Electrolyte concentration analysis device and electrolyte concentration analysis method

Abstract

The purpose of the present invention is to detect that an inappropriate reagent has been provided in an electrolyte concentration analysis device. With reference to FIG. 2, this electrolyte concentration analyzer calculates a first ratio between the electromotive force of a sample and the electromotive force of a reagent, the concentration of which is known when one type of ion-selective electrode is used, and calculates a second ratio between the electromotive force of the reagent when two types of ion-selective electrodes are used. The first ratio and the second ratio are used to determine whether the reagent is normal.

Description

Technical Field

[0001] This invention relates to an electrolyte concentration analysis device. Background Technology

[0002] Automated analytical devices are known for analyzing biological samples such as blood and urine. Electrolyte concentration analyzers are integrated into these automated analytical devices. These analyzers are configured to analyze electrolyte components such as sodium (Na), potassium (K), and chloride (Cl) in the sample.

[0003] Most electrolyte concentration analysis devices employ a method known as the ion-selective electrode method (ISE method). The ISE method determines the electrolyte concentration in a sample by measuring the potential difference between an ion-selective electrode (ISE) and a reference electrode. The ion-selective electrode possesses an ion-sensing membrane that generates a potential difference in response to ionic components.

[0004] This potential varies depending on the electrolyte concentration in the sample. To maintain a reference potential, the reference electrode is configured to contact a solution known as the reference electrode solution. For example, a high-concentration KCl solution is used as the reference electrode solution.

[0005] As an ion-selective electrode or reference electrode, a flow cell type device can also be formed to achieve high throughput. In this flow cell type device, a flow path for supplying the sample to be measured is provided inside the housing, and the sensing membrane is grounded to the flow path.

[0006] In clinical examinations, methods for quantifying the concentration of electrolytes in biological samples (blood, especially serum, plasma, urine, etc.) include undilution methods and dilution methods. The undilution method involves directly measuring the biological sample without diluting it. The dilution method uses a predetermined amount of diluent to dilute a predetermined amount of biological sample, and then measures the diluted sample using methods such as ISE. In the dilution method, a smaller volume of sample solution is required, and the concentrations of coexisting substances such as proteins and lipids in the measurement solution are low, resulting in less contamination from these coexisting substances. Therefore, high stability can be achieved in the ISE method.

[0007] In electrolyte concentration analysis devices used for biological examinations, the combination of flow-through cell-based ISE and dilution methods has become the mainstream approach. Sample dilution is performed using a container called a dilution tank. The diluted biological sample prepared in the dilution tank is then piped to a flow-through cell-type ion-selective electrode for measurement.

[0008] Electrolyte concentration analysis devices typically use multiple reagents. These reagents may consist of, for example, (a) calibrators for calibration, (b) cleaning solutions for cleaning ion-selective electrodes, and (c) maintenance reagents for adjusting electrodes, flow paths, and sample dispensing mechanisms.

[0009] The reagent is manually added to the predetermined position of the device. However, this operation is susceptible to human error. In Patent Document 1, as a method to confirm that the reagent has been properly set, the ratio of the electromotive force of the set reagent to that of a liquid with a known electrolyte concentration in one of the electrolyte parameters is compared with a reference range.

[0010] Existing technical documents

[0011] Patent documents

[0012] Patent Document 1: EP2458389 Summary of the Invention

[0013] The problem that the invention aims to solve

[0014] Human error in setting reagents on the device can lead to inadequate cleaning and maintenance, potentially causing data corruption. Specifically, this includes situations such as reagent dilution, replenishment, concentration due to prolonged storage in the device, and mixing of different reagents due to the addition of other liquids without cleaning the container. The method described in Patent Document 1 may be unable to detect such inappropriate reagent settings.

[0015] The present invention was made in view of the above-mentioned problems, and its object is to detect improper reagent settings in an electrolyte concentration analysis device.

[0016] Methods for solving problems

[0017] The electrolyte concentration analysis device of the present invention calculates a first ratio between the electromotive force of a sample with a known concentration when using one ion-selective electrode and the electromotive force of a reagent, calculates a second ratio between the electromotive forces of the reagent when using two ion-selective electrodes, and uses the first ratio and the second ratio to determine whether the reagent is normal.

[0018] Invention Effects

[0019] The electrolyte concentration analysis apparatus according to the present invention can detect situations where inappropriate reagents are used. Other aspects, structures, and advantages of the present invention will become clear through the following description of embodiments. Attached Figure Description

[0020] Figure 1 This is a schematic diagram showing the general structure of the electrolyte concentration analysis device 1000 according to Embodiment 1.

[0021] Figure 2 This is a flowchart for detecting reagents improperly applied to region A1301.

[0022] Figure 3This is a flowchart for detecting reagents improperly applied to region B1302.

[0023] Figure 4 Examples of reagent ratios and determinations using the above flowchart are provided.

[0024] Figure 5 This is a flowchart of the electrolyte concentration analysis device 1000 of Embodiment 2 used to detect the situation where reagents are improperly placed in region B1302.

[0025] Figure 6 Indicates the ratio of reagents and the amount used. Figure 5 Examples of flowchart determinations. Detailed Implementation

[0026] <Implementation Method 1>

[0027] Figure 1 This is a schematic diagram showing the general structure of the electrolyte concentration analysis device 1000 according to Embodiment 1 of the present invention. The electrolyte concentration analysis device 1000 is an electrolyte concentration analysis device equipped with a flow cell type ion-selective electrode.

[0028] The measurement control device 1100 (control device) functions as a measuring unit responsible for measurements in the electrolyte concentration analyzer 1000, and as a control unit responsible for various controls based on the measurement results. Furthermore, the measurement control device 1100 also functions as a display control unit that controls the display of measurement results, etc., on the display unit 1110. The display unit 1110 displays data based on received data (measurement results, warnings, others).

[0029] The dilution tank 1010 is a container supplied with a diluted sample solution or an internal standard solution after the sample and diluent are mixed. The dilution tank 1010 alternately supplies diluted sample solution and internal standard solution, thereby alternately performing the determination of diluted sample solution and internal standard solution.

[0030] The sample supply unit 1020 supplies the sample container 1022, which is mounted on the sample mounting platform 1021, to the sample dispensing mechanism 1023. The sample dispensing mechanism 1023 has the function of drawing samples from the sample container 1022 and discharging them into the dilution tank 1010. The diluent dispensing mechanism 1030 is a device for dispensing diluent from the diluent tank 1031 through the diluent flow path 1032 into the dilution tank 1010. The internal standard solution dispensing mechanism 1040 has the function of dispensing internal standard solution 1043 from the internal standard solution tank 1041 through the internal standard solution flow path 1042 into the dilution tank 1010.

[0031] The liquid delivery mechanism 1050 performs a pumping action to draw diluted sample solution or internal standard solution from dilution tank 1010 to the ion-selective electrodes 1071-1073, and also has the function of drawing ion solution or reference electrode solution from liquid junction 1080 and discarding it into waste liquid tank 1052. The reference electrode solution delivery mechanism 1060 is configured to draw reference electrode solution from reference electrode solution tank 1061 and deliver it to reference electrode 1090 via reference electrode solution flow path 1062.

[0032] Diluted sample solution or internal standard solution is supplied from dilution tank 1010 to Cl ion selective electrode 1071, K ion selective electrode 1072, and Na ion selective electrode 1073. Meanwhile, reference electrode solution is supplied to reference electrode 1090 from reference electrode solution delivery mechanism 1060. A liquid junction 1080, serving as a passage for diluted sample solution and reagents in a flow cell configuration, is provided between Cl ion selective electrode 1071, K ion selective electrode 1072, or Na ion selective electrode 1073 and reference electrode 1090.

[0033] The waste liquid mechanism 1200 has the function of opening the solenoid valve 1201 to discharge the liquid via the waste liquid flow path 1202 when there is liquid in the waste dilution tank 1010.

[0034] The reagent holder 1300 has region A1301 and region B1302. Reagent container A1311 is disposed in region A1301. Reagent container A1311 is intended to hold reagent A. Reagent container B1312 is disposed in region B1302. Reagent container B1312 is intended to hold reagent B.

[0035] Another method of supplying reagents is to place the reagents from the sample supply unit 1020 onto the sample placement table 1021 for delivery to the sample dispensing mechanism 1023. In this case, the sample placement table 1021 serves as an area for placing the reagents.

[0036] Figure 2 This is a flowchart used to detect situations where reagents have been improperly applied to region A1301. The following explanation... Figure 2 Each step.

[0037] ( Figure 2 Step S210: (First)

[0038] The sample dispensing mechanism 1023 collects the reagent from the reagent container A1311 located in area A1301 and discharges it into the dilution tank 1010. The electromotive force is measured using flow-through cell type ion-selective electrodes 1071-1073 after passing through the measurement solution suction nozzle 1051. The measurement control device 1100 measures the electromotive force (Na) of one electrolyte item (e.g., Na) of the reagent in reagent container A1311 and the same electrolyte item of a sample with a known electrolyte concentration. S and Na IS Calculate the ratio using Equation 1 (Ratio 1):

[0039] Ratio 1=Na S / Na IS …Formula 1

[0040] ( Figure 2 Step S210: Second, S230)

[0041] The measurement control device 1100 compares ratio 1 with the reference range of reagent (reagent A) that should be set in area A1301. If it is outside the reference range (S210: No), it is determined to be abnormal, and a message requesting replacement of reagent A is output (S230). If it is within the reference range, proceed to S220.

[0042] ( Figure 2 Step S210: Supplement)

[0043] Samples with known electrolyte concentrations include, for example, internal standard solution 1043. Internal standard solution 1043 is supplied to dilution tank 1010 via internal standard solution dispensing mechanism 1040, and its electromotive force (Na) is measured using flow-through cell type ion-selective electrodes 1071-1073. IS The reference range is pre-stored in the measurement control device 1100, or it is calculated using the electrolyte concentration based on the electromotive force measured in advance using appropriate reagent A. In the latter case, the reference range is set to a value that can be determined by the electrolyte concentration.

[0044] ( Figure 2 Step S220: (First)

[0045] The measuring control device 1100 measures the electromotive force of any two electrolyte items in the reagent container A1311 and calculates the ratio (ratio 2) using Equation 2. For example, the ratio of Na and K is calculated here:

[0046] Ratio 2=Na S / K S …Formula 2

[0047] ( Figure 2 Step S220: Part Two ~ S240)

[0048] The measurement control device 1100 compares ratio 2 with the reference range of reagent (reagent A) that should be set in area A1301. If it is outside the reference range (S220: No), it is determined to be abnormal, and a message requesting replacement of reagent A is output (S230). If it is within the reference range (S220: Yes), it is determined to be normal, and the balance of reagent A is updated (S240).

[0049] ( Figure 2 (Step S240: Supplement)

[0050] The remaining amount of reagent can be confirmed, for example, by the liquid level detection function of the sample dispensing mechanism. The liquid level detection function refers to the function of detecting the liquid level by capturing the changes in electrostatic capacitance or resistance, and other electrical characteristics, due to the contact or proximity of the sample dispensing probe 1024 at the front end of the sample dispensing mechanism 1023 with the liquid surface.

[0051] Figure 3 This is a flowchart used to detect situations where reagents are improperly set in region B1302. For the reagents in region B1302, baseline ranges for reagent-specific ratios 1 and 2 are also determined, and implementation is carried out accordingly. Figure 2 The same treatment applies.

[0052] Figure 4 The reagent ratios and examples of judgments using the above flowchart are shown. A case where the judgment is normal is explained. When normal reagent A is set in area A1301, in... Figure 2 In the flowchart, both ratio 1 and ratio 2 are within the baseline range, which is considered normal. With normal reagent B set in region B1302, in... Figure 3 In the flowchart, both ratio 1 and ratio 2 are within the baseline range, which is considered normal.

[0053] This explains the situations that would be considered abnormal in the determination of ratio 1. When normal reagent A is placed in area B1302, in... Figure 3 In the flowchart, ratio 1 is outside the baseline range, which is considered abnormal. When reagent B is concentrated 30 times and set in region B1302, Figure 3 In the flowchart, ratio 1 is outside the baseline range and is therefore considered abnormal. When reagent B is diluted 10 times and set in region B1302, Figure 3 In the flowchart, ratio 1 is outside the baseline range and is therefore considered abnormal.

[0054] This describes a situation where a result is considered normal in ratio 1 but abnormal in ratio 2. When reagent A is diluted 30 times and placed in area B1302, in... Figure 3In the flowchart, ratio 1 is within the baseline range, but ratio 2 is outside the baseline range, therefore it is judged as abnormal. When reagent B is concentrated 30 times and set in region A1301, Figure 2 In the flowchart, ratio 1 is within the baseline range, but ratio 2 is outside the baseline range, therefore it is judged as abnormal. When reagent A is filled into a container after reagent B has been concentrated and dried, and the container is placed in area A1301, in... Figure 2 In the flowchart, ratio 1 is within the baseline range, but ratio 2 is outside the baseline range, so it is judged as abnormal.

[0055] exist Figure 4 In the third example from the right, reagent A is set in region B1302, so it should have been known to be an incorrect reagent at the time point of judgment ratio 1. However, in this example, reagent A is diluted 30 times and set in region B1302 to perform the judgment process corresponding to region B1302. Figure 3 The flowchart shows the process, where the value range of reagent B is used for determination. Subsequently, ratio 1 accidentally falls within the normal range. As a result, ratio 1 is incorrectly determined to be normal, while ratio 2 is abnormal, thus ultimately allowing the detection of the incorrectly set reagent. Figure 4 In the second example from the right, compared to the third example from the right, reagent A and dilution are interchanged with reagent B and concentration, but the consideration method is the same. The measurement control device 1100 can also output a judgment result indicating that such a test was accidentally passed by ratio 1.

[0056] exist Figure 4 In the first example from the right, reagents A and B are mixed in the container. However, the majority of the electromotive force (EMF) of Na is generated by reagent A, while reagent B has a negligible effect on the EMF of Na. Therefore, ratio 1 is mistakenly judged as normal, but ratio 2 is abnormal, thus ultimately allowing the detection of incorrectly configured reagents.

[0057] Thus, in the determination of ratio 1, errors in the normal reagent setting position, concentration, and dilution can be detected. In the determination of ratio 2, situations such as adding reagent to an inappropriate container, setting concentrated or diluted reagent to the wrong area, and mixing different reagents can be detected. By using both ratio 1 and ratio 2, inappropriate settings in all cases can be detected. In addition to outputting the determination result of whether the reagent is normal, the measurement control device 1100 can also output messages indicating situations suspected to be caused by such abnormalities.

[0058] <Implementation Method 2>

[0059] Figure 5This is a flowchart illustrating the use of the electrolyte concentration analysis device 1000 according to Embodiment 2 of the present invention to detect situations where reagents are improperly applied to region B1302. The structure of the electrolyte concentration analysis device 1000 is the same as that of Embodiment 1. S510~S520 and Figure 3 S310~S320 are the same, but if the conditions in S520 are met, S530 is further implemented.

[0060] ( Figure 5 Step S530: (First step)

[0061] The measuring control device 1100 measures the electromotive force of any two electrolyte items of the reagent in reagent container B1312 and calculates the ratio (ratio 3) using Equation 3. The electrolyte items in this step are different from those in S520. In S520, the ratio of Na to K is calculated; therefore, in this step, the ratio of Cl to K is calculated:

[0062] Ratio 3 = Cl S / K S …Formula 3

[0063] ( Figure 5 Step S530: Part Two)

[0064] The measurement control device 1100 compares ratio 3 with the reference range of reagent (reagent B) that should be set in area B1302. If it is outside the reference range (S530: No), it is determined to be abnormal, and a message requesting replacement of reagent B is output (S540). If it is within the reference range (S530: Yes), it is determined to be normal, and the balance of reagent B is updated (S550).

[0065] ( Figure 5 :Replenish)

[0066] When calculating ratio 3, the electrolyte concentration calculated based on the electromotive force can also be used. In this case, the reference range for this step is set to a value that can be determined based on the electrolyte concentration. For reagents in areas other than area B1302, the reagent-specific ratios 1 to 3 can also be used to perform normal determination in the same way. Ratio 4 can also be calculated in addition to ratio 3, and normal determination based on this ratio can be performed. Ratio 4 is calculated for two electrolyte items that are different from ratios 1 to 3. The measurement control device 1100 can also set electrodes for calculating ratios 2 and 3 for each type of reagent in each area. In addition, it is also possible to select whether to use ratio 3 for each type of reagent in each area.

[0067] Figure 6The reagent ratios and examples of judgments using the above flowchart are shown. A case where the judgment is normal is explained. When normal reagent B is set in area B1302, in... Figure 5 In the flowchart, ratios 1, 2, and 3 are all within the baseline range, and are therefore considered normal.

[0068] This explains the circumstances under which an anomaly is determined. When a normal reagent C is set in region B1302, in... Figure 5 In the flowchart, ratios 1 and 2 are within the baseline range, but ratio 3 is outside the baseline range, therefore it is judged as abnormal. Assuming reagent C is placed in region B1302, using embodiment 1... Figure 3 When judging the flowchart, ratios 1 and 2 are within the baseline range, so they are judged as normal and no setting error can be detected.

[0069] Specifically, by setting reagent C in region B1302, the judgment criteria corresponding to region B1302 are implemented. Figure 5 (Flowchart of the test), where the normal ranges of ratios 1 and 2 in the judgment criteria coincidentally match the ratios of reagent C. Thus, ratios 1 to 2 are mistakenly judged as normal, but ratio 3 is abnormal, thereby ultimately detecting a reagent that has been incorrectly set. The measurement control device 1100 can also output a judgment result indicating that the checks of ratios 1 to 2 have been passed by chance.

[0070] As a reason for reagent C's abnormality, consider any of the following: an incorrect reagent was set for region B1302; the concentration of the reagent set for region B1302 was incorrect; an incorrect reagent was set for an incorrect region; or the correct reagent and the incorrect reagent were mixed. In addition to outputting a result indicating whether the reagent is normal, the measurement control device 1100 can also output a message indicating a situation where such an abnormality is suspected.

[0071] Thus, in Embodiment 3, by adding the determination of Ratio 3 to Ratio 1 to Ratio 2, it is possible to detect inappropriate reagent settings more accurately than in Embodiment 1.

[0072] <Regarding variations of the present invention>

[0073] In the above embodiments, examples of using the electromotive force of Na and the electromotive force of K to calculate ratio 2 are described. This is because cleaning solutions mostly use reagents containing large amounts of Na and Cl, such as sodium hypochlorite, and using a ratio of Na and K with a large concentration difference or electromotive force difference makes it easier to show the characteristics of the reagent to be judged.

[0074] In the above embodiments, it was explained that S210 is implemented using a Na ion selective electrode 1073, and S220 is implemented using both a Na ion selective electrode 1073 and a K ion selective electrode 1072. It is not necessary to use a shared ion selective electrode between S210 and S220; two different ion selective electrodes can be used in S220. For example, a Cl ion selective electrode 1071 and a K ion selective electrode 1072 can be used. The same applies to S310 and S320, and to S510 and S520.

[0075] In the above embodiments, it is described that S520 is implemented using Na ion selective electrode 1073 and K ion selective electrode 1072, and S530 is implemented using Cl ion selective electrode 1071 and K ion selective electrode 1072. The combination of ion selective electrodes in S520 to S530 is not limited to this, as long as the combination of ion selective electrodes used to calculate ratio 2 is different from the combination of ion selective electrodes used to calculate ratio 3.

[0076] In the above embodiments, the numerator and denominator when calculating ratios 1 to 3 are not limited to the numerator and denominator described above; the numerator and denominator can also be reversed. For example, ratio 1 can also be Na. IS / Na S Ratio 2 = K S / Na S .

[0077] In the above embodiments, Na in S210 S Na in S220 S The values ​​common to each step can be used, or they can be re-measured for each step. The same applies when a common ion-selective electrode is used between other steps.

[0078] In the above embodiments, the measurement and control device 1100 can be composed of hardware such as circuit devices with its functions installed, or it can be composed of software with its functions installed by a computing device such as a CPU (Central Processing Unit).

[0079] In the above embodiments, regions A1301, B1302, and the specimen placement table 1021 all function as placement sections for reagent containers. When a reagent container is placed on the specimen placement table 1021, the specimen placement table 1021 can also be divided according to reagent type, similar to the reagent holder 1300. Therefore, there is a possibility that a reagent container may be incorrectly placed in a region of the specimen placement table 1021. In the above embodiments, the steps for detecting incorrect placement in regions A1301 and B1302 can be applied to incorrect placement in the same regions of the specimen placement table 1021.

[0080] Explanation of reference numerals in the attached figures

[0081] 1000··· Electrolyte Concentration Analysis Device

[0082] 1010···Dilution Tank

[0083] 1020··· Specimen Supply Department

[0084] 1021··· Specimen Setting Platform

[0085] 1022···Specimen container

[0086] 1023··· Specimen Distribution Center

[0087] 1024··· Specimen injection probe

[0088] 1030··· Diluent Dispensing Mechanism

[0089] 1031··· Diluent Tank

[0090] 1032··· Diluent Flow Path

[0091] 1040···Internal standard solution dispensing mechanism

[0092] 1041··· Internal standard solution tank

[0093] 1042···Internal Standard Fluid Flow Path

[0094] 1043···Internal Standard Solution

[0095] 1050··· Liquid delivery mechanism

[0096] 1051··· Measuring solution suction nozzle

[0097] 1052··· Waste Liquid Tank

[0098] 1060···Reference electrode liquid delivery mechanism

[0099] 1061···Reference electrode solution container

[0100] 1062···Reference electrode fluid flow path

[0101] 1071···Cl ion selective electrode

[0102] 1072···K ion-selective electrode

[0103] 1073···Na ion selective electrode

[0104] 1080··· Liquid Joint

[0105] 1090···Reference Electrode

[0106] 1100··· Measurement and Control Device

[0107] 1110··· Display Department

[0108] 1200··· Waste Liquid Mechanism

[0109] 1201···Solenoid Valve

[0110] 1202··· Waste Liquid Flow Path

[0111] 1300···Reagent Holder

[0112] 1301··· Area A

[0113] 1302··· Area B

[0114] 1311···Reagent Container A

[0115] 1312···Reagent container B.

Claims

1. An electrolyte concentration analysis device, which uses an ion-selective electrode to determine the concentration of ions contained in a sample, characterized in that, The electrolyte concentration analysis device includes: Two or more ion-selective electrodes, comprising a first ion-selective electrode that selectively reacts to a first ion and a second ion-selective electrode that selectively reacts to a second ion; as well as A control device that uses the electromotive force of the ion-selective electrode to determine the ion concentration within the sample. The control device acquires the first electromotive force of the sample and the second electromotive force of the reagent, respectively, based on the known ion concentration measured using any one of the two or more ion-selective electrodes. The control device calculates a first ratio between the first electromotive force and the second electromotive force. The control device acquires the third electromotive force and the fourth electromotive force of the reagent, respectively measured using any two of the two or more ion-selective electrodes. The control device calculates a second ratio between the third electromotive force and the fourth electromotive force. The control device uses the first ratio and the second ratio to determine whether the reagent is normal.

2. The electrolyte concentration analysis device according to claim 1, characterized in that, If the first ratio is outside the first range, the control device determines that the reagent is abnormal.

3. The electrolyte concentration analysis device according to claim 2, characterized in that, If the first ratio is within the first range, the control device also calculates the second ratio. If the second ratio is within the second range, the control device determines that the reagent is normal; if the second ratio is outside the second range, the control device determines that the reagent is abnormal.

4. The electrolyte concentration analysis device according to claim 2, characterized in that, The electrolyte concentration analysis device also includes a placement section for holding a reagent container that holds the reagent. If the first ratio is outside the first range, the control device outputs a judgment result indicating that the reagent is abnormal based on either the incorrect reagent being set in the placement unit or the incorrect concentration of the reagent.

5. The electrolyte concentration analysis device according to claim 3, characterized in that, The electrolyte concentration analysis device also includes a placement section for holding a reagent container that holds the reagent. If the second ratio is outside the second range, the control device outputs a judgment result indicating that the reagent is abnormal based on any of the following: adding the wrong reagent to the reagent container; the concentration of the component in the reagent measured by the ion-selective electrode used to calculate the first ratio is correct but the type of reagent is wrong; or the correct reagent and the wrong reagent are mixed.

6. The electrolyte concentration analysis device according to claim 3, characterized in that, The electrolyte concentration analysis device also includes a placement section for each type of reagent, which is used to hold a reagent container for storing the reagent. The control device sets the first range according to each type of reagent or according to each of the loading portions. When the first ratio is within the first range and the second ratio is outside the second range, the control device outputs a judgment result that incorrectly determines the first ratio to be normal, based on the fact that although the reagent was set for the incorrect placement portion, the first range corresponding to the incorrect placement portion was set to treat the reagent as normal.

7. The electrolyte concentration analysis device according to claim 1, characterized in that, The two or more ion-selective electrodes further include a third ion-selective electrode that selectively responds to a third ion. The control device uses the third ion-selective electrode to measure the fifth electromotive force of the reagent. The control device calculates a third ratio between the third electromotive force and the fifth electromotive force, or a third ratio between the fourth electromotive force and the fifth electromotive force. The control device uses the first ratio, the second ratio, and the third ratio to determine whether the reagent is normal.

8. The electrolyte concentration analysis device according to claim 7, characterized in that, If the first ratio is within a first range, the control device also calculates the second ratio. If the second ratio is within the second range, the control device also calculates the third ratio. If the third ratio is outside the third range, the control device determines that the reagent is abnormal; if the third ratio is within the third range, the control device determines that the reagent is normal.

9. The electrolyte concentration analysis device according to claim 8, characterized in that, The electrolyte concentration analysis device also includes a placement section for holding a reagent container that holds the reagent. If the third ratio is outside the third range, the control device outputs a determination result indicating that the reagent is abnormal based on any one of the following: the wrong reagent is set in the placement unit, the concentration of the reagent is incorrect, the wrong reagent is set in the placement unit at an incorrect concentration, or the correct reagent is mixed with the wrong reagent.

10. The electrolyte concentration analysis device according to claim 1, characterized in that, Any one of the two or more ion-selective electrodes is a sodium ion-selective electrode that responds selectively to sodium ions. Any one of the two or more ion-selective electrodes is a potassium ion-selective electrode that responds selectively to potassium ions.

11. The electrolyte concentration analysis device according to claim 10, characterized in that, When the reagent is a cleaning solution, the control device uses the sodium ion selective electrode to measure the first electromotive force and the second electromotive force, uses the sodium ion selective electrode to measure the third electromotive force, and uses the potassium ion selective electrode to measure the fourth electromotive force.

12. A method for analyzing electrolyte concentration, using an ion-selective electrode to determine the concentration of ions contained in a sample, characterized in that, The electrolyte concentration analysis method comprises the following steps: The first electromotive force of a sample with a known ion concentration and the second electromotive force of a reagent are obtained by using any one of two or more ion-selective electrodes, wherein the two or more ion-selective electrodes include a first ion-selective electrode that selectively reacts to a first ion and a second ion-selective electrode that selectively reacts to a second ion. Calculate the first ratio between the first electromotive force and the second electromotive force; Obtain the third electromotive force and the fourth electromotive force of the reagent, respectively, by using any two of the two or more ion-selective electrodes; Calculate the second ratio between the third electromotive force and the fourth electromotive force; and The first ratio and the second ratio are used to determine whether the reagent is normal.

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