Automatic analyzer and analysis method therefor

Abstract

To provide an automatic analyzer which reduces a work burden of calibration by a user.SOLUTION: Provided is an automatic analyzer, including: an analysis unit that analyzes a sample containing standard solutions in which a concentration of a specific component is known; an operation unit that specifies a measurement item, a known concentration, and an installation location in association with each other for each standard solution; and a control unit that creates a calibration curve of the predetermined measurement item using the known concentration of the standard solution and a measurement value of the standard solution by the analysis unit; wherein the operation unit specifies a correlation between a measurement value and a concentration for each measurement item, and the control unit rearranges an order of a plurality of measurement values obtained correspondingly to the installation location on the basis of the correlation with respect to the standard solution having a common measurement item, and creates the calibration curve of the measurement item.SELECTED DRAWING: Figure 5

Description

[Technical field]

[0001] The present invention relates to an automatic analyzer. [Background technology]

[0002] Automated analyzers for clinical testing analyze specific components in a sample by mixing a biological sample such as blood or urine with a reagent and measuring the absorbance of the mixed solution. The measured value is not the exact concentration of the specific component in the sample, but is converted to concentration by comparing it with a calibration curve that has been created in advance through a calibration operation. In calibration, a standard solution of known concentration is used as the sample and a calibration curve is created based on the relationship between the measured value of the standard solution and the known concentration. However, because the calibration curve changes depending on the condition of the device and the installation environment, it is necessary to perform calibration periodically to maintain the reliability of the analysis.

[0003] Standard solutions with one or more concentrations used for calibration must be installed in a pre-designated location, and if they are installed in the wrong location, a calibration curve cannot be created, or the analytical precision will decrease due to an inaccurate calibration curve. For example, Patent Document 1 discloses that when creating a calibration curve with an automatic analyzer, it is possible to check for installation errors of standard solutions necessary for creating the calibration curve. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2013-68441 A Summary of the Invention [Problem to be solved by the invention]

[0005] Although the technology described in Patent Document 1 makes it possible to know when calibration has failed due to incorrect placement of standard solution, the user must re-install the standard solution and perform calibration. In addition, the more bottles of standard solution there are, the higher the possibility of misplacing the standard solution.

[0006] An object of the present invention is to provide an automatic analyzer and an analysis method thereof that reduce the workload of the user in carrying out calibration. [Means for solving the problem]

[0007] In order to solve the above-mentioned problems, the present invention provides an automatic analyzer comprising an analysis unit that analyzes samples containing a standard solution having a known concentration of a specific component, an operation unit that specifies, in correspondence with each other, a measurement item, a known concentration, and an installation location for each of the standard solutions, and a control unit that creates a calibration curve for a specified measurement item using the known concentration of the standard solution and the measurement value of the standard solution measured by the analysis unit, wherein the operation unit specifies, for each measurement item, a correlation between the measurement value and the concentration, and the control unit rearranges the order of multiple measurement values ​​obtained corresponding to the installation location for the standard solutions having a common measurement item based on the correlation, to create the calibration curve for the measurement item. Effect of the Invention

[0008] According to the present invention, it is possible to provide an automatic analyzer and an analysis method thereof that reduce the workload of the user in carrying out calibration. [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 is a diagram showing an example of the configuration of an automatic analyzer. [Diagram 2] An example of a screen for inputting the known concentration of a standard solution [Diagram 3] An example of a screen for setting the correlation between measurement values ​​and concentrations and the position area of ​​the standard solution for each measurement item. [Figure 4] Functional block diagram of the control unit related to the creation of the calibration curve [Diagram 5] Flowchart showing an example of a flow for creating a calibration curve [Figure 6] An explanatory diagram showing how to rearrange the order of measurement values DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] An automatic analyzer according to an embodiment of the present invention will be described with reference to the drawings. In the following, an automatic analyzer that measures the absorbance of a sample (specimen) such as blood or urine will be described as an example, but the present invention can also be applied to automatic analyzers that perform other measurements, such as electromotive force measurements and scattered light measurements.

[0011] First, the overall configuration of the automatic analyzer will be described. FIG. 1 is a diagram showing an example of the configuration of the automatic analyzer. As shown in FIG. 1, the automatic analyzer mainly includes an analysis unit 1, a storage unit 14, a display unit 15, an operation unit 16, and a control unit 17. The analysis unit 1 also includes a conveying line 4, a sample dispensing mechanism 5, a reagent dispensing mechanism 6, a reagent disk 8, a reaction disk 10, an agitation unit 11, a photometer 12, a cleaning unit 13, and the like. The samples analyzed by the analysis unit 1 also include standard solutions, which will be described later.

[0012] The transport line 4 transports a sample rack 3 on which a plurality of sample containers 2 containing samples are mounted, to a position accessed by a sample dispensing mechanism 5. The example in Fig. 1 employs a rack system in which a plurality of sample containers 2 are transported by the sample rack 3, but a disk system in which a plurality of sample containers 2 mounted in a circular pattern are transported by the rotation of a rotating disk may also be employed.

[0013] The reagent disk 8 stores a plurality of reagent containers 7 that contain reagents to be reacted with samples, and rotates to move the reagent containers 7 to positions accessible by the reagent dispensing mechanism 6. The reaction disk 10 holds a plurality of reaction containers 9 into which samples and reagents are dispensed in a circumferential shape, and rotates to move the reaction containers 9 to predetermined positions. The sample dispensing mechanism 5 dispenses samples from the sample containers 2 mounted on the sample rack 3 transported by the transport line 4 to the reaction containers 9. The reagent dispensing mechanism 6 dispenses reagents from the reagent containers 7 to the reaction containers 9 into which the samples have been dispensed. The number of reagents dispensed into the reaction containers 9 is not limited to one, and may be multiple. The stirring unit 11 is arranged around the reaction disk 10 and stirs the samples and reagents in the reaction containers 9.

[0014] The photometer 12 is arranged around the reaction disk 10, and measures the absorbance of the mixture in the reaction container 9 stirred by the stirring unit 11 every time the reaction container 9 passes in front of it. The measured absorbance is converted into the concentration of a specific component contained in the sample using a calibration curve prepared in advance. The calibration curve is prepared by performing a calibration including measuring the absorbance of a mixture (reaction solution) obtained by mixing (reacting) a standard solution with a known concentration of the specific component with a reagent. Note that a standard solution with a concentration of the specific component that is approximately zero and does not react with the reagent is called a first standard solution (standard solution with the first concentration), and is often saline solution, purified water, or the like. The cleaning unit 13 is arranged around the reaction disk 10, and cleans the reaction container 9 after the analysis is completed.

[0015] The storage unit 14 is, for example, a hard disk drive (HDD) or a solid state drive (SSD), and stores the absorbance measured by the photometer 12, the concentration converted from the absorbance, and the like. The display unit 15 is, for example, a liquid crystal display or a touch panel, and displays the absorbance, the concentration, and a screen to be described later with reference to FIG. 2 and FIG. 3. The operation unit 16 is, for example, a keyboard or a mouse, and performs operations such as inputting conditions required for analysis and requesting analysis. In addition, when the display unit 15 is a touch panel, a GUI (Graphical User Interface) displayed on the touch panel functions as the operation unit 16. The control unit 17 is, for example, a computing device such as a CPU (Central Processing Unit), and controls each unit and executes various calculations. The calculations performed by the control unit 17 include calculations for creating a calibration curve for a predetermined measurement item using the known concentration of the standard solution and the measured value of the standard solution by the analysis unit 1.

[0016] Next, the setting of the standard solution used for calibration will be described with reference to FIGS.

[0017] Fig. 2 is an example of a screen for inputting the known concentration of a standard solution. The screen illustrated in Fig. 2 is composed of a standard solution list 21, a measurement item list 22, a concentration input field 23, an update button 24, etc. In this screen, the rows in the table on the left side correspond to the standard solutions, and the rows in the table on the right side correspond to the measurement items.

[0018] The standard solution list 21 displays the standard solution names of the standard solutions registered in the automatic analyzer. When a specific standard solution name (a2 in the example of FIG. 2) is selected from the standard solution list 21, a measurement item list 22 and a concentration input field 23 corresponding to the standard solution are displayed. When a known concentration is input in the concentration input field 23 and an update button 24 is operated, the known concentration is stored in the memory unit 14. The input of the known concentration may be performed by a person related to the manufacturer of the standard solution, or may be performed by a user (operator) of the automatic analyzer while referring to the attached document of the standard solution or information printed on the container body of the standard solution. In FIG. 2, the number displayed in the column of the input frame of the concentration input field 23 corresponds to the number of the standard solution of the target measurement item. FIG. 2 shows, as an example, a case where the standard solution a2 is the second standard solution (standard solution with the second concentration) of the measurement item A and 5.0 is input as the concentration. When one standard solution is used commonly for a plurality of measurement items, it is possible to input the concentration for the plurality of measurement items in the measurement item list 22.

[0019] Fig. 3 is an example of a screen for setting the correlation between measurement values ​​and concentrations, and the position area of ​​the standard solution for each measurement item. The screen illustrated in Fig. 3 is composed of a measurement item list 31, a position area input field 32, a correlation selection field 33, an update button 34, and the like. In addition, in this screen, the rows of the table correspond to the measurement items. In this specification, a collection of installation locations for multiple standard solutions is referred to as a position area, and the position area is assigned to each measurement item.

[0020] The measurement item list 31 displays the measurement items registered in the device. It is also possible to set, for each measurement item, the position area in which the standard solution is placed and the correlation between the measurement value and the concentration. The name of the standard solution is displayed in the position area input field 32 according to the input content in the concentration input field 23 in FIG. 2. Note that numbers are also displayed in the columns of the position area input field 32, just like the concentration input field 23, and indicate the concentration of the standard solution displayed according to the input content in the concentration input field 23.

[0021] In the position area input field 32, the installation location of each displayed standard solution can be set. Furthermore, if the standard solution for which the installation location has been set is a standard solution used in common for a plurality of measurement items, the installation locations for the other measurement items for which the standard solution is used are also updated. FIG. 3 shows, as an example, a case in which the installation locations for standard solutions a1, a2, and a3 used in measurement item A are set as a1:1-1, a2:1-2, and a3:1-3. In XY, X represents the number of the sample rack 3, and Y represents the position within the rack. X and Y are natural numbers, and the maximum value of X is determined by the number of racks, and the maximum value of Y is determined by the number of possible installation positions per rack.

[0022] In the correlation selection field 33, the correlation between the measured value and the concentration for each measurement item can be selected from a pull-down menu including "Increase (positive correlation)," "Decrease (negative correlation)," and "Not specified." The correlation selection may be performed by a person related to the manufacturer of the standard solution or by a user of the automatic analyzer.

[0023] In this way, the operation unit 16 of this embodiment not only specifies the measurement item, known concentration, and installation location for each standard solution in association with each other, but also specifies the correlation between the measurement value and the concentration for each measurement item. When the update button 34 is operated, the memory unit 14 stores the position area entered in the position area input field 32 and the correlation selected in the correlation selection field 33.

[0024] When the analysis unit 1 measures a standard solution (having a common measurement item) placed in a position area set in the position area input field 32, the control unit 17 creates a calibration curve for the measurement item using one or more measured values ​​obtained. At this time, if "increase" or "decrease" is selected in the correlation selection field 33 for the measurement item, the control unit 17 rearranges the order of the multiple measured values ​​obtained corresponding to the installation locations based on the selected correlation to create a calibration curve. Therefore, in the position area for each measurement item, the standard solution can be placed in any installation location regardless of the installation order. However, a standard solution used in common for multiple measurement items must be placed in a specific installation location set in the position area input field 32. For example, for measurement item A in FIG. 3, standard solutions a1, a2, and a3 are dedicated standard solutions for measurement item A and are not standard solutions used in common for multiple measurement items, so standard solutions a1, a2, and a3 can be placed in any installation location within the position areas (1-1, 1-2, 1-3). When "not specified" is selected in the correlation selection field 33, the control unit 17 creates a calibration curve without rearranging the order of a plurality of measurement values ​​obtained corresponding to the installation location.

[0025] FIG. 4 is a functional block diagram of the control unit related to the creation of the calibration curve. As shown in FIG. 4, the control unit 17 has an analysis control unit 171, a measurement value acquisition unit 172, a correlation determination unit 173, a linking unit 174, and a calibration curve creation unit 175. The analysis control unit 171 controls the operation of each unit such as each dispensing mechanism. The measurement value acquisition unit 172 acquires measurement values ​​necessary for creating a calibration curve from the analysis unit 1. The correlation determination unit 173 reads out the correlation stored in the storage unit 14 and determines whether the measurement value and the concentration are positively correlated or negatively correlated. The linking unit 174 links the measurement value and the concentration based on the multiple measurement values ​​acquired by the measurement value acquisition unit 172 and the correlation determined by the correlation determination unit 173. The calibration curve creation unit 175 creates a calibration curve based on the measurement value and the concentration linked by the linking unit 174.

[0026] Next, a flow of creating a calibration curve using each standard solution will be described with reference to Fig. 5. Fig. 5 is a flow chart showing an example of a flow of creating a calibration curve.

[0027] First, the user places the standard solution of the measurement item for which calibration is to be performed in the position area specified in the position area input field 32. The analysis control unit 171 controls the analysis unit 1 to perform measurements on each standard solution placed in the position area (step S501). The analysis unit 1 performs multiple measurements, repeating the same measurement multiple times for each standard solution.

[0028] Thereafter, the measurement value acquiring unit 172 calculates an average value from the multiple results obtained by the multiple measurements of the standard solution by the analysis unit 1, and sets this as the measurement value (step S502).

[0029] Furthermore, the correlation determination unit 173 reads out the correlation stored in the storage unit 14, and determines whether the correlation between the measurement value and the concentration is "increased" or not (step S503). If it is determined to be "increased", the linking unit 174 rearranges the measurement values ​​in ascending order (step S505) and links the measurement values ​​to the concentrations. Thereafter, the calibration curve creation unit 175 creates a calibration curve based on the measurement values ​​and concentrations linked by the linking unit 174 (step S508).

[0030] If it is determined in step S503 that the correlation is not "increased", the correlation determination unit 173 determines whether the correlation between the measurement value and the concentration is "decreased" (step S504). If it is determined that the correlation is "decreased", the linking unit 174 rearranges the measurement values ​​in descending order (step S506) and links the measurement values ​​to the concentrations. Thereafter, the calibration curve creation unit 175 creates a calibration curve based on the measurement values ​​and concentrations linked by the linking unit 174 (step S508).

[0031] If it is determined in step S504 that the measurement is not "decreased", the linking unit 174 does not rearrange the order of the measurement values ​​(step S507), and links the measurement values ​​and concentrations in the original order. After that, the calibration curve creation unit 175 creates a calibration curve based on the measurement values ​​and concentrations (step S508).

[0032] Fig. 6 is an explanatory diagram showing how to rearrange the order of measurement values. For example, for measurement item A, the correlation between measurement value and concentration is set to "increase", the concentrations of standard solutions a1, a2, and a3 used are set to "0.0, 5.0, 10.0", and the position areas in which each standard solution is placed are set to "1-1, 1-2, 1-3". Here, it is assumed that the user places standard solution a1 in installation location 1-2 and standard solution a2 in installation location 1-1, and performs measurements.

[0033] The graph on the left (before sorting) shows the results when multiple measured values ​​obtained corresponding to the installation location are linked to the concentrations in the correct order. In this case, it is difficult to create a calibration curve, and calibration must be performed again. Even if a calibration curve can be created, an inaccurate calibration curve may result in a decrease in analytical accuracy.

[0034] On the other hand, the graph on the right (after sorting) shows the results when multiple measurement values ​​obtained corresponding to the installation location are sorted so that the order is positively correlated, and the sorted measurement values ​​are linked to the concentration. In this case, a calibration curve can be created, and there is no need to perform calibration again.

[0035] In this way, according to this embodiment, except for standard solutions commonly used for a plurality of measurement items, a suitable calibration curve can be created even if the standard solution is placed in any installation location within the specified position area, thereby reducing the workload of the user. As a method for making the automatic analyzer recognize information such as the measurement items and known concentrations of the standard solutions used for calibration, it is possible to attach a barcode corresponding to the information to the container containing the standard solution. However, the cost of attaching the barcode and the possibility of erroneous attachment and reading errors of the barcode cannot be ignored.

[0036] In addition, the operation of the automatic analyzer differs from facility to facility, and some facilities may not wish to rearrange. Therefore, it is desirable to improve usability by providing an option for not rearranging, i.e., an option for not specifying a correlation.

[0037] In this embodiment, even if there is a data abnormality other than the misplacement of the standard solution, for example, a data abnormality caused by the device or reagent, there is a possibility that the data is automatically rearranged to create a calibration curve. Therefore, a step of checking whether the data abnormality is caused by the device or reagent may be provided. For example, since the first standard solution is a transparent liquid and does not react with the reagent, and the color tone of the reagent is reflected in the absorbance of the first standard solution, deterioration of the reagent can be checked by setting an allowable range for the absorbance of the reaction solution of the first standard solution and the reagent.

[0038] In addition, data abnormality may be checked by checking whether the difference between multiple absorbances obtained by multiple measurements of a standard solution exceeds an upper limit. Data abnormality may also be checked by checking whether the sensitivity (slope of the calibration curve) calculated from the absorbance of the reaction solution of the first standard solution and the reagent, the absorbance of the reaction solution of a standard solution other than the first standard solution and the reagent, and the concentration of each standard solution exceeds an allowable range. Data abnormality may also be checked by checking whether the standard deviation of the difference between the approximation equation of the calibration curve and the measured absorbance exceeds an upper limit in a nonlinear calibration curve that is a curved or broken line calibration curve, or a multipoint linear calibration curve that is a calibration curve that linearly approximates a combination of three or more absorbances and concentrations.

[0039] If a data abnormality is confirmed by these steps, a notification is displayed on the display unit 15. For example, even if a large difference in absorbance values ​​obtained by multiple measurements due to an apparatus malfunction, rather than a misplaced standard solution, occurs and the data are rearranged in an order different from the original concentration order, the user can still notice the occurrence of a data abnormality.

[0040] The present invention is not limited to the above-described embodiment, but includes various modifications and combinations. In addition, it is also possible to add, delete, or replace part of the configuration of the embodiment with another configuration. [Explanation of symbols]

[0041] 1...analysis section, 2...sample container, 3...sample rack, 4...transport line, 5...sample dispensing mechanism, 6...reagent dispensing mechanism, 7...reagent container, 8...reagent disk, 9...reaction container, 10...reaction disk, 11...mixing section, 12...photometer, 13...cleaning section, 14...storage section, 15...display section, 16...operation section, 17...control section, 21...standard solution list, 22...measurement item list, 23...concentration input field, 24...update button, 31...measurement item list, 32...position area input field, 33...correlation selection field, 34...update button, 171...analysis control section, 172...measurement value acquisition section, 173...correlation determination section, 174...linking section, 175...calibration curve creation section

Claims

1. an analysis unit for analyzing a sample containing a standard solution having a known concentration of a specific component; an operation unit for specifying a measurement item, a known concentration, and an installation location for each of the standard solutions in association with each other; a control unit that creates a calibration curve for a predetermined measurement item using the known concentration of the standard solution and a measurement value of the standard solution by the analysis unit, The operation unit specifies a correlation between a measurement value and a concentration for each measurement item, The control unit is characterized in that, for the standard solutions having a common measurement item, an order of a plurality of measurement values ​​obtained corresponding to the installation location is rearranged based on the correlation, thereby creating the calibration curve for the measurement item.

2. 2. The automated analyzer according to claim 1, When a positive correlation is specified as the correlation, The control unit creates the calibration curve by rearranging the plurality of measurement values ​​in ascending order; When a negative correlation is specified as the correlation, The automatic analyzer according to claim 1, wherein the control unit creates the calibration curve by rearranging the order of the multiple measurement values ​​in descending order.

3. 2. The automated analyzer according to claim 1, A position area, which is a collection of multiple installation locations, is assigned to each measurement item. The automatic analyzer is characterized in that the standard solutions having common measurement items are placed at any desired placement location within the position area.

4. The automatic analyzer according to claim 3, An automatic analyzer, characterized in that the standard solution used commonly for a plurality of measurement items is placed in a specific installation location within the position area for each measurement item.

5. 2. The automated analyzer according to claim 1, If the correlation is not specified by the operation unit, The control unit creates a calibration curve for a common measurement item of the standard solution without rearranging the order of multiple measurement values ​​obtained corresponding to the installation location.

6. an analysis unit for analyzing a sample containing a standard solution having a known concentration of a specific component; an operation unit for specifying a measurement item, a known concentration, and an installation location for each of the standard solutions in association with each other; and a control unit that creates a calibration curve for a predetermined measurement item using a known concentration of the standard solution and a measurement value of the standard solution by the analysis unit, a step of the operation unit specifying a correlation between a measurement value and a concentration for each measurement item; and a step of the control unit rearranging an order of a plurality of measurement values ​​obtained corresponding to the installation location for the standard solutions having a common measurement item based on the correlation, thereby creating the calibration curve for the measurement item.

Images