JP5931231B2 - Automatic analyzer - Google Patents

Description

  The present invention relates to an analytical apparatus for clinical examination that performs qualitative and quantitative analysis of biological samples such as blood and urine, and more particularly to an automatic analyzer that has a function of creating a calibration curve for performing concentration calculation.

  An analyzer for a clinical test measures a specific component in a biological sample such as blood and urine. As a general movement, each sample and reagent are dispensed into a reaction vessel with a dedicated nozzle, stirred, and then reacted for a certain period of time. The information is obtained from information such as absorbance and luminescence obtained from the reaction solution. Concentration calculation for the item to be performed. When the concentration is calculated in this way, a calibration curve is used that uses the absorbance or the amount of luminescence per concentration as an index. As a method for creating a calibration curve, an example in the case of performing concentration calculation using absorbance is shown below. First, the absorbance per a plurality of concentrations is measured using several standard solutions with predetermined concentrations, and the relationship between the measured concentration and the absorbance is plotted. Thereafter, these points are connected by a linear or non-linear regression equation to create a calibration curve.

  The number of standard solutions to be measured when creating a calibration curve varies depending on the item, but there is also a standard solution common to a plurality of items. Therefore, it is difficult for the device user to accurately grasp how much measurement of the target item will be possible.

  In addition, because multiple standard solutions are used, if you forget to request a standard solution measurement or forget to install a standard solution in the device, a calibration curve will not be created and you will be asked to create a calibration curve again. Must be done and is very inconvenient.

  Patent Document 1 shows a function of displaying the remaining measurement time of each standard solution (hereinafter referred to as remaining time) on the GUI. In creating a calibration curve, the measurement results of all standard solutions required for the item must be available. However, with multiple standard solutions, the number of items assigned to each standard solution may differ, or the standard solutions may not be next to each other, so even if the remaining time is displayed for each standard solution, The time for obtaining the target item must be calculated by checking the remaining time of all the standard solutions on the GUI, which is not very advantageous. In addition, in order to confirm whether the necessary standard solution is measured, it is necessary to confirm one by one on the GUI, which increases the work amount of the apparatus user.

JP 2010-151707 A

  Workers in clinical settings such as clinical laboratory technicians are kept to a minimum in the flow of reducing medical expenses, and one engineer is in charge of multiple tasks and is extremely busy. Therefore, if we know the time when we can leave the device we are in charge of, we can concentrate on other tasks. As described above, the current analyzer can output the time until the measurement is completed for each sample. For patient specimens, the remaining time for each specimen can be displayed, so that the scheduled report time for the doctor can be grasped, and the remaining time output for each specimen can be said to be a convenient function.

  The calibration curve creation work is basically performed at a very busy time immediately before a large amount of specimen is carried to the laboratory. In addition, a plurality of standard solutions (specimens) are measured per item for preparing a calibration curve. As described above, a plurality of standard solutions are measured for one item, and a plurality of standard solutions are measured for one standard solution. Since the conditions change from time to time, such as when an item is used, the user of the device knows how many minutes it will be possible to measure and forgetting to install a standard solution or forget to request a measurement. It was difficult.

  The present invention allows the user of the device to forget the installation of reagents used for the measurement items to be measured, forget the measurement requests, and to know the time when the items to be measured can be measured with minimal operations such as screen operations. it can. Another object of the present invention is to be able to check the measurement status of each standard solution on one GUI so that the business can be performed efficiently.

  The configuration of the present invention for solving the above problems is as follows.

  When creating a standard curve using a standard solution to measure the concentration of components contained in biological samples such as blood (blood cells or liquid components), urine, and cerebrospinal fluid, the measurement status for each measurement item (measurement completed) This is an automatic analyzer having a function of outputting identification information for identifying whether the measurement is in progress and before measurement, the remaining time until the measurement is completed, and the measurement status of each standard solution.

A representative invention of the present application includes a reaction disk on which a reaction vessel for reacting a sample and a reagent is mounted, a light source that irradiates light to the reaction vessel, a photometer that detects light transmitted through the reaction vessel, Storage means for storing calibration curve data for calculating the concentration of a component contained in the sample, measurement curve data measured using a standard solution of known concentration as the sample, stored in the storage means, and the luminous intensity A control unit that calculates a component concentration of a measurement item included in the sample from information detected by a meter and the calibration curve data stored in the storage unit; and an information device that outputs a measurement status of the calibration curve data; The control unit outputs, to the information device, identification information that can identify before measurement and during measurement for each measurement item, and a plurality of the control units are used for measuring the calibration curve data of one measurement item. All standard solutions When the measurement is started, the control unit outputs the identification information that can identify that the measurement item is being measured as the measurement state of the calibration curve data to the information device, and the plurality of standards. When measurement of all the standard solutions is not started, the control unit is an automatic analyzer that outputs the identification information that can identify that the measurement item is before measurement to the information device .

  In another representative invention of the present application, a reaction disk on which a reaction vessel for reacting a sample and a reagent is placed, a light source for irradiating light to the reaction vessel, and a light intensity for detecting light transmitted through the reaction vessel. A storage unit for storing calibration curve data for calculating the concentration of a component contained in the sample, and the calibration curve data is measured using a standard solution with a known concentration as the sample and stored in the storage unit, In addition, a control unit that calculates the component concentration of the measurement item contained in the sample from the information detected by the photometer and the calibration curve data stored in the storage means, and outputs the measurement status of the calibration curve data For each measurement item, the control unit outputs identification information that can identify measurement success and measurement failure to the information device, and is used for measuring the calibration curve data of one measurement item. Out of several standard solutions If the part is measured fails, the control unit, for the measurement status of the one of the measurement items, is identification information capable of identifying a measurement failure automatic analyzer that outputs to the information device.

In another representative invention of the present application, a reaction disk on which a reaction vessel for reacting a sample and a reagent is placed, a light source for irradiating light to the reaction vessel, and a light intensity for detecting light transmitted through the reaction vessel. A storage unit for storing calibration curve data for calculating the concentration of a component contained in the sample, and the calibration curve data is measured using a standard solution with a known concentration as the sample and stored in the storage unit, In addition, a control unit that calculates the component concentration of the measurement item contained in the sample from the information detected by the photometer and the calibration curve data stored in the storage means, and outputs the measurement status of the calibration curve data The control unit, for each measurement item as a measurement state of the calibration curve data, all of a plurality of standard solutions used for measurement of the calibration curve data of the one measurement item Measurement of standard solution started This is an automatic analyzer that outputs identification information that can identify before and during measurement to the information device depending on whether or not the measurement is in progress.

  The present invention allows the user of the device to forget the installation of reagents used for the measurement items to be measured, forget the measurement requests, and to know the time when the items to be measured can be measured with minimal operations such as screen operations. it can. In addition, since the measurement status of each standard solution can be confirmed on one GUI, work can be efficiently performed.

It is the figure which added the conceptual diagram of a control system to the upper surface layout of the principal part of an automatic analyzer by this invention. It is a figure which shows an example of the GUI display by this invention. It is a figure which shows an example of the GUI display by this invention. It is a figure which shows an example of the GUI display by this invention. It is a figure which shows an example of the GUI display by this invention. It is a figure which shows an example of the GUI display by this invention. It is a figure which shows an example of the GUI display by this invention. It is a figure which shows an example of the GUI display by this invention. It is a figure which shows an example of the GUI display by this invention.

  Hereinafter, an automatic analyzer for clinical testing, a screen configuration and functions will be described with reference to FIGS. 1 to 9 according to an embodiment of the present invention.

  First, an example of an automatic analyzer to which the present invention is applied will be described with reference to FIG. FIG. 1 is a diagram in which a conceptual diagram of a control system is added to the top layout of the main part of the automatic analyzer. The automatic analyzer to which the present invention is directed is provided with a mechanism for collecting a predetermined amount of a liquid such as a sample or a reagent using a dispensing nozzle. In the following description, an automatic analyzer for clinical tests that analyzes biological samples such as blood and urine will be described as an example. Is not to be done.

  The automatic analyzer 1 is arranged concentrically with the sample disk 2 and the sample container 3 arranged concentrically, the reaction disk 4 and the reaction container 5 arranged concentrically, the sample dispensing mechanism 6 and the reagent disk 7. Reagent container 8 containing various reagents, reagent dispensing mechanism 9, stirring mechanism 10, light source 11, photometer (multi-wavelength photometer) 12, A / D converter 13, reaction container cleaning mechanism 14, dispensing nozzle A cleaning mechanism 15 is provided.

  The analysis by the automatic analyzer 1 is performed in the following order. First, the sample dispensing mechanism 6 dispenses the sample to be analyzed from the sample container 3 to the reaction container 5. Next, the reagent dispensing mechanism 9 dispenses a reagent used for analysis from the reagent container 8 to the reaction container 5. Subsequently, the mixed solution is stirred by the stirring mechanism 10. Light generated from the light source 11 and transmitted through the reaction vessel 5 containing the mixed solution is detected and measured by a photometer (multi-wavelength photometer) 12 and transmitted to the interface 17 via the A / D converter 13. The computer 18 includes a control unit, and the measurement result obtained as a result of the calculation by the control unit is stored in the storage unit 19 and is output to the information device, for example, displayed on the display unit 20. The dispensing nozzle cleaning mechanism 15 cleans the tip of the dispensing nozzle each time the sample dispensing mechanism 6 and the reagent dispensing mechanism 9 dispense a sample or reagent. The reaction vessel 5 after the reaction is washed by the reaction vessel washing mechanism 14 and repeatedly used for the next reaction. The operation mechanisms of these analyzers are all controlled by a control unit included in the computer 18 via the communication means 16 and the interface 17.

  In calculating the above measurement results, a calibration curve is used. The calibration curve data is measured in advance before measuring a sample having a predetermined item of unknown concentration. Calibration curve data can be created by using a standard solution with a predetermined concentration of a predetermined item and determining the relationship between the concentration and information detected by the photometer. Based on the obtained relationship, the concentration of the predetermined item can be obtained from the information detected by the photometer for the sample having the unknown concentration.

  The specific example which outputs the measurement condition of the calibration curve data of the automatic analyzer in this invention to an information apparatus is demonstrated using FIGS. For convenience of explanation, in FIG. 2 to FIG. 9, display contents of the measurement situation when the display unit 20 provided in the automatic analyzer is an information device will be described. However, it is not always necessary to output to the display unit 20, and the measurement status is output to an information device such as a printer that prints the measurement status on a paper medium or a mobile device that displays the measurement status. Also good. That is, as long as the operator can recognize the measurement state, the effect of the present invention can be obtained by outputting to any information device.

  FIGS. 2 to 9 show an example of the measurement status confirmation information display on the GUI, and create a calibration curve using the five standard solutions (STD1 to STD5) for the measurement item C (TestC) (hereinafter referred to as calibration). This example shows

  The GUI is broadly classified into a parent screen 21 indicating each device operation category and a child screen 22 indicating a detailed situation with respect to the parent screen. When the standard solution measurement status 23 is displayed in the sub-screen 22, the “standard solution measurement status display area for each item” 24 and the item “designated item” specified in the area 24 are displayed in the sub-screen 22. "Standard solution measurement status display area" 25 is displayed.

  In the standard solution measurement status display area 24 for each item, the current measurement status, item name, reagent installation location, reagent usage status, calibration execution method, and all items necessary for the item being calibrated are displayed. The remaining time until the measurement of the standard solution is completed is displayed. In the current measurement status, P (during measurement; processing), S (successful calibration; successful), and F (calibration failed; failed) are displayed as necessary. However, the measurement status is not limited to S, P, and F as long as it is identification information that can identify the completion of measurement, during measurement, and before measurement. For example, it is only necessary that the operator can identify each situation such as color and hatching. In this example, the user can identify the completion of measurement by displaying S and P, the measurement in progress by displaying P, and the measurement before by blank.

  In the standard solution measurement status display area 25 of the designated item, as the standard solution measurement status of the item selected in the standard solution measurement status display area 24 for each item, the current measurement status, each standard solution name, each standard solution The installation location, the analysis start time of each standard solution, and the remaining time until the completion of measurement of each standard solution are displayed. As in the standard solution measurement status display area 24 for each item, P (measuring; Processing), S (calibration successful; Successful), and F (calibration failure: Failed) are required for the current measurement status. Depending on the display. As with the above, this may be identification information that can be identified by the operator.

  FIG. 2 illustrates an example in which “standard solution measurement status display area for each item” 24 and “standard solution measurement status display area of specified item” 25 are displayed on the same screen. The display screen may be switched and displayed by selecting a predetermined item from the item name column in the “standard solution measurement status display area for each item” 24 without being displayed. However, by displaying these areas together on the same screen, it becomes possible to check the measurement status of each standard solution on one GUI, so that work can be performed efficiently.

  FIG. 2 shows a GUI when “Test C” is requested to be measured by the calibration method for all points. When “TestC” is selected in the standard solution measurement status display area 24 for each item, the names of five standard solutions that are all standard solutions required for “TestC” are displayed in the standard solution measurement status display area 25 of the designated item. The location of the standard solution is shown. Note that STD1 to STD5 are standard solutions having different concentrations with respect to components.

  FIG. 3 shows a GUI when “Test C” is requested to be measured by a blank calibration execution method. When “TestC” is selected in the standard solution measurement status display area 24 for each item, the name of the standard solution 1 (STD1) and the standard solution 1 (STD1) are displayed in the standard solution measurement status display area 25 of the designated item. The installation location is indicated.

  That is, even for the same item, the required standard solution differs by changing the calibration execution method, and the standard solution corresponding to this calibration execution method is displayed in the standard solution measurement status display area 25 of the designated item. Thus, the control unit outputs the measurement status and displays it on the display unit.

  FIG. 4 shows a GUI when “Test C” is requested to be measured by the calibration execution method for all points, and the apparatus starts measurement up to standard solution 3 (STD 3). In this state, since measurement of all standard solutions has not been started, nothing is displayed in the “status” and “remaining time” columns in the standard solution measurement status display area 24 for each item. That is, the operator can easily recognize that the corresponding reagent is in a state before measurement by visually confirming that nothing is displayed in the “situation” column or “remaining time” column. When “TestC” is selected in the standard solution measurement status display area 24 for each item, the standard solution 1 (STD1) and standard solution 2 in which measurement is started are displayed in the standard solution measurement status display area 25 of the designated item. (STD2), “P” is displayed in the “Status” column of Standard Solution 3 (STD3), and the time is displayed in the “Analysis Start Time” and “Remaining Time” columns. That is, the operator can easily recognize that the corresponding reagent is being measured by visually checking the “situation” column and the “remaining time” column. At this stage, since the measurement of all necessary standard solutions has not started, the “status column” in the standard solution measurement status display area 24 for each item is displayed as identification information before measurement.

  FIG. 5 shows a GUI when “Test C” is requested to be measured by the calibration execution method for all points, and the apparatus starts measuring all the standard solutions (STD1 to STD5). In this state, since all standard solutions have been measured, “P” is displayed in the “Status” column in the standard solution measurement status display area 24 for each item, and time is displayed in the “Remaining time” column. The When “TestC” is selected in the standard solution measurement status display area 24 for each item, “P” is displayed in the “status” column of all standard solutions in the standard solution measurement status display area 25 of the designated item. In the “Analysis start time” and “Remaining time” fields, time is displayed. Therefore, the operator can recognize the remaining time when the measurement is completed in the calibration execution method for all points with respect to “TestC”. The “remaining time” in the standard solution measurement status display area 24 for each item is the largest remaining time in the “remaining time” in the standard solution measurement status display area 25 of the specified item, and the control unit displays the remaining time. To the output. In FIG. 5, since the remaining time of the standard solution 5 (STD5) corresponds to this, “10 minutes” is displayed as the remaining time.

  In Fig. 6, when "TestC" is requested to perform the calibration using the calibration method for all points, the device starts measuring all the standard solutions, but forgets to install only the standard solution 4 (STD). The GUI is shown. In this state, only the measurement of the standard solution 4 (STD4) is not performed and normal calibration cannot be performed. Therefore, “F” is displayed in the “status” column in the standard solution measurement status display area 24 for each item, Nothing is displayed in the “Remaining time” column. Further, when “TestC” is selected in the standard solution measurement status display area 24 for each item, the standard solution measurement status display area 25 of the designated item is different from FIG. 5 in that only “standard solution 4 (STD4)” is displayed. “F” is displayed in the “status” column, nothing is displayed in the “analysis start time” and “remaining time” columns. In this way, the operator can visually confirm that the calibration of “TestC” has been completed but has failed, and further, “analysis start time” of the standard solution 4 (STD4) in the standard solution measurement status display area 25 of the designated item. When the column is blank, it can be understood that the analysis of the standard solution 4 has not been started, which is an opportunity to notice that the standard solution is forgotten to be installed or the measurement request is forgotten.

  In FIG. 7, “TestC” is requested to perform the calibration with the all-point calibration execution method, and the apparatus starts measuring all the standard solutions. However, the amount of standard solution 4 (STD4) is small, and the second time of STD4. The GUI when the standard solution of was not able to be measured is shown. In this state, only the second measurement of STD 4 is not performed, and normal calibration cannot be performed. Therefore, “F” is displayed in the “Status” column in the standard solution measurement status display area 24 for each item, and “Remaining” Nothing is displayed in the “Time” column. Further, when “TestC” is selected in the standard solution measurement status display area 24 for each item, the “situation” of the second time of STD 4 is not displayed in the standard solution measurement status display area 25 of the designated item, unlike FIG. “F” is displayed in the column, and nothing is displayed in the “analysis start time” and “remaining time” columns. By displaying in this way, it becomes an opportunity to notice that the standard solution 4 (STD4) is insufficient.

  FIG. 8 shows a GUI when “Test C” is requested to be measured by the calibration execution method for all points and the measurement is completed up to the standard solution 3 (STD 3). In this state, since measurement of all the standard solutions has not been completed, “P” is displayed in the “status” column in the standard solution measurement status display area 24 for each item, and the “remaining time” column is the most. The remaining time of the standard solution is displayed for a long time until the measurement is completed. When “TestC” is selected in the standard solution measurement status display area 24 for each item, the standard solution 1 (STD1) and standard solution 2 (standard solution 2 ( “S” is displayed in the “status” column of STD2) and standard solution 3 (STD3), and nothing is displayed in the “remaining time” column. Note that “P” is displayed in the “Status” column of the standard solution 4 and the standard solution 5 that are still being measured, and the remaining time until the measurement is completed is displayed in the “Remaining time” column.

  FIG. 9 shows the GUI when “Test C” is requested to be measured by the calibration execution method for all points, and the calibration is successful after the measurement of all the standard solutions is completed. In this state, since measurement of all the standard solutions has been completed, “S” is displayed in the “status” column in the standard solution measurement status display area 24 for each item, and nothing is displayed in the “remaining time” column. Do not show. When “TestC” is selected in the standard solution measurement status display area 24 for each item, “S” is displayed in the “status” column of all standard solutions in the standard solution measurement status display area 25 of the designated item. Nothing is displayed in the “Remaining time” column.

  The embodiment of the present application has been described above. According to the present invention, the measurement status of the calibration curve data can be easily confirmed for each measurement item, and the user of the device forgets to install the reagent used for the measurement item to be measured or requests the measurement with a minimum operation such as screen operation. You can forget exactly what time you want to measure the item you want to measure.

  In addition, by checking the scheduled calibration curve creation time for each item by the device user, it is possible to accurately grasp the time away from the device and concentrate on other work that can be done within the free time. Improvement is possible.

1 automatic analyzer 2 sample disk 3 sample container 4 reaction disk 5 reaction container 6 sample dispensing mechanism 7 reagent disk 8 reagent container 9 reagent dispensing mechanism 10 stirring mechanism 11 light source 12 photometer (multi-wavelength photometer)
13 A / D converter 14 Reaction vessel cleaning mechanism 15 Dispensing nozzle cleaning mechanism 16 Communication means 17 Interface 18 Computer 19 Storage means 20 Display section 21 Parent screen 22 Subscreen 23 Standard solution measurement status screen tab 24 Standard solution measurement status for each item Display area 25 Standard solution measurement status display area for specified items

Claims (10)

A reaction disk on which a reaction vessel for reacting the sample and the reagent is placed;
A light source for irradiating the reaction vessel with light;
A photometer for detecting light transmitted through the reaction vessel;
Storage means for storing calibration curve data for calculating the component concentration contained in the sample;
The calibration curve data is measured using a standard solution with a known concentration as a sample, stored in the storage means, and from the information detected by the photometer and the calibration curve data stored in the storage means, A control unit for calculating the component concentration of the measurement item contained in the sample;
An information device that outputs the measurement status of the calibration curve data,
For each measurement item, the control unit outputs identification information that can identify before measurement and during measurement to the information device,
When measurement of all the standard solutions among a plurality of standard solutions used for measurement of the calibration curve data of one measurement item is started, the control unit, as the measurement status of the calibration curve data, Outputting the identification information for identifying that the measurement item is being measured to the information device ,
When measurement of all the standard solutions is not started among the plurality of standard solutions, the control unit outputs the identification information that can identify that the measurement item is before measurement to the information device. A featured automatic analyzer. The automatic analyzer according to claim 1, wherein
The case where measurement of all the standard solutions is not started among the plurality of standard solutions means that the measurement of the standard solution is not started for any of the plurality of standard solutions, or An automatic analyzer characterized in that the measurement of the standard solution is not started for at least one of them . The automatic analyzer according to claim 2,
The automatic analysis apparatus is characterized in that the control unit displays nothing in a column for outputting identification information that can be identified as being measured as identification information that can be identified before the measurement. In the automatic analyzer in any one of Claims 1-3,
For each standard solution with a known concentration used for measurement of the calibration curve data of one of the measurement items, the measurement status of the standard solution is as follows:
The said control part outputs the identification information which can identify before measurement and during measurement to the said information equipment, The automatic analyzer characterized by the above-mentioned. The automatic analyzer according to claim 4,
For each standard solution of a known concentration used for measuring the calibration curve data of one measurement item, the control unit can identify the standard solution measurement status so that it can identify before measurement, during measurement, and measurement completion. Outputting information to the information device,
The control unit switches the output from the measurement to the measurement completion identification information for each standard solution of the known concentration in a state where the identification information for identifying that the measurement item is being measured is output to the information device. An automatic analyzer characterized by that. The automatic analyzer according to claim 5, wherein
The control unit outputs, as the measurement state of the calibration curve data, identification information that can identify before measurement, during measurement, and measurement completion to the information device for each measurement item,
When the output of all of the standard solutions of known concentrations used for measurement of the calibration curve data of one measurement item is switched from being measured to identification information indicating completion of measurement, the control section An automatic analyzer characterized in that the output of the measurement status of a measurement item is switched from the measurement to the identification information of measurement completion. A reaction disk on which a reaction vessel for reacting the sample and the reagent is placed;
A light source for irradiating the reaction vessel with light;
A photometer for detecting light transmitted through the reaction vessel;
Storage means for storing calibration curve data for calculating the component concentration contained in the sample;
The calibration curve data is measured using a standard solution with a known concentration as a sample, stored in the storage means, and from the information detected by the photometer and the calibration curve data stored in the storage means, A control unit for calculating the component concentration of the measurement item contained in the sample;
An information device that outputs the measurement status of the calibration curve data,
The control unit, for each measurement item, outputs identification information that can identify measurement success and measurement failure to the information device,
When a part of a plurality of standard solutions used for measurement of the calibration curve data of one measurement item fails in measurement, the control unit performs measurement failure for the measurement state of the one measurement item. An automatic analyzer that outputs identification information capable of identifying the information to the information device. A reaction disk on which a reaction vessel for reacting the sample and the reagent is placed;
A light source for irradiating the reaction vessel with light;
A photometer for detecting light transmitted through the reaction vessel;
Storage means for storing calibration curve data for calculating the component concentration contained in the sample;
The calibration curve data is measured using a standard solution with a known concentration as a sample, stored in the storage means, and from the information detected by the photometer and the calibration curve data stored in the storage means, A control unit for calculating the component concentration of the measurement item contained in the sample;
An information device that outputs the measurement status of the calibration curve data,
The control unit starts measurement of all standard solutions of a plurality of standard solutions used for measurement of the calibration curve data of one measurement item for each measurement item as the measurement state of the calibration curve data. An automatic analyzer that outputs identification information that can identify before and during measurement to the information device depending on whether or not the measurement is performed. In the automatic analyzer in any one of Claims 1-7,
The control unit outputs a measurement situation for each measurement item and a measurement situation for each standard solution on one screen of the information device. In the automatic analyzer in any one of Claims 1-9,
The automatic analysis apparatus, wherein the information device is a display unit that displays the measurement status of the calibration curve data or a mobile device that displays the measurement status of the calibration curve data.