JP5518630B2 - Automatic analyzer - Google Patents

Description

  Embodiments described herein relate generally to an automatic analyzer that analyzes a component contained in a test sample collected from a subject.

  The automatic analyzer is intended for biochemical test items and immunological test items, etc., and by measuring the color change caused by the reaction between the test sample and the reagent, analysis data expressed by the concentration and enzyme activity of each test item Is generated. In addition, each electrolyte item such as sodium ion, potassium ion, and chlorine ion contained in the biochemical test item is measured by measuring the change in electromotive force of the ion selective electrode that selectively responds to the electrolyte. Generate analytical data expressed in concentration.

  When measuring an electrolyte using an electrolyte measurement unit equipped with this ion-selective electrode, the test sample and a calibration sample for calibrating the test sample are sucked from the container containing the sample to the ion-selective electrode. Measure by sucking with a pump. For example, if the calibration sample stored in the container is smaller than the measurable amount, the sample sucked before the calibration sample is sucked remains on the ion selective electrode, and the remaining liquid is measured to obtain analysis data. There is a problem that generates.

  In order to prevent this problem, when a calibration sample of a measurable amount or more is supplied to the storage container, the sample container is provided with a pair of liquid level detection electrodes that are in contact with the calibration sample and a detection circuit connected to the electrodes. There is known a method for detecting whether or not a calibration sample more than a measurable amount is supplied to the sample and whether or not the calibration sample is sucked into the ion selective electrode from the sample container.

JP 2004-251799 A

  However, in order to detect the calibration sample supplied to the storage container, it is necessary to provide an electrode and a detection circuit for detecting the calibration sample, and there is a problem that the configuration of the electrolyte measurement unit is complicated. Further, there remains a problem that the abnormality of the analysis data cannot be detected when the test sample cannot be sucked up to the ion selective electrode.

  The embodiment has been made to solve the above-described problems, and an object thereof is to provide an automatic analyzer that can detect an abnormality of analysis data with a simple configuration.

In order to achieve the above object, an automatic analyzer according to an embodiment includes a suction unit that sucks a sample contained in a container, a detection unit that detects a component contained in the sample sucked by the suction unit, and the detection The signal detected by the means is collected at each monitoring time at the timing of the monitoring process to generate a plurality of monitor data, and collected at every measuring time at the timing of the measurement process that follows the monitoring process to generate sample data Based on the sample data and a normal calibration curve prepared in advance, and determining whether the analysis data is normal based on the monitor data and a judging means, wherein the measuring step is shorter than the monitor step, the measurement time is shorter than the monitor time, the monitor Engineering Is divided into an aspirating process including a time during which the sample is aspirated by the aspirating means and a stabilizing process following the aspirating process, and the signal processing means converts the signal detected by the detecting means into the aspirating process. Collecting at a timing to generate suction monitor data, the determination means includes first sample data generated at the timing of the measurement step that continues before the suction step, and the measurement step that continues after the stabilization step. The upper limit value is a value obtained by adding a preset allowable value to the higher value of the second sample data generated at the above timing, and the lower limit value is a value obtained by subtracting the allowable value from the lower value. When the suction monitor data is within the allowable range, it is determined that the second sample data is normal, and the suction monitor data is out of the allowable range. Wherein the engagement second sample data is characterized in that so as to determined to be abnormal.

The figure which shows the structure of the automatic analyzer which concerns on embodiment. The perspective view which shows the structure of the analysis part which concerns on embodiment. The figure which shows the structure of the electrolyte measurement unit which concerns on embodiment. Sectional drawing which shows the structure of the ion sensor unit which concerns on embodiment. The figure which shows attraction | suction of the mixed sample and calibration sample which concern on embodiment. The figure which shows the 1st standard signal and calibration signal which are output from the amplifier which concerns on embodiment. The figure which shows the 2nd standard signal and calibration signal which are output from the amplifier which concerns on embodiment. The figure which shows an example of the test signal and calibration signal which are output from the amplifier which concerns on embodiment. The figure which shows an example of 1st standard sample data and calibration sample data which concern on embodiment, 2nd standard sample data and calibration sample data, test sample data, and calibration sample data. The figure which shows an example of the analytical curve of the electrolyte item which concerns on embodiment. The figure which shows an example of the monitor data produced | generated by the signal processing part by the measurement of the test sample which concerns on embodiment. The figure which shows an example of the stabilization monitor data greatly inclined which concerns on embodiment.

  Hereinafter, embodiments will be described with reference to the drawings.

  FIG. 1 is a block diagram illustrating a configuration of an automatic analyzer according to the embodiment. The automatic analyzer 100 includes an analysis unit 24 that measures each sample such as a standard sample and a test sample collected from a subject, an analysis control unit 25 that controls the measurement operation of the analysis unit 24, and an analysis unit 24. A signal processing unit 26 that collects and processes signals when measured and generates each sample data such as standard sample data and test sample data, and each inspection based on each sample data generated by the signal processing unit 26 And a data processing unit 30 for generating a calibration curve for the items and generating analysis data.

  Further, the automatic analyzer 100 determines whether or not the sample data is normal based on the monitor data generated before the generation of each sample data by the signal processing unit 26, and performs data processing based on the determination result. A determination unit 40 for determining whether the calibration curve generated by the unit 30 and the generated analysis data are normal, an output unit 50 for outputting the analysis data generated by the data processing unit 30, and each test System control for overall control of an operation unit 53 for inputting analysis conditions of items and various command signals, an analysis control unit 25, a signal processing unit 26, a data processing unit 30, a determination unit 40, and an output unit 50 Part 54.

  FIG. 2 is a perspective view showing the configuration of the analysis unit 24. The analysis unit 24 rotates a sample container 17 that stores each sample such as a standard sample and a test sample, a sample disk 5 that holds the sample container 17, and a plurality of reaction containers 3 arranged on the circumference. A reaction disk 4 that can be held, a sample dispensing probe 16 that performs dispensing to suck the sample in the sample container 17 held on the sample disk 5 and discharge the sample into the reaction container 3, and the sample dispensing probe 16 And a sample dispensing arm 10 which is supported so as to be rotatable and vertically movable.

  In addition, a reagent container 6 that accommodates a first reagent and a two reagent system of the first reagent that react with the components of the test item included in each sample, a reagent container 1 that stores the reagent container 6, and a reagent container 1 A reagent rack 1a that holds the stored reagent container 6 so as to be rotatable, and a part that is sucked into the reaction container 3 from which the first reagent in the reagent container 6 held in the reagent rack 1a is sucked and discharged. A first reagent dispensing probe 14 for performing the injection is provided. The first reagent dispensing arm 8 that supports the first reagent dispensing probe 14 so as to be rotatable and vertically movable, and the first stirring for stirring the sample discharged into the reaction container 3 and the mixed sample of the first reagent. A child 18 and a first stirring arm 20 that supports the first stirring bar 18 so as to be rotatable and vertically movable are provided.

  In addition, a reagent container 7 that stores a second reagent that forms a pair with the first reagent of the two-reagent system, a reagent container 2 that stores the reagent container 7, and a reagent container 7 stored in the reagent container 2 are rotated. A reagent rack 2a that can be held, and a second reagent part that performs dispensing to suck the second reagent in the reagent container 7 held in the reagent rack 2a and discharge it into the reaction container 3 from which the first reagent has been discharged. A probe 15 is provided. In addition, a second reagent dispensing arm 9 that supports the second reagent dispensing probe 15 so as to be rotatable and vertically movable, and a sample discharged into the reaction container 3, a mixed sample of the first reagent, and the second reagent, A second agitator 19 for agitation and a second agitator arm 21 that supports the second agitator 19 so as to be rotatable and vertically movable are provided.

  Further, in order to measure each sample, a photometric unit 13 for measuring the components of each inspection item contained in the mixed sample in the reaction container 3, and an electrolyte contained in the mixed sample by sucking the mixed sample in the reaction container 3 Measured by an electrolyte measurement unit 22 that measures each component electrolyte such as sodium ion, potassium ion, and chlorine ion, and a reaction vessel 3 and a photometric unit 13 in which a mixed sample is sucked by the electrolyte measurement unit 22 And a reaction container cleaning unit 12 for cleaning the inside of the reaction container 3 containing the mixed sample.

  Then, the electrolyte measurement unit 22 sucks the mixed sample including the standard sample and the test sample from the reaction container 3 in order to measure the standard sample and the test sample. Then, an electrolyte component contained in the sucked mixed sample is detected, and a standard signal or a test signal obtained by amplifying the detected signal is output to the signal processing unit 26.

  Further, the photometric unit 13 irradiates light to the reaction container 3 that rotates, and detects the set wavelength light among the light transmitted through the mixed sample including the standard sample and the test sample. Then, the standard signal amplified by detecting the wavelength light transmitted through the mixed sample including the standard sample and the detected signal amplified by detecting the wavelength light transmitted through the mixed sample including the test sample are output to the signal processing unit 26. To do.

  The analysis control unit 25 includes a mechanism that rotationally drives the sample disk 5, the reagent rack 1 a, and the reagent rack 2 a of the analysis unit 24, and a mechanism that rotationally drives the reaction disk 4. In addition, a mechanism for rotating and vertically driving the sample dispensing arm 10, the first reagent dispensing arm 8, the second reagent dispensing arm 9, the first stirring arm 20, and the second stirring arm 21 is provided. Moreover, the mechanism which drives the reaction container washing | cleaning unit 12 up and down is provided. Further, a mechanism for driving each unit of the electrolyte measurement unit 22 is provided. In addition, a control circuit that controls a mechanism that drives each unit of the analysis unit 24 is provided.

  The signal processing unit 26 includes a multiplexer, an analog / digital conversion circuit, and the like, collects standard signals output from the electrolyte measurement unit 22 of the analysis unit 24 at a monitoring process timing for each monitoring time, and digitally collects the collected analog signals. A plurality of monitor data converted into signals are generated. Then, the generated plurality of monitor data is output to the determination unit 40. In addition, the standard signal continuously output from the electrolyte measurement unit 22 is collected at every measurement time shorter than the monitor time at a measurement step timing shorter than the monitor step following the monitor step, and the collected analog signal is digitally converted. A plurality of data converted into signals is processed to generate standard sample data. Then, the generated standard sample data is output to the data processing unit 30 and the determination unit 40.

  Further, the test signals output from the electrolyte measurement unit 22 are collected every monitoring time at the timing of the monitoring process, and a plurality of monitor data is generated by converting the collected analog signals into digital signals. Then, the generated plurality of monitor data is output to the determination unit 40. Further, the test signal continuously output from the electrolyte measurement unit 22 is collected at every measurement time at the timing of the measurement process, and a plurality of data obtained by converting the collected analog signal into a digital signal is processed to generate test sample data. To do. Then, the generated test sample data is output to the data processing unit 30 and the determination unit 40.

  Further, standard signals and test signals output from the photometry unit 13 of the analysis unit 24 are collected at predetermined time intervals, and standard sample data and test sample data obtained by converting the collected signals into digital signals are generated. Then, the generated standard sample data and test sample data are output to the data processing unit 30 and the determination unit 40.

  The data processing unit 30 in FIG. 1 includes a calculation unit 31 that creates a calibration curve and generates analysis data from the standard sample data and test sample data output from the signal processing unit 26, and a calibration created by the calculation unit 31. And a storage unit 32 for storing lines, generated analysis data, standard sample data generated by the signal processing unit 26, test sample data, monitor data, and the like.

  The calculation unit 31 creates a calibration curve based on the standard sample data of each inspection item generated by the signal processing unit 26. Then, abnormality information is added to the calibration curve determined to be abnormal by the determination unit 40, and the created normal calibration curve and the calibration curve to which the abnormality information is added are stored in the storage unit 32 and output to the output unit 50. To do.

  Further, based on the test sample data of each test item generated by the signal processing unit 26 and a normal calibration curve created in advance, analysis data represented by an activity value, a concentration value, or the like is generated. Here, for the test sample data of each test item output from the signal processing unit 26, a normal calibration curve of the test item is read from the storage unit 32, and the test sample data is read using the read calibration curve. Generate analytical data from Then, abnormality information is added to the analysis data determined to be abnormal by the determination unit 40, and normal analysis data and analysis data with the abnormality information added are stored in the storage unit 32 and output to the output unit 50.

  Further, each sample data such as standard sample data, test sample data, and monitor data stored in the storage unit 32 is read to create a graph showing the time-series change of each data, and the created graph is output to the output unit 50. To do.

  The storage unit 32 includes a hard disk or the like, and stores the calibration curve created by the calculation unit 31 for each inspection item. Further, the analysis data generated by the calculation unit 31 is stored for each test sample. In addition, a plurality of monitor data generated for each measurement of the standard sample by the signal processing unit 26, standard sample data generated subsequently to this data, a plurality of monitor data generated for each measurement of the test sample, and this data The test sample data and the like that are subsequently generated are stored.

  Based on a plurality of monitor data output from the signal processing unit 26 for each measurement of each sample by the electrolyte measurement unit 22 of the analysis unit 24, the determination unit 40 generates standard sample data and test data that are subsequently generated from the monitor data. Each sample data such as sample data is normal data due to normal operation of each unit in the analysis unit 24, or is abnormal data whose accuracy is greatly reduced due to abnormal operation of each unit, or each unit It is determined whether the data is unstable data whose accuracy may be reduced due to unstable operation.

  When the standard sample data or the test sample data is abnormal, the calibration curve of the electrolyte item measured by the electrolyte measurement unit 22 of the analysis unit 24 and the abnormality information of the analysis data are output to the data processing unit 30. When the standard sample data or the test sample data is unstable, warning information having an abnormal level lower than the abnormal information of the calibration curve or analysis data of the electrolyte item is output to the data processing unit 30. Further, it is determined whether the calibration curve and analysis data of the inspection item measured by the photometry unit 13 of the analysis unit 24 are normal. And when it determines with it being abnormal, the abnormality information is output to the calculating part 31 of the data processing part 30. FIG.

  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 or the like, and the normal calibration curve and analysis data output from the data processing unit 30, the calibration curve and analysis data to which abnormality information is added, a graph, and the like are set according to a preset format. Print out on printer paper.

  The display unit 52 includes a monitor such as a CRT or a liquid crystal panel. The display unit 52 displays an analysis condition setting screen for setting analysis conditions such as a standard sample and a calibration curve for each inspection item, and is output from the data processing unit 30. The calibration curve and analysis data that are normal and the calibration curve and analysis data to which abnormality information is added are displayed.

  The operation unit 53 includes input devices such as a keyboard, a mouse, a button, and a touch key panel, sets analysis conditions for each examination item, inputs subject information such as a subject ID and subject name of the subject, and subjects Various inputs such as selection of inspection items to be analyzed for each sample, standard sample measurement operation of each inspection item, and sample measurement operation are performed.

  The system control unit 54 includes a CPU and a storage circuit, and stores input information such as command signals supplied from the operation unit 53, analysis conditions for each test item, subject information, and test items selected for each test sample. To do. Based on the input information, control of the entire system is performed such as control for causing each unit of the analysis unit 24 to perform measurement operation in a predetermined sequence of a predetermined cycle, control for creating a calibration curve and generation and output of analysis data.

  Hereinafter, the configuration of the electrolyte measurement unit 22 in the analysis unit 24, the collection and processing of signals in the signal processing unit 26, and the determination in the determination unit 40 will be described with reference to FIGS.

First, the configuration of the electrolyte measurement unit 22 will be described with reference to FIGS.
FIG. 3 is a diagram showing the configuration of the electrolyte measurement unit 22. This electrolyte measurement unit 22 is a mixture of an ion sensor unit 60 that detects an electrolyte, a standard sample or a test sample stored in the reaction vessel 3, and a first reagent of an electrolyte item for diluting the sample. A calibration unit 61 that houses a calibration sample for calibrating the sample, a suction pump 62 that sucks the mixed sample in the reaction vessel 3 and the calibration sample stored in the calibration unit 61 into the ion sensor unit 60, and an ion sensor unit A tube 63 communicating between the pump 60 and the suction pump 62 and an amplifier 64 for amplifying and measuring a signal detected by the ion sensor unit 60 are provided.

  FIG. 4 is a cross-sectional view showing the configuration of the ion sensor unit 60. The ion sensor unit 60 includes a composite electrode 65 that detects a plurality of electrolytes that are components contained in each sample of the mixed sample and the calibration sample sucked by the suction pump 62, and one end portion that guides each sample into the composite electrode 65. Includes a suction nozzle 66 detachably attached to the lower end portion of the composite electrode 65. The calibration sample is filled in the composite electrode 65 and the suction nozzle 66 before the measurement is started in the analysis unit 24 and during the standby after the measurement is completed. During the measurement, the sample is moved between the reaction vessel 3 and the calibration unit 61 by a moving mechanism (not shown) in order to suck the mixed sample and the calibration sample.

  The composite electrode 65 has a through-hole 65a that is set to a predetermined temperature such as 37 ° C. and extends in the vertical direction. Then, by contacting each sample, three ions that selectively detect three types of electrolytes (sodium ion, potassium ion, and chlorine ion) that are specific components contained in each sample and show potentials according to the concentration. A selective electrode (ISE) 651 to 653 and a reference electrode 654 showing a reference potential with respect to each ISE 651 to 653 by being in contact with each sample.

  In the ISE 651, a sensitive film for detecting sodium ions contained in each sample forms a part of the through hole 65a. In addition, the ISE 652 is spaced apart from the ISE 651, and a sensitive film that detects potassium ions contained in each sample forms a part of the through hole 65a. Further, the ISE 653 is disposed on the ISE 652 so as to be separated from each other, and a sensitive film that detects chlorine ions contained in each sample forms a part of the through hole 65a. Furthermore, the reference electrode 654 is spaced apart from the ISE 653, and the liquid junction in contact with each sample forms part of the through hole 65a.

  Each of the ISEs 651 to 653 generates an electromotive force E that is a potential difference corresponding to the activity of each electrolyte included in each sample flowing into the through hole 65a with the reference electrode 654. This electromotive force E is proportional to the logarithm ln (C) of the concentration C of each electrolyte under the condition that the temperature and the activity coefficient are constant, and based on the Nernst equation, the slope S and the intercept are constants specific to each ion sensor. It is represented by a first expression {E = E0 + S × ln (C)} including each term of E0.

  The calibration unit 61 shown in FIG. 3 includes a calibration sample bottle 611 in which a calibration sample is accommodated, and a storage container 612 that accommodates the calibration sample that is sucked into the ion sensor unit 60 at the same temperature as the composite electrode 65. A calibration sample pump 613 for supplying the calibration sample in the calibration sample bottle 611 into the storage container 612, and a discharge for discharging the unnecessary calibration sample remaining in the storage container 612 after being sucked into the ion sensor unit 60. A liquid pump 614.

  The suction pump 62 is accommodated in the mixed sample in the reaction container 3 in which the suction nozzle 66 of the ion sensor unit 60 is set to the same temperature as the composite electrode 65 or in the storage container 612 of the calibration unit 61 under the control of the analysis control unit 25. While stopping at the position where the calibration sample is entered, suction is performed through the tube 63. By this suction, as shown in FIG. 5A, the mixed sample in the reaction vessel 3 flows into the suction nozzle 66 filled with, for example, a calibration sample, and the mixed sample that has flowed in is guided to the suction nozzle 66. It flows into the composite electrode 65 filled with the calibration sample. When the suction operation is stopped, the suction nozzle 66 and the composite electrode 65 are filled with the mixed sample replaced from the calibration sample. Further, after suctioning, discharging is performed. By this discharge, the calibration sample that has flowed out of the ion sensor unit 60 into the tube 63 is discharged into the drainage tank 67.

  Also, as shown in FIG. 5B, the calibration sample in the storage container 612 flows into the suction nozzle 66 filled with the mixed sample, and the flowed calibration sample is guided to the suction nozzle 66 and becomes the mixed sample. It flows into the filled composite electrode 65. The suction nozzle 66 and the composite electrode 65 are filled with a calibration sample replaced from the mixed sample. In addition, the mixed sample that has flowed into the tube 63 from the ion sensor unit 60 by the discharge after the suction is discharged into the drainage tank 67.

  As described above, the inside of the ion sensor unit 60 is filled with one of the calibration sample or the mixed sample, and only the other sample is sucked into the ion sensor unit 60 filled with the one sample. Inflow of air into the through hole 65a can be prevented. As a result, air flows into the through-hole 65a and is electrically disconnected, thereby preventing the resistance between the ISEs 651 to 653 and the reference electrode 654 from becoming abnormally high, thereby preventing the amplifier 64 from making measurement impossible. be able to.

  The amplifier 64 of the ion sensor unit 60 in which a mixed sample including a first standard sample containing a low concentration of electrolyte among the two first and second standard samples, which is a standard sample of an electrolyte item, is aspirated. The electromotive force between each ISE 651 to 653 and the reference electrode 654 is amplified, and the amplified first standard signal is output to the signal processing unit 26. In addition, for example, between the ISEs 651 to 653 and the reference electrode 654 in which a mixed sample including a second standard sample containing an electrolyte at a higher concentration than the first standard sample after the first standard sample is sucked. The power is amplified, and the amplified second standard signal is output to the signal processing unit 26. Further, the electromotive force between each ISE 651 to 653 and the reference electrode 654 in which the mixed sample including the test sample is sucked after each of the first and second standard samples is amplified, and the amplified test signal is signaled. The data is output to the processing unit 26.

  In addition, the amplifier 64 contains a higher concentration of electrolyte than, for example, the mixed sample containing the first standard sample before the suction of each mixed sample of the mixed sample containing the first standard sample or the mixed sample containing the test sample. And amplifying the electromotive force between each of the ISEs 651 to 653 and the reference electrode 654 in which a calibration sample for cleaning containing a lower concentration of electrolyte than the mixed sample including the second standard sample is sucked, and A calibration signal for cleaning, which is an amplified electrical signal, is output to the signal processing unit 26.

  Further, the amplifier 64 continuously sucks the calibration sample for calibration after each mixed sample of the mixed sample including the first standard sample, the mixed sample including the second standard sample, and the mixed sample including the test sample. The electromotive force between each of the ISEs 651 to 653 and the reference electrode 654 is amplified, and a calibration signal for calibration that is the amplified electric signal is output to the signal processing unit 26.

Next, with reference to FIGS. 2 to 8, for example, a signal between the ISE 651 and the reference electrode 654 amplified by the amplifier 64 of the electrolyte measurement unit 22 and a timing at which this signal is collected by the signal processing unit 26 will be described. .
FIG. 6 is a diagram showing a first standard signal and a calibration signal output from the amplifier 64. The signal 70 is a mixed sample including a calibration signal 71 corresponding to the concentration of the calibration sample of the ion sensor unit 60 and a first standard sample that is output after the calibration signal 71 and is aspirated after the calibration sample is aspirated. The first standard signal 72 corresponding to the suction of the first standard signal 72 and the calibration sample for the calibration of the first standard sample that is output after the first standard signal 72 is sucked after the mixed sample is sucked. And a corresponding calibration signal 73.

  The first standard signal 72 is m from when the suction of the mixed sample including the mth (m is an integer of 1 or more) first standard sample is started until the suction of the (m + 1) th calibration sample is started. It is output from the amplifier 64 at the timing of the first first standard sample suction step TL. In this first standard sample aspirating step TL, for example, 8.8 seconds on the front side is set as the monitoring step Ta, and for example, 0.2 seconds, which is shorter than the monitoring step Ta following the monitoring step Ta, is set as the measuring step Tb. Divided into two steps. The monitoring process Ta is divided into a suction process Ta1 including a time during which the mixed sample is sucked by the suction operation of the suction pump 62 and a stabilization process Ta2 having a longer time than the suction process Ta1 connected after the suction process Ta1. .

  Then, in the suction step Ta1 in which the inside of the ion sensor unit 60 is switched from the calibration sample to the mixed sample containing the first standard sample, the electrolyte in the ion sensor unit 60 changes in the low concentration direction, which is the concentration direction included in the mixed sample. Thus, the first standard signal 72 fluctuates in the lower direction. In addition, in the stabilization process Ta2 and the measurement process Tb in which the inside of the ion sensor unit 60 is filled with the mixed sample, the electrolyte concentration in the ion sensor unit 60 becomes uniform over time, and the mixed sample in the ion sensor unit 60 is obtained. Since the temperature becomes the same as that of the composite electrode 65, the potential of the ISE 651 in response to a change in the electrolyte concentration during suction or a temperature change in the mixed sample converges. Due to this convergence, the first standard signal 72 is stabilized.

  The signal processing unit 26 collects the first standard signal 72 output from the amplifier 64 for each monitoring time at the timing of the monitoring step Ta, converts the collected signal into a digital signal, and generates a plurality of monitor data. Then, the generated plurality of monitor data is output to the determination unit 40. Further, the first standard signal 72 output from the amplifier 64 is collected at the measurement step Tb at every measurement time shorter than the monitor interval, and a plurality of data obtained by converting the collected signal into a digital signal is averaged, for example. To generate first standard sample data. Then, the generated first standard sample data is output to the data processing unit 30 and the determination unit 40.

  As described above, in the measurement process Tb, the first standard sample data can be generated with high accuracy by collecting the stable static portion of the first standard signal 72 every measurement time. Further, a monitoring process Ta is provided before the measurement process Tb, and in the monitoring process Ta, a portion including the dynamic fluctuation of the first standard signal 72 is collected at every monitoring time, so that the monitor data is not increased indiscriminately. Can be generated. Thereby, the load concerning the signal processing in the signal processing unit 26 and the time required for the signal processing can be suppressed, and the amount of monitor data stored in the storage unit 32 can be suppressed.

  The calibration signal 73 is output from the amplifier 64 at the timing of the (m + 1) -th calibration sample suction step TC that continues after the m-th first standard sample suction step TL. This calibration sample suction step TC is divided into a monitor step Ta and a measurement step Tb, as in the first standard sample suction step TL. The monitoring process Ta is divided into a suction process Ta1 and a stabilization process Ta2 in the same manner as the monitoring process Ta in the first standard sample suction process TL.

  Then, in the suction step Ta1 in which the inside of the ion sensor unit 60 is replaced with the calibration sample from the mixed sample containing the first standard sample, the electrolyte in the ion sensor unit 60 changes in the high concentration direction, which is the concentration direction contained in the calibration sample. As a result, the calibration signal 73 varies in the higher direction. Further, in the stabilization process Ta2 and the measurement process Tb in which the ion sensor unit 60 is filled with the calibration sample, the electrolyte concentration in the ion sensor unit 60 becomes uniform, and the calibration sample in the ion sensor unit 60 becomes the composite electrode 65. By reaching the same temperature, the potential of the ISE 651 in response to fluctuations in the electrolyte concentration during suction and temperature fluctuations in the mixed sample converges. Due to this convergence, the calibration signal 73 is stabilized.

  The signal processing unit 26 collects the calibration signal 73 output from the amplifier 64 for each monitoring time at the timing of the monitoring step Ta, and generates a plurality of monitor data obtained by converting the collected signal into a digital signal. Then, the generated plurality of monitor data is output to the determination unit 40. Further, the calibration signal 73 output from the amplifier 64 is collected every measurement time at the timing of the measurement step Tb, and a plurality of data obtained by converting the collected signal into a digital signal is processed to correct the first standard sample data. Generate calibration sample data. Then, the generated calibration sample data is output to the data processing unit 30 and the determination unit 40.

  As described above, in the measurement process Tb, the calibration sample data can be generated with high accuracy by collecting a stable static portion of the calibration signal 73 for each measurement time. In addition, a monitor process Ta is provided before the measurement process Tb, and in the monitor process Ta having a longer time than the measurement process Tb, the monitor data is collected by collecting a portion including the dynamic variation of the calibration signal 73 at each monitor time. It can be generated without increasing darkly. Thereby, the load concerning the signal processing in the signal processing unit 26 and the time required for the signal processing can be suppressed. In addition, the amount of monitor data stored in the storage unit 32 can be suppressed.

  The calibration signal 71 is output from the amplifier 64 at the timing of the first first standard sample suction step TL from the start of the first calibration sample suction until the same time as the first standard sample suction step TL has elapsed. Is done.

  The signal processing unit 26 collects the calibration signal 71 output from the amplifier 64 for each measurement time at the timing of the measurement step Tb, and processes the plurality of data obtained by converting the collected signal into a digital signal to generate calibration sample data. To do. Then, the generated calibration sample data is output to the determination unit 40.

  FIG. 7 is a diagram showing a second standard signal and a calibration signal output from the amplifier 64. This signal 80 is a mixed sample including a calibration signal 81 corresponding to the concentration of the calibration sample of the ion sensor unit 60 and a second standard sample that is output after the calibration signal 81 and is aspirated after the calibration sample 81 is aspirated. The second standard signal 82 corresponding to the concentration of the second standard signal 82, and the concentration of the calibration sample for calibration of the second standard sample that is output after the second standard signal 82 is aspirated after the mixed sample is aspirated. And a corresponding calibration signal 83.

  The calibration signal 81 is output from the amplifier 64 at the timing of the (m + 1) -th calibration sample suction step TC that follows the m-th first standard sample suction step TL.

  The second standard signal 82 is the same as the first standard sample suction step TL after the suction of the mixed sample including the second standard sample (n is an integer of 1 or more) starts ( m + n + 1) is output from the amplifier 64 at the timing of the n-th second standard sample suction step TH until the start of suction of the calibration sample. The second standard sample suction step TH is divided into a monitor step Ta and a measurement step Tb, as in the first standard sample suction step TL. The monitoring process Ta is divided into a suction process Ta1 and a stabilization process Ta2 in the same manner as the monitoring process Ta in the first standard sample suction process TL.

  In the suction step Ta1 in which the inside of the ion sensor unit 60 is switched from the calibration sample to the mixed sample including the second standard sample, the electrolyte in the ion sensor unit 60 changes in the high concentration direction, which is the concentration direction included in the mixed sample. Thus, the second standard signal 82 varies in the higher direction. In addition, in the stabilization process Ta2 and the measurement process Tb in which the ion sensor unit 60 is filled with the mixed sample, the electrolyte concentration in the ion sensor unit 60 becomes uniform, and the mixed sample in the ion sensor unit 60 becomes the composite electrode 65. By reaching the same temperature, the potential of the ISE 651 in response to fluctuations in the electrolyte concentration during suction and temperature fluctuations in the mixed sample converges. Due to this convergence, the second standard signal 82 is stabilized.

  The signal processing unit 26 collects the second standard signal 82 output from the amplifier 64 for each monitoring time at the timing of the monitoring step Ta, and generates a plurality of monitor data obtained by converting the collected signal into a digital signal. Then, the generated plurality of monitor data is output to the determination unit 40. In addition, the second standard signal 82 output from the amplifier 64 is collected every measurement time at the timing of the measurement step Tb, and a plurality of data obtained by converting the collected signal into a digital signal is processed to obtain second standard sample data. Is generated. Then, the generated second standard sample data is output to the data processing unit 30 and the determination unit 40.

  As described above, in the measurement process Tb, the second standard sample data can be generated with high accuracy by collecting the stable static portion of the second standard signal 82 every measurement time. In addition, a monitoring process Ta is provided before the measurement process Tb, and in the monitoring process Ta, a portion including the dynamic fluctuation of the second standard signal 82 is collected at every monitoring time, so that monitor data is not increased indiscriminately. Can be generated. Thereby, the load concerning the signal processing in the signal processing unit 26 and the time required for the signal processing can be suppressed. In addition, the amount of monitor data stored in the storage unit 32 can be suppressed.

  The calibration signal 83 is output from the amplifier 64 at the timing of the (m + n + 1) -th calibration sample suction step TC that is continued after the n-th second standard sample suction step TH. Then, in the suction step Ta1 in which the inside of the ion sensor unit 60 is replaced with the calibration sample from the mixed sample containing the second standard sample, the electrolyte in the ion sensor unit 60 changes in the low concentration direction, which is the concentration direction contained in the calibration sample. As a result, the calibration signal 83 fluctuates in the lower direction. Further, in the stabilization process Ta2 and the measurement process Tb in which the ion sensor unit 60 is filled with the calibration sample, the electrolyte concentration in the ion sensor unit 60 becomes uniform, and the calibration sample in the ion sensor unit 60 becomes the composite electrode 65. By reaching the same temperature, the potential of the ISE 651 in response to fluctuations in the electrolyte concentration during suction and temperature fluctuations in the mixed sample converges. Due to this convergence, the calibration signal 83 is stabilized.

  The signal processing unit 26 collects the calibration signal 83 output from the amplifier 64 for each monitoring time at the timing of the monitoring step Ta, and generates a plurality of monitor data obtained by converting the collected signal into a digital signal. Then, the generated plurality of monitor data is output to the determination unit 40. Further, the calibration signal 83 output from the amplifier 64 is collected for each measurement time at the timing of the measurement step Tb, and a plurality of data obtained by converting the collected signal into a digital signal is processed to correct the second standard sample data. Generate calibration sample data. Then, the generated calibration sample data is output to the data processing unit 30 and the determination unit 40.

  As described above, in the measurement step Tb, the calibration sample data can be generated with high accuracy by collecting the stable static portion of the calibration signal 83 for each measurement time. In addition, a monitor process Ta is provided before the measurement process Tb, and in the monitor process Ta, a portion including dynamic fluctuations of the calibration signal 83 is collected at every monitor time, thereby generating monitor data without increasing darkly. Can do. Thereby, the load concerning the signal processing in the signal processing unit 26 and the time required for the signal processing can be suppressed, and the amount of monitor data stored in the storage unit 32 can be suppressed.

  FIG. 8 is a diagram illustrating an example of a test signal and a calibration signal output from the amplifier 64. This signal 90 is a concentration of a mixed sample including a calibration signal 91 corresponding to the concentration of the calibration sample of the ion sensor unit 60 and a test sample that is output after the calibration signal 91 and is aspirated after the calibration sample is aspirated. And a calibration signal 93 corresponding to the concentration of the calibration sample for calibration of the test sample that is aspirated after the mixed sample is aspirated, which is output following the test signal 92. Composed.

  The test signal 92 is a signal of the test sample suction step TS from the start of suction of the mixed sample including the test sample until the start of suction of the calibration sample after elapse of the same time as the first standard sample suction step TL. It is output from the amplifier 64 at timing. The test sample suction process TS is divided into a monitor process Ta and a measurement process Tb, as in the first standard sample suction process TL. The monitoring process Ta is divided into a suction process Ta1 and a stabilization process Ta2 in the same manner as the monitoring process Ta in the first standard sample suction process TL.

  In the suction step Ta1 in which the inside of the ion sensor unit 60 is switched from the calibration sample to the mixed sample including the test sample, the electrolyte concentration contained in the mixed sample in the ion sensor unit 60 is higher than the electrolyte concentration contained in the calibration sample. Or the same height direction when they are the same, or the lower direction when they are the same. Here, the test signal 92 fluctuates in the high direction when it fluctuates in the higher direction when the electrolyte concentration contained in the mixed sample is higher than the electrolyte concentration contained in the calibration sample. Further, in the stabilization process Ta2 and the measurement process Tb in which the ion sensor unit 60 is filled with the mixed sample, the electrolyte concentration in the ion sensor unit 60 becomes uniform, and the mixed sample becomes the same temperature as the composite electrode 65. The potential of ISE 651 in response to fluctuations in the electrolyte concentration during suction and temperature fluctuations in the mixed sample converges. Due to this convergence, the test signal 92 is stabilized.

  The signal processing unit 26 collects the test signal 92 output from the amplifier 64 for each monitoring time at the timing of the monitoring step Ta, and generates a plurality of monitor data obtained by converting the collected signal into a digital signal. Then, the generated plurality of monitor data is output to the determination unit 40. Further, the test signal 92 output from the amplifier 64 is collected for each measurement time at the timing of the measurement step Tb, and a plurality of data obtained by converting the collected signal into a digital signal is processed to generate test sample data. Then, the generated test sample data is output to the data processing unit 30 and the determination unit 40.

  Thus, in the measurement step Tb, the test sample data can be generated with high accuracy by collecting a stable static portion of the test signal 92 for each measurement time. In addition, a monitor process Ta is provided before the measurement process Tb, and in the monitor process Ta, monitor data is generated without increasing darkly by collecting portions including dynamic fluctuations of the test signal 92 at every monitor time. be able to. Thereby, the load concerning the signal processing in the signal processing unit 26 and the time required for the signal processing can be suppressed. In addition, by measuring a large number of test samples, the amount of monitor data that can be stored in the storage unit 32 can be suppressed.

  The calibration signal 93 is output from the amplifier 64 at the timing of the calibration sample suction step TC that follows the test sample suction step TS. Then, in the suction step Ta1 in which the ion sensor unit 60 replaces the mixed sample including the test sample with the calibration sample, the electrolyte in the ion sensor unit 60 changes in the low concentration direction, which is the concentration direction included in the calibration sample. The calibration signal 93 fluctuates in the lower direction. Further, in the stabilization process Ta2 and the measurement process Tb in which the ion sensor unit 60 is filled with the calibration sample, the electrolyte concentration in the ion sensor unit 60 becomes uniform, and the calibration sample in the ion sensor unit 60 becomes the composite electrode 65. By reaching the same temperature, the potential of the ISE 651 in response to fluctuations in the electrolyte concentration during suction and temperature fluctuations in the mixed sample converges. Due to this convergence, the calibration signal 93 is stabilized.

  The signal processing unit 26 collects the calibration signal 93 output from the amplifier 64 for each monitoring time at the timing of the monitoring step Ta, and generates a plurality of monitor data obtained by converting the collected signal into a digital signal. Then, the generated plurality of monitor data is output to the determination unit 40. Further, the calibration signal 93 output from the amplifier 64 is collected every measurement time at the timing of the measurement step Tb, and a plurality of data obtained by converting the collected signal into a digital signal is processed to calibrate the test sample data for calibration. Generate data. Then, the generated calibration sample data is output to the data processing unit 30 and the determination unit 40.

  Thus, in the measurement process Tb, the calibration sample data can be generated with high accuracy by collecting the stable static portion of the calibration signal 93 for each measurement time. In addition, a monitoring process Ta is provided before the measurement process Tb, and in the monitoring process Ta, a portion including dynamic fluctuations of the calibration signal 93 is collected at every monitoring time, thereby generating monitor data without increasing darkly. Can do. Thereby, the load concerning the signal processing in the signal processing unit 26 and the time required for the signal processing can be suppressed. In addition, by measuring a large number of test samples, the amount of monitor data that can be stored in the storage unit 32 can be suppressed.

  The calibration signal 91 is output from the amplifier 64 at the timing of the calibration sample suction step TC that is connected before the test sample suction step TS. The signal processing unit 26 collects the calibration signal 91 output from the amplifier 64 at each measurement time at the timing of the measurement process Tb, and processes a plurality of data obtained by converting the collected signal into a digital signal to generate calibration sample data. To do. Then, the generated calibration sample data is output to the determination unit 40.

Next, with reference to FIGS. 3 to 9, an example of creating a calibration curve for electrolyte items and generating analysis data in the data processing unit 30 will be described.
FIG. 9 shows the first standard sample data and the calibration sample data for calibrating the data, the second standard sample data and the calibration sample data for calibrating the data, the test sample data, and the calibration sample data for calibrating the data. It is the figure which showed an example. The calculation unit 31 of the data processing unit 30 includes first standard sample data EL output from the signal processing unit 26 by measurement of the first and second standard samples, calibration sample data ELC for calibrating this data, and first data A calibration curve is created based on the two standard sample data EH and the calibration sample data EHC for calibration of this data.

  Here, the first standard sample calibration data ΔEL is obtained by subtracting the calibration sample data ELC from the first standard sample data EL. Further, the second standard sample calibration data ΔEH is obtained by subtracting the calibration sample data EHC from the second standard sample data EH. The obtained first and second standard sample calibration data ΔEL, ΔEH, the first standard value CL indicating the concentration of the electrolyte contained in the preset first standard sample, and the electrolyte contained in the second standard sample As shown in FIG. 10, the first function {Y = ΔEL + S × (lnX−lnCL)} {S = (ΔEH−ΔEL) / ln (CH / CL)} A calibration curve D represented by

  Further, analysis data is generated based on the test sample data ES output from the signal processing unit 26 by the measurement of the test sample and the calibration sample data ESC for calibration of this data. Here, the test sample calibration data ΔES is obtained by subtracting the calibration sample data ESC from the test sample data ES. Then, by substituting the test sample calibration data ΔES into the term Y of the first function to obtain the term X, analysis data CS that is the concentration of the electrolyte contained in the test sample is generated.

  The determination unit 40, based on each monitor data output from the signal processing unit 26, generates first standard sample data EL, calibration sample data ELC, second standard sample data EH generated after the monitor data, It is determined whether each sample data of the calibration sample data EHC, the test sample data ES, and the calibration sample data ESC is normal.

  When it is determined that the first standard sample data EL or the calibration sample data ELC is abnormal, or when it is determined that the second standard sample data EH or the calibration sample data EHC is abnormal, the calibration curve D is abnormal. It is determined that Further, when it is determined that the test sample data ES or the calibration sample data ESC is abnormal, it is determined that the analysis data CS is abnormal.

Next, an example of determination in the determination unit 40 will be described with reference to FIGS. 3 to 12.
FIG. 11 is a diagram showing an example of monitor data generated by the signal processing unit 26 by measuring the test sample. The monitor data is obtained by monitoring the plurality of monitor data S2M generated by collecting the test signal 92a output from the amplifier 64 at the timing of the monitoring step Ta and the calibration signal 93a output subsequent to the test signal 92a. It is composed of a plurality of monitor data C2M generated by collecting at the timing of the process Ta.

  The monitor data S2M is generated after the calibration sample data ESC1 generated by collecting the calibration signal 91a output from the amplifier 64 before the test signal 92a, for example, calibration sample data generated by collecting the test signal 92a. This is data generated before the test sample data ES2 showing a higher value than ESC1. The monitor data S2M is obtained from a plurality of suction monitor data S2M1 generated by collecting at the timing of the suction process Ta1 and a plurality of stabilization monitor data S2M2 generated by collecting at the timing of the stabilization process Ta2. It is calibrated.

  The monitor data C2M is data generated after the test sample data ES2 and generated before the calibration sample data ESC2 generated by collecting the calibration signal 93a. The monitor data C2M is obtained from a plurality of suction monitor data C2M1 generated by collecting at the timing of the suction process Ta1 and a plurality of stabilization monitor data C2M2 generated by collecting at the timing of the stabilization process Ta2. Composed.

The determination unit 40 determines whether or not the test sample data ES2 is normal based on the suction monitor data S2M1 and the stabilization monitor data S2M2.
First, a determination is made based on the suction monitor data S2M1. The upper value is obtained by adding a preset allowable value to the higher value of the calibration sample data ESC1 generated before the monitor data S2M and the test sample data ES2 generated after the monitor data S2M, and the lower one An allowable range W1 having a lower limit value obtained by subtracting the allowable value from the value is provided. When all the suction monitor data S2M1 are within the allowable range W1, it is determined that the test sample data ES2 is normal. Further, when at least one suction monitor data S2M1 is out of the allowable range W1, it is determined that the test sample data ES2 is abnormal.

  Next, the determination is made based on the stabilization monitor data S2M2. The inclination of the stabilization monitor data S2M2 is obtained, and when the obtained inclination is within a preset allowable inclination range, it is determined that the test sample data ES2 is normal. As shown in FIG. 12, when the obtained inclination is greatly inclined and deviated from the allowable inclination range, it is determined that the test sample data ES2 is unstable.

  Here, since all the suction monitor data S2M1 are within the allowable range W1, and the slope of the stabilization monitor data S2M2 is within the allowable slope range near 0, it is determined that the test sample data ES2 is normal. .

The determination unit 40 determines whether or not the calibration sample data ESC2 is normal based on the suction monitor data C2M1 and the stabilization monitor data C2M2.
First, the determination is made based on the suction monitor data C2M1. A value obtained by adding a preset allowable value to the higher value of the test sample data ES2 generated before the monitor data C2M and the calibration sample data ESC2 generated after the monitor data C2M is set as the upper limit value. An allowable range W2 is provided in which a value obtained by subtracting the allowable value from the value is a lower limit value. When all the suction monitor data C2M1 are within the allowable range W2, it is determined that the calibration sample data ESC2 is normal. If at least one suction monitor data C2M1 is out of the allowable range W2, it is determined that the calibration sample data ESC2 is abnormal.

  Next, the determination is made based on the stabilization monitor data C2M2. The inclination of the stabilized monitor data C2M2 is obtained, and when the obtained inclination is within a preset allowable inclination range, it is determined that the calibration sample data ESC2 is normal. On the other hand, if it is out of the allowable inclination range, it is determined that the calibration sample data ESC2 is unstable.

  Here, for example, two suction monitor data C2M11 and C2M12 out of the suction monitor data C2M1 are out of the allowable range W2, and therefore it is determined that the calibration sample data ESC2 is abnormal. Accordingly, analysis data generated based on the calibration sample data ESC2, that is, the test sample calibration data ΔES2 is obtained by subtracting the calibration data ESC2 from the test sample data ES2, and the obtained test sample calibration data ΔES2 is obtained as shown in FIG. It is determined that the analysis data generated by substituting the term Y of the function 1 to obtain the term X is abnormal.

  Then, after the analysis data to which the abnormality information displayed on the display unit 52 is added is designated by an input from the operation unit 53, when an input operation for displaying the graph is performed, the calculation unit 31 is stored in the storage unit 32. The calibration sample data ESC1, monitor data S2M, test sample data ES2, monitor data C2M, and data used for determination of the calibration sample data ESC2 are read out, and a graph arranged in time series is created. Next, the generated graph is displayed and output on the display unit 52.

  In this way, each data used for determination of analysis data can be graphed and displayed on the display unit 52. Thereby, failure diagnosis of the apparatus can be easily performed.

  Next, an example of the cause when it is determined that the calibration sample data ESC2 is abnormal will be described. In the suction step Ta1 in which the inside of the ion sensor unit 60 is replaced with the calibration sample from the mixed sample including the test sample, for example, when the calibration sample in the calibration sample bottle 611 is insufficient and is not supplied to the storage container 612, the ion sensor unit 60 has the inside. The calibration sample is not aspirated and air is aspirated. When the suction operation is performed by the suction pump 62, the resistance between the ISE 651 and the reference electrode 654 becomes abnormally high due to electrical disconnection by the air flowing into the through-hole 65a, and the measurement is performed by the amplifier 64. It becomes impossible. Therefore, the calibration signal 93a indicates a signal represented by a peak indicated by a broken line as shown in FIG. 11 in the suction step Ta1. Thereby, the suction monitor data C2M11 and C2M12 deviating from the allowable range W2 are generated.

  After the suction operation is stopped, when the mixed sample remaining on the wall surface forming the through-hole 65a is electrically connected so that the resistance between the ISE 651 and the reference electrode 654 decreases to an extent that can be measured by the amplifier 64. Due to the mixed sample remaining on the surface of the sensitive film of ISE 651, the calibration signal 93a in the stabilization process Ta2 shows substantially the same level as the test signal 92a in the stabilization process Ta2. Thereby, the calibration sample data ESC2 shows substantially the same value as the test sample data ES2. Therefore, the analytical data shows the same value as the electrolyte concentration contained in the calibration sample regardless of the concentration higher than the electrolyte concentration contained in the calibration sample.

  If the suction nozzle 66 is bent and cannot enter the mixed sample accommodated in the reaction container 3 or the calibration sample accommodated in the storage container 612, air is sucked into the ion sensor unit 60 due to the above-described cause. Therefore, it is determined that the test sample data and the calibration sample data are abnormal.

  In addition, after the suction operation is stopped, if the space between the ISE 651 and the reference electrode 654 is electrically disconnected by air so as not to be measured by the amplifier 64, the state incapable of being measured by the amplifier 64 continues. The sample data ESC2 shows an abnormal value. Thereby, it can be easily determined that the analysis data generated using the calibration sample data ESC2 is abnormal.

  When the composite electrode 65 is not maintained at the set predetermined temperature, or when the mixed sample in the reaction container 3 is not maintained at the set predetermined temperature, the calibration sample in the storage container 612 is set. When the predetermined temperature is not maintained, or when the response speed is lowered due to deterioration of the sensitive film of ISE651, the slopes of the respective stabilization monitor data S2M2 and C2M2 are out of the allowable slope range, and the test sample data It can be determined that ES2 and calibration sample data ESC2 are unstable.

  Thus, based on the monitor data S2M, it is possible to determine whether or not the test sample data ES2 generated following this data is normal. Further, based on the monitor data C2M, it can be determined whether or not the calibration sample data ESC2 generated following this data is normal. When it is determined that the suction monitor data S2M1 or the suction monitor data C2M1 is abnormal, it can be determined that the analysis data generated based on the test sample data ES2 and the calibration sample data ESC2 is abnormal. When it is determined that the stabilization monitor data S2M2 or the stabilization monitor data C2M2 is unstable, it is determined that the analysis data generated based on the test sample data ES2 and the calibration sample data ESC2 is unstable data. can do.

  Note that the determination results of the suction monitor data S2M1 and the suction monitor data C2M1 have priority over the determination results of the stabilization monitor data S2M2 and the stabilization monitor data C2M2. Therefore, even if it is determined that the stabilization monitor data S2M2 or the stabilization monitor data C2M2 is unstable, if it is determined that the suction monitor data S2M1 or the suction monitor data C2M1 is abnormal, it is determined that the analysis data is abnormal. .

  According to the embodiment described above, the first and second standard sample suction steps TL and TH, the test sample suction step TS, and the measurement step Tb in each sample suction step of the calibration sample suction step TC include the first By collecting each signal of the standard signal, the second standard signal, the test signal, and the calibration signal at each measurement time, the first standard sample data, the second standard sample data, the test sample data, and the calibration Each sample data of the sample data can be generated with high accuracy. In addition, a monitor process Ta is provided before the measurement process Tb, and in the monitor process Ta, monitor signals can be generated without increasing by collecting each signal every monitor time. Thereby, the load concerning the signal processing in the signal processing unit 26 and the time required for the signal processing can be suppressed. In addition, by measuring a large number of test samples, the amount of monitor data that can be stored in the storage unit 32 can be suppressed.

  Then, based on the monitor data S2M, it can be determined whether or not the test sample data ES2 generated following this data is normal. Further, based on the monitor data C2M, it can be determined whether or not the calibration sample data ESC2 generated following this data is normal. When it is determined that the suction monitor data S2M1 or the suction monitor data C2M1 is abnormal, it can be determined that the analysis data generated based on the test sample data ES2 and the calibration sample data ESC2 is abnormal. If it is determined that the stabilization monitor data S2M2 or the stabilization monitor data C2M2 is abnormal, it is determined that the analysis data generated based on the test sample data ES2 and the calibration sample data ESC2 is unstable data. be able to. Thereby, the abnormality information can be output to the output unit 50.

  As described above, it is possible to detect an abnormality in the analysis data with a simple configuration, and prevent misdiagnosis due to the abnormality in the analysis data.

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

3 Reaction vessel 22 Electrolyte measurement unit 25 Analysis control unit 26 Signal processing unit 30 Data processing unit 31 Calculation unit 32 Storage unit 40 Determination unit 60 Ion sensor unit 61 Calibration unit 62 Suction pump 63 Tube 64 Amplifier 65 Composite electrode 66 Suction nozzle 67 Exhaust Liquid tank 611 Calibration sample bottle 612 Storage container 613 Calibration sample pump 614 Drain pump

Claims (4)

A suction means for sucking the sample contained in the container;
Detection means for detecting a component contained in the sample sucked by the suction means;
The signal detected by the detecting means is collected at every monitoring time at the timing of the monitoring process to generate a plurality of monitoring data, and collected at every measuring time at the timing of the measurement process connected after the monitoring process, and sample data Signal processing means for generating
Calculation means for generating analysis data based on the sample data and a normal calibration curve created in advance,
Determination means for determining whether or not the analysis data is normal based on the monitor data ,
The measuring step is shorter than the monitoring step,
The measurement time is shorter than the monitoring time,
The monitoring step is divided into an aspiration step including a time during which the sample is aspirated by the aspiration means and a stabilization step continued after the aspiration step,
The signal processing means collects the signals detected by the detection means at the timing of the suction step to generate suction monitor data,
The determination means includes: first sample data generated at the timing of the measurement process that continues before the suction process; and second sample data that is generated at the timing of the measurement process that continues after the stabilization process. An upper limit is set to a value obtained by adding a preset allowable value to a higher value, and a lower limit is set to a value obtained by subtracting the allowable value from a lower value, and the suction monitor data is set to the allowable range. The second sample data is determined to be normal when the value is within the range, and the second sample data is determined to be abnormal when the suction monitor data is outside the allowable range. Automatic analyzer characterized by The signal processing means collects the signals detected by the detection means at the timing of the stabilization process to generate stabilization monitor data,
The determination means obtains an inclination of the stabilization monitor data, and determines that the second sample data is normal when the inclination is within a preset allowable inclination range, and the inclination is the allowable inclination. 2. The automatic analyzer according to claim 1 , wherein when the second sample data is out of the range, it is determined that the second sample data is unstable. 3. The container comprises a reaction container containing a mixed sample containing a test sample collected from a subject and a storage container containing a calibration sample for calibrating the mixed sample,
The first sample data is data generated by aspiration of one of the mixed sample or the calibration sample,
It said second sample data, the claim 1 or characterized in that it is a data generated by the suction of the other sample automatic analyzer according to claim 2. The detecting device, the automatic analyzer according to any one of claims 1 to 3, characterized in that an ion-selective electrode and reference electrode.

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