阅读说明：本技术 自动分析装置 (Automatic analyzer ) 是由 薮谷千枝 山田巧 饭岛昌彦 于 2018-02-15 设计创作，主要内容包括：本发明将进行多个不同分析的测定单元集成为一台自动分析装置中,要求即使在某个测定单元发生异常时,仍能使可动作的其它测定单元工作。然而,关于共通管理的试剂、消耗品,存在如下问题：即使在实施屏蔽以不使用某个测定单元的情况下,屏蔽的状况不被反映,为了不使用的测定单元对不必要的准备分配时间。自动分析装置包括：对收纳检体的检体容器进行保持的样本盘、对收纳试剂的试剂容器进行保持的试剂盘、分别进行不同种类的分析的至少2个以上不同的测定单元、以及对所述测定单元进行控制的控制部,该自动分析装置的特征在于,包括显示部,该显示部对表示该2个以上的测定单元的操作的流程的作业流程区域以及显示各测定单元的可否使用状况的概览区域进行显示,所述概览区域具有能够对是否使用所述各测定单元进行选择的是否使用单元选择部,所述控制部基于所述是否使用单元选择部中设定的信息,对所述显示部进行控制以使得变更所述作业流程区域的显示。(The present invention integrates a plurality of measurement units for different analyses into one automatic analyzer, and requires that other measurement units which are operable even when an abnormality occurs in a certain measurement unit be operated. However, the following problems exist with respect to commonly managed reagents and consumables: even when masking is performed so that a certain measurement unit is not used, the state of masking is not reflected, and time is allocated to unnecessary preparations for the measurement unit not used. The automatic analysis device includes: the automatic analyzer includes a display unit that displays a work flow area indicating a flow of an operation of the 2 or more measurement units and an overview area indicating a usability of each measurement unit, the overview area having a unit-of-use-not-use-unit selecting unit that can select whether to use each measurement unit, and the control unit controls the display unit to change a display of the work flow area based on information set in the unit-of-use-not-use-unit selecting unit.)

1. An automated analysis device comprising: a reagent tray that holds a plurality of reagent containers that store reagents; at least 2 or more different measurement units that perform different kinds of analyses using the reagents, respectively; and a control unit for controlling the measurement unit, wherein the automatic analyzer is characterized in that,

a display unit that displays a reagent overview screen showing the remaining amount and arrangement information of the reagent in each of the plurality of reagent containers held in the reagent disk as detailed information on the reagent used in each of the 2 or more measurement units,

in the unit-for-use-or-not-use selector capable of selecting whether or not to use each of the 2 or more measurement units, when the use of at least one measurement unit of the 2 or more measurement units is not selected,

the display unit is controlled so as not to display the remaining amount and arrangement information of the reagent in the reagent container using the measurement unit that has not been selected on the reagent overview screen.

2. An automated analysis device comprising: a reagent tray that holds a plurality of reagent containers that store reagents; at least 2 or more different measurement units that perform different kinds of analyses using the reagents, respectively; and a control unit for controlling the measurement unit, wherein the automatic analyzer is characterized in that,

a display unit that displays a reagent overview screen showing the remaining amount and arrangement information of the reagent in each of the plurality of reagent containers held in the reagent disk as detailed information on the reagent used in each of the 2 or more measurement units,

in the unit-for-use-or-not-use selector capable of selecting whether or not to use each of the 2 or more measurement units, when use of at least one measurement unit of the 2 or more measurement units is selected,

the display unit is controlled so that only the remaining amount and arrangement information of the reagent in the reagent container using the selected measurement unit are displayed on the reagent overview screen.

3. The automatic analysis device according to claim 1 or 2,

the display unit further displays a work flow area indicating a flow of the operation of the 2 or more measurement units,

the control unit controls the display unit to change the display of the work flow area based on the information set in the unit-of-use or non-use selection unit.

4. The automatic analysis device according to claim 3,

the workflow area has at least 1 or more buttons for confirming operation information relating to preparation of measurement by the measurement unit, that is, more detailed information on measurement for maintenance, reagent, and consumable, calibration, and control, respectively.

5. The automatic analysis device according to claim 4,

the control unit controls the display unit so that the button displays identification information indicated by a color or a mark based on information on whether or not the corresponding measurement preparation is performed.

6. The automatic analysis device according to claim 3,

the display unit displays a setting unit that can set whether to change the display of the work flow area based on the information set in the unit selecting unit.

7. The automatic analysis device according to claim 6,

the flow of the operation of the measurement unit shown in the work flow area includes at least 2 or more of the measurements of maintenance, reagents and consumables, calibration, and control as operation information related to the measurement preparation of the measurement unit,

the setting unit may set whether or not to change the display of the work flow area for each or all of the 2 or more pieces of operation information based on the information set in the use-or-nonuse unit selecting unit.

8. The automatic analysis device according to claim 3,

when a button for confirming more detailed information on maintenance in the workflow area is selected,

the control unit controls the display unit to display a maintenance screen recommended to be executed based on information of a period preset for each maintenance item and information of an elapsed time since the previous execution of maintenance.

9. The automatic analysis device according to claim 3,

when a button for confirming more detailed information on the measurement of the calibration and control in the work flow area is selected,

the control unit controls the display unit so that a correction/control screen is displayed, the correction/control screen being a screen recommending the execution of correction and/or the measurement of control based on information on the execution status of correction and the measurement status of control.

Technical Field

The present invention relates to an automatic analyzer for analyzing the amount of components contained in a sample such as blood or urine, and more particularly to an automatic analyzer capable of measuring biochemical analysis items and coagulation time items.

Background

A sample test for processing a sample such as blood or urine collected from a patient is classified into a plurality of test fields such as biochemical test, immunological test, blood coagulation test, and the like, and diagnosis and confirmation of therapeutic effect are performed by integrating the results of the plurality of tests.

For example, biochemical tests for measuring components such as sugars, lipids, proteins, and enzymes by reacting a sample with a reagent and immunoassays for measuring components such as bacteria and viruses by an antigen-antibody reaction, and antibodies, hormones, tumor markers, and the like generated when bacteria and viruses enter the human body are known as tests for analyzing components such as blood and urine. Biochemical tests generally involve mixing a sample and a reagent, measuring the color change caused by a chemical reaction by using an automatic biochemical analyzer that transmits light, and immunological tests generally involve adding an antibody that binds an antigen contained in a sample to a luminophore to cause an antigen-antibody reaction, washing the unbound antibody, and measuring the amount of light emitted by the bound antibody. However, with the recent development of measuring instruments and measuring reagents, even with the use of biochemical automatic analyzers, it is possible to measure transmitted light or scattered light with higher sensitivity by using a measuring method such as immunoturbidimetry or latex agglutination, and also to measure a part of tumor markers, hormones, and the like, and therefore, in some cases, a single device can be used for processing test items that conventionally require a plurality of devices, and the difference between the two is small.

In the blood coagulation test, there are a test for measuring a factor controlling a blood coagulation reaction such as ATIII, an enzyme acting at a fibrinolytic stage such as PIC and the like, a by-product generated by a fibrinolytic reaction such as D dimer and FDP, and a test for a hemostatic function such as PT, APTT and fibrinogen, which are tests for measuring a precipitated fibrin by activating a blood coagulation factor contained in a sample and performing a blood coagulation reaction, and the test for a hemostatic function measures a blood coagulation time (hereinafter, may be simply referred to as a hemostatic function test, a blood coagulation time measurement, and the like). In recent years, a blood coagulation test apparatus that can cope with both of absorbance measurement and blood coagulation time measurement has also appeared so as to be able to cover the above-described blood coagulation test items.

Patent document 1 describes a device in which a plurality of types of measurement units having different measurement principles such as biochemical tests, immunological tests, and hemostatic function tests are integrated into 1 unit, and a case where a space is saved by sharing a part of components in the device such as a reagent supply unit and a reagent transfer unit is described.

In addition, patent document 2 describes the following technique: in an automatic analysis system in which a plurality of analysis units are connected via a transmission line, operations required by an operator are displayed on a screen in which the current state of the apparatus is reflected, and the analysis units required for preparatory operations are displayed by being distinguished by colors or the like, so that even for an operator who is not familiar with the operation of the apparatus, the preparatory operations can be accurately performed on the analysis units required for the preparatory operations.

Disclosure of Invention

Technical problem to be solved by the invention

When a plurality of kinds of analyses having different measurement items are measured by a single apparatus or system, various preparations such as various maintenance, replacement, calibration, and precision management of reagents and consumables are required in each apparatus or measurement unit, and therefore, a complicated and long-time operation is required. In particular, in an apparatus in which a plurality of functions are integrated into 1, operators who are not familiar with the apparatus often use the apparatus at night, and it is necessary to simplify the work when performing the above preparation. For example, for some reason, when one of the plurality of measurement units cannot be used, it is necessary to prevent unnecessary work from occurring as much as possible.

However, none of the above-mentioned patent documents 1 and 2 considers improvement of the work efficiency in the case where a certain measurement unit cannot be used. Therefore, in an analysis apparatus in which reagents and samples are managed in common by 1 system as in patent document 1 and analysis items are respectively assigned to a plurality of different analysis units, when an analysis unit necessary for a preparation operation is displayed separately by color separation or the like as in patent document 2, if a certain analysis unit is not used for some reason, the above-described situation is not reflected, and thus unnecessary preparation of a reagent or the like is promoted, and as a result, useless work may occur.

Technical scheme for solving technical problem

As one mode for solving the above problems, there is provided an automatic analyzer including: a sample tray for holding a sample container for storing a sample; a reagent tray that holds reagent containers that store reagents; at least 2 different measurement units for performing different kinds of analyses; and a control unit that controls the measurement units, wherein the automatic analyzer includes a display unit that displays a work flow area indicating an operation flow of the 2 or more measurement units and an overview area that displays a usability status of each measurement unit, the overview area includes a usability unit selection unit that can select whether or not each measurement unit is used, and the control unit controls the display unit so as to change a display of the work flow area based on information set in the usability unit selection unit.

Effects of the invention

According to the above-described aspect, in the automatic analyzer of a composite type including a plurality of analysis units each having a plurality of functions, whether or not to use can be selected for each analysis unit, and information can be provided to the operator by reflecting in the display that the preparation in advance is not recommended with respect to the analysis unit that is not used, whereby waste of time due to unnecessary preparation can be eliminated. Here, the preparation information includes preparation, calibration, controlled measurement, maintenance, and the like of a reagent.

Further, by avoiding the preparation of an undesired reagent or the like, the reagent is prevented from being undesirably unsealed, and the reagent can be prevented from deteriorating due to evaporation or a change in pH. Further, even in measurement and maintenance of calibration and control, by preventing unnecessary execution and executing the measurement at a timing suitable for execution, analysis can be performed under more appropriate conditions, which contributes to obtaining highly reliable analysis results with high accuracy.

Drawings

Fig. 1 is a diagram showing a basic configuration of a hybrid automatic analyzer according to the present embodiment.

Fig. 2(a) is a diagram showing an example of a system overview screen of the automatic analyzer according to the present embodiment.

Fig. 2(b) is a diagram showing an example of a system overview screen of the automatic analyzer according to the present embodiment.

Fig. 2(c) is a diagram showing an example of a system overview screen of the automatic analyzer according to the present embodiment.

Fig. 3(a) is a diagram showing an example of a maintenance screen of the automatic analyzer according to the present embodiment.

Fig. 3(b) is a diagram showing an example of a maintenance screen of the automatic analyzer according to the present embodiment.

Fig. 4 is a diagram showing an example of a display setting screen when a cell of the automatic analyzer according to the present embodiment is masked.

Fig. 5 is a diagram showing an example of a screen for setting a maintenance cycle of the automatic analyzer according to the present embodiment.

Fig. 6(a) is a diagram showing an example of a reagent disk overview screen of the automatic analyzer according to the present embodiment.

Fig. 6(b) is a diagram showing an example of a reagent disk overview screen of the automatic analyzer according to the present embodiment.

Fig. 7 is a diagram showing an example of a reagent replacement print screen of the automatic analyzer according to the present embodiment.

Fig. 8 is a diagram showing an example of calibration and QC screens of the automatic analyzer according to the present embodiment.

Fig. 9 is a diagram showing an example of a recommended screen for calibration of the automatic analyzer according to the present embodiment.

Detailed Description

Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. In general, components having the same functions in the drawings are denoted by the same reference numerals, and the description thereof will be omitted.

(Overall Structure of the device)

Fig. 1 shows a basic configuration of a composite automatic analyzer according to the present embodiment. Here, as an embodiment of the automatic analyzer, an example of a complex automatic analyzer that performs biochemical analysis and coagulation analysis (measurement of a coagulation fibrinolysis marker and a coagulation time) will be described. In this example, the automatic analyzer includes an absorption spectrophotometer for performing biochemical analysis and analysis of a thrombofibrinolytic marker, a scattering photometer for measuring a clotting time, and an ISE (ion selective electrode) unit for performing electrolyte analysis.

More specifically, as shown in the figure, the automatic analyzer 1 is mainly composed of a reaction disk 10, a sample disk 20, a 1 st reagent disk 30-1, a 2 nd reagent disk 30-2, an absorption photometer 40, a scattering photometer 45, a coagulation time measuring unit 50, an ISE unit 60, a computer 70, and the like.

The reaction disk 10 as a reaction vessel holding portion is a disk-shaped unit that can intermittently rotate in the left-right direction, and a plurality of reaction cells 11 made of a light-transmissive material are arranged along the circumferential direction of the reaction disk 10. The reaction unit 11 is maintained at a predetermined temperature (e.g., 37 ℃) via the thermostatic bath 12.

A plurality of specimen containers 21 for storing biological samples such as blood and urine are arranged on the specimen tray 20 serving as the specimen container holding portion in the circumferential direction of the inner and outer circles in the configuration example shown in the present figure.

A sample dispensing mechanism 22 is disposed in the vicinity of the sample disk 20. The sample dispensing mechanism 22 sucks a predetermined amount of sample from the sample container 21 located at a dispensing (sucking) position on the sample disk 20, and discharges the sample into the reaction cell 11 located at a dispensing (discharging) position 10a on the reaction disk 10.

The 1 st and 2 nd reagent trays 30-1 and 30-2, which are reagent container holding parts, are provided with a plurality of 1 st and 2 nd reagent bottles 31-1 and 31-2, to which labels indicating reagent identification information are attached, respectively, along the circumferential direction of the 1 st and 2 nd reagent trays 30-1 and 30-2. The reagent Identification information includes a barcode, RFID (Radio Frequency Identification), and the like, and here, a case of using a barcode will be described as an example. The 1 st and 2 nd reagent bottles 31-1 and 31-2 contain reagent solutions corresponding to analysis items to be analyzed by the automatic analyzer 1.

The 1 st and 2 nd reagent barcode reading devices 32-1 and 32-2 read the reagent barcodes attached to the outer walls of the 1 st and 2 nd reagent bottles 31-1 and 31-2 at the time of registration of the reagents. The read reagent information is registered in the memory 77 together with the position information on the 1 st reagent disk 30-1 and the 2 nd reagent disk 30-2. Further, a 1 st reagent dispensing mechanism 33-1 and a 2 nd reagent dispensing mechanism 33-2 are disposed in the vicinity of the 1 st reagent disk 30-1 and the 2 nd reagent disk 30-2, respectively. When reagent dispensing is performed, the liquid transfer nozzles provided in the liquid transfer units suck reagent from the 1 st and 2 nd reagent bottles 31-1 and 31-2 corresponding to the test items at the dispensing (sucking) positions 30-1a and 30-2a on the 1 st and 2 nd reagent disks 30-1 and 30-2, respectively, and discharge the reagent into the corresponding reaction cells 11 located at the dispensing (discharging) positions 10b and 10c on the reaction disk 10, respectively. The reaction disk 10 is housed in a constant temperature bath 12 and maintained at a constant temperature of about 37 ℃.

Here, the absorption photometer 40 is disposed on the outer periphery side of the reaction disk 10. Light emitted from a light source 41 (for an absorption photometer) disposed near the center of the inner periphery of the reaction disk 10 is measured by the absorption photometer 40 through the reaction cell 11. Thus, a measurement section comprising the absorption spectrophotometer 40 and the light source 41 (for an absorption spectrophotometer) disposed to face each other with the reaction disk 10 interposed therebetween serves as a first measurement section.

The scattering photometer 45 is also disposed on the outer peripheral side of the reaction disk 10. The light emitted from a light source 46 (for a scattering photometer) disposed near the center of the inner peripheral side of the reaction disk 10 is scattered by the reaction cell 11, and measured by a scattering photometer 45. Thus, a measurement unit including a scattering photometer 45 and a light source 46 (for a scattering photometer) disposed to face each other with the reaction disk 10 interposed therebetween is used as a second measurement unit.

Each reaction cell 11 containing a reaction solution that is a mixture of a sample and a reagent measures light each time it passes across the front of the absorption photometer 40 and the scattering photometer 45 during the rotation of the reaction disk 10. The analog signal of the transmitted light and the scattered light measured for each sample is input to a/D (analog/digital) converters 72, 73. The used reaction unit 11 can be repeatedly used by cleaning the inside thereof by the reaction unit cleaning mechanism 34 disposed near the reaction disk 10.

Next, a control system and a signal processing system in the automatic analyzer 1 of fig. 1 will be briefly described. The computer 70 is connected to A/D converters 72 to 75 and a control computer 76 via an interface 71. The computer 70 transmits a signal as a command to the control computer 75 of each mechanism, and controls the operation of each mechanism such as the sample dispensing mechanism 22 and the reagent dispensing mechanisms 33-1a and 33-2 b. The computer acquires the photometric values converted into digital signals by the A/D converters 72-75.

The interface 71 is connected to a memory 77 as a storage device, and stores information such as reagent identification information, sample identification information, analysis parameters, analysis item request contents, calibration results, and analysis results.

The control computer 76 in the present figure is connected to each of the components and described as a means for controlling the entire automatic analyzer, but may be configured to include a control unit for controlling each of the components independently.

Next, an analysis operation when the items measured by the absorption photometer 40 of the automatic analyzer 1 of fig. 1 are a first measurement item and the items measured by the scattering photometer 45 are a second measurement item, and the first and second measurement items are analyzed will be described. Analysis parameters related to items that can be analyzed by the automatic analyzer 1 are input in advance by an operator via the operation screen 68, and are stored in the memory 67. The sample dispensing mechanism 22 dispenses a predetermined amount of sample from the sample container 21 to the reaction cell 11 at the dispensing position 10a in accordance with the analysis parameters in order to request and instruct each sample analysis for the test item.

The reaction cell 11 to which the sample is dispensed is transferred by rotation of the reaction disk 10, and is stopped at a dispensing (reagent receiving) position 10b or 10 c. The 1 st reagent dispensing mechanism 33-1 and the 2 nd reagent dispensing mechanism 33-2 dispense a predetermined amount of reagent solution to the reaction cell 11 in accordance with the analysis parameters corresponding to the test items. Here, the order of dispensing the sample and the reagent may be reversed from the above example, and the reagent may precede the sample.

When the reaction cell 11 crosses the photometry position, photometry is performed by the absorption photometer 40 and the scattering photometer 45, and a voltage change obtained from a change in light intensity by the a/D converter (for absorption photometer) 72 and the a/D converter (for scattering photometer) 73 is digitally converted. After that, the converted data is acquired by the computer 70 via the interface 71. According to the configuration using the reaction disk 70 of the turntable system, since the samples can be continuously dispensed by the rotation operation of the disk, a high throughput can be obtained.

Next, the computer 70 calculates density data based on the numerical data converted into signal values as described above and calibration curve data measured and stored in advance by an analysis method designated for each inspection item, and outputs the density data to the operation screen 78.

The calculation of the concentration data described above may be performed by the control computer 76 instead of the computer 70.

Next, an analysis operation when analyzing a third measurement item with an item measured in the coagulation time unit of the automatic analyzer 1 of fig. 1 as the third measurement item will be described. Here, the measurement unit constituted by the coagulation time detection unit 50 serves as a third measurement unit. The reaction vessel (disposable reaction vessel) 52 stored in the reaction vessel storage unit 53 is transferred to the sample dispensing station 54 by the reaction vessel transfer mechanism 55. The sample dispensing mechanism 22 sucks a sample from the detection container 21 and dispenses the sample into the disposable reaction container 52 transferred to the sample dispensing station 54 as described above.

Next, the reaction container (disposable reaction container) 52 to which the sample is dispensed is conveyed to the coagulation time detecting unit 50 by the reaction container transfer mechanism 55, and the temperature is raised to 37 ℃. On the other hand, the reagent kept cold in the 1 st reagent disk 30-1 is sucked from the 1 st reagent bottle 32-1 corresponding to the test item by the 1 st reagent dispensing mechanism 33-1, discharged into the corresponding empty reaction cell 11 provided on the reaction disk 10, and heated to about 37 ℃. In addition, here, as an example, a case where the reagent disposed in the 1 st reagent bottle 32-1 of the 1 st reagent disk 30-1 is analyzed will be described, and the reagent disposed in the 2 nd reagent bottle 32-2 of the 2 nd reagent disk 30-2 can be used for the third measurement item depending on the analysis condition.

After a certain period of time has elapsed, the reagent stored in the reaction cell 11 whose temperature has been raised as described above is sucked by the reagent dispensing mechanism 56 having a reagent temperature raising function, and then the temperature is raised further (for example, 40 ℃) in the mechanism. Here, the reaction container (disposable reaction container) 52 containing the sample, which is heated to 37 ℃ as described above, is transferred to the measurement channel 51 in the coagulation time detection unit 50, which will be described later, by the reaction container transfer mechanism 55. Thereafter, the reagent dispensing mechanism 56 with a reagent temperature increasing function discharges the heated reagent to the reaction vessel (disposable reaction vessel) 52. By this discharge of the reagent, a coagulation reaction of the sample and the reagent is started in the reaction container (disposable reaction container) 52.

The coagulation time detector 50 as the third measurement unit includes a plurality of measurement channels 51 each including a light source and a light receiving unit (not shown), and the light receiving unit collects measurement data based on transmitted light or scattered light at predetermined short measurement time intervals (for example, 0.1 second) after the reagent is discharged as described above. The collected measurement data is obtained by the computer 70 through the interface 71 by digitally converting the voltage change obtained from the change in light intensity by the a/D converter 74. The computer 70 uses the data of the thus-converted numerical values to find the coagulation time. After that, based on the obtained blood coagulation time and calibration curve data generated and stored in advance from the examination items, concentration data of the target examination item is obtained and output to the operation screen 78 of the computer 70. The used reaction vessel (disposable reaction vessel) 52 is transferred by the reaction vessel transfer mechanism 55 and discarded in the reaction vessel discarding part 57. Here, the blood coagulation time and concentration data may be calculated by the control computer 76.

Next, an analysis operation when the items measured by the ISE section 60 of the automatic analyzer 1 of fig. 1 are set as fourth measurement items and the fourth measurement items are analyzed will be described. Here, the measurement unit constituted by the ISE unit 60 is set as the fourth measurement unit. The sample dispensing mechanism 22 dispenses a predetermined amount of sample into the ISE dilution tank 61. In the ISE dilution tank 61, after dispensing the diluent, measurement is performed while the diluent passes through the Na electrode 62, the K electrode 63, the C1 electrode 64, and the comparison electrode 65 together with the internal standard solution reagent, and the measurement is converted by the a/D converter (for ISE unit) 75 and recorded as an electromotive force with respect to the comparison electrode 65.

Here, the control computer 76 of the automatic analyzer 1 is characterized in that the absorption photometer 40, the scattering photometer 45, the coagulation time detecting unit 50, and the ISE unit 60 are controlled by a temperature control board and a motor controller for each unit. The measurement data is also connected to different A/D converters 72 to 75, and is independently controlled. That is, when a mechanism is not used, only necessary units can be operated by selecting a setting not using a specific unit.

Next, a measurement flow when the automatic analyzer 1 is used to perform the inspection will be described. The operator, after switching on the power of the device, carries out the preparation required for carrying out the analysis that day. When the preparation is performed, the operator performs an operation with reference to the system overview screen displayed on the operation screen 78.