JP2022034183A - Automatic analyzer - Google Patents

Abstract

To provide an automatic analyzer which can set a calibration measurement method for a bottle set with simple operation regardless of operation patterns of calibration so as to reduce workloads of operators.SOLUTION: An automatic analyzer includes: a step S01 of extracting a bottle set as a combination of reagent containers holding reagents used for each analysis item, so as to display a calibration state screen including a bottle set list in which a list of the extracted bottle sets is displayed; and a step S06 of storing a batch request set table in which selection logic of a calibration measurement method is set for each bottle set, so as to set the calibration measurement method in accordance with the selection logic in the batch request set table for each bottle set in the bottle set list with instruction of an operator.SELECTED DRAWING: Figure 6

Description

The present invention relates to an automatic analyzer for clinical examination that performs qualitative and quantitative analysis of biological samples such as blood and urine, and particularly relates to an automatic analyzer capable of holding a plurality of reagent containers for one reagent.

In the analyzer for clinical examination, a sample such as blood or urine is dispensed from the sample container to the reaction vessel by the sample dispensing mechanism, and the reagent is dispensed from the reagent container to the reaction vessel into which the sample is dispensed by the reagent dispensing mechanism. Dispense and stir. After that, the reaction is carried out for a certain period of time, and the concentration of the target item contained in the sample is calculated by measuring the absorbance and the amount of luminescence obtained from the reaction solution.

When multiple reagent containers are used to analyze one item, they are classified as the first reagent container, the second reagent container, the third reagent container, and so on, depending on the time from sample dispensing to reagent dispensing. To. Regarding the reagent containers classified in this way, when only the first reagent container is used, when the first reagent container and the second reagent container are used, when the first reagent container and the third reagent container are used, the first Depending on the analysis item, such as when using the 1st to 3rd reagent containers, a pattern of a single substance or various combinations may occur.

Here, it is assumed that there is an analysis item using the first reagent container and the second reagent container, and it is assumed that a plurality of the first reagent container and the second reagent container can be mounted on the automatic analyzer. For example, if two first reagent containers and three second reagent containers are installed in the device and "reagent registration" is requested, the device reads the bar code attached to each reagent container and reads each reagent container. recognize. In addition, the instrument calculates the combination of reagent containers used in the analysis. In this case, since there are two first reagent containers and three second reagent containers, there are 6 (= 2 × 3) possible combination patterns (hereinafter, may be referred to as “bottle set”). Is.

In order to perform qualitative and quantitative analysis of biological samples such as blood and urine, standard solution samples (hereinafter referred to as "calibrators") adjusted to a plurality of known concentrations in advance are prepared for each bottle set. It is necessary to analyze using the reagent of the container and obtain the relational expression between the concentration and the absorbance or the concentration and the amount of luminescence (hereinafter referred to as "calibration curve"). The calibration curve data measured in this way is stored for each bottle set.

In addition, in order to confirm that the stored calibration curve is appropriate, a sample having a known concentration (hereinafter referred to as “control”) is analyzed using the bottle set. If the result of calculating the measured value (control concentration) using the calibration curve data of the bottle set is within a predetermined threshold value, the calibration curve data is considered to be appropriate.

In the following, creating calibration curve data is referred to as calibration, and confirming that the calibration curve is appropriate is referred to as control measurement. In addition, as a name combined with other words, "calib", which is an abbreviation for calibration, may be used.

If the automated analyzer has only one bottle set for one analysis item, the bottle set is used up and the next bottle set is used in the middle of the routine work of analyzing a plurality of patient samples. At the time of (referred to as "changeover"), calibration and control measurements need to be interrupted and performed for this new bottle set. Therefore, a time loss occurs during routine work.

Patent Document 1 is configured to be able to acquire calibration curve data not only for the bottle set currently used for one analysis item but also for a plurality of bottle sets that may be used after the changeover. We disclose an automatic analyzer that measures calibration and control for each bottle set in advance before the start of routine work and eliminates the time loss of changeover during routine work.

Similar to Patent Document 1, Patent Document 2 is configured so that calibration curve data can be acquired for each of a plurality of bottle sets used at present and in the future, as well as reagent exchange and the previous calibration. We will disclose an automated analyzer equipped with a function to automatically create a calibration and control measurement implementation schedule in consideration of cases where a certain period of time has passed and certain conditions such as poor measurement results of the control sample are met.

Japanese Unexamined Patent Publication No. 2013-21741 Japanese Unexamined Patent Publication No. 2009-168730

There are various types of calibration curve methods for creating calibration curve data, such as the characteristics of the calibration curve (straight line, non-straight line), the calibration curve of the bottle set obtained by the measurement of the calibrator, or other bottles. The operation to select the calibration measurement method is done according to the situation such as whether it is inherited from the set, whether the entire calibration curve must be created, or whether a part of the calibration curve should be updated. There is.

Calibration is performed with a combination of reagents used for each analysis item, and in an automated analyzer in which multiple reagent containers for reagents required for measurement are held in advance in the device, calibration is performed for each combination of reagent containers. There is a need to. In actual operation, depending on the nature of the reagent of the analysis item, part or all of the calibration curve data of the bottle set currently in use should be inherited by the waiting bottle set to reduce the number of measurement points for calibration. Is also done. For example, if the waiting bottle set is in the same lot as the bottle set in use, there is no problem even if the calibration of the bottle set in use is taken over as it is. As described above, by narrowing down the calibration measurement to a necessary range in terms of inspection accuracy, there is an effect that the cost and cost required for calibration can be reduced.

However, in Patent Documents 1 and 2, when the automatic analyzer holds a plurality of bottle sets for each analysis item, the calibration measurement method is set differently for the plurality of bottle sets. Even so, there is no way to efficiently specify a calibration measurement method for multiple bottle sets. As the number of analysis items, the type of reagent used for one analysis, and the number of reagent containers held by the device increases, the number of bottle sets that need to set the calibration measurement method increases, which is a difficult task for the operator. , Can be a factor of erroneous input.

In the present invention, even when different calibration measurement methods are set for a plurality of bottle sets related to one analysis item, they can be set by a simple operation and the workload of the operator is reduced. The purpose is.

An automatic analyzer capable of holding a plurality of reagent containers for one reagent according to an embodiment of the present invention includes a computer having a calculation unit and a data storage unit, and an output unit connected to the computer. The calculation unit extracts a bottle set that is a combination of reagent containers held for the reagent used for each analysis item, and the output unit performs calibration including a list of the extracted bottle sets. The status screen is displayed, the data storage unit stores the batch request setting table that defines the selection logic of the calibration measurement method for each bottle set, and the calculation unit receives the operator's instruction and the bottle set in the bottle set list. Set the calibration measurement method that matches the selection logic of the batch request setting table for each.

Further, the automatic analyzer capable of holding a plurality of reagent containers for one reagent, which is another embodiment of the present invention, has a computer having a calculation unit and a data storage unit, and the calculation unit is A bottle set, which is a combination of holding reagent containers for the reagents used for each analysis item, is extracted, and the data storage unit performs calibration when a predetermined event occurs in the automatic analyzer. The automatic request setting table that defines the selection logic of the calibration measurement method for each set is stored, and the calculation unit receives the occurrence of a predetermined event and performs calibration by the calibration measurement method according to the automatic request setting table. Request a calibration measurement for the bottle set.

Regardless of the operation pattern of various calibrations, the operator can set the calibration measurement method for each bottle set with a simple operation, and the workload of the operator can be reduced.

Issues, configurations and effects other than those described above will be clarified by the following description of the embodiments.

This is an example of the caliber batch request setting screen. It is a figure which shows the data structure of the batch request setting table. It is an overall block diagram of an automatic analyzer. This is an example of a caliber status screen. This is an example of a caliber status screen. It is a flowchart of the calibration measurement batch request flow of Example 1. FIG. It is a batch request setting table for the bottle set of analysis item A. It is a figure explaining the change of the display content of a bottle set list (excerpt). This is an example of the caliber automatic request setting screen. It is a figure which shows the data structure of the automatic request setting table. It is a flowchart of the calibration measurement automatic request flow of Example 2. This is an example of the quality control status screen. This is an example of the quality control status screen. This is an example of the control batch request setting screen.

Hereinafter, examples of the present invention will be described with reference to the accompanying drawings.

The overall configuration of the automated analyzer will be described with reference to FIG. The automatic analyzer 100 mainly includes a sample disk 101, a reaction disk 104, a sample dispensing mechanism 106, a reagent disk 107, a reagent dispensing mechanism 110, a sound wave irradiation mechanism 111, a stirring mechanism 112, a photometric mechanism 114, and a reaction vessel cleaning mechanism 115. , Has an overall control unit 121. On the sample disk 101, a sample container 103 for accommodating the sample 102 is arranged concentrically. The reaction vessel 202 is arranged concentrically on the reaction disk 104, and the arranged reaction vessel 202 is kept at a constant temperature by the constant temperature bath circulating liquid 113. On the reagent disk 107, reagent containers 109 containing various reagents 108 are arranged concentrically.

The overall control unit 121 includes a control circuit 116, a metering circuit 117, and a computer 118. The computer 118 includes an input unit 119 (for example, a pointing device, a keyboard, etc.), a graphical user interface (GUI) related to measurement results and various operations. ) Etc. are connected to the output unit 120. In the example of FIG. 3, the control circuit 116 of the overall control unit 121 is connected to each component unit to control the entire device, but each component unit is configured to have an independent control unit. You can also do it.

The analysis by the automatic analyzer 100 is mainly carried out as follows. First, the sample 102 installed on the sample disk 101 is dispensed from the sample container 103 to the reaction container 202 on the reaction disk 104 by the sample dispensing mechanism 106. After that, the reaction vessel 202 containing the sample 102 is moved to the reagent dispensing position by the rotational operation of the reaction disk 104, and the reagent dispensing mechanism 110 moves the reagent 108 used for analysis from the reagent vessel 109 to the sample 102. Dispense into the containing reaction vessel 202. The mixed solution of the sample 102 and the reagent 108 contained in the reaction vessel 202 is referred to as a reaction solution 122. Subsequently, the reaction liquid 122 in the reaction vessel 202 is degassed by the sound wave irradiation mechanism 111, and then the reaction liquid 122 in the reaction vessel 202 is stirred by the stirring mechanism 112. The reaction vessel 202 is kept at a constant temperature, for example, 37 ° C. by the constant temperature bath circulating liquid 113 filled in the lower part of the reaction disk 104, in order to promote the reaction and stabilize the progress of the reaction.

When the reaction liquid 122 in the reaction vessel 202 passes through the photometric mechanism 114 as the reaction disk 104 rotates, its optical characteristic change is measured via the photometric circuit 117. The photometric data thus obtained is sent to the computer 118, the concentration of the target component in the sample is obtained by the arithmetic unit 123 in the computer 118, and the obtained data is stored in the data storage unit 124. , The result is displayed on the output unit 120. The reaction vessel 202 after the reaction is washed by the reaction vessel cleaning mechanism 115 and is repeatedly used for the next reaction, or is discarded in a reaction vessel disposal section (not shown).

Next, the process up to setting the bottle set in the automatic analyzer as shown in FIG. 3 will be described. Here, a certain analysis item (item name TEST1) in which the sample concentration is measured using the first reagent container and the second reagent container will be described as an example.

This process is executed, for example, at the start of one day's operation of the device. The operator puts the necessary reagent container into the device according to the inspection schedule of the device on the day. Depending on the amount of reagent used estimated from the test schedule, the device may need to hold multiple reagent containers for the same reagent. Here, it is assumed that two reagent containers for the first reagent and two second reagent containers for the second reagent used in the analysis item TEST1 are installed on the reagent disk 107. When distinguishing these, each reagent container shall be referred to as "first reagent container 1", "first reagent container 2", "second reagent container 1", and "second reagent container 2".

When the operator instructs the automatic analyzer 100 to register the remaining amount of the reagent from the input unit 119, the automatic analyzer 100 drives the reagent dispensing mechanism 110 and the reagent disk 107 to calculate the remaining amount of the reagent in each reagent container. The automatic analyzer 100 recognizes that the reagent container can be used when the remaining amount of the reagent in each reagent container is in a state where it can be used in the analysis once or more (the number of remaining tests is one or more), and the reagent used in the analysis. Register the bottle set according to the combination of containers in the device (referred to as reagent pairing process).

In this case, since both the first reagent container and the second reagent container are held by two, bottle set 1: [first reagent container 1, second reagent container 1], bottle set 2: [first reagent container 1]. , 2nd reagent container 2], Bottle set 3: [1st reagent container 2, 2nd reagent container 1], Bottle set 4: [1st reagent container 2, 2nd reagent container 2] are registered (key brackets) Indicates a combination of reagent containers).

Here, since the bottle set is used for the bottle sets 1 to 4 (in ascending order), the combination of the reagent containers of each bottle set is also determined according to the use priority of the reagent containers. In this example, the first reagent container 1 has a higher usage priority than the first reagent container 2, and the second reagent container 1 has a higher usage priority than the second reagent container 2. Further, on the operation screen described later, the bottle set is displayed as "in use", "standby 1", "standby 2", and "standby 3" in order from the bottle set to be used first. Here, the processing up to the setting of the bottle set for the analysis item TEST1 has been described, but the bottle set is similarly set for the mounted reagents for the other analysis items executed by the apparatus.

Even with the same reagent, correct results cannot be obtained with the same calibration curve data due to slight differences in concentration and the like depending on the reagent container. That is, it is necessary to use the calibration curve data for each bottle set in the analysis, and therefore the calibration needs to be performed for each bottle set. There are multiple calibration measurement methods, and an appropriate measurement method is set for each bottle set.

For example, when creating a new non-linear calibration curve, calibrators having different concentrations (for example, from a calibrator having a low concentration to standard solution 1, standard solution 2, standard solution 3, ... Standard solution N) are used. Apply "all-point calibration" to measure 3 or more and create a calibration curve. If the calibration curve is a straight line, in addition to all-point calibration, "blank calibration" that creates a calibration curve using only standard solution 1, and another calibration curve with a different concentration from standard solution 1 are used. The created "2-point calibration" can be applied. On the other hand, instead of creating a new one, the calibration curve calculated by another bottle set can be taken over and a part of the calibration curve data can be updated to obtain the calibration curve data of the bottle set. In this case, in addition to the above-mentioned "blank calibration" and "2-point calibration", "span calibration" that calculates a part of the calibration curve using one calibrator other than the standard solution 1 can be applied. The operator is required to set which measurement method is applied to perform the calibration for each bottle set according to the properties of the reagents of the analysis items.

In the first embodiment, the operator sets and executes the calibration measurement method for the bottle set for each analysis item registered in the apparatus.

FIG. 4 shows a caliber (calibration) status screen 501 in which an operator requests calibration from an automated analyzer. The bottle set list 502 of the status screen 501 displays a list of bottle sets held by the apparatus. On this screen, you can select any row in Listing 502 to request calibration of the bottle set in the selected row, set availability, and check the calibration measurement status. It has become. The configuration of the caliber status screen 501 will be described below. The row selection in the bottle set list 502 can be selected for each row or for a plurality of rows at the same time.

The buttons arranged on the lower side of the status screen 501 are mainly buttons provided for setting the availability of the bottle set or confirming the measurement status of the calibration.

The QC mask setting button 505 is used for mask setting / cancellation based on the control measurement result. If the result of the control measurement of the selected bottle set exceeds the threshold value, the calibration curve data is incorrect. In this case, the QC mask is set, and in this case, the bottle set cannot be used for the measurement of the patient sample, but can be used only for the calibration measurement and the control measurement.

The caliber mask setting button 506 is used to set / cancel the mask based on the calibration failure. If calibration of the selected bottle set fails, set the caliber mask, in which case the bottle set cannot be used for patient sample measurement, control measurement, only for calibration measurement. Can be done.

The results of the calibration measurement are stored in the device. The carb trace button 507, the calib result button 508, and the reaction process monitor button 509 are for the operator to confirm the accumulated calibration measurement results. Specifically, by pressing the caliber trace button 507, a screen for tracing and displaying the measurement date and the calibration measurement result for the selected bottle set is opened. Pressing the caliber result button 508 opens a screen displaying the latest calibration measurement results for the selected bottle set. Pressing the reaction process monitor button 509 opens a screen that displays the amount of light in the reaction process of the latest calibration measurement of the selected bottle set.

On the other hand, on the right side of the status screen 501, a button for requesting calibration measurement of the bottle set is mainly provided. The selection combo box 503 and the batch request button 504 are for collectively setting the measurement method for each bottle set according to predetermined conditions. Although the details will be described later, by pressing the batch request button 504, the calibration measurement method can be collectively set for the bottle sets listed in the bottle set list 502.

The setting buttons 307 to 311 are used to individually modify the collectively set measurement methods. That is, the setting buttons 307 to 311 set the calibration measurement method of the selected bottle set to blank calibration (307), 2-point calibration (308), all-point calibration (309), and span calibration (310), respectively. , Used to change to not request (311). It is also possible to individually set the calibration measurement method for each bottle set using these buttons from the beginning without making a batch request.

By pressing the registration button 514, the set contents are stored in the device, and the calibration request for each bottle set is executed with the contents.

Further, the batch request setting edit button 510 is used when it is desired to change the content of the measurement method registered when the batch request button 504 is pressed. This will also be described later.

Next, each column of the bottle set list 502 will be described. Reagent position 502a indicates a position on the reagent disk 107 on which the reagent container of the bottle set is mounted. The number on the left side indicates the position of the first reagent container, and the number on the right side indicates the position of the second reagent container. The item name 502b is the name of the analysis item, and the usage status 502c indicates the usage priority of the bottle set. From the above information, it can be seen that, for example, four bottle sets are registered in the analysis item TEST1 using two reagents. The reagent lot 502d is a lot number of the reagent container constituting the bottle set. Reagents in reagent bottles with the same lot number can be considered to be exactly the same, which also affects the choice of calibration measurement method. The caliber inheritance 502e shows information about the inheritance source of the calibration curve of the bottle set. "Bottle" is from the past calibration measurement of the bottle set, "Lot" is from the calibration measurement of the bottle set of the same lot as the bottle set, and "Item" is the calibration curve from the calibration measurement of the bottle set of different lots. Indicates that it inherits. This column is provided because the bottle set mounted on the device adopts a mechanism to inherit the calibration curve from some kind of bottle set, and the operator should review the measurement method based on this information. Is possible.

In the bottle set list 502, all the bottle sets mounted on the apparatus are displayed for the analysis items to be carried out in the future. Bottle sets that have been consumed by the timing of the status screen 501 display are deleted from the bottle set list 502, and the usage status 502c is advanced for the remaining bottle sets.

Without the batch request mechanism described later, the operator would set the calibration measurement method for all the bottle sets displayed in the bottle set list 502 one by one. This is a burden on the operator. Even if the bottle sets have the same analysis item (for example, TEST1), not all the same measurement methods are selected. Depending on the analysis item, all points are calibrated with the "in use" bottle set, but with the "standby 1" bottle set, there is no problem with calibration with fewer calibrators to measure, for example, blank calibration is selected, or You may choose not to request calibration measurements. In particular, the number of bottle sets that must be set increases as the number of analysis items increases, the types of reagents used for analysis items increase, and the number of reagent containers mounted on the device increases, which increases the burden on the operator. Further increase.

In order to reduce the burden on the operator, in this embodiment, the selection logic of the calibration measurement method of the bottle set is defined in advance, and the measurement method is collectively set for the bottle set that matches the selection logic. Specifically, the bottle set for a certain analysis item is classified using two conditions, and the calibration measurement method is determined in advance for each classification. The set selection logic is determined, for example, when the automatic analyzer is installed, and is stored in the data storage unit 124 of the computer 118. When the operator presses the batch request button 504 on the status screen 501, the calculation unit 123 performs calibration that matches the selection logic stored in the data storage unit 124 for each of the bottle sets listed in the bottle set list 502. Set the measurement method.

The two categories used in the selection logic are "usage status" and "measurement status". In the "usage status" classification, the bottle set is "in use set" (usage status 502c is "in use" bottle set) and other "standby sets" (usage status 502c is "standby 1", "standby 2").・ ・ Classify as bottle set). In the "measurement status" classification, the bottle sets classified by "usage status" are further classified into "with results" (calibration measurement was performed with the bottle set's own reagent) and "no results" (with the bottle set's own reagent). It is classified as one that has not been calibrated, that is, one that inherits the calibration curve of another bottle set).

The calibration measurement method determined according to the classification of the bottle set is registered in the data storage unit 124 as a batch request setting database. FIG. 2 shows the data structure of the batch request setting table 401 registered in the batch request setting database. There may be multiple patterns in the daily operating trends of automated analyzers. In such a case, a plurality of batch request setting tables can be registered in the batch request setting database so that the setting contents of the calibration measurement method can be changed according to the operation tendency of the device. The batch request setting table 401 includes a table name 401a, an item name 401b, a usage status 401c, a measurement status 401d, and a measurement method 401e.

FIG. 6 shows the calibration measurement batch request flow of the first embodiment. First, the operator opens the caliber status screen (FIG. 4) (S01). At this time, the bottle set for each analysis item is displayed in the bottle set list 502 for the reagent container held by the apparatus and having one or more remaining tests. The batch request setting table is selected from the selection combo box 503 by the table name 401a (S02), and the batch request button 504 is pressed (S03).

The calculation unit 123 acquires the analysis item, the usage status, and the calibration measurement status for each bottle set in the bottle set list 502 (S04), and the analysis items, the usage status, and the measurement status match with respect to the batch request setting table. The line to be used is searched (S05), and the calibration measurement method registered in the batch request setting table is set for the bottle set (S06). Steps S04 to S06 are repeated until all the bottle sets in the bottle set list 502 have been set (S07).

FIG. 5 shows a screen after the calibration measurement method is set for all the bottle sets in the bottle set list 502 of the caliber status screen 501 of FIG. Information on the factor 502f of the bottle set list 502 and the measurement method 502g has been added. The factor 502f indicates a trigger for which the calibration measurement method is set, and in the first embodiment, the factor 502f is set by the operator at an arbitrary timing, so that the “manual” is displayed. The calibration measurement method set according to the batch request setting table of the table name "normal business day" is displayed in the measurement method 502g. The operator may change the measurement method by using the setting buttons 307 to 311 for the measurement method set collectively. After that, when the operator presses the registration button 514, the calibration measurement by the measurement method registered in the bottle set list 502 is requested.

It is also possible to modify the contents of the batch request setting table instead of the calibration measurement method for each bottle set. In this case, by pressing the batch request setting edit button 510 of FIG. 4 (FIG. 5), the caliber (calibration) batch request setting screen 301 of FIG. 1 is displayed.

In the batch request setting table list 302 on the left side of the setting screen 301, the batch request setting table registered in the batch request setting database of the device is displayed in a list. When the "normal business day" table in the batch request setting table list 302 is selected in the selection box 303, the measurement method list 304 for each analysis item is displayed. The content displayed in the measurement method list 304 is the content of the batch request setting table shown in FIG.

In the measurement method list 304, select a single or multiple lines of the analysis item for which you want to modify the measurement method, and if the measurement method you want to modify is "No result" in "In use set", "Used" in the usage combo box 305. Select "Medium", "No result" in the measurement status combo box 306, and press any of the setting buttons 307 to 310 corresponding to the desired calibration measurement method (blank, 2 points, all points, span). The same applies to other analysis items. When the registration button 314 is pressed after the correction, the contents of the batch request setting table are updated.

The batch request setting table is designed to determine the calibration measurement method based on two classifications, but the present invention is not limited to this. It may be set based on any one classification, or the third and subsequent classifications may be set. Further, the bottle set is not limited to being divided into two according to the classification, and may be divided into three or more.

FIGS. 7A and 7B show changes when the operator requests calibration measurement several times using the batch request setting function of this embodiment in one day. In this example, the bottle set of analysis item A is targeted, analysis item A uses the first reagent and the second reagent, and the device has two reagent containers each at the start of operation (the morning of the day). Suppose it is retained. FIG. 7A shows a batch request setting table for the bottle set of analysis item A.

FIG. 7B shows changes in the display contents on the bottle set list 502 (however, excerpts of items 502a, 502c, 502e, and 502g).

The bottle set list 701 is a display at the stage when the reagent pairing process is completed. The four bottle sets are listed. In each case, the calibration curve is inherited from the calibration measurement of bottle sets of different lots, so the caliber inheritance is an "item".

By pressing the batch request button in this state, the measurement method is set for each bottle set according to the batch request setting table of FIG. 7A. The display at this time is the bottle set list 702. Since no calibration measurement has been performed for any of the bottle sets, a "no result" measurement method is set.

After performing the calibration measurement with the contents of the bottle set list 702, the caliber status screen is displayed again and the batch request button is pressed to display the bottle set list 703. At this time, since the calibration measurement is performed for each bottle set, the caliber inheritance is changed to "bottle" and the measurement method of "result" is set.

After that, when the second reagent container 1 is consumed, the bottle set of the standby 1 is used. At this time, when the operator displays the caliber status screen and presses the batch request button, the bottle set list 704 is displayed. The conventional bottle sets of "standby 1", "standby 2", and "standby 3" are moved up to "in use", "standby 1", and "standby 2", respectively. In both cases, the calibration measurement is performed, so the caliber inheritance is "bottle", but the "in use" bottle set is the first calibration measurement after "in use", so all Point calibration is set.

After performing the calibration measurement with the contents of the bottle set list 704, when the operator displays the caliber status screen again and presses the batch request button, the bottle set list 705 is displayed. In this way, the measurement method is set for each bottle set according to the batch request setting table of FIG. 7A.

In the first embodiment, an example in which the operator requests the calibration measurement from the caliber status screen has been described, but in the second embodiment, an example in which the apparatus automatically performs the calibration measurement at a predetermined event will be described.

FIG. 8 is a caliber (calibration) automatic request setting screen. In this example, when the events of "reagent exchange", "timeout", and "QC failure" occur, the bottle set that needs to be calibrated is automatically requested to be calibrated by the predetermined measurement method. Set. Also, in the case of reagent exchange, the bottle set used for sample analysis is changed, so different settings can be made depending on whether the bottle set used next is the bottle set used so far and whether or not the lot has been changed. It has been made. In the case of reagent exchange without changing lots, different calibration measurement methods can be set based on "usage status" and "measurement status" as described in Example 1.

In addition to the reagent exchange, the "reagent exchange" event includes the case where a new bottle set is registered in the device. The "timeout" event occurs when a certain amount of time has passed since the last calibration measurement. The "QC failure" event occurs when a control sample is measured using a bottle set and the control result exceeds a threshold.

The analysis item list 802 is displayed on the left side of the caliber automatic request setting screen 801. In the selection box 803, the analysis item displayed in the analysis item list 802 is selected, and the calibration measurement method for each event is set for each analysis item. Measurement method Using the combo boxes 804 to 810, the operator sets the calibration measurement method for each event. The set contents are registered in the automatic request setting table 901 as shown in FIG. 9 and held in the data storage unit 124.

FIG. 10 shows a flow for automatically requesting calibration measurement by a predetermined calibration measurement method when a bottle set is newly or re-registered in the device by using the calibration automatic request function.

When the operator requests the reagent remaining amount registration (S11), the apparatus calculates the reagent remaining amount and performs the reagent pairing process as described above (S12). If the bottle set is new or re-registered, the arithmetic unit 123 requests calibration measurement by the measurement method set as the "reagent exchange" event.

The calculation unit 123 determines whether the bottle set is new or re-registered (S13), and acquires analysis items, usage status, and calibration measurement status for the new or re-registered bottle set (S14). Search the automatic request setting table for rows that match the analysis items, usage status, and measurement status (S15), and request the bottle set to perform calibration measurement using the measurement method registered in the automatic request setting table (S15). S16). Steps S13 to S16 are repeated until all bottle sets have been processed (S17). Note that re-registration means re-registering the calibrated bottle set in the device, and in this case as well, calibration can be automatically requested.

In the above two examples, the calibration measurement has been described, but in the control measurement as well, the batch or automatic request can be performed as in the calibration measurement. In the following, the description of the parts common to the first embodiment will be omitted, and the parts peculiar to the control measurement will be mainly described.

FIG. 11 shows a quality control (QC) status screen 1001 in which an operator requests an automatic analyzer for control measurement. In the bottle set list 1002 of the status screen 1001, the bottle sets held by the apparatus are displayed in a list. The columns 1002a to 1002c, 1002f, 1002g of the bottle set list 1002 are the same as the columns 502a to 502c, 502f, 502g of the bottle set list 502 of the caliber status screen 501 (see FIG. 5). On the other hand, in the bottle set list 1002, a control name 1002d indicating the name of the control to be used and a sample type 1002e indicating the type of the sample to be analyzed are provided. Even with the same bottle set, the control used for measurement may differ depending on the sample to be tested. In that case, the combination of the bottle set and the control is displayed. For example, in the example of FIG. 11, two types of bottle sets for the analysis item TEST1 are displayed in the bottle set list 1002, one is when the control QC1 is used and the other is when the control QC2 is used.

The operator selects any row in the bottle set list 1002 and locks the measurement request so that the bottle set in the selected row is not requested for measurement, canceled, or accidentally requested manually or automatically. You can do it. In this list as well, the rows can be selected for each row or for a plurality of rows at the same time. In addition, after the control measurement, the reaction process can be confirmed on a separate screen, and the transition of the measurement result can be confirmed.

On the right side of the status screen 1001, a button for requesting control measurement of the bottle set is mainly provided. With the selection combo box 1003 and the batch request button 1004, the measurement method can be collectively set for each bottle set according to predetermined conditions. On the other hand, the measurement method can be individually set or modified using the setting buttons 1007 to 1011. As the measurement method, three types can be selected: the same control measurement is repeated three times (1007), the same control measurement is repeated twice (1008), and the control measurement is performed once (1009). In addition, the request invalid button (1010) can be set to forcibly cancel the measurement request that was mistakenly requested manually, or the function that automatically requests the control measurement along with the calibration measurement, and the release button (1011) selects it. You can cancel the setting of the controlled measurement. Further, similarly to the caliber status screen 501, a registration button 1006 and a batch request setting edit button 1005 are provided.

Without the batch request mechanism described later, the operator would set the control measurement method for all the bottle sets displayed in the bottle set list 1002 one by one. This is a burden on the operator. This is because, in the case of control measurement as well as calibration measurement, not all bottle sets with the same analysis item (for example, TEST1) and the same control (for example, QC1) select the same measurement method. For example, it may be possible to select that the control measurement is performed twice with the "in use" bottle set, but not yet with the "standby 1" bottle set.

In order to reduce the burden on the operator, in this embodiment, the selection logic of the control measurement method of the bottle set is defined in advance, and the measurement method is collectively set for the bottle set that matches the selection logic. For example, as in the case of calibration measurement, when the selection logic is the usage priority of the bottle set and whether or not the control measurement is performed by the bottle set itself, the batch request setting table for the control measurement setting (Fig.) 2) or the automatic request setting table (see FIG. 9) may be stored in the data storage unit 124 of the computer 118. The data structure is the same, and each measurement method is the measurement method in the case of control measurement.

FIG. 12 shows a screen after the control measurement method is set for all bottle sets × controls in the bottle set list 1002 by pressing the batch request button 1004. Information on the factor 1002f of the bottle set list 1002 and the measurement method 1002g has been added.

Similar to the calibration measurement method, it is also possible to modify the contents of the batch request setting table for control measurement. In this case, by pressing the batch request setting edit button 1005 in FIG. 11 (FIG. 12), the control batch request setting screen 1101 in FIG. 13 is displayed. Since the control batch request setting screen 1101 is the same as the calibration batch request setting screen 301 shown in FIG. 1, detailed description thereof will be omitted.

The batch request setting table for control measurement is also not limited to determining the control measurement method based on two classifications, and even if it is set based on any one classification, the third and subsequent classifications are set. You may. Further, the bottle set is not limited to being divided into two according to the classification, and may be divided into three or more. Further, when the measurement method of the bottle set is changed depending on the control used for the measurement, the measurement method can be set for each combination of the analysis item and the control.

100 ... Automatic analyzer, 101 ... Sample disk, 102 ... Sample, 103 ... Sample container, 104 ... Reaction disk, 106 ... Sample dispensing mechanism, 107 ... Reagent disk , 108 ... Reagent, 109 ... Reagent container, 110 ... Reagent dispensing mechanism, 111 ... Sonic irradiation mechanism, 112 ... Stirring mechanism, 113 ... Constant temperature bath circulating liquid, 114 ...・ Measuring mechanism, 115 ・ ・ ・ Reaction container cleaning mechanism, 116 ・ ・ ・ Control circuit, 117 ・ ・ ・ Measuring circuit, 118 ・ ・ ・ Computer, 119 ・ ・ ・ Input unit, 120 ・ ・ ・ Output unit, 121 ・ ・-Overall control unit, 122 ... reaction liquid, 123 ... calculation unit, 124 ... data storage unit, 202 ... reaction container, 301 ... caliber batch request setting screen, 302 ... batch request Setting table list, 303 ... selection box, 304 ... measurement method list, 305 ... usage status combo box, 306 ... measurement status combo box, 307-311 ... setting button, 314 ... Registration button, 315 ... Cancel button, 401 ... Bulk request setting table, 501 ... Calib status screen, 502 ... Bottle set list, 503 ... Selection combo box, 504 ... Bulk request button , 505 ... QC mask setting button, 506 ... Calib mask setting button, 507 ... Calib trace button, 508 ... Calib result button, 509 ... Reaction process monitor button, 510 ... Collective request Setting edit button, 514 ... Registration button, 701 to 705 ... Bottle set list (excerpt), 801 ... Calib automatic request setting screen, 802 ... Analysis item list, 803 ... Selection box, 804 ~ 810 ... Measurement method combo box, 901 ... Automatic request setting table, 1001 ... Quality control status screen, 1002 ... Bottle set list, 1003 ... Selection combo box, 1004 ... Batch request Button, 1005 ... Batch request setting edit button, 1006 ... Registration button, 1007-1011 ... Setting button 1101 ... Control batch request setting screen 1102 ... Batch request setting table list 1103.・ ・ Selection box, 1104 ・ ・ ・ Measurement method list, 1105 ・ ・ ・ Usage status combo box, 1106 ・ ・ ・ Measurement status combo box, 1114 ・ ・ ・ Registration button, 1115 ・ ・ ・ Cancel button.

Claims (15)

An automated analyzer that can hold multiple reagent containers for one reagent.
A computer with a calculation unit and a data storage unit,
It has an output unit connected to the computer and has an output unit.
The calculation unit extracts a bottle set that is a combination of reagent containers held for the reagent used for each analysis item, and the calibration status including a bottle set list in which the extracted bottle sets are listed in the output unit. Display the screen,
The data storage unit stores a batch request setting table that defines the selection logic of the calibration measurement method for each bottle set.
The calculation unit is an automatic analyzer that receives an instruction from an operator and sets a calibration measurement method that matches the selection logic of the batch request setting table for each bottle set in the bottle set list. In claim 1,
The calibration status screen includes a setting button for individually selecting a calibration measurement method.
An automatic analyzer whose calibration measurement method set according to the batch request setting table in the bottle set list can be individually modified by the setting button. In claim 1,
The calibration status screen includes a batch request setting edit button for modifying the batch request setting table.
The output unit is an automatic analyzer that displays a calibration batch request setting screen that corrects the contents of the batch request setting table in response to the pressing of the batch request setting edit button. In claim 1,
The selection logic of the batch request setting table is a predetermined calibration measurement method based on whether the use priority of the bottle set or the calibration curve of the bottle set is created by the calibration measurement of the bottle set. Select an automatic analyzer. In claim 1,
The data storage unit stores a plurality of the batch request setting tables, and stores the plurality of batch request setting tables.
The calculation unit is an automatic analyzer that sets a calibration measurement method that matches the selection logic of the batch request setting table selected by the operator on the calibration status screen for each bottle set in the bottle set list. An automated analyzer that can hold multiple reagent containers for one reagent.
It has a computer with a calculation unit and a data storage unit,
The calculation unit extracts a bottle set, which is a combination of reagent containers held for the reagents used for each analysis item.
The data storage unit stores an automatic request setting table that defines a selection logic of a calibration measurement method for each bottle set when performing calibration when a predetermined event occurs in the automatic analyzer.
The calculation unit is an automatic analyzer that receives the occurrence of the predetermined event and requests calibration measurement for a bottle set to be calibrated by a calibration measurement method that matches the selection logic of the automatic request setting table. In claim 6,
As the predetermined event, the reagent container is replaced, the reagent is newly registered or re-registered, the timeout is elapsed from the previous calibration measurement, and the result of measuring the control sample exceeds the threshold value. Automatic analyzer including. In claim 6,
The selection logic of the automatic request setting table is a predetermined calibration measurement method based on whether the use priority of the bottle set or the calibration curve of the bottle set is created by the calibration measurement of the bottle set. Select an automatic analyzer. An automated analyzer that can hold multiple reagent containers for one reagent.
A computer with a calculation unit and a data storage unit,
It has an output unit connected to the computer and has an output unit.
The calculation unit extracts a bottle set that is a combination of reagent containers held for the reagent used for each analysis item, and the quality control status including a bottle set list in which the extracted bottle sets are displayed in a list in the output unit. Display the screen,
The data storage unit stores a batch request setting table that defines the selection logic of the control measurement method for each bottle set.
The calculation unit is an automatic analyzer that receives an instruction from an operator and sets a control measurement method that matches the selection logic of the batch request setting table for each bottle set in the bottle set list. In claim 9.
An automated analyzer displayed in the bottle set list as a combination of the bottle set and control measurement. In claim 9.
The quality control status screen includes a setting button for individually selecting a control measurement method.
An automatic analyzer whose control measurement method set according to the batch request setting table in the bottle set list can be individually modified by the setting button. In claim 9.
The quality control status screen includes a batch request setting edit button for modifying the batch request setting table.
The output unit is an automatic analyzer that displays a control batch request setting screen that modifies the contents of the batch request setting table in response to the pressing of the batch request setting edit button. In claim 9.
The selection logic of the batch request setting table is an automatic analyzer that determines a control measurement method for each bottle set based on the use priority of the bottle set or whether or not the control measurement is performed by the bottle set itself. In claim 9.
The data storage unit stores a plurality of the batch request setting tables, and stores the plurality of batch request setting tables.
The calculation unit is an automatic analyzer that sets a control measurement method that matches the selection logic of the batch request setting table selected by the operator on the quality control status screen for each bottle set in the bottle set list. In claim 9.
An automatic analyzer for which a manual control measurement request or an automatic control measurement request is forcibly canceled for a bottle set in which request invalidity is registered in the bottle set list.

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