Automatic analyzer

Abstract

To provide an automatic analyzer that enables reduction in burden on a user upon updating calibration curve information, and efficiency of updating the calibration curve information.SOLUTION: An automatic analyzer (100) has: an analysis unit (4) that acquires a detection signal based on a chemical action between a tested sample and a reaction reagent and between the reaction reagent and a calibration reagent; an acquisition unit (6) that acquires a reservation date / time for updating calibration curve information designated by a user; a data processing unit (8) that updates the calibration curve information based on the detection signal on the basis of the chemical action between the reaction reagent and the calibration reagent acquired by the analysis unit; and a control unit (9) that controls the analysis unit to acquire the detection signal based on the chemical action between the reaction reagent and calibration reagent at the reservation date / time set by a setting unit.SELECTED DRAWING: Figure 8

Description

[Technical Field]

[0001] The present invention relates to an automatic analyzer for analyzing a test sample. [Background technology]

[0002] In automated analyzers, which are primarily used in the field of in vitro diagnostics, calibration curves are used to convert acquired detection signals into concentration and other quantitative information of analytical items. Calibration curves reflect the response characteristics of the measurement system used to measure the test sample. Typically, calibration curves are created as a relationship between the detection signal obtained by measuring the results of the chemical reaction between a reaction reagent and calibration reagents of different concentration levels in a measurement system under the same conditions as the measurement system used to measure the test sample, and the concentration of the calibration reagent.

[0003] In an automatic analyzer, changes in response characteristics over time due to deterioration of reaction reagents, etc. are unavoidable, so the identity of the measurement system is essentially ensured by setting an expiration date for the calibration curve based on empirical rules.

[0004] When the expiration date has passed, it is necessary to remeasure the reaction reagents in order to update the calibration curve information. In an automated analyzer with a high availability rate, it is preferable to systematically update the calibration curve information before the expiration date of the calibration curve.

[0005] Patent Document 1 discloses an automatic analyzer that creates an implementation plan including a planned date for measuring a standard reagent to create a calibration curve, and has a function for displaying order information including the type and quantity of the standard reagent to be used for the measurement when the planned implementation date arrives. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Japanese Patent Application Laid-Open No. 2011-237211 Summary of the Invention [Problem to be solved by the invention]

[0007] However, in order to start the measurement of the standard reagent in the automatic analyzer of Patent Document 1, the user must check the display of the order information and press the execute button.

[0008] An object of the present invention is to provide an automatic analyzer that reduces the burden on the user when updating calibration curve information and makes it possible to update calibration curve information more efficiently. [Means for solving the problem]

[0009] The automatic analyzer of this embodiment has a storage unit that stores reaction reagents and calibration reagents, a memory unit that stores calibration curve information related to the reaction reagents and the expiration date of the calibration curve information, an analysis unit that acquires detection signals based on the chemical reaction between the test sample and the reaction reagent and between the reaction reagent and the calibration reagent, an acquisition unit that acquires a reservation date and time for updating the calibration curve information specified by the user, a data processing unit that updates the calibration curve information based on the detection signals based on the chemical reaction between the reaction reagent and the calibration reagent acquired by the analysis unit, and a control unit that controls the analysis unit to acquire detection signals based on the chemical reaction between the reaction reagent and the calibration reagent at the reservation date and time acquired by the acquisition unit.

[0010] In the automatic analyzer of this embodiment, it is preferable that the reaction reagents and calibration reagents are sealed in cartridge containers that are marked with indicators indicating their respective attributes, and that the storage unit is a refrigerator that stores the reaction reagents and calibration reagents sealed in the cartridge containers.

[0011] The automatic analyzer of this embodiment preferably further includes a monitoring unit that monitors the inventory of reaction reagents and calibration reagents stored in the storage unit, and the control unit obtains inventory information in the storage unit of the reaction reagents and calibration reagents required to update the calibration curve information by controlling the monitoring unit before the reservation date and time, and the control unit issues a warning if there is a shortage of reaction reagents and calibration reagents required to update the calibration curve information based on the inventory information.

[0012] In the automatic analyzer according to this embodiment, it is preferable that the storage unit further stores measurement request information relating to the analysis items of the test sample, and that calibration curve information is stored for each analysis item.

[0013] In the automated analyzer according to this embodiment, if multiple measurements for multiple calibration reagents are required to update the calibration curve information, the setting unit preferably sets a reservation date and time for each measurement.

[0014] In the automatic analyzer according to this embodiment, it is preferable that the acquisition unit displays a guide of reservation dates and times that can be specified by the user based on the expiration date of the calibration curve information.

[0015] In the automatic analyzer according to this embodiment, the control unit preferably notifies the user that the calibration curve information will be updated before the scheduled date and time.

[0016] In the automatic analyzer according to this embodiment, it is preferable that the control unit controls the analysis unit to acquire a detection signal based on the chemical reaction between the quality control reagent and the reaction reagent, the quantitative information of which is known, and that the data processing unit determines whether the calibration curve information updated by the data processing unit is valid based on the detection signal.

[0017] In the automatic analyzer according to this embodiment, the control unit preferably determines whether the calibration curve information updated by the data processing unit is valid, based on the shape of the calibration curve information or statistical data.

[0018] In the automatic analyzer of this embodiment, when the control unit determines that the calibration curve information updated by the data processing unit is valid, it is preferable that the setting unit sets a reservation date and time for the next update of the calibration curve information within the new expiration date and time. [Effects of the Invention]

[0019] The automatic analyzer according to the present invention reduces the burden on the user when updating calibration curve information and makes it possible to update calibration curve information more efficiently. [Brief explanation of the drawings]

[0020] [Figure 1] 1 is a block diagram showing an outline of an automatic analyzer 100. FIG. [Figure 2] (a) shows an example of a cartridge container containing a reaction reagent, (b) shows an example of a cartridge container containing a calibration reagent, and (c) shows an example of a cartridge container containing a quality control reagent. [Figure 3] 2 is an example of a plan view showing a monitoring unit 3 arranged inside a refrigerator 2. FIG. [Figure 4] FIG. 10 is a flow diagram illustrating mode selection. [Figure 5] FIG. 10 is a diagram showing an example of a reservation mode selection screen. [Figure 6] FIG. 10 is a diagram showing an example of information related to a calibration curve. [Figure 7] FIG. 10 is a diagram illustrating an example of measurement request information. [Figure 8] FIG. 10 is a process flow diagram when a designated reservation mode is selected. [Figure 9] 10A shows an example of a confirmation screen for determining the calibration curve, and FIG. 10B shows an example of a reservation confirmation screen for updating the calibration curve information next time. [Figure 10] FIG. 10 is a process flow diagram when the automatic reservation mode is selected. [Figure 11] FIG. 10 is a diagram illustrating an example of a warning display. [Figure 12] FIG. 10 is a diagram showing another example of a warning display. DETAILED DESCRIPTION OF THE INVENTION

[0021] The automated analyzer will now be described in detail with reference to the drawings, although it should be understood that the present invention is not limited to the drawings or the embodiments described below.

[0022] FIG. 1 is a block diagram showing an outline of an automatic analyzer 100. As shown in FIG.

[0023] The automatic analyzer 100 is configured to include a sample placement section 1, a refrigerator 2, a monitoring section 3, an analysis section 4, a memory section 5, a user interface section 6, a setting section 7, a data processing section 8, and a control section 9, which are arranged in a housing not shown.

[0024] The sample placement unit 1 is a placement stage for placing a test sample to be analyzed. The refrigerator 2 functions as a storage unit that stores reaction reagents, calibration reagents, quality control reagents, etc. at low temperatures to prevent deterioration. If the various reagents can be stored at room temperature, they do not necessarily need to be stored at low temperatures.

[0025] The monitoring unit 3 monitors the inventory of various reagents stored in the refrigerator 2 and acquires inventory information. The analysis unit 4 is a measurement mechanism that automatically acquires a detection signal from a reaction reagent mixed with a test sample, mixes a reaction reagent with a calibration reagent and acquires a detection signal from the mixed reagent, and mixes a reaction reagent with a quality control reagent and acquires a detection signal from the mixed reagent. The reagents are transported from the refrigerator 2 to the analysis unit 4 by a transport mechanism (not shown).

[0026] The storage unit 5 is a memory that stores information 40 relating to the calibration curve, measurement request information 50, and the like, and is configured by a semiconductor memory, a magnetic disk device, an optical disk device, an HDD (Hard Disk Drive), or the like.

[0027] The user interface unit 6 includes input devices such as a keyboard, buttons, and a mouse for receiving various inputs from the user, and a display device such as a liquid crystal display for displaying various data, guidance, warnings, etc. The user interface unit 6 may also be a touch panel or the like in which the input device and the display device are integrally formed.

[0028] The setting unit 7 automatically sets the reservation date and time. The data processing unit 8 creates and updates a calibration curve based on the detection signal acquired by the analysis unit 4, and converts the detection signal into quantitative information for the analysis item using information 40 related to the calibration curve. The control unit 9 controls the entire automatic analyzer 100, including the refrigerator 2, monitoring unit 3, analysis unit 4, memory unit 5, user interface unit 6, setting unit 7, data processing unit 8, etc. The setting unit 7, data processing unit 8, and control unit 9 each have a CPU (Central Processing Unit), RAM (Random-Access Memory), ROM (Read-Only Memory), etc., and operate according to individual programs. Note that the setting unit 7, data processing unit 8, and control unit 9 may be formed as multiple software function blocks operating on a single CPU.

[0029] The control unit 9 causes the analysis unit 4 to acquire a detection signal based on the biochemical interaction between the test sample and the reaction reagent, and causes the data processing unit 8 to convert the detection signal into quantitative information for the analysis item based on information 40 about the calibration curve stored in the memory unit 5.

[0030] The control unit 9 also causes the analysis unit 4 to acquire a detection signal based on the chemical reaction between the reaction reagent and the calibration reagent at the reserved date and time set by the setting unit 7 or the reserved date and time specified by the user using the user interface unit 6. Furthermore, the control unit 9 updates the calibration curve information using the data processing unit 8 based on the acquired detection signal, and stores the updated calibration curve information in the memory unit 5.

[0031] The "detection signal" refers to the output signal of a detector (not shown) possessed by the analysis unit 4, and can be a physical quantity such as various energies, light intensity, current, potential, charge amount, frequency, displacement, particle number, time, etc., as well as a ratio or function with respect to a reference value. The "quantitative information" refers to the purpose of the analysis, i.e., the amount, intensity, or size of the analytical item of interest, and examples thereof include concentration, activity, activity, and titer.

[0032] "Calibration curve information" refers to a two-dimensional plot of the detection signals constituting the calibration curve and the quantitative information of the analysis items, or a mathematical relational expression based thereon and its accompanying information. In this application, "calibration curve information" includes "master calibration curve data," "calibration data," and "coefficients of the calibrated calibration curve," which will be described later. "Additional information" typically includes the analysis items to which the calibration curve can be applied, the reagent lot, and the expiration date of the reagent, and may also include traceability information on how the calibration curve was obtained.

[0033] "Creating a calibration curve" (also called calibration) refers to obtaining "master calibration curve data," which is the relational equation between the detection signal and the quantitative information, by statistically processing the detection signal based on the chemical action of a reaction reagent and a calibration reagent having different known quantitative information.

[0034] "Updating calibration curve information" refers to measuring a predetermined number of calibration reagents to update the "master calibration curve data" and obtaining "calibration data" and "calibrated calibration curve coefficients" for correcting the calibration curve through predetermined statistical processing. Note that the "predetermined number" in "updating calibration curve information" is usually a number smaller than that used in "creating the calibration curve," but it does not necessarily have to be a small number. Note that in this application, "calibration reagent" is used interchangeably with calibrator or standard reagent.

[0035] Figure 2(a) shows an example of a cartridge container containing a reaction reagent, Figure 2(b) shows an example of a cartridge container containing a calibration reagent, and Figure 2(c) shows an example of a cartridge container containing a quality control reagent.

[0036] In Figure 2, a resin double container 10 with two connected wells is used as an example of a cartridge container for various freeze-dried reagents stored in the refrigerator 2. The double container 10 is a plastic container in which cylindrical recesses, each with an inner diameter of 6 mm at the opening and a height of 20 mm, are arranged side by side with a minimum wall thickness of about 1 mm between them.

[0037] In the cartridge container 10 shown on the left side of Figure 2(a), a solid-phase reagent immobilized on magnetic particles is contained in one well as an FT4 immunoreaction reagent, and an enzyme-labeled labeled reagent is contained in the other well, both in a freeze-dried state and sealed with an aluminum foil seal 20. The surface of the aluminum foil seal 20 is marked with the name of the test item and an identification code 21 (two-dimensional code). The right side of Figure 2(a) shows the cartridge containers 10 arranged on a tray 11 with a grid of holding holes. A barcode 22 indicating the contents of the reagent container is marked on the upper right edge of the tray 11.

[0038] Figure 2(b) shows a freeze-dried version of the FT4 calibration reagent set, containing calibration reagents 1 through 3, each containing a target component at a concentration corresponding to three levels, housed in a cartridge container 10 of the same shape and dimensions as the cartridge container 10 for the immunoreaction reagent shown in Figure 2(a). In the example shown on the left side of Figure 2(b), the same calibration reagent component is housed in two adjacent wells. Since the device can distinguish the positions of the two wells, different calibration reagents may be housed in two adjacent wells. An identification code 21 identifying the contents of each well is printed on the surface of the aluminum foil seal 20 of the calibration reagent cartridge container 10. The right side of Figure 2(b) shows the calibration reagent cartridge containers 10 arranged on a tray 11 with a grid of holding holes. The numbers in the ovals indicate the calibration reagents 1 through 3. A barcode 22 indicating the type of container—FT4 calibration reagent set—is printed on the upper right edge of the tray 11.

[0039] Figure 2(c) shows a freeze-dried version of a quality control reagent QC sample set containing three concentration levels of reagents (Multi-3L, Multi-3M, and Multi-3H) in a cartridge container 10 of the same shape and dimensions as the cartridge container 10 for the immunoreaction reagent shown in Figure 2(a). In the example shown on the left side of Figure 2(c), the same quality control reagent components are contained in two adjacent wells. Since the device can distinguish the positions of the two wells, different quality control reagents may be contained in two adjacent wells. An identification code 21 identifying the contents of each well is printed on the surface of the aluminum foil seal 20 of the cartridge container 10 for the quality control reagent. The right side of Figure 2(c) shows the cartridge containers 10 for the quality control reagent arranged on a tray 11 with a grid of holding holes. The numbers in the ovals indicate the number of the quality control reagent: "Multi-3L" corresponds to "1," "Multi-3M" to "2," and "Multi-3H" to "3." A barcode 22 indicating the type of container, a QC sample set, which is a quality control reagent, is attached to the upper right edge of the tray 11.

[0040] The various reagents may be sealed in other containers as well as the double-container 10 shown in Figure 2. Although the tray 11 shown in Figure 2 is designed to accommodate 32 double-container 10, any tray capable of accommodating any number of containers may be used. Furthermore, the tray 11 may accommodate 32 double-container 10 as shown in Figure 2(a), 24 double-container containers arranged on the left side of the tray as shown in Figure 2(b), or 24 double-container containers arranged on the upper side of the tray as shown in Figure 2(c).

[0041] FIG. 3 is an example of a plan view showing the monitoring unit 3 disposed inside the refrigerator 2. As shown in FIG.

[0042] Figure 3 shows the interior of the refrigerator 2 as seen from above. Six trays 11, each containing the cartridge containers 10 shown in Figure 2, are arranged side by side in the refrigerator 2. The trays 11 are also arranged in multiple tiers downward (in the Z direction) from the surface in the figure. The monitoring unit 3 includes an XYZ-axis movable head 13, an identification code reading unit 14, and a means 15 for detecting the presence or absence of the cartridge containers 10.

[0043] The XYZ-axis movable head 13 can be moved intermittently by a movement mechanism (not shown) along a trajectory suitable for reading the identification information on the cartridge containers 10 arranged in a matrix inside the refrigerator 2. The XYZ-axis movable head 13 is equipped with a chuck transport means (not shown) that lifts the cartridge containers 10 and transports them to a predetermined position, and can select the cartridge container 10 to be used and place it in the standby position 12 for the analysis unit 4.

[0044] FIG. 4 is a flow diagram illustrating mode selection.

[0045] First, the user selects a reservation mode (step S1) using the input device of the user interface unit 6. Depending on the selected mode (step S2), the control unit 9 executes either the designated reservation mode (step S3) or the automatic reservation mode (step S4), and registers the reservation date and time for updating the calibration curve information in the measurement request information 50.

[0046] The "designated reservation mode" is a reservation mode in which the user specifies the reservation date and time for updating the calibration curve information, and is a method that leaves it to the discretion of the user who is aware of the operating status or measurement request status of the automatic analyzer 100. The "automatic reservation mode" is a reservation mode in which the control unit 9 automatically sets the reservation date and time for updating the calibration curve information, and is a method that reliably prevents forgetting to make a reservation and is suitable for keeping the calibration curve in a valid state at all times without placing a burden on the user.

[0047] FIG. 5 is a diagram showing an example of a reservation mode selection screen.

[0048] The screen shown in Fig. 5 is displayed on the display device of the user interface unit 6, and the user selects the reservation mode (step S1 in Fig. 4) using the input device of the user interface unit 6. The information on "analysis item," "analysis reagent batch," "master calibration curve data," "calibration reagent batch," and "calibration curve expiration date" shown in Fig. 5 is pre-stored in the storage unit 5 as information 40 related to the calibration curve, and is information extracted by the user using the "analysis item" as a key.

[0049] The reservation mode can be selected for each analysis item. The user selects the reservation mode by entering "designated reservation" or "automatic reservation" in the "reservation mode" field on the screen shown in Figure 5. It is also possible to move the cursor to the "reservation mode" field and select "designated reservation" or "automatic reservation" from a pull-down menu.

[0050] In the example shown in Figure 5, "designated reservation mode" has been selected for the analysis item "FT4," and "automatic reservation mode" has been selected for the analysis item "TSH." The reservation mode can be set for each analysis item. Flexible operation is possible, such as selecting designated reservation mode for analysis items that are normally tested infrequently but for which it is possible to predict when a large number of test requests will be received, and specifying automatic reservation mode for analysis items that are specified for frequent routine tests and therefore always require a valid calibration curve.

[0051] If "designated reservation mode" is selected, moving the cursor to the "reservation date and time" field will display a guide message 30 such as "Please set within the expiration date," and the user will input the reservation date and time accordingly. If "automatic reservation mode" is selected, the user does not need to input a reservation date and time, and the setting unit 7 will automatically set the reservation date and time and display it in the "reservation date and time" field. In Figure 5, the background color of the input cell for the reservation date and time that does not require input by the user is gray.

[0052] When the "designated reservation mode" is selected, the control unit 9 can also display on the display device of the user interface unit 6 a date and time that can be entered, taking into consideration the time required to measure the calibration reagent corresponding to the analysis item, the expiration date and time of the calibration curve, the reservation date and time for creating other calibration curves, and the inspection schedule of the automatic analyzer 100. Furthermore, if the user enters an inappropriate date and time in the "reservation date and time" field, the control unit 9 can also display an error message on the display device of the user interface unit 6.

[0053] The user can set the advance notification option and / or the automatic calibration curve determination option by entering information in the "Advance notification" and "Automatic calibration curve determination" fields on the screen shown in Figure 5. Note that the entries in the "Advance notification" and "Automatic calibration curve determination" fields can be changed or canceled later for each "analysis item."

[0054] The "advance notification" option notifies the user after a reservation for updating the calibration curve information has been made and before the calibration curve information update is actually performed. When the advance notification option is set, the control unit 9 displays an advance notification screen on the display device of the user interface unit 6 a predetermined time before the scheduled date and time. At the time of advance notification, the user may be asked again to confirm whether or not to update the calibration curve information as scheduled, or the control may be such that the notification is simply given without prompting the user for confirmation again. The advance notification option can be applied to both designated reservation mode and automatic reservation mode.

[0055] The "automatic calibration curve evaluation" option automatically evaluates the validity of the updated calibration curve information after the calibration curve information has been updated. Specifically, a quality control sample (also called a "QC sample") is mixed with a reaction reagent, a detection signal is acquired by the analysis unit 4, and a plot is created showing the relationship between the previously determined quantitative information and the detection signal. The created plot is compared with the updated calibration curve, and the updated calibration curve is evaluated based on the shape of the calibration curve and / or its statistical validity. The automatic calibration curve evaluation option can be applied to both designated reservation mode and automatic reservation mode.

[0056] FIG. 6 is a diagram showing an example of information 40 relating to the calibration curve.

[0057] Information 40 relating to the calibration curve is stored in the storage unit 5. In the example shown in Fig. 6, the information 40 relating to the calibration curve includes "analysis item," "reaction reagent batch," "master calibration curve data," "master calibration curve data registration date," "calibration reagent batch," "concentration 1," "concentration 2," "concentration 3," "calibration data," "coefficient of calibrated calibration curve," "date of previous calibration reagent measurement," "calibration curve expiration date," "reservation date and time," "advance notification," "reservation mode," and "QC sample for calibration curve confirmation." Other information may be added to the information 40 relating to the calibration curve.

[0058] The "master calibration curve data" is data obtained by measuring a calibration reagent with the corresponding reaction reagent (specified by the analysis item name and reaction reagent batch) using the automated analyzer 100 to obtain a detection signal, and expressing the relationship between the valued quantitative information (usually concentration) xi and the detection signal yi in a plot format as a set of component representations, for example, {x1i, y1i} (concentration level i = 1 to 6). The "master calibration curve data" may also be expressed as a mathematical regression equation.

[0059] The "master calibration curve data" corresponds to the analysis item name and reaction reagent batch, and is usually provided in the form of an identification code attached to the reaction reagent package. When updating calibration curve information in the automated analyzer 100, calibration data {x1j, Y1j} (concentration level j = 1, 2, 3) is obtained by measuring a calibration reagent with fewer concentration levels than the standard reagent used to create the "master calibration curve data." "Concentration 1" through "Concentration 3" indicate the concentration levels of the calibration reagent. Here, x1j is the valued quantitative information of the calibration reagent, and Y1j is the detection signal of the calibration reagent. The master calibration curve data is corrected using predetermined statistical processing based on the calibration data. While this depends on the regression equation fitting method, the calibration curve information is updated by calculating the regression equation coefficients A1, B1, C1, and D1. The time when the calibration curve information is properly updated is the calibration curve confirmation date and is treated as the start of the calibration curve's validity period. The expiration date of the calibration curve is the date on which the calibration curve was established plus the expiration period (for example, 90 days).

[0060] In the information relating to the calibration curve whose "analysis item" is "FT4" shown in FIG. 6, the "reservation mode" is set to "designated reservation mode" and the "advance notification" is set to "required," corresponding to the selection screen in FIG. 5. In the example of information relating to the calibration curve whose "analysis item" is "TSH" shown in FIG. 6, the "reservation mode" is set to "automatic reservation mode" and the "advance notification" is set to "not required," corresponding to the selection screen in FIG. 5. In the information relating to the calibration curve whose "analysis item" is "AFP" shown in FIG. 6, the calibration data and the rest of the information are blank. This indicates that the master calibration curve data and calibration reagent for the AFP reaction reagent have been registered in the automated analyzer 100, but the calibration curve information has not yet been updated.

[0061] "QC sample for calibration curve confirmation" refers to a "quality control sample." If a "quality control sample" is registered as calibration curve information 40, the "automatic calibration curve evaluation" option described above can be executed immediately after updating the calibration curve information. When the "analysis item" shown in Figure 6 is "FT4," "Multi-3" is registered as the "QC sample for calibration curve confirmation." Therefore, if the "automatic calibration curve evaluation" option is set for "FT4," the "automatic calibration curve evaluation" option will be executed using "Multi-3."

[0062] FIG. 7 is a diagram showing an example of the measurement request information 50.

[0063] The information entered on the selection screen shown in Fig. 5, the reservation date and time set in the setting unit 7, and part of the information 40 relating to the calibration curve are compiled as measurement request information 50 as shown in Fig. 7 and stored in the memory unit 5. The control unit 9 executes various processes while controlling the analysis unit 4, data processing unit 8, etc. based on the measurement request information 50 stored in the memory unit 5. Therefore, in addition to the calibration reagent, the measurement request information 50 also registers information relating to the test sample to be measured by the automatic analyzer 100 and the quality control sample.

[0064] In the example of Figure 7, no scheduled start date and time has been set for test samples numbered 1 and 2, so user operation is required. However, measurement is possible once the user performs the required operation. For samples numbered 3 to 5, the sample type is all calibration reagent, and the sample IDs are "ADJ75-002-C1," "ADJ75-002-C2," and "ADJ75-002-C3" (corresponding to FT4 calibration reagent, calibration reagent batch, and concentration levels 1, 2, and 3). For samples numbered 3 to 5, the number of measurements is three, the analysis item (measurement reagent) is all FT4-011, the scheduled start date and time of measurement is 2021 / 4 / 14 6:00 (start of sample number 3), and the scheduled end date and time of measurement is 2021 / 4 / 14 6:06 (end of sample number 5).

[0065] In the example of Figure 7, three quality control samples (Multi-3L, Multi-3M, and Multi-3H) with different concentration levels, shown as numbers 6 to 8, are registered for the same analysis items (measurement reagents) as numbers 3 to 5. Furthermore, following the measurement of number 5, measurements of three quality control samples with different concentration levels, shown as numbers 6 to 8, are scheduled.

[0066] In the example of Figure 7, the scheduled start date and time and the scheduled end date and time have not been entered for numbers 11 and 12. This is because no measurement reservation has yet been made for this calibration reagent. Note that, like the test samples numbers 1 and 2, these require user operation, but once the user performs the required operation, they will be ready for measurement.

[0067] FIG. 8 is a process flow diagram when the designated reservation mode is selected.

[0068] The processing flow of Figure 8 is executed by the CPU controlling or cooperating with other components by a software program pre-stored in the ROM or the like of the control unit 9. When the designated reservation mode is selected in the flow shown in Figure 4 (step S3), the control unit 9 acquires the reservation date and time entered by the user for the analysis item for which the designated reservation mode is selected via the input device of the user interface unit 6, and registers it in the measurement request information 50 (step S10). Next, the control unit 9 acquires the measurement request information 50 from the storage unit 5 and starts preparation for measurement (step S11).

[0069] Next, the control unit 9 waits until a predetermined time (for example, four hours before) before the reservation date and time (step S12), and executes the above-mentioned "advance notification" option (step S13). The "advance notification" option is executed only when the "advance notification" option is selected on the selection screen shown in Fig. 5. Note that the processing flow may not include "advance notification," and even if "advance notification" is given, the user may not be asked to decide whether to proceed as scheduled.

[0070] Next, the control unit 9 moves the XYZ-axis movable head 13 of the monitoring unit 3 to check whether or not there is an inventory of reagents required to update the calibration curve information (step S14). If there is an insufficient inventory, the control unit 9 displays a warning on the display device of the user interface unit 6 (step S20), and ends the series of processes without updating the calibration curve information.

[0071] If the necessary reagents are in stock in step S14, the control unit 9 waits until the reserved date and time (step S15), and when the reserved date and time arrives, the analysis unit 4 carries out measurement using the reaction reagent and calibration reagent while transporting the necessary reagents from the refrigerator 2 based on the measurement request information 50 (step S16). For example, if the "analysis item" shown in Figure 7 is FT4, the control unit 9 will chemically react the calibration reagents with sample IDs "ADJ75-002-C1," "ADJ75-002-C2," and "ADJ75-002-C3" with the reaction reagent three times each, and the analysis unit 4 will acquire a detection signal.

[0072] Next, based on the detection signal acquired in step S16, the control unit 9 causes the data processing unit 8 to create "calibration data" and "coefficients of the calibrated calibration curve" for calibrating the "master verification line data" registered in the calibration curve information 40 shown in Fig. 6 (step S17). The acquisition of the detection signal in step S16 and the creation of the "calibration data" and "coefficients of the calibrated calibration curve" in step S17 are collectively referred to as updating the calibration curve information.

[0073] Next, the control unit 9 executes the "automatic calibration curve determination" option described above for the calibration curve updated in steps S16 and S17 (step S18). For example, when the "analysis item" shown in FIG. 7 is "FT4," the control unit 9 chemically reacts each of the quality control samples with the sample IDs "Multi-3L," "Multi-3M," and "Multi-3H" with the reaction reagent three times, and acquires detection signals in the analysis unit 4. Next, the control unit 9 determines the "calibration data" and the "coefficient of the calibrated calibration curve" based on the acquired detection signals. The "automatic calibration curve determination" option is executed only when the "automatic calibration curve determination" option is selected on the selection screen shown in FIG. 5. Note that a processing flow that does not perform the "automatic calibration curve determination" may also be used.

[0074] If it is determined in step S18 that the validity is high, the control unit 9 registers the "calibration data" and "coefficients of the calibrated calibration curve" created in step S17 in the information 40 related to the calibration curve in place of the previous information (step S19). If it is determined in step S18 that the validity is low, the control unit 9 displays a warning on the display device of the user interface unit 6 (step S20), and ends the series of processes without registering the "calibration data" and "coefficients of the calibrated calibration curve" created in step S17 in place of the previous information in the information 40 related to the calibration curve.

[0075] Finally, the control unit 9 executes a request to specify the next reservation date and time (step S21), and ends the series of processes. An example of the procedure for requesting the next reservation date and time will be described with reference to FIG.

[0076] FIG. 9(a) shows an example of a confirmation screen for determining the calibration curve, and FIG. 9(b) shows an example of a reservation confirmation screen for updating the next calibration curve information.

[0077] When the "calibration data" and "calibrated calibration curve coefficients" created in step S17 are registered in the calibration curve information 40 (step S19), a confirmation message 60 such as that shown in FIG. 9(a) is displayed on the display device of the user interface unit 6. When the "OK" button in the confirmation message 60 is clicked with the cursor, the confirmation message 60 closes, and a reservation confirmation message 61 such as that shown in FIG. 9(b) is displayed. When the "YES" button in the reservation confirmation message 61 is clicked with the cursor, the reservation mode selection screen such as that shown in FIG. 5 is displayed again. This function can prevent the user from forgetting to make a reservation.

[0078] Alternatively, the process may be terminated by registering the "calibration data" and "calibrated calibration curve coefficient" created in step S17 in the calibration curve information 40 (step S19) without requesting the next reservation date and time (step S21).

[0079] In the designated scheduled mode, the calibration curve information is automatically updated at the reserved date and time specified by the user, allowing the user to set an appropriate reservation date and time at their discretion, based on their understanding of the operating status or measurement request status of the automatic analyzer 100.

[0080] FIG. 10 is a process flow diagram when the automatic reservation mode is selected.

[0081] The processing flow in Fig. 10 is executed by the CPU controlling or cooperating with other components in accordance with a program pre-stored in the ROM or the like of the control unit 9. The processing from step S11 to step S20 in the processing flow in Fig. 8 is the same as the processing in the processing flow in Fig. 10, and therefore description thereof will be omitted.

[0082] When the automatic reservation mode is selected in the flow shown in FIG. 4 (step S4), the control unit 9 obtains the "calibration curve expiration date" from the information 40 regarding the calibration curve for the analysis item for which the automatic reservation mode is selected, and transmits it to the setting unit 7 (step S30).

[0083] Next, the setting unit 7 sets a reservation date and time before the expiration date of the calibration curve, taking into consideration the received expiration date of the calibration curve, the time required for measurement of the calibration reagent corresponding to the analysis item, reservation dates and times for updating other calibration curve information, and the inspection schedule of the automatic analyzer 100 (step S31). The reservation date and time set by the setting unit 7 is registered in the measurement request information 50 by the control unit 9.

[0084] When the "calibration data" and "calibrated calibration curve coefficient" created in step S17 are registered in the information 40 relating to the calibration curve in place of the previous information (step S19), the control unit 9 acquires the updated calibration curve expiration date accordingly and transmits it to the setting unit 7, and controls it to set the next reservation date and time (step S32), thereby completing the series of processes.

[0085] Alternatively, the process may be terminated without setting the next reservation date and time (step S32) and until the "calibration data" and "calibrated calibration curve coefficient" created in step S17 are registered in the calibration curve information 40 (step S19).

[0086] The automatic scheduling mode ensures that reservations are not forgotten and makes it possible to keep the calibration curve valid at all times without imposing a burden on the user.

[0087] FIG. 11 is a diagram showing an example of a warning display.

[0088] In the process flows shown in Figures 8 and 10, if sample inventory is insufficient in step S14, a warning is displayed (step S20) and the process is terminated. However, it is also possible to display a warning such as that shown in Figure 11 to prompt the user to replenish the sample. If the user replenishes the missing sample and clicks the "OK" button after the warning display shown in Figure 11 is displayed, the process returns to step S14 to check the inventory again, and if there are no problems, the process continues from step S15 onwards. Furthermore, if the user clicks the "Cancel" button after the display shown in Figure 11 is displayed, the process is terminated as before. Note that the "tip" in Figure 11 refers to the disposable pipette tip to be used.

[0089] FIG. 12 is a diagram showing another example of a warning display.

[0090] In the process flows shown in Figures 8 and 10, a prior notification is issued (step S13) before checking the sample inventory (step S14). However, if there is a shortage of sample inventory, a warning may be displayed in addition to the prior notification. Figure 12 shows an example in which a prior notification and a warning for a shortage of inventory are displayed on a single screen.

[0091] As in the case of Fig. 11, if the user refills the missing sample and clicks the "OK" button after the warning display shown in Fig. 12 is displayed, the process returns to step S14 to check the inventory again, and if there are no problems, the process continues from step S15 onwards. Also, if the user clicks the "Cancel" button after the display shown in Fig. 12 is displayed, the series of processes will end as before.

[0092] The following will explain in detail how the user specifies the reservation date and time in the designated reservation mode (see FIG. 8), including modified examples.

[0093] In step S10 of Fig. 8, the user inputs the reservation date and time using the input device of the user interface unit 6 on the reservation mode selection screen as shown in Fig. 5. However, in the following cases, it is preferable to display a warning on the display device of the user interface unit 6 and prompt the user to input another scheduled date and time: (1) If the entered scheduled date and time is later than the "calibration curve expiration date" of the target analysis item; (2) The scheduled date and time you entered overlaps with the date and time of another scheduled calibration curve update; and (3) When the input scheduled date and time overlaps with an already scheduled inspection schedule for the automatic analyzer 100.

[0094] When the user selects the designated reservation mode, the control unit 9 may display on the display device of the user interface unit 6 reservation dates and times for updating other calibration curve information that are already reserved and that are up to a predetermined date and time before (e.g., three days before) the "calibration curve expiration date" of the target analysis item, and that do not overlap with the already scheduled inspection schedule of the automated analyzer 100. Conversely, the control unit 9 may display on the display device of the user interface unit 6 date and times that can be designated and that are up to a predetermined date and time before (e.g., three days before) the "calibration curve expiration date" of the target analysis item. By displaying in this manner, the user can specify a reservation date and time after checking the available reservation dates and times on the display device of the user interface unit 6.

[0095] When the user selects the designated reservation mode, there may be multiple measurements required to update the calibration curve information. For example, if the analysis item shown in Figure 7 is FT4, measurements are required for each of the calibration reagents with sample IDs "ADJ75-002-C1," "ADJ75-002-C2," and "ADJ75-002-C3." In this case, one reservation date and time indicates the start date and time of measurement of the calibration reagent with the first sample ID "ADJ75-002-C1" and the period until the end of measurement of the calibration reagent with the sample ID "ADJ75-002-C3."

[0096] Note that one reservation date and time may indicate the start date and time to the end date and time of measurement of a calibration reagent with a sample ID of "ADJ75-002-C1." When the analysis item shown in FIG. 7 is FT4, updating the calibration curve information requires specifying three reservation dates and times. Therefore, when the user selects the specified reservation mode, it is preferable to display a message on the display device of the user interface unit 6 indicating that three reservation dates and times must be specified.

[0097] The method of setting the reservation date and time by the setting unit 7 in the automatic reservation mode (see FIG. 10) will be described in detail below, including modified examples.

[0098] In step S30 of FIG. 10, the setting unit 7 automatically sets a scheduled date and time that satisfies the following conditions (1) to (3): (1) The scheduled date and time entered is later than the "calibration curve expiration date" of the target analysis item; (2) The scheduled date and time entered does not overlap with any other scheduled date and time for updating calibration curve information; and (3) The input scheduled date and time does not overlap with an inspection schedule for the automated analyzer 100 that has already been scheduled.

[0099] However, in the automated analyzer 100, there are cases where the inspection schedule is set later. In such cases, it is necessary to decide in advance whether to prioritize the automatic setting of the scheduled date and time by the setting unit 7 or the inspection schedule. If the automatic setting of the scheduled date and time by the setting unit 7 is prioritized and overlaps with the inspection schedule, a warning can be displayed on the display screen of the display device of the user interface unit 6 that sets the inspection schedule, prompting the user to change the inspection schedule.

[0100] Conversely, when the inspection schedule has priority, if the scheduled date and time set by the setting unit 7 overlaps with the inspection schedule or is immediately before the inspection schedule, the setting unit 7 may move the scheduled date and time to a date and time immediately after the inspection schedule that satisfies the above conditions (1) to (3). This is because there is a high possibility that the automatic analyzer 100 will be in better condition if the scheduled date and time is set after the inspection.

[0101] When the user selects automatic reservation mode, there may be multiple measurements required to update the calibration curve information. For example, if the analysis item shown in Figure 7 is FT4, measurements are required for each of the calibration reagents with sample IDs "ADJ75-002-C1," "ADJ75-002-C2," and "ADJ75-002-C3." In this case, one reservation date and time indicates the start date and time of measurement for the calibration reagent with the first sample ID "ADJ75-002-C1" and the period until the end of measurement for the calibration reagent with the sample ID "ADJ75-002-C3."

[0102] Note that one reservation date and time may indicate the start date and time to the end date and time of measurement of a calibration reagent with a sample ID of "ADJ75-002-C1." When the analysis item shown in FIG. 7 is FT4, three reservation dates and times must be specified when updating calibration curve information. Therefore, the setting unit 7 must set three reservation dates and times. In this case, the setting unit 7 may set the three reservation dates and times consecutively, or may set the three reservation dates and times at intervals, sandwiching other events (such as updates to other calibration curve information or inspection schedules).

[0103] It should be understood that those skilled in the art can make various changes, substitutions and alterations thereto without departing from the spirit and scope of the present invention. [Explanation of symbols]

[0104] 1 Sample placement section 2. Refrigerated storage 3 Monitoring Department 4 Analysis Department 5 Storage section 6 User Interface 7. Settings 8 Data Processing Unit 9 Control Unit 10 Cartridge container (two-compartment container) 11 Tray 12 Standby position 13 XYZ axis movable head 14 Identification code reader 40 Information about calibration curves 50 Measurement request information 100 automatic analyzer

Claims

1. a storage unit for storing reaction reagents and calibration reagents; a storage unit that stores calibration curve information regarding the reaction reagent and a validity period of the calibration curve information; an analysis unit that acquires a detection signal based on a chemical reaction between a test sample and the reaction reagent, and between the reaction reagent and the calibration reagent; an acquisition unit that acquires a reservation date and time for updating the calibration curve information designated by a user; a data processing unit that updates the calibration curve information based on the detection signal based on a chemical reaction between the reaction reagent and the calibration reagent obtained by the analysis unit; a control unit that controls the analysis unit to acquire a detection signal based on a chemical reaction between the reaction reagent and the calibration reagent at the reservation date and time acquired by the acquisition unit; An automatic analyzer having the above structure.

2. the reaction reagent and the calibration reagent are sealed in cartridge containers having indices indicating their respective attributes; The automated analyzer according to claim 1 , wherein the storage unit is a refrigerator that stores the reaction reagent and the calibration reagent sealed in cartridge containers.

3. a monitoring unit that monitors an inventory of the reaction reagent and the calibration reagent stored in the storage unit; the control unit acquires inventory information of the storage unit of the reaction reagent and the calibration reagent required for updating the calibration curve information by controlling the monitoring unit before the reservation date and time; The automatic analyzer according to claim 1 , wherein the control unit issues a warning when the reaction reagent and the calibration reagent required for updating the calibration curve information are insufficient based on the inventory information.

4. The storage unit further stores measurement request information regarding analysis items of the test sample, 4. The automatic analyzer according to claim 1, wherein the calibration curve information is stored for each of the analysis items.

5. The automatic analyzer according to claim 4 , wherein when a plurality of measurements for a plurality of calibration reagents are required to update the calibration curve information, the acquisition unit acquires reservation dates and times for each measurement.

6. 6. The automatic analyzer according to claim 1, wherein the acquisition unit displays a reservation date and time that can be specified by a user based on the expiration date of the calibration curve information.

7. 7. The automatic analyzer according to claim 1, wherein the control unit issues a notification that updating of the calibration curve information will be executed before the reserved date and time.

8. The automatic analyzer according to any one of claims 1 to 7, wherein the control unit controls the analysis unit to acquire a detection signal based on a chemical reaction between a quality control reagent having known quantitative information and the reaction reagent, and determines whether the calibration curve information updated by the data processing unit is valid based on the detection signal.

9. The automatic analyzer according to claim 8 , wherein the control unit determines whether the calibration curve information updated by the data processing unit is valid based on a shape or statistical data of the calibration curve information.

10. The automatic analyzer according to claim 8 or 9, wherein when the control unit determines that the calibration curve information updated by the data processing unit is valid, the control unit prompts a user to input a reservation date and time for the next update of the calibration curve information within a new expiration date.

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