JP2008076342A - Automatic analyzer - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To enable an abnormality of analysis data to be detected by using a simple structure. <P>SOLUTION: An automatic analyzer is provided with an electrolyte measuring unit 19 which measures a mixed liquid of a test sample being diluted by m times with a first reagent of an electrolyte item and a calibration sample 72b for calibrating the mixed liquid and creates testing data and calibration data, an arithmetic section 31 which calculates calibration testing data from the testing data by using the calibration data created by the electrolyte measuring unit 19 and creates analysis data from the calculated calibration testing data, and an output section 40 for outputting the analysis data created by a data processing section 30. The electrolyte concentration of the calibration sample 72b is set to be a dilution internal standard value determined by dividing a standard outlying value which is included in a standard outside range of the electrolyte item, by above number m. When the analysis data created by the arithmetic section 31 are within an abnormal range including the standard outlying value, the analysis data are judged to be abnormal. <P>COPYRIGHT: (C)2008,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 automatically analyzing components contained in a test sample such as blood and urine collected from a human.

  The automatic analyzer is intended for biochemical test items and immunological test items of the components contained in the test sample, and most items are the test sample dispensed into the reaction container and the reagent corresponding to each item to be analyzed. The concentration of various substances to be measured and the activity of the enzyme in the test sample are measured by measuring the amount of light transmission of the change in color tone and the like caused by the reaction of the mixed solution.

  On the other hand, electrolyte items such as sodium ion, potassium ion, and chlorine ion among biochemical test items are measured by measuring the electromotive force of an ion selective electrode that selectively responds to the activity of each electrolyte. Measure the electrolyte concentration in the sample.

  When measuring using an electrolyte measurement unit having this ion-selective electrode, the electromotive force of the ion-selective electrode varies in a short time, so that the test sample is measured every time a test sample is measured or each time a plurality of test samples are measured. As an internal standard for calibrating, a calibration sample having an electrolyte concentration set to a value corresponding to the reference range is measured. Note that the reference range is 95% including the median of measured values obtained by measuring statistically reliable numbers of healthy reference solids having the same sex, age, lifestyle, and test sample collection conditions. It is the range included and is calculated for each item.

  In the case of the direct method in which the test sample is not diluted, the electrolyte concentration contained in the calibration sample is set to a value within the reference range. In the case of the dilution method in which the test sample is diluted and measured, the calibration sample The electrolyte concentration is set to a value obtained by dividing the value within the reference range by the dilution factor for diluting the test sample.

  In the measurement using the electrolyte measurement unit, when the calibration sample supplied to the sample container is smaller than the measurable amount, or the suction pump that sucks the calibration sample or test sample into the ion selective electrode performs the suction operation. Even when the test sample or the calibration sample cannot be sucked, the previously sucked liquid may remain and the remaining liquid may be measured.

  In these cases, even if the electrolyte concentration of the test sample is outside the reference range, there is almost no difference in the electromotive force of the test sample relative to the electromotive force of the internal standard calibration sample. Analytical data is generated. For this reason, analysis data within the reference range to which no error information is added, such as an apparatus abnormality or out of the reference range, is determined to be normal and is not measured again. Therefore, there is a problem that the abnormality of the analysis data cannot be noticed.

  For example, a calibration sample set to 14.0 mmol / L obtained by dividing a mixed solution of a test sample diluted 10 times with a reagent by 140 mmol / L, which is within the reference range of sodium ions, by a dilution factor of 10 is used. Even when the sodium ion concentration in the test sample is 155 mmol / L outside the reference range, the difference in electromotive force between the diluted test sample and the calibration sample is 0. Sodium ion analysis data is generated as a value near 140 mmol / L.

In order to prevent this problem, the sample container is provided with a pair of liquid level detection electrodes that come into contact with the calibration sample when a calibration sample exceeding the measurable amount is supplied, and a detection circuit connected to the electrode. There is known a method for detecting whether or not a calibration sample more than a measurable amount has been supplied to the container and whether or not the calibration sample has been sucked into the ion selective electrode from the sample container (for example, Patent Documents). 1).
JP 2004-251799 A

  However, in order to detect the calibration sample supplied to the sample container, it is necessary to provide an electrode and a detection circuit, 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 liquid mixture cannot be sucked into the ion selective electrode.

  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 detect an abnormality in analysis data with a simple configuration.

  In order to achieve the above object, an automatic analyzer of the present invention according to claim 1 is an automatic analyzer for measuring a mixed solution of a test sample and a reagent corresponding to a measurement item of the test sample. Measuring means for generating test data by measuring the mixed solution diluted at a predetermined magnification, and measuring the calibration sample for calibrating the test data to generate calibration data; and the measuring means Analytical data for calculating calibration test data from the test data using the calibration data generated by the above, and generating analysis data using a calibration curve of the measurement items created in advance from the calculated calibration test data A concentration obtained by dividing the concentration of the component of at least one of the measurement items included in the calibration sample by the predetermined magnification, the value outside the reference range included outside the reference range of the item. Characterized in that so as to set the parts standard value.

  According to a fourth aspect of the present invention, there is provided an automatic analyzer for measuring a measurement item of a test sample, generating the test data by measuring the test sample, and further generating the test data. Measuring means for measuring a calibration sample for calibration and generating calibration data, and using the calibration data generated by the measuring means to calculate calibration test data from the test data, and calculating the calibration test Analysis data generation means for generating analysis data using a calibration curve prepared in advance from the data, and the concentration of the component of at least one of the measurement items included in the calibration sample is determined as a reference for this item It is characterized in that it is set to a value outside the reference range included outside the range.

  According to the present invention, the measurement item of the test sample and the concentration of the component of at least one of the measurement items included in the calibration sample for calibrating the test sample are outside the reference range of this item. An analysis data abnormality can be detected with a simple configuration in which a value corresponding to a certain value outside the reference range is set, and misdiagnosis due to the analysis data abnormality can be prevented.

  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 performs measurement of items selected for various items of standard samples and test samples, an analysis control unit 20 that controls measurement operations of the analysis unit 18, and each item. Data for creating a calibration curve for each item and generating analysis data by processing the standard data of the standard sample output from the analysis unit 18 and the test data of the test sample by measuring the standard sample and test sample A processing unit 30; an output unit 40 that outputs a calibration curve and analysis data from the data processing unit 30; an input of analysis conditions such as a standard sample and a calibration curve for each item; and an operation unit 50 that inputs various command signals. A system control unit 60 that controls the analysis control unit 20, the data processing unit 30, and the output unit 40 in an integrated manner.

  FIG. 2 is a perspective view of the analysis unit 18. The analysis unit 18 includes a reagent bottle 7 containing a first reagent that selectively reacts with components of each item included in the standard sample and the test sample, and a second reagent paired with the first reagent, A reagent rack 1 for storing bottles 7, a reagent cabinet 2 for storing reagent racks 1 for storing reagent bottles 7 containing first reagents, and a reagent rack 1 for storing reagent bottles 7 containing second reagents are stored. A reagent storage 3, a reaction disk 5 having a plurality of reaction vessels 4 arranged on the circumference, a sample cup 17 for storing samples such as standard samples and test samples for each item, and a sample cup 17 for storing samples The disc sampler 6 is set.

  In each cycle, the reagent store 2, the reagent store 3, and the disc sampler 6 rotate, and the reaction disc 5 rotates and stops at a position controlled by the analysis control unit 20.

  The analysis unit 18 sucks the first and second reagents from the reagent bottles 7 of the reagent storages 2 and 3 for each cycle, and then discharges the first and second reagent dispensing probes 14, 15 and a dispensing probe 16 that sucks a sample from the sample cup 17 of the disk sampler 6 and then discharges the sample to the reaction container 4.

  A first reagent dispensing arm 8, a second reagent dispensing arm 9, and a dispensing reagent that hold the first reagent dispensing probe 14, the second reagent dispensing probe 15, and the dispensing probe 16 so as to be rotatable and vertically movable. A note arm 10 is provided.

  Further, for each cycle, the mixture of the sample and the first reagent in the reaction container 4, the stirring unit 11 for stirring the mixture of the sample, the first reagent and the second reagent, the sample and the first reagent, And the mixture of the sample and the first reagent, the sample, the first reagent, and the second reagent, and the electrolyte measurement unit 19 for measuring the electrolyte items of sodium ion, potassium ion, and chlorine. A photometric unit 13 for photometry of the reaction vessel 4 containing a mixed solution with a reagent, and a washing unit 12 for sucking the mixed solution after the measurement in the reaction vessel 4 and washing and drying the inside of the reaction vessel 4 are provided. Yes.

  After the electrolyte measurement unit 19 sucks the standard solution of the electrolyte item from the reaction container 4 and the mixed solution of the test sample in which the electrolyte item is selected, and measures the mixed solution to generate the standard data and the test data, The data is output to the data processing unit 30.

  The photometry unit 13 irradiates light to the reaction container 4 that rotates and generates standard data or test data obtained by converting light transmitted through a mixed solution containing a standard sample or test sample into absorbance, and then performs data processing. To the unit 30.

  Thereafter, the measurement of the mixed solution is finished, and the reaction vessel 4 washed and dried by the washing unit 12 is used again for the measurement.

  The analysis control unit 20 rotates the reagent storage 2, the reagent storage 3, and the disk sampler 6, rotates the reaction disk 5, the dispensing arm 10, the first reagent dispensing arm 8, the second reagent dispensing arm 9, And a mechanism for rotating and moving the stirring unit 11 up and down, moving the cleaning unit 12 up and down, driving the stirring unit 11 and the like, and a control unit for each mechanism.

  In addition, a dispensing pump that sucks and discharges a sample from the sample dispensing probe 16, each reagent pump that sucks and discharges the first and second reagents from the first and second reagent dispensing probes 14 and 15, and the washing unit 12. Various pumps such as a cleaning pump for supplying and sucking a cleaning liquid for cleaning the inside of the reaction vessel 4 and a drying pump for drying the inside of the reaction vessel 4 and various pump control units are provided.

  Furthermore, the control part which controls each unit of the electrolyte measurement unit 19 is provided.

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

  The calculation unit 31 creates a calibration curve from the standard data of each item output from the electrolyte measurement unit 19 or the photometry unit 13 of the analysis unit 18, stores it in the storage unit 32, and outputs it to the output unit 40. Further, based on the test data of each item output from the electrolyte measurement unit 19 or the photometry unit 13, the calibration curve of the item is read from the storage unit 32. Then, using the read calibration curve, analysis data such as an activity value and a concentration value is generated from the test data of the item, and the generated analysis data is stored in the storage unit 32 and output to the output unit 40.

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

  The output unit 40 includes a printing unit 41 that prints and outputs a calibration curve, analysis data, and the like output from the data processing unit 30 and a display unit 42 that displays and outputs it. The printing unit 41 includes a printer and prints out the calibration curve, analysis data, and the like output from the data processing unit 30 on a printer sheet based on a preset format. The display unit 42 includes a monitor such as a CRT or a liquid crystal panel, and displays a screen for setting analysis conditions such as a standard sample and a calibration curve for each item, and a calibration curve and analysis data output from the data processing unit 30. Etc. are displayed.

The operation unit 50 includes input devices such as a keyboard, a mouse, a button, and a touch key panel, sets analysis conditions such as standard samples and calibration curves for each item, and subjects such as subject IDs and subject names. Various operations such as input of information, selection of items to be measured for each test sample of the subject, standard sample measurement operation of each item, test sample measurement operation, and the like are performed.
The system control unit 60 includes a CPU and a storage circuit (not shown). An operator command signal supplied from the operation unit 50, analysis conditions such as a standard sample and a calibration curve for each item, subject information, and each test sample. After storing information such as measurement items, based on such information, control that causes each unit constituting the analysis unit 18 to perform measurement operation in a predetermined sequence of a predetermined cycle, or creation of a calibration curve, generation and output of analysis data The system as a whole is controlled.

  Next, details of the configuration of the electrolyte measurement unit 19 will be described with reference to FIGS. 1 to 4. FIG. 3 is a diagram showing the configuration of the electrolyte measurement unit 19. Hereinafter, an example of measurement of each electrolyte item of sodium ion, potassium ion, and chlorine ion will be described.

  The electrolyte measurement unit 19 includes samples such as first and second standard samples L and H and test samples for preparing a calibration curve for each electrolyte item, and a first reagent for diluting the sample m times. A calibration sample bottle 72a for storing a calibration sample 72b for calibrating the mixed solution and an ion sensor unit 81 that selectively responds to an electromotive force to each electrolyte contained in the mixed solution or the calibration sample 72b.

  In addition, the calibration unit 70 for storing the calibration sample 72b in the calibration sample bottle 72a, the mixed solution in the reaction container 4 of the analysis unit 18 and the calibration sample 72b stored in the calibration unit 70 are sucked into the ion sensor unit 81. In addition, a suction pump 82 for discharging to the drainage tank 82a and a signal processing unit 83 for measuring the electromotive force of the ion sensor unit 81 are provided.

  The ion sensor unit 81 includes three ion-selective electrodes (sodium ion-selective electrode, potassium ion-selective electrode, and chloride ion-selective electrode) that selectively respond to potential to each electrolyte, and a reference that holds a constant potential. A flow-type composite electrode 81a composed of electrodes, and a suction nozzle 81b connected to the inlet side of the flow-through port of the flow-type composite electrode 81a for sucking the mixed solution and the calibration sample 72b into the flow-type composite electrode 81a And. And it moves between the reaction container 4 and the calibration part 70 by the ion sensor unit moving mechanism which is not shown in figure.

  Each ion selective electrode of the flow-through composite electrode 81a selectively responds as an electromotive force to each electrolyte in the mixed solution or the calibration sample 72b with the reference electrode.

  The electromotive force with respect to sodium ions as cations is directly proportional to the logarithm ln (CNa) of the sodium ion concentration CNa under the condition that the temperature and activity coefficient are constant, and the slope SNa and the intercept which are constants of a linear function from the Nernst equation. Using E0Na, the electromotive force ENa = E0Na + SNa × ln (CNa). Similarly, an electromotive force for potassium ions as cations is expressed by an electromotive force EK = E0K + SK × ln (CK) using a potassium ion concentration CK, a slope SK, and an intercept E0K.

  The electromotive force for chloride ions as anions is inversely proportional to the logarithm ln (CCL) of the chloride ion concentration CCL under the condition that the temperature and activity coefficient are constant, and the slope SCL and intercept which are constants of a linear function from the Nernst equation. Using E0CL, the electromotive force ECL = E0CL−SCL × ln (CCL).

  Since the slope of each electromotive force differs for each ion selective electrode, it can be obtained by measuring the first and second standard samples L and H. Further, since the slices are different for each ion-selective electrode and are likely to vary, the section is calibrated by measuring the calibration sample 72b for each sample measurement or for each of a plurality of sample measurements.

  The calibration unit 70 sucks the sample container 71 that stores the calibration sample 72b, the calibration sample pump 72 that supplies the calibration sample 72b into the sample container 71, and the unnecessary calibration sample 72b from the sample container 71. A drainage pump 74 for discharging to the outside of the sample container 71 is provided. The calibration sample pump 72 and the drainage pump 74 are controlled by the analysis control unit 20.

  The component concentration of at least one of the electrolyte items to be measured included in the calibration sample 72b is a diluted internal standard value obtained by dividing a value outside the reference range included outside the reference range of the item by m times m. Is set. Here, the sodium ion concentration of the sodium item is set to the sodium diluted internal standard value (CSNa / m) obtained by dividing the sodium reference out-of-range value CSNa included outside the reference range of this item by m times m. . The potassium ion concentration is set to a potassium diluted internal standard value (CSK / m) obtained by dividing the potassium reference range value CSK, which is within the reference range of this item, by m. Furthermore, the chlorine ion concentration is set to a chlorine diluted internal standard value (CSCL / m) obtained by dividing the chlorine reference range value CSCL, which is within the reference range of this item, by m times m.

  The calibration sample 72 b stored in the sample container 71 is sucked from the suction nozzle 81 b of the ion sensor unit 81 moved to the sample container 71.

  The calibration sample pump 72 sucks the calibration sample 72b from the calibration sample bottle 72a and supplies the calibration sample 72b having a supply amount V1 or more larger than the suction amount of the suction pump 82 into the sample container 71.

  The drainage pump 74 discharges the unnecessary calibration sample 72b remaining in the sample container 71 after the suction operation of the suction pump 82 from the sample container 71 with a suction amount of a discharge amount V2 larger than the supply amount V1.

  The suction pump 82 is controlled by the analysis control unit 20 to suck the mixed liquid in the reaction container 4 and the calibration sample 72b in the sample container 71 into the ion sensor unit 81 and to mix the calibration sample 72b in the ion sensor unit 81 and the mixture. The liquid is discharged to the drain tank 82a.

  The signal processing unit 83 generates the electromotive force of each electrolyte contained in the mixed solution of the first and second standard samples L and H sucked into the ion sensor unit 81, the mixed solution of the test sample, and the calibration sample 72b. After measuring and amplifying the measured electromotive force signal, the signal is converted into a digital signal to generate first and second standard data, test data, and calibration data. Then, each generated data is output to the calculation unit 31 of the data processing unit 30.

  FIG. 4 is a diagram showing an example of a calibration curve for the sodium item of the electrolyte item. The calibration curve DNa of, for example, the sodium item represented on the X and Y axes is based on the first and second standard data generated by the measurement of the mixed solution of the first and second standard samples L and H. It is formed by a function calculated by the calculation unit 31 of the data processing unit 30.

  If the lower limit of the reference range of the sodium item is the lower limit value CNL and the upper limit is the upper limit value CNH, the concentration of sodium ions contained in the first standard sample L is set to the first standard value CL lower than the lower limit value CNL. The concentration of sodium ions contained in the second standard sample H is set to a second standard value CH that is higher than the upper limit value CNH, and is stored in the storage circuit of the system control unit 60.

  Further, the sodium reference out-of-range value CSNa of the sodium item is set, for example, between the upper limit value CNH and the second standard value CH outside the reference range. The reference range is the median of analysis data obtained by measuring statistically reliable numbers of test samples of healthy subjects with the same sex, age, lifestyle, and test sample collection conditions. Is a range that includes 95%.

Next, creation of a calibration curve DNa will be described.
The electrolyte measurement unit 19 of the analysis unit 18 generates the first standard data ENaL by measuring the mixed solution of the first standard sample L diluted m times with the first reagent of the electrolyte item, and also generates the first standard data ENaL. Calibration data ENaSL is generated by measuring the calibration sample 72b for calibrating the data ENaL. Further, the second standard data ENaH is generated by measuring the mixed solution of the second standard sample H diluted m-fold with the first reagent of the electrolyte item, and the calibration for calibrating the second standard data ENaH Calibration data ENaSH is generated by measuring the sample 72b.

  The calculation unit 31 of the data processing unit 30 calculates the first calibration standard data ΔENaLS by subtracting the calibration data ENaSL from the first standard data ENaL from the electrolyte measurement unit 19. Further, the second calibration standard data ΔENaHS is calculated by subtracting the calibration data ENaSH from the second standard data ENaH from the electrolyte measurement unit 19.

  Then, on the X and Y axes representing the X axis in logarithm, the first standard value CL and the PL coordinates (CL, ΔENaLS) of the first calibration standard data ΔENaLS, the second standard value CH, and the second standard value A calibration curve formed by a function Y = ΔENaLS + SNa × (lnX−lnCL) {SNa = (ΔENaHS−ΔENaLS) / ln (CH / CL)} that passes through the PH coordinates (CH, ΔENaHS) of the calibration standard data ΔENaHS. Expressed as DNa.

Next, generation of analysis data will be described.
In order to generate the analysis data of the sodium item of the test sample Ai, first, the test sample Ai was measured by measuring the mixed solution of the test sample Ai diluted m times with the first reagent and the calibration sample 72b of the test sample Ai. Data ENai and this calibration data ENaiS are generated. Next, the calibration test data ΔENaiS is calculated by subtracting the calibration data ENaiS from the test data ENai. The calculated calibration test data ΔENaiS is substituted for Y of the function Y = ΔENaLS + SNa × (lnX−lnCL) to obtain the value of X, whereby the analysis data CNai [= CL × exp of the sodium item of the test sample Ai is obtained. {(ΔENaiS−ΔENaLS) / SNa}] is generated.

  By the way, when an operation failure occurs due to a failure of a unit such as the calibration sample pump 72 or the suction pump 82, failure information is output to the output unit 40 by detection of a position sensor or the like provided in the unit. Can be prevented in advance.

  However, in the tube connecting the calibration sample bottle 72 a and the calibration sample pump 72, between the calibration sample pump 72 and the sample container 71, and between the ion sensor unit 81 and the suction pump 82, for example, waste such as scale is used. May adhere or deposit. In addition, when the test sample is serum containing fibrin, fibrin may adhere to the tip or inside of the suction nozzle 81b. Due to the adhesion and accumulation of this unwanted material, there arises a problem that the calibration sample 72b cannot be supplied into the sample container 71 and a problem that the calibration sample 72b and the mixed liquid cannot be sucked into the ion sensor unit 81.

  When this problem occurs, if the calibration sample 72b supplied in the sample container 71 is smaller than the measurable amount, the previously sucked liquid mixture remains even if the calibration sample 72b is sucked into the ion sensor unit 81. The mixed solution is measured instead of the calibration sample 72b. Further, if one of the liquid mixture of the calibration sample 72b or the test sample Ai cannot be sucked into the ion sensor unit 81, the other liquid sucked before remains in the ion sensor unit 81, and instead of one liquid. The other liquid will be measured.

  Thus, if the other liquid is measured instead of one liquid, the same liquid is continuously measured, and each calibration test data ΔEiS (ΔENaiS for the sodium item, potassium item, and chlorine item). , ΔEKiS, ΔECLiS) becomes 0 or a value close to 0. Accordingly, each calibration test data ΔEiS is generated as data that is the same as or near the calibration data EiS (ENaiS, EKiS, ECLiS).

  For this reason, the analysis data CNai of the sodium item is a sodium reference out-of-range value CSNa or a value near this value. The analysis data CKi of the potassium item is a potassium reference range value CSK or a value near this value. Furthermore, the analysis data CCLi of the chlorine item becomes a chlorine reference range value CSCL or a value near this value.

  When the analysis data CNai of the sodium item of the test sample Ai is within a predetermined abnormal range including the preset sodium reference range out-value CSNa, the number of analysis data deviating from the reference range is small, Since the number of analysis data that falls within the abnormal range is small, it is determined that all the analysis data Ci for the sodium, potassium, and chlorine items of the test sample Ai are abnormal, and abnormal information is added to each analysis data. The data is stored in the storage unit 32 and output to the output unit 40.

  As described above, when the analysis data CNai of the sodium item is within a predetermined abnormal range set in advance, it is determined that the analysis data CKi of the potassium item and the analysis data CCLi of the chlorine item generated together with the analysis data CNai are abnormal. The abnormality information can be output to the output unit 40.

  In addition, by setting the component concentration of more items among the measurement target items included in the calibration sample to the diluted internal standard value corresponding to the value outside the reference range, the diluted internal standard value corresponding to the value outside the reference range When the analysis data of the item set in the item is within the preset abnormal range at the same time, it can be determined more accurately that the analysis data of the item to be measured is abnormal.

  Hereinafter, the operation of the automatic analyzer 100 according to the embodiment will be described with reference to FIGS. 1 to 5. FIG. 5 is a flowchart showing an example of the operation of the automatic analyzer 100. In the automatic analyzer 100, the calibration curves DNa, DK, DCl of the respective electrolyte items created by the measurement of the first and second standard samples L, H by the standard sample measurement operation of the electrolyte items in advance are stored in the data processing unit 30. Are stored in the storage unit 32.

  The subject information such as the subject ID and subject name of the subject of the test sample A1 is input from the operation unit 50, and, for example, an electrolyte item is selectively input to the test sample A1. Then, after the sample cup 17 containing the test sample A1 is set on the disc sampler 6, when the test sample measurement operation is performed from the operation unit 50, the automatic analyzer 100 starts operation (step S1).

  The system control unit 60 instructs the analysis control unit 20, the data processing unit 30, and the output unit 40 to perform an operation for measuring the electrolyte item of the test sample A1. Based on the instruction, the analysis control unit 20 controls each unit of the analysis unit 18 to measure each electrolyte item of the test sample A1.

  The sample dispensing probe 16 of the analysis unit 18 sucks the test sample A1 from the sample cup 17 of the disk sampler 6 and discharges it 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 discharges the first reagent to the reaction container 4 containing the test sample A1. The stirring unit 11 stirs the mixed solution of the test sample A1 diluted m times with the first reagent in the reaction vessel 4.

  The suction pump 82 of the electrolyte measurement unit 19 sucks the mixed liquid of the test sample A1 from the reaction container 4 into the ion sensor unit 81 (step S2).

  The signal processing unit 83 measures the electromotive force according to each electrolyte item of the ion sensor unit 81 and then generates each test data ENa1, EK1, ECL1 of each electrolyte item of the test sample A1 to generate the data processing unit 30. To the operation unit 31 (step S3).

  The calibration sample pump 72 of the calibration unit 70 sucks the calibration sample 72b from the calibration sample bottle 72a and supplies it to the sample container 71 (step S4).

  The ion sensor unit 81 moves horizontally in the direction of the arrow L1 shown in FIG. 3 by the ion sensor unit moving mechanism, and then descends into the sample container 71. The suction pump 82 sucks the calibration sample 72b from the sample container 71 into the ion sensor unit 81 (step S5).

  The signal processing unit 83 measures the electromotive force corresponding to each electrolyte item of the ion sensor unit 81, then generates each calibration data ENa1S, EK1S, ECL1S of each electrolyte item of the calibration sample 72b and outputs it to the calculation unit 31. (Step S6).

  The calculation unit 31 subtracts the calibration data ENa1S, EK1S, ECL1S from the test data ENa1, EK1, ECL1 output from the signal processing unit 83 to calculate the calibration test data ΔENa1S, ΔEK1S, ΔECL1S. Next, each calibration curve DNa, DK, DCl of the electrolyte item is read from the storage unit 32, and each analysis data CNa1, CK1 is read from each calibration test data ΔENa1S, ΔEK1S, ΔECL1S using the read calibration curves DNa, DK, DCL. , CCL1 is generated (step S7).

  When the generated analysis data CNa1 is within the abnormal range (Yes in step S8), it is determined that each analysis data CNa1, CK1, CCL1 is abnormal. For example, “the calibration sample is supplied to the sample container at the supply amount V1 or more. Abnormal information such as “It is not supplied or liquid cannot be sucked into the ion sensor unit” is created and added to each analysis data CNa1, CK1, CCL1 (step S9).

  If the generated analysis data CNa1 is out of the abnormal range (No in step S8), it is determined that each analysis data CNa1, CK1, CCL1 is normal, and the process proceeds to step S10.

  After “No” in step S8 or after step S9, the operation unit 31 determines that the analysis data CNa1, CK1, CCL1 of the test sample A1 to which abnormality information has been added, or the test sample determined to be normal due to no in step S8. The analysis data CNa1, CK1, and CCL1 of A1 are stored in the storage unit 32 and output to the output unit 40 (step S10).

  When the analysis data CNa1, CK1, CCL1 of the test sample A1 to which the abnormality information is added or the analysis data CNa1, CK1, CCL1 of the normal test sample A1 are output to the output unit 40, the system The control unit 60 instructs the analysis control unit 20, the data processing unit 30, and the output unit 40 to stop the operation, whereby the automatic analyzer 100 ends the operation (step S11).

  When the abnormality information is output together with each analysis data CNa1, CK1, CCL1 of the test sample A1 to the output unit 40, the operator checks the electrolyte measurement unit 19 and then remeasures the test sample A1.

  According to the embodiment of the present invention described above, the component concentration of at least one item among the items to be measured included in the calibration sample for calibrating the sample diluted to a predetermined magnification is determined. By setting the diluted internal standard value obtained by dividing the out-of-reference value included outside the reference range by the predetermined magnification, a preset abnormal range in which the analysis data of the one item includes the out-of-reference value If it is, the analysis data of the item to be measured can be determined to be abnormal.

  In addition, abnormality information can be added to the analysis data determined to be abnormal and stored in the storage unit 32, and the abnormality information can be output to the output unit 40.

  Accordingly, it is possible to check the apparatus other than the failure of each analysis unit, and it is possible to reduce the re-measurement work time, labor, and waste of the test sample due to delay in finding abnormal analysis data. In addition, misdiagnosis due to abnormal analysis data can be prevented.

  The present invention is not limited to the above embodiment. For example, the sample container 71 is arranged at a position where the sample can be discharged by the sample dispensing probe 16, and the sample discharged from the sample dispensing probe 16 is the first one. The component concentration of at least one of the measurement target items included in the calibration sample for calibrating the sample is measured by sucking into the ion sensor unit 81 without being diluted with one reagent. By setting a value outside the reference range included outside the reference range of one item, when the analysis data of the one item is within a preset abnormal range including a value outside the reference range, the item of the measurement target It can be determined that the analysis data is abnormal.

The figure which shows the structure of the automatic analyzer by the Example of this invention. The figure which shows the structure of the analysis part which concerns on the Example of this invention. The figure which shows the detail of a structure of the electrolyte measurement unit which concerns on the Example of this invention. The figure which shows the detail of calibration of the detection part 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 Measurement Unit 20 Analysis Control Unit 30 Data Processing Unit 31 Calculation Unit 32 Storage 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 Flow-through composite electrode 81b Suction nozzle 82 Suction pump 82a Drain tank

Claims (4)

In an automatic analyzer that measures a mixed solution of a test sample and a reagent corresponding to the measurement item of the test sample,
Measuring means for measuring the mixed solution diluted with the reagent at a predetermined magnification to generate test data, and further measuring a calibration sample for calibrating the test data to generate calibration data;
Calculate calibration test data from the test data using the calibration data generated by the measuring means, and generate analysis data using a calibration curve of the measurement items created in advance from the calculated calibration test data Analyzing data generating means for
The concentration of the component of at least one of the measurement items included in the calibration sample is set to a diluted internal standard value obtained by dividing a value outside the reference range included outside the reference range of this item by the predetermined magnification. An automatic analyzer characterized by doing so. Output means for outputting the analysis data generated by the analysis data generation means;
When the analysis data of the item is within a predetermined abnormality range including the value outside the reference range, it is determined that the analysis data of the measurement item is abnormal, and the abnormality information is output to the output unit. The automatic analyzer according to claim 1.   2. The automatic analyzer according to claim 1, wherein the measuring means measures the concentration of the electrolyte contained in the mixed solution and the calibration solution using an ion selective electrode. In an automatic analyzer that measures the measurement items of a test sample,
Measuring means for measuring the test sample to generate test data, and further measuring a calibration sample for calibrating the test data to generate calibration data;
Analysis data generation for calculating calibration test data from the test data using the calibration data generated by the measuring means, and generating analysis data using a calibration curve prepared in advance from the calculated calibration test data Means and
An automatic analyzer characterized in that the concentration of a component of at least one item among the measurement items included in the calibration sample is set to a value outside the reference range included outside the reference range of this item.

Images