Electrolyte analyzer and results display method for electrolyte analyzer

The electrolyte analyzer uses an ion selective electrode to display calibration results with normal and out-of-normal ranges, addressing the challenge of understanding calibration outcomes and failures, enhancing intuitive analysis.

WO2025225236A1PCT designated stage Publication Date: 2025-10-30HITACHI HIGH TECH CORP +1
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Patent Information

Application Number
PCT/JP2025/011254
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-04-24
Filing Date
2025-03-21
Publication Date
2025-10-30

AI Technical Summary

Technical Problem

Conventional electrolyte analyzers struggle with intuitive understanding of calibration results and identifying the cause of calibration failures, especially when internal standard solutions are diluted, as they do not account for device-specific variations.

Method used

An electrolyte analyzer that uses an ion selective electrode to measure specific ions, displaying calibration results with a normal range area and out-of-normal range area, and information obtained by calibration, with calibration results displayed in arrays in different directions for intuitive understanding.

Benefits of technology

Enables clearer grasping of calibration results and easier identification of calibration failures, facilitating prompt corrective actions.

✦ Generated by Eureka AI based on patent content.

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Abstract

A results display region 410 that displays calibration results includes a within-normal range region 504 that indicates a normal range for the calibration results, an out-of-normal range region 505 that indicates outside the normal range for the calibration results, and a slope results display region 510, an IS concentration display region 511, and an S3 concentration display region 512, which are obtained by calibration. A computer 27 displays, aligned in a first direction, an Na acquired information display region 521, a K acquired information display region 522, and a Cl acquired information display region 523, which are test items for prescribed ions, and displays, as calibration results in a second direction that is different from the first direction, the slope results display region 510, the IS concentration display region 511, and the S3 concentration display region 512. As a consequence, this provides an electrolyte analyzer and a results display method for an electrolyte analyzer, which enable a more intuitive comprehension of the calibration results.
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Description

Electrolyte analyzer and method for displaying results of electrolyte analyzer

[0001] The present invention relates to an electrolyte analyzer and a method for displaying calibration results of an electrolyte analyzer.

[0002] Patent document 1 describes an automatic analyzer that includes an analysis result acquisition means for acquiring analysis results for multiple quality control samples for each of multiple analysis items, a quality control value derivation means for deriving quality control values ​​that indicate the analytical accuracy for each combination of analysis item and quality control sample using the analysis results, a graph generation means for generating a graph on which the quality control values ​​are plotted, a first screen generation means for generating a first screen including the graph, and a display means for displaying the first screen.

[0003] Patent No. 5542317

[0004] In an electrolyte analyzer such as that described in Patent Document 1, the calibration results are displayed simply as numbers or on a screen where values ​​are plotted on a graph, and even if the calibration results are within the standard, it is difficult to clearly understand what the values ​​are relative to the expected median or judgment threshold value.

[0005] Furthermore, once calibration fails, it is necessary to understand the principles of electrolyte measurement and then deduce the cause of the calibration failure, which is a high hurdle.

[0006] Recent electrolyte analyzers sometimes employ a method in which a concentrated internal standard solution is diluted with water for each measurement.

[0007] In conventional electrolyte analyzers, the concentration of the internal standard solution is essentially constant, excluding the effect of concentration caused by evaporation when the container is opened. Therefore, the calibration result can be confirmed simply by checking the slope value.

[0008] In contrast, in a newly designed electrolyte analyzer in which the internal standard solution is diluted with water for each measurement, the diluted internal standard solution is not necessarily constant due to some internal influences of the device, such as deterioration over time or component failure, and so it has become necessary to determine whether the internal standard solution has been diluted correctly during calibration. In other words, it has become necessary to determine whether not only the slope value but also other parameters such as the IS concentration and S3 value are normal.

[0009] The present invention proposes an electrolyte analyzer that allows a calibration result to be more intuitively grasped, and a method for displaying the results of the electrolyte analyzer.

[0010] The present invention includes multiple means for solving the above-mentioned problems. One example of such a means includes an electrolyte analysis unit that uses an ion selective electrode to measure the concentration of a specific ion in a sample and the concentration of the specific ion in a sample of known concentration for calibration, a display unit that displays information for an operator, and a display control unit that causes the display unit to display the calibration results measured by the electrolyte analysis unit, wherein a result display area in which the calibration results are displayed includes a normal range area that indicates the normal range of the calibration results, an out-of-normal range area that indicates the outside of the normal range of the calibration results, and information obtained by the calibration, and the display control unit displays the calibration test items for the specific ions in an array in a first direction, and displays the calibration results in an array in a second direction different from the first direction.

[0011] According to the present invention, the calibration results can be more intuitively grasped. Problems, configurations, and effects other than those described above will become apparent from the following description of the embodiments.

[0012] FIG. 1 is a diagram illustrating a schematic configuration of an electrolyte analyzer according to an embodiment of the present invention. FIG. 2 is a diagram illustrating the principle of three-point calibration using three types of calibrators in an electrolyte analyzer. FIG. 3 is a diagram illustrating an example of a display screen for calibration results in an electrolyte analyzer according to an embodiment. FIG. 4 is a partially enlarged view of the display screen for calibration results in FIG. 3. FIG. 5 is a partially enlarged view of the calibration result display area in FIG. 4. FIG. 5 is a diagram illustrating an example of an operator's workflow regarding sample measurement in an electrolyte analyzer. FIG. 6 is a diagram illustrating an example of a workflow for determining whether calibration in an electrolyte analyzer is successful. FIG. 6 is a diagram illustrating a display procedure for the display screen for calibration results in an electrolyte analyzer according to an embodiment. FIG. 7 is a diagram illustrating an overview of a screen in which all calibration results have been erased when calibration is updated in an electrolyte analyzer according to an embodiment. FIG. 8 is a diagram illustrating an example of a display screen for new calibration results that are displayed when calibration is completed in an electrolyte analyzer according to an embodiment. FIG. 9 is a diagram illustrating an example of a display screen for calibration results by IS autocalib in an electrolyte analyzer according to an embodiment. FIG. 10 is a diagram illustrating an example of a display screen for calibration results by IS autocalib in an electrolyte analyzer according to an embodiment. FIG. 11 is a diagram illustrating an example of a display screen for calibration results by IS autocalib in an electrolyte analyzer according to an embodiment. FIG. 12 is a diagram illustrating an example of a display screen for calibration results by full calibration in an electrolyte analyzer according to an embodiment. FIG. 1 is a diagram showing an example of a display screen for calibration results by full calibration in the electrolyte analyzer of the embodiment. FIG. 2 is a diagram showing an example of a display screen for calibration results by full calibration in the electrolyte analyzer of the embodiment. FIG. 3 is a diagram showing an example of a display screen for a case where only an item of a certain electrode deviates from the median in the electrolyte analyzer of the embodiment. FIG. 4 is a diagram showing another example of a display screen for calibration results in the electrolyte analyzer of the embodiment. FIG. 5 is a diagram showing another example of a display screen for calibration results in the electrolyte analyzer of the embodiment.FIG. 10 is a diagram showing another example of the display screen of the calibration result in the electrolyte analyzer of the embodiment.

[0013] An embodiment of an electrolyte analyzer and a method for displaying results of an electrolyte analyzer according to the present invention will be described with reference to Figures 1 to 21. In the drawings used in this specification, identical or corresponding components are designated by identical or similar reference numerals, and repeated description of these components may be omitted.

[0014] First, the overall configuration of the electrolyte analyzer will be described with reference to Fig. 1. Fig. 1 is a diagram schematically showing the overall configuration of the electrolyte analyzer according to this embodiment.

[0015] The electrolyte analyzer 100 shown in FIG. 1 is broadly composed of a sample dispensing unit 101 that performs processing on the sample to be analyzed, an analysis unit 102 that uses an ion selective electrode 1 to measure the concentration of a specific ion in a sample and the concentration of a specific ion in a sample of known concentration for calibration, a reagent unit 103 that supplies reagents used in the analysis unit 102, and a mechanism unit 104.

[0016] The specimen dispensing unit 101 has a specimen dispensing mechanism 13 and a transport unit (not shown for convenience of illustration). The specimen to be measured is placed in a specimen container 14 and transported by the transport unit to the vicinity of the specimen dispensing mechanism 13. The specimen dispensing mechanism 13 dispenses the specimen by aspirating it from the specimen container 14 and discharging it into the dilution tank 10, and then draws it into the electrolyte analyzer 100.

[0017] The analysis section 102 is composed of a dilution tank 10, a preheater 11, a shipper nozzle 12, a dilution liquid nozzle 18, an internal standard liquid nozzle 19, a waste liquid suction nozzle 20, an ion selective electrode (ISE) 1, a reference electrode 2, a pinch valve 17, a voltmeter 25, an amplifier 26, and a computer 27.

[0018] The specimen dispensed into the dilution tank 10 by the specimen dispenser 101 is diluted and stirred with the diluent discharged from the diluent nozzle 18 into the dilution tank 10. The specimen diluted and stirred in the dilution tank 10 (diluted specimen) is aspirated by the shipper nozzle 12 and sent to the analysis unit 102, and the waste liquid remaining in the dilution tank 10 is aspirated by the waste liquid aspirator nozzle 20 and discharged into the waste liquid tank 31.

[0019] The reference electrode solution stored in the reference electrode solution bottle 5 is sent to the reference electrode 2 by operating the sipper syringe 9 while the pinch valve 17 is closed. By opening the pinch valve 17 in this state, the diluted sample solution sent to the flow path of the ion selective electrode 1 and the reference electrode solution sent to the flow path of the reference electrode 2 come into contact with each other, and the ion selective electrode 1 and the reference electrode 2 are electrically connected.

[0020] The computer 27 is connected to the sample dispensing section 101, the analysis section 102, the reagent section 103, and each mechanism within the mechanism section 104 via a wired or wireless network line, and is a calculation processing mechanism that controls the overall operation of the electrolyte analysis device 100 and displays the calibration results measured by the analysis section 102 on the display device 40.

[0021] For example, the opening and closing operations of the solenoid valves 16 provided in the sample dispensing section 101, the analysis section 102, the reagent section 103, and the mechanism section 104, as well as the liquid delivery operations (liquid delivery amounts) of the syringes 7, 8, and 9 are controlled to calculate the concentration of the electrolyte in the sample based on the potential difference generated between the ion selective electrode 1 and the reference electrode 2 and the calibration curve obtained by calibration performed in advance.

[0022] More specifically, the ion selective electrode 1 is provided with a sensor for detecting specific ions in the sample, such as sodium ions (Na + ), potassium ions (K + ), chloride ion (Cl - The ion selective electrode 1 outputs an electromotive force corresponding to the concentration of each ion in the sample.

[0023] The computer 27 acquires the electromotive force between the ion selective electrode 1 and the comparison electrode 2 via the voltmeter 25 and the amplifier 26, calculates the ion concentration in the sample from the acquired electromotive force, and displays it on the display device 40 or stores it in the memory device 45.

[0024] Furthermore, after each sample measurement, the computer 27 ejects an internal standard solution adjusted to a certain concentration from the internal standard solution nozzle 19 into the dilution tank 10 during the period until the next sample measurement, and performs a measurement in the same manner as for the sample. The computer 27 then uses the measurement results to correct for potential fluctuations due to temperature changes, etc., i.e., corrects the sample measurement results.

[0025] This computer 27 can be configured as a computer equipped with a CPU (Central Processing Unit), RAM (Random Access Memory), storage device, and I / O port, and the RAM, storage device, and I / O port are configured to be able to exchange data with the CPU via an internal bus. The I / O port is connected to each of the above-mentioned mechanisms and controls their operation. Operation control is performed by loading a program stored in the storage device into the RAM and executing it with the CPU. In addition, an input / output device is connected to the computer 27, allowing input from an operator and displaying measurement results.

[0026] The control processes for the operations to be executed may be integrated into one program, or may be divided into multiple programs, or may be a combination of these.

[0027] Some or all of the programs stored in each device may be implemented using dedicated hardware or may be modularized. Furthermore, various programs may be installed in each device from a program distribution server or external storage media, or may be used to update existing devices.

[0028] Furthermore, each device may be an independent device connected to a wired or wireless network, or two or more devices may be integrated.

[0029] The display device 40 is a part that displays screens containing various information for the operator, such as an operation screen for ordering measurement items to be measured for the sample to be measured, a screen for checking the measurement results, etc., and is configured with a liquid crystal display or the like. In particular, a calibration result screen 400 including a result display area 410 in which the calibration results shown in Fig. 3 etc. are displayed is displayed. Details thereof will be described later.

[0030] It is not necessary for the display to be an LCD, but it may be replaced with a printer or the like, or it may be configured with a display and a printer or the like, or it may be a touch panel type display for inputting various parameters and settings, measurement results, measurement request information, instructions to start and stop analysis, etc. based on the displayed operation screen.

[0031] Returning to FIG. 1 , the reagent section 103 is a mechanism for supplying reagents used in measurement and cleaning, and is the section where the concentrated internal standard solution bottle 3, the diluent bottle 4, and the reference electrode solution bottle 5 are installed, and has a degassing mechanism 6, a filter 15, and a dilution and reduction section 24.

[0032] A concentrated internal standard bottle 3 containing a concentrated internal standard solution (concentrated reagent) and a diluent bottle 4 containing a diluent are connected to an internal standard nozzle 19 and a diluent nozzle 18, respectively, by flow paths that pass through a filter 15. The internal standard nozzle 19 and the diluent nozzle 18 are installed with their tips inserted into the dilution tank 10. Furthermore, a reference electrode solution bottle 5 containing a capture electrode solution is connected to the reference electrode 2 by a flow path that passes through a filter 15.

[0033] The concentrated internal standard solution contained in the concentrated internal standard solution bottle 3 is an internal standard solution concentrated to a known concentration, and by diluting and reducing it with a diluent to a predetermined concentration, the internal standard solution to be used in the measurement is produced.

[0034] A dilution / reduction unit 24 is provided on the flow path from the concentrated internal standard solution bottle 3 to the internal standard solution nozzle 19, and is connected by a flow path to a pure water production device 21, a supply water tank 22, and a pump 23. In the dilution / reduction unit 24, the concentrated internal standard solution is diluted and reduced with pure water at a predetermined ratio. The pure water referred to here may be water that does not contain more than a certain amount of impurities, or may be water that has been deionized. A degassing mechanism 6 is connected to the flow path between the pure water production device 21 and the dilution / reduction unit 24, the flow path between the dilution solution bottle 4 and the dilution tank 10, and the flow path between the reference electrode solution bottle 5 and the reference electrode 2, and a degassed solution is discharged into the dilution tank 10.

[0035] It is desirable that the dilution and reduction unit 24 be provided in the flow path between the concentrated internal standard solution bottle 3 and the dilution tank 10, but this is not limitative. For example, a pure water nozzle for supplying pure water may be provided in the dilution tank 10, and the concentrated internal standard solution may be diluted and reduced using pure water in the dilution tank 10.

[0036] The mechanism section 104 has an internal standard solution syringe 7, a diluent syringe 8, a sipper syringe 9, an electromagnetic valve 16, etc., and is responsible for various operations such as liquid transfer.

[0037] The internal standard solution is introduced into the dilution and reduction unit 24 at a fixed ratio of concentrated internal standard solution and pure water by operating the internal standard solution syringe 7 and the solenoid valve 16. As a result, the concentrated internal standard solution is diluted with pure water and adjusted to a predetermined concentration.

[0038] Although the above-described electrolyte analyzer 100 has been described as an example of a type that uses a concentrated internal standard solution after dilution, it is also possible to use an electrolyte analyzer that uses an internal standard solution without diluting it.

[0039] Furthermore, although the example has been described in which the analysis unit 102 only analyzes electrolytes, the analysis device may also be of a type that further includes an analysis unit that analyzes other analysis items, such as colorimetric analysis items, within the same housing.

[0040] Furthermore, it is also possible to provide an analysis unit for analyzing different analysis items and a processing unit for performing pre-processing and post-processing in different housings to create a modular analysis system.

[0041] Next, the display screen of the calibration result in the electrolyte analyzer 100 according to this embodiment and the display method thereof will be described with reference to FIGS. 2 to 21. FIG.

[0042] First, an example of a display screen for calibration results will be described with reference to Figures 2 to 5. Figure 2 is a diagram illustrating the principle of three-point calibration using three types of calibrators in an electrolyte analyzer. The following description will be given assuming that calibration of electrolyte measurements of Na, K, and Cl is performed using three calibration points. In three-point calibration, in addition to low-concentration and high-concentration calibrators that determine the slope, a third calibrator that determines the intercept is used.

[0043] When performing calibration, a calibration method using three calibrators is called full calibration, and a calibration method in which the internal standard solution bottle is replaced and only the IS concentration value is simply updated is called IS autocalib.

[0044] Figure 2 explains the principle of three-point calibration using three types of calibrators. Note that a Na electrode is used as an example here. Furthermore, depending on the method, if only two types of calibrators are used, the information obtained as a result of calibration may differ from this example, but basically, the calibration method is similar for electrolyte measurements.

[0045] The horizontal axis of Figure 2 is the logarithm of ion concentration, and the vertical axis is the electromotive force (EMF) generated at the electrode. For the Na electrode and K electrode, the graph shows an upward slope, with the electromotive force increasing with concentration. On the other hand, for the Cl electrode, the graph shows a downward slope, inversely proportional to the logarithm of the concentration.

[0046] In calibration, a calibration curve is obtained by measuring low-concentration standard solution S1 and high-concentration standard solution S2. The inclination of this calibration curve is called the slope, and is defined as slope = (EMF-S2-EMF-S1) / log[(S2 concentration) / (S1 concentration)].

[0047] In addition, by measuring the calibrator, a correction value can be obtained from the standard solution and the actual sample, but to obtain this correction value, the value calculated from the assigned value of the third calibrator and the calibration curve becomes the S3 concentration.

[0048] Fig. 3 is a diagram showing an example of a display screen for calibration results in the electrolyte analyzer of the embodiment. Calibration result screen 400 displayed on display device 40 shown in Fig. 3 includes a parameter display area 401 in which the calibration test items, the execution date and time, the actual measured values ​​at each ion selective electrode 1, and the presence or absence of an alarm are displayed in a table format, a result value display area 403 in which the numerical values ​​of the acquired information for each test item of Na, K, and Cl are displayed in a table format, and a result display area 410 in which the calibration results are displayed.

[0049] FIG. 4 is a partially enlarged view of the calibration result display screen of FIG. 3, with the focus on a result display area 410 of the calibration result screen 400.

[0050] As shown in FIG. 4, the result display area 410 displays, at the top of the screen, a calibration result summary display area 530 that displays whether the executed calibration was successful or not, for example, "Failed" if one or more of the test items are outside the normal range, and "Successful" otherwise, and a calibration method summary display area 531 that displays whether the executed calibration was full calibration (displayed as "Full" on the screen) or IS autocalibration (displayed as "Autocalibration" on the screen).

[0051] In addition, the result display area 410 displays, from left to right in the figure, a test item display area 500, a slope result display area 510, an IS concentration display area 511, and an S3 concentration display area 512 as information obtained by calibration on the column side (second axis direction), and an acquisition information display area 520, an Na acquisition information display area 521, a K acquisition information display area 522, and a Cl acquisition information display area 523 as information obtained from the top to bottom in the figure on the row side (first axis direction).

[0052] In this way, the computer 27 displays the Na acquisition information display area 521, K acquisition information display area 522, and Cl acquisition information display area 523, which are test items for specific ions, in a first direction, and also displays the slope result display area 510, IS concentration display area 511, and S3 concentration display area 512, which are calibration results, in a second direction different from the first direction.

[0053] Also, as shown in FIG. 4, a table format in which the first direction and the second direction intersect perpendicularly can be used.

[0054] FIG. 5 is a partial enlarged view of the calibration result display area in FIG. 4, focusing on the slope result of the Na item in the Na acquisition information display area 521 of the result display area 410.

[0055] As shown in Figure 5, the display area for each acquired information of each test item displayed in the result display area 410 includes a measurement value 501, a lower limit boundary 502, an upper limit boundary 503, a normal range area 504, a normal range area 505, a measurement value display mark 506, an upper limit value display area 507, and a lower limit value display area 508.

[0056] As shown in FIG. 5, an in-normal range area 504 indicating the normal range of the calibration result and an out-of-normal range area 505 indicating the out-of-normal range of the calibration result are displayed in a single band.

[0057] In addition, a lower boundary 502 and an upper boundary 503 are displayed to distinguish between the normal range area 505 and the normal range area 504, so that the upper and lower boundaries that define the boundaries between the normal range area 504 and the normal range area 505 are highlighted.

[0058] Furthermore, the numerical value of the upper boundary 503 , which is the boundary between the normal range area 504 and the out-of-normal range area 505 , is displayed in an upper limit value display area 507 , and the numerical value of the lower boundary 502 is displayed in a lower limit value display area 508 .

[0059] 5, the measurement value 501, which is the calibration result, is displayed as a numerical value on a band in addition to the result numerical value display area 403. Note that the area displaying the measurement value 501 may be below the band.

[0060] Furthermore, the measurement value 501, which is the numerical value of the calibration result, is displayed at the position of the actual value in proportion to the numerical value of the boundary between the normal range area 504 and the out-of-normal range area 505. As a result, the normal average value of the target measurement value 501 coincides with the center of the band-shaped area that is midway between the lower limit boundary 502 and the upper limit boundary 503, so that the deviation of the measurement value 501 from the center can be seen at a glance.

[0061] Furthermore, between the measurement value 501 and the band, the calibration result is displayed as a measurement value display mark 506. The area where the measurement value display mark 506 is displayed may be below the band, and does not have to be on the same side as the measurement value 501.

[0062] As with the measurement value 501, the measurement value display mark 506 can be displayed at the position of the actual value in proportion to the boundary value between the normal range area 504 and the out-of-normal range area 505.

[0063] The calibration result measurement value 501 and the measurement value display mark 506 can be displayed at the upper or lower limit of the display when the calibration result is outside the display range. Details of this will be described later.

[0064] In clinical electrolyte analysis, calibration is performed before measuring a patient's sample. The flow of sample measurement by an operator at this time will be described with reference to Figure 6. Figure 6 is a diagram showing an example of the operator's workflow regarding sample measurement in an electrolyte analyzer.

[0065] First, as shown in FIG. 6, the operator performs preparations for measurement such as attaching electrodes and setting up a reagent (step S601), and instructs the apparatus to perform calibration (step S602).

[0066] The operator then checks the calibration result screen 400 displayed on the display device 40 as shown in FIG. 3 (step S603), and if he determines that there are no problems, he instructs the device to analyze the quality control sample, i.e., to perform QC (step S604).

[0067] The operator then checks the QC result screen displayed on the display device 40 (which may be in the same format as the calibration result screen 400 in Figure 3, or in a different format) (step S605), and if he determines that there are no problems, he instructs the device to perform measurements on the patient sample (step S606).

[0068] On the other hand, if it is determined in step S603 that there is a problem with the calibration results, or in step S605 that there is a problem with the QC results, the operator returns the process to step S601, checks for abnormalities in the reagents or electrodes, or re-installs or replaces them, and then executes the above steps again.

[0069] Next, the flow of determining whether or not the calibration was successful in step S603 in Fig. 6 will be described with reference to Fig. 7. Fig. 7 is a diagram showing an example of a workflow for determining whether or not the calibration in the electrolyte analyzer was successful.

[0070] First, as shown in FIG. 7 , the operator looks at the parameter display area 401 and the result value display area 403 in the calibration result screen 400 displayed on the display device 40, and in particular the slope result display area 510 in the Na acquisition information display area 521, the K acquisition information display area 522, and the Cl acquisition information display area 523 in the result display area 410, and determines whether the slope value for each test item is within the standard range (step S701).

[0071] If it is determined in step S701 that the slope value is within the standard, the operator then looks at the IS concentration display area 511 in the Na acquisition information display area 521, the K acquisition information display area 522, and the Cl acquisition information display area 523 in the result display area 410 to determine whether the IS concentration value for each test item is within the standard (step S702).

[0072] If it is determined in step S702 that the IS concentration value is within the standard, the operator then looks at the S3 concentration display area 512 in the Na acquisition information display area 521, the K acquisition information display area 522, and the Cl acquisition information display area 523 in the result display area 410 to determine whether the S3 concentration value for each test item is within the standard (step S703).

[0073] If it is determined in step S703 that the S3 density value is within the standard range, then there is no problem with all the acquired information, and it is determined that the calibration has been successful (step S704).

[0074] On the other hand, if it is determined that the slope value is outside the standard in step S701, the IS density value is outside the standard in step S702, or the S3 density value is outside the standard in step S703, it is determined that the calibration has failed (step S705).

[0075] Although it is possible to make a judgment from either or both of the result numerical value display area 403 in the calibration result screen 400 or the calibration result summary display area 530 in the result display area 410 without referring to the result display area 410, it is preferable to check the acquisition information of each test item in the result display area 410, in which the Na acquisition information display area 521, K acquisition information display area 522, and Cl acquisition information display area 523, which are test items for specific ions, are displayed in a first direction, as in the flow of Figure 7 described above, and the slope result display area 510, IS concentration display area 511, and S3 concentration display area 512, which are calibration results, are displayed in a second direction different from the first direction, as is easier to understand visually.

[0076] Next, the procedure for controlling the display of the calibration result screen 400 on the display device 40 in the computer 27 will be described with reference to Figures 8 to 10. Figure 8 is a diagram showing the display procedure for the calibration result display screen in the electrolyte analyzer of the embodiment, Figure 9 is a diagram showing an overview of the screen in a state where all calibration results have been temporarily erased when the calibration is updated, and Figure 10 is a diagram showing an example of a display screen of new calibration results that is displayed when the calibration is completed.

[0077] As shown in FIG. 8, when the computer 27 attempts to perform the calibration shown in FIG. 6, it first erases the previous calibration (step S801) and its result (step S802) once (step S803).

[0078] Fig. 9 shows a state in which all calibration results have been temporarily erased when the calibration has been updated. As shown in Fig. 9, on a calibration result screen 400A displayed on the display device 40, the area in which the result display area 410 in the calibration result screen 400 shown in Fig. 3 is displayed is blank, and only a parameter display area 401A and a result numerical value display area 403A are displayed.

[0079] Thereafter, the computer 27 checks the progress of the calibration (step S804), and when it is determined that the calibration is complete, displays the results of the current calibration (step S805).

[0080] 10, when calibration is completed, a new calibration result screen 400B is displayed, which includes a parameter display area 401B, a result value display area 403B, and also a result display area 410B. This new calibration result screen 400B is displayed to determine the result, regardless of whether the calibration was successful or unsuccessful.

[0081] When using three calibrators, the operator typically checks the slope value, IS concentration value, and S3 value in the result display area 410B, and if all are within the standard, the operator determines that the calibration is normal and completes the calibration. If any one of the values ​​is outside the standard, the operator determines that the calibration has failed and searches for the cause of the failure.

[0082] On the other hand, if the calibration is not completed, the calibration result remains hidden as shown in FIG. 9 (step S806), and the process waits for the calibration result to be completed and displayed.

[0083] FIG. 11 is a diagram showing an example of a display screen of the calibration result by IS autocalib in the electrolyte analyzer of the embodiment.

[0084] The result display area 410C shown in FIG. 11 displays the results of calibration using IS autocalib, which updates the electromotive force of the internal standard solution and performs calibration without measuring the sample, and the calibration method summary display area 531 is "autocalib."

[0085] The other areas are substantially the same as the result display area 410 shown in Fig. 4, although the detailed values ​​of the measurement values ​​501 and the display positions of the measurement value display marks 506 are different, and therefore details are omitted. Figures 12 to 17, which will be described below, are also substantially the same, and details are omitted.

[0086] FIG. 12 shows an example of a display screen of the calibration results by IS autocalib in the electrolyte analyzer of the embodiment, and is an example of the display of the calibration results by IS autocalib when the internal standard solution is outside the standard range.

[0087] In the result display area 410D shown in FIG. 12, the calibration results show that the IS concentration display area 511 for all of the items Na, K, and Cl is below the lower limit reference value, and the measurement value 501 and measurement value display mark 506 are displayed as pointing above the out-of-normal range area 505 below the lower limit boundary 502. In this case, it is suspected that the concentrated IS mechanism (the mechanism from the concentrated internal standard bottle 3 to the internal standard nozzle 19 and from the diluent bottle 4 to the diluent nozzle 18) is malfunctioning for some reason. In this case, according to the flowchart in FIG. 7, the calibration will fail and subsequent measurements will be impossible. In this case, the calibration result summary display area 530 will clearly state that the calibration has ended in failure, saying "Calibration has failed."

[0088] FIG. 13 shows an example of a display screen of the calibration results by IS Autocalib in the electrolyte analyzer of the embodiment, and is an example of the display of the calibration results by IS Autocalib when the internal standard solution is within the standard but there is a deviation from the median.

[0089] In the result display area 410E shown in Figure 13, if the calibration results show that for all items of Na, K, and Cl, the IS concentration does not fall below the lower limit reference value of the IS concentration display area, but there is a deviation from the median, then the concentration IS mechanism is suspected to be malfunctioning for some reason.

[0090] At this time, if the flow chart of Figure 7 is followed, the calibration will be successful, but caution is required as there is a possibility of subsequent measurement failure. By referring to the IS concentration display area 511, it can be easily determined that it is advisable to take measures such as maintenance or replacement of each consumable item as necessary.

[0091] Next, a display screen of the calibration result by full calibration will be described with reference to Fig. 14 to Fig. 16. Fig. 14 to Fig. 16 are diagrams showing an example of a display screen of the calibration result by full calibration.

[0092] 14 is an example of a display when the value of the third calibrator is outside the standard during full calibration and the calibration fails, and as shown in the S3 concentration display area 512, as a result of the calibration, the measurement values ​​501 and measurement value display marks 506 for all of the items Na, K, and Cl exceed the upper boundary 503 and are displayed in the out-of-normal range area 505. When the upper limit reference value of the S3 concentration display area is exceeded in this way, it is suspected that an error occurred due to inattention on the part of the operator or that a different calibrator was placed instead of the calibrator that should have been measured in S3.

[0093] In this case, according to the flowchart in Figure 7, calibration will fail and subsequent measurements will be impossible, but by referring to the S3 concentration display area 512, it will be much easier to guess the cause of the failure than with the conventional result display screen.

[0094] 15, as shown in the S3 concentration display area 512, the calibration results show that the measured values ​​501 and measured value display marks 506 for all the items Na, K, and Cl are displayed within the normal range area 504, but are displayed near the upper boundary 503, indicating deviation from the median. In this case, a mistake due to inattention on the part of the operator, or a concentration or mixing error of the calibrator to be measured in S3 is suspected.

[0095] At this time, even if the calibration is successful, care must be taken to avoid the possibility of failure in subsequent measurements, as shown in the flowchart of Figure 7. It is easy to determine that it is desirable to take measures such as maintenance or replacement of consumables as necessary.

[0096] 16, as shown in the S3 concentration display area 512, the calibration results show that the measured values ​​501 and measured value display marks 506 for all the items Na, K, and Cl are displayed within the normal range area 504, but are displayed near the lower limit boundary 502, indicating deviation from the median. In this case, a mistake due to inattention on the part of the operator or a mistake in mixing the calibrators to be measured in S3 is suspected.

[0097] In this case, too, it is necessary to be careful according to the flowchart in Figure 7, since there is a possibility that subsequent measurements may fail even if the calibration is successful, and it is easy to determine that it is desirable to take measures such as maintenance or replacement of various consumables as necessary.

[0098] FIG. 17 is a diagram showing an example of a display screen in the electrolyte analyzer of the embodiment when only a certain electrode item has deviation from the median value.

[0099] The result display area 410I shown in Figure 17 is an example of a display when, as a result of calibration, the Na slope value does not fall below the lower limit reference value of the display area by the slope result display area 510, but there is a deviation from the median value, as shown in the slope result display area 510 of the Na acquisition information display area 521.

[0100] In this case, there is no problem with the slope values ​​of K and Cl, so deterioration of the Na electrode in the ion selective electrode 1 is suspected. At this time, by looking at the result display area 410I, the operator can take into consideration the number of measurements thereafter and determine that they should consider replacing the Na electrode or the ion selective electrode 1 itself.

[0101] By referring to the result display areas 410D to 410I shown in FIGS. 12 to 17, it becomes easier to guess the cause of the calibration failure without fully understanding the operation and performance of the device.

[0102] FIG. 18 is a diagram showing another example of the display screen of the calibration result in the electrolyte analyzer of the embodiment.

[0103] The result display area 410J shown in Figure 18 is an example of a display when the matrix of the electrode items and the elements constituting the calibration in the result display area 410 shown in Figure 4 is swapped, and the acquired information display area 520J, Na acquired information display area 521J, K acquired information display area 522J, and Cl acquired information display area 523J are displayed on the column side (first axis direction) from left to right in the figure, and the information obtained by calibration is displayed on the row side (second axis direction) from top to bottom in the figure, with the test item display area 500J, slope result display area 510J, IS concentration display area 511J, and S3 concentration display area 512J.

[0104] The matrix of the electrode items and calibration elements in FIG. 18 and FIG. 4 may be switched on a setting screen (not shown).

[0105] FIG. 19 is a diagram showing another example of the display screen of the calibration result in the electrolyte analyzer of the embodiment.

[0106] In the result display area 410K shown in FIG. 19, deviation from the median is emphasized as a display of the calibration result.

[0107] For example, the white band-shaped area is the normal range area 504K, and both ends of the band-shaped area are the out-of-normal range areas 505K, and the lower limit reference value and upper limit reference value are displayed integrally with the upper limit value display area and lower limit value display area, respectively.

[0108] Furthermore, the measurement value 501K and the measurement value display mark 506K are displayed at the position of the actual value in proportion to the numerical value of the boundary between the normal range area 504K and the out-of-normal range area 505K.

[0109] In this case, as shown in the IS concentration display area 511K and S3 concentration display area 512K of the Na acquisition information display area 521K and the K acquisition information display area 522K, and the slope result display area 510K and S3 concentration display area 512K of the Cl acquisition information display area 523K, when the IS concentration for K is within the normal range, the area shaded with downward-sloping stripes extending from the center of the normal range area 504K indicating the normal range is within the normal range, and its area indicates the degree of deviation from the center. Therefore, the smaller the area shaded with downward-sloping stripes, the lower the deviation from the center and the closer it is to the normal value.

[0110] Furthermore, as shown in the slope result display area 510K of the K acquisition information display area 522K and the IS concentration display area 511K of the Cl acquisition information display area 523K, if the slope value for K is outside the normal range, the area painted with a downward left stripe extending from the center of the normal range area 504K indicating the normal range to the out-of-normal range area 505K at the end indicates that it is outside the normal range.

[0111] Furthermore, a calibration result summary display area 530K is displayed below each test item in the test item display area 500K.

[0112] FIG. 20 is a diagram showing another example of the display screen of the calibration result in the electrolyte analyzer of the embodiment.

[0113] 20, the display portion of the result display area 410L includes a curve. For example, an acquisition information display area 520L is displayed in an area next to an Na acquisition information display area 521L and a K acquisition information display area 522L. Areas corresponding to the test item display area 500, slope result display area 510, IS concentration display area 511, and S3 concentration display area 512 are provided within the Na acquisition information display area 521L, K acquisition information display area 522L, and Cl acquisition information display area 523L, respectively.

[0114] FIG. 21 is a diagram showing another example of the display screen of the calibration result in the electrolyte analyzer of the embodiment.

[0115] 21, the display portion of the result display area 410M is mainly composed of straight lines. For example, an Na acquisition information display area indicated by a "circle" (circle) and a K acquisition information display area indicated by a "triangle" (triangle), and a Cl acquisition information display area indicated by a "◇" (circle) are displayed in either an inside-normal-range area 504M sandwiched between an upper boundary 503M and a lower boundary 502M or an outside-normal-range area 505M above the upper boundary 503M or below the lower boundary 502M, thereby displaying the test item display area 500M, the calibration result summary display area 530, the calibration method summary display area 531, the acquisition information display area 520M, the measurement values ​​501M, and the measurement value display marks 506M as rows from the top to the bottom of the drawing.

[0116] In addition, a slope result display area 510M, an IS density display area 511M, and an S3 density display area 512M are displayed as columns from the left side in the drawing.

[0117] These display methods also make it easier to grasp whether an abnormality has occurred and its cause, as with FIG. 4 and the like, compared to conventional screens.

[0118] Next, the effects of this embodiment will be described.

[0119] The electrolyte analyzer 100 of the present embodiment described above includes an analysis unit 102 that uses an ion selective electrode 1 to measure the concentration of a specific ion in a sample and the concentration of a specific ion in a calibration sample of known concentration, a display device 40 that displays information for an operator, and a computer 27 that causes the display device 40 to display the calibration results measured by the analysis unit 102. A result display area 410 that displays the calibration results includes an in-normal range area 504 that indicates the normal range of the calibration results, an out-of-normal range area 505 that indicates the outside of the normal range of the calibration results, a slope result display area 510 obtained by the calibration, an IS concentration display area 511, and an S3 concentration display area 512. The computer 27 displays a Na acquisition information display area 521, a K acquisition information display area 522, and a Cl acquisition information display area 523, which are test items for specific ions, arranged in a first direction, and also displays the slope result display area 510, the IS concentration display area 511, and the S3 concentration display area 512, which are the calibration results, arranged in a second direction different from the first direction.

[0120] Recently, clinical testing sites have been moving towards labor-saving and a wide variety of equipment. This means that one clinical laboratory technician must be responsible for many pieces of equipment. Meanwhile, blood analyzers themselves are becoming more and more multifunctional, and for safety reasons, there are an increasing number of models where the operation of the equipment cannot be directly observed.

[0121] Therefore, there is a demand for a PC operation unit (interface) for an automatic analyzer that allows intuitive operation with fewer screens.

[0122] In the calibration of electrolyte measurements as in this embodiment, a particular characteristic of electrolyte measurements is that a certain calibrator is measured simultaneously in the same measurement, and as a result, there are problems particular to the calibration operation of electrolyte measurements.

[0123] Many technologies have been invented to display calibration and QC results, but all of them require multiple UI screens and do not provide an intuitive solution for busy operators. In particular, the means for determining calibration abnormalities have always focused on differences from past calibration results, and no technology has been provided to intuitively grasp failures, such as mistakes due to lack of attention.

[0124] In contrast, the display of calibration results according to the present invention visualizes the measurement values ​​in different positions for the Na acquisition information display area 521, K acquisition information display area 522, Cl acquisition information display area 523, which are the results of a single calibration measurement on one screen, and the slope result display area 510, IS concentration display area 511, and S3 concentration display area 512, which are the calibration results, even if whether or not each measurement item (Na, K, Cl) is within the normal range differs. This makes it possible to intuitively understand whether the calibration was successful or unsuccessful, the degree of deterioration of consumable parts, and the cause of unsuccessful calibration.

[0125] Furthermore, by displaying the normal range area 504 and the out-of-normal range area 505 in a band shape, displaying the calibration results as numerical values, or displaying the calibration results as marks, the normal range and the abnormal range can be more clearly grasped, and it is possible to more intuitively understand whether the results were normal or not.

[0126] Furthermore, by displaying the numerical value of the calibration result at the position of the actual value in proportion to the numerical value of the boundary between the normal range area 504 and the out-of-normal range area 505, and by displaying the mark of the calibration result at the position of the actual value in proportion to the numerical value of the boundary between the normal range area 504 and the out-of-normal range area 505, the median value expected for the measurement element coincides with the center of the band-shaped display area, so the relative proportion of the measurement value 501 to the lower limit boundary 502 and the upper limit boundary 503 is visualized, and the deviation can also be understood intuitively, making it easier for the operator to grasp the situation.

[0127] Furthermore, by displaying the calibration results at the upper or lower limit of the display range when the results are outside the display range, the display area does not become larger than necessary, and it is possible to avoid situations where the results are difficult to understand.

[0128] Furthermore, by highlighting and displaying the upper and lower boundaries that define the boundary between the normal range area 504 and the out-of-normal range area 505, and in particular by displaying the numerical values ​​of the upper and lower boundaries that define the boundary between the normal range area 504 and the out-of-normal range area 505, it becomes easier to understand whether the calibration results were normal.

[0129] Furthermore, because the first direction and the second direction intersect perpendicularly, a large amount of information can be clearly displayed in a tabular format within one area, making it possible to convey information that suggests the cause of a problem to the operator in a visually easy-to-understand manner.

[0130] Furthermore, in a typical electrolyte analyzer, the internal standard solution is used as is after being drawn from a bottle. However, in the case of an electrolyte analyzer that uses a concentrated internal standard solution while diluting it, as shown in FIG. 1 , the dilution mechanism itself may be the cause of a problem. Therefore, in the case of electrolyte analyzer 100 that further includes a dilution mechanism for diluting the internal standard solution used in sample measurement, an interface such as the result display area 410 described above is very useful for inferring the cause of a problem.

[0131] <Others> The present invention is not limited to the above-described embodiments, and various modifications and applications are possible. The above-described embodiments have been described in detail to clearly explain the present invention, and the present invention is not necessarily limited to those having all of the described configurations.

[0132] 1...Ion selective electrode 2...Reference electrode 3...Concentrated internal standard solution bottle 4...Dilution solution bottle 5...Reference electrode solution bottle 6...Degassing mechanism 7...Internal standard solution syringe 8...Dilution solution syringe 9...Sipper syringe 10...Dilution tank 11...Preheater 12...Sipper nozzle 13...Sample dispensing mechanism 14...Sample container 15...Filter 16...Solenoid valve 17...Pinch valve 18...Dilution solution nozzle 19...Internal standard solution nozzle 20...Waste liquid suction nozzle 21...Pure water production device 22...Supply water tank 23...Pump 24...Dilution and reduction section 25...Voltmeter 26...Amplifier 27...Computer (display control section) 31...Waste liquid tank 40...Display device (display section) 45...Storage device 100...Electrolyte analyzer 101...Sample dispensing section 102...Analysis section (electrolyte analysis section) 103...Reagent section 104...Mechanism section 400, 400A, 400B...Calibration result screen 401, 401A, 401B...Parameter display area 403..., 403A, 403B...Result numerical value display area 410, 410B, 410C, 410D, 410E, 410F, 410G, 410H, 410I, 410J, 410K, 410L, 410M...Result display area 500, 500J, 500K, 500M...Test item display area 501, 501K, 501M...Measured value 502, 502M...Lower limit boundary 503, 503M...Upper limit boundary 504, 504K, 504M...Normal range area (normal range area) 505, 505K, 505M...Out of normal range area (out of normal range area) 506, 506K, 506M...Measurement value display mark 507...Upper limit value display area 508...Lower limit value display area 510, 510J, 510K, 510M...Slope result display area 511, 511J, 511K, 511M...IS concentration display area 512, 512J, 512K, 512M...Concentration display area 520, 520J, 520L, 520M...Acquisition information display area 521, 521J, 521K, 521L...Na acquisition information display area 522, 522J, 522K, 522L...K acquisition information display area 523, 523J, 523K, 523L...Cl acquisition information display area 530, 530K...Calibration result summary display area 531...Calibration method summary display area

Claims

1. An electrolyte analyzer comprising: an electrolyte analyzer that uses an ion selective electrode to measure the concentration of a specific ion in a sample and the concentration of the specific ion in a sample of known concentration for calibration; a display that displays information for an operator; and a display control unit that causes the display to display the calibration results measured by the electrolyte analyzer, wherein the result display area in which the calibration results are displayed includes a normal range area that indicates the normal range of the calibration results, an out-of-normal range area that indicates the outside of the normal range of the calibration results, and information obtained by the calibration, and the display control unit displays the calibration test items for the specific ions in a first direction, and displays the calibration results in a second direction different from the first direction.

2. An electrolyte analyzer according to claim 1, wherein the normal range region and the out-of-normal range region are displayed in the form of bands.

3. An electrolyte analyzer according to claim 1, wherein the calibration result is displayed as a numerical value.

4. An electrolyte analyzer according to claim 3, wherein the numerical value of the calibration result is displayed at the position of the actual value in proportion to the numerical value of the boundary between the normal range area and the out-of-normal range area.

5. An electrolyte analyzer according to claim 1, wherein the calibration result is displayed as a mark.

6. An electrolyte analyzer according to claim 5, wherein the mark of the calibration result is displayed at a position of an actual value in proportion to the numerical value of the boundary between the normal range area and the out-of-normal range area.

7. An electrolyte analyzer according to claim 6, wherein when the calibration result is outside the display range, it is displayed at the upper or lower display limit.

8. An electrolyte analyzer according to claim 1, wherein an upper boundary and a lower boundary that define the boundaries between the normal range region and the out-of-normal range region are displayed in an emphasized manner.

9. An electrolyte analyzer according to claim 1, wherein the electrolyte analyzer displays numerical values ​​of upper and lower boundaries that define the boundaries between the normal range region and the out-of-normal range region.

10. An electrolyte analyzer according to claim 1, wherein the first direction and the second direction intersect perpendicularly.

11. An electrolyte analyzer according to claim 1, further comprising a dilution mechanism for diluting the internal standard solution used in measuring the sample.

12. A method for displaying calibration results in an electrolyte analyzer comprising: an electrolyte analysis unit that uses an ion selective electrode to measure the concentration of a specific ion in a sample and the concentration of the specific ion in a sample of known concentration for calibration; and a display unit that displays information for an operator, wherein the result display area in which the calibration results are displayed displays: a normal range area that indicates the normal range of the calibration results; an out-of-normal range area that indicates the outside of the normal range of the calibration results; and information obtained by the calibration; and the test items for the calibration of the specific ions are displayed in a first direction, and the calibration results are displayed in a second direction different from the first direction.

Citation Information

Patent Citations

  • Analyzer

    JP2009121817A

  • Automatic analyzer and display method of analysis accuracy control

    JP2010078477A

  • Electrolyte analysis method and electrolyte analyzer

    JP2010133742A

  • Electrolyte analyzer

    JP2011122823A

  • Liquid mixer, electrolyte analyzer and liquid mixing method

    JP2022077629A