JP7109965B2 - automatic analyzer - Google Patents

Description

An embodiment of the present invention relates to an automatic analyzer that analyzes components contained in a sample collected from a subject.

Automated analyzers target biochemical test items, immunological test items, etc., and detect changes in color tone and turbidity caused by reactions between samples and reagents. Generate analytics data. In addition, the automatic analyzer uses the electrolyte item of the biochemical test items as the target item, and analyzes expressed by the concentration by detecting the electrolyte using an ion selective electrode (ISE) that selectively responds to this electrolyte. Generate data.

In an automated analyzer equipped with an ISE, one of the first or second solutions is aspirated to the ISE by a suction pump, and if one solution is less than a measurable amount, before aspirating the other solution A device is known that can solve the problem that the other solution sucked into the ion-selective electrode remains on the ion-selective electrode and the remaining solution is measured.

However, when a measurable amount of one of the solutions can be aspirated, even if there is an abnormality in the electrolyte measurement unit with the ISE, the abnormality cannot be detected, resulting in deterioration of analysis data.

JP 2012-42359 A

A problem to be solved by the present invention is to provide an automatic analyzer capable of preventing deterioration of analysis data.

In order to achieve the above object, an automatic analyzer according to an embodiment includes a suction unit that performs a first solution suction operation and before or after this suction operation performs a second solution suction operation; a detection unit for detecting a specific component contained in each of the first and second solutions sucked by the suction operation; generating a plurality of pieces of first data that are collected in a time period until a first time elapses and that change in time series; a plurality of pieces of second data are generated by collecting in a time period from the start of the aspiration operation of the second solution to the elapse of the second time; a signal processing unit that collects in a time period until the time period 2 elapses and generates a plurality of third data; and a determination unit that determines the presence or absence of an abnormality.

1 is a block diagram showing the configuration of an automatic analyzer according to an embodiment; FIG. FIG. 2 is a perspective view showing an example of the configuration of an analysis section according to the embodiment; The figure which shows an example of a structure of the electrolyte measurement part which concerns on embodiment. The figure which shows an example of a structure of the detection part which concerns on embodiment. FIG. 4 is a diagram showing each solution sucked into the detection unit by the suction operation of the suction pump according to the embodiment; FIG. 4 is a diagram showing an example of a signal from a detection unit amplified by a signal processing unit according to the embodiment; FIG. 4 is a diagram showing an example of determination data generated by the signal processing unit according to the embodiment; The figure for demonstrating an example of the 1st determination which concerns on embodiment. The figure for demonstrating an example of the 1st determination which concerns on embodiment. The figure which shows an example which 1st determination which concerns on embodiment is not performed. The figure for demonstrating an example of the 2nd determination which concerns on embodiment. The figure for demonstrating an example of the 2nd determination which concerns on embodiment. FIG. 4 is a diagram showing an example of generation of standard data and management data according to the embodiment; The figure which shows an example of production|generation of the calibration data and management analysis data which concern on embodiment.

Embodiments will be described below with reference to the drawings.

FIG. 1 is a block diagram showing the configuration of an automatic analyzer according to an embodiment. This automatic analyzer 100 is included in the mixed liquid of each sample and each reagent by dispensing each sample of the standard sample, test sample and control sample corresponding to each inspection item and the reagent corresponding to each inspection item. An analysis unit 10 is provided for detecting the component of the inspection item. The automatic analyzer 100 also includes a drive section 30 that drives a plurality of units for dispensing each sample and each reagent of the analysis section 10 , and an analysis control section 31 that controls the drive section 30 .

The automatic analyzer 100 also includes a signal processing unit 32 that collects signals for detecting each test item component contained in each mixture in the analysis unit 10 and generates a plurality of data. The automatic analyzer 100 also includes a determination unit 33 that determines whether or not the analysis unit 10 is abnormal based on a plurality of data generated by the signal processing unit 32 .

The automatic analyzer 100 also includes an arithmetic unit 34 that generates calibration data, analysis data, and management analysis data based on the plurality of data generated by the signal processing unit 32 . The automatic analyzer 100 also includes a data storage unit 35 that stores a plurality of data generated by the signal processing unit 32 and each data generated by the calculation unit 34 .

The automatic analyzer 100 also includes a display section 36 that displays each data generated by the calculation section 34 . The automatic analyzer 100 also has an input unit 37 for inputting for setting analysis parameters for each inspection item, inputting for setting a sample ID and each inspection item for each sample, and the like. The automatic analyzer 100 also includes a system control section 38 that controls the analysis control section 31 , signal processing section 32 , determination section 33 , calculation section 34 , data storage section 35 and display section 36 .

FIG. 2 is a perspective view showing an example of the configuration of the analysis section 10. As shown in FIG. The analysis unit 10 includes a sample container 11 that accommodates a standard sample, a test sample, and a control sample, and a sample rack 12 that holds the sample container 11 . The analysis unit 10 also includes a first reagent container 13 containing a first reagent that reacts with a component of each test item contained in each sample, for example, a one-reagent system or a two-reagent system, and a plurality of first reagent containers. and a first reagent rack 14 that movably holds the container 13 . The analysis unit 10 also includes a second reagent container 15 that stores a second reagent paired with the first reagent of the two-reagent system, and a second reagent rack 16 that movably holds a plurality of second reagent containers 15 . It has The analysis unit 10 also includes a plurality of reaction vessels 17 arranged on a circumference, and a reaction disk 18 holding the reaction vessels 17 so as to be rotatable.

In addition, the analysis unit 10 vertically moves and rotates the sample dispensing probe 19 that dispenses each sample in the sample container 11 held by the sample rack 12 into the reaction container 17 and the sample dispensing probe 19 . and a sample pipetting arm 20 for supporting. The analysis unit 10 also includes a first reagent dispensing probe 21 for dispensing the first reagent in each first reagent container 13 held in the first reagent rack 14 into the reaction container 17, and a first reagent dispensing probe and a first reagent dispensing arm 22 that supports 21 so as to be vertically movable and rotatable. The analysis unit 10 also includes a second reagent dispensing probe 23 for dispensing the second reagent in each of the second reagent containers 15 held in the second reagent rack 16 into the reaction container 17, and a second reagent dispensing probe and a second reagent dispensing arm 24 that supports 23 vertically and rotatably.

The analysis unit 10 also includes a stirring unit 25 that stirs the mixed liquid of each sample and each first reagent dispensed into each reaction container 17 and the mixed liquid of each sample, each first reagent and each second reagent. I have. The analysis unit 10 also includes a photometry unit 26 that optically detects test item components contained in the mixed liquid in each reaction container 17 stirred by the stirring unit 25 . Further, the analysis unit 10 aspirates the liquid mixture in each reaction vessel 17 that has been stirred by the stirring unit 25, and extracts electrolyte components in the liquid mixture, such as sodium ions, potassium ions, and chloride ions. An electrolyte measurement unit 27 for electrochemically detecting an electrolyte is provided. The analysis section 10 also includes a cleaning unit 28 that cleans each reaction vessel 17 .

Then, the photometry unit 26 irradiates each reaction container 17 with light and detects the light transmitted through each of the mixture containing the standard sample, the mixture containing the test sample, and the mixture containing the control sample, The detected signal is output to the signal processing section 32 . In addition, the electrolyte measurement unit 27 detects and detects each electrolyte in each of the mixed liquid containing the standard sample, the mixed liquid containing the test sample, and the mixed liquid containing the control sample sucked from each reaction container 17. A signal is output to the signal processing unit 32 .

Returning to FIG. 1 , the drive unit 30 has a transport mechanism and a motor for driving the transport mechanism, and transports and moves the sample rack 12 of the analysis unit 10 . Further, the driving section 30 has motors for rotating the first and second reagent racks 14 and 16, respectively, and moves the first and second reagent containers 13 and 15, respectively. Further, the drive unit 30 has a motor for rotating the reaction disk 18, and moves each reaction container 17 to stop at each stop position. Further, the drive unit 30 has motors for rotating and driving the sample pipetting arm 20, the first reagent pipetting arm 22 and the second reagent pipetting arm 24, respectively, and the motors for vertically driving the sample pipetting probe 19, The first reagent-dispensing probe 21 and the second reagent-dispensing probe 23 are moved. Further, the driving section 30 has a mechanism for driving each unit of the electrolyte measuring section 27 .

The analysis control unit 31 has a CPU and a memory circuit, and analyzes the analysis parameters of each inspection item input from the input unit 37, the sample ID, the standard sample identified by this sample ID, the test sample, and the control sample. Based on the input information such as the set inspection items, the drive section 30 is controlled to operate each unit of the analysis section 10 .

When an input to start calibration is received from the input unit 37, the analysis control unit 31 moves the sample rack 12, moves the first reagent container 13, moves the second reagent container 15, and dispenses the standard sample. , the dispensing of the first reagent, the dispensing of the second reagent, and the stirring of the mixed solution.

Further, when an input to start testing is received from the input unit 37, the analysis control unit 31 moves the sample rack 12, the first reagent container 13, the second reagent container 15, the test sample and the control sample. , the dispensing of the first reagent, the dispensing of the second reagent, and the stirring of the mixture.

The signal processing unit 32 includes an amplifier circuit, a multiplexer, an analog/digital conversion circuit, and the like. Then, the signal processing unit 32 amplifies the detection signals of the photometry unit 26 and the electrolyte measurement unit 27 of the analysis unit 10, collects them at predetermined time intervals, and collects a plurality of test items used in the determination unit 33 and the calculation unit 34. data.

The determination unit 33 includes a CPU and a memory circuit, and determines whether or not the analysis unit 10 is abnormal based on a plurality of data for each inspection item generated by the signal processing unit 32 .

The computing unit 34 includes a CPU and a memory circuit, generates standard data using a plurality of data of each inspection item generated by the signal processing unit 32, and stores the standard data of each inspection item and the standard sample of the inspection item in advance. Generate calibration data showing the relationship with the set standard value. Further, the calculation unit 34 generates test data using a plurality of data of each test item generated by the signal processing unit 32, and uses the calibration data of the test item for the test data to determine the activity value and the Generate analytical data expressed in concentration values. In addition, the calculation unit 34 generates management data using a plurality of data for each inspection item generated by the signal processing unit 32, and uses the calibration data of the inspection item for the management data to calculate an activity value and a concentration value. Generate management analysis data represented by

The data storage unit 35 includes a storage such as a hard disk drive (HDD). The data storage unit 35 stores a plurality of data items for each inspection item generated by the signal processing unit 32 . The data storage unit 35 also stores the calibration data, analysis data, and management analysis data of each inspection item generated by the calculation unit 34 .

The display unit 36 has a monitor such as a CRT or liquid crystal panel. The display unit 36 displays a screen for setting standard values such as the concentrations of the components contained in the standard sample for each inspection item and control values such as the concentrations of the components for each inspection item contained in the control samples. , a screen for setting parameters for executing the calibration operation and inspection operation of each inspection item, a screen for setting the sample ID for identifying the sample and the inspection item for each sample, and the like are displayed. Also, the display unit 36 displays the calibration data, analysis data, and management analysis data generated by the calculation unit 34 .

The input unit 37 includes input devices such as a keyboard, mouse, buttons, and touch key panel. The input unit 37 provides input for setting the standard value of the standard sample and the control value of the control sample corresponding to each inspection item, input for setting the parameter of each inspection item, and setting the sample ID and inspection item. Enter data for

The system control unit 38 includes a CPU and a memory circuit, and receives input information such as command signals input from the input unit 37, standard values and control values for each inspection item, parameters for each inspection item, sample IDs, and information on inspection items. After being stored in the storage circuit, the analysis control unit 31, signal processing unit 32, determination unit 33, calculation unit 34, data storage unit 35, and display unit 36 are integrated to control the entire system based on these input information. .

1 to 14, the configuration of the electrolyte measurement unit 27 in the analysis unit 10, the processing of the detection signal of the electrolyte measurement unit 27 in the signal processing unit 32, and the determination in the determination unit 33 will be described in detail. do.

First, the configuration of the electrolyte measurement unit 27 will be described with reference to FIGS. 2 to 5. FIG.

FIG. 3 is a diagram showing an example of the configuration of the electrolyte measuring section 27. As shown in FIG. The electrolyte measurement unit 27 includes a detection unit 40 that detects each electrolyte, and a calibration solution storage unit 41 that stores a calibration solution containing each electrolyte at a predetermined concentration. The electrolyte measurement unit 27 also includes a suction unit 43 that sucks each solution of the mixed solution in the reaction container 17 and the calibration solution in the calibration solution storage unit 41 to the detection unit 40 . The electrolyte measurement unit 27 also includes a waste liquid tank 47 that stores each solution that is detected by the detection unit 40 and becomes unnecessary.

FIG. 4 is a diagram showing an example of the configuration of the detection section 40. As shown in FIG. The detection unit 40 is arranged movably between the reaction container 17 and the calibration solution storage unit 41 by the driving unit 30, and includes a composite electrode 45 maintained at a constant temperature such as 37° C., and a lower end of the composite electrode 45. and a suction nozzle 46 detachably attached to the part. The composite electrode 45 is composed of three ion selective electrodes (ISE) 451 to 453 and a reference electrode 454, and has a through hole 45a communicating with the suction nozzle 46 and passing through the ISEs 451 to 453 and the reference electrode 454.

The ISE 451 has a sensitive membrane that selectively responds to sodium ions, which are the target electrolyte, and forms a part of the through-hole 45a, and generates a potential corresponding to the activity of sodium ions in each solution. The ISE 452 also has a sensitive membrane that selectively responds to potassium ions, which are the target electrolyte, and forms a part of the through-hole 45a, and generates a potential corresponding to the activity of potassium ions in each solution. The ISE 453 also has a sensitive membrane that selectively responds to chloride ions, which are the target electrolyte, and forms a part of the through-hole 45a, and generates a potential corresponding to the activity of chloride ions in each solution. The reference electrode 454 also has a liquid junction that forms part of the through hole 45a, and generates a constant potential with respect to each solution.

Each ISE 451 and 452 exchanges each target electrolyte with the reference electrode 454 under the condition that the activity coefficient of each solution flowing into the through-hole 45a is constant by the suction operation of each solution by the suction unit 43. Generates an electromotive force proportional to the logarithm of the concentration. In addition, the ISE 453 and the reference electrode 454 are connected to the reference electrode 454 by the logarithm of the concentration of the target electrolyte under the condition that the activity coefficient of each solution flowing into the through-hole 45a is constant due to the suction operation of each solution by the suction unit 43. Generates an inversely proportional electromotive force.

The calibration liquid container 41 shown in FIG. 3 includes a calibration liquid bottle 411 , a storage container 412 , a calibration liquid pump 413 , and a drainage pump 414 . The calibration liquid bottle 411 contains a calibration liquid for calibrating each mixed liquid. The calibration liquid pump 413 has, for example, a syringe and a plunger, and sucks the calibration liquid in the calibration liquid bottle 411 by driving the plunger by the drive unit 30 and supplies it into the storage container 412 . The storage container 412 is a container that stores the calibration liquid supplied by the calibration liquid pump 413 at the same temperature as the composite electrode 45 . The drain pump 414 is a pump that drains the calibration liquid remaining in the storage container 412 after being sucked into the detection section 40 by the suction section 43 .

Here, the standard samples for the electrolyte item consist of two types of first and second standard samples with known and different concentrations of each electrolyte. A second standard sample is dispensed into the reaction vessel 17, and the first reagent dispensing probe 21 dispenses the first reagent of the electrolyte item into the reaction vessel 17 into which the respective first and second standard samples have been dispensed. . Further, when the inspection operation is executed, the sample dispensing probe 19 dispenses each sample, such as a test sample with an unknown concentration of each electrolyte or a control sample with a known concentration of each electrolyte, into the reaction container 17, and each sample is The first reagent dispensing probe 21 dispenses the first reagent of the electrolyte item into the reaction container 17 into which the is dispensed.

By dispensing the first standard sample and the first reagent, the first standard sample is diluted with the first reagent in the reaction vessel 17, and a mixed solution (first mixture). In addition, due to the dispensing of the second standard sample and the first reagent, the second standard sample is diluted with the first reagent in the reaction container 17, and a mixed solution (second 2 mixture). Further, by dispensing the test sample and the first reagent, the test sample becomes a mixed solution (third mixed solution) in the reaction container 17 in which the test sample is diluted with the first reagent. Further, by dispensing the control sample and the first reagent, the control sample becomes a mixed solution (fourth mixed solution) in the reaction container 17 in which the control sample is diluted with the first reagent.

The suction unit 43 includes a suction pump 431 and a tube 432 communicating between the suction pump 431 and the detection unit 40 . The suction pump 431 has, for example, a syringe pump composed of a syringe and a plunger. Then, as shown in FIG. 5A, the suction pump 431 is moved to a position where the detection section 40 is moved by the driving section 30 and the suction nozzle 46 enters each of the first to fourth liquid mixtures in the reaction vessel 17. , the plunger drive of the drive unit 30 performs a suction operation for sucking each of the first to fourth liquid mixtures. Before and after the suction pump 431 sucks each of the first to fourth liquid mixtures, the detection unit 40 is moved by the driving unit 30 and the suction nozzle 46 is moved to the storage container 412 as shown in FIG. 5(b). When the plunger is driven by the drive unit 30, the plunger of the driving unit 30 is driven to perform a suction operation for sucking the calibration liquid.

Next, the operation of the signal processing section 32 will be described with reference to FIGS. 2 to 7. FIG.

The signal processing unit 32 performs the suction operation of the calibration solution (pre-calibration solution) by the suction unit 43, the suction operation of each of the first to fourth mixed solutions following this suction operation, and the calibration solution following this suction operation. In response to the suction operation of the (post-calibration liquid) and each suction operation, the detection unit 40 detects the pre-calibration liquid, the first mixed liquid, the second mixed liquid, the third mixed liquid, the fourth mixed liquid, and the post-calibration liquid. A signal obtained by detecting each electrolyte contained in each solution of the calibration solution is generated in a first time period from the start of each suction operation until the first time has passed and after the first time has passed since the start of each suction operation. A plurality of pieces of data are generated by collecting data at predetermined intervals in a second time period from 1 to 2 until a second time elapses.

Then, the signal processing unit 32 collects in the first time zone according to the suction operation of the first solution and generates a plurality of first data as a plurality of data used for determination by the determination unit 33. , collected during a second time period to generate a plurality of second data. In addition, the signal processing unit 32 sets the plurality of data used for determination by the determining unit 33 according to the second solution aspirating operation before or after the first solution aspirating operation in the second time period. to generate a plurality of third data.

The above-described first and second solutions used for determination by the determination unit 33 will be described. Each solution of a calibration solution, a first mixed solution, a second mixed solution, and a fourth mixed solution containing a known or constant concentration of each electrolyte is defined as a first or second solution, and A second solution is a solution in which the concentration of each electrolyte is different from that of the first solution. Therefore, when each of the first and second mixed liquids is used as the first solution, the pre-calibration liquid or the post-calibration liquid becomes the second solution.

In addition, in the fourth mixed solution, the solution containing each electrolyte different in concentration from each electrolyte in the calibration solution is defined as the first or second solution. Therefore, when the fourth mixed liquid is used as the first solution, the pre-calibration liquid or the post-calibration liquid becomes the second solution.

Further, when the post-calibration solution is the first solution, each electrolyte concentration different from that in the first mixed solution, the second mixed solution, or the calibration solution, which is the suction operation before the suction operation of the post-calibration solution Any one of the fourth mixtures containing becomes the second solution.

In the following, the second mixed solution is assumed to be the first solution and the pre-calibration solution is assumed to be the second solution. A signal processing unit when, for example, the ISE 451 of the detection unit 40 detects the electrolyte contained in each solution of the pre-calibration solution, the second mixed solution, and the post-calibration solution in response to the suction operation of the post-calibration solution following the operation. 32 will be described.

In addition, the pre-calibration solution suction operation, the suction operation of each mixture of the first mixed solution, the third mixed solution, and the fourth mixed solution following this suction operation, and the post-calibration following this suction operation The operation of the signal processing unit 32 when the ISE 451 detects the electrolyte contained in each solution of the pre-calibration liquid, each mixed liquid, and the post-calibration liquid according to the liquid suction operation is as follows. Since the operation is performed in the same manner as when the electrolyte contained in each solution of the mixed solution and the post-calibration solution is detected, the explanation thereof is omitted.

Further, the suction operation of the pre-calibration solution, the suction operation of each of the first mixed solution, the second mixed solution, the third mixed solution, and the fourth mixed solution following this suction operation, and this suction When each ISE 452, 453 detects the electrolyte contained in each solution of the pre-calibration liquid, each mixed liquid, and the post-calibration liquid in response to the suction operation of the post-calibration liquid following the operation, the operation of the signal processing unit 32 is as follows. , the ISE 451 detects the electrolyte contained in each solution of the pre-calibration solution, the second mixed solution, and the post-calibration solution, so the description thereof will be omitted.

FIG. 6 is a diagram showing an example of the signal of the detection section 40 amplified by the signal processing section 32. As shown in FIG. This signal 50 includes a signal 51 amplified in response to the aspiration of the pre-calibration liquid, a signal 52 amplified in response to the aspiration of the second mixed liquid, and a signal 52 amplified in response to the aspiration of the post-calibration liquid. and a signal 53.

Each of the signals 51, 52, and 53 has a first time period T1 from the start of each suction operation until the first time period has elapsed, and a second time period T1 from the first time period since the start of each suction operation. is divided into a second time period T2 until the elapse of . The first time period T1 corresponds to a time period during which the solution sucked by the start of each suction operation flows into the through-hole 45a and the through-hole 45a is replaced with the solution. The second time slot T2 corresponds to the time slot after each suction operation is stopped and the through-hole 45a is replaced with the sucked solution.

A signal 51 indicates that a time T, which is the sum of the first and second times after the start of the aspiration operation of the pre-calibration liquid when the aspiration operation before the aspiration operation of the pre-calibration liquid is, for example, the aspiration operation of the calibration liquid, has elapsed. It is a signal until The signal 51 is stable in the first and second time periods T1 and T2 because the potential of the ISE 451 does not fluctuate due to the replacement of the calibration solution with the same electrolyte concentration in the through hole 45a.

A signal 52 is a signal from when the second mixed liquid aspirating operation is started after time T from the start of the pre-calibration liquid aspirating operation until time T elapses from the start of the second mixed liquid aspirating operation. The signal 52 rises during the first time period T1 because the potential of the ISE 451 increases due to the replacement of the through-hole 45a from the calibration solution to the second mixed solution having the high electrolyte concentration, and the through-hole 45a rises to the second mixed solution. , the ISE 451 exhibits a potential corresponding to the second liquid mixture, and is stabilized in the second time zone T2.

A signal 53 is a signal from the start of the post-calibration liquid aspiration operation after the time T from the start of the second mixed liquid aspiration operation until the time T elapses from the start of the post-calibration liquid aspiration operation. The signal 53 drops in the first time period T1 because the potential of the ISE 451 is lowered due to the replacement of the through-hole 45a with the calibration solution having a low electrolyte concentration from the second mixed solution, and the through-hole 45a is replaced with the calibration solution. Afterwards, the ISE 451 exhibits a potential corresponding to the calibration solution, so that it stabilizes in the second time zone T2.

If the aspirating operation before the aspirating operation of the pre-calibration solution is the aspirating operation of the second mixed solution, the signal 51 falls in the first time period T1 and then remains in the second period of time in the same manner as the signal 53. It stabilizes at zone T2.

FIG. 7 is a diagram showing an example of determination data generated by the signal processing unit 32. As shown in FIG.

The signal processing unit 32 collects the signals 52 in the first time period T1 according to the suction operation of the second mixed liquid as a plurality of data used for determination by the determination unit 33, and generates a plurality of first data. are collected during a second time period T2 to generate a plurality of second data. Further, the signal processing unit 32 collects the signals 51 in the second time period T2 according to the aspiration operation of the pre-calibration liquid as a plurality of data used for determination by the determination unit 33, and collects a plurality of third data. Generate data.

Next, the operation of the determination unit 33 will be described with reference to FIGS. 7 to 12. FIG.

Based on the plurality of first to third data generated by the signal processing unit 32, the determination unit 33 makes determinations consisting of first and second determinations as to whether or not the electrolyte measurement unit 27 is abnormal.

First, the first determination will be explained. The determination unit 33 selects a plurality of time-series-changing initial first data among the plurality of first data generated by the signal processing unit 32 by collecting the first time period T1 and the first data. A first relational expression represented by, for example, a linear regression equation is obtained, which indicates the relationship of time when the signal corresponding to the data was collected. Further, the determination unit 33 determines that all the first data including the initial plurality of first data that change in time series among the plurality of first data and the signal corresponding to this first data are A second relational expression representing a time relation at the time of collection, which is represented by a monotonically increasing function by, for example, linear interpolation or non-linear interpolation between two adjacent first data, is obtained.

In addition, the determination unit 33 determines the relationship between the plurality of second data generated by the signal processing unit 32 by collecting the second time period T2 and the time when the signal corresponding to the second data was collected. A third relational expression represented by, for example, a linear regression equation is obtained. In addition, the determination unit 33 obtains, for example, an average value of the plurality of terminal stage second data that is most stable in the second time period T2 among the plurality of second data, and the signal processing unit 32 calculates the second data. Among the plurality of third data generated by the collection of the time period T2, the average value of the plurality of terminal stage third data that is most stable in the second time period T2 is obtained, and the difference between the two average values is calculated. Let 2 and 3 data difference.

Note that when the first solution is the post-calibration solution and the second solution is the second mixed solution, a plurality of the plurality of The relationship between time when all the first data including a plurality of initial first data that change in time series among the first data and the signals corresponding to this first data are collected The second relational expression shown is represented by a monotonically decreasing function.

The determination unit 33 makes a first determination based on the first to third relational expressions and the second and third data differences.

8 and 9 are diagrams for explaining an example of the first determination.

In FIG. 8, the first line Ls1 indicated by the first relational expression is a straight line, the second line Ls2 indicated by the second relational expression is a monotonically changing curve, and the third relational expression The third line Ls3 shown is a straight line. The first line Ls1 and the third line Ls3 are in contact with the second line Ls2, and the first line Ls1 and the third line Ls3 intersect at one point.

The determination unit 33 obtains the area E1 of the hatched area surrounded by the first line Ls1, the second line Ls2, and the third line Ls3, and the second and third data difference D1. A first determination is made depending on whether or not E1 is within an allowable range corresponding to the preset second and third data difference D1. Here, since the area E1 is within the allowable range corresponding to the preset difference D1, the determination unit 33 determines that the electrolyte measurement unit 27 is normal.

Since the sensitivities of the ISEs 451, 452, and 453 change depending on the frequency of use, a plurality of allowable ranges are set according to the sensitivities of the ISEs 451, 452, and 453 that are in a usable state. is obtained, the allowable range corresponding to the difference is selected and used for the first determination.

In FIG. 9, the first line Ls4 indicated by the first relational expression is a straight line, the second line Ls5 indicated by the second relational expression is a monotonically changing curve, and the third relational expression The third line Ls6 shown is a straight line. The first line Ls4 and the third line Ls6 are in contact with the second line Ls5, and the first line Ls and the third line Ls3 intersect at one point.

The determination unit 33 obtains the area E2 of the hatched area surrounded by the first line Ls4, the second line Ls5, and the third line Ls6, and the second and third data difference D2, and calculates the area A first determination is made based on whether or not E2 is within a preset allowable range corresponding to the second and third data difference D2.

Here, the difference between the difference D2 and the difference D1 is slight, the allowable range corresponding to the difference D1 is used, and the area E2 is larger than the area E1 and is out of the allowable range corresponding to the difference D1. A first code is added to the judgment data consisting of a plurality of first to third data used for the judgment when the electrolyte measurement unit 27 is judged to be abnormal. Then, the determination unit 33 causes the display unit 36 to display the abnormality information of the electrolyte measurement unit 27 .

In the electrolyte measurement unit 27, if the area surrounded by the first to third lines expands, the sensitive membranes of the ISEs 451, 452, and 453 deteriorate and become dirty, resulting in lower sensitivity and response speed, which leads to worsening of analysis data. It will be.

In this manner, by performing the first determination for each suction operation from one of the first and second solutions to the other solution, an abnormality in the electrolyte measuring section 27 can be quickly detected. In addition, by displaying the abnormality information of the electrolyte measurement unit 27 on the display unit 36, it is possible to notify the abnormality of the electrolyte measurement unit 27 and prompt inspection or replacement of parts, so that deterioration of analysis data thereafter can be prevented. can be prevented.

Note that, as shown in FIG. 10, the first straight line Ls7 indicated by the first relational expression and the third line Ls9 indicated by the third relational expression are straight lines that intersect at one point, and the second relational expression If the second line Ls8 represented by the formula is a curve that touches the first line Ls7 and the third line Ls9 and has an inflection point that intersects the third line Ls9 at one point, the first line The area E3 of the region surrounded by Ls7, the second line Ls8 and the third line Ls9, and the area E4 of the region surrounded by the second line Ls8 and the third line Ls9 can be obtained. In this case, even if either the area E3 or the area E4 is within the allowable range corresponding to the preset second and third data difference D3, the second line Ls8 is an abnormal curve. It is judged that each ISE 451, 452, 453 is abnormal in response, and the first judgment is not executed.

Next, the second determination will be explained. The determination unit 33 determines a plurality of initial first data that change in time series among the plurality of first data generated by the collection in the first time period T1 and a signal corresponding to the first data. A first relational expression represented by a linear regression equation is obtained that indicates the relationship of time when is collected. Further, the determining unit 33 performs a linear regression that indicates the relationship between the plurality of third data generated by the collection in the second time period T2 and the time when the signal corresponding to the third data was collected. Obtain the fourth relational expression expressed by the following equation. Then, the determination unit 33 determines the time at the intersection of the first line indicated by the first relational expression and the fourth line indicated by the fourth relational expression and the start time of the suction operation of the second liquid mixture. A second determination is made based on and.

11 and 12 are diagrams for explaining an example of the second determination.

In FIG. 11, the first line Ls10 is a straight line represented by the first relational expression, and the fourth line Ls11 is a straight line represented by the fourth relational expression. Also, the operation of sucking the second liquid mixture is started at time t0, and the first line Ls10 and the fourth line Ls11 intersect at time t1. Since the difference between the time t0 and the time t1 is within the preset allowable range W, the determination unit 33 determines that the electrolyte measurement unit 27 is normal.

In FIG. 12, the first line Ls12 is the straight line indicated by the first relational expression, and the fourth line Ls13 is the straight line indicated by the fourth relational expression. Also, the operation of sucking the second liquid mixture is started at time t0, and the first line Ls12 and the fourth line Ls13 intersect at time t2.

Here, the determination unit 33 determines that there is an abnormality in the electrolyte measurement unit 27 because the difference between the time t0 and the time t2 is outside the preset allowable range W. A second code is added to the judgment data consisting of data. Then, the determination unit 33 causes the display unit 36 to display the abnormality information of the electrolyte measurement unit 27 .

In the electrolyte measurement unit 27, when the difference between the start time of the suction operation and the time at the intersection of the first and fourth lines increases, the deterioration of the suction pump 431 and the tube 432 of the suction unit 43 and the detection unit 40 or the suction pump 431 Due to the poor connection of the connection part with the liquid supply amount and the suction response, the replacement of the first or second solution in the detection unit 40 from one solution to the other solution becomes insufficient, This would lead to deterioration of analytical data.

In this way, by performing the second determination for each suction operation from one of the first and second solutions to the other solution, an abnormality in the electrolyte measuring section 27 can be quickly detected. In addition, by displaying the abnormality information of the electrolyte measurement unit 27 on the display unit 36, it is possible to notify the abnormality of the electrolyte measurement unit 27 and prompt inspection or replacement of parts, so that deterioration of analysis data thereafter can be prevented. can be prevented.

Next, with reference to FIGS. 13 and 14, an example of generation of standard data, calibration data, management data, and management analysis data for each electrolyte item in the calculation unit 34 will be described. The standard data, calibration data, management data, and management analysis data generated by the calculation unit 34 through the detection of the electrolyte by the detection unit 40, for example, ISE451, will be described below. The calculation unit 34 generates standard data, calibration data, control data, and control analysis data by detecting the electrolyte of each ISE 452 and 453 in the same manner as in the case of ISE 451, so the explanation thereof will be omitted.

FIG. 13 is a diagram showing an example of generation of standard data and management data. FIG. 14 is a diagram showing an example of generation of calibration data and management analysis data.

In FIG. 13, the calculation unit 34 generates at the end of the second time period T2 among the plurality of third data generated by the signal processing unit 32 in accordance with the suction operation of the pre-calibration solution of the electrolyte measurement unit 27. A plurality of the obtained second data are averaged to generate the first calibration data ELC. Further, the calculation unit 34 selects a plurality of pieces of second data generated by the signal processing unit 32 in accordance with the suction operation of the first liquid mixture, for example, a plurality of pieces of data generated at the end of the second time period T2. The second data are averaged to generate first pre-calibration standard data EL. Then, the calculation unit 34 subtracts the first calibration data ELC from the first pre-calibration standard data EL to generate the first standard data ΔEL.

The calculation unit 34 selects the plurality of second data generated at the end of the second time period T2 among the plurality of third data generated by the signal processing unit 32 in accordance with the aspiration operation of the pre-calibration solution. Averaging is performed to generate second calibration data EHC. Further, the calculation unit 34 averages the plurality of second data generated at the end of the second time period T2 among the plurality of second data generated according to the suction operation of the second liquid mixture. It is processed to generate second pre-calibration standard data EH. Next, the calculation unit 34 subtracts the second calibration data EHC from the second pre-calibration standard data EH to generate the second standard data ΔEH.

In FIG. 14, the calculation unit 34 generates first and second standard data ΔEL, ΔEH, and first and second standard values indicating concentrations of electrolytes contained in preset first and second standard samples. Based on CL and CH, calibration data D represented by a first function {Y=ΔEL+S×(lnX−lnCL)}{S=(ΔEH−ΔEL)/ln(CH/CL)} is generated. Then, if the first or second code is added to any one of the plurality of second and third data used to generate the calibration data D, the calculation unit 34 determines that the calibration data D is Add a first or second code. The display unit 36 displays the calibration data D and the first or second code.

In FIG. 13, the calculation unit 34 averages the plurality of third data generated at the end of the second time period T2 among the plurality of third data generated according to the pre-calibration liquid aspirating operation. processed to generate third calibration data ESC. Further, the calculation unit 34 averages the plurality of second data generated at the end of the second time period T2 among the plurality of second data generated according to the suction operation of the fourth liquid mixture. It is processed to generate pre-calibration management data ES. Next, the calculation unit 34 subtracts the third calibration data ESC from the pre-calibration management data ES to generate management data ΔES.

In FIG. 14, the calculation unit 34 substitutes the control data ΔES for the term Y of the first function to obtain the term X, thereby generating the control analysis data CS corresponding to the concentration of each electrolyte contained in the control sample. . Then, the calculation unit 34 adds the first or second code to the analysis data generated using the calibration data D to which the first or second code is added and to the control analysis data CS. Further, if the first or second code is added to any one of the plurality of second and third data used to generate the management analysis data CS, the calculation unit 34 determines that the management analysis data Add the first or second code to CS. The display unit 36 displays the management analysis data CS and the first or second code.

The first to third calibration data ELC, EHC, and ESC are collected during the second time period T2 according to the calibration liquid aspiration operation following the first to fourth mixed liquid aspiration operations. A plurality of data at the end of the plurality of data generated by the above may be replaced with each of the first to third calibration data generated by averaging.

By displaying the calibration data D, the analysis data, and the control analysis data CS to which the first or second code is added on the display unit 36 in this manner, the calibration data generated when the electrolyte measurement unit 27 is abnormal can be displayed. Data D, analysis data, and management analysis data CS can be notified.

According to the embodiment described above, the signal of the detection unit 40 is collected in the first and second time periods T1 and T2 according to the suction operation of the first solution, and a plurality of first and second data are obtained. is collected in a second time period T2 according to the aspiration operation of the second solution to generate a plurality of third data, and from one of the first or second solutions to the other solution Abnormality of the electrolyte measurement unit 27 can be quickly detected by making determination for each suction operation.

In addition, by displaying the abnormality information of the electrolyte measurement unit 27 on the display unit 36, it is possible to prompt inspection of the electrolyte measurement unit 27 and replacement of parts, so that subsequent deterioration of analysis data can be prevented.

By displaying the calibration data D, the analysis data, and the control analysis data CS to which the first or second code is added on the display unit 36, the calibration data D generated when the electrolyte measurement unit 27 is abnormal can be displayed. , analysis data, and management analysis data CS.

While several embodiments of the invention have been described, these embodiments have been presented by way of example and are not intended to limit the scope of the invention. These novel embodiments can be implemented in various other forms, and various omissions, replacements, and modifications can be made without departing from the scope of the invention. These embodiments and their modifications are included in the scope and gist of the invention, and are included in the scope of the invention described in the claims and equivalents thereof.

27 electrolyte measurement unit 32 signal processing unit 33 determination unit 40 detection unit 43 suction unit

Claims (7)

a suction unit that performs a suction operation of the first solution and performs a suction operation of the second solution before or after the suction operation;
a detection unit that detects a specific component contained in each of the first and second solutions sucked by the suction operation of the suction unit;
A plurality of first data that change in time series are generated by collecting detection signals from the detection unit during a period from when the first solution aspirating operation is started until a first period of time elapses. and generating a plurality of second data by collecting in a time period from the elapse of the first time to the elapse of the second time from the start of the aspiration operation of the first solution, a signal processing unit that collects and generates a plurality of third data during a time period from the elapse of the first time period to the elapse of the second time period from the start of the aspiration operation of the solution in 2;
a determination unit that determines whether there is an abnormality in the suction unit or the detection unit based on the plurality of first to third data ;
The determination unit is
A first relationship indicating a relationship between a plurality of initial first data of the plurality of first data that change in time series and a time when a signal corresponding to the first data is collected. and a second formula showing the relationship between all of the first data that change in time series among the plurality of first data and the time when the signal corresponding to this first data was collected Obtaining a relational expression and a third relational expression indicating the relationship between the plurality of second data and the time when the signal corresponding to the second data was collected;
A straight line that intersects a first line represented by the first relational expression and a third line represented by the third relational formula at one point, and a second line represented by the second relational formula is a curve that touches the first line and the third line and has an inflection point that intersects the third line at one point, it is determined that there is an abnormality in the detection unit.
Automatic analyzer. a suction unit that performs a suction operation of the first solution and performs a suction operation of the second solution before or after the suction operation;
a detection unit that detects a specific component contained in each of the first and second solutions sucked by the suction operation of the suction unit;
A plurality of first data that change in time series are generated by collecting detection signals from the detection unit during a period from when the first solution aspirating operation is started until a first period of time elapses. and generating a plurality of second data by collecting in a time period from the elapse of the first time to the elapse of the second time from the start of the aspiration operation of the first solution, a signal processing unit that collects and generates a plurality of third data during a time period from the elapse of the first time period to the elapse of the second time period from the start of the aspiration operation of the solution in 2;
a determination unit that determines whether or not there is an abnormality in the suction unit or the detection unit based on the plurality of first to third data;
prepared,
The determining unit determines a relationship between a plurality of initial first data that change in time series among the plurality of first data and a time when a signal corresponding to the first data is collected. and the relationship between all of the first data that change in time series among the plurality of first data and the time when the signal corresponding to this first data was collected and a third relational expression showing the relationship between the plurality of second data and the time when the signal corresponding to the second data was collected, and obtaining the first to determine whether or not there is an abnormality in the detection unit based on the third relational expression and preset allowable ranges corresponding to the plurality of second and third data;
The judging unit uses a first line indicated by the first relational expression, a second line indicated by the second relational expression, and a third line indicated by the third relational expression The area of the enclosed region is obtained, and if the area is within the allowable range, it is determined that there is no abnormality in the detection unit, and if the area is outside the allowable range, it is determined that there is an abnormality in the detection unit. do
Automatic analyzer. The first and the third relational expressions are linear regression equations,
The second relational expression is represented by a function that monotonically increases or decreases by linear interpolation or nonlinear interpolation between two adjacent first data,
3. The allowable range according to claim 2, wherein the allowable range is a allowable range corresponding to a difference between an average value of the plurality of second data and an average value of the plurality of third data among a plurality of preset allowable ranges. Autoanalyzer as described. a suction unit that performs a suction operation of the first solution and performs a suction operation of the second solution before or after the suction operation;
a detection unit that detects a specific component contained in each of the first and second solutions sucked by the suction operation of the suction unit;
A plurality of first data that change in time series are generated by collecting detection signals from the detection unit during a period from when the first solution aspirating operation is started until a first period of time elapses. and generating a plurality of second data by collecting in a time period from the elapse of the first time to the elapse of the second time from the start of the aspiration operation of the first solution, a signal processing unit that collects and generates a plurality of third data during a time period from the elapse of the first time period to the elapse of the second time period from the start of the aspiration operation of the solution in 2;
a determination unit that determines whether or not there is an abnormality in the suction unit or the detection unit based on the plurality of first to third data;
prepared,
The determining unit determines a relationship between a plurality of initial first data that change in time series among the plurality of first data and a time when a signal corresponding to the first data is collected. and a fourth relational expression showing the relationship between the plurality of third data and the time when the signals corresponding to the third data were collected, and obtaining the first and the fourth relational expressions Based on the fourth relational expression and a preset allowable range, the presence or absence of an abnormality in the suction unit is determined,
The determination unit determines the time at the intersection of the first line indicated by the first relational expression and the fourth line indicated by the fourth relational expression and the start time of the aspiration operation of the first solution. If the difference is outside the allowable range, it is determined that there is an abnormality in the suction unit,
Automatic analyzer. 5. The automatic analyzer according to claim 4, wherein said first and said fourth relational expressions are linear regression expressions. 6. The automatic analyzer according to any one of claims 1 to 5 , wherein concentrations of said component in said first and said second solutions are different. the component is an ion,
7. The automatic analyzer according to any one of claims 1 to 6 , wherein the detection unit has an ion sensor that detects the ions contained in each of the first and second solutions.

Images