Automatic analysis device and analysis method thereof

Abstract

Provided is an automatic analysis device that reduces the workload of calibration by a user, the automatic analysis device being provided with: an analysis unit that analyzes a sample containing a standard solution having a known concentration of a specific component; an operation unit that associates and specifies a measurement item, a known concentration, and an installation location for each of the standard solutions; and a control unit that creates a calibration line for a predetermined measurement item using a known concentration of the standard solution and a measurement value of the standard solution based on the analysis unit, the operation unit specifies a correlation between the measurement value and the concentration for each measurement item, and the standard solution for which the measurement item is common, and the calibration line for the predetermined measurement item is created using the known concentration of the standard solution and the measurement value of the standard solution based on the analysis unit. The control unit arranges a plurality of measurement values obtained corresponding to the installation sites in order according to the correlation, and creates the measurement lines for the measurement items.

Description

Technical Field

[0001] The invention relates to an automatic analyzing device. Background Art

[0002] The automatic analyzer used for clinical examination mixes biological samples such as blood and urine with reagents, measures the absorbance of the mixed solution, and analyzes the specific components in the sample. The measured value is not the concentration of the specific component in the sample itself, but is converted into a concentration by comparing it with a calibration curve made in advance through a calibration (correction) action. In calibration, a standard solution of known concentration is measured as a sample, and a calibration curve is made based on the relationship between the measured value of the standard solution and the known concentration. However, the calibration curve changes depending on the state of the device, the setting environment, etc., so it is necessary to calibrate regularly to maintain the reliability of the analysis.

[0003] The standard solution with a concentration of 1 or more used for calibration needs to be set in a pre-specified place. If it is set in the wrong place, the calibration curve cannot be produced, or the analysis accuracy is reduced due to the inaccurate calibration curve. For example, Patent Document 1 discloses the following content: when producing a calibration curve in an automatic analyzer, it is possible to confirm the setting error of the standard solution required for the calibration curve production.

[0004] Prior art literature

[0005] Patent Document 1: Japanese Patent Application Publication No. 2013-68441 Summary of the invention

[0006] Problems to be solved by the invention

[0007] In the technology described in Patent Document 1, although it is possible to detect the situation where calibration fails due to incorrect setting of the standard solution, the user needs to set the standard solution again to perform calibration. In addition, the more the number of standard solutions increases, the higher the possibility of incorrect setting of the standard solutions.

[0008] An object of the present invention is to provide an automatic analysis device and an analysis method thereof that reduce the workload of calibration on a user.

[0009] Means for solving problems

[0010] In order to solve the above-mentioned problem, the automatic analysis device of the present invention comprises: an analysis unit, which analyzes a sample of a standard solution containing a specific component with a known concentration; an operation unit, which specifies the measurement item, the known concentration and the setting location by associating them according to the standard solution; and a control unit, which uses the known concentration of the standard solution and the measurement value of the standard solution based on the analysis unit to prepare a calibration curve for a specified measurement item, wherein the operation unit specifies the correlation between the measurement value and the concentration according to the measurement item, and for the standard solution common to the measurement items, the control unit arranges the order of multiple measurement values ​​obtained corresponding to the setting location according to the correlation to prepare the calibration curve for the measurement item.

[0011] Effects of the Invention

[0012] According to the present invention, it is possible to provide an automatic analysis device and an analysis method thereof that reduce the workload of calibration on the user. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 This is a diagram showing an example of the configuration of an automatic analyzer.

[0014] Figure 2 This is an example of a screen for inputting known concentrations of standard solutions.

[0015] Figure 3 This is an example of a screen for setting the correlation between the measurement value and the concentration and the position area of ​​the standard solution for each measurement item.

[0016] Figure 4 This is a functional block diagram of the control unit related to the creation of calibration curves.

[0017] Figure 5 This is a flowchart showing an example of the process of preparing a calibration curve.

[0018] Figure 6 This is an explanatory diagram showing the order in which the measured values ​​are arranged. DETAILED DESCRIPTION

[0019] The automatic analyzer of the embodiment of the present invention is described with reference to the accompanying drawings. Hereinafter, an automatic analyzer for measuring the absorbance of a sample (specimen) such as blood or urine is described as an example, but the present invention can also be applied to an automatic analyzer for measuring other measurements such as electromotive force measurement and scattered light measurement.

[0020] First, the overall structure of the automatic analyzer will be described. Figure 1 FIG. 1 is a diagram showing an example of the structure of an automatic analysis device. Figure 1As shown, 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. In addition, the analysis unit 1 has a conveying line 4, a sample dispensing mechanism 5, a reagent dispensing mechanism 6, a reagent disk 8, a reaction disk 10, a stirring unit 11, a photometer 12, a cleaning unit 13, etc. In addition, the sample analyzed by the analysis unit 1 also includes a standard solution described later.

[0021] The transport line 4 transports the sample rack 3 carrying a plurality of sample containers 2 containing samples to a position accessed by the sample dispensing mechanism 5. Figure 1 In the example of FIG. 1 , a rack method is used in which a plurality of sample containers 2 are transported by a sample rack 3 , but a disk method may be used in which a plurality of sample containers 2 placed in a circular shape are transported by a rotating disk.

[0022] The reagent disk 8 stores a plurality of reagent containers 7 containing reagents that react with the sample, and rotates to move the reagent containers 7 to a position accessed by the reagent dispensing mechanism 6. The reaction disk 10 holds a plurality of reaction containers 9 into which the sample and reagent are dispensed in a circumferential shape, and rotates to move the reaction containers 9 to a predetermined position. The sample dispensing mechanism 5 dispenses the sample from the sample container 2 mounted on the sample rack 3 transported by the conveying line 4 to the reaction container 9. The reagent dispensing mechanism 6 dispenses the reagent from the reagent container 7 to the reaction container 9 into which the sample is dispensed. In addition, the reagent dispensed into the reaction container 9 is not limited to one, but may be multiple. The stirring unit 11 is arranged around the reaction disk 10 to stir the sample and reagent in the reaction container 9.

[0023] The photometer 12 is arranged around the reaction disk 10, and measures the absorbance of the mixed solution in the reaction container 9 after being stirred by the stirring unit 11 every time the reaction container 9 crosses the front. The measured absorbance is converted into the concentration of the specific component contained in the sample using a pre-made calibration curve. The calibration curve is made by performing a calibration, which includes measuring the absorbance of a mixed solution (reaction solution) formed by mixing (reacting) a standard solution with a known concentration of a specific component with a reagent. In addition, a standard solution whose concentration of the specific component is approximately zero and does not react with the reagent is called a first standard solution (a standard solution of the first concentration), which is usually physiological saline, purified water, etc. The cleaning unit 13 is arranged around the reaction disk 10 to clean the reaction container 9 after the analysis is completed.

[0024] The storage unit 14 is, for example, a hard disk drive (HDD) or a solid state drive (SSD), and stores absorbance measured by the photometer 12, concentration calculated from absorbance, and the like. The display unit 15 is, for example, a liquid crystal display or a touch panel, and displays absorbance, concentration, and the like. Figure 2 , Figure 3The screen described later, etc. The operating unit 16 is, for example, a keyboard and a mouse, and performs operations such as inputting conditions required for analysis and entrusting analysis. In addition, when the display unit 15 is a touch panel, the GUI (Graphical User Interface) displayed on the touch panel functions as the operating unit 16. The control unit 17 is, for example, a computing unit such as a CPU (Central Processing Unit), which controls each unit and performs various operations. The calculation of the control unit 17 also includes the calculation for making a calibration curve of a specified measurement item using the known concentration of the standard solution and the measurement value of the standard solution based on the analysis unit 1.

[0025] Next, according to Figure 2 and Figure 3 The following describes the setting of the standard solution used for calibration.

[0026] Figure 2 This is an example of a screen for inputting known concentrations of standard solutions. Figure 2 The illustrated screen includes 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 of the table on the left correspond to standard solutions, and the rows of the table on the right correspond to measurement items.

[0027] The standard solution list 21 displays the standard solution names of the standard solutions registered in the automatic analyzer. Figure 2 In the example a2), a list of measurement items 22 and a concentration input column 23 corresponding to the standard solution are displayed. When a known concentration is input in the concentration input column 23 and the update button 24 is operated, the known concentration is stored in the storage unit 14. In addition, the input of the known concentration can be performed by personnel related to the manufacturer of the standard solution, or by the user (operator) of the automatic analyzer while referring to the attachments of the standard solution or the information printed on the container body of the standard solution. Figure 2 In the example, the number displayed in the column of the input box of the concentration input field 23 corresponds to the concentration of the standard solution of the target measurement item. Figure 2 This indicates that the standard solution a2 is the second standard solution (standard solution of the second concentration) of measurement item A, and 5.0 is input for its concentration. If one standard solution is commonly used in a plurality of measurement items, concentrations can be input for a plurality of measurement items in the measurement item list 22 .

[0028] Figure 3 This is an example of a screen for setting the correlation between the measurement value and the concentration and the position area of ​​the standard solution for each measurement item. Figure 3The illustrated screen is composed of a measurement item list 31, a location area input field 32, a correlation selection field 33, an update button 34, etc. In addition, in this screen, the rows of the table correspond to the measurement items. In addition, in this specification, the set of locations where multiple standard solutions are set is called a location area, and the location area is allocated according to the measurement item.

[0029] The measurement item list 31 displays the measurement items registered in the device. In addition, the location area where the standard solution is set and the correlation between the measurement value and the concentration can be set for each measurement item. Figure 2 The standard solution name is displayed in the position area input field 32 according to the input content in the concentration input field 23. In addition, the column of the position area input field 32 is also displayed with a number similar to the concentration input field 23, indicating the concentration number of the standard solution displayed according to the input content in the concentration input field 23.

[0030] In the position area input field 32, the setting location of each displayed standard solution can be set. In addition, if the standard solution for which the setting location is set is a standard solution commonly used in multiple measurement items, the setting location is also updated for other measurement items using the standard solution. As an example, Figure 3 This indicates that the installation locations of the standard solutions a1, a2, and a3 used in the measurement item A are set to a1: 1-1, a2: 1-2, and a3: 1-3. In addition, regarding XY, X represents the number of the sample rack 3, and Y represents the position in 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 locations per rack.

[0031] In the correlation selection column 33, the correlation between the measured value and the concentration can be selected from a drop-down menu including "increase (positive correlation)", "decrease (negative correlation)" and "no designation" according to the measurement item. In addition, the correlation selection operation can be performed by the manufacturer of the standard solution or by the user of the automatic analyzer.

[0032] In this way, the operation unit 16 of the present embodiment specifies the correlation between the measurement value and the concentration for each measurement item in addition to associating and specifying the measurement item, the known concentration, and the installation location for each standard solution. When the update button 34 is operated, the storage unit 14 stores the position area input in the position area input column 32 and the correlation selected in the correlation selection column 33.

[0033] In addition, when the analysis unit 1 measures the standard solution (common to the measurement items) set in the position area set in the position area input column 32, the control unit 17 uses the one or more measurement values ​​obtained to prepare the calibration curve of the measurement item. At this time, when "increase" or "decrease" is selected in the correlation selection column 33 of the measurement item, the control unit 17 arranges the order of the multiple measurement values ​​obtained corresponding to the setting location according to the selected correlation to prepare the calibration curve. Therefore, in the position area of ​​each measurement item, the standard solution can be set at any setting location regardless of the setting order of the standard solution. However, the standard solution commonly used in multiple measurement items must be set at a specific setting location set in the position area input column 32. For example, with respect to Figure 3 For the measurement item A, the standard solutions a1, a2, and a3 are dedicated standard solutions for the measurement item A, and are not standard solutions commonly used in multiple measurement items. Therefore, the standard solutions a1, a2, and a3 can be set at any setting location within the position area (1-1, 1-2, 1-3). When "No Designation" is selected in the correlation selection column 33, the control unit 17 does not arrange the order of the multiple measurement values ​​obtained corresponding to the setting location and creates the calibration curve.

[0034] Figure 4 This is a functional block diagram of the control unit related to the production of the calibration curve. Figure 4 As shown, the control unit 17 has: an analysis control unit 171, a measurement value acquisition unit 172, a correlation determination unit 173, a correlation unit 174, and a calibration curve preparation 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 the measurement value required for the preparation of the calibration curve from the analysis unit 1. The correlation determination unit 173 reads the correlation stored in the storage unit 14 and determines whether the measurement value is positively correlated or negatively correlated with the concentration. The correlation unit 174 associates the measurement value with 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 preparation unit 175 prepares the calibration curve based on the measurement value and concentration associated by the correlation unit 174.

[0035] Next, according to Figure 5 The procedure for preparing a calibration curve using each standard solution is described below. Figure 5 This is a flowchart showing an example of the process of preparing a calibration curve.

[0036] First, the user sets the standard solution of the measurement item to be calibrated in the position area specified in the position area input field 32. The analysis control unit 171 controls the analysis unit 1 to perform measurement on each standard solution set in the position area (step S501). The analysis unit 1 performs multiple measurement of repeating the same measurement multiple times on each standard solution.

[0037] Thereafter, the measurement value acquisition unit 172 calculates an average value from a plurality of results obtained by the multiple measurements of the standard solution by the analysis unit 1 and uses the average value as the measurement value (step S502 ).

[0038] Furthermore, the correlation determination unit 173 reads the correlation stored in the storage unit 14, and determines whether the correlation between the measured value and the concentration is "increase" (step S503). If it is determined to be "increase", the association unit 174 arranges the order of the measured values ​​in ascending order (step S505), and associates the measured values ​​with the concentration. Thereafter, the calibration curve preparation unit 175 prepares the calibration curve based on the measured value and the concentration associated by the association unit 174 (step S508).

[0039] If it is determined that the value is not "increased" in step S503, the correlation determination unit 173 determines whether the correlation between the measured value and the concentration is "decreased" (step S504). If it is determined that the value is "decreased", the correlation unit 174 arranges the measured values ​​in descending order (step S506) to correlate the measured values ​​with the concentration. After that, the calibration curve preparation unit 175 prepares the calibration curve based on the measured value and the concentration correlated by the correlation unit 174 (step S508).

[0040] In step S504, if it is determined that the value is not "decreased", the correlating unit 174 does not arrange the order of the measured values ​​(step S507), and correlates the measured values ​​and the concentrations while maintaining the original order. Then, the calibration curve creating unit 175 creates a calibration curve based on the measured values ​​and the concentrations (step S508).

[0041] Figure 6 This is an explanatory diagram showing the order of arranging measurement values. For example, for measurement item A, the correlation between the measurement value and the concentration is set to "increase", the concentrations of the standard solutions a1, a2, and a3 used are set to "0.0, 5.0, 10.0", and the location areas where the standard solutions are set are set to "1-1, 1-2, 1-3". Here, the user sets the standard solution a1 at the setting location 1-2 and the standard solution a2 at the setting location 1-1 to perform the measurement.

[0042] The chart on the left (before arrangement) shows the result of sequentially associating the concentrations of the multiple measured values ​​obtained corresponding to the setting location. In this case, it is difficult to make the calibration curve and it must be calibrated again. Even if the calibration curve can be made, the analysis accuracy may be reduced due to an inaccurate calibration curve.

[0043] On the other hand, the graph on the right (after arrangement) shows the result of arranging a plurality of measured values ​​corresponding to the installation locations in a sequence that is positively correlated and associating the arranged measured values ​​with the concentrations. In this case, a calibration curve can be created without the need for recalibration.

[0044] Thus, according to the present embodiment, in addition to the standard solution commonly used in a plurality of measurement items, even if the standard solution is set at any setting place in the designated position area, an appropriate calibration curve can be made, and therefore, the user's workload can be reduced. In addition, as a method for making the automatic analyzer recognize the measurement items, known concentrations and other information of the standard solution used for calibration, it is also considered to paste a bar code corresponding to the information on the container containing the standard solution. However, the cost of pasting the bar code, the possibility of pasting errors of the bar code and the reading errors cannot be ignored.

[0045] In addition, the operation of the automatic analyzer varies from facility to facility, and there are cases where alignment is not desirable depending on the facility. Therefore, it is preferable to provide an option for not performing alignment, that is, an option for not specifying a correlation, to improve the usability.

[0046] In addition, in the present embodiment, in the case of data abnormalities other than the placement error of the standard solution, such as data abnormalities caused by the device or reagent, it is also possible to automatically arrange and create a calibration curve. Therefore, a step of confirming whether the data abnormality is caused by the device, reagent, etc. can also be provided. For example, 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. Therefore, by setting an allowable range for the absorbance of the reaction solution of the first standard solution and the reagent, the degradation of the reagent can be confirmed.

[0047] In addition, it is also possible to confirm whether the data is abnormal by whether the difference between multiple absorbances obtained by multiple measurements of the standard solution exceeds the upper limit. In addition, it is also possible to confirm whether the data is abnormal by whether the sensitivity (slope of the calibration line) calculated based on the absorbance of the reaction solution of the first standard solution and the reagent, the absorbance of the reaction solution of the standard solution other than the first standard solution and the reagent, and the concentration of each standard solution exceeds the allowable range. In addition, in the non-linear calibration line of the calibration line as a curve or a broken line, and the multi-point linear calibration line as a calibration line obtained by linearly approximating a combination of more than 3 absorbances and concentrations, it is also possible to confirm whether the data is abnormal by whether the standard deviation of the difference between the approximate formula of the calibration line and the measured absorbance exceeds the upper limit.

[0048] When data abnormality is confirmed through such a procedure, a notification is displayed on the display unit 15. For example, even if the difference between a plurality of absorbances obtained by multiple measurements is large due to a device failure, not because of a mistake in placing the standard solution, and the concentrations are arranged in an order different from the original order, the user can still notice the occurrence of data abnormality.

[0049] The present invention is not limited to the above-described embodiments, and includes various modifications and combinations. In addition, other structures may be added, deleted, or replaced with a part of the structure of the embodiment.

[0050] Description of Reference Numerals

[0051] 1…analyzing 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…stirring 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 column, 24…update button, 31…measurement item list, 32…position area input column, 33…correlation selection column, 34…update button, 171…analysis control section, 172…measurement value acquisition section, 173…correlation determination section, 174…correlation section, 175…calibration curve creation section.

Claims

1. An automatic analysis device comprising: an analysis unit that analyzes a sample containing a standard solution having a known concentration of a specific component; an operation unit for specifying the measurement item, the known concentration, and the installation location in association with the standard solution; a control unit that creates a calibration curve for a predetermined measurement item using the known concentration of the standard solution and the measurement value of the standard solution by the analysis unit, It is characterized in that The operation unit specifies the correlation between the measurement value and the concentration according to the measurement item, Regarding the standard solution common to the measurement items, the control unit arranges the order of a plurality of measurement values ​​obtained corresponding to the installation locations according to the correlation, and creates the calibration curve for the measurement item.

2. The automatic analysis device according to claim 1, characterized in that When a positive correlation is designated as the correlation, the control unit arranges the plurality of measured values ​​in ascending order to create the calibration curve. When negative correlation is designated as the correlation relationship, the control unit arranges the order of the plurality of measurement values ​​in descending order to create the calibration curve.

3. The automatic analysis device according to claim 1, characterized in that The automatic analyzer allocates a position area as a set of a plurality of installation locations for each measurement item, and the standard solution common to the measurement items is installed at any installation location in the position area.

4. The automatic analysis device according to claim 3, characterized in that The standard solution commonly used in a plurality of measurement items is placed at a specific location within the position area of ​​each measurement item.

5. The automatic analysis device according to claim 1, characterized in that When the correlation is not designated by the operation unit, the control unit creates a calibration curve for the measurement item without arranging the order of a plurality of measurement values ​​obtained corresponding to the installation locations with respect to the standard solution common to the measurement items.

6. An analysis method using an automatic analysis device, the automatic analysis device comprising: an analysis unit that analyzes a sample containing a standard solution having a known concentration of a specific component; an operation unit for specifying the measurement item, the known concentration, and the installation location in association with the standard solution; a control unit that creates a calibration curve for a predetermined measurement item using the known concentration of the standard solution and the measurement value of the standard solution by the analysis unit, It is characterized in that The analysis method of the automatic analysis device comprises: The operation unit specifies the correlation between the measurement value and the concentration according to the measurement item; A step in which the control unit arranges the order of a plurality of measurement values ​​obtained corresponding to the installation locations with respect to the standard solution common to the measurement items according to the correlation relationship to create the calibration curve for the measurement item.

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