected and displayed in accordance with the correction flag.

7. The calibration curve setting method according to any one of claims 2 to 6, wherein in the display of the first calibration curve, the first calibration curve and the second calibration curve are displayed side by side. further comprising accepting an instruction to set the displayed first calibration curve as a usable calibration curve.

9. The calibration curve setting method according to claim 1, wherein the screen includes history information of correction performed on the first calibration curve.

10. The calibration curve setting method according to claim 9, wherein the history information of correction includes information indicating whether or not correction of a calibration curve is performed.

11. The calibration curve setting method according to claim 9 or 10, wherein the screen further includes a calibration curve list indicating a plurality of calibration curves created in the past.

6. The calibration curve setting method according to any one of claims 2 to 5, wherein further comprising accepting a selection of the first calibration curve from the plurality of calibration curves displayed in the calibration curve list; displaying the selected first calibration curve; and setting the first calibration curve displayed in accordance with the accepted selection as a usable calibration curve.

13. The calibration curve setting method according to claim 1, wherein the correction of the first calibration curve is a parallel movement of the first calibration curve.

8. The calibration curve setting method according to any one of claims 2 to 7, wherein ​ ​ ​ ​ ​ ​ ​ ​ 12. The calibration curve setting method according to claim 11, wherein ​ ​ ​ ​ ​ ​ ​ 14. A calibration curve setting program product that sets a calibration curve, causing a computer to execute: creating a first calibration curve from a measurement value obtained by measuring a standard sample whose concentration of a predetermined component is known; creating a second calibration curve by correcting the created first calibration curve; displaying a screen for assisting an operator in restoring the second calibration curve to the first calibration curve; accepting an instruction to restore the second calibration curve to the first calibration curve; and when the instruction is accepted, displaying the first calibration curve.

15. A sample analysis apparatus that analyzes a sample using a calibration curve, comprising: a measurement unit that measures a standard sample whose concentration of a predetermined component is known; a control unit; and a display unit that displays information, the control unit executing: creating a first calibration curve from a measurement value obtained by measuring a standard sample whose concentration of a predetermined component is known; creating a second calibration curve by correcting the created first calibration curve; displaying, with the display unit, a screen for assisting an operator in restoring the second calibration curve to the first calibration curve; accepting an instruction to restore the second calibration curve to the first calibration curve; and when the instruction is accepted, displaying, with the display unit, the first calibration curve. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​

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