Automatic analysis device

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; a setting unit (7) that sets a first measurement date / time for updating calibration curve information within an expiration date; an acquisition unit (6) that acquires a second measurement date / time for updating the calibration curve information designated by the user; a selection unit (6) that selects any of a first mode in which the first measurement date / time is automatically set and a second mode in which the user designates the second measurement date / time; 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 selection unit to acquire the detection signal based on the chemical action between the reaction reagent and calibration reagent at the first measurement date / time or the second measurement date / time in accordance with the selection by the selection unit.SELECTED DRAWING: Figure 4

Description

Technical Field

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

Background Art

[0002] In an automatic analyzer mainly used in the field of in vitro diagnosis, a calibration curve is used to convert the acquired detection signal into concentration or other quantitative information of an analysis item. The calibration curve reflects the response characteristics of the measurement system for measuring the test sample. Usually, the calibration curve is created as a relational expression between the detection signal obtained by measuring the result of the chemical action between the calibration reagent at different concentration levels and the reaction reagent in a measurement system under the same conditions as the measurement system for measuring the test sample, and the concentration of the calibration reagent.

[0003] In an automatic analyzer, since the change over time in the response characteristics due to deterioration of the reaction reagent or the like cannot be avoided, it is considered to substantially ensure the identity of the measurement system by setting an expiration date for the calibration curve based on empirical rules.

[0004] When the expiration date has passed, it is necessary to re-measure the reaction reagent to update the calibration curve information. In an automatic analyzer with a high operation rate, it is preferable to plan and implement the update operation of the calibration curve information before the expiration date of the calibration curve.

[0005] Patent Document 1 discloses an automatic analyzer having a function of creating an implementation plan including the scheduled date for measuring a standard reagent for creating a calibration curve, and displaying order information including the type and quantity of the standard reagent to be used for measurement when the scheduled date for implementation arrives.

Prior Art Documents

Patent Documents

[0006]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0007] However, in the automated analyzer described in Patent Document 1, the user had to confirm the order information displayed and press the execute button in order to start measuring the standard reagent.

[0008] The present invention aims to provide an automated analyzer that reduces the burden on the user when updating calibration curve information and improves the efficiency of updating calibration curve information. [Means for solving the problem]

[0009] The automated analyzer according to this embodiment includes: a storage unit for storing reaction reagents and calibration reagents; a storage unit for storing calibration curve information and the expiration date of the calibration curve information related to the reaction reagents; an analysis unit for acquiring detection signals based on the chemical interaction between the test sample and the reaction reagent and the reaction reagent and the calibration reagent; a setting unit for setting a first measurement date and time for updating the calibration curve information within the expiration date; an acquisition unit for acquiring a second measurement date and time for updating the calibration curve information specified by the user; a selection unit for selecting either a first mode in which the first measurement date and time is set automatically or a second mode in which the user specifies the second measurement date and time; a data processing unit for updating the calibration curve information based on the detection signals acquired by the analysis unit based on the chemical interaction between the reaction reagent and the calibration reagent; and a control unit for controlling the analysis unit to acquire detection signals based on the chemical interaction between the reaction reagent and the calibration reagent at the first measurement date and time or the second measurement date and time according to the selection by the selection unit.

[0010] In the automated analyzer according to this embodiment, the reaction reagent and calibration reagent are preferably sealed in cartridge containers marked with indicators indicating their respective attributes, and the storage unit is a refrigerator for storing the reaction reagent and calibration reagent sealed in cartridge containers.

[0011] In the automated analyzer according to this embodiment, it is preferable that the control unit further includes a monitoring unit that monitors the inventory of reaction reagents and calibration reagents stored in the storage unit, and that the control unit acquires inventory information of reaction reagents and calibration reagents in the storage unit necessary for updating calibration curve information by controlling the monitoring unit before the scheduled date and time, and that the control unit issues a warning if there is a shortage of reaction reagents and calibration reagents necessary for updating calibration curve information based on the inventory information.

[0012] In the automated analyzer according to this embodiment, it is preferable that the memory unit further stores measurement request information regarding the analysis items of the sample to be tested, and calibration curve information is stored for each analysis item.

[0013] In the automated analyzer according to this embodiment, it is preferable that the setting unit sets a reservation date and time for each measurement when multiple measurements of multiple calibration reagents are required in order to update the calibration curve information.

[0014] In the automated analyzer according to this embodiment, it is preferable that the control unit notifies the user before the scheduled date and time to update the calibration curve information.

[0015] In the automated 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 a quality control reagent and a reaction reagent with known quantitative information, and that the data processing unit determines whether the updated calibration curve information is valid based on the detection signal.

[0016] In the automated analyzer according to this embodiment, it is preferable that the control unit 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.

[0017] In the automated analyzer according to this embodiment, it is preferable that the setting unit, when the control unit determines that the calibration curve information updated by the data processing unit is valid, sets a reservation date and time for the next update of the calibration curve information within the new validity period.

[0018] In the automatic analyzer according to this embodiment, when the first measurement date and time or the second measurement date and time overlap with the inspection of the automatic analyzer, or when it is immediately before the inspection, if it is before the expiration date, it is preferable to move the first measurement date and time or the second measurement date and time after the inspection.

[0019] In the automatic analyzer according to this embodiment, it is preferable that the acquisition unit guides and displays a reserved date and time that can be specified by the user based on the expiration date of the calibration curve information.

Effect of the Invention

[0020] In the automatic analyzer according to the present invention, when updating the calibration curve information, it is possible to reduce the burden on the user and improve the efficiency of updating the calibration curve information.

Brief Description of the Drawings

[0021] [Figure 1] It is a block diagram showing an overview of the automatic analyzer 100. [Figure 2] (a) shows an example of a cartridge container filled with a reaction reagent, (b) shows an example of a cartridge container filled with a calibration reagent, and (c) shows an example of a cartridge container filled with a precision control reagent. [Figure 3] It is an example of a plan view showing the monitoring unit 3 arranged inside the cold storage 2. [Figure 4] It is a flowchart showing mode selection. [Figure 5] It is a diagram showing an example of a selection screen for the reservation mode. [Figure 6] It is a diagram showing an example of information regarding the calibration curve. [Figure 7] It is a diagram showing an example of measurement request information. [Figure 8] It is a flowchart when the designated reservation mode is selected. [Figure 9] (a) shows an example of a confirmation screen for calibration curve determination, and (b) is a diagram showing an example of a reservation confirmation screen for updating the next calibration curve information. [Figure 10] It is a flowchart when the automatic reservation mode is selected. [Figure 11] This figure shows an example of a warning display. [Figure 12] This figure shows other examples of warning displays. [Modes for carrying out the invention]

[0022] The automated analyzer will be described in detail below with reference to the drawings. However, it should be understood that the present invention is not limited to the drawings or the embodiments described below.

[0023] Figure 1 is a block diagram showing a schematic representation of the automated analyzer 100.

[0024] The automated analyzer 100 is configured to include a sample placement unit 1, a refrigerator 2, a monitoring unit 3, an analysis unit 4, a storage unit 5, a user interface unit 6, a setting unit 7, a data processing unit 8, and a control unit 9, etc., which are arranged in a housing (not shown).

[0025] The sample placement section 1 is a platform for placing the sample to be analyzed. The refrigerator 2 functions as a storage section for storing reaction reagents, calibration reagents, and quality control reagents at low temperatures to prevent deterioration. If the various reagents can be stored at room temperature, it is not always necessary to store them at low temperatures.

[0026] 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 detection signals from reaction reagents mixed with the test sample, mixes the reaction reagents with calibration reagents and acquires detection signals from the mixed reagents, and mixes the reaction reagents with quality control reagents and acquires detection signals from the mixed reagents. The transport of reagents from the refrigerator 2 to the analysis unit 4 is performed by a transport mechanism not shown.

[0027] The memory unit 5 is a memory that stores calibration curve information 40 and measurement request information 50, and is composed of a semiconductor memory, magnetic disk drive, optical disk drive, or HDD (Hard Disk Drive), etc.

[0028] The user interface unit 6 includes input devices such as a keyboard, buttons, and a mouse for receiving various inputs from the user, and display devices such as a liquid crystal display for displaying various data, guidance, and warnings. The user interface unit 6 may also be a touch panel or the like in which the input devices and display devices are integrally formed.

[0029] 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 of the analysis item using the calibration curve information 40. The control unit 9 controls the entire automatic analyzer 100, including the refrigerator 2, monitoring unit 3, analysis unit 4, storage 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), and ROM (Read-Only Memory), etc., and operate by individual programs. The setting unit 7, data processing unit 8, and control unit 9 may also be formed as multiple software function blocks operating on a single CPU.

[0030] 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 the data processing unit 8 converts the detection signal into quantitative information of the analysis item based on the calibration curve information 40 stored in the storage unit 5.

[0031] Furthermore, the control unit 9 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 in the setting unit 7, or at the reserved date and time specified by the user using the user interface unit 6. In addition, based on the acquired detection signal, the control unit 9 updates the calibration curve information using the data processing unit 8 and stores the updated calibration curve information in the storage unit 5.

[0032] "Detection signal" refers to the output signal of a detector (not shown) in the analysis unit 4, and can be a physical quantity such as energy, light intensity, current, potential, charge, frequency, displacement, particle number, time, and ratios or functions with reference values. "Quantitative information" refers to the amount, intensity, or size of the analytical item of interest, which is the purpose of the analysis, and can be exemplified by concentration, activity, activity, titer, etc.

[0033] "Calibration curve information" refers to a two-dimensional plot of the detection signal and quantitative information of the analytical item that constitute the calibration curve, or a mathematical relationship formula and its associated information based thereon. In this application, "calibration curve information" includes the "master calibration curve data," "calibration data," and "calibrated calibration curve coefficients" described later. "Associated information" usually includes the analytical item to which the calibration curve can be applied, the reagent lot, and the expiration date of the reagent, and may also include traceability information that led to the acquisition of the calibration curve.

[0034] "Creating a calibration curve" (also called calibration) refers to obtaining "master calibration curve data," which is a relationship between the detection signal and quantitative information, by statistically processing the detection signal based on the chemical reaction between the reaction reagent and a calibration reagent that has known quantitative information different from that of the reaction reagent.

[0035] "Updating calibration curve information" refers to obtaining "calibration data" and "calibrated calibration curve coefficients" for updating the "master calibration curve data" by measuring a predetermined number of calibration reagents and correcting the calibration curve through predetermined statistical processing. The "predetermined number" in "updating calibration curve information" is usually less than the number used in "creating the calibration curve," but it does not necessarily have to be less. In this application, "calibration reagent" is used interchangeably with "calibrator" or "standard reagent."

[0036] Figure 2(a) shows an example of a cartridge container filled with reaction reagents, Figure 2(b) shows an example of a cartridge container filled with calibration reagents, and Figure 2(c) shows an example of a cartridge container filled with quality control reagents.

[0037] Figure 2 shows an example of a cartridge container for various freeze-dried reagents stored in the refrigerator 2, using a double-well plastic container 10 with two wells connected together. Both double-well containers 10 are plastic containers in which cylindrical recesses with an inner diameter of 6 mm and a height of 20 mm are arranged side by side, separated by a minimum wall thickness of about 1 mm.

[0038] The cartridge container 10 shown on the left side of Figure 2(a) contains FT4 immunoassay reagents: a solid-phase reagent immobilized on magnetic particles in one well and an enzyme-labeled reagent 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 in a tray 11 with a grid of holding holes. A barcode 22 indicating the contents of the reagent containers is attached to the upper right edge of the tray 11.

[0039] Figure 2(b) shows a configuration in which calibration reagents 1 to 3, each containing the target component at three concentration levels corresponding to different levels, are contained in a lyophilized state in a cartridge container 10 identical in shape and dimensions to the immunoassay reagent cartridge container 10 shown in Figure 2(a). In the example shown on the left side of Figure 2(b), the same calibration reagent component is contained in two adjacent wells. Note that the device can distinguish between the positions of the two wells, so different calibration reagents may be contained in two adjacent wells. The surface of the aluminum foil seal 20 of the calibration reagent cartridge container 10 is marked with an identification code 21 that identifies the contents of each. The right side of Figure 2(b) shows a configuration in which the calibration reagent cartridge containers 10 are arranged in a tray 11 with a grid of holding holes. The numbers in the ovals indicate the numbers of calibration reagents 1 to 3. The upper right edge of the tray 11 is marked with a barcode 22 indicating the type of container, which is the FT4 calibration reagent set.

[0040] Figure 2(c) shows a configuration in which three types of reagents (Multi-3L, Multi-3M, Multi-3H) corresponding to three concentration levels are contained in a lyophilized state in a cartridge container 10 identical in shape and size to the immunoassay reagent cartridge container 10 shown in Figure 2(a), serving as a quality control reagent QC sample set. In the example shown on the left side of Figure 2(c), the same quality control reagent components are contained in two adjacent wells. Note that the device can distinguish between the positions of the two wells, so different quality control reagents may be contained in two adjacent wells. The surface of the aluminum foil seal 20 of the quality control reagent cartridge container 10 is marked with an identification code 21 that identifies the contents of each. The right side of Figure 2(c) shows a configuration in which the quality control reagent cartridge containers 10 are arranged in a tray 11 with a grid of holding holes. The numbers in the ovals indicate the numbers of the quality control reagents, with "Multi-3L" corresponding to "1", "Multi-3M" to "2", and "Multi-3H" to "3". A barcode 22 is attached to the upper right edge of tray 11, indicating the type of container, which is a QC sample set, a quality control reagent.

[0041] Various reagents may be sealed in containers other than the double-compartment container 10 shown in Figure 2. Also, although the tray 11 shown in Figure 2 is designed to hold 32 double-compartment containers 10, any tray that can hold any container may be used. Furthermore, the tray 11 may hold 32 double-compartment containers 10 as shown in Figure 2(a), or 24 double-compartment containers may be packed tightly on the left side of the tray as shown in Figure 2(b), or 24 double-compartment containers may be packed tightly on the top side of the tray as shown in Figure 2(c).

[0042] Figure 3 is an example of a plan view showing the monitoring unit 3 located inside the refrigerator 2.

[0043] Figure 3 shows the interior of the refrigerator 2 as seen from above. Inside the refrigerator 2, six trays 11 containing the cartridge containers 10 shown in Figure 2 are arranged in a row. In addition, the trays 11 are stacked in multiple layers downwards (in the Z direction) from the surface shown in the figure. The monitoring unit 3 is equipped with an XYZ axis movable head 13, an identification code reading unit 14, and a means 15 for detecting the presence or absence of cartridge containers 10, etc.

[0044] The XYZ-axis movable head 13 is capable of intermittently moving along a trajectory suitable for reading identification information on cartridge containers 10 arranged in a matrix inside the refrigerator 2, by means of a moving mechanism (not shown). The XYZ-axis movable head 13 is equipped with a chuck transport means (not shown) for lifting the cartridge containers 10 and transporting them to a predetermined position, allowing the user to select the cartridge container 10 to be used and place it in a standby position 12 for the analysis unit 4.

[0045] Figure 4 is a flowchart illustrating mode selection.

[0046] First, the user selects a reservation mode using the input device of the user interface unit 6 (step S1). The control unit 9 executes either a specified reservation mode (step S3) or an automatic reservation mode (step S4) according to the selected mode (step S2), and registers the reservation date and time for updating the calibration curve information in the measurement request information 50.

[0047] The "Specified Reservation Mode" is a reservation mode in which the user specifies the reservation date and time for updating the calibration curve information, leaving the decision to the user's discretion based on the operating status of the automatic analyzer 100 or the measurement request status. 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, which is a suitable method for reliably preventing users from forgetting to make a reservation and keeping the calibration curve always valid without burdening the user.

[0048] Figure 5 shows an example of the reservation mode selection screen.

[0049] The screen shown in Figure 5 is displayed on the display device of the user interface unit 6, so the user selects the reservation mode (step S1 in Figure 4) using the input device of the user interface unit 6. The information shown in Figure 5, "Analysis Item," "Analysis Reagent Batch," "Master Calibration Curve Data," "Calibration Reagent Batch," and "Calibration Curve Expiration Date," is pre-stored in the storage unit 5 as calibration curve information 40, and is information extracted by the user using "Analysis Item" as the key.

[0050] The reservation mode can be selected for each analysis item. Users select the reservation mode by entering either "Specified Reservation" or "Automatic Reservation" in the "Reservation Mode" field on the screen shown in Figure 5. Alternatively, when the cursor is moved to the "Reservation Mode" field, a dropdown menu may be provided allowing selection of either "Specified Reservation" or "Automatic Reservation."

[0051] In the example shown in Figure 5, the "Specified Reservation Mode" is selected for the analysis item "FT4," and the "Automatic Reservation Mode" is selected for the analysis item "TSH." The reservation mode can be set for each analysis item. Flexible operation is possible, such as selecting Specified Reservation Mode for analysis items that are usually tested infrequently but for which a large number of test requests can be predicted, and setting Automatic Reservation Mode for analysis items designated as routine tests with high testing frequency, as an effective calibration curve is always required.

[0052] When "Specified Reservation Mode" is selected, moving the cursor to the "Reservation Date and Time" field displays a guidance message 30, such as "Please set within the validity period," which the user should consider when entering the reservation date and time. When "Automatic Reservation Mode" is selected, the user does not need to enter a reservation date and time; the setting unit 7 automatically sets the reservation date and time and displays it in the "Reservation Date and Time" field. In Figure 5, the background color of the reservation date and time input cells, which do not require user input, is gray.

[0053] When "Specified Reservation Mode" is selected, the control unit 9 can also display on the user interface unit 6's display device the time required to measure the calibration reagent corresponding to the analysis item, the expiration date of the calibration curve, the reservation date and time for creating other calibration curves, and the inspection schedule of the automatic analyzer 100, etc., that can be entered. 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 user interface unit 6's display device.

[0054] Users can set the pre-notification option and / or the automatic calibration curve determination option by entering information in the "Pre-notification" and "Automatic Calibration Curve Determination" fields on the screen shown in Figure 5. Note that the input in the "Pre-notification" and "Automatic Calibration Curve Determination" fields can be changed or canceled later for each "Analysis Item".

[0055] The "advance notification" option notifies the user after a calibration curve information update has been scheduled but before the update is 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 the advance notification, the system may ask the user again to confirm whether or not to perform the calibration curve information update as scheduled, or it may simply notify the user and not ask for confirmation again. The advance notification option can be applied to both the specified reservation mode and the automatic reservation mode.

[0056] The "Automatic Calibration Curve Determination" option automatically determines the validity of updated calibration curve information after the calibration curve information has been updated. Specifically, a quality control sample (also called a "QC sample") and a reaction reagent are mixed, a detection signal is acquired in the analysis unit 4, and a plot is created showing the relationship between the previously known quantitative information and the detection signal. The created plot is compared with the updated calibration curve, and the updated calibration curve is judged based on its shape and / or statistical validity. The automatic calibration curve determination option can be added to both the specified reservation mode and the automatic reservation mode.

[0057] Figure 6 shows an example of 40 pieces of information regarding the calibration curve.

[0058] The calibration curve information 40 is stored in the memory unit 5. In the example shown in Figure 6, the calibration curve information 40 consists of "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", "calibrated calibration curve coefficient", "previous calibration reagent measurement date", "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 calibration curve information 40.

[0059] The "master calibration curve data" is data obtained by measuring the calibration reagent using the corresponding reaction reagent (specified by the name of the analysis item and the reaction reagent batch) with the automated analyzer 100, acquiring the detection signal, and representing the relationship between the assigned quantitative information (usually concentration) xi and the detection signal yi in a plotted format as a set of component representations, for example, {x1i, y1i} (concentration level i=1~6). The "master calibration curve data" may also be expressed using a mathematical regression equation.

[0060] The "master calibration curve data" corresponds to the name of the analysis item and the batch of the reaction reagent, and is usually provided in the form of an identification code attached to the reaction reagent package. When updating the calibration curve information with the automated analyzer 100, a calibration reagent consisting of fewer concentration levels than the standard reagent used to create the "master calibration curve data" is measured to obtain calibration data, for example, {x1j, Y1j} (concentration levels j=1,2,3). "Concentration 1" to "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 by predetermined statistical processing based on the calibration data. Depending on the regression fitting method, the calibration curve information is updated by determining the coefficients A1, B1, C1, and D1 of the regression equation. The date when the calibration curve information is properly updated becomes the date the calibration curve is finalized and is treated as the start of the validity period of the calibration curve. The validity period of the calibration curve is the date the calibration curve is finalized plus the validity period (e.g., 90 days).

[0061] In the calibration curve information for "FT4" as the "analysis item" shown in Figure 6, the "reservation mode" is set to "specified reservation mode" and "prior notification" is set to "required," corresponding to the selection screen in Figure 5. In the example of calibration curve information for "TSH" as the "analysis item" shown in Figure 6, the "reservation mode" is set to "automatic reservation mode" and "prior notification" is set to "not required," corresponding to the selection screen in Figure 5. In the calibration curve information for "AFP" as the "analysis item" shown in Figure 6, the fields below "calibration data" are blank. This indicates that although the master calibration curve data and calibration reagents for the AFP reaction reagent are registered in the automated analyzer 100, the calibration curve information has not yet been updated.

[0062] "QC sample for calibration curve confirmation" refers to "quality control sample." If "quality control sample" is registered as information 40 regarding the calibration curve, the aforementioned "automatic calibration curve determination" option can be executed immediately after updating the calibration curve information. In the case of "FT4" as shown in Figure 6, "Multi-3" is registered as the "QC sample for calibration curve confirmation," so if the "automatic calibration curve determination" option is set for "FT4," the "automatic calibration curve determination" option will be executed using "Multi-3."

[0063] Figure 7 shows an example of measurement request information 50.

[0064] The information entered on the selection screen shown in Figure 5, the reservation date and time set in the setting unit 7, and some of the calibration curve information 40 are compiled as measurement request information 50 as shown in Figure 7 and stored in the storage unit 5. The control unit 9 executes various processes while controlling the analysis unit 4 and the data processing unit 8, etc., based on the measurement request information 50 stored in the storage unit 5. Therefore, in addition to calibration reagents, the measurement request information 50 also registers information about the test samples to be measured by the automated analyzer 100 and quality control samples.

[0065] In the example in Figure 7, no start date and time are set for test samples number 1 and 2, so user operation is required, but measurement will be possible once the user performs the prescribed operation. Samples 3 to 5 are all calibration reagents, and their sample IDs are "ADJ75-002-C1", "ADJ75-002-C2", and "ADJ75-002-C3" (corresponding to FT4 calibration reagent - calibration reagent batch - concentration levels 1, 2, and 3). For samples 3 to 5, the number of measurements is 3 each, the analysis item (measurement reagent) is FT4-011 for all, the scheduled start date and time of measurement is 2021 / 4 / 14 6:00 (start of sample 3), and the scheduled end date and time of measurement is 021 / 4 / 14 6:06 (end of sample 5).

[0066] In the example shown in Figure 7, three quality control samples (Multi-3L, Multi-3M, and Multi-3H) with different concentration levels, shown in numbers 6-8, are registered for the same analytical items (measuring reagents) as numbers 3-5. Furthermore, following the measurement of number 5, measurements of the three quality control samples with different concentration levels shown in numbers 6-8 are scheduled.

[0067] In the example in Figure 7, the scheduled start and end dates and times are not entered for numbers 11 and 12. This is because no measurement reservation has yet been made for this calibration reagent. Similar to the test samples (numbers 1 and 2), user intervention is required, but measurement will be possible once the user performs the prescribed operation.

[0068] Figure 8 is a processing flow diagram when the specified reservation mode is selected.

[0069] The processing flow in Figure 8 is executed by the CPU controlling or cooperating with other components using a software program pre-stored in the ROM of the control unit 9. If the specified 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 specified reservation mode has been 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 preparing for measurement (step S11).

[0070] Next, the control unit 9 waits until a predetermined time before the scheduled date and time (for example, 4 hours before) (step S12), and then executes the aforementioned "advance notification" option (step S13). The "advance notification" option is executed only if the "advance notification" option is selected on the selection screen shown in Figure 5. Note that the processing flow may also be designed without "advance notification," and even if "advance notification" is performed, the user does not need to be asked to decide whether or not to proceed as scheduled.

[0071] Next, the control unit 9 moves the XYZ axis movable head 13 of the monitoring unit 3 to check whether there is sufficient stock of reagents necessary for updating the calibration curve information (step S14). If there is insufficient stock, the control unit 9 displays a warning on the display device of the user interface unit 6 (step S20) and terminates the series of processes without updating the calibration curve information.

[0072] 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, based on the measurement request information 50, it transports the necessary reagents from the refrigerator 2 and performs the measurement using the reaction reagent and calibration reagent in the analysis unit 4 (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 the detection signal.

[0073] Next, based on the detection signal acquired in step S16, the control unit 9 instructs the data processing unit 8 to create "calibration data" and "calibrated calibration curve coefficients" to calibrate the "master validation curve data" registered in the calibration curve information 40 shown in Figure 6 (step S17). The acquisition of the detection signal in step S16 and the creation of the "calibration data" and "calibrated calibration curve coefficients" in step S17 together are referred to as updating the calibration curve information.

[0074] Next, the control unit 9 executes the aforementioned "automatic calibration curve determination" option on the calibration curve updated in steps S16 and S17 (step S18). For example, if the "analysis item" shown in Figure 7 is "FT4", the control unit 9 chemically reacts quality control samples with sample IDs "Multi-3L", "Multi-3M", and "Multi-3H" with the reaction reagent three times each, and acquires detection signals in the analysis unit 4. Next, the control unit 9 determines the "calibration data" and the "calibrated calibration curve coefficients" 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 Figure 5. Note that a processing flow without "automatic calibration curve determination" is also possible.

[0075] If the effectiveness is determined to be high in step S18, the control unit 9 registers the "calibration data" and "calibrated calibration curve coefficients" created in step S17 into the calibration curve information 40 in place of the previous information (step S19). If the effectiveness is determined to be low in step S18, the control unit 9 displays a warning on the display device of the user interface unit 6 (step S20), and terminates the series of processes without registering the "calibration data" and "calibrated calibration curve coefficients" created in step S17 into the calibration curve information 40 in place of the previous information.

[0076] Finally, the control unit 9 executes a request to specify the next reservation date and time (step S21), and terminates the series of processes. An example of the procedure for requesting the next reservation date and time will be explained using Figure 9.

[0077] Figure 9(a) shows an example of a confirmation screen for calibration curve confirmation, and Figure 9(b) shows an example of a reservation confirmation screen for updating calibration curve information next time.

[0078] 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, as shown in Figure 9(a), is displayed on the display device of the user interface unit 6. When the "OK" button of the confirmation message 60 is clicked with the cursor, the confirmation message 60 is closed, and then a reservation confirmation message 61, as shown in Figure 9(b), is displayed. When the "YES" button of the reservation confirmation message 61 is clicked with the cursor, the reservation mode selection screen, as shown in Figure 5, is displayed again. This function helps prevent users from forgetting to make reservations.

[0079] Alternatively, the process may be terminated after registering the "calibration data" and "calibrated calibration curve coefficients" created in step S17 into the calibration curve information 40 (step S19), without executing the request to specify the next reservation date and time (step S21).

[0080] In the specified schedule mode, the calibration curve information is automatically updated at the reservation date and time specified by the user. This allows the user to set an appropriate time for the reservation based on the operating status of the automatic analyzer 100 or the status of measurement requests.

[0081] Figure 10 is a processing flow diagram when the automatic reservation mode is selected.

[0082] The processing flow in Figure 10 shows that the CPU controls or collaborates with other components to execute the process based on a program pre-stored in the ROM of the control unit 9. The processing in steps S11 to S20 in the processing flow of Figure 8 is the same as the processing in the processing flow of Figure 10, so its explanation is omitted.

[0083] In the flow shown in Figure 4, if the automatic reservation mode is selected (step S4), the control unit 9 obtains the "calibration curve expiration date" from the calibration curve information 40 for the analysis item for which the automatic reservation mode was selected and transmits it to the setting unit 7 (step S30).

[0084] Next, the setting unit 7 takes into account the received calibration curve expiration date, the time required to measure the calibration reagent corresponding to the analysis item, the reservation date and time for updating other calibration curve information, and the inspection schedule of the automatic analyzer 100, and sets the reservation date and time before the calibration curve expiration date (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.

[0085] When the "calibration data" and "calibrated calibration curve coefficients" created in step S17 are registered in the calibration curve information 40 in place of the previous information (step S19), the control unit 9 obtains 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 ending the series of processes.

[0086] Alternatively, the process may be terminated after the "calibration data" and "calibrated calibration curve coefficients" created in step S17 are registered in the calibration curve information 40 (step S19), without performing the setting of the next reservation date and time (step S32).

[0087] The automatic scheduling mode ensures that reservations are not forgotten and keeps the calibration curve always valid without burdening the user.

[0088] Figure 11 shows an example of a warning display.

[0089] In the processing flows shown in Figures 8 and 10, if the sample stock was insufficient in step S14, a warning was displayed (step S20), and the series of processes was terminated. However, it is also possible to display a warning, such as the one shown in Figure 11, to prompt the user to replenish the sample. If the user replenishes the insufficient sample after the warning shown in Figure 11 and clicks the "OK" button, the process should return to step S14 to check the stock again, and if there are no problems, the process from step S15 onwards should continue. Also, if the user clicks the "Cancel" button after the display shown in Figure 11, the series of processes will be terminated as before. Note that the "tip" shown in Figure 11 refers to the disposable pipette tip to be used.

[0090] Figure 12 shows another example of a warning sign.

[0091] In the processing flows shown in Figures 8 and 10, a pre-notification was performed (step S13), followed by a check of the sample inventory (step S14). However, if there is a shortage in the sample inventory, a warning display may be issued in addition to the pre-notification. Figure 12 shows an example where the pre-notification and the warning display for insufficient inventory are displayed on a single screen.

[0092] Similar to the case in Figure 11, if the user replenishes the missing sample after the warning shown in Figure 12 and clicks the "OK" button, the system should return to step S14 to check the inventory again, and if there are no problems, the process from step S15 onwards should continue. Also, if the user clicks the "Cancel" button after the display shown in Figure 12, the series of processes will end as before.

[0093] The following explains in detail, including variations, how users specify the reservation date and time in the designated reservation mode (see Figure 8).

[0094] In step S10 of Figure 8, the user enters the reservation date and time using the input device of the user interface unit 6 on the reservation mode selection screen as shown in Figure 5. However, in the following cases, it is preferable to display a warning on the display device of the user interface unit 6 to prompt the user to enter an alternative reservation 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) If the entered scheduled date and time overlaps with a scheduled date and time for updating other calibration curve information that has already been booked; and (3) If the entered scheduled date and time overlaps with an already scheduled inspection schedule for the automated analyzer 100.

[0095] If the user selects the specified reservation mode, the control unit 9 may display on the display device of the user interface unit 6 a period that does not overlap with the reservation date and time for updating other calibration curve information that has already been reserved, and with the scheduled maintenance schedule of the automatic analyzer 100, up to a predetermined date and time (for example, 3 days before) the "calibration curve expiration date" of the target analysis item. Conversely, the control unit 9 may also display on the display device of the user interface unit 6 any available dates and times up to a predetermined date and time (for example, 3 days before) the "calibration curve expiration date" of the target analysis item. By displaying the information in this manner, the user can confirm the available dates and times on the display device of the user interface unit 6 and then specify the reservation date and time.

[0096] If the user selects the specified 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 will indicate the start date and time of the measurement for the calibration reagent with sample ID "ADJ75-002-C1", and the period until the end of the measurement for the calibration reagent with sample ID "ADJ75-002-C3".

[0097] Furthermore, one reservation date and time may be set to indicate the start and end times of the measurement of the calibration reagent with a single sample ID, "ADJ75-002-C1". When the analysis item shown in Figure 7 is FT4, it becomes necessary to specify three reservation dates and times when updating the calibration curve information. Therefore, it is preferable that the display device of the user interface unit 6 informs the user that three reservation dates and times need to be specified when the user selects the specified reservation mode.

[0098] The following will explain in detail, including modified examples, how to set the reservation date and time using the setting unit 7 in automatic reservation mode (see Figure 10).

[0099] In step S30 of Figure 10, the setting unit 7 automatically sets the scheduled date and time that satisfies the following conditions (1) to (3): (1) The entered scheduled date and time must be later than the "calibration curve expiration date" of the target analysis item; (2) The entered scheduled date and time do not overlap with the scheduled date and time for updating other calibration curve information that has already been booked; and (3) The entered scheduled date and time must not overlap with an already scheduled inspection schedule for the automated analyzer 100.

[0100] However, in the automatic analyzer 100, the inspection schedule may be 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 takes priority and it overlaps with the inspection schedule, a warning should be displayed on the display screen of the display device of the user interface unit 6 where the inspection schedule is set, prompting the user to change the inspection schedule.

[0101] Conversely, if the inspection schedule takes priority, and 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 the automatic analyzer 100 is more likely to be in better condition after the inspection.

[0102] If 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 will indicate the start date and time of the measurement for the calibration reagent with sample ID "ADJ75-002-C1", and the period until the end of the measurement for the calibration reagent with sample ID "ADJ75-002-C3".

[0103] Note that one reservation date and time may indicate the start and end times of the measurement of a calibration reagent with a single sample ID, "ADJ75-002-C1". If the analysis item shown in Figure 7 is FT4, then three reservation dates and times must be specified when updating the calibration curve information. Therefore, the setting unit 7 needs to set three reservation dates and times. In this case, the setting unit 7 may set the three reservation dates and times consecutively, or it may set the three reservation dates and times non-consecutively, with other events (such as updating other calibration curve information or scheduling checks) in between.

[0104] Those skilled in the art will understand that various changes, substitutions, and modifications can be made without departing from the spirit and scope of the present invention. [Explanation of symbols]

[0105] 1. Sample placement section 2. Cooler 3 Monitoring Department 4 Analysis Department 5 Storage section 6. User Interface Section 7. Settings section 8. Data Processing Unit 9. Control Unit 10 Cartridge containers (double containers) 11 trays 12 Standby position 13 XYZ axis movable head 14. Identification code reading unit 40. Information on Calibration Curves 50 Measurement Request Information 100 automatic analyzer

Claims

1. A storage section for storing reaction reagents and calibration reagents, A storage unit that stores calibration curve information for the reaction reagent and the expiration date of the calibration curve information, An analysis unit that acquires a detection signal based on the chemical reaction between the test sample and the reaction reagent, and between the reaction reagent and the calibration reagent, A setting unit that sets a first measurement date and time for updating the calibration curve information within the aforementioned validity period, An acquisition unit that acquires a second measurement date and time for updating the calibration curve information specified by the user, A selection unit that allows the user to select either a first mode in which the first measurement date and time is set automatically, or a second mode in which the user specifies the second measurement date and time. A data processing unit updates the calibration curve information based on the detection signal obtained by the analysis unit, which is based on the chemical reaction between the reaction reagent and the calibration reagent. A control unit controls the analysis unit to acquire a detection signal based on the chemical reaction between the reaction reagent and the calibration reagent at the first measurement date and time or the second measurement date and time corresponding to the selection by the selection unit, It has, The setting unit moves the first measurement date and time or the second measurement date and time to after the inspection if the first measurement date and time or the second measurement date and time coincides with an inspection of the automatic analyzer, or if it is immediately before the inspection, provided that it is before the expiration date.

2. The reaction reagent and the calibration reagent are sealed in cartridge containers marked with indicators indicating their respective attributes. The automatic analyzer according to claim 1, wherein the storage unit is a refrigerator for storing the reaction reagent and the calibration reagent sealed in cartridge containers.

3. The system further includes a monitoring unit that monitors the inventory of the reaction reagents and calibration reagents stored in the storage unit, The control unit acquires inventory information of the reaction reagents and calibration reagents in the storage unit, which are necessary for updating the calibration curve information, before the first measurement date and time or the second measurement date and time, by controlling the monitoring unit. The control unit issues a warning if, based on the inventory information, the reaction reagent and calibration reagent necessary for updating the calibration curve information are insufficient, according to the automated analyzer according to claim 1 or 2.

4. The memory unit further stores measurement request information regarding the analysis items of the sample being tested. The automated analyzer according to any one of claims 1 to 3, wherein the calibration curve information is stored for each analysis item.

5. The automatic analyzer according to claim 4, wherein the setting unit or the acquisition unit sets or acquires the first measurement date and time or the second measurement date and time for each measurement when multiple measurements of multiple calibration reagents are required for updating the calibration curve information.

6. The automatic analyzer according to any one of claims 1 to 5, wherein the control unit notifies the system to perform an update of the calibration curve information before the first measurement date and time or the second measurement date and time.

7. The automatic analyzer according to any one of claims 1 to 6, wherein the control unit controls the analysis unit to acquire a detection signal based on the chemical reaction between a quality control reagent with 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.

8. The automatic analyzer according to claim 7, wherein the control unit determines whether the calibration curve information updated by the data processing unit is valid based on the shape or statistical data of the calibration curve information.

9. The automatic analyzer according to claim 7 or 8, wherein the setting unit, when the control unit determines that the calibration curve information updated by the data processing unit is valid, sets the first measurement date and time for the next update of the calibration curve information within a new validity period.

10. The automatic analyzer according to any one of claims 1 to 9, wherein the acquisition unit displays a second measurement date and time that can be specified by the user based on the expiration date of the calibration curve information.

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