Automated analyzer and measurement method using same

Abstract

The reliability of a measurement result is reduced due to the deterioration of an ISE reagent remaining in a flow path during the standby time of an electrolyte analysis unit. Therefore, when the automatic analysis device (1) accepts a measurement instruction for a patient specimen requiring measurement using the electrolyte analysis unit (8), if the standby time of the electrolyte analysis unit is equal to or greater than a predetermined time, the automatic analysis device (1) determines the deterioration of the residual reagent remaining in the flow path of the electrolyte analysis unit before the measurement of the patient specimen.

Description

Technical Field

[0001] The present invention relates to an automatic analyzer for performing qualitative and quantitative analysis on components such as blood and urine collected from a patient specimen, and a measurement method using the automatic analyzer. Background Art

[0002] Automatic analyzers are used in hospital examination rooms and examination centers. Examinations of specimens performed in hospital examination rooms require that they be started quickly in emergencies, even during surgery, at night, or on weekends, and that measurement results be obtained with the same high reliability as in normal examinations. Automatic analyzers have a colorimetric analysis unit and an electrolyte analysis unit. In the electrolyte analysis unit using the ion-selective electrode method, three reagents (hereinafter referred to as ISE reagents) are used: an internal standard solution, a diluent, and a reference electrode solution. Therefore, if the ISE reagent deteriorates, correct measurement results cannot be obtained. Generally, the deterioration of the reagent is a gradual daytime change, so the change is small and difficult to detect. Patent document 1 discloses detecting abnormal measurement values ​​caused by reagent deterioration based on the change pattern (approximately 1 month) of the daily calibration results.

[0003] Prior art literature

[0004] Patent Literature

[0005] Patent Document 1: Japanese Patent Application Laid-Open No. 2013-213841 Summary of the Invention

[0006] Problems to be solved by the invention

[0007] Patent Document 1 can only detect abnormalities at the time of calibration. Furthermore, by detecting abnormalities based on a fluctuation pattern, it fails to account for the degradation of ISE reagent (residual reagent) remaining in the flow path during the device's standby period. The present invention aims to detect residual reagent degradation during the device's standby period and improve the reliability of measurement results from an automated analyzer.

[0008] Means for solving problems

[0009] An automatic analysis device as one embodiment of the present invention includes: an electrolyte analysis unit, which measures electrolyte concentration based on an ion-selective electrode method and is capable of measuring at least chloride ion concentration; and a control unit, which, upon receiving a measurement instruction for a patient specimen that needs to be measured using the electrolyte analysis unit, determines the deterioration of residual reagent remaining in the flow path of the electrolyte analysis unit before the measurement of the patient specimen if the standby time of the electrolyte analysis unit is longer than a predetermined time.

[0010] Effects of the Invention

[0011] When the electrolyte analysis unit's standby time exceeds a predetermined time, residual reagent deterioration is determined before patient specimen measurement, thereby eliminating abnormal measurement values ​​caused by ISE reagent deterioration within the flow path and improving the reliability of measurement results. Other issues and novel features will become apparent from the description and accompanying drawings of this specification. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 This is a hardware structure diagram of the automatic analysis device.

[0013] Figure 2 This is a schematic diagram of the electrolyte analysis unit.

[0014] Figure 3 This is a graph showing the results of continuous measurement of the quality control sample with a standby time of 0 hours.

[0015] Figure 4 This is a graph showing the results of continuous measurement of the quality control sample with a standby time of 2 hours.

[0016] Figure 5 This is a graph showing the results of continuous measurement of the quality control sample with a standby time of 5 hours.

[0017] Figure 6 This is a graph showing the results of continuous measurement of the quality control sample with a standby time of 17 hours.

[0018] Figure 7 This is a flow chart of sample measurement in the electrolyte analysis unit.

[0019] Figure 8 This is a flowchart for determining deterioration of ISE reagents.

[0020] Figure 9 This is a diagram for explaining a method for determining the predetermined time X that is a benchmark for determining ISE reagent degradation.

[0021] Figure 10 This is the details of the ISE reagent deterioration determination flowchart in Example 1.

[0022] Figure 11 This is an example of a screen for determining deterioration of the ISE reagent in Example 1.

[0023] Figure 12 This is the details of the ISE reagent degradation determination flowchart in Example 2.

[0024] Figure 13 This is an example of a screen for determining deterioration of the ISE reagent in Example 2. DETAILED DESCRIPTION

[0025] The embodiments of the present invention will be described in detail with reference to the accompanying drawings. In the following embodiments, the constituent elements (including element steps, etc.) are not necessarily essential unless otherwise specified or unless they are clearly considered to be essential in principle.

[0026] use Figure 1 , the overall structure of the automatic analysis device of this embodiment is described. Figure 1 This is a hardware configuration diagram showing the overall configuration of the automatic analyzer.

[0027] An automatic analyzer 1 is a specimen testing device that automatically analyzes specimens collected from patients. The automatic analyzer 1 includes a mechanism for dispensing a predetermined amount of patient specimen and reagent using a sample dispensing mechanism 7 and a reagent dispensing mechanism 6, which react the resulting sample and reagent. While this description uses a disk-based automatic analyzer as an example, the present invention is not limited to this mechanism; for example, a rack-based automatic analyzer may also be used.

[0028] Automatic analyzer 1 includes a colorimetric analyzer and an electrolyte analyzer. The colorimetric analyzer primarily comprises a sample disk 2, which carries sample cups 3 containing specimens and rotates a disk-shaped stage to move any specimen to a sampling position; a reagent disk 4, which carries reagent bottles containing reaction reagents and rotates to move any reagent to a dispensing position; a reaction vessel 5, maintained at a constant temperature by constant-temperature water, allowing a predetermined amount of patient specimen to react with the reagent; a reagent dispensing mechanism 6, which dispenses a predetermined amount of reagent from a reagent bottle into the reaction vessel 5; a sample dispensing mechanism 7, which dispenses a predetermined amount of sample from the sample cup 3 into the reaction vessel 5; and a photometer 13, which measures the progress of the chemical reaction between the specimen and the reagent using absorptiometry. The electrolyte analyzer 8 measures electrolyte concentrations using an ion-selective electrode method using electrodes that selectively respond to specific ions.

[0029] A computer (control unit) 10 is connected to each mechanism of the automatic analyzer 1 via an interface 9. The computer 10 controls each mechanism and inputs measurement results obtained by each analysis unit into the computer 10. The computer 10 calculates the sample concentration based on the measurement results and outputs the obtained sample concentration to a printer 11 and a monitor 12.

[0030] Figure 2 This is a structural diagram of the electrolyte analysis unit 8 using the ion selective electrode method. Figure 2The overall structure of the electrolyte analysis unit 8 will be described. The electrolyte analysis unit 8 includes ion-selective electrodes with membranes sensitive to target ions, specifically, a Na (sodium) ion electrode 21, a K (potassium) ion electrode 20, a Cl (chloride) ion electrode 19, a reference electrode 23, and a potentiometer 15 for measuring the potential difference between each of the ion-selective electrodes 19 and 21 and the reference electrode 23. A sipper syringe 26 aspirates the sample or reagent toward the ion-selective electrode or the reference electrode. A pinch valve 22 switches the flow path, allowing either aspiration toward the ion-selective electrode or the reference electrode 23 to be performed.

[0031] The basic operation of the ion selective electrode method is to perform the measurement of the internal standard solution 16 , the measurement of the sample, and the measurement of the internal standard solution 16 as a set, and the concentrations of Na ions, K ions, and Cl ions can be simultaneously measured in one measurement.

[0032] During measurement of the internal standard solution 16, after being dispensed into the dilution tank 18, the internal standard solution 16 is drawn toward the ion-selective electrodes 19 to 21. Meanwhile, the reference electrode solution 24 is drawn toward the reference electrode 23. The potential difference between each of the ion-selective electrodes 19 to 21 and the reference electrode 23 is measured using the potentiometer 15. Thus, the electromotive force of each of the ion-selective electrodes 19 to 21 is measured after electromotive force correction for the internal standard solution 16. Furthermore, the reference electrode solution 24 is passed through the degassing tank 25 to remove air bubbles before being drawn toward the reference electrode 23.

[0033] During sample measurement, a predetermined amount of sample is dispensed from the sample cup 3 into the dilution reservoir 18 by the sample dispensing mechanism 7. Meanwhile, a predetermined amount of diluent 17 is dispensed into the dilution reservoir 18 to dilute the sample at a predetermined rate. Furthermore, the diluent 17 passes through a degassing tank 25 to remove air bubbles before being dispensed into the dilution reservoir 18. The diluted sample is then drawn toward the ion-selective electrodes 19-21, while the reference electrode solution 24 is drawn toward the reference electrode 23. The potential difference between each of the ion-selective electrodes 19-21 and the reference electrode 23 is measured using a potentiometer 15. This allows the electromotive force of each of the ion-selective electrodes 19-21 to be measured after electromotive force correction for the diluted sample.

[0034] The concentration of the diluted sample can be calculated based on the difference between the electromotive force of each of the ion-selective electrodes 19 to 21 measured for the internal standard solution 16 and the electromotive force of each of the ion-selective electrodes 19 to 21 measured for the diluted sample. This concentration calculation is performed by the electrolyte concentration calculation unit 14 of the computer 10. The electrolyte concentration calculation unit 14 can be installed as software using an electrolyte concentration calculation program executable by the computer 10 that calculates the electrolyte concentration based on the potential difference.

[0035] Thus, in the ion-selective electrode method, ISE reagents (internal standard solution 16, diluent 17, reference electrode solution 24) are used to calculate concentrations. Furthermore, due to the structure of the electrolyte analysis unit 8, the internal standard solution 16 and diluent 17 are ejected through the flow path to the dilution tank 18, and the reference electrode solution 24 is drawn through the flow path to the reference electrode 23, thereby constantly maintaining the ISE reagents in each flow path.

[0036] use Figures 3 to 6 , the degradation of the ISE reagent in the flow path is described. Figures 3 to 6 The diagram shows the results of continuously measuring Cl ions in 50 quality control samples after the electrolyte analysis unit 8 was left on standby for a predetermined period of time. Figures 3 to 6 The standby times are 0 hours, 2 hours, 5 hours, and 17 hours, respectively. The standby time here refers to the time from reagent priming (priming) in the electrolyte analysis unit 8 to the start of the continuous measurement. Reagent priming refers to the process of supplying ISE reagent from each ISE reagent bottle to each flow channel, replacing the ISE reagent remaining in the flow channel with the ISE reagent from each ISE reagent bottle.

[0037] According to the comparison of these measurement results, when the standby time becomes longer, the variation of the Cl ion measurement value can be seen to increase. Specifically, in the first half of the continuous measurement, the longer the standby time, the more significant the mountain-shaped variation in the measurement value, and in the second half of the continuous measurement, the deviation of the measurement value becomes smaller. It is believed that the reason for such variation is that the Cl ion electrode responds to the components produced by the deterioration of the ISE reagent remaining in the flow path. The Cl ion electrode 19 responds not only to Cl ions, but also to other ions (called interfering ions) with properties similar to Cl ions. Therefore, if interfering ions are produced due to the deterioration of the ISE reagent, the measurement value of the Cl ion increases. The deterioration of the ISE reagent progresses equally even in the bottle and in the flow path, and the interfering ions produced in the relatively small amount of ISE reagent retained in the flow path are also relatively high in concentration. Figure 5 、 Figure 6 The reason for the gradual increase in Cl ion measurement values ​​is believed to be due to a concentration gradient within the flow path caused by the deterioration of residual reagent. Replacing the deteriorated ISE reagent within the flow path with fresh ISE reagent from the bottle stabilizes the Cl ion measurement values. The timing of the gradual increase in measurement values ​​and the peak value depends on the flow path volume and varies depending on the instrument model. Such fluctuations in ion measurement values ​​are not observed for Na and K ions.

[0038] Therefore, in this embodiment, if the standby time exceeds a predetermined time, the electrolyte analysis unit measures a flow path confirmation sample (Example 1), or the colorimetric analysis unit measures components resulting from ISE reagent degradation (Example 2), before performing a patient specimen measurement. This determines whether the residual reagent has deteriorated. Based on the determination result, the device selects a maintenance type and notifies the user.

[0039] Example 1

[0040] use Figure 7 , the sample measurement operation of the electrolyte analysis unit 8 will be described. Each step is controlled by the computer 10.

[0041] S01 : The user activates the automatic analyzer 1 . The user inputs an activation instruction to the computer 10 , and each mechanism including the electrolyte analysis unit 8 is activated via the interface 9 .

[0042] S02: Initial operation starts. The content of the initial operation is pre-set by the user. In the case of the electrolyte analysis unit 8, it usually includes cleaning of each mechanism constituting the electrolyte analysis unit 8 and reagent preparation, which replaces the ISE reagent in the flow path with a new reagent from a bottle.

[0043] S03 to S04: Waiting until a patient sample measurement instruction including electrolyte analysis is issued. Upon receiving a patient sample measurement instruction from the computer 10 (S04), the waiting state (S03) is terminated and the process proceeds to step S05.

[0044] S05: In this embodiment, before receiving the patient sample measurement instruction (S04) and starting the electrolyte analysis, an ISE reagent degradation determination is performed. Details will be described later. In the following steps S06-S09, the electrolyte analysis unit 8 performs the electrolyte analysis of the patient sample, as follows.

[0045] S06: With the pinch valve 22 closed, the reference electrode solution 24 is drawn toward the reference electrode 23 via the pipette syringe 26. The reference electrode solution 24 is degassed by passing through the degassing tank 25. Meanwhile, the internal standard solution 16 is dispensed into the dilution tank 18. With the pinch valve 22 open, the internal standard solution 16 in the dilution tank 18 is drawn toward the Cl ion electrode 19, the K ion electrode 20, and the Na ion electrode 21 via the pipette syringe 26. Any residual solution remaining in the dilution tank 18 is drawn away by a vacuum nozzle (not shown) and discarded. The potential difference (electromotive force) between the internal standard solution 16 and the reference electrode solution 24 is then measured by the potentiometer 15.

[0046] S07: After the patient specimen is dispensed into the dilution tank 18 and the diluent 17 is dispensed, stirring is performed for mixing. At this time, the diluent 17 is degassed by passing through the degassing tank 25. Next, the diluted specimen is measured in the same manner as in step S06. Specifically, with the pinch valve 22 closed, the reference electrode solution 24 is drawn toward the reference electrode 23 using the pipette syringe 26. Meanwhile, with the pinch valve 22 open, the diluted specimen in the dilution tank 18 is drawn toward the Cl ion electrode 19, the K ion electrode 20, and the Na ion electrode 21 using the pipette syringe 26. The potential difference (electromotive force) between the diluted specimen and the reference electrode solution 24 is then measured using the potentiometer 15. Any residual liquid remaining in the dilution tank 18 is aspirated and discarded using a vacuum nozzle.

[0047] In addition, although the measurement of a patient sample is described in this flow, the standard solution used for calibration and the quality control sample used for measurement quality control are also measured by the same method as that described here.

[0048] S08: Cleaning the dilution tank 18.

[0049] S09: Measure the internal standard solution 16 in the same manner as S06. If the measurement instruction continues, the process returns to step S07 to perform the patient sample measurement. By looping through steps S07 to S09 and performing continuous measurement, the measurement can be completed with the internal standard solution measurement. As a result, for example, the flow path from the dilution tank 18 to the ion selective electrode can be shifted to the standby state while the internal standard solution 16 is filled.

[0050] S10: The potential difference measured by the potentiometer 15 is input to the computer 10 via the interface 9. The computer 10 calculates the electrolyte concentration of the patient sample based on the measurement results of the internal standard solution and the patient sample. The obtained concentration is output to the printer 11 and the monitor 12. When performing continuous measurement, the processing of step S10 can be performed in parallel with the measurement by the electrolyte analysis unit 8.

[0051] S11: The electrolyte analysis unit 8 automatically stops and shifts to the standby state (S03).

[0052] Figure 8 This is a flowchart showing the deterioration determination of the ISE reagent of Example 1. Figure 7 Each step is controlled by the computer 10.

[0053] S21: The computer 10 measures the standby time of the electrolyte analyzer 8. Specifically, it is the time from the completion of the initial operation (S02) to the reception of the patient sample measurement instruction (S04), or from the automatic stop (S11) to the reception of the patient sample measurement instruction (S04).

[0054] S22: If the waiting time measured in step S21 is longer than the predetermined time X (Yes), proceed to step S23; if it is shorter than the predetermined time X (No), proceed to step S06 (measurement of internal standard solution) for electrolyte analysis of the patient sample.

[0055] S23: Perform measurement for determining deterioration of the ISE reagent.

[0056] S24: The computer 10 determines ISE reagent degradation based on the ISE reagent degradation determination results. If the ISE is determined to be degraded (Yes), the process proceeds to maintenance selection (S25). If the ISE is determined not to be degraded (No), the process proceeds to step S06 (internal standard solution measurement) to perform electrolyte analysis on the patient sample. Details of steps S23-S25 will be described later.

[0057] Next, use Figure 9 An example of a method for determining the length of the predetermined time X in step S22 will be described. Figures 3 to 6 The method shown is a method of measuring a predetermined number of quality control samples at different waiting times and determining the predetermined time X based on the measurement results. Figure 9 The horizontal axis of the graph represents the standby time, and the vertical axis represents the variation in the Cl ion measurement value. The variation in the Cl ion measurement value is the variation or rate of change in the continuously measured Cl ion concentration results (variation and rate of change will be described later). Furthermore, the deviation in the variation in the Cl ion measurement value is calculated. The deviation CI can be calculated using the standard deviation SD as follows.

[0058] CI = ±3SD (99.7% confidence interval)

[0059] For example, in Figure 9 In the data, the change in standby time from 1 to 3 hours is low relative to the change in standby time + CI for 0 hours, so it can be determined that there is no degradation. On the other hand, the change in standby time from 4 to 5 hours is high relative to the change in standby time + CI for 0 hours, so it can be determined that there is degradation. Based on this, the predetermined time X can be determined to be 3 hours.

[0060] Next, use Figure 10 The details of steps S23 to S25 are described below. Step S31 is equivalent to Figure 8 Step S23, steps S32~S35 in the process are equivalent to Figure 8 Steps S24 and S36~S37 in the process are equivalent to Figure 8 Step S25 in the process.

[0061] S31: The electrolyte analysis unit 8 measures the Cl ion concentration of the flow path confirmation sample a predetermined number of times. This predetermined number of times, which must be at least three, is determined by the user based on the type of fluctuation being monitored and the device model. The flow path confirmation sample is not limited to any type, as long as it is within the measurable concentration range determined by the device. The samples measured continuously need to be the same, but different samples can also be measured continuously for each measurement.

[0062] S32: Calculate the variation of the Cl ion measurement value for determining deterioration of the ISE reagent. The variation can be the variation or rate of change in the continuously measured Cl ion concentration measurement results.

[0063] The amount of change is explained. Here, the amount of change refers to the difference between the measured value of the designated sample and the measured value of the first sample in the continuously measured values ​​of the sample. In this case, it is sufficient to specify the sample that is most affected by the degradation of the ISE reagent. The location of the sample that is most affected by the degradation of the ISE reagent varies depending on the model. For example, in Figure 6 In this case, the specimen most affected by ISE reagent degradation appears at the 13th specimen. Therefore, if the predetermined number of times ( S31 ) is set to 13 and the 13th specimen is designated as the specimen for calculating the change, the change is calculated as the difference between the measured value of the 13th specimen (107.3 mmol / L) and the measured value of the first specimen (102.2 mmol / L), resulting in a change of 5.1 mmol / L.

[0064] Next, the rate of change is explained. Here, the rate of change refers to the slope obtained by performing a first approximation on the measurement results of the continuously measured values ​​of the specimens from the measurement value of the first specimen to the measurement value of the designated specimen. Considering the accuracy of the approximation, it is preferable to use more than three specimens. Similarly, the specimen most affected by the deterioration of the ISE reagent can be specified. For example, in Figure 6 In the case of , if the rate of change is calculated as the slope obtained by linear approximation of 13 measurement results from the measurement value of the first specimen to the measurement value of the 13th specimen, the rate of change is 0.36.

[0065] S33: If the amount of change calculated in step S32 is greater than or equal to a predetermined value A (YES), the ISE reagent is determined to be degraded, and flow path maintenance is determined to be necessary before patient sample measurement, and the process proceeds to step S34. On the other hand, if the amount of change calculated in step S32 is less than the predetermined value A (NO), the ISE reagent is not degraded, and the process proceeds to patient sample measurement (S06). The predetermined value A, which serves as the determination threshold, is arbitrarily determined by the user based on the concentration of the flow path verification sample and the management level of each facility.

[0066] S34: Determine the level of ISE reagent degradation. If the fluctuation amount calculated in step S32 is greater than a predetermined value B (Yes), the ISE reagent degradation level is determined to be high, and the process proceeds to step S35. If the fluctuation amount is less than the predetermined value B (No), the ISE reagent degradation level is determined to be low, and reagent preparation is performed to replace the ISE reagent remaining in the flow path (S37). The predetermined value B, which serves as the threshold for determination, is set by the user based on the concentration of the flow path confirmation sample and the management level of each facility. Predetermined value B is set to be greater than predetermined value A.

[0067] S35: Determine the cause of the high level of degradation of the ISE reagent and determine the necessary maintenance. Figures 3 to 6 As shown in the measurement results, the longer the waiting time, the more severe the reagent degradation, and the greater the fluctuation in the measured value. On the other hand, if the ISE reagent degradation level is high despite a short waiting time, it is considered that dirt has accumulated in the ISE reagent flow path. If the waiting time is less than the predetermined time Y hours (Yes), it is determined that dirt has accumulated in the ISE reagent flow path, and flow path cleaning with detergent is recommended (S36). If the waiting time is longer than Y hours (No), it is determined that degradation has progressed due to the long waiting time, and reagent preparation is performed (S37). The predetermined time Y, which serves as the judgment threshold, is set by the user at an arbitrary value based on past ISE degradation judgment results and the operation of each facility. The predetermined time Y is set to a value greater than the predetermined time X.

[0068] Figure 11 This is an example of a screen for determining degradation of an ISE reagent using the electrolyte analysis unit 8. The degradation determination screen includes a condition setting area 30 and a determination result display area 40.

[0069] In the condition setting area 30, the number of measurements of the flow path confirmation sample is set from the measurement number setting section 31, the name of the flow path confirmation sample is set from the flow path confirmation sample setting section 32, the type of variation used for degradation judgment is set from the variation type setting section 33, the predetermined value A is set from the variation predetermined value A setting section 34, the predetermined value B is set from the variation predetermined value B setting section 35, and the predetermined time Y is set from the predetermined time setting section 36.

[0070] After the flow path confirmation sample is measured ( S31 ), the measurement results are displayed in the determination result display area 40 . The scheduled time X display section 43 displays the scheduled time X used for this determination, and the standby time display section 44 displays the standby time for this measurement. The measurement result display section 41 displays the results of measurements performed on the flow path confirmation sample set by the flow path confirmation sample setting section 32 for the number of measurements set by the measurement count setting section 31 . The fluctuation calculated based on the measurement results and the type of fluctuation set by the fluctuation type setting section 33 is displayed in the fluctuation display section 45 , and recommended maintenance is displayed in the recommended maintenance display section 42 .

[0071] Thus, in Example 1, if the standby time exceeds a predetermined time, the electrolyte analysis unit measures a flow path confirmation sample before patient specimen measurement, and uses the result to determine ISE reagent degradation. This eliminates abnormal measurement values ​​caused by ISE reagent degradation within the flow path, thereby improving the reliability of measurement results. Furthermore, by determining whether ISE reagent flow path maintenance is necessary and notifying the system of the necessary maintenance items, it is possible to reduce maintenance research time.

[0072] Example 2

[0073] In Example 1, degradation of the ISE reagent is determined by measuring the electrolyte of the flow path confirmation sample using the ISE reagent. In Example 2, degradation of the residual reagent is determined by measuring the concentration of interfering ions generated by degradation of the ISE reagent remaining in the flow path using a colorimetric analysis unit. Figure 1 A combined automatic analyzer with a colorimetric analysis unit and an electrolyte analysis unit as shown can perform the disclosure of this embodiment. While the methods for determining residual reagent degradation differ between Examples 1 and 2, they are otherwise common. Therefore, as Example 2, the description will focus on the method for determining residual reagent degradation, and any redundant explanation will be omitted. Figure 12 This is a flowchart for determining the deterioration of the residual reagent in Example 2. Step S41 is equivalent to Figure 8 Step S23, steps S42 to S45 in the process are equivalent to Figure 8 Steps S24 and S46~S47 in the process are equivalent to Figure 8 Step S25 in the process.

[0074] In the following description, only interfering ions are described. However, when this process is executed, interfering ions that cause errors in the calculation of Cl ion concentration due to deterioration of the ISE reagent are identified, and the concentration of the identified interfering ions can be detected by colorimetric analysis.

[0075] S41: The dilution liquid ejected from the dilution tank 18 of the electrolyte analysis unit 8 is divided by the sample dispensing mechanism 7 and ejected into the reaction container 5 of the colorimetric analysis unit. The reagent bottle provided on the reagent disk 4 is taken by the reagent dispensing mechanism 6 and ejected into the reaction container 5 from which the dilution liquid has been ejected. The absorbance that changes due to the reaction between the interfering ions in the dilution liquid and the reagent is measured by the photometer 13. The interfering ion concentration is calculated based on the change in absorbance. This measurement is performed continuously for a predetermined number of times. The predetermined number of times needs to be at least 3 times, which is determined by the user based on the type of variation to be monitored and the model of the device.

[0076] S42: Calculating the variation of the interfering ion concentration for determining degradation of the ISE reagent. As in Example 1, the variation can be the variation or rate of change in the interfering ion concentration measurement results obtained by continuous measurement.

[0077] S43: If the amount of change calculated in step S42 is greater than or equal to a predetermined value A (YES), the ISE reagent is determined to be degraded, and flow path maintenance is determined to be necessary before patient sample measurement, and the process proceeds to step S44. On the other hand, if the amount of change calculated in step S42 is less than the predetermined value A (NO), the ISE reagent is not degraded, and the process proceeds to patient sample measurement (S06). The predetermined value A, which serves as the determination threshold, is arbitrarily determined by the user based on the management level of each facility.

[0078] S44: Determine the degradation level of the ISE reagent. If the fluctuation amount calculated in step S42 is greater than or equal to a predetermined value B (Yes), the ISE reagent degradation level is determined to be high, and the process proceeds to step S45. If the fluctuation amount is less than the predetermined value B (No), the ISE reagent degradation level is determined to be low, and reagent preparation is performed to replace the ISE reagent remaining in the flow path (S47). The predetermined value B, which serves as the determination threshold, is set by the user based on the management level of each facility. Predetermined value B is set to be greater than predetermined value A.

[0079] S45: The cause of the high ISE reagent degradation level is estimated and necessary maintenance is determined. If the waiting time is less than the predetermined time Y hours (Y) (Yes), it is determined that the cause of rapid degradation in a short period of time is within the ISE reagent flow path, and cleaning of the flow path with a detergent is recommended (S46). If the waiting time is longer than Y hours (No), degradation is determined to be progressing due to the long waiting time, and reagent preparation is performed (S47). The predetermined time Y, which serves as the determination threshold, is set by the user based on past ISE degradation determination results and the operation of each facility. The predetermined time Y is set to a value greater than the predetermined time X.

[0080] Figure 13This is an example of a screen for determining deterioration of an ISE reagent using a colorimetric analysis unit. The degradation determination screen includes a condition setting area 50 and a determination result display area 60 .

[0081] In the condition setting area 50, the number of ISE reagent measurements is set in the measurement number setting section 51, the name of the ISE reagent to be measured is set in the determination object setting section 52, the type of fluctuation used for degradation determination is set in the fluctuation type setting section 53, the predetermined value A is set in the fluctuation predetermined value A setting section 54, the predetermined value B is set in the fluctuation predetermined value B setting section 55, and the predetermined time Y is set in the predetermined time setting section 56.

[0082] After the ISE reagent is measured ( S41 ), the measurement results are displayed in the determination result display area 60 . The scheduled time X display section 63 displays the scheduled time X used for this determination, and the standby time display section 64 displays the standby time for this determination. The measurement result display section 61 displays the results of measurements performed on the ISE reagent set by the determination target setting section 52 for the number of measurements set by the measurement count setting section 51 . The fluctuation calculated based on the measurement results and the type of fluctuation set by the fluctuation type setting section 53 is displayed in the fluctuation display section 65 , and recommended maintenance is displayed in the recommended maintenance display section 62 .

[0083] Thus, in Example 2, when the standby time exceeds a predetermined time, the colorimetric analysis unit measures the concentration of interfering ions contained in the diluent before patient specimen measurement. This result is used to determine diluent degradation. This eliminates abnormal measurement values ​​caused by diluent degradation within the flow path, thereby improving the reliability of measurement results. Furthermore, by determining whether ISE reagent flow path maintenance is necessary and notifying the user of the required maintenance items if necessary, maintenance research time can be reduced.

[0084] In Example 2, the concentration of interfering ions contained in the dilution solution was measured, but the same applies to the internal standard solution. In addition, the type of interfering ions is not limited as long as they are ions that can be measured by the colorimetric analysis unit.

[0085] The present invention is not limited to the above-described embodiments and includes various variations. For example, the above-described embodiments and variations are examples described in detail to facilitate understanding of the present invention and are not necessarily limited to having all the structures described. Furthermore, a portion of the structure of a particular embodiment or variation can be replaced with the structure of another embodiment or variation, and the structure of another embodiment or variation can be added to the structure of a particular embodiment or variation. Furthermore, other structures can be added, deleted, or substituted for a portion of the structure of each embodiment or variation.

[0086] Explanation of symbols

[0087] 1: Automatic analyzer, 2: Sample tray, 3: Sample cup, 4: Reagent tray, 5: Reaction vessel, 6: Reagent dispensing mechanism, 7: Sample dispensing mechanism, 8: Electrolyte analysis unit, 9: Interface, 10: Computer, 11: Printer, 12: Monitor, 13: Photometer, 14: Electrolyte concentration calculation unit, 15: Potentiometer, 16: Internal standard solution, 17: Dilution solution, 18: Dilution tank, 19: Cl ion electrode, 20: K ion electrode, 21: Na ion electrode, 22: Pinch valve, 23: Reference electrode, 24: Reference electrode solution, 25: Degassing tank, 26: Pipette injection Emitter, 30, 50: Condition setting area, 31, 51: Number of measurements setting section, 32: Flow path confirmation sample setting section, 33, 53: Fluctuation type setting section, 34, 54: Predicted fluctuation value A setting section, 35, 55: Predicted fluctuation value B setting section, 36, 56: Predicted time setting section, 40, 60: Judgment result display area, 41, 61: Measurement result display section, 42, 62: Recommended maintenance display section, 43, 63: Predicted time X display section, 44, 64: Standby time display section, 45, 65: Fluctuation display section, 52: Judgment target setting section.

Claims

1. An automatic analysis device, characterized in that have: an electrolyte analysis unit that measures electrolyte concentration using an ion-selective electrode method and is capable of measuring at least chloride ion concentration; and Control Department, When the control unit receives a measurement instruction for a patient sample that needs to be measured using the electrolyte analysis unit, and if the standby time of the electrolyte analysis unit is longer than a predetermined time, the control unit determines the deterioration of the residual reagent remaining in the flow path of the electrolyte analysis unit before the measurement of the patient sample.

2. The automatic analysis device according to claim 1, characterized in that The electrolyte analysis unit includes a dilution tank, an ion selective electrode, a reference electrode, a flow path for ejecting an internal standard solution into the dilution tank, a flow path for ejecting a dilution liquid into the dilution tank, a flow path for drawing the liquid in the dilution tank toward the ion selective electrode, and a flow path for drawing a reference electrode solution toward the reference electrode.

3. The automatic analysis device according to claim 1, characterized in that The control unit causes the electrolyte analysis unit to continuously measure the chloride ion concentration of the flow path confirmation sample a predetermined number of times, and determines the deterioration of the residual reagent based on the measurement result of the chloride ion concentration of the flow path confirmation sample.

4. The automatic analysis device according to claim 3, characterized in that The control unit performs measurement of the patient sample when the fluctuation amount of the chloride ion concentration of the flow path confirmation sample measured continuously is less than a predetermined value, and recommends replacement of residual reagent remaining in the flow path or flow path maintenance when it is greater than the predetermined value.

5. The automatic analysis device according to claim 4, characterized in that The control unit calculates, as the variation, a difference between a first measurement value and measurement values ​​of a specified number of measurements, or a slope obtained by linearly approximating the first measurement value and measurement values ​​up to the specified number of measurements, based on the measurement values ​​of the flow path confirmation sample measured continuously.

6. The automatic analysis device according to claim 1, characterized in that The automatic analyzer includes a colorimetric analysis unit capable of measuring the concentration of interfering ions that cause measurement errors in the chloride ion concentration in the electrolyte analysis unit. The control unit causes the colorimetric analysis unit to continuously measure the concentration of the interfering ions in the residual reagent a predetermined number of times, and determines whether the residual reagent has deteriorated based on the measurement result of the concentration of the interfering ions in the residual reagent.

7. The automatic analysis device according to claim 6, characterized in that The control unit performs measurement of the patient sample when the concentration fluctuation of the interfering ions in the continuously measured residual reagent is less than a predetermined value, and recommends replacement of the residual reagent remaining in the flow path or flow path maintenance when it is greater than the predetermined value.

8. The automatic analysis device according to claim 7, characterized in that The control unit calculates, as the variation, a difference between a first measurement value and measurement values ​​of a specified number of measurements, or a slope obtained by linearly approximating the first measurement value and measurement values ​​up to the specified number of measurements, based on the continuously measured values ​​of the residual reagent.

9. A method for measuring a patient sample using an automatic analyzer, the automatic analyzer comprising an electrolyte analyzer and a control unit, the electrolyte analyzer performing electrolyte concentration measurement using an ion-selective electrode method and capable of measuring at least chloride ion concentration, wherein: The control unit measures the standby time of the electrolyte analysis unit when receiving a measurement instruction of a patient sample to be measured using the electrolyte analysis unit. The control unit determines deterioration of a residual reagent remaining in a flow path of the electrolyte analysis unit before measurement of the patient sample when the standby time of the electrolyte analysis unit is equal to or longer than a predetermined time.

10. The measuring method according to claim 9, characterized in that The electrolyte analysis unit continuously measures the chloride ion concentration of the flow path confirmation sample a predetermined number of times. The control unit determines the deterioration of the residual reagent based on the measurement result of the chloride ion concentration of the flow channel confirmation sample.

11. The measuring method according to claim 10, characterized in that The control unit performs measurement of the patient sample when the fluctuation amount of the chloride ion concentration of the flow path confirmation sample measured continuously is less than a predetermined value, and recommends replacement of residual reagent remaining in the flow path or flow path maintenance when it is greater than the predetermined value.

12. The measuring method according to claim 11, characterized in that The control unit calculates, as the variation, a difference between a first measurement value and measurement values ​​of a specified number of measurements, or a slope obtained by performing a linear approximation between the first measurement value and measurement values ​​up to the specified number of measurements, based on the measurement values ​​of the flow path confirmation sample measured continuously.

13. The measuring method according to claim 9, characterized in that The automatic analyzer includes a colorimetric analysis unit capable of measuring the concentration of interfering ions that cause measurement errors in the chloride ion concentration in the electrolyte analysis unit. The colorimetric analysis unit continuously measures the concentration of the interfering ions in the residual reagent a predetermined number of times, The control unit determines whether the residual reagent has deteriorated based on a measurement result of the concentration of the interfering ions in the residual reagent.

14. The measuring method according to claim 13, characterized in that The control unit performs measurement of the patient sample when the concentration fluctuation of the interfering ions in the continuously measured residual reagent is less than a predetermined value, and recommends replacement of the residual reagent remaining in the flow path or flow path maintenance when the concentration fluctuation is greater than the predetermined value.

15. The measuring method according to claim 14, characterized in that The control unit calculates, as the variation, a difference between a first measurement value and measurement values ​​of a specified number of measurements, or a slope obtained by linearly approximating the first measurement value and measurement values ​​up to the specified number of measurements, based on the continuously measured values ​​of the residual reagent.

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