JP4843360B2 - Automatic analyzer and calibration curve creation method thereof - Google Patents

Description

  The present invention relates to an automatic analyzer that analyzes components of a test sample and a calibration curve creation method thereof, and more particularly, to an automatic analyzer that analyzes components contained in body fluids such as human blood and urine, and to create a calibration curve thereof. Regarding the method.

  The automatic analyzer can measure various changes in the color of the test sample by measuring the amount of transmitted light and determining the absorbance by the reaction of the mixture of the test sample collected from the sample and the reagent. Devices that quantitatively analyze the concentrations and activity values of various components are known.

  In this automatic analyzer, in order to analyze each item of the components in the test sample, the amount of samples and reagents such as standard samples and test samples used for the measurement in advance for each item, the reaction time of the mixture, the calibration It is necessary to set analysis conditions such as the type of line, the standard sample for creating a calibration curve, and the wavelength of light. A calibration curve is created by measuring a standard sample set in advance for each item and obtaining the absorbance. After that, items for each test sample selected from the many items that can be analyzed by creating a calibration curve are measured, and analytical data such as concentration and activity values are generated. Used for diagnosis.

  The calibration curve is formed by a function that interpolates between the calibration value pre-valued for the standard sample and the coordinates of the absorbance of this standard sample. The function is set based on the characteristics of the reaction between the sample and the reagent of each item. Is done. If there are two standard samples, the coordinates between the two points are represented by a straight line. In addition, if there are n standard samples (n ≧ 3), adjacent coordinates are represented by straight lines or curves, and it is known that functions represented by curves include exponential functions and spline functions. (For example, refer to Patent Document 1).

  The calibration curve in FIG. 8 shows the calibration values C0 to C5 of the six standard samples and the adjacent coordinates P0 to P5 of the absorbances A0 to A5 obtained by the measurement of the standard samples (each calibration Each section divided by values) is formed by functions y = f1 (x) to y = f5 (x) for interpolating with curves. Then, each function y = f1 (x) to y = f5 (x) in the section is obtained by obtaining the coefficient of each function from simultaneous equations in which coordinates other than adjacent coordinates are taken into consideration between adjacent coordinates. be able to.

Analysis data is generated using a calibration curve. When the absorbance Ai obtained by measuring the test sample is larger than, for example, the absorbance A2 in the section and smaller than the absorbance A3, the value Ci of the x coordinate intersecting the absorbance Ai of the y coordinate of the function y = f3 (x) is obtained. Is generated. Further, when the absorbance of the test sample is outside the interval exceeding the absorbance A5, the function y = f5 (x) for interpolating between the coordinates P4 and P5 is extrapolated outside the interval, and the extrapolated function y = f5 ( It is generated by obtaining the value of the x coordinate that intersects the absorbance of the test sample at the y coordinate of x).
JP-A-10-332694

  However, since the function y = f5 (x) is obtained by taking into consideration the coordinates other than the adjacent coordinates between the adjacent coordinates, as shown in FIG. 9, the slope of the function is once negative outside the interval of the calibration curve. May become positive after becoming. In this case, the x-coordinate value Cs1 that intersects the absorbance As of the y-coordinate of the test sample is an abnormally larger value than the expected monotonically increasing function x-coordinate value Cs2, so this analysis data is used for diagnosis. There is a risk of misdiagnosis.

  Further, as shown in FIG. 10, the function may become a monotonously decreasing function. In this case, since there is no x coordinate that intersects the absorbance As of the y coordinate of the test sample, analysis data cannot be generated, and an analysis data error is output for an item that cannot generate analysis data. Therefore, after completion of the measurement, the test sample of the item including the analysis data error is diluted and remeasured, and there is a problem that the measurement takes time and labor.

  The present invention has been made to solve the above problems, and an object of the present invention is to provide an automatic analyzer capable of measuring a test sample outside a section of a calibration curve and a calibration curve creation method thereof.

In order to achieve the above object, an automatic analyzer of the present invention according to claim 1 is configured to measure a test sample and a plurality of standard samples to generate test sample data and standard sample data, and Based on the calibration value of the standard sample and the standard sample data generated by the analyzing means, a first function for interpolating between the calibration value and each coordinate adjacent to the standard sample data of the calibration value; A calibration means for creating a calibration curve having a slope of the same sign as the first function and formed by a second function extrapolating the first function, and a maximum calibration of the standard sample Section setting means for setting a section between a value and an extended area value larger than the calibration value; and the test sample outside the range of the standard sample data among the test sample data generated by the analysis means Previous to data Using the first function when the first function is a monotonically increasing or decreasing function with the set interval by the interval setting means, the object with the second function when not monotonic increase and monotonic decreasing function An analysis data generation unit that generates analysis data from the sample data and an output unit that outputs the analysis data generated by the analysis data generation unit are provided.

The calibration curve generating method of the automatic analyzer according to the present invention according to claim 8 is a method for measuring a test sample and a plurality of standard samples, generating test sample data and standard sample data by an analysis means, and A first function that interpolates between the calibration value and each coordinate adjacent to the standard sample data of the calibration value based on the calibration value and the standard sample data generated by the analyzing means, A calibration curve having a slope of the same sign as the first function and formed by a second function extrapolating the first function is created by the calibration means, and the maximum calibration value of the standard sample is , a section of greater extension region value than the calibration value set by the section setting unit, of the test sample data generated by said analyzing means, said test sample data outside the range of the standard sample data On the other hand Using the first function when the first function is a monotonically increasing or decreasing function with the set interval by the interval setting means, the object with the second function when not monotonic increase and monotonic decreasing function Analysis data is generated from the sample data by analysis data generation means, and the analysis data generated by the analysis data generation means is output by output means.

  According to the present invention, the first function that interpolates each section divided by the calibration value of the standard sample with a curve, and the first function that has the same sign as the first function and extrapolates the first function. By creating a calibration curve formed by the function of 2, the analysis data can be generated with high accuracy from the sample data outside the section, so that it can be measured efficiently.

  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 illustrating the configuration of the automatic analyzer according to the embodiment. The automatic analyzer 100 is output from the analysis unit 18 that measures the standard sample and the test sample, the analysis control unit 20 that controls the analysis unit 18, and the analysis unit 18 that measures the standard sample and the test sample. A data processing unit 30 for processing standard sample data and test sample data to generate a calibration curve and generating analysis data, an output unit 40 for outputting a calibration curve and analysis data from the data processing unit 30, and An input of analysis conditions such as standard samples and calibration curves of items, an operation unit 50 for inputting various command signals, and a system control unit 60 for controlling the analysis control unit 20, the data processing unit 30, and the output unit 40 in an integrated manner. And.

  FIG. 2 is a perspective view of the analysis unit 18. The analysis unit 18 includes a reagent bottle 7 containing a reagent such as a first reagent and a second reagent paired with a first reagent that selectively reacts to components of each item included in a standard sample or a test sample. The reagent rack 1 for storing the reagent bottle 7, the reagent rack 2 for storing the reagent rack 1 for storing the reagent bottle 7 containing the first reagent, and the reagent rack for storing the reagent bottle 7 containing the second reagent 1, a reagent storage 3 for storing 1, a reaction disk 5 in which a plurality of reaction containers 4 are arranged on the circumference, and a disk sampler 6 for setting a sample container 17 for storing a sample such as a standard sample or a test sample. ing.

  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.

  Further, the analysis unit 18 sucks the first and second reagents (not shown) from the reagent bottles 7 at the first and second reagent suction positions (not shown) of the reagent storages 2 and 3 for each cycle, and then the first and second reagents (not shown). Samples were aspirated from the first and second reagent dispensing probes 14 and 15 to be dispensed into the reaction container 4 stopped at the two reagent discharge position and the sample container 17 at a position controlled by the analysis control unit 20 of the disk sampler 6. Thereafter, a dispensing probe 16 for dispensing the reaction container 4 stopped at a sample discharge position (not shown) is provided.

  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 stirring unit 11 that stirs the mixed liquid of sample + first reagent, sample + first reagent + second reagent, etc. in the reaction vessel 4 stopped at the stirring position (not shown), and this mixed liquid A photometric unit 13 for measuring the reaction vessel 4 including the photocontainer from a photometric position (not shown), and a washing for washing and drying the inside of the reaction vessel 4 while sucking the liquid mixture after measurement in the reaction vessel 4 stopped at the washing / drying position Unit 12.

  The photometry unit 13 irradiates light from the photometry position to the reaction container 4 that rotates, converts the light transmitted through the mixed solution containing the standard sample into absorbance, generates standard sample data, and then enters the data processing unit 30. Output. In addition, light that has passed through the liquid mixture containing the test sample is converted into absorbance to generate test sample data, which is then output to the data processing unit 30. Thereafter, the measurement of the mixed liquid is completed, and the reaction vessel 4 washed and dried 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 vertically moving the agitating unit 11 and vertically moving the cleaning unit 12, and a control unit for each mechanism.

  In addition, a dispensing pump for aspirating and discharging a sample from the sample dispensing probe 16, a first reagent pump for aspirating and discharging a first reagent from the first reagent dispensing probe 14, and a second reagent dispensing probe 14 A second reagent pump for sucking and discharging the second reagent from the cleaning pump, a cleaning pump for supplying and sucking the cleaning liquid for cleaning the reaction container 4 from the cleaning unit 12, and a drying pump for drying the reaction container 4 Various pumps and various pump control units. Furthermore, a mechanism for driving the stirring unit 11 to be stirred and a control unit are provided.

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

  The calculation unit 31 includes a calibration unit 33 that creates a calibration curve from the standard sample data output from the photometry unit 13 of the analysis unit 18, and analysis data that generates analysis data from the test sample data output from the photometry unit 13. And a generation unit 34.

  The calibration unit 33 creates a calibration curve based on the standard sample data of each item output from the analysis unit 18 and the calibration value of the standard sample corresponding to the standard sample data, and outputs the calibration curve to the output unit 40 and the storage unit 32.

  The analysis data generation unit 34 reads the calibration curve of each item from the storage unit 32 with respect to the test sample data of each item output from the analysis unit 18, and then uses the read calibration curve to determine the concentration and activity value. Are generated and output to the output unit 40 and stored in the storage unit 32.

  The storage unit 32 includes a hard disk or the like, stores the calibration curve output from the calibration unit 33 for each item, and stores the analysis data output from the analysis data generation unit 34 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 standard sample setting screen and a calibration curve setting screen for setting analysis conditions such as a standard sample and a calibration curve for each item, and the data processing unit 30. Display the calibration curve, analysis data, etc. output from

  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, calibration 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, an example of setting a standard sample and a calibration curve for analysis conditions will be described with reference to FIGS.

  FIG. 3 is a diagram showing a screen for setting a standard sample which is a part of the analysis conditions. The standard sample setting screen 70 includes an “item” area where preset item names are displayed, a “standard sample” column, a “value” column corresponding to a “standard sample” column, and a “standard sample”. "Position" column corresponding to "column". Then, the standard sample setting screen display operation of each item from the operation unit 50 is displayed on the display unit 42 of the output unit 40, and information on each item set on the standard sample setting screen 70 is an internal storage circuit of the system control unit 60. Saved in.

  In the “standard sample” column, “0” to “n” are displayed in order from the top, and a maximum of (n + 1) standard samples can be set for each item.

  In the “value” column, square frames 70 a 0 to 70 an corresponding to “0” to “n” in the “standard sample” column are arranged. Then, the calibration values assigned to the respective standard samples used in the calibration of each item are input in the respective square frames in order from the top.

  In the “position” column, square frames 70b0 to 70bn corresponding to “0” to “n” in the “standard sample” column are arranged. And the number of the position of the disk sampler 6 which sets the sample container 17 which accommodated each standard sample used for every item is input in each square frame.

  Here, the standard samples ST0 to STm used in the calibration of the item A are set on the standard sample setting screen 70. The calibration values C0 to Cm (C0 <C1 <... <C (m−1) <Cm) of the respective standard samples ST0 to STm are inputted into the respective square frames 70a0 to 70am. Further, the respective positions D0 to Dm of the disk sampler 6 in which (m + 1) sample containers 17 that accommodate the respective standard samples ST0 to STm are set are inputted into the respective square frames 70b0 to 70bm.

  FIG. 4 is a diagram showing a screen for setting a calibration curve that is a part of the analysis conditions. The calibration curve setting screen 80 includes an “item” area in which a preset item name is displayed, a “standard calibration curve type” field, a “straight line extrapolation” field, and a “section” field. It consists of columns. The calibration curve information displayed on the display unit 42 of the output unit 40 by the calibration curve setting screen display operation of each item from the operation unit 50 and the calibration curve information set on the calibration curve setting screen 80 is stored in the internal storage circuit of the system control unit 60. Saved in.

  On the right side of the “standard calibration curve type” column, a square frame 80a for selecting and inputting a function suitable for the reaction characteristics of the sample and the reagent for creating a calibration curve to be used for each item is arranged. The calibration curve function includes a calibration value of each standard sample set on the standard sample setting screen 70 and each coordinate P (calibration value, standard sample) of the standard sample data generated by measuring the standard sample corresponding to the calibration value. Data) is a straight line that interpolates between adjacent coordinates P (calibration value, standard sample data), and there is also a coordinate other than the adjacent coordinates between adjacent coordinates P (calibration value, standard sample data). There are “spline”, “exponential” and the like which are interpolated with curves such as spline function and exponential function taking into consideration, and a function selected and input from these is displayed in the square frame 80a.

  On the right side of the column “Extrapolate with a straight line” is a function that interpolates with a curve set in the square frame 80a of the “Standard calibration curve type” column. A square frame 80b for setting whether or not to perform insertion is arranged.

  Then, when “perform extrapolation using a straight line” is set, “R” is input in the rectangular frame 80b. With this setting, a linear function is extrapolated to a section that is equal to or greater than the maximum calibration value of the standard sample set on the standard sample setting screen 70 of each item.

  Here, as the “standard calibration curve type” of item A, “spline” is selected and set, and “extrapolation by straight line” is set.

  On the right side of the “section” column, square frames 80c and 80d for inputting an extended section outside the section with respect to the calibration curve selected and inputted in the square frame 80a of the “standard calibration curve type” column. Is arranged. If “perform extrapolation by straight lines” is not selected, even if a section is input to the square frames 80c and 80d, it becomes invalid.

  FIG. 5 is a diagram showing an example of a calibration curve for item A. FIG. The calibration curve A represented on the x and y axes includes a first function generated based on the function set on the calibration curve setting screen 80 of the item A, and a second function derived from the first function. Formed by functions.

  The first function of the calibration curve A is that each section [{C0, C1} to {C (m) divided by adjacent calibration values when the calibration values C0 to Cm of the standard samples ST0 to STm are arranged in ascending order. -1), Cm}] (within the section), each interpolation function is composed of y = S1 (x) to y = Sm (x).

  Each interpolation function y = S1 (x) to y = Sm (x) is a coefficient of a setting function represented by a quadratic or higher order polynomial such as a cubic spline function set on the calibration curve setting screen 80 of item A. , Each calibration value C0 to Cm set on the standard sample setting screen 70 of item A is set as the x coordinate, and standard sample data A (absorbance A0 to Am) generated by measurement of the standard samples ST0 to STm by the analysis unit 18 ( A0 <A1 <... <A (m−1) <Am) is obtained by using the coordinates P0 (C0, A0) to Pm (Cm, Am) having y coordinates.

  For example, the interpolating function Si (x) that interpolates the coordinates P (i-1) and the coordinates Pi adjacent to each other in the section {C (i-1), Ci} uses the coordinates other than the coordinates adjacent to the setting function. Is obtained by calculating the coefficient of. Each interpolation function y = S1 (x) to y = Sm (x) obtained in this way is represented as a monotone increasing function.

  When the first function is a monotonically increasing function, the absorbances A0 to Am correspond to A0 <A1 <... <A (corresponding to C0 <C1 <... <C (m-1) <Cm. m-1) <Am. If this relationship does not hold, it is assumed that there was some abnormality during calibration, and an error code is added to the standard sample data and output to the output unit 40. The first function is that the absorbances A0 to Am correspond to C0 <C1 <... <C (m-1) <Cm, A0> A1>...> A (m-1)> Am It may be a monotone decreasing function that satisfies the following relationship.

  The second function is a section {Cm or more} (outside the section) larger than the calibration value Cm, and the interpolation function y = Sm (x) of the section {C (m−1), Cm} at the inner end of the section is excluded. This is the function to insert. The linear differential coefficient Sm ′ (Cm) of the interpolation function y = Sm (x) at the coordinates Pm (Cm, Am) at the end of the section {C (m−1), Cm} is set as the slope, and the coordinates Pm (Cm, Am ) Is represented as a linear extrapolation function y = Sm ′ (Cm) (x−Cm) + Am. For this reason, the slope of the extrapolation function has the same sign as the first function and is a monotonically increasing function. When the first function is a monotone decreasing function, the extrapolation function is also a monotone decreasing function.

  As described above, the first function constituted by the interpolation function for interpolating each section in the section with the curve passes through the maximum calibration value of the standard sample and the coordinates of the standard sample data generated from the standard sample. By obtaining a linear function whose slope is expressed by the first derivative of the interpolation function at the coordinates, an approximate second that has the same sign as the first function and extrapolates the first function Functions can be provided outside the interval. Then, it is possible to create a calibration curve that monotonously increases or monotonously decreases by the first and second functions.

  Returning to FIG. 4, the calibration curve A of item A will be described below as an example. When “perform extrapolation using straight lines” is not selected, the interpolation function y = Sm (x) of the section {C (m−1), Cm} at the inner end of the section is used outside the section.

  The maximum calibration value Cm is input in the square frame 80c, and the extension region value C (m + 1) such as the measurement limit region of the item is input in the square frame 80d that is larger than the maximum calibration value Cm.

  When “Extrapolate by straight line” is selected and an extension section is set in the square frames 80c and 80d, {C (m−1), Cm} of the set extension section {Cm, C (m + 1)} is set. When the interpolation function y = Smax (x) monotonously increases or monotonously decreases, the interpolation function y = Sm (x) is also used in the interval {Cm, C (m + 1)}. Further, when the interpolation function Sm (x) does not monotonously increase or decrease, the extrapolation function y = Sm ′ (Cm) (x−Cm) + Am is used.

  Next, the operation of measuring the standard sample and the test sample by the automatic analyzer 100 will be described with reference to FIGS.

  FIG. 6 is a flowchart showing an operation for measuring a standard sample. When an analysis condition setting operation for setting the analysis conditions such as the standard sample and calibration curve of item A is performed from the operation unit 50, the system control unit 60 displays information on the analysis conditions such as the standard sample and calibration curve of item A. Save to the internal memory circuit. Thereafter, the sample container 17 containing the standard samples ST0 to STm of the item A is set at the positions “D0” to “Dm” of the disc sampler 6.

  When the calibration operation of item A is performed from the operation unit 50, the automatic analyzer 100 starts an operation of measuring each standard sample ST0 to STm (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 a standard sample measurement operation for performing the calibration of the item A, and outputs information on the analysis conditions of the item A. .

  The analysis control unit 20 controls each unit of the analysis unit 18 based on the instruction of the system control unit 60 and the analysis condition information, and performs the standard sample measurement operation of item A. The photometric unit 13 of the analysis unit 18 measures the standard samples ST0 to STm of the item A and generates standard sample data A (absorbance A0 to Am) (step S2). Thereafter, the generated standard sample data A is output to the calibration unit 33 of the calculation unit 31 of the data processing unit 30.

  Based on the analysis condition information of the item A output from the system control unit 60 and the standard sample data output from the photometry unit 13, the calibration unit 33 selects each section {C0, C1} to {Cm, Am} ( The coefficients of the interpolation functions y = S1 (x) to y = Sm (x) for interpolating (in the section) are obtained (step S3).

  If “perform extrapolation by straight line” is set on the calibration curve setting screen 80 (Yes in step S4), the process proceeds to step S5. Also, when “perform extrapolation using straight lines” is not set (No in step S4), each interpolation function y = S1 (x) to y = Sm (x) for obtaining each coefficient in each section in the section. Is generated and output to the output unit 40 and stored in the storage unit 32 (step S6). Thereafter, the process proceeds to step S13.

  In step S5, when sections are set in the square frames 80c and 80d of “section” on the calibration curve setting screen 80 (Yes in step S5), for example, Cm and C (m + 1) are stored in the square frames 80c and 80d. If set, the process proceeds to step S7. If no section is set in the square frames 80c and 80d (No in step S5), the process proceeds to step S8.

  Next, when the interpolation function y = Sm (x) monotonously increases in the section {Cm, C (m + 1)} (Yes in step S7), each interpolation function y = S1 (x) to y = Sm (in the section) x) and a calibration curve C composed of the interpolation function y = Sm (x) of the section {Cm, C (m + 1)} are generated and output to the output unit 40 and stored in the storage unit 32 (step S9). . Thereafter, the process proceeds to step S13.

  If the interpolation function y = Sm (x) does not monotonously increase in the section {Cm, C (m + 1)} (No in step S7), the process proceeds to step S8.

  Next, a first-order differential coefficient Sm ′ (Cm) at y = Sm (x) at the coordinates Pm (Cm, Am) is obtained. If the obtained first derivative Sm ′ (Cm) is positive (Yes in step S8), the extrapolation function y = Sm ′ (Cm) (x−Cm) + Am used in the section {over Cm} is Obtained (step S10).

  If the primary differential coefficient Sm ′ (Cm) is 0 or negative (No in step S8), the interpolation functions y = S1 (x) to y = Sm (x) in the section are invalidated, and the “calibration curve” Calibration error information such as “Failed to create” is output to the output unit 40 and stored in the storage unit 32 (step S11).

  Thus, generation of abnormal data can be prevented by invalidating the calibration curve and outputting calibration error information.

  Next, a calibration curve A composed of each interpolation function y = S1 (x) to y = Sm (x) in the section and extrapolation function y = Sm ′ (Cm) (x−Cm) + Am outside the section. Is generated and output to the output unit 40 and stored in the storage unit 32 (step S12).

  Then, the calibration curve B generated in step S6, the calibration curve C created in step S9, the calibration error information created in step 11 or the calibration curve A created in step S12 is output to the output unit 40. When the data is output, the system 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 standard sample measurement operation for item A is completed (step S13).

  FIG. 7 is a flowchart showing an operation for measuring a test sample. It is assumed that the calibration curve A of item A is stored in the storage unit 32 of the data processing unit 30 of the automatic analyzer 100 by the measurement of the standard sample described in FIG.

  When the subject information such as the subject ID and subject name of the subject is input from the operation unit 50 and the item A of the subject sample is selected and input, an automatic analysis is performed when the subject sample measurement operation is performed. The apparatus 100 starts a test sample measurement operation (step S21).

  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 item A of the test sample. Based on this instruction, the analysis control unit 20 causes each unit of the analysis unit 18 to perform the measurement operation of the item A of the test sample. With this measurement operation, the photometric unit 13 of the analysis unit 18 measures the item A of the test sample and generates analysis data A (absorbance Ac) (step S22). Thereafter, the generated absorbance Ac is output to the analysis data generation unit 34 of the calculation unit 31 of the data processing unit 30.

  The analysis data generation unit 34 reads the calibration curve A of the item A from the storage unit 32 with respect to the absorbance Ac of the item A output from the photometry unit 13 and then analyzes the absorbance Ac using the read calibration curve A. Performs operations to generate data.

  When the absorbance Ac is greater than the absorbance Am of the standard sample STm of item A (Yes in step S23), analysis is performed using the extrapolation function y = Sm ′ (Cm) (x−Cm) + Am of the calibration curve A. Data A is generated (step S24).

  Here, the figure is the analysis data A of the item A of the test sample by substituting the absorbance Ac into y of the extrapolation function y = Sm ′ (Cm) (x−Cm) + Am and obtaining the value of x. Cs shown in FIG. 5 is generated.

  In this way, when test sample data corresponding to outside the section is generated, approximate analysis data can be generated using an extrapolation function having the same slope as the first function.

  When the absorbance Ac is equal to or smaller than the absorbance Am (No in step S23), the interpolation functions y = S1 (x) to y = Sm (x) in the interval of the calibration curve A are expressed. Using this, the analysis data A ′ is generated (step S25).

  Here, assuming that the absorbance Ac corresponds to the interval {C (i−1), Ci}, the value of x is obtained by substituting Ac for y in the interpolation equation y = Si (x) in that interval. Thus, Ci shown in FIG. 5 which is analysis data A ′ of item A is generated.

  The analysis data generation unit 34 outputs the analysis data A generated in step S24 or the analysis data A ′ generated in step S25 to the output unit 40 and saves it in the storage unit 32 (step S26).

  Then, when the analysis data from the data processing unit 30 is output to the output unit 40, the system control unit 60 instructs the analysis control unit 20, the data processing unit 30, and the output unit 40 to stop the operation. The test sample measurement operation ends (step S27).

  6 and 7 are not limited to the above-described embodiment, and may be performed when the first function of the calibration curve is a monotonously decreasing function, for example. In this case, a calibration curve C is created in the case of monotonic decrease in step S7, an extrapolation function is obtained in step S8 when Sm ′ (Cm) <0, and in the case of As <Am in step S23. The analysis data A is generated using an extrapolation function.

  According to the embodiment of the present invention described above, the maximum of the standard sample is compared with the first function constituted by the interpolation function that interpolates each section in the section divided by the calibration value of the standard sample with a curve. By obtaining a linear function that passes through the calibration value and the coordinates of the standard sample data generated from this standard sample and whose slope is represented by the first derivative of the interpolation function at that coordinate, the slope having the same sign as the first function is obtained. And a second function for extrapolating the first function can be provided outside the section.

  By this second function, approximate analysis data can be generated from test sample data outside the interval. In addition, since a calibration curve that monotonously increases or monotonously decreases by the first and second functions can be created, a wide range of measurements can be handled.

  Also, an extension section between the maximum calibration value of the standard sample and an extension area value larger than this calibration value is set, and the interpolation function of the end section in the section is set for the test sample data of the set extension section. If the extension function is the same monotonically increasing or decreasing function as the first function even in the extension interval, the interpolation data is used to generate analysis data, and if it is not the same monotonic increasing or decreasing function as the first function, By using the function of 2, it is possible to cope with a wide range of measurements.

  As a result, it is possible to prevent misdiagnosis and efficiently perform measurement without taking time and labor for re-measurement.

The block diagram which shows the structure of the automatic analyzer which concerns on 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 an example of the standard sample setting screen which concerns on the Example of this invention. The figure which shows an example of the calibration curve setting screen which concerns on the Example of this invention. The figure which shows an example of the calibration curve which concerns on the Example of this invention. The flowchart which shows the operation | movement which measures the standard sample which concerns on the Example of this invention. The flowchart which shows the operation | movement which measures the standard sample which concerns on the Example of this invention. The figure which shows a general calibration curve. The figure which shows an example of the conventional calibration curve. The figure which shows an example of the conventional calibration curve.

Explanation of symbols

18 Analysis unit 20 Analysis control unit 30 Data processing unit 31 Calculation unit 32 Storage unit 33 Calibration unit 34 Analysis data generation unit 40 Output unit 41 Printing unit 42 Display unit 50 Operation unit 60 System control unit 70 Standard sample setting screen 80 Calibration curve Setting screen 100 Automatic analyzer

Claims (8)

Analysis means for measuring a test sample and a plurality of standard samples to generate test sample data and standard sample data;
Based on the calibration value of the standard sample and the standard sample data generated by the analysis means, a first function for interpolating between the calibration value and each coordinate adjacent to the standard sample data of the calibration value. And a calibration means for creating a calibration curve formed by a second function having the same sign as the first function and extrapolating the first function,
Section setting means for setting a section between the maximum calibration value of the standard sample and an extended area value larger than the calibration value;
Of the test sample data generated by the analysis means , the first function increases monotonously in the section set by the section setting means with respect to the test sample data outside the range of the standard sample data. Or an analysis data generating means for generating analysis data from the test sample data using the first function when the function is a monotonically decreasing function and using the second function when the function is not a monotonically increasing function or a monotonic decreasing function ;
An automatic analyzer comprising output means for outputting the analysis data generated by the analysis data generation means.   The second function passes through the maximum calibration value of the standard sample and the coordinates of the standard sample data generated from the standard sample, and the slope is expressed by the first derivative of the first function at the coordinates. The automatic analyzer according to claim 1, wherein the automatic analyzer is a function.   The automatic analyzer according to claim 1, wherein the first function is a quadratic or higher order function.   The automatic analyzer according to claim 1, wherein the first function is a spline function. The first function is an interpolation function for interpolating between adjacent coordinates of the maximum calibration value of the standard sample and the coordinates of standard sample data generated from the standard sample. 2. The automatic analyzer according to 2. A calibration curve is created based on the standard sample data obtained by measuring a plurality of standard samples and the coordinates of the calibration values of the standard sample, and the test sample obtained by measuring the test sample using the created calibration curve In an automatic analyzer that generates analytical data from data,
A first function that interpolates a section composed of coordinates of the maximum calibration value of the standard sample among the coordinate sections is obtained, and the first function is extrapolated based on the slope of the obtained first function. A calibration means for determining whether or not the second function is used
An automatic analyzer characterized by comprising. The calibration means invalidates the second function when the first function is not one of a monotonically increasing function or a monotonically decreasing function, and invalidates the second function when the second function is not the one function. 7. The automatic analyzer according to claim 6, wherein information is output to the output means. A test sample and a plurality of standard samples are measured, and test sample data and standard sample data are generated by the analysis means,
Based on the calibration value of the standard sample and the standard sample data generated by the analysis means, a first function for interpolating between the calibration value and each coordinate adjacent to the standard sample data of the calibration value. And a calibration curve formed by a calibration means having a slope of the same sign as the first function and formed by a second function extrapolating the first function,
Set the interval between the maximum calibration value of the standard sample and the extended region value larger than this calibration value by the interval setting means,
Of the test sample data generated by the analysis means, the first function increases monotonously in the section set by the section setting means with respect to the test sample data outside the range of the standard sample data. Or using the first function when the function is a monotonically decreasing function, and generating analytical data from the test sample data using the second function when the function is not monotonically increasing and not monotonically decreasing, by the analytical data generating means,
A calibration curve creation method for an automatic analyzer, wherein the analysis data generated by the analysis data generation means is output by output means.

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