JP2016090239A - Automatic analyzer and automatic analysis method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an automatic analyzer allowing a user to intuitively recognize a changeover of a calibration curve guaranteed by a measurement value of a control sample.SOLUTION: An automatic analyzer includes: a measurement section for measuring characteristics of a reaction liquid that reacts a specimen to be measured with a reagent; a measurement control section that causes the measurement section to perform calibration measurement using a calibrator as the specimen to be measured at least for each lot of the reagent and to perform control measurement using a control specimen as the specimen to be measured at predetermined timing after the calibration measurement using a reagent of the same lot as that of the calibration measurement; a display part for displaying measurement results in the measurement section; and a display control part that causes the display part to sequentially plot-display the measurement result of the control measurement in the measurement section, while changing a symbol mark for each calibration curve used for acquiring the measurement result.SELECTED DRAWING: Figure 1

Description

  The present invention relates to an automatic analyzer and an automatic analysis method, and more particularly to an automatic analyzer and an automatic analysis method having an accuracy management function.

  As an automatic analyzer, a biochemical analyzer that analyzes a biological component contained in a specimen such as blood or urine is known. In such an automatic analyzer, in order to ensure measurement accuracy, accuracy management is performed using a calibrator (standard sample) whose concentration is known in advance and a control sample (accuracy control sample). For this reason, the automatic analyzer has a function of measuring the absorbance of a reaction solution obtained by reacting a calibrator and a reagent, and creating a calibration curve (calibration curve) as a concentration-absorbance characteristic. Moreover, in order to guarantee a calibration curve, it has a function of measuring the absorbance of a reaction solution obtained by reacting a control sample and a sample.

  The calibration curve created by the calibrator measurement as described above is performed, for example, for each reagent lot or each reagent bottle. On the other hand, the measurement of the control sample is performed immediately after creating the calibration curve, and may be performed every predetermined time interval or every time the number of unknown samples reaches a predetermined number. The measurement value of the control sample is plotted on a chart for quality control and displayed on the display unit of the automatic analyzer. In addition, when the absorbance measured for the control sample is within the control allowable value, the automatic analyzer determines that there is no abnormality in the device and the reagent, and measures the unknown sample using the calibration curve.

  In recent years, as disclosed in the following cited document 1, there is also one that serves as both a calibrator for creating a calibration curve and a control sample. This cited reference 1 states that “the measured values of the control sample are plotted in the quality control chart, the data at the time of creating the calibration curve are plotted with red round marks, and the data measured for each other specified number of samples is black. It is plotted with a square mark and can be distinguished from each other. "

JP-A-11-142212

  The automatic analyzer as described above needs to continuously measure a large amount of specimen samples at a high speed and perform the above-described accuracy control in the process. For this reason, among the measurement values of the control sample that are sequentially plotted against the chart for accuracy control, which calibration curve is guaranteed, switching of the calibration curve guaranteed by the measurement value of the control sample, It is required to be intuitively recognizable.

  In order to achieve such an object, the automatic analyzer of the present invention comprises a measuring unit for measuring the characteristics of a reaction solution obtained by reacting a sample to be measured and a reagent, and a calibrator for the measuring unit. Perform calibration measurement as a sample at least for each lot of the reagent, and perform control measurement using the control sample as the sample to be measured at a predetermined timing after the calibration measurement. A measurement control unit to be used, a display unit for displaying a measurement result in the measurement unit, a measurement result of the control measurement in the measurement unit, a symbol mark for each calibration curve used to obtain the measurement result And a display control unit that sequentially displays the plot on the display unit.

  The automatic analysis method of the present invention is an automatic analysis method for measuring the characteristics of a reaction solution obtained by reacting a sample to be measured and a reagent, and performs calibration measurement using a calibrator as the sample to be measured. The control measurement is performed for each lot, and the control sample is used as the sample to be measured at a predetermined timing after the calibration measurement, using the same lot of reagent as the calibration measurement, and the measurement result of the control measurement is The symbol mark is changed for each calibration curve used to obtain the measurement result, and the plot is sequentially displayed.

  According to the automatic analyzer and the automatic analysis method of the present invention as described above, when a calibration curve is obtained as a result of calibration measurement, it is possible to intuitively recognize the switching of the calibration curve guaranteed by the measurement value of the control sample. It is.

It is a schematic block diagram which shows the automatic analyzer of embodiment to which this invention is applied. It is a block diagram which shows the internal structural example of the input-output control part with which the automatic analyzer of embodiment is provided. It is a flowchart which shows the automatic analysis method using the automatic analyzer of embodiment. It is a figure which shows the example 1 of a display of the analysis result in the automatic analysis method of embodiment. It is a figure which shows the example 2 of a display of the analysis result in the automatic analysis method of embodiment.

  Embodiments of an automatic analyzer and an automatic analysis method of the present invention will be described below in detail with reference to the drawings.

≪Automatic analyzer≫
FIG. 1 is a schematic configuration diagram showing an automatic analyzer according to the first embodiment. As an example, an automatic analyzer 1 in which the present invention is applied to a biochemical analyzer that analyzes biological components contained in a specimen such as blood and urine. FIG.

  As shown in FIG. 1, the automatic analyzer 1 includes a measuring unit 1a and an input / output control unit 1b. Among these, the measurement part 1a is provided with the sample turntable 2, the dilution turntable 3, the 1st reagent turntable 4, the 2nd reagent turntable 5, and the reaction turntable 6, for example. The measurement unit 1a includes a sample dilution pipette 7, a sampling pipette 8, a dilution stirring device 9, a dilution washing device 11, a first reagent pipette 12, a second reagent pipette 13, a first reaction stirring device 14, and a second reaction stirring device 15. A multi-wavelength photometer 16 and a reaction vessel cleaning device 18. On the other hand, the input / output control unit 1b includes a measurement control unit, a display control unit, a display unit, and the like which are not illustrated here. Details of these components will be described below.

[Measurement unit 1a]
<Sample turntable 2>
The sample turntable 2 is formed in a substantially cylindrical container shape having an axial end (upper side in FIG. 1) opened. The sample turntable 2 has a configuration in which a plurality of sample containers 21 are held in a plurality of rows along the periphery thereof, and the held dilution containers 23 are conveyed in both directions of the circumference.

  Each sample container 21 held on the sample turntable 2 stores a sample to be measured as a measurement target. The sample to be measured is a sample sample such as blood or urine, a calibrator (standard sample) for creating a calibration curve, and a control sample (quality control sample) for accuracy control. The control sample may also serve as a calibrator. The sample turntable 2 is configured to hold these various types of specimens to be measured at predetermined positions. In addition to the sample container 21, the sample turntable 2 may contain a diluent container in which a diluent is stored.

  The sample turntable 2 as described above is supported so as to be rotatable along the circumferential direction by a drive mechanism (not shown). The sample turntable 2 is rotated at a predetermined speed in a predetermined angular range in the circumferential direction by a driving mechanism (not shown).

<Dilution turntable 3>
Like the sample turntable 2, the dilution turntable 3 is formed in a substantially cylindrical container shape having one axial end (upper side in FIG. 1) opened, and a plurality of dilution containers 23 are formed along the periphery thereof. It is the structure which hold | maintains and conveys the hold | maintained dilution container 23 in both directions of the circumference.

  A sample to be measured (hereinafter referred to as “diluted sample”) that has been sucked and diluted from the sample container 21 arranged on the sample turntable 2 is injected into the dilution container 23 held on the dilution turntable 3.

  Like the sample turntable 2, such a dilution turntable 3 is rotatably supported along a circumferential direction by a drive mechanism (not shown), and rotates at a predetermined speed in a predetermined angular range in the circumferential direction. .

<First Reagent Turntable 4 and Second Reagent Turntable 5>
Similar to the sample turntable 2, the first reagent turntable 4 and the second reagent turntable 5 are formed in a container shape having a substantially cylindrical shape with one axial end (upper side in FIG. 1) opened.

  The first reagent turntable 4 holds a plurality of first reagent containers 24 along the peripheral edge thereof, and the second reagent turntable 5 holds a plurality of second reagent containers 25 along the peripheral edge thereof, respectively. The first reagent container 24 and the second reagent container 25 are transported in both directions of the circumference.

  The first reagent is dispensed from the reagent bottle into the plurality of first reagent containers 24 held on the first reagent turntable 4. The second reagent is dispensed from the reagent bottle into the second reagent container 25 held on the second reagent turntable 5.

  Like the sample turntable 2, the first reagent turntable 4 and the second reagent turntable 5 are supported by a drive mechanism (not shown) so as to be rotatable along the circumferential direction, and have a predetermined angular range in the circumferential direction. Each time it rotates at a predetermined speed.

<Reaction turntable 6>
The reaction turntable 6 is disposed between the dilution turntable 3, the first reagent turntable 4, and the second reagent turntable 5, and has a substantially cylindrical shape with one axial end (upper side in FIG. 1) opened. It is formed in a container shape. The reaction turntable 6 is configured to hold a plurality of reaction vessels 26 along the periphery thereof and to convey the held reaction vessels 26 in both directions of the circumference.

  The reaction container 26 held on the reaction turntable 6 includes a diluted sample sampled from the dilution container 23 of the dilution turntable 3, a first reagent sampled from the first reagent container 24 of the first reagent turntable 4, The sampled second reagent is injected from the second reagent container 25 of the two-reagent turntable 5. In the reaction container 26, the diluted specimen, the first reagent, and the second reagent are agitated to perform the reaction.

  The reaction turntable 6 is configured to always keep the temperature of the reaction vessel 26 constant by a thermostat not shown.

  Further, like the sample turntable 2, such a reaction turntable 6 is rotatably supported along a circumferential direction by a driving mechanism (not shown), and rotates at a predetermined speed in a predetermined angular range in the circumferential direction. To do.

<Sample dilution pipette 7>
The sample dilution pipette 7 is arranged around the sample turntable 2 and the dilution turntable 3. The sample dilution pipette 7 is supported so as to be movable in the axial direction (for example, up and down direction) of the sample turntable 2 and the dilution turntable 3 by a dilution pipette drive mechanism (not shown). The sample dilution pipette 7 is supported by a dilution pipette driving mechanism so as to be rotatable along a horizontal direction substantially parallel to the openings of the sample turntable 2 and the dilution turntable 3. The sample dilution pipette 7 reciprocates between the sample turntable 2 and the dilution turntable 3 by rotating along the horizontal direction. When the sample dilution pipette 7 moves between the sample turntable 2 and the dilution turntable 3, the sample dilution pipette 7 passes through a cleaning device (not shown).

  This sample dilution pipette 7 inserts a tip portion into the sample container 21 of the sample turntable 2 and sucks a predetermined amount of the sample to be measured. The sample dilution pipette 7 has a tip inserted into the dilution container 23 of the dilution turntable 3, and a sample to be measured and a predetermined amount of diluent (for example, physiological saline) supplied from the sample dilution pipette 7 itself. Water) is discharged into the dilution container 23. As a result, the sample to be measured is diluted to a predetermined multiple concentration in the dilution container 23. Thereafter, the sample dilution pipette 7 is washed by a washing device.

<Sampling pipette 8>
The sampling pipette 8 is arranged between the dilution turntable 3 and the reaction turntable 6. The sampling pipette 8 can be moved in the axial direction (vertical direction) of the dilution turntable 3 and can be rotated in the horizontal direction by a sampling pipette drive mechanism (not shown) as well as the sample dilution pipette 7. Yes. The sampling pipette 8 reciprocates between the dilution turntable 3 and the reaction turntable 6.

  The sampling pipette 8 inserts a tip portion into the dilution container 23 of the dilution turntable 3 to aspirate a predetermined amount of diluted specimen. Then, the sampling pipette 8 discharges the diluted diluted sample into the reaction container 26 of the reaction turntable 6 and injects the diluted sample into the reaction container 26.

<Dilution stirring device 9>
The dilution stirring device 9 is arranged around the dilution turntable 3. The dilution stirrer 9 inserts a stirring bar (not shown) into the dilution container 23 and stirs the sample to be measured and the diluted solution.

<Dilution cleaning device 11>
The dilution cleaning device 11 is arranged around the dilution turntable 3. The dilution cleaning device 11 is a device for cleaning the dilution container 23 after the diluted specimen is aspirated by the sampling pipette 8. The dilution cleaning device 11 has a plurality of dilution container cleaning nozzles. The plurality of dilution container cleaning nozzles are connected to a waste liquid pump (not shown) and a detergent pump (not shown). The dilution cleaning device 11 inserts a dilution container cleaning nozzle into the dilution container 23 and drives the waste liquid pump to suck in the diluted specimen remaining in the dilution container 23 by the inserted dilution container cleaning nozzle. Then, the dilution cleaning device 11 discharges the sucked diluted specimen to a waste liquid tank (not shown).

  Thereafter, the dilution cleaning device 11 supplies the detergent from the detergent pump to the dilution container cleaning nozzle, and discharges the detergent into the dilution container 23 from the dilution container cleaning nozzle. The inside of the dilution container 23 is washed with this detergent. Thereafter, the dilution cleaning device 11 sucks the detergent through the dilution container cleaning nozzle and dries the inside of the dilution container 23.

<First reagent pipette 12>
The first reagent pipette 12 is disposed between the reaction turntable 6 and the first reagent turntable 4. The first reagent pipette 12 can be moved in the axial direction (vertical direction) of the reaction turntable 6 and supported so as to be rotatable in the horizontal direction by a first reagent pipette drive mechanism (not shown). The first reagent pipette 12 reciprocates between the first reagent turntable 4 and the reaction turntable 6.

  The first reagent pipette 12 inserts a tip portion into the first reagent container 24 of the first reagent turntable 4 and aspirates a predetermined amount of the first reagent. Then, the first reagent pipette 12 discharges the sucked first reagent into the reaction container 26 of the reaction turntable 6.

<Second reagent pipette 13>
The second reagent pipette 13 is disposed between the reaction turntable 6 and the second reagent turntable 5. Similarly to the first reagent pipette 12, the second reagent pipette 13 can be moved in the axial direction (vertical direction) and horizontal direction of the reaction turntable 6 and rotated by a second reagent pipette drive mechanism (not shown). Supported as possible. The second reagent pipette 13 reciprocates between the second reagent turntable 5 and the reaction turntable 6.

  The second reagent pipette 13 inserts a tip portion into the second reagent container 25 of the second reagent turntable 5 and aspirates a predetermined amount of the second reagent. Then, the second reagent pipette 13 discharges the sucked second reagent into the reaction container 26 of the reaction turntable 6.

<First reaction stirrer 14 and second reaction stirrer 15>
The first reaction stirring device 14 and the second reaction stirring device 15 are arranged around the reaction turntable 6. The first reaction stirrer 14 and the second reaction stirrer 15 insert a stirring bar (not shown) into the reaction vessel 26 and stir the contents of the reaction vessel 26. For example, the first reaction stirrer 14 agitates the diluted specimen and the first reagent in the reaction container 26 while the second reagent is discharged. The second reaction stirring device 15 stirs the diluted specimen and the second reagent in the reaction container 26 in a state where the diluted specimen and the second reagent are discharged, or in a state where the first reagent is further discharged. As a result, the reaction between the diluted specimen, the first reagent, and the second reagent is performed uniformly and rapidly.

<Multi-wavelength photometer 16>
The multi-wavelength photometer 16 is a measuring unit and is disposed so as to face the outer wall of the reaction turntable 6 around the reaction turntable 6. The multi-wavelength photometer 16 is injected into the reaction vessel 26 and optically measures the diluted specimen that has reacted with the first chemical liquid and the second chemical liquid, and the amounts of various components in the specimen are referred to as “absorbance”. It is output as numerical data to detect the reaction state of the diluted specimen.

<Reaction vessel cleaning device 18>
The reaction vessel cleaning device 18 is a device for cleaning the inside of the reaction vessel 26 that has been inspected. The reaction container cleaning device 18 has a plurality of reaction container cleaning nozzles. The plurality of reaction container cleaning nozzles are connected to a waste liquid pump (not shown) and a detergent pump (not shown), similarly to the dilution container cleaning nozzle. In addition, since the washing | cleaning process in the reaction container washing | cleaning apparatus 18 is the same as that of the dilution washing | cleaning apparatus 11 mentioned above, the description is abbreviate | omitted.

[Input / output control unit 1b]
The input / output control unit 1b is connected to the drive mechanism of each component constituting the measurement unit 1a and the multi-wavelength photometer 16. FIG. 2 is a block diagram illustrating an internal configuration example of the input / output control unit 1b. The configuration of the input / output control unit 1b shown in FIG. 2 will be described below with reference to FIG.

  The input / output control unit 1 b includes a control unit 31, a measurement control unit 32 and a display control unit 33 constituting the control unit 31, a recording unit 34, a display unit 35, an input unit 36, and an interface unit 37. The control unit 31, the recording unit 34, the display unit 35, the input unit 36, and the interface unit 37 are connected to each other via a bus 38 so as to be able to transfer data. Details of these components are as follows.

<Control unit 31>
The control unit 31 is configured by a CPU (Central Processing Unit) or the like, and controls the operation of each unit in the automatic analyzer 1. The control unit 31 includes a measurement control unit 32 and a display control unit 33.

<Measurement control unit 32>
The measurement control unit 32 controls the operation timing of each drive mechanism constituting the measurement unit 1 a and also controls the measurement timing of the luminous intensity at the multiwavelength photometer 16. Under the control of the measurement control unit 32, the measurement unit 1a dilutes the sample to be measured in each sample container 21 held on the sample turntable 2 to a predetermined concentration, and the first reagent and the second reagent are diluted with respect to the diluted sample. The reagent is mixed and reacted, and the absorbance of the reacted reaction solution is measured.

  The absorbance measurement as described above is performed using a sample specimen such as blood or urine as a specimen to be measured. Such measurement is similarly performed in calibration measurement using a calibrator for creating a calibration curve as a sample to be measured and control measurement using a control sample for accuracy control as a sample to be measured.

  In particular, the measurement control unit 32 causes the measurement unit 1a to perform calibration measurement using the calibrator as a sample to be measured at a predetermined timing. The calibration measurement is performed at least for each reagent lot and may be performed for each reagent bottle. Further, the measurement control unit 32 causes the measurement unit 1a to perform control measurement using the control sample as a measurement sample at a predetermined timing after the calibration measurement. The control measurement is a measurement for guaranteeing the calibration curve obtained by the calibration measurement, and is performed using the same lot and the same bottle reagent as the calibration measurement for obtaining the calibration curve to be guaranteed. . The measurement result of such a control measurement is a value obtained by using a calibration curve obtained by a calibration measurement performed using the same lot and the same bottle reagent as the control measurement.

  A specific example of the timing for performing the calibration measurement and the control measurement as described above will be described in the subsequent automatic analysis method.

<Display control unit 33>
The display control unit 33 acquires data measured by the multi-wavelength photometer 16 of the measurement unit 1a, creates a display screen regarding measurement results of diluted samples obtained by diluting each sample to be measured from the measurement data, The created display screen is displayed on the display unit 35. In particular, for the measurement result of the control measurement, the symbol mark is changed for each calibration curve used to obtain the measurement result, and the plot is sequentially displayed. A specific example of the procedure for changing the symbol mark will be described in the subsequent automatic analysis method.

  The display control unit 33 creates a display screen in which the lot number and bottle number of the reagent used for the control measurement are associated with the symbol mark indicating the measurement result of the control measurement, and displays the created display screen on the display unit 35. Let

<Recording unit 34>
The recording unit 34 is configured by a large-capacity recording device such as an HDD (Hard disk drive) or a semiconductor memory, for example, and the program executed by the control unit 31, parameters, calibration curve, measurement result, input made by the input unit 36 Record operations etc.

<Display unit 35>
The display unit 35 displays an operation screen of the analyzer, a measurement result in the multi-wavelength photometer 16 of the measurement unit 1a, and the like. An example of the measurement result display screen will be described later. For the display unit 35, for example, a liquid crystal display device or the like is used.

<Input unit 36>
The input unit 36 receives an operation input to the automatic analyzer 1 performed by the user and outputs an input signal to the control unit 31. For the input unit 36, for example, a mouse, a keyboard, a touch panel, or the like is used.

<Interface unit 37>
The interface unit 37 is connected to the multi-wavelength photometer 16 of the measurement unit 1a and the driving mechanism of each component of the measurement unit 1a. Thereby, the measurement data of the diluted specimen output from the multiwavelength photometer 16 is transferred to the display control unit 33 via the interface unit 37. Further, the drive mechanism of each component of the measurement unit 1 a is controlled by an instruction from the display control unit 33 transmitted via the interface unit 37.

≪Automatic analysis method≫
FIG. 3 is a flowchart illustrating an automatic analysis method using the automatic analyzer 1 according to the embodiment. Below, the automatic analysis method implemented by the control part 31 in the automatic analyzer 1 is demonstrated, referring FIG. 1 and FIG. 2 along the flowchart of FIG. Note that the automatic analysis method described here relates to accuracy management by calibration measurement and control measurement performed before or between measurements on a large amount of sample specimens.

  First, as preparations for carrying out automatic analysis using the automatic analyzer 1, a sample container 21 storing a sample sample, a sample container 21 storing a calibrator, and a control sample are stored at predetermined positions on the sample turntable 2. The sample container 21 thus obtained is held. The calibrator may also serve as a control sample.

  Further, the first reagent container 24 storing the first reagent of the lot number and the bottle number is held at a predetermined position of the first reagent turntable 4, and the second reagent turntable 5 has the lot number and the bottle number of the first reagent container 24. The second reagent container 25 storing the second reagent is held. These pieces of information are recorded in the recording unit 34 of the automatic analyzer 1.

  Hereinafter, according to the flow of FIG. 3, the accuracy management of the automatic analyzer 1 is performed as follows.

[Step S1]
In step S1, quality control conditions are set. Here, first, measurement conditions relating to calibration measurement and control measurement during automatic analysis of a large amount of sample specimens using the automatic analyzer 1 are set. The set measurement conditions are input from the input unit 36 and recorded in the recording unit 34. The measurement conditions to be set are as follows, for example.

  As the measurement condition (1), timing for performing calibration measurement and the number of times of calibration measurement are set. Here, in one calibration measurement, a plurality of absorbance measurements are performed using a number of calibrators capable of creating one calibration curve as the sample to be measured.

  As the measurement condition (2), the lot number and bottle number of the first reagent and the lot number and bottle number of the second reagent used for each calibration measurement are set. These numbers are automatically obtained from the reagent barcode or set manually. For example, when performing calibration measurement of one calibration curve segment, the lot number and bottle number of the reagent used for calibration measurement of one calibration curve segment are set. When performing calibration measurement of three calibration curve segments, the lot number and bottle number of each reagent used for each calibration measurement are set.

  Furthermore, the timing for performing the control measurement is set as the measurement condition (3). The timing at which the control measurement is performed includes at least immediately after the calibration measurement, and further is set every predetermined time or every time measurement of a predetermined number of sample specimens is completed. Here, as an example of the timing for performing the control measurement, only immediately after the calibration measurement is set.

  As the measurement condition (4), the number [n] (for example, 3) of control samples to be subjected to the control measurement is set at each timing at which the control measurement is performed. In addition, measurement conditions (dilution concentration, etc.) are set for each control sample.

[Step S2]
In step S2, a determination is made to start calibration. In step S <b> 2, the measurement control unit 32 determines whether or not the timing for performing the calibration measurement set as the measurement condition (1) has been reached. Then, step S2 is repeated until it is determined that it has been reached (YES), and when it is determined that it has been reached (YES), the process proceeds to the next step S3.

  It should be noted that the start of calibration is determined to have reached the timing for performing calibration measurement slightly before or after the predetermined timing set in advance as the measurement condition (1) in consideration of the measurement efficiency of the sample specimen. It may be a configuration.

[Step S3]
In step S3, calibration measurement is performed. In step S3, the measurement control unit 32 uses the calibrator of each concentration as the sample to be measured with respect to the measurement unit 1a, and the first reagent and the second reagent of the predetermined lot number and bottle number set in the measurement condition (2). A series of calibration measurements with reagents are performed. For example, a series of calibrations using lot number 001-bottle number 0001 as the first reagent and lot number 001-bottle number 0002 as the second reagent is performed.

[Step S4]
In step S4, a calibration curve is created. In step S4, the display control unit 33 creates a calibration curve in which measurement results in a series of calibration measurements are associated with the concentration of each calibrator. The created calibration curve is recorded in the recording unit 34 and displayed on the display unit 35.

[Step S5]
In step S5, control measurement is performed. In step S5, the measurement control unit 32 controls the measurement unit 1a as a measurement test using a predetermined control sample immediately after the calibration measurement in step S3 is completed according to the setting of the measurement condition (3). Make measurements. In this control measurement, the first reagent and the second reagent having the same lot number and bottle number as used in the calibration measurement in step S3 are used. The measurement control unit 32 records the measurement result in this control measurement in the recording unit 34 in association with the lot number and bottle number of the first reagent and the lot number and bottle number of the second reagent.

[Step S6]
In step S6, the measurement result of the control measurement is displayed as a plot. In step S6, the display control unit 33 causes the display unit 35 to plot and display the measurement result in step S5. At this time, plot display using a predetermined symbol mark is performed. FIG. 4 shows an example of a plot display. The plot display shown in FIG. 4 is a quality control chart called a so-called X chart, in which the horizontal axis represents the measurement times of the control measurement, and the vertical axis represents the measurement values of the control measurement.

  For example, if the measurement result obtained in step S5 is the measurement result of the first control measurement, the absorbance measured as the measurement result is added to the first position on the horizontal axis in the quality control chart. Display. At this time, the measurement result of the control measurement is plotted on the quality control chart using, for example, [black circle] as a symbol mark.

  In step S6, the display control unit 33 creates a display screen in which the lot number and bottle number of the reagent used for the control measurement are associated with the symbol mark indicating the measurement result of the control measurement, and displays the created display screen. This is displayed on the unit 35. FIG. 5 shows an example of the display screen associated in this way. The table shown in FIG. 5 shows the aspiration date, aspiration time, result (measurement result), display (symbol mark of plot display), and comment (first reagent lot number-bottle number), which is the date when the control measurement was performed. , The second reagent lot number-bottle number) in association with each other.

[Step S7]
In step S7, it is determined whether or not the number of control measurements has reached n samples. In step S7, the measurement control unit 32 determines whether or not the control measurement has been performed for the number [n] (for example, three) of the control samples set in advance as the measurement condition (4). Only when it is determined that the measurement has been made (YES), the process proceeds to the next step S8. If it is determined that the measurement has not been made (NO), the process returns to step S5, and steps S5 and S6 are repeated.

  As a result, the three measurement results indicated by the black circle symbol marks are plotted and displayed on the display unit 35 as shown in FIG. These plot-displayed measurement results are the results of the control measurement using the first reagent and the second reagent of the same lot number and bottle number as the calibration measurement performed in step S3, and immediately before that, step S4 Guarantee the calibration curve created in. Also, as shown in FIG. 5, three columns of information associated with the three black circle symbol marks are displayed.

[Step S8]
On the other hand, in step S8, it is determined whether or not to continue the control measurement. In step S8, the measurement control unit 32 determines that the control measurement is continued (YES) when all the control measurements at the timing set in the measurement condition (3) are not performed. Then, the process proceeds to step S9. On the other hand, when all the control measurements are performed at the timing set in the measurement condition (3), it is determined that the control measurement is not continued (NO). Then, the process proceeds to step S10.

[Step S9]
In step S9, the control measurement start is determined. In step S9, the measurement control unit 32 determines whether or not the timing for performing the control measurement set as the measurement condition (3) has been reached. Then, step S9 is repeated until it is determined that it has been reached (YES). When it is determined that it has been reached (YES), the process returns to the next step S5, and steps S5 to S9 are repeated.

[Step S10]
On the other hand, in step S10, it is determined whether or not to continue the calibration measurement. In step S10, the measurement control unit 32 determines that the calibration measurement is continued (YES) when all the calibration measurements at the timing set in the measurement condition (1) are not performed. Then, the process proceeds to step S11. On the other hand, when all the calibration measurements are performed at the timing set in the measurement condition (1), it is determined that the calibration measurement is not continued (NO). Then, the quality control flow is terminated.

[Step S11]
In step S11, the symbol mark of the plot display indicating the measurement result of the control measurement is changed. In step S11, the display control unit 33 changes the symbol mark used for the plot display when plotting the measurement result of the control measurement performed thereafter. Here, for example, in the previous step S6, the symbol mark of the plot display is changed from the previously used [black circle] to, for example, [black triangle].

  After the above step S11, the process returns to step S2, and when it is determined at step S2 that the calibration is started (YES), the process proceeds to step S3 to perform calibration measurement. This calibration measurement uses a reagent set in the measurement condition (1). Thereafter, step S4 and subsequent steps are repeated.

  As a result, in step S6 performed thereafter, the display control unit 33 sequentially displays the measurement result of the control measurement in step S5 on the display unit 35 using [black triangle] as a symbol mark. (See FIG. 4). This symbol mark is used for the measurement result of the control measurement until the calibration curve to be used is switched when the reagent is switched. Also. The display control unit 33 displays the changed symbol mark on the display unit 35 in association with the lot number and bottle number of the reagent used for the control measurement (see FIG. 5).

  4 and 5, the control measurement is performed as the measurement condition (3) only immediately after the calibration measurement, and the number of control samples [n] at the time of the control measurement is set to three as the measurement condition (4). Shows the case. For this reason, the measurement result of the control measurement is plotted and displayed with the symbol mark changed for every three measurement results. The measurement result of the control measurement plotted with the same symbol mark assures a calibration curve created by one calibration measurement performed immediately before.

  Note that while the above-described calibration start determination in step S2 is repeated and the control measurement start determination in step S9 is repeated, measurement on the sample specimen is performed. At this time, quantitative analysis using a calibration curve that has already been prepared is performed, but measurement relating to the sample specimen is performed using the reagent of the same lot number and bottle number as in the calibration measurement when creating the calibration curve. .

<Effects of automatic analyzer and automatic analysis method>
In the automatic analyzer 1 described above and the automatic measurement method using the same, each time the calibration measurement is performed, the measurement result of the control measurement performed using the same reagent as the calibration measurement uses a different symbol mark. Is displayed as a plot. For this reason, the measurement result of the control measurement that guarantees one calibration curve created by the calibration measurement can be grasped as one piece of information for each symbol mark. As a result, it is possible to intuitively recognize the switching of the calibration curve guaranteed by the measurement value of the control sample.

  DESCRIPTION OF SYMBOLS 1 ... Automatic analyzer, 1a ... Measurement part, 32 ... Measurement control part, 33 ... Display control part, 35 ... Display part

Claims (5)

A measurement unit for measuring the characteristics of a reaction solution obtained by reacting a sample to be measured and a reagent;
The measurement unit performs calibration measurement using the calibrator as the sample to be measured for each lot of the reagent, and performs control measurement using the control sample as the sample to be measured after the calibration measurement. A measurement control unit that performs the calibration using the same lot of reagent as the calibration measurement, and
A display unit for displaying a measurement result in the measurement unit;
A display control unit that changes the symbol mark for each calibration curve used to obtain the measurement result, and sequentially displays the measurement result of the control measurement in the measurement unit on the display unit. Analysis equipment. 2. The display control unit causes the display unit to display the reagent lot used in the calibration measurement and the control measurement in association with the symbol mark indicating the measurement result of the control measurement. Automatic analyzer described in 1. The measurement control unit causes the measurement unit to perform the calibration measurement every time the reagent bottle containing the reagent is changed, and uses the reagent in the same reagent bottle as the calibration measurement to perform the control measurement. The automatic analyzer according to claim 1 or 2. The display control unit causes the display unit to display the reagent bottle used for the calibration measurement and the control measurement in association with the symbol mark indicating the measurement result of the control measurement. The automatic analyzer described. An automatic analysis method for measuring characteristics of a reaction solution obtained by reacting a sample to be measured with a reagent,
Perform calibration measurement using the calibrator as the sample to be measured at least for each lot of the reagent,
Control measurement using the control sample as the sample to be measured is performed using a reagent of the same lot as the calibration measurement at a predetermined timing after the calibration measurement,
An automatic analysis method in which the measurement results of the control measurement are sequentially plotted and displayed by changing the symbol mark for each calibration curve used to obtain the measurement results.

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