Automatic analysis device and automatic analysis method

Abstract

In order to ensure device performance at the time of performing automatic blank calibration, perform automatic blank calibration, and measure changes over time in a liquid mixture obtained by mixing a specimen and a reagent, this automatic analysis device is provided with: a reaction container capable of accommodating the specimen and the reagent; an analysis unit that measures the liquid mixture contained in the reaction container; and a control unit that, prior to the execution of the automatic blank calibration, executes an analysis preparation operation including a temperature detection operation of the reaction tank for adjusting the temperature of the reaction vessel and other operations, and confirms whether the state of the automatic analysis device is stable (fig. 3).

Description

Technical Field

[0001] The present disclosure relates to an automatic analysis device and an automatic analysis method. Background Art

[0002] Automatic analyzers perform measurements on biological samples (also referred to as specimens) such as blood and urine and process the resulting data. For example, an automatic analyzer measures the change in absorbance over time for a solution after a certain amount of sample and reagent are mixed and stirred to react, and calculates the concentration of the target substance, enzyme activity value, etc. as the measured value. In order to perform maintenance and inspection of such an automatic analyzer, an operator needs to perform maintenance on the device. Maintenance items are variously carried out depending on the purpose, such as items performed by clinical examination technicians or service personnel of the device manufacturer, and items performed automatically by the device. Based on the results of the maintenance, the operator cleans the device and replaces consumables.

[0003] Operators regularly measure standard solutions for reagent calibration or precision control samples for checking the status of the device and reagents in automatic analyzers. This allows them to understand the status of reagents and samples and to notice any abnormalities in the device status before measuring biological samples.

[0004] In addition, in automatic analyzers, blank calibration is sometimes performed. Blank calibration is the action of measuring the absorbance of the reagent dispensed into the reaction container to determine the absorbance at zero concentration of the target substance (item). By performing this blank calibration, a standard curve corresponding to the state of each reagent can be drawn. For reagents that are prone to deterioration, it is expected that blank calibration will be performed more frequently than other reagents. The results of the blank calibration can be used to confirm the reagent status and evaluate the replacement of the reagent. In the inspection room, it is often routine to perform blank calibration before measuring the precision control sample or biological sample, or just after the reagent is replaced.

[0005] In recent years, due to the expansion of laboratory work, the number of clinical laboratory technicians dedicated to handling automated analyzers has been decreasing. Clinical laboratory technicians have limited time and workload allocated to each piece of equipment. Therefore, there is a demand to automate daily maintenance and analysis operations within automated analyzers to reduce the workload of clinical laboratory technicians.

[0006] For example, Patent Document 1 discloses an automatic analyzer that performs automatic blank calibration using the system water of the device as a standard liquid. Specifically, Patent Document 1 states that "when system water is used as a blank standard liquid, the system water discharged from the pretreatment specimen dispensing mechanism 8 to the reaction container 9 reacts with the reagent dispensed from the reagent dispensing mechanism 13, and the absorbance change of the reaction liquid is measured in the same manner as the above-mentioned process of using the pretreatment liquid as a blank standard liquid." By being able to perform automatic blank calibration, for example, if it is set to automatically complete the process from powering on the device to blank calibration in accordance with the working hours of the clinical laboratory technician, the actions required for sample measurement such as maintenance of the device and blank calibration are completed before starting work, so there is an advantage that the operator can start sample measurement immediately after starting work.

[0007] Prior art literature

[0008] Patent Literature

[0009] Patent Document 1: Japanese Patent Application Laid-Open No. 2011-226889 Summary of the Invention

[0010] Problems to be solved by the invention

[0011] However, the automatic analyzer described in Patent Document 1 does not confirm whether the device state before automatic blank calibration is suitable for absorbance measurement. Therefore, automatic blank calibration may be performed in a state unsuitable for absorbance measurement, making it impossible to guarantee the accuracy of the analysis results of the automatic analyzer.

[0012] In view of such circumstances, the present disclosure proposes a technique for ensuring device performance when automatic blank calibration is performed.

[0013] Means for solving problems

[0014] In order to solve the above-mentioned problems, the present disclosure proposes an automatic analysis device that performs automatic blank calibration and measures the time-dependent changes in a mixed liquid obtained by mixing a specimen and a reagent. The automatic analysis device comprises: a reaction container that can accommodate the specimen and the reagent; a reaction tank that regulates the temperature of the reaction container; an analysis unit that measures the mixed liquid accommodated in the reaction container; and a control unit. Before performing the automatic blank calibration, the control unit performs an analysis preparation action including a temperature detection action of the reaction tank and other actions to confirm whether the state of the automatic analysis device is stable.

[0015] Further features related to the present disclosure will become apparent from the description and drawings of this specification. In addition, the present disclosure is realized by the combination of elements and a plurality of elements, the detailed description below, and the scope of the appended claims.

[0016] The descriptions in this specification are merely typical examples and do not limit the scope of patent protection claimed or application examples of the present disclosure in any sense.

[0017] Effects of the Invention

[0018] According to the technology disclosed in the present invention, automatic blank calibration is performed when it is determined that the device state of the automatic analyzer is good, so the result of the automatic blank calibration is ensured by the analysis performance. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is a diagram showing a schematic configuration example of an automatic analyzer 100 that is commonly applicable to each embodiment.

[0020] Figure 2A This figure shows the batch preparation operation setting screen when the automatic blank calibration is not selected (not executed).

[0021] Figure 2B This figure shows the batch preparation operation setting screen when automatic blank calibration is selected (executed).

[0022] Figure 3 This is a flowchart for explaining an example of analysis preparation operation before execution of automatic blank calibration in the batch preparation operation.

[0023] Figure 4 It means in Figure 2A The diagram shows a configuration example of a batch preparation operation setting screen 400 in which a timeout setting function for blank calibration is added to the batch preparation operation setting screen.

[0024] Figure 5 This is a flowchart for explaining the automatic setting process of the maintenance execution order in the batch preparation list.

[0025] Figure 6 1 is a diagram showing a configuration example of an analysis parameter setting screen 600 for each item of automatic blank calibration.

[0026] Figure 7 This is a flowchart for explaining the batch preparation operation in the second embodiment when the standby time for stabilization of the light source lamp 113 is omitted.

[0027] Figure 8 1 is a diagram showing a configuration example of a batch preparation operation setting screen 800 for setting the time reduction mode. DETAILED DESCRIPTION

[0028] Hereinafter, the embodiments of the present disclosure will be described using the accompanying drawings. In the following embodiments, the constituent elements (including element steps, etc.) are not required except for cases specifically indicated and cases clearly considered to be required in principle. In addition, part of the structure of each embodiment can be replaced with the structure of another embodiment. Furthermore, the structure of another embodiment can be added to the structure of each embodiment. In addition, with respect to a part of the structure of each embodiment, other structures can be added, deleted, or replaced.

[0029] (1) First embodiment

[0030] <Configuration Example of Automatic Analyzer>

[0031] Figure 1 This is a diagram showing a schematic configuration example of an automatic analyzer 100 that is commonly applicable to each embodiment.

[0032] The automatic analyzer 100 includes a specimen mounting unit 110, an analysis unit 120, a control unit (control device: for example, a computer) 130, and a display device 140. In the specimen mounting unit 110, specimens such as blood and urine are dispensed into a specimen container 101 provided on a specimen transport rack 102 and transported to the positions of the specimen dispensing mechanisms 103 and 104 of the analysis unit 120. Hereinafter, such a specimen transport mechanism is referred to as a rack type. Into the reaction container 105, the specimen sucked from the specimen container 101 by the specimen dispensing mechanisms 103 and 104 and the reagent sucked from the reagent bottle 108 in the reagent disk 109 by the reagent dispensing mechanisms 106 and 107 are dispensed. The reaction container 105 (also referred to as a reaction unit (cell)) is arranged on the circumference of the reaction tank 115 located in the analysis unit 120. The reaction liquid of the specimen and the reagent is stirred by the ultrasonic wave emitted by the stirring device 111. Then, the reaction container 105 rotates and moves. Each time the reaction vessel 105 passes along the optical axis of the spectrophotometer 112 (dashed line), the absorbance of the reaction solution is measured. The spectrophotometer 112 includes a light source lamp 113 and a detector 114. The detector 114 receives light transmitted from the light source lamp 113 through the reaction vessel 105. The control unit 130 calculates the concentration of the target component in the reaction solution based on the measured absorbance information and displays the result on the display device 140.

[0033] In the automatic analyzer 100, the control unit 130 performs various maintenance on the sample setting unit 110 and the analysis unit 120 to maintain the performance of each mechanism. The display device 140 includes a monitoring screen that displays the operating status of the automatic analyzer 100 and an input device such as a keyboard.

[0034] Furthermore, this embodiment is described assuming a rack type, but the operation of this embodiment described below can also be applied to a tray type automatic analyzer in which the specimen containers 101 are placed on a tray on the upper surface of the device.

[0035] In the automatic analyzer 100, the measurement performed for the correction and status confirmation of the reagent is called calibration. The sample to be measured uses a blank standard solution that does not contain the target substance component and one or more standard solutions (also called calibrants) with known concentrations of the target substance. The calibration that only measures the absorbance of the reaction solution of the blank standard solution and the reagent is called blank calibration. The blank standard solution used in the blank calibration uses ion exchange water (also called pure water) used as the device system water, physiological saline, or a zero-concentration standard solution dedicated to the reagent. In addition, the automatic analyzer 100 of this embodiment is configured to automatically perform an analysis preparation action (described later). In addition, the automatic analyzer 100 is configured to be able to perform automatic blank calibration in response to the operator's selection, and is configured to automatically perform blank absorbance measurement before its execution when automatic blank calibration is selected.

[0036] <About batch preparation actions>

[0037] The automatic analyzer 100 must perform maintenance (recommended maintenance) at various scheduled times, such as immediately after powering on, when device performance becomes unstable, before analysis begins, and before shutting down the device for the day. The function in which the operator selects any number of these maintenance items and lists them, and the control unit 130 executes the maintenance items registered in the list, is called a batch preparation operation. For example, batch preparation operations can be performed at power-on, upon waking from sleep mode, before analysis begins, or at any other time specified by the operator.

[0038] Furthermore, in this embodiment, actions that verify analytical performance within maintenance items and device status inspection items that do not rely on operator settings are collectively referred to as analysis preparation actions. For example, (i) blank absorbance measurement of reaction vessel 105, (ii) detection of the lighting time of light source lamp 113, and (iii) temperature measurement of reaction tank 115 are examples of analysis preparation actions. Furthermore, in this embodiment, temperature measurement of reaction tank 115, which has not been previously performed as an analysis preparation action, is included in the analysis preparation actions before automatic blank calibration is performed.

[0039] (i) Blank absorbance measurement of reaction vessel 105

[0040] The blank absorbance measurement of the reaction vessel 105 refers to measuring the absorbance in a state where only the system water of the device is dispensed into the reaction vessel 105. In the present embodiment, the blank absorbance measurement is implemented by an item installed on the device as a maintenance item. For example, a photometric inspection that measures the blank absorbance of one reaction vessel 105 and a unit blank measurement that measures the blank absorbance of all reaction vessels 105 installed in the reaction tank 115 (the time required is longer than the photometric inspection) correspond to the blank absorbance measurement (maintenance item). The reaction vessel 105 deteriorates during repeated measurements and is prone to dirt and damage inside and outside the container, so it needs to be replaced regularly. For example, when the device is operated under standard conditions of use, it is recommended to replace the reaction vessel 105 with a new one every month. This is because if the measurement is performed in a state with dirt or scratches, it may not be possible to measure the accurate absorbance.

[0041] (ii) Lighting time detection of the light source lamp 113

[0042] The detection of the lighting time of the light source lamp 113 is an action required to ensure the stability of the light intensity, based on the characteristic that the lamp dims immediately after being lit and stabilizes as the light intensity increases over time. In a conventional automatic analyzer 100, a standby time is required from the time the light source lamp 113 is turned on until a predetermined time has passed. The absorbance measured when the light intensity of the light source lamp 113 is insufficient may be higher than the original absorbance of the sample, as in the case of measuring a sample with high turbidity. In addition, as an example of a lamp used for the light source lamp 113, there is a halogen lamp. It is known that the light intensity of such a halogen lamp gradually decreases as the total lighting time increases. For example, in the automatic analyzer 100, it is recommended that the light source lamp 113 be replaced with a new one every six months. Because the light source lamp 113 generates heat, a standby time is required until the temperature of the components and its surroundings stabilizes in order to perform stable measurements.

[0043] In addition, in the conventional analysis preparation operation, whether the light source lamp 113 is stable is also confirmed, but the determination of whether it is stable is based on the operator's visual observation. On the other hand, in the first embodiment, the lighting time of the light source lamp 113 is detected, and based on the result, it is automatically determined whether the next analysis preparation operation (temperature detection of the reaction tank 115) should be performed (refer to Figure 3 ).

[0044] (iii) Temperature detection of reaction tank 115

[0045] The temperature detection of the reaction tank 115 is necessary because the temperature of the reaction tank 115 affects the performance of the reagent in the reaction container 105 and the reaction accuracy of the specimen and the reagent. In order to ensure the performance of the specimen and the reagent, the temperature of the reaction tank 115 is maintained in the range of 37.0±0.1°C in the automatic analyzer 100. This temperature range is within the range of the optimal temperature of the enzyme contained in the reagent. In addition, when the water temperature has not fully risen, such as after the power of the automatic analyzer 100 is just turned on, or when the water temperature becomes very high, the reaction efficiency of the reagent is reduced and accurate measurement results cannot be obtained. Therefore, the specimen measurement cannot be performed while the temperature of the reaction tank 115 is outside the said range.

[0046] In the above-mentioned analysis preparation action, confirmation of the lighting time of the light source lamp 113 and execution of blank absorbance measurement of the reaction vessel 105 were not necessary for the measurement of the specimen in the past. In addition, in the automatic blank calibration described in Patent Document 1, the above-mentioned analysis preparation action is not necessarily performed in the batch preparation action. For example, when the operator measures the sample without performing a photometer check, even if there is small garbage attached to the reaction vessel 105 into which the sample is dispensed, if the garbage is not removed in the simple inspection of the automatic analyzer before the analysis action, it may be impossible to measure the accurate absorbance. In addition, in the previous automatic analyzer and Patent Document 1, temperature detection of the reaction tank 115 is necessary for the measurement of the specimen. However, in this case, it is performed at a fixed time after the batch preparation action is completed and before the measurement action of the specimen begins.

[0047] In contrast, the automatic analyzer of this embodiment is characterized in that these analysis preparation operations are necessarily performed during the batch preparation operation for performing automatic blank calibration, thereby ensuring analysis performance that could not be ensured in the batch preparation operation of conventional automatic analyzers.

[0048] <Blank Calibration in Batch Preparation and Registration of Analysis Preparation>

[0049] Figure 2A as well as Figure 2B This is a diagram for explaining the blank calibration and the registration of the analysis preparation operation in the batch preparation operation. Figure 2A This is a diagram showing a setting screen for the batch preparation operation when the automatic blank calibration is not selected (not executed). Figure 2B This is a diagram showing a setting screen for a batch preparation operation when automatic blank calibration is selected (executed).

[0050] like Figure 2A as well as Figure 2BAs shown, the batch preparation operation setting screen 200 includes an item list 201 including at least one maintenance item and analysis preparation item; a batch preparation list 202; a registration group name 203; a check box 204 for enabling execution of blank calibration; an add arrow 205; and a delete arrow 206.

[0051] (i) When automatic blank calibration is not performed

[0052] Without performing automatic blank calibration, Figure 2A In the example, the operator can select only the maintenance items and analysis preparation items that they want to register as batch preparation actions from the item list 201 and add them to the batch preparation list 202 (for example, by clicking the target item and pressing the add arrow 205). In addition, if they want to temporarily exclude specific selected items from the batch preparation list 202, for example, the operator can click the target item in the batch preparation list 202 and press the delete arrow 206.

[0053] When the selection of items included in the batch preparation list 202 is completed, the control unit 130 stores (registers) the items registered in the batch preparation list 202 as a group of batch preparation actions in a storage device (not shown) in response to the operator's registration instruction. Then, by selecting the registered group, the operator can automatically execute the group in ascending order of the numbers in the list. For example, Figure 2A As shown, if the batch preparation list 202 includes the reaction tank water replacement and ISE reagent priming as a group, when the operator selects this group, the operations are executed in that order (reaction tank water replacement → ISE reagent priming). The registered batch preparation list 202 is managed by the registered group name 203 at the top of the screen, and selection can be made on a group-by-group basis (the selection screen is not shown).

[0054] (ii) When automatic blank calibration is performed

[0055] Automatic blank calibration is set by enabling (checking) the automatic blank calibration selection box 204 located at the top of the batch setup action setting screen 200. At this time, analysis setup action items performed before the automatic blank calibration are automatically included in the batch setup action list. Analysis setup action items other than the cell blank measurement (e.g., temperature measurement of the reaction tank 115) are not displayed in the item list 201 and are therefore registered only to the control unit 130.

[0056] When automatic blank calibration is set, a cell blank measurement or a photometer check for measuring the blank absorbance of the reaction container 105 is automatically added to the batch preparation list 202. Figure 2BThe figure shows a state where a photometer check has been automatically added. Cell blank measurement is a maintenance item corresponding to blank absorbance measurement of reaction vessel 105. If the reaction vessel 105 is contaminated or damaged, an alarm can be issued indicating that it is unusable (maintenance / replacement recommendation). The automatically added items (cell blank measurement or photometer check, or both) can be pre-registered by the operator, or the operator can be required to select them each time when automatic blank calibration is enabled.

[0057] As a result, the operator does not need to manually register the analysis preparation actions, and the omission of registration and execution of the analysis preparation actions required for automatic blank calibration is eliminated. In addition, in the automatic analyzer 100 of this embodiment, the information of the standard solution used for the automatic calibration measurement during the batch preparation action can be registered and changed by entering a code (not shown) in the analysis parameter setting screen, similar to the existing automatic analyzers. As a result, the setting of the standard solution in the blank calibration can be selected for each item from system water or any sample prepared by the operator (physiological saline, calibration, etc.). Therefore, in the case of wanting to perform calibration of only an arbitrary sample, the corresponding code unique to the above arbitrary sample can be entered in the column specifying the zero-concentration standard solution.

[0058] <Analysis of the details of the preparation action>

[0059] Figure 3 This is a flowchart for explaining an example of analysis preparation operation before execution of automatic blank calibration in the batch preparation operation.

[0060] (i) S301 and S308

[0061] After the batch preparation operation begins, the control unit 130 determines whether the light source lamp 113 has been continuously illuminated for at least a predetermined time to confirm that the light intensity is stable. If the predetermined time is less than the predetermined time, the control unit 130 waits until the predetermined time is reached. For example, if the predetermined time is set to 30 minutes, the halogen lamp used in the light source lamp 113 is fully illuminated, and it is assumed that the light intensity is sufficient for absorbance measurement.

[0062] (ii)S302

[0063] The control unit 130 detects the temperature of the reaction vessel 115 .

[0064] (iii)S303

[0065] The control unit 130 determines whether the temperature of the reaction tank 115 is within a predetermined range (e.g., a range specified in a specification). If the temperature of the reaction tank 115 is within the predetermined range (S303: Yes), the process proceeds to S304. On the other hand, if the temperature of the reaction tank 115 is not within the predetermined range (S303: No), the process proceeds to S309.

[0066] (iv)S304

[0067] The control unit 130 reads the elapsed time and measurement result from the blank absorbance measurement of the reaction container 105 performed just before (the last blank absorbance measurement), and determines whether it exceeds the predetermined time (for example, 24 hours) set in advance by the operator, or whether the result just before (last time) is outside the predetermined absorbance range (for example, the range given in the specifications).

[0068] If the predetermined time has passed or the immediately preceding result is outside the predetermined absorbance range (S304: Yes), the process proceeds to S305. If the predetermined time has passed and the immediately preceding result is within the predetermined absorbance range (S304: No), the process proceeds to S307.

[0069] (v)S305

[0070] The control unit 130 performs a blank absorbance measurement of the reaction vessel 105. In this embodiment, the blank absorbance measurement of the reaction vessel 105 performed in S305 is assumed to be performed as a maintenance item. Therefore, this operation differs from the absorbance measurement of a water blank automatically performed before sample measurement in the automatic analyzer 100.

[0071] (vi)S306

[0072] The control unit 130 determines whether the blank absorbance value of the reaction vessel 105 measured in S305 satisfies a predetermined absorbance range (e.g., a range specified in the same specifications as described above). If the blank absorbance value is within the predetermined absorbance range (S306: Yes), the process proceeds to S307. If the blank absorbance value is outside the predetermined absorbance range (S306: No), the process proceeds to S311.

[0073] (vii)S307

[0074] The control unit 130 performs automatic blank calibration based on the requested analysis item and analysis parameters. Furthermore, if the immediately preceding blank absorbance measurement result and elapsed time for the reaction vessel 105 fall within the predetermined range (S304: No), the current blank absorbance measurement for the reaction vessel 105 can be omitted. This reduces maintenance time while ensuring device performance.

[0075] (viii)S309

[0076] In S303 , when the temperature of the reaction vessel 115 is outside the predetermined range ( S303 : No), the control unit 130 waits until a predetermined time has passed.

[0077] (ix)S310

[0078] The control unit 130 again determines whether the temperature of the reaction tank 115 is within the predetermined time. If the temperature of the reaction tank 115 is within the predetermined time (S310: Yes), the process proceeds to S304. On the other hand, if the temperature of the reaction tank 115 is still outside the predetermined time (S310: No), the process proceeds to S311.

[0079] (x)S311

[0080] The control unit 130 interrupts the batch preparation operation and displays an alarm (message, etc.) on the display device 140. For example, if the predetermined temperature range of the reaction tank 115 is set to 37.0±0.1°C, this coincides with the optimal temperature range for the reagent reaction. Therefore, reactions at reaction tank temperatures unsuitable for the reagent reaction can be suppressed.

[0081] Furthermore, in S306, if the blank absorbance of the reaction vessel 105 deviates from the predetermined range, the control unit 130 also outputs an alarm on the screen of the display device 140, notifying the operator that calibration has not been performed due to an abnormality in the batch preparation operation, and interrupting the batch preparation operation. Thus, calibration is not performed if there is an abnormality in the reaction vessel 105. Therefore, the operator can perform calibration using a normal reaction vessel 105 after performing necessary maintenance, ensuring analytical performance.

[0082] In addition, in the automatic analyzer of the past, even when the result of the photometer inspection or the unit blank measurement indicates an abnormal value, no alarm is output except in specific cases. This is because it is impossible to immediately determine that the photometer is abnormal based on the unit box measurement result. In addition, even if the unit blank measurement result indicates an abnormal value, it is possible to skip the reaction vessel 105 indicating the abnormal value without using it. Therefore, in order to view the result, the operator needs to open the maintenance screen of the operating unit. Moreover, the operator who is not a full-time operator of the automatic analyzer is not familiar with the operation and may not be able to fully confirm the result or deal with adverse conditions. According to the present embodiment, an alarm for abnormal detection is issued in S311, so the operator can reliably and in real time notice the abnormality of the analysis preparation action and can take appropriate measures according to the information shown in the alarm.

[0083] Furthermore, as described above, if the temperature of the reaction tank 115 or the blank absorbance of the reaction vessel 105 is abnormal during the batch preparation operation, the batch preparation operation is interrupted and the automatic blank calibration is not performed. This prevents calibration failures caused by poor status of the automatic analyzer 100. This reduces reagent waste and saves time and effort in re-measurements. Furthermore, by notifying the operator with an alarm, delays in reporting can be avoided.

[0084] <Timeout Setting>

[0085] exist Figure 3 In the process of S304, the setting of the scheduled time is explained. Figure 4 It means in Figure 2A The diagram shows a configuration example of a batch preparation operation setting screen 400 in which a timeout setting function for blank calibration is added to the batch preparation operation setting screen.

[0086] In the batch preparation action setting screen 400, when the operator presses the blank calibration setting button 401 in the lower right corner, a pop-up screen 402 appears for setting the analysis preparation action for automatic blank calibration. In pop-up screen 402, if the operator enables (checks) the blank absorbance check timeout checkbox, the validity period of the last blank absorbance measurement value of the reaction vessel 105 in the selected batch preparation action list can be set. For example, if the timeout 403 is set to 4 hours, the blank absorbance result of the reaction vessel 105 within 24 hours of the execution of the batch preparation action including the automatic blank calibration can be used instead. Therefore, a second absorbance measurement is not required. Even if the power is off, data within 24 hours can be stored and used in the control unit 130.

[0087] Furthermore, the operator can set a threshold for blank absorbance measurements of the reaction vessel 105 by entering a predetermined value in the allowable absorbance field 404. For example, if the operator enables the daytime allowable absorbance (24-hour allowable absorbance) (by checking the box), the control unit 130 will invalidate the blank absorbance measurement of the reaction vessel 105 if the difference from the previous blank absorbance measurement falls outside a predetermined range, thereby aborting the measurement before automatic blank calibration is performed. By aborting the calibration, calibration failures caused by contamination, damage, or deterioration of the reaction vessel 105, such as the light source lamp 113, can be prevented, allowing the operator to perform necessary maintenance and replacement of consumables. Consequently, the status of contamination and damage of the reaction vessel 105, as well as deterioration of the light source lamp 113 and detector 114, can be readily confirmed, minimizing the impact on analytical performance. Furthermore, by comparing the absorbance value with the previous blank absorbance measurement to confirm performance, the operator can be notified of, for example, the replacement time for the reaction vessel 105 or the light source lamp 113. This allows the replacement cycles for consumables, previously recorded by the operator, to be recorded and managed on the device. This prevents falsely high measurement results due to deterioration of consumables caused by neglected replacement, damage to the reaction vessel 105, or contamination.

[0088] (2) Second embodiment

[0089] Reference Figures 5 to 7 , explaining the second embodiment of the present disclosure. In addition, Figure 1 The configuration example of the automatic analyzer 100 shown above can also be applied to the second embodiment. In addition, the functions of the first embodiment and the functions of the second embodiment can be used in combination as long as they are not contradictory.

[0090] <Automatic Setting of Maintenance Execution Order in Batch Preparation List>

[0091] Figure 5 This is a flowchart for explaining the automatic setting process of the maintenance execution order in the batch preparation list.

[0092] (i)S501

[0093] The control unit 130 accepts registration of the batch preparation list A by the operator on the batch preparation operation setting screen 200 .

[0094] (ii)S502

[0095] The control unit 130 determines whether automatic blank calibration is included in the registered batch preparation list A. If batch preparation list A includes automatic blank calibration (S502: Yes), the process moves to step S503. On the other hand, if batch preparation list A does not include automatic blank calibration (S502: No), the process moves to step S504.

[0096] (iii)S503

[0097] The control unit 130 lowers the execution order of the automatic blank calibration operation included in the batch preparation list A to the end.

[0098] (iv)S504

[0099] The control unit 130 determines whether a maintenance item that turns off the light source lamp 113 during maintenance is included in the batch preparation list A. If a maintenance item that turns off the light source lamp 113 is included (S504: Yes), the process proceeds to S505. On the other hand, if a maintenance item that turns off the light source lamp 113 is not included (S504: No), the process proceeds to S506.

[0100] Furthermore, maintenance items that require the light source lamp 113 to be extinguished during execution include, for example, replacing the light source lamp 113, replacing the water in the reaction tank 115, and cleaning the reaction tank by draining the water from the reaction tank 115. For example, in an automatic analyzer 100 equipped with a light source lamp 113 that requires 30 minutes to illuminate before reaching maximum light intensity, imagine a scenario where an operator adds the replacement of the light source lamp 113 to the end of a batch preparation list with a total execution time of 10 minutes. In this case, in conventional automatic analyzers, the light source lamp 113 is replaced after the 10-minute batch preparation operation, requiring a 30-minute waiting time even after the replacement is completed. In contrast, in the second embodiment of the automatic analyzer 100 equipped with this function, the batch preparation operation of replacing the light source lamp 113 is automatically placed at the beginning of the execution order. This allows other batch preparation operations (10 minutes) to be performed during the 30-minute waiting time after the light source lamp 113 is replaced. Therefore, in this case, the time from the start of the batch preparation operation to the start of the automatic blank calibration can be shortened by 10 minutes.

[0101] (v)S505

[0102] The control unit 130 shifts the order of the corresponding maintenance items (items that turn off the light source lamp 113 when executed) in the batch preparation list A to the top.

[0103] (vi)S506

[0104] The control unit 130 completes the updating of the batch preparation list A.

[0105] <Parameter setting screen for each item of automatic blank calibration>

[0106] Figure 61 is a diagram showing a configuration example of an analysis parameter setting screen 600 for each item of automatic blank calibration. The analysis parameter setting screen 600 can be displayed, for example, by an operator selecting analysis parameter setting from a menu display (not shown).

[0107] The analysis parameter setting screen 600 includes, for example, an analysis parameter item setting section 601 , an automatic calibration setting section 602 , and an automatic blank calibration setting section 603 .

[0108] In the analysis parameter setting screen 600, for example, the operator can select the item he wants to edit from the analysis parameter list (for example, the blood test item list) shown in the analysis parameter item setting section 601, and edit various parameter settings. In the automatic analyzer 100, the automatic calibration setting section 602 can be used to set the timing for recommending the implementation of automatic calibration. In addition, in this embodiment, the setting of the timeout time 604 can be registered from the automatic blank calibration setting section 603. Therefore, the operator can set the timing for implementing the automatic blank calibration for the item selected from the analysis parameter item setting section 601. Figure 6 In the example, "blank" indicates blank calibration. Specifically, the automatic calibration setting unit 602 allows you to set whether to perform automatic blank calibration when reagents are replaced between batches or bottles. Furthermore, you can also set whether to perform automatic blank calibration for reagents within a bottle (reagents within the same bottle). Furthermore, in the analysis parameter setting screen 600, if the execution of each automatic blank calibration is set, the timeout period can be set using the automatic blank calibration setting unit 603 located on the same setting screen (i.e., without going through other screens (e.g., the screen for setting the recommended timeout period)).

[0109] By being able to perform the above-mentioned settings, the operator can decide whether the automatic blank calibration of each analysis parameter can be implemented. For example, by setting a timeout 604 in a project where the status of a reagent that is prone to deterioration is to be confirmed more frequently than other reagents, more reliable reagent monitoring can be performed. For example, in a reagent and measurement project where the status of a reagent that is prone to deterioration is to be confirmed more frequently than other reagents, a timeout 604 is set so that the measurement can be performed with the set timeout, thereby enabling reliable reagent monitoring. That is, if the timeout is within the set timeout, the measurement is performed using the target reagent. If the timeout is exceeded, the measurement using the target reagent is not performed. Reagents are stored at a fixed temperature, but some reagents deteriorate after a certain period of time after being unsealed, or the components in some reagents precipitate. Therefore, by checking the blank absorbance by dividing the time from unsealing (timeout), problems related to reagents (changes in blank absorbance caused by reagent degradation) can be solved. In addition, when the automatic analyzer 100 is in a standby state and the timeout has passed, it is also possible to prioritize the measurement of the corresponding project at the start of operation.

[0110] <Wait Time After Light Source Lamp 113 is Turned On Omitted: Time Shortening Mode>

[0111] Figure 7 This is a flowchart for explaining the batch preparation operation in the second embodiment when the standby time for stabilization of the light source lamp 113 is omitted. Figure 7 The batch preparation action shown is for example the same as Figure 3 The analysis preparation operation or batch preparation operation (normal mode) shown is distinguished from the above and is referred to as a "time reduction mode" (which may also be referred to as an "emergency mode" or the like). Figure 8 1 is a diagram showing a configuration example of a batch preparation operation setting screen 800 for setting the time reduction mode. Figure 8 The execution of the time reduction mode can be set (selected) by checking the time reduction mode selection box 801 in the batch preparation operation setting screen 800. When the normal mode (with the standby time of the light source lamp 113) is selected, the operator can simply uncheck the time reduction mode selection box 801.

[0112] (i)S701

[0113] When the time reduction mode is selected, the control unit 130 records the variable A defining the number of blank absorbance measurements of the reaction vessel 105 to 1 in the internal memory (not shown) upon starting the batch preparation operation, and holds the analysis preparation until the temperature of the reaction vessel 115 reaches a predetermined range. Furthermore, other maintenance items can be performed during the preparation hold in S701.

[0114] (ii)S702

[0115] When the control unit 130 detects that the temperature of the reaction vessel 115 has reached a predetermined time, the control unit 130 instructs the analysis unit 120 to measure the blank absorbance of the reaction vessel 105. In response to the instruction from the control unit 130, the analysis unit 120 measures the blank absorbance of the reaction vessel 105.

[0116] (iii)S703

[0117] The control unit 130 determines whether the blank absorbance of the reaction vessel 105 measured in step 702 is within a predetermined range. If the blank absorbance is within the predetermined range (S703: Yes), the process proceeds to S704. On the other hand, if the blank absorbance is outside the predetermined range (S703: No), the process proceeds to S705.

[0118] (iv)S704

[0119] The control unit 130 starts blank calibration measurement.

[0120] (v)S705

[0121] The control unit 130 determines whether the value of variable A exceeds a predetermined integer value (previously set value). If the value of variable A is less than or equal to an arbitrary integer value (set value N) (S705: No), the process proceeds to S706. If the value of variable A is greater than (exceeds) the arbitrary integer value (set value N) (S705: Yes), the process proceeds to S708. The arbitrary integer value (N) indicates the number of repetitions for blank absorbance measurement of the reaction vessel 105, and the operator can set any value.

[0122] (vi)S706

[0123] The control unit 130 adds 1 to the current value of the variable A to obtain a variable A′ (A′=A+1), and stores the variable A′ in an internal memory (not shown) or the like.

[0124] (vii)S707

[0125] The control unit 130 stops (stands by) processing the reaction vessel 105 for a predetermined time (arbitrary set value) from the moment the blank absorbance obtained in the most recent measurement is determined to be outside a predetermined range, thereby ensuring the stability of the light source lamp 113. This prevents repeated measurement of the reaction vessel blank absorbance while the light intensity of the light source lamp 113 is unstable.

[0126] Then, after waiting for the predetermined time, the control unit 130 performs blank absorbance measurement of the reaction container 105 again in S703 .

[0127] (viii)S708

[0128] The control unit 130 determines that the blank absorbance measurement of the reaction container 105 has failed, displays an alarm, and interrupts the batch preparation operation for which execution has been instructed.

[0129] As described above, according to this embodiment, by utilizing a portion of the standby time until the light intensity of the light source lamp 113 stabilizes for blank absorbance measurement of the reaction vessel 105, it is expected that the time required for batch preparation operations can be shortened. Furthermore, in S703, when the aforementioned daytime (24-hour) permissible absorbance is enabled, if the measured blank absorbance of the reaction vessel 105 falls within the permissible daytime absorbance range, the control unit 130 determines that the spectrophotometer 112 is stable and initiates blank calibration measurement in S704.

[0130] Furthermore, this operation has been described with respect to the automatic analyzer 100 , but the technology is also applicable to an analyzer that performs analysis using system water and is not limited to the field of use.

[0131] (3) Summary

[0132] (i) According to this embodiment, in the automatic analyzer 100, the control unit 130 performs analysis preparation operations, including temperature detection of the reaction vessel 105 to adjust the temperature of the reaction vessel 105 and other operations (such as blank absorbance measurement of the reaction vessel 105 and detection of the lighting time of the light source lamp 113), before executing automatic blank calibration to confirm whether the state of the automatic analyzer 100 is stable. Then, if the control unit 130 determines that a predetermined time has passed since the light source lamp 113 was turned on, it measures the blank absorbance of the reaction vessel 105. Thus, blank calibration is automatically performed after confirming the state of the automatic analyzer 100, thereby avoiding calibration failures caused by device malfunctions. For example, the analysis preparation operations include measuring the blank absorbance of the reaction vessel 105. If the blank absorbance value obtained through the analysis preparation operations is within a predetermined range, the control unit 130 automatically performs blank calibration. However, blank absorbance measurement need not be performed every time. For example, when the blank absorbance obtained in the last blank absorbance measurement is within a predetermined range and within a predetermined time from the last blank absorbance measurement, the control unit 130 determines that the blank absorbance of the reaction container 105 is below the predetermined value, does not remeasure the blank absorbance, and automatically performs blank calibration (S304→S307).

[0133] When the temperature of the reaction vessel 115 is within a predetermined temperature range, the control unit 130 performs automatic blank calibration. After the light source lamp 113 stabilizes, the temperature range of the reaction vessel 115 is further checked to determine whether blank calibration can be performed appropriately, thereby improving the accuracy of blank calibration.

[0134] In the automatic analyzer 100 of this embodiment, the control unit 130 performs the following processing: displays a batch preparation action setting screen 200 for setting analysis preparation action items from a plurality of maintenance items on the screen of the display device 140; and registers the selected maintenance items as batch preparation actions in the storage unit in response to an input selection instruction. The batch preparation action setting screen 200 includes a blank calibration selection field 204 for selecting the execution of automatic blank calibration. When automatic blank calibration is selected (when the checkbox in the blank calibration selection field 204 is checked), the control unit 130 additionally executes maintenance items (photometer inspection, cell blank measurement) in addition to the maintenance items selected as the batch preparation action. This ensures that the necessary maintenance items required for executing the automatic blank calibration are reliably executed, thereby ensuring the accuracy of the blank calibration.

[0135] Furthermore, if the batch preparation operation specified by the operator includes turning off the light source lamp 113 as a maintenance item, the control unit 130 starts the batch preparation operation from the moment the light source lamp 113 is turned off. Since it takes time for the light source lamp 113 to stabilize, the time until stabilization can be used to check other maintenance items, enabling efficient analysis preparation.

[0136] The second embodiment of the present disclosure proposes a time shortening mode for the analysis preparation action. In detail, the control unit 130 displays a mode setting screen for setting the time shortening mode on the screen of the display device 140, and the time shortening mode omits the standby action of the predetermined time after the light source lamp 113 is turned on before the action of the light source lamp irradiating the reaction vessel 105 is stabilized. When the operator sets (selects) the time shortening mode, the control unit 130 performs automatic blank calibration after confirming that the blank absorbance measurement of the reaction vessel 105 is within the predetermined range. Then, when it is determined that the blank absorbance measurement of the reaction vessel 105 is not within the predetermined range, the control unit 130 repeatedly performs the blank absorbance measurement (the number of repetitions is pre-set (limited) to N times). Thus, the standby time until the amount of light of the light source lamp 113 is stabilized can be used for the blank absorbance measurement action of the reaction vessel 105, thereby shortening the time of the batch preparation action.

[0137] (ii) The functions of the present embodiment can also be implemented by the program code of the software. In this case, a storage medium having the program code recorded thereon is provided to a system or device, and the computer (or CPU, MPU) of the system or device reads the program code stored in the storage medium. In this case, the program code read out from the storage medium itself implements the functions of the above-mentioned embodiment, and the program code itself and the storage medium having the program code stored thereon constitute the present disclosure. As a storage medium for supplying such a program code, for example, a floppy disk, CD-ROM, DVD-ROM, hard disk, optical disk, optical magnetic disk, CD-R, magnetic tape, non-volatile memory card, ROM, etc. are used.

[0138] Alternatively, an OS (operating system) or the like running on a computer may perform a portion or all of the actual processing based on the instructions of the program code, and the functions of the aforementioned embodiments may be realized through such processing. Alternatively, after the program code is read from a storage medium and written to a memory on a computer, a CPU or the like of the computer may perform a portion or all of the actual processing based on the instructions of the program code, and the functions of the aforementioned embodiments may be realized through such processing.

[0139] Furthermore, the program code of the software that implements the functions of the implementation method can also be distributed via a network, thereby storing it in a storage device such as a hard disk or memory or a storage medium such as a CD-RW or CD-R of the system or device, and when in use, the computer (or CPU, MPU) of the system or device reads and executes the program code stored in the storage device or the storage medium.

[0140] The processes and techniques described herein are not inherently associated with any specific device and can also be implemented by a combination of components. In addition, various types of general-purpose devices can also be added. In order to perform the functions of this embodiment and each example, a dedicated device can also be constructed. In addition, various functions can also be formed by appropriately combining multiple components disclosed in this embodiment and each example. For example, several components can be deleted from all the components shown in the embodiment and each example, and the components of different examples can also be appropriately combined.

[0141] In this disclosure, specific examples are described, but these examples are for illustration (understanding the technology of the present disclosure) and not for limitation in all respects. If one has general knowledge of the technical field, it is believed that many combinations of hardware, software, and firmware corresponding to the technology of the present disclosure can be understood. For example, the software described can be implemented by a wide range of programs or scripting languages such as assembler, C / C++, Perl, Shell, PHP, Java (registered trademark), etc.

[0142] Furthermore, in the above-described embodiment, the control lines and information lines are those considered necessary for explanation, and not all control lines and information lines are necessarily shown in the product. All components may be connected to each other.

[0143] In addition, anyone with ordinary knowledge in this technical field can clearly understand other implementations of the present disclosure based on the present embodiment and the examples. The description and specific examples are only typical examples, and the technical scope and concept of the present disclosure are shown in the scope of the subsequent patent protection requests.

[0144] Explanation of symbols

[0145] 101 specimen container

[0146] 102 specimen transport rack

[0147] 103, 104 specimen dispensing mechanism

[0148] 105 reaction vessel

[0149] 106, 107 reagent dispensing mechanism

[0150] 108 reagent bottles

[0151] 109 reagent tray

[0152] 110 specimen installation department

[0153] 111 stirring device

[0154] 112 Spectrophotometer

[0155] 113 light source lamp

[0156] 114 detector

[0157] 115 reaction tank

[0158] 120 Analysis Department

[0159] 130 Control Department

[0160] 140 display device.

Claims

1. An automatic analyzer that performs automatic blank calibration and measures the temporal change of a mixed solution obtained by mixing a sample and a reagent, characterized in that: The automatic analysis device comprises: a reaction container capable of containing the specimen and the reagent; an analysis unit configured to measure the mixed solution contained in the reaction container; a reaction tank for regulating the temperature of the reaction container; as well as Control Department, Before executing the automatic blank calibration, the control unit executes an analysis preparation operation including an operation for detecting the temperature of the reaction vessel and other operations to confirm whether the state of the automatic analyzer is stable.

2. The automatic analysis device according to claim 1, characterized in that The automatic analyzer further comprises: a light source lamp for irradiating the reaction container; and a detector for detecting transmitted light when the reaction container is irradiated with light. The analysis preparation action includes an action of measuring the blank absorbance of the reaction container, The control unit executes the automatic blank calibration when the blank absorbance is within a predetermined range.

3. The automatic analysis device according to claim 2, characterized in that The control unit determines that the blank absorbance of the reaction container is equal to or less than a predetermined value when the blank absorbance obtained by the previous blank absorbance measurement is within a predetermined range and within a predetermined time from the previous blank absorbance measurement.

4. The automatic analysis device according to claim 2, characterized in that The control unit measures the blank absorbance of the reaction container when it is determined that a predetermined time has elapsed since the light source lamp was turned on.

5. The automatic analysis device according to claim 1, characterized in that When the temperature of the reaction tank is within a predetermined temperature range, the control unit performs the automatic blank calibration.

6. The automatic analysis device according to claim 1, characterized in that The control unit executes the following processing: displaying a batch preparation operation setting screen for setting items of the analysis preparation operation from a plurality of maintenance items on a screen of a display device; And in response to the input selection instruction, the selected maintenance items are registered in the storage unit as batch preparation actions.

7. The automatic analysis device according to claim 6, characterized in that The batch preparation operation setting screen includes a blank calibration selection field for selecting execution of the automatic blank calibration. When execution of the automatic blank calibration is selected, the control unit additionally executes a maintenance item other than the maintenance item selected as the batch preparation operation.

8. The automatic analysis device according to claim 7, characterized in that When the execution of the automatic blank calibration is selected, the control unit executes the automatic blank calibration after executing all the maintenance items included in the batch preparation operation.

9. The automatic analysis device according to claim 6, characterized in that When the batch preparation operation includes turning off a light source lamp as the maintenance item, the control unit starts the batch preparation operation from turning off the light source lamp.

10. The automatic analysis device according to claim 1, characterized in that The control unit displays a mode setting screen for setting a time shortening mode on the screen of the display device. The time shortening mode omits a standby action for a predetermined time after the light source lamp is turned on until the action of the light source lamp irradiating the reaction container stabilizes. When the time shortening mode is set, the automatic blank calibration is performed after confirming that the blank absorbance measurement of the reaction container is within a predetermined range.

11. The automatic analysis device according to claim 10, characterized in that When it is determined that the blank absorbance measurement of the reaction container is not within a predetermined range, the control unit repeatedly performs the blank absorbance measurement.

12. An automatic analysis method, wherein a control unit of an automatic analysis apparatus controls execution of a blank calibration and measurement of a temporal change of a mixed solution obtained by mixing a sample and a reagent by an analysis unit, characterized in that: The automatic analysis method comprises: Before executing the automatic blank calibration, the control unit executes an analysis preparation operation, the analysis preparation operation including an operation of detecting the temperature of a reaction tank for regulating the temperature of a reaction container capable of accommodating the specimen and the reagent, and other operations; and The control unit executes the automatic blank calibration after confirming whether the state of the automatic analyzer is stable through the analysis preparation operation.

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