JP2009047638A - Automatic analyzer - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an automatic analyzer capable of preventing an abnormality of analysis data. <P>SOLUTION: The automatic analyzer includes a composite electrode 81a having a first and a second standard sample L, H, and an ion selective electrode for detecting electrolyte contained in a sample to be inspected and a reference electrode; a signal processor 83 for producing the first and the second data L, H and data to be inspected based on the first and the second standard sample L, H from the composite electrode 81a and the detection signal of the sample to be inspected; and a determination section 40 for determining normality of the ion selective electrode based on the first and the second standard data L, H produced by the signal processor 83; in which the determination section 40 determines that the ion selective electrode is normal when the additional standard data of the first and the second data L, H is within a normal range predetermined. Meanwhile, the determination section 40 determines that the ion selective electrode is abnormal when the additional data is not within the normal range and display-outputs abnormal information of the electrode in the display 52. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to an automatic analyzer for analyzing components contained in a liquid, and more particularly to an automatic analyzer for analyzing components contained in a test sample such as blood or urine collected from a human.

  The automatic analyzer is intended for biochemical test items and immunological test items, etc., and changes such as color tone caused by the reaction of the mixture of the test sample dispensed into the reaction container and the reagent corresponding to each test item to be analyzed. By analyzing the amount of transmitted light, analytical data represented by the concentration of components and enzyme activity in the test sample is generated. In addition, in the items of electrolytes such as sodium ion, potassium ion, and chlorine ion in the biochemical test items, an ion-selective electrode that selectively responds to each electrolyte, which is a detection means for detecting each electrolyte, and a constant potential are provided. By measuring between the generated reference electrodes, analysis data represented by the electrolyte concentration in the test sample is generated. Then, whether or not the subject of the test sample is healthy is diagnosed based on whether or not the generated analysis data is within the reference range set for each test item.

  By the way, when an ion selective electrode is used for a long time, a sensitive membrane for detecting the electrolyte of the ion selective electrode is deteriorated and sensitivity is lowered, and the selectivity to each electrolyte and SN ratio (signal to noise ratio) are lowered. There is a problem that accuracy of analysis data deteriorates. In order to prevent this problem, an ion-selective electrode error is displayed when a calibration curve created based on standard data generated by measuring a standard sample with a known electrolyte concentration falls below a predetermined gradient. To display.

  In addition, in an electrolyte detection unit including, for example, a flow-through composite electrode composed of an ion-selective electrode and a reference electrode, idle suction due to poor connection in a suction nozzle for guiding a test sample attached to the composite electrode to the inside Due to clogging of coagulation components in the blood, there is a problem that the test sample is not supplied into the composite electrode and air is sucked. In this case, since the air flowing between the ion selective electrode and the reference electrode becomes high resistance, the output of the composite electrode may become abnormal or impossible to measure.

  However, even if the ion-selective electrode or reference electrode is abnormal due to leakage of internal liquid, for example, the same phenomenon occurs as when empty suction or clogging occurs, so whether the output abnormality is due to composite electrode or empty suction or clogging. It takes time to make a decision, and the inspection may be delayed. In order to solve this problem, an automatic analyzer provided with a pressure sensor for detecting whether or not a test sample or the like has been sucked from a suction nozzle is known (for example, see Patent Document 1).

According to this automatic analyzer, when the pressure data obtained from the pressure sensor is out of the normal range, it is determined that the suction nozzle is defective, and a suction nozzle clogging error or an empty suction error is displayed. When the pressure data obtained from the pressure sensor is within the normal range and the output from the composite electrode is abnormal, it is determined that the ion selective electrode is abnormal and an ion selective electrode error is displayed.
JP-A-8-233771

  However, since the analysis of the electrolyte component in the test sample requires higher accuracy than other test items, the ion selectivity is compared with the abnormal output at the time of empty suction or clogging as in Patent Document 1. In the detection method that is unclear enough to judge the abnormal output when the electrode is abnormal, the composite electrode when analysis data that should slightly exceed the reference range falls within the reference range due to the ion selective electrode From this output, there is a problem that the ion selective electrode cannot be determined to be abnormal.

  The present invention has been made to solve the above-described problems, and an object of the present invention is to provide an automatic analyzer that can prevent abnormality of analysis data.

  In order to achieve the above object, an automatic analyzer according to the present invention is an automatic analyzer that analyzes a test sample and components of a test item included in the test sample. Based on an ion-selective electrode that detects an electrolyte component contained in the sample and the test sample, the first and second standard samples detected by the ion-selective electrode, and a detection signal of the test sample, The signal processing means for generating the first and second standard data and the test data, and the addition standard data obtained by adding the first and second standard data generated by the signal processing means are within a preset normal range. And determining means for determining that the ion-selective electrode is normal in some cases and determining that the ion-selective electrode is abnormal when out of the normal range.

  According to the present invention, when the addition standard data obtained by adding two standard data generated by measuring two standard samples is within a preset normal range, the detection means used to detect the standard sample is When it is determined to be normal and the detection means is out of the normal range, it is possible to prevent generation of abnormal analysis data by determining that the detection unit is abnormal.

  Hereinafter, an embodiment of an automatic analyzer according to the present invention will be described with reference to FIGS.

  FIG. 1 is a block diagram showing a configuration of an automatic analyzer according to an embodiment of the present invention. This automatic analyzer 100 includes an analysis unit 18 that measures standard samples and test samples of various test items, an analysis control unit 20 that controls the measurement operation of the analysis unit 18, and a standard sample and test samples of test items. A data processing unit 30 for processing the standard data of the standard sample output from the analysis unit 18 by the measurement and the test data of the test sample to create a calibration curve and generate analysis data for each inspection item; A determination unit 40 that determines whether or not the unit of the analysis unit 18 that detects the component of the test item based on the standard data output from the unit 18 is normal, and a calibration curve and a generation generated by the data processing unit 30 Output unit 50 for outputting the analyzed data, operation unit 60 for inputting analysis conditions for inspection items and various command signals, analysis control unit 20, data processing unit 30, determination unit 40, and output unit 50 Oversee And a system control unit 61 for controlling.

  FIG. 2 is a perspective view showing the configuration of the analysis unit 18. The analysis unit 18 includes a first reagent that selectively reacts with a component of each test item included in a sample such as a standard sample or a test sample of each test item, and a second reagent that is paired with the first reagent. A reagent bottle 7 containing the reagent bottle 7, a reagent rack 1 containing the reagent bottle 7, a reagent storage 2 containing the reagent rack 1 containing the reagent bottle 7 containing the first reagent, and a second reagent A reagent store 3 for storing the reagent rack 1 in which the reagent bottles 7 are stored, a reaction disk 5 in which a plurality of reaction containers 4 are arranged on the circumference, a sample cup 17 for storing samples, and a sample for storing samples And a disk sampler 6 in which a cup 17 is accommodated.

  Further, the sample dispensing probe 16 for dispensing the sample from the sample cup 17 of the disk sampler 6 and discharging it to the reaction vessel 4 and the first and second reagents from the reagent bottles 7 of the reagent containers 2 and 3 are aspirated. The first and second reagent dispensing probes 14 and 15 that perform dispensing to be discharged into the reaction container 4, the sample dispensing arm 10 that holds the sample dispensing probe 16 so as to be rotatable and vertically movable, and a first And first and second reagent dispensing arms 8 and 9 that hold the second reagent dispensing probes 14 and 15 so as to be rotatable and vertically movable.

  Furthermore, the mixture of the sample and the first reagent in the reaction vessel 4, the stirring unit 11 for stirring the mixture of the sample, the first reagent, and the second reagent, and the electrolyte item by sucking the mixture from the reaction vessel 4 Detection unit 19 for detecting electrolytes such as sodium ion, potassium ion and chlorine, which are components of the above, photometry unit 13 for photometry of reaction vessel 4 containing the mixture, and mixed solution after measurement in reaction vessel 4 And a washing unit 12 for washing and drying the inside of the reaction vessel 4.

  The electrolyte detection unit 19 sucks from the reaction container 4 a mixed solution of the standard sample of the electrolyte item and the test sample in which the electrolyte item is selected, detects the electrolyte component of the sucked mixed solution, and obtains standard data and test data. Generate. Then, the generated standard data is output to the data processing unit 30 and the determination unit 40. Further, the generated test data is output to the data processing unit 30.

  The photometric unit 13 irradiates the rotating reaction vessel 4 with light, converts light of a preset wavelength that has passed through a mixture of the standard sample and the test sample into absorbance, and outputs standard data and test data. Is generated. Then, the generated standard data and test data are output to the data processing unit 30.

  The analysis control unit 20 includes a mechanism that rotates the reagent storage 2, the reagent storage 3, and the disk sampler 6, a mechanism that rotates the reaction disk 5, a sample dispensing arm 10, a first reagent dispensing arm 8, and a second reagent. A mechanism for rotating and vertically moving the dispensing arm 9 and the stirring unit 11, a mechanism for moving the cleaning unit 12 up and down, and a mechanism for driving the stirring unit 11 to stir are provided.

  Also, a sample dispensing pump that sucks and discharges a sample from the sample dispensing probe 16, a reagent pump that sucks and discharges the first and second reagents from the first and second reagent dispensing probes 14 and 15, respectively, and a washing unit 12 And a mechanism for driving each pump such as a drying pump for drying the inside of the reaction vessel 4 from the cleaning unit 12, a mechanism for driving each unit of the electrolyte detection unit 19, and the like. Further, a control circuit for controlling each mechanism is provided.

  The data processing unit 30 in FIG. 1 includes a calculation unit 31 that generates a calibration curve from standard data output from the analysis unit 18 and generates analysis data from test data, and a calibration curve generated by the calculation unit 31 and the generation thereof. And a storage unit 32 for storing the analyzed data.

  The calculation unit 31 creates a calibration curve from the standard data of each inspection item output from the electrolyte detection unit 19 or the photometry unit 13 of the analysis unit 18. Moreover, the determination information output from the determination part 40 is added to the calibration curve corresponding to this determination information. The created calibration curve and the calibration curve to which the determination information is added are stored in the storage unit 32 and output to the output unit 50.

  Further, in accordance with the test data of each test item output from the electrolyte detection unit 19 or the photometry unit 13, the calibration curve of the test item is read from the storage unit 32. Then, using the read calibration curve, analysis data represented by an activity value, a concentration value, or the like is generated from the test data, and the generated analysis data is stored in the storage unit 32 and output to the output unit 50.

  The storage unit 32 includes a hard disk or the like, stores a calibration curve output from the calculation unit 31 for each inspection item, and stores analysis data for each test sample.

  The determination unit 40 determines whether or not the detection unit that detects the component of the electrolyte item is normal based on the standard data output from the electrolyte detection unit 19 of the analysis unit 18. If it is determined that the detection unit is abnormal, the abnormality information is output to the system control unit 61. The abnormality information is output to the calculation unit 31 of the data processing unit 30.

  The output unit 50 includes a printing unit 51 that prints out a calibration curve, analysis data, and the like output from the data processing unit 30 and a display unit 52 that displays the output. The printing unit 51 includes a printer and prints out the calibration curve, analysis data, and the like output from the data processing unit 30 on printer paper based on a preset format. The display unit 52 includes a monitor such as a CRT or a liquid crystal panel, displays an analysis condition setting screen for setting analysis conditions such as a standard sample and a calibration curve for each item, and a calibration curve output from the data processing unit 30. And display analysis data.

The operation unit 60 includes input devices such as a keyboard, a mouse, a button, and a touch key panel. The operation unit 60 sets analysis conditions such as a standard sample and a calibration curve for each examination item, a subject ID such as a subject ID and a subject name. Various operations such as input of sample information, selection of inspection items to be analyzed for each test sample, standard sample measurement operation of each test item, and test sample measurement operation are performed.
The system control unit 61 includes a CPU and a storage circuit (not shown). An operator command signal supplied from the operation unit 60, analysis conditions for each test item, sample information, test items selected for each test sample, and the like. Save the input information. Then, based on the input information, control of the entire system is performed such as control for causing each unit of the analysis unit 18 to perform measurement operation in a predetermined sequence of a fixed cycle, creation of a calibration curve, control for generation and output of analysis data, and the like. In addition, the abnormality information of the detection unit output from the determination unit 40 is displayed on the display unit 52 of the output unit 50.

  Next, with reference to FIG. 1 thru | or FIG. 5, the structure of the electrolyte detection unit 19 and the calibration curve of an electrolyte item are demonstrated. FIG. 3 is a diagram showing the configuration of the electrolyte detection unit 19. FIG. 4 is a diagram showing standard data of electrolyte items. FIG. 5 is a diagram showing a calibration curve of electrolyte items.

  In FIG. 3, the electrolyte detection unit 19 includes a calibration sample 72b for calibrating a mixed solution in which a sample such as a standard sample of an electrolyte item or a test sample is diluted with a first reagent of an electrolyte item at a predetermined magnification, A calibration sample bottle 72a containing the calibration sample 72b and an ion sensor unit 81 for detecting a mixed solution of the sample and an electrolyte contained in the calibration sample 72b are provided.

  Further, the calibration unit 70 that sucks and stores the calibration sample 72b in the calibration sample bottle 72a, and the calibration liquid 72b stored in the reaction container 4 of the analysis unit 18 and the calibration unit 70 are stored in the ion sensor unit 81. A suction pump 82 for suctioning and discharging to the drainage tank 82a and a signal processing unit 83 for processing a detection signal of the ion sensor unit 81 are provided.

  The ion sensor unit 81 is, for example, an ion-selective electrode (sodium) that is a detection means that detects an electrolyte (sodium ion, potassium ion, chlorine ion) of three electrolyte items (sodium item, potassium item, chlorine item) and responds to a potential. A composite electrode 81a composed of an ion-selective electrode, a potassium ion-selective electrode, and a chloride ion-selective electrode) and a reference electrode for generating a constant potential, and a mixed liquid connected to the inlet side of the composite electrode 81a And a suction nozzle 81b for guiding the calibration sample 72b into the composite electrode 81a. And it moves between the reaction container 4 and the calibration part 70 by the moving mechanism which is not shown in figure.

  Each ion selective electrode of the composite electrode 81a selectively responds to each electrolyte contained in the mixed solution or the calibration sample 72b with the reference electrode, and generates an electromotive force according to the activity of the electrolyte. This electromotive force E is proportional to the logarithm ln (C) of the electrolyte concentration C under the condition that the temperature and the activity coefficient are constant, and the gradient S and the constant S peculiar to each ion selective electrode based on the Nernst equation. It is expressed by a first expression {E = E0 + S × ln (C)} including each term of the intercept E0.

  The calibration unit 70 includes a sample container 71 for storing the calibration sample 72b, a calibration sample pump 72 for supplying the calibration sample 72b into the sample container 71, and a calibration sample 72b stored in the sample container 71. A drainage pump 74 that discharges the calibration sample 72 b that has become unnecessary after being sucked into the sample 81 to the outside of the sample container 71 is provided.

  The suction pump 82 sucks the calibration sample 72 b in the sample container 71 into the ion sensor unit 81. Further, the mixed solution in the reaction container 4 is sucked before or after the calibration sample 72b is sucked. Then, together with the suction, the calibration sample 72b or the mixed liquid in the ion sensor unit 81 is discharged to the drain tank 82a.

  FIG. 4 is a diagram showing standard data of electrolyte items. The signal processing unit 83 is an electrolyte contained in a mixed solution of two first and second standard samples L and H, which are standard samples of electrolyte items sucked into the composite electrode 81a of the ion sensor unit 81, and a calibration sample 72b. After detecting and outputting the detection signal from the composite electrode 81a that is detected and amplified, it is converted into a digital signal at a predetermined timing.

  The first standard data EL of the first standard sample L, the calibration data ESL of the calibration sample 72b for calibrating the first standard data EL, the second standard data EH of the second standard sample H, And the calibration data ESH of the calibration sample 72b for calibrating the second standard data EH is generated. Then, the generated data is output to the calculation unit 31 of the data processing unit 30.

  Further, for example, the test data Ei and the test data Ei are calibrated based on the detection signal from the composite electrode 81a that is output by detecting the electrolyte contained in the mixed solution of the test sample i and the calibration sample 72b. Calibration data ESi is generated. Then, the generated data is output to the calculation unit 31.

  The calculation unit 31 of the data processing unit 30 calculates the first calibration standard data ΔELS by subtracting the calibration data ESL from the first standard data EL from the electrolyte detection unit 19. Further, the second calibration standard data ΔEHS is calculated by subtracting the calibration data ESH from the second standard data EH. The calculated first and second calibration standard data ΔELS, ΔEHS, and the first and second standard values CL, which are the concentration values of the electrolyte contained in the first and second standard samples L, H set in advance, A calibration curve is created using CH.

  Further, the calibration test data ΔEiS is calculated by subtracting the calibration data ESi from the test data Ei from the electrolyte detection unit 19. Then, analysis data of the electrolyte item in the test sample i is generated from the calibration test data ΔEiS using the calibration curve.

  FIG. 5 is a diagram showing a calibration curve of electrolyte items. On the X and Y axes where the X axis is expressed by the logarithm ln (C) of the electrolyte concentration and the Y axis is expressed by the electromotive force E, the PL coordinates (CL, ΔELS) and a straight line passing through the second standard value CH and the PH coordinates (CH, ΔEHS) of the second calibration standard data ΔEHS are the first function {Y = ΔELS + S × (lnX−lnCL)} {S = It is expressed as a calibration curve D created by (ΔEHS−ΔELS) / ln (CH / CL)}. By substituting the calibration test data ΔEiS of the test sample i into the term Y of the first function to obtain the term X, analysis data Ci that is the electrolyte concentration of the test sample i is generated.

  Next, the determination of the composite electrode 81a will be described with reference to FIGS. FIG. 6 is a diagram for explaining the determination criteria in the determination unit 40. FIG. 7 is a diagram showing first and second calibration standard data ΔELS and ΔEHS of two types of composite electrodes 81a that are normal and abnormal.

  In FIG. 6, the x-axis represents the analytical data generated by the analysis of, for example, the potassium item of the determination sample having a known electrolyte concentration, in units of mmol / L as a deviation value from the determination value preset in the determination sample. It is represented by The y-axis represents the addition standard data obtained by adding the second calibration standard data to the first calibration standard data of the potassium item in units of mV.

  Here, the sample for analysis is analyzed using a plurality of composite electrodes 81a having a normal curve of a potassium item having a normal gradient equal to or higher than a predetermined value and not generating an abnormal output that causes a potassium ion selective electrode error. It was. The plurality of composite electrodes 81a include a composite electrode 81a having a potassium ion-selective electrode in which the analysis data of the potassium item deviates from the determination value beyond the allowable range, and the plurality of composite electrodes 81a are used. It was found that there was a correlation represented by a linear regression equation (y = −7.25x−1.00) by performing a regression analysis on the relationship between the obtained plurality of added calibration standard data and the deviation value. The allowable range is set based on the reference range of each inspection item. If the reference range is narrow, the allowable range is narrowed.

  As shown in FIG. 7, the first calibration standard data ΔEKLS1 whose deviation value is out of the allowable range shows a tendency to be larger than the first calibration standard data ΔEKLS2 whose deviation value is within the allowable range. Further, the second calibration standard data ΔEKHS1 in which the deviation value is out of the allowable range shows a tendency to be larger than the second calibration standard data ΔEKHS2 in which the deviation value is within the allowable range. Therefore, the additional calibration standard data whose deviation value is out of the allowable range shows a tendency to be larger than the additional calibration standard data whose deviation value is within the allowable range.

  Here, assuming that the deviation value is, for example, ± 0.15 mmol / L as the allowable range of the analysis data of the potassium item, a range of −2.09 to 0.09 mV is obtained by substituting ± 0.15 mmol / L into the regression equation. It is possible to calculate a normal range using as a criterion.

  In the determination unit 40, the first and second calibration standard data ΔELS and ΔEHS from the first standard data EL, calibration data ESL, second standard data EH, and calibration data ESH of each electrolyte item from the electrolyte detection unit 19 are used. Is calculated, and additional calibration standard data obtained by adding the first and second calibration standard data ΔELS and ΔEHS is obtained. It is determined whether or not the ion selective electrode of the electrolyte item of the composite electrode 81a used for generating each standard data is normal depending on whether or not the obtained addition calibration standard data is within a preset normal range. To do.

  When the obtained addition calibration standard data is within the normal range, the ion-selective electrode of the electrolyte item corresponding to the standard data of the composite electrode 81a used to generate the first and second standard data EL and EH is obtained. Determined to be normal.

  When the obtained addition standard data is out of the normal range, the ion-selective electrode of the electrolyte item corresponding to the standard data of the composite electrode 81a used for generating the first and second standard data EL and EH is obtained. Judged to be abnormal. Then, the electrode abnormality information is output to the system control unit 61 and the calculation unit 31. The system control unit 61 displays and outputs the electrode abnormality information output from the determination unit 40 on the display unit 52 of the output unit 50.

  As described above, when the addition standard data of each electrolyte item is out of the normal range set in advance, the ion selectivity of the electrolyte item of the composite electrode 81a used for generating the first and second standard data EL and EH. It is possible to determine that the electrode is abnormal, and display and output the electrode abnormality information on the display unit 52. Thereby, generation | occurrence | production of the abnormal analysis data using an abnormal ion selective electrode can be prevented beforehand.

  Hereinafter, an example of the operation of the automatic analyzer 100 will be described with reference to FIGS. 1 to 8. FIG. 8 is a flowchart showing the operation of the automatic analyzer 100. After the two sample cups 17 containing the first and second standard samples L and H are set on the disc sampler 6, when the standard sample measurement operation is performed from the operation unit 60, the automatic analyzer 100 starts operation. (Step S1).

  The system control unit 61 controls the analysis control unit 20, the data processing unit 30, the determination unit 40, and the output unit 50. The analysis control unit 20 controls each unit of the analysis unit 18 to measure the first and second standard samples L and H.

  The sample dispensing probe 16 of the analysis unit 18 sucks the first standard sample L from the sample cup 17 of the disk sampler 6 and discharges it to the reaction container 4. Next, the second standard sample H is sucked from the sample cup 17 and discharged to the reaction container 4. The first reagent dispensing probe 14 sucks the first reagent of the electrolyte item from the reagent bottle 7 of the reagent store 2 and puts the first reagent into the reaction container 4 containing the first and second standard samples L and H, respectively. Is discharged. The agitation unit 11 agitates the mixed solution of the first reagent and the first and second standard samples L and H in the reaction container 4.

  The ion sensor unit 81 of the electrolyte detection unit 19 moves horizontally in the direction of the arrow L2 shown in FIG. The suction pump 82 sucks the mixed liquid of the first standard sample L from the reaction container 4 into the composite electrode 81 a of the ion sensor unit 81. The signal processing unit 83 generates first standard data ENaL, EKL, and ECLL of the first standard sample L from the detection signal of the composite electrode 81a and outputs the first standard data ENaL, EKL, and ECLL to the calculation unit 31 and the determination unit 40 of the data processing unit 30. (Step S2).

  The calibration sample pump 72 of the calibration unit 70 sucks the calibration sample 72 b from the calibration sample bottle 72 a and supplies it to the sample container 71. The ion sensor unit 81 moves horizontally in the direction of the arrow L1 shown in FIG. The suction pump 82 sucks the calibration sample 72b from the sample container 71 into the composite electrode 81a. The signal processing unit 83 generates calibration data ENaSL, EKSL, and ECLSL for each electrolyte item of the calibration sample 72b from the detection signal of the composite electrode 81a, and outputs the calibration data ENaSL, EKSL, and ECLSL to the calculation unit 31 and the determination unit 40 (step S3).

  The ion sensor unit 81 moves horizontally in the L2 direction and then descends into the reaction container 4. The suction pump 82 sucks the mixed solution of the second standard sample H from the reaction container 4 into the composite electrode 81a. The signal processing unit 83 generates second standard data ENaH, EKH, and ECLH of the second standard sample H from the detection signal corresponding to each electrolyte item of the composite electrode 81a and outputs the second standard data ENaH, EKH, and ECLH to the calculation unit 31 and the determination unit 40. (Step S4).

  The calibration sample pump 72 sucks the calibration sample 72b from the calibration sample bottle 72a and supplies it to the sample container 71. The ion sensor unit 81 moves horizontally in the L1 direction and then descends into the sample container 71. The suction pump 82 sucks the calibration sample 72b from the sample container 71 into the composite electrode 81a. The signal processing unit 83 generates calibration data ENaSH, EKSH, ECLSH of each electrolyte item of the calibration sample 72b from the detection signal corresponding to each electrolyte item of the composite electrode 81a, and outputs the calibration data ENaSH, EKSH, ECLSH to the calculation unit 31 and the determination unit 40 (step). S5).

  The calculation unit 31 calculates the first calibration standard data ΔENaLS, ΔEKLS, ΔECLLS by subtracting the calibration data ENaSL, EKSL, ECLSL from the first standard data ENaL, EKL, ECLL output from the signal processing unit 83. To do. Further, the second calibration standard data ΔENaHS, ΔEKHS, and ΔECLHS are calculated by subtracting the calibration data ENaSH, EKSH, ECLSH from the second standard data ENaH, EKH, ECLH output from the signal processing unit 83. Then, calibration curves DNa, DK, DCL for each electrolyte item are created from the calculated calibration standard data (step S6).

  The determination unit 40 calculates each first calibration standard data ΔENaLS, ΔEKLS, ΔECTLS and each second calibration standard data ΔENaHS, ΔEKHS, ΔECLHS from each standard data and each calibration data output from the signal processing unit 83, Further, add calibration standard data is obtained.

  Then, when each obtained additional calibration standard data is out of the normal range of each electrolyte item (No in step S7), the ion selective electrode of the composite electrode 81a corresponding to the obtained additional calibration standard data is abnormal. Determination is made, and electrode abnormality information such as “the ion selective electrode is abnormal” is output to the calculation unit 31 and the system control unit 61.

  If the obtained additional calibration standard data is within the preset normal range (Yes in step S7), it is determined that the ion selective electrode of the composite electrode 81a corresponding to the obtained additional calibration standard data is normal. The determination result is output to the calculation unit 31.

  After “No” in step S7, the system control unit 61 displays and outputs the electrode abnormality information on the display unit 52 (step S8).

  On the other hand, the calculation unit 31 adds the electrode abnormality information output from the determination unit 40 to the calibration curves DNa, DK, and DCL corresponding to this information (step S9).

  After step S8 and step S9, the calculation unit 31 saves the calibration curves DNa, DK, and DCL in the storage unit 32 and outputs them to the output unit 50 (step S9).

  When the calibration curves DNa, DK, and DCL are displayed on the display unit 52 of the output unit 50, the system control unit 61 stops the analysis control unit 20, the data processing unit 30, the determination unit 40, and the output unit 50. By doing so, the automatic analyzer 100 ends the operation (step S11).

  According to the embodiment of the present invention described above, the first and second standard data EL and EH and the calibration data generated by the measurement of the mixed solution of the first and second standard samples L and H and the calibration sample 72b. Based on ELS and EHS, addition calibration standard data of each electrolyte item is obtained, and when the obtained addition calibration standard data is within a preset normal range, the ion selectivity of the composite electrode 81a corresponding to the addition calibration standard data It can be determined that the electrode is normal. If the additional calibration standard data is outside the preset normal range, it is determined that the ion selective electrode of the composite electrode 81a corresponding to the additional calibration standard data is abnormal, and the electrode abnormality information is displayed on the display unit. 52 can be displayed and output.

  As a result, generation of abnormal analysis data lacking accuracy can be prevented in advance, and re-measurement work and time due to delay in discovery of abnormal analysis data, the first and second standard samples L, H and waste of the calibration sample 72b can be reduced. In addition, misdiagnosis due to abnormal analysis data can be prevented.

The figure which shows the structure of the automatic analyzer by the Example of this invention. The perspective view which shows the structure of the analysis part which concerns on the Example of this invention. The figure which shows the structure of the electrolyte detection unit which concerns on the Example of this invention. The figure which shows the standard data of the electrolyte item which concerns on the Example of this invention. The figure which shows the analytical curve of the electrolyte item which concerns on the Example of this invention. The figure for demonstrating the criterion based on the Example of this invention. The figure which shows the 1st and 2nd calibration standard data of the composite electrode which is normal and abnormal which concerns on the Example of this invention. The flowchart which shows operation | movement of the automatic analyzer which concerns on the Example of this invention.

Explanation of symbols

4 Reaction Vessel 18 Analysis Unit 19 Electrolyte Detection Unit 20 Analysis Control Unit 30 Data Processing Unit 31 Calculation Unit 32 Storage Unit 40 Determination Unit 70 Calibration Unit 71 Sample Container 72 Calibration Sample Pump 72a Calibration Sample Bottle 72b Calibration Sample 74 Drainage Pump 81 Ion Sensor unit 81a Composite electrode 81b Suction nozzle 82 Suction pump 82a Drain tank

Claims (3)

In the automatic analyzer that analyzes the test sample and the components of the test items contained in the test sample,
An ion-selective electrode for detecting an electrolyte component contained in the first and second standard samples of the test item and the test sample;
Signal processing means for generating first and second standard data and test data based on detection signals of the first and second standard samples and the test sample detected by the ion selective electrode;
When the addition standard data obtained by adding the first and second standard data generated by the signal processing means is within a preset normal range, it is determined that the ion selective electrode is normal, and from the normal range An automatic analyzer comprising: determination means for determining that the ion selective electrode is abnormal when it is detached. Analysis data generation means for generating analysis data from the test data generated by the signal processing means based on the first and second standard data generated by the signal processing means;
The normal range includes the addition standard data of the first and second standard data generated using the ion selective electrode that is abnormal in advance, and the determination sample generated based on the first and second standard data. Analysis data, addition standard data of first and second standard data generated using a normal ion-selective electrode, and analysis of the determination sample generated based on the first and second standard data The regression equation created by the regression analysis of the data is substituted with a value of a preset allowable range of the analysis data of the determination sample, and is a range of the value obtained by the substitution. The automatic analyzer according to 1. Output means for outputting the analysis data generated by the analysis data generation means;
The automatic analyzer according to claim 1, wherein the determination unit outputs abnormality information of the ion selective electrode to the output unit.

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