CN114076828A - Automatic analyzer - Google Patents
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- CN114076828A CN114076828A CN202110805076.1A CN202110805076A CN114076828A CN 114076828 A CN114076828 A CN 114076828A CN 202110805076 A CN202110805076 A CN 202110805076A CN 114076828 A CN114076828 A CN 114076828A
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- 239000003153 chemical reaction reagent Substances 0.000 claims abstract description 155
- 238000000691 measurement method Methods 0.000 claims abstract description 97
- 238000004458 analytical method Methods 0.000 claims abstract description 71
- 238000005259 measurement Methods 0.000 claims description 97
- 238000011088 calibration curve Methods 0.000 claims description 38
- 238000013500 data storage Methods 0.000 claims description 19
- 238000004364 calculation method Methods 0.000 claims description 12
- 238000003825 pressing Methods 0.000 claims description 10
- 238000003908 quality control method Methods 0.000 claims description 10
- 239000000284 extract Substances 0.000 claims description 6
- 238000003556 assay Methods 0.000 claims description 5
- 238000007726 management method Methods 0.000 claims description 3
- 239000013068 control sample Substances 0.000 claims description 2
- 238000006243 chemical reaction Methods 0.000 description 39
- 239000000523 sample Substances 0.000 description 26
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- 238000012360 testing method Methods 0.000 description 4
- 239000008280 blood Substances 0.000 description 3
- 210000004369 blood Anatomy 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 239000013610 patient sample Substances 0.000 description 3
- 238000012545 processing Methods 0.000 description 3
- 238000003756 stirring Methods 0.000 description 3
- 210000002700 urine Anatomy 0.000 description 3
- 238000002835 absorbance Methods 0.000 description 2
- 230000002776 aggregation Effects 0.000 description 2
- 238000004220 aggregation Methods 0.000 description 2
- 239000012472 biological sample Substances 0.000 description 2
- 239000012295 chemical reaction liquid Substances 0.000 description 2
- 238000004140 cleaning Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 238000004020 luminiscence type Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- 238000004451 qualitative analysis Methods 0.000 description 2
- 238000004445 quantitative analysis Methods 0.000 description 2
- 230000001174 ascending effect Effects 0.000 description 1
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Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00594—Quality control, including calibration or testing of components of the analyser
- G01N35/00693—Calibration
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/01—Arrangements or apparatus for facilitating the optical investigation
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00594—Quality control, including calibration or testing of components of the analyser
- G01N35/00693—Calibration
- G01N2035/00702—Curve-fitting; Parameter matching; Calibration constants
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2201/00—Features of devices classified in G01N21/00
- G01N2201/12—Circuits of general importance; Signal processing
- G01N2201/127—Calibration; base line adjustment; drift compensation
Abstract
The automatic analyzer of the present invention can set a calibration measurement method for a bottle group by a simple operation without depending on an operation mode of calibration, thereby reducing a work load on an operator. A bottle group, which is a combination of reagent containers held for each reagent used for each analysis item, is extracted, a calibration status screen (501) including a bottle group list (502) in which the extracted bottle group is displayed in list is displayed (S01), a collective request setting table (401) in which selection logic of a calibration measurement method for each bottle group is determined is stored, and a calibration measurement method that matches the selection logic of the collective request setting table is set for each bottle group in the bottle group list upon receiving an instruction from an operator (S06).
Description
Technical Field
The present invention relates to an automatic analyzer for clinical examination that performs qualitative/quantitative analysis of a biological sample such as blood or urine, and more particularly to an automatic analyzer capable of holding a plurality of reagent containers for 1 reagent.
Background
In an analyzer for clinical examination, a sample such as blood or urine is dispensed from a sample container into a reaction container by a sample dispensing mechanism, and a reagent is dispensed from a reagent container into a reaction container into which the sample is dispensed by a reagent dispensing mechanism, and the mixture is stirred. Then, the reaction is allowed to proceed for a certain period of time, and the absorbance, the luminescence amount, and the like obtained from the reaction solution are measured, whereby the concentration of the target item contained in the sample is calculated.
When a plurality of reagent containers are used to analyze one item, the reagent containers are classified into a first reagent container, a second reagent container, and a third reagent container … according to the time from sample dispensing to reagent dispensing. The reagent containers classified in this way may be individually or variously combined depending on the analysis items, such as a case of using only the first reagent container, a case of using the first reagent container and the second reagent container, a case of using the first reagent container and the third reagent container, and a case of using the first reagent container to the third reagent container.
Here, it is assumed that there is an analysis item using the first reagent container and the second reagent container, and the automatic analyzer is provided with a plurality of first reagent containers and a plurality of second reagent containers that can be mounted thereon, respectively. For example, if 2 first reagent containers and 3 second reagent containers are set in the apparatus and "reagent registration" is requested, the apparatus reads the bar codes attached to the respective reagent containers and identifies the respective reagent containers. The apparatus then calculates a combination of reagent containers to be used for the analysis. In this case, since there are 2 first reagent containers and 3 second reagent containers, there are 6 (2 × 3) possible combination patterns (hereinafter, sometimes referred to as "bottle sets").
In order to perform qualitative/quantitative analysis of biological samples such as blood and urine, it is necessary to analyze standard solution samples (hereinafter, referred to as "calibrator") adjusted to a plurality of known concentrations in advance using reagents of corresponding reagent containers for each vial group, and to obtain a relational expression (hereinafter, referred to as "calibration curve") between the concentration and the absorbance or between the concentration and the amount of luminescence. The calibration curve data thus determined are stored for each vial group.
In order to confirm that the stored calibration curve is appropriate, a sample (hereinafter referred to as "control") having a known concentration is analyzed using the vial set. If the result of calculating the measured value (concentration of the control) using the calibration curve data of the bottle group is within a predetermined threshold value, the calibration curve data is considered appropriate.
Hereinafter, an event of creating calibration curve data is referred to as calibration (calibration), and an event of confirming that the calibration curve is appropriate is referred to as control measurement. In addition, "calib (キャリブ)" that is an omission of alignment may be used as a name to be combined with another word.
If the automatic analyzer has only 1 vial group for 1 analysis item, it is necessary to perform calibration and measurement of control items for a new vial group when the vial group is used up and the next vial group is used (referred to as "change over") in the middle of a routine operation for analyzing a plurality of patient samples. Therefore, a loss in time occurs in the routine work.
Documents of the prior art
Patent document
Patent document 1: japanese patent laid-open publication No. 2013-217741
Patent document 2: japanese laid-open patent publication No. 2009-168730
Disclosure of Invention
Problems to be solved by the invention
There are various calibration measurement methods for creating calibration curve data, and the calibration measurement method can be selected and used according to the characteristics (straight line and non-straight line) of the calibration curve, whether the calibration curve of a vial group is obtained by measurement by a calibrator or inherited from another vial group, whether the entire calibration curve must be created, and whether a partial section of the calibration curve should be updated.
The calibration is performed by a combination of reagents used for each analysis item, and in an automatic analyzer that holds a plurality of reagent containers for reagents necessary for measurement in advance in the analyzer, the calibration needs to be performed for each combination of reagent containers. In actual operation, depending on the nature of the reagent of the analysis item, the number of measurement points used for calibration is also reduced by making the bottle group on standby to inherit a part or all of the calibration curve data of the currently used bottle group. For example, if the bottle group on standby is the same batch as the bottle group in use, there is no problem even if the calibration of the bottle group in use is directly inherited. In this way, by performing the calibration measurement within a required range in terms of inspection accuracy, the cost and cost for calibration can be reduced.
However, in patent documents 1 and 2, when the automatic analyzer holds a plurality of bottle groups for each analysis item, there is no means for efficiently specifying a calibration measurement method for a plurality of bottle groups even if an operation is performed in which a measurement method for calibration is set differently for a plurality of bottle groups. The larger the number of analysis items, the types of reagents used for 1 analysis, and the number of reagent containers held by the device, the larger the number of vial groups required to set the calibration measurement method, which may cause an operator to perform an extremely large operation and cause erroneous input.
The purpose of the present invention is to enable setting by a simple operation and to reduce the workload on an operator even when an operation is performed in which different calibration measurement methods are set for a plurality of bottle groups relating to 1 analysis item.
Means for solving the problems
An automatic analyzer according to an embodiment of the present invention, which can hold a plurality of reagent containers for 1 reagent, includes: a computer having an arithmetic section and a data storage section; and an output unit connected to the computer, wherein the calculation unit extracts a bottle group, which is a combination of reagent containers held for reagents used for each analysis item, displays a calibration status screen including a bottle group list in which the extracted bottle group is displayed in a list, the data storage unit stores a summary request setting table that determines a selection logic of a calibration measurement method for each bottle group, and the calculation unit receives an instruction from an operator and sets a calibration measurement method for each bottle group in the bottle group list, the calibration measurement method being identical to the selection logic of the summary request setting table.
In addition, an automatic analyzer according to another embodiment of the present invention, which can hold a plurality of reagent containers for 1 reagent, includes a computer having a calculation unit and a data storage unit, wherein the calculation unit extracts a bottle group, which is a combination of reagent containers held for each reagent used in an analysis item, the data storage unit stores an automatic request setting table that determines a selection logic of a calibration measurement method for each bottle group when a predetermined event occurs in the automatic analyzer, and the calculation unit receives the occurrence of the predetermined event and requests calibration measurement for the bottle group for which calibration is performed by a calibration measurement method that matches the automatic request setting table.
Effects of the invention
Regardless of the operation mode of each calibration, the operator can set the calibration measurement method for each bottle group by a simple operation, and the work load on the operator can be reduced.
Problems, structures, and effects other than those described above will become apparent from the following description of the embodiments.
Drawings
Fig. 1 shows an example of a calibration summary request setting screen.
Fig. 2 is a diagram showing a data structure of the collective request setting table.
Fig. 3 is an overall configuration diagram of the automatic analyzer.
Fig. 4 is an example of a calibration status screen.
Fig. 5 is an example of a calibration status screen.
Fig. 6 is a flowchart of a calibration measurement summary delegation flow of embodiment 1.
FIG. 7A is a table showing the aggregate order settings of the bottle groups for analysis item A.
Fig. 7B is a diagram illustrating a change in the display content of the bottle group list (excerpted).
Fig. 8 is an example of a calibration automatic request setting screen.
Fig. 9 is a diagram showing a data structure of the automatic request setting table.
Fig. 10 is a flowchart of an automatic calibration measurement request procedure according to embodiment 2.
Fig. 11 is an example of the quality control situation screen.
Fig. 12 is an example of the quality control situation screen.
Fig. 13 is an example of a control product collection request setting screen.
Description of the reference numerals
100 … automatic analyzer
101 … sample tray
102 … test specimen
103 … sample container
104 … reaction disc
106 … sample dispensing mechanism
107 … reagent disk
108 … reagent
109 … reagent container
110 … reagent dispensing mechanism
111 … sound wave irradiation mechanism
112 … stirring mechanism
113 … thermostatic bath circulating liquid
114 … light measuring mechanism
115 … reaction vessel cleaning mechanism
116 … control circuit
117 … photometric circuit
118 … computer
119 … input part
120 … output part
121 … integral control part
122 … reaction solution
123 … arithmetic unit
124 … data storage section
202 … reaction vessel
301 … calibration summary request setting screen
302 … aggregate request set list
303 … selection box
304 … list of measurement methods
305 … usage status combo box
306 … determination condition combo box
307 to 311 … setting button
314 … registration button
315 … cancel button
401 … aggregate request setup table
501 … calibration status screen
502 … bottle group List
503 … selection combo box
504 … aggregation delegate button
505 … QC shield setting button
506 … calibration mask set button
507 … calibration tracking button
508 … calibration results button
509 … reaction Process monitoring button
510 … aggregate request settings edit button
514 … registration button
701 ~ 705 … bottle group list (extract)
801 … calibration automatic request setting screen
802 … analyzing item lists
803 … selection box
804-810 … measurement method combined frame
901 … automatic request setting table
1001 … screen for precision management status
1002 … list of bottle groups
1003 … selection combo box
1004 … aggregation delegate button
1005 … aggregate request setting edit button
1006 … registration button
1007 to 1011 … setting button
1101 … control product collection request setting screen
1102 … aggregate request set Table List
1103 … selection box
1104 … list of measurement methods
1105 … usage status combo box
1106 … measurement status combo box
1114 … registration button
1115 … cancel the button.
Detailed Description
Hereinafter, embodiments of the present invention will be described with reference to the drawings.
The overall configuration of the automatic analyzer will be described with reference to fig. 3. 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, an acoustic wave irradiation mechanism 111, a stirring mechanism 112, a photometric mechanism 114, a reaction vessel washing mechanism 115, and an overall controller 121. In the sample disk 101, sample containers 103 for storing samples 102 are arranged concentrically. In the reaction tray 104, the reaction vessels 202 are arranged in concentric circles thereof, and the arranged reaction vessels 202 are maintained at a constant temperature by the constant-temperature bath circulating liquid 113. In the reagent disk 107, reagent containers 109 containing various reagents 108 are arranged in concentric circles.
The overall control unit 121 includes a control circuit 116, a photometric circuit 117, and a computer 118, and the computer 118 is connected to an input unit 119 (e.g., a pointing device, a keyboard, and the like), and an output unit 120 that displays measurement results and a Graphical User Interface (GUI) related to various operations, and the like. In the example of fig. 3, the control circuit 116 of the overall control unit 121 is connected to each component to configure the overall control device.
The analysis performed by the automatic analyzer 100 is mainly performed as follows. First, the sample 102 set 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. Thereafter, the reaction vessel 202 containing the sample 102 is moved to the reagent dispensing position by the rotation operation of the reaction disk 104, and the reagent dispensing mechanism 110 dispenses the reagent 108 used for analysis from the reagent vessel 109 to the reaction vessel 202 containing the sample 102. The mixture of the sample 102 and the reagent 108 contained in the reaction container 202 is referred to as a reaction solution 122. Next, the reaction liquid 122 in the reaction container 202 is degassed by the acoustic wave irradiation mechanism 111, and then the reaction liquid 122 in the reaction container 202 is stirred by the stirring mechanism 112. The reaction vessel 202 is maintained at a constant temperature, for example, 37 ℃ by circulating the liquid 113 through a constant temperature bath filled in the lower portion of the reaction tray 104, thereby promoting the reaction and stabilizing the progress of the reaction.
As the reaction disk 104 rotates, the reaction solution 122 in the reaction container 202 passes through the photometric mechanism 114, and changes in optical characteristics are 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, the obtained data is stored in the data storage unit 124, and the result is displayed in the output unit 120. The reaction vessel 202 after the reaction is cleaned by the reaction vessel cleaning mechanism 115 and is repeatedly used for the next reaction or discarded in a reaction vessel disposal part not shown.
Next, a process before the bottle group is set in the automatic analyzer shown in fig. 3 will be described. Here, a description will be given taking as an example a certain analysis item (item name TEST1) for measuring a sample concentration using a first reagent container and a second reagent container.
This processing is executed, for example, at the start of one-day operation of the apparatus. The operator inserts the required reagent containers into the device according to the current day's inspection schedule of the device. The apparatus needs to hold a plurality of reagent containers holding the same reagent according to the usage amount of the reagent estimated by the examination. Here, it is assumed that 2 first reagent containers for the first reagent and 2 second reagent containers for the second reagent used in the analysis item TEST1 are provided on the reagent disk 107. In the case of distinguishing them, the respective reagent containers are 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 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 reagent in each reagent container. When the remaining amount of the reagent in each reagent container is equal to or more than 1 time in the analysis (the number of remaining tests is equal to or more than 1), the automatic analyzer 100 recognizes that the reagent container can be used, and registers a vial group corresponding to a combination of the reagent containers used in the analysis in the analyzer (referred to as a reagent pairing process).
In this case, since the first reagent container and the second reagent container each hold 2, the registration bottle group 1: first reagent container 1, second reagent container 1, vial group 2: first reagent container 1, second reagent container 2, vial group 3: first reagent container 2, second reagent container 1, vial group 4: [ first reagent container 2, second reagent container 2] (the square brackets indicate the combination of the reagent containers).
Here, since the bottle groups are used in ascending order of bottle groups 1 to 4, the combination of the reagent containers in each bottle group is also determined according to the priority of use of the reagent containers. This example is an example of a case where the first reagent container 1 has higher priority for use than the first reagent container 2, and the second reagent container 1 has higher priority for use than the second reagent container 2. The bottle group is displayed as "in use", "standby 1", "standby 2", and "standby 3" in order from the first used bottle group on an operation screen described later. Here, the process up to the setting of the vial group is described with respect to the analysis item TEST1, but the vial group is similarly set with respect to the reagent to be loaded with respect to other analysis items to be executed by the apparatus.
Even the same reagent cannot obtain accurate results even with the same calibration curve data due to slight differences in concentration or the like depending on the reagent container. That is, calibration curve data for each vial group needs to be used in the analysis, and thus calibration needs to be performed for each vial group. There are various measurement methods for calibration, and an appropriate measurement method is set for each vial group.
For example, when a non-linear calibration curve is newly created, an "all-point calibration" of the calibration curve is created by using calibrators that measure different concentrations of 3 or more (for example, the calibrators having a low concentration are set to the standard solutions 1, 2, 3, and …, respectively). If the calibration curve is a straight line, in addition to the full-point calibration, "blank calibration" in which the calibration curve is prepared using only the standard solution 1, and "2-point calibration" in which the calibration curve is prepared using the standard solution 1 and another 1 calibrator having a different concentration may be applied. In contrast, instead of creating a new calibration curve, the calibration curve data of the bottle group may be created by updating a part of the calibration curve data by inheriting the calibration curve calculated in another bottle group. In this case, in addition to the above-described "blank calibration" and "2-point calibration", a "span calibration" (which calculates a part of the calibration curve using a calibrator other than 1 standard solution 1) can be applied. The operator is required to set which measurement method is applied to perform calibration of each vial group according to the nature of the reagent of the analysis item.
[ example 1]
In example 1, the operator sets a measurement method for calibration for each bottle group of analysis items registered in the apparatus and executes the measurement method.
Fig. 4 shows a calibration status screen 501 for requesting the operator to calibrate the automatic analyzer. In the bottle group list 502 of the status screen 501, a list of bottle groups held by the apparatus is displayed. In this screen, an arbitrary line in the list 502 is selected, and not only the calibration of the bottle group in the selected line is requested, but also the usability can be set, or the measurement state of the calibration can be confirmed. The configuration of the calibration status screen 501 will be described below. The selection of rows in the bottle group list 502 can also be made on a per 1 row basis or multiple rows can be selected simultaneously.
The button disposed on the lower side of the status screen 501 is provided mainly for confirmation of usability setting of the bottle group or measurement status of calibration.
A QC mask (mask) setting button 505 is used for setting/releasing a mask based on the control measurement result. If the results of the control measurements for the selected vial group exceed the threshold, the calibration curve data is not appropriate. In this case, QC mask setting is performed, and in this case, the vial group cannot be used for measurement of a patient sample, and can be used only for calibration measurement and control measurement.
The calibration mask setting button 506 is used for mask setting/release based on a calibration failure. When the calibration of the selected vial group fails, the calibration mask is set, and in this case, the vial group cannot be used for measurement of a patient sample and measurement of a control, but can be used only for calibration measurement.
The results of the calibration measurements are stored in the device. The calibration trace button 507, the calibration result button 508, and the reaction process monitoring button 509 are buttons for the operator to confirm the results of the stored calibration measurement. Specifically, by pressing the calibration trace button 507, a screen for tracing and displaying the measurement date and the calibration measurement result is opened for the selected bottle group. By pressing the calibration result button 508, a screen displaying the result of the latest calibration measurement of the selected vial group is opened. By pressing the reaction progress monitor button 509, a screen for displaying the light amount of the reaction progress of the latest calibration measurement of the selected vial group is opened.
On the other hand, a button for requesting calibration and measurement of the bottle group is mainly provided on the right side of the status screen 501. The selection combo box 503 and the collection request button 504 are used to collectively set the measurement method for each bottle group according to predetermined conditions. As will be described later in detail, the calibration measurement method can be collectively set for the bottle groups listed in the bottle group list 502 by pressing the collective request button 504.
Setting buttons 307 to 311 are used to individually correct the measurement method of the collective setting. Specifically, the setting buttons 307 to 311 are used to change the calibration measurement method of the selected vial group to blank calibration (307), 2-point calibration (308), full-point calibration (309), span calibration (310), and no request (311). Further, instead of collectively requesting, the calibration measurement method for each bottle group may be individually set from the beginning using these buttons.
By pressing the registration button 514, the set contents are stored in the device, and the contents are used to execute a commission of calibration for each bottle group.
The total request setting edit button 510 is used when the content of the measurement method registered when the total request button 504 is pressed is to be changed. This will be described later.
Next, each column of the bottle group list 502 will be described. The reagent position 502a indicates a position on the reagent disk 107 where the reagent containers of the vial group are mounted. In addition, the left-hand numerals indicate the positions of the first reagent containers, and the right-hand numerals indicate the positions of the second reagent containers. The item name 502b is the name of the analysis item, and the use status 502c indicates the use priority of the bottle group. From the above information, for example, 4 vial groups were registered in the analysis item TEST1 using 2 reagents. Reagent lot 502d is the lot number of the reagent containers that make up the vial set. The reagents of reagent bottles with the same lot number are considered to be identical, and therefore also influence the choice of the calibration measurement method. The information about the inheritance source of the calibration curve for this vial group is shown in calibration inheritance 502 e. "vial" indicates that the calibration curve was inherited from a past calibration assay for that vial group, "batch" indicates that the calibration curve was inherited from a calibration assay for a vial group from the same batch as that vial group, and "item" indicates that the calibration curve was inherited from a calibration assay for a vial group from a different batch. This column is provided for the purpose of adopting a mechanism for inheriting a calibration curve from some of the bottle groups mounted on the apparatus, and the operator can review the measurement method based on this information.
In the bottle group list 502, all bottle groups mounted on the apparatus are displayed for analysis items to be performed in the future. The bottle group consumed before the timing displayed on the status screen 501 is deleted from the bottle group list 502, and the use status 502c is shifted up for the remaining bottle groups.
If there is no mechanism for a summary request described later, the operator sets the calibration measurement method for all the bottle groups displayed in the bottle group list 502 one by one. This becomes a burden on the operator. Even for the same bottle group of analysis items (for example, TEST1), the same measurement method is not necessarily selected for all. Depending on the analysis items, the full-dot calibration is performed in the "in-use" vial group, but in the "standby 1" vial group, there is no problem in the calibration by the calibrator with reduced measurement, and for example, a selection may be made such as blank calibration or not requesting calibration measurement. In particular, the number of bottle groups that must be set increases with the number of analysis items, the number of types of reagents used in the analysis items, and the number of reagent containers mounted on the device, and the burden on the operator increases further.
In order to reduce such a burden on the operator, in the present embodiment, the selection logic of the calibration measurement method for the bottle group is determined in advance, and the measurement methods are collectively set for the bottle groups that match the selection logic. Specifically, a group of bottles for a certain analysis item is classified using 2 conditions, and a calibration measurement method is determined in advance for each classification. The set selection logic is determined, for example, at the time of assembling the automatic analyzer, and is stored in the data storage unit 124 of the computer 118. When the operator presses the collective request button 504 on the status screen 501, the arithmetic unit 123 sets a calibration measurement method that matches the selection logic stored in the data storage unit 124 for each of the bottle groups listed in the bottle group list 502.
The 2 categories used for the selection logic are "use condition" and "measured condition". The "use status" classification is to classify the bottle group into an "in-use group" (the bottle group whose use status 502c is "in use") and other "standby group" (the bottle group whose use status 502c is "standby 1", "standby 2" …). The "measurement status" classification further classifies the bottle groups classified by the "usage status" into "result-present" (bottle group subjected to calibration measurement using the reagent of the bottle group itself) and "no-result" (bottle group not subjected to calibration measurement using the reagent of the bottle group itself, that is, bottle group that inherits the calibration curve of the other bottle group).
The calibration measurement method specified by the classification of the bottle group is registered in the data storage unit 124 as a collective request setting database. Fig. 2 shows a data structure of a summary request setting table 401 registered in the summary request setting database. There are sometimes a plurality of modes of the one-day operation tendency of the automatic analysis device. In this case, a plurality of summary request setting tables can be registered in the summary request setting database so that the setting contents of the calibration measurement method can be changed according to the operation tendency of the apparatus. The collective 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 401 e.
Fig. 6 shows a calibration measurement summary request flow in example 1. First, the operator opens the calibration status screen (fig. 4) (S01). At this time, the reagent containers with the remaining number of tests held by the apparatus being 1 or more are displayed with the bottle group list 502 for each analysis item. The summary request setting table is selected from the selection combo box 503 based on the table name 401a (S02), and the summary request button 504 is pressed (S03).
The arithmetic unit 123 acquires the analysis item, the use status, and the alignment measurement status for each bottle group in the bottle group list 502 (S04), searches the summary request setting table for a line in which the analysis item, the use status, and the measurement status match (S05), and sets the alignment measurement method registered in the summary request setting table for the bottle group (S06). Steps S04 to S06 are repeated until all bottle groups in the bottle group list 502 have been set (S07).
Fig. 5 shows a screen in which calibration measurement methods are set for all bottle groups in the bottle group list 502 in the calibration status screen 501 of fig. 4. Information on factors 502f and measurement methods 502g in the bottle group list 502 is added. The factor 502f indicates a trigger for setting the calibration measurement method, and in example 1, the operator sets the trigger at an arbitrary timing, and thus "manual" is displayed. The measurement method 502g displays a calibration measurement method set in accordance with a summary request setting table having a table name of "normal business day". The operator may change the measurement method for the collective setting using the setting buttons 307 to 311. Then, the operator presses the registration button 514, and thereby requests calibration measurement based on the measurement method registered in the bottle group list 502.
The contents of the summary order setting table may be corrected without calibrating the measurement method for each bottle group. In this case, by pressing the collective request setting edit button 510 in fig. 4 (fig. 5), the calibration collective request setting screen 301 in fig. 1 is displayed.
In the summary request setting table list 302 on the left side of the setting screen 301, the summary request setting tables registered in the summary request setting database of the apparatus are displayed in a list. When the "normal business day" table in the collective request setting table list 302 is selected in the selection box 303, a measurement method list 304 for each analysis item is displayed. The content displayed in the measurement method list 304 is the content of the collective request setting table shown in fig. 2.
In the measurement method list 304, one or more lines of analysis items to be corrected of the measurement method are selected, and if the measurement method to be corrected is "no result" of the "in-use group", the "in-use" is selected in the use condition combination box 305, the "no result" is selected in the measurement condition combination box 306, and any one of the setting buttons 307 to 310 corresponding to the desired calibration measurement method (blank, 2-point, full-point, range) is pressed. The same applies to other analysis items. When the registration button 314 is pressed after the correction, the content of the summary request setting table is updated.
The collective request setting table determines the calibration measurement method from 2 classifications, but is not limited to this. The setting may be performed based on any 1 classification, or the third and subsequent classifications may be set. The number of bottles divided into 2 bottles by classification is not limited, and may be 3 or more.
Fig. 7A and 7B show changes in the case where the operator requests several calibration measurements using the collective request setting function of the present embodiment on a certain day. In this example, the first reagent and the second reagent are used for the analysis item a, and 2 reagent containers are held in the apparatus at the start of the operation (in the morning of the day). Fig. 7A shows a summary request setting table for a bottle group of analysis item a.
Fig. 7B shows a change in the display content of the bottle group list 502 (in which the excerpts of the items 502a, 502c, 502e, and 502 g).
The vial group list 701 is a display at a stage after the reagent pairing process is completed. The 4 vial groups are displayed as a list. Since the calibration curve is inherited from calibration measurements for groups of bottles, each from a different batch, the calibration inheritance becomes a "project".
In this state, the total request button is pressed, and the measurement method is set for each bottle group in accordance with the total request setting table shown in fig. 7A. The display at this point is a bottle group list 702. Since no calibration measurement was performed for any of the bottle groups, a "no result" measurement method was set.
After the calibration measurement is performed using the contents of the vial group list 702, the calibration status screen is displayed again, and when the collective commission button is pressed, the vial group list 703 is displayed. At this time, since each vial group performs calibration measurement, the calibration inheritance is changed to "vial" and a "resulting" measurement method is set.
Thereafter, when the second reagent container 1 is consumed, the bottle group of the standby 1 is used. At this time, when the operator displays the calibration status screen and presses the collective commission button, the bottle group list 704 is displayed. The bottle groups of the conventional "standby 1", "standby 2" and "standby 3" were shifted to "in use", "standby 1" and "standby 2", respectively. Since the calibration measurements were all performed, the calibration successor is "bottle", but since the "in use" bottle set becomes the first calibration measurement after becoming "in use", the full-dot calibration is set.
After the calibration measurement is performed using the contents of the bottle group list 704, when the operator again displays the calibration status screen and presses the collective request button, the bottle group list 705 is displayed. Thus, the measurement method is set for each bottle group in accordance with the collective request setting table of fig. 7A.
[ example 2]
In embodiment 1, an example in which the operator requests the calibration measurement from the calibration status screen is described, but in embodiment 2, an example in which the apparatus automatically performs the calibration measurement at a predetermined event is described.
Fig. 8 is a calibration automatic request setting screen. In this example, when the events "reagent replacement", "timeout", and "QC failure" occur, calibration is automatically requested by a predetermined measurement method for a vial group requiring calibration. Further, since the set of bottles used for sample analysis is changed when the reagent is replaced, the set of bottles to be used next can be set differently depending on whether or not the set of bottles used so far is changed from a batch. In the case of reagent replacement without lot change, as described in example 1, different calibration measurement methods can be set depending on the "usage status" and the "measurement status".
In the event of "reagent replacement", the case where a vial group is newly registered in the apparatus is included in addition to the reagent replacement. The "timeout" event occurs when a certain time has elapsed since the last calibration measurement performed. The event of "QC failure" occurs when the vial set is used to perform a control detector assay and the control result exceeds a threshold.
An analysis item list 802 is displayed on the left side of the automatic calibration request setting screen 801. In a selection box 803, the analysis items displayed in the analysis item list 802 are selected, and a calibration measurement method for each event is set for each analysis item. Using the measurement method combination blocks 804-810, the operator presets the calibration measurement method for each event. The set contents are registered in an automatic request setting table 901 as shown in fig. 9 and stored in the data storage unit 124.
Fig. 10 shows a flow of calibration measurement automatically requesting a predetermined calibration measurement method when a bottle group is newly registered or newly registered in the apparatus by the automatic request function of calibration.
When the operator requests registration of the remaining amount of reagent (S11), the apparatus calculates the remaining amount of reagent and performs reagent matching processing as described above (S12). When the vial group is new or is newly registered, the calculation unit 123 requests calibration measurement in the measurement method set as the "reagent replacement" event.
The arithmetic unit 123 determines whether or not the bottle group is new or re-registered (S13), acquires analysis items, usage conditions, and calibration measurement conditions for the new or re-registered bottle group (S14), searches the automatic request setting table for a line in which the analysis items, usage conditions, and measurement conditions match (S15), and requests the bottle group to perform calibration measurement based on the measurement method registered in the automatic request setting table (S16). Steps S13 to S16 are repeated until the processing is completed for all the bottle groups (S17). Further, the re-registration means that the set of bottles on which the calibration has been performed is re-registered in the apparatus, and in this case, the calibration can be automatically requested.
[ example 3]
Although the calibration measurement is described in the above 2 examples, the control measurement can be integrated or automatically requested in the same manner as the calibration measurement. Hereinafter, the description of the portions common to example 1 will be omitted, and the portions specific to the control measurement will be mainly described.
Fig. 11 shows a Quality Control (QC) status screen 1001 in which an operator requests the automatic analyzer to perform measurement of a control. In the bottle group list 1002 of the status screen 1001, a list of bottle groups held by the apparatus is displayed. Columns 1002a to 1002c, 1002f, and 1002g of the bottle group list 1002 are the same as columns 502a to 502c, 502f, and 502g of the bottle group list 502 on the calibration status screen 501 (see fig. 5). On the other hand, the bottle group list 1002 is provided with a control name 1002d indicating the name of the control used and a sample type 1002e indicating the type of the sample whose analysis item is the target. Even in the same vial group, if samples to be examined are different, the control used for measurement may be different, and in this case, the control is displayed by a combination of the vial group and the control. For example, in the example of fig. 11, 2 cases of using the control QC1 and using the control QC2 are displayed in the bottle group list 1002 for the bottle group of the analysis item TEST 1.
The operator can select an arbitrary row of the bottle group list 1002, and request measurement to a bottle group in the selected row, or cancel the request, or lock the request for measurement so as to avoid erroneous manual request or automatic request. In this list, the selection of the row can be performed every 1 row or simultaneously selecting a plurality of rows. After the control measurement, the reaction process or the transition of the measurement result may be checked on another screen.
A button for requesting the measurement of the control items of the bottle group is mainly provided on the right side of the status screen 1001. By selecting the combo box 1003 and the total request button 1004, the measurement method can be collectively set for each bottle group according to predetermined conditions. On the other hand, the measurement method can be individually set or corrected using the setting buttons 1007 to 1011. As the measurement method, 3 kinds of the same control measurement (1007) repeated 3 times, the same control measurement (1008) repeated 2 times, and the control measurement (1009) performed 1 time can be selected. Moreover, the request invalidation button (1010) can be set to forcibly cancel a measurement request which is erroneously manually requested or a function of automatically requesting a control measurement in association with a calibration measurement, and the setting of the control measurement selected by the cancel button (1011) can be canceled. In addition, a registration button 1006 and a collective request setting edit button 1005 are provided in the same manner as the calibration status screen 501.
If there is no mechanism of a summary request described later, the operator sets the control measurement method for all the bottle groups displayed in the bottle group list 1002 one by one. This becomes a burden on the operator. This is because, in the case of the control measurement, as in the case of the calibration measurement, even in the same bottle group of the same analysis item (for example, TEST1) and the same control (for example, QC1), the same measurement method is not necessarily selected for all the bottles. For example, it is also possible to select 2 measurements of the control in the "in use" bottle group, but not to perform the measurement in the "standby 1" bottle group.
In order to reduce such a burden on the operator, in the present embodiment, the selection logic of the control measurement method for the bottle group is determined in advance, and the measurement methods are collectively set for the bottle groups that match the selection logic. For example, in the case where the priority of use of the bottle group and whether or not the bottle group itself performs the control measurement are used as the selection logic, as in the case of the calibration measurement, the data storage unit 124 of the computer 118 may store a summary request setting table (see fig. 2) or an automatic request setting table (see fig. 9) for the control measurement setting. The data structure is the same, and the measurement method is the measurement method in the case of control measurement.
Fig. 12 shows a screen after setting the control measuring method for all the bottle groups × controls in the bottle group list 1002 by pressing the collective request button 1004. Information on factors 1002f and measurement methods 1002g in the bottle group list 1002 is added.
Similarly to the calibration measurement method, the contents of the collective request setting table for the control measurement can be corrected. In this case, by pressing a total request setting edit button 1005 in fig. 11 (fig. 12), a control total request setting screen 1101 in fig. 13 is displayed. The control product collection request setting screen 1101 is the same as the calibration collection request setting screen 301 shown in fig. 1, and therefore, detailed description thereof is omitted.
The collective request setting table for the control measurement is not limited to the method of determining the control measurement method based on 2 classifications, and may be set based on any 1 classification, or may be set to third and subsequent classifications. The number of bottles divided into 2 bottles by classification is not limited, and may be 3 or more. In addition, when the measurement method of the bottle group is changed according to the control used for the measurement, the measurement method can be set for each combination of the analysis item and the control.
Claims (15)
1. An automatic analyzer capable of holding a plurality of reagent containers for one reagent,
the automatic analysis device comprises:
a computer having an arithmetic section and a data storage section; and
an output section connected to the computer,
the calculation unit extracts a vial group that is a combination of reagent containers held for reagents used for each analysis item, displays a calibration status screen including a vial group list in which the extracted vial group is displayed in a list on the output unit,
the data storage unit stores a summary request setting table that determines a selection logic of a calibration measurement method for each of the bottle groups,
the calculation unit receives an instruction from an operator, and sets a calibration measurement method that matches the selection logic of the summary request setting table for each of the bottle groups in the bottle group list.
2. The automatic analysis device according to claim 1,
the calibration status screen includes a setting button for individually selecting a calibration measurement method,
the calibration measurement method set in the bottle group list according to the summary request setting table can be individually corrected by the setting button.
3. The automatic analysis device according to claim 1,
the calibration status screen includes a summary request setting edit button for correcting the summary request setting table,
the output unit receives the pressing of the summary request setting edit button, and displays a calibration summary request setting screen for correcting the contents of the summary request setting table.
4. The automatic analysis device according to claim 1,
the selection logic of the collective order setting table selects a predetermined calibration measurement method based on the priority of use of the bottle group or whether or not a calibration curve for the bottle group is created by a calibration measurement for the bottle group.
5. The automatic analysis device according to claim 1,
the data storage unit stores a plurality of the summary request setting tables,
the calculation unit sets a calibration measurement method, which is selected by an operator on the calibration status screen and which matches the selection logic of the summary request setting table, for each of the bottle groups in the bottle group list.
6. An automatic analyzer capable of holding a plurality of reagent containers for one reagent,
the automatic analyzer includes a computer having an arithmetic section and a data storage section,
the operation unit extracts a bottle group, which is a combination of reagent containers held in a reagent used for each analysis item,
the data storage unit stores an automatic request setting table that determines a selection logic of a calibration measurement method for each of the bottle groups when calibration is executed when a predetermined event occurs in the automatic analyzer,
the calculation unit receives the occurrence of the predetermined event, and requests calibration measurement for the bottle group to be calibrated by a calibration measurement method in accordance with the selection logic of the automatic request setting table.
7. The automatic analysis device according to claim 6,
the predetermined events include replacement of a reagent container, replacement of a reagent as new registration or re-registration, timeout after a predetermined time has elapsed since the last calibration measurement, and QC failure in which the result of measurement of the control sample exceeds a threshold.
8. The automatic analysis device according to claim 6,
the selection logic of the automatic order setting table selects a predetermined calibration measurement method based on the priority of use of the bottle group or whether a calibration curve of the bottle group is created by a calibration measurement of the bottle group.
9. An automatic analyzer capable of holding a plurality of reagent containers for one reagent,
the automatic analysis device comprises:
a computer having an arithmetic section and a data storage section; and
an output section connected to the computer,
the computing unit extracts a vial group that is a combination of reagent containers held for reagents used for each analysis item, displays a vial group list including vial groups in which the extracted vial group is displayed in a list on the output unit,
the data storage unit stores a summary request setting table that determines selection logic of a control measurement method for each of the bottle groups,
the calculation unit receives an instruction from an operator, and sets a control measurement method in accordance with the selection logic of the summary request setting table for each of the bottle groups in the bottle group list.
10. The automatic analysis device according to claim 9,
in the vial group list, a combination of the vial group and control assays is displayed.
11. The automatic analysis device according to claim 9,
the accuracy management status screen includes a setting button for individually selecting a control measurement method,
the control measurement method set in the bottle group list according to the collective request setting table can be individually corrected by the setting button.
12. The automatic analysis device according to claim 9,
the accuracy management status screen includes a summary request setting edit button for correcting the summary request setting table,
the output unit receives the pressing of the summary request setting edit button, and displays a control summary request setting screen for correcting the contents of the summary request setting table.
13. The automatic analysis device according to claim 9,
the selection logic of the collective request setting table determines a control measurement method for each of the bottle groups based on the use priority of the bottle group or whether control measurement is performed by the bottle group itself.
14. The automatic analysis device according to claim 9,
the data storage unit stores a plurality of the summary request setting tables,
the calculation unit sets a control measurement method, which is selected by an operator on the quality control situation screen and which matches the selection logic of the summary request setting table, for each of the bottle groups in the bottle group list.
15. The automatic analysis device according to claim 9,
in the bottle group list, a manual control measurement request or an automatic control measurement request is forcibly cancelled for a bottle group for which a request is not registered.
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| EP1772736B1 (en) | 2004-07-22 | 2013-07-03 | Wako Pure Chemical Industries, Ltd. | Analysis assisting method, analyzer, remote computer, data analyzing method, program, and reagent container |
| JP4576307B2 (en) | 2005-09-12 | 2010-11-04 | 株式会社日立ハイテクノロジーズ | Automatic analyzer |
| JP4851267B2 (en) | 2006-08-18 | 2012-01-11 | シスメックス株式会社 | Sample analyzer |
| JP2009036515A (en) | 2007-07-31 | 2009-02-19 | Hitachi High-Technologies Corp | Autoanalyzer |
| JP5535047B2 (en) | 2010-11-18 | 2014-07-02 | 株式会社日立ハイテクノロジーズ | Automatic analyzer |
| JP6180721B2 (en) | 2012-10-25 | 2017-08-16 | 株式会社日立ハイテクノロジーズ | Automatic analyzer |
| JP6374148B2 (en) | 2013-08-30 | 2018-08-15 | シスメックス株式会社 | Sample analyzer and sample analysis method |
| JP6403197B2 (en) | 2014-11-11 | 2018-10-10 | 日本電子株式会社 | Automatic analyzer and operation designation method |
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