JP5171352B2 - Immunoassay apparatus and immunoassay method - Google Patents

Description

The present invention relates to the immune analyzer and immunoassay how.

In laboratories such as hospitals and examination centers, analyzers that can selectively measure a plurality of measurement items are widely used.
In such a laboratory, there are a sample ID operation and a rack ID operation as operation methods for specifying a sample and its measurement item.
The sample ID operation is an operation method in which a measurement order is determined by associating a sample barcode (sample ID) attached to a sample container and identifying a sample with a measurement item for the sample.

On the other hand, in the rack ID operation, a measurement order is attached to a rack that holds a sample container, and a rack barcode (ID) for identifying the rack and the position of the sample in the rack are associated with the measurement item for the sample. It is an operation method to determine
The sample ID operation is widely used for an analyzer that uses a sample such as a blood cell counter without centrifuging. On the other hand, the rack ID operation is widely used for analyzers that are used after centrifuging a specimen, such as an immune analyzer, a blood coagulation measuring device, and a biochemical analyzer.

As an analyzer capable of selectively measuring a plurality of measurement items, an analyzer that reads a sample barcode and a rack barcode and determines the measurement item of the sample based on the read information is known (for example, , See Patent Document 1).
Further, the analyzer described in Patent Document 1 can designate either one of the sample ID range and the rack ID range, and a sample having a sample ID within the designated range or a rack within the designated range. It is also disclosed that a common measurement item is designated for a sample stored in a rack having an ID.
JP 2008-39471 A

In recent years, there has been a demand for performing both sample ID operation and rack ID operation on an analyzer that is used after centrifuging a sample, such as an immune analyzer, a blood coagulation measuring device, or a biochemical analyzer.
However, conventional analyzers have not been able to meet this demand. Note that the analyzer described in Patent Document 1 designates a common measurement item for a plurality of specimens, and cannot cope with a normal examination operation in which the measurement items differ for each specimen.

Therefore, the present invention responds to the desire to perform both sample ID operation and rack ID operation, and also provides convenience of sample ID operation even when sample ID operation is used complementarily while using rack ID operation as a basis. An object of the present invention is to provide an analyzer capable of preventing the loss of performance .

  From one aspect, the present invention is set by a first setting unit that sets information corresponding to rack ID operation, a second setting unit that sets information corresponding to sample ID operation, and the first setting unit. A mode selection means for automatically selecting a rack ID mode for measuring a specimen based on information or a specimen ID mode for measuring a specimen based on information set by the second setting means; and the mode selection means According to the mode selected by the above, an analyzer is provided that includes a measurement unit that measures a sample and an analysis unit that analyzes a measurement result of the measurement unit.

According to the analyzer of the present invention, the rack ID mode or the sample ID mode is automatically selected based on the set information, and the sample is measured in the selected mode.
Therefore, the analyzer of the present invention can cope with either sample ID operation or rack ID operation.

From another point of view, the present invention relates to an immunoassay apparatus capable of handling operations using rack identification information and operations using sample identification information, and a sample transport unit that transports a rack capable of holding a plurality of sample containers A display unit, a measurement order registration screen for designating measurement items of a sample, a rack registration information, a first registration screen for registration in association with the holding position of the sample container in the rack, and the sample identification information One of the second registration screens for registering in association with each other is displayed on the display unit, order registration means for receiving the registration of the measurement order via the displayed registration screen, and the rack transported by the sample transport unit rack identification information, and an identification information reading unit that is configured to be able to read the specimen identification information for each specimen container held in the rack, position in the rack of the sample container Depending on the position recognizing means for recognizing the position by the reading result and the position recognition means of the identification information by the identification information reading unit recognition result, measurements of the first or registered in the second registration screen A measurement item determining unit that determines a measurement item of the sample with reference to the order , and a measurement unit that performs measurement on the measurement item determined by the measurement item determination unit with respect to the sample transported by the sample transport unit; , and a analysis section for analyzing the measurement result of the measuring portion, said first registration screen includes an activation means for activating said second registration screen, the order registration means, said first and said Of the second registration screens, the first registration screen is displayed on the display unit as an initial screen, and when the activation means is operated on the first registration screen, the second registration screen is displayed on the display unit. Provide immunity analyzer characterized in that it is displayed.

According to the immunoassay analyzer of the present invention, it can accommodate any of test samples ID management and the rack ID management. Moreover, the convenience of the sample ID operation can be prevented from being impaired even when the sample ID operation is used in a complementary manner while using the rack ID operation as a basis.

The measurement item determination unit is configured to register the measurement order that matches the rack identification information read by the identification information reading unit and the position recognized by the position recognition unit via the first registration screen. Preferably, the measurement item specified by the measurement order is determined as the measurement item of the measurement performed by the measurement unit.

Said first registration screen is a screen for setting the measurement order at the rack unit, the rack identification information of the rack is read, it is preferable to prohibit editing of the first registration screen for that rack.

The first registration screen is capable of accepting registration of a measurement order in association with sample identification information for identifying a sample, the rack identification information, and the position, and is read by the identification information reading unit. The rack identification information and the position recognized by the position recognition means coincide with the rack identification information and position set on the first registration screen, and the sample identification information read by the identification information reading unit is It is preferable to further include a measurement prohibiting unit that prohibits measurement by the measurement unit when it does not match the sample identification information set in association with the rack identification information and the position on one registration screen .

If the measurement item determination means cannot determine the measurement item of the sample even with reference to the measurement order registered on the first or second registration screen, the measurement item determination means preferably queries the external computer for the measurement item. .

The second registration screen is preferably capable of accepting measurement order registration in association with a plurality of specimen identification information .

The measurement item determining means, the rack identification information read by the identification information reading unit and the position recognized by the position recognition means do not match the rack identification information and position registered in the first registration screen, When the sample identification information read by the identification information reading unit matches the sample identification information registered on the second registration screen, the measurement item is selected based on the measurement order corresponding to the matched sample identification information. It is preferable to determine .

The second registration screen includes completion instruction means for accepting completion of the second registration screen, and the order registration means starts from the second registration screen to the first registration screen when the completion instruction means is operated. It is preferable to return the registration screen .

  The second registration screen is preferably displayed as a dialog.
  It is preferable that the second registration screen does not include an area for inputting rack identification information and a holding position of the sample container in the rack.

  From another viewpoint, the present invention provides rack identification information for identifying a rack capable of holding a plurality of sample containers, a position of the sample container held in the rack in the rack, and a measurement item for the sample in the sample container And an identification information reading unit that reads the sample identification information of the sample to be analyzed, and the rack identification information of the rack that holds the sample container containing the sample. Position recognition means for recognizing the position of the sample container in the rack, rack identification information read by the identification information reading unit, and a position recognized by the position recognition means by the first setting means. If the set rack identification information and position do not match, the external information is read out based on the sample identification information read by the identification information reading unit. A measurement item determining means for inquiring a measurement item to a computer and determining the measurement item; a measurement section for measuring the measurement item determined by the measurement item determining means for the specimen; and the measurement section And an analysis unit that analyzes the measurement result.

According to the analyzer according to the present invention, the rack identification information, the position of the sample container in the rack, and the sample identification information can be read. In the case of sample ID (sample identification information) operation, the measurement item is determined by inquiry of the measurement item to an external computer. In the case of rack ID (rack identification information) operation, based on the first information. Measurement items are determined.
Therefore, both sample ID operation and rack ID operation can be supported.

From another viewpoint, the present invention is a sample immunoassay method, which is a first method for registering a measurement order specifying a measurement item of a sample in association with rack identification information and a holding position of the sample container in the rack. A first display step for displaying a registration screen, and a second registration screen for registering a measurement order in association with sample identification information when the activation display included in the first registration screen is operated. 2 display step, an order receiving step for receiving measurement order registration via the first or second registration screen, a transporting step for transporting a rack holding a plurality of sample containers, and rack identification information of the transported rack , and the position for recognizing the identification information reading step of reading the sample identification information of the sample held in the rack, the position in the rack of the sample container And identification step, in response to the identification information reading position of the recognition result in the read result and the position recognition step of the identification information in step, with reference to the measurement order is registered through the first or the second screen, A measurement item determination step for determining a measurement item of the sample, a measurement step for measuring the measurement item determined in the measurement item determination step for the transported sample, and a measurement result in the measurement step is analyzed an analysis step of an immune analysis method comprising.

In still another aspect, the present invention provides a computer with rack identification information for identifying a rack capable of holding a plurality of sample containers, the position of the sample container held in the rack in the rack, and the sample container. First setting means for setting first information in which measurement items for a sample are associated with each other;
Second setting means for setting second information in which sample identification information for identifying a sample and measurement items for the sample are associated with each other;
An acquisition means for acquiring the read identification information from the identification information reading unit for reading the sample identification information of the sample to be analyzed and the rack identification information of the rack holding the sample container containing the sample;
Position recognition means for recognizing the position of the sample container in the rack;
A measurement item for determining a measurement item of a sample with reference to the set first information or the second information in accordance with a reading result of identification information by the identification information reading unit and a position recognition result by the position recognition unit Decision means,
Is a computer program for an analysis apparatus for causing

According to the present invention, both sample ID operation and rack ID operation can be supported. Moreover, the convenience of the sample ID operation can be prevented from being impaired even when the sample ID operation is used in a complementary manner while using the rack ID operation as a basis.

Hereinafter, embodiments of the analyzer of the present invention will be described in detail with reference to the accompanying drawings.
[Overall configuration of the device]
FIG. 1 is an explanatory plan view showing the overall configuration of an analyzer according to an embodiment of the present invention.
An analyzer 1 according to an embodiment of the present invention is used as an immune analyzer, a blood coagulation measuring device, or a biochemical analyzer.

  As schematically shown in FIG. 1, the analyzer 1 is a measurement unit (measurement unit) 2 composed of a plurality of mechanisms (components) and a data processing unit electrically connected to the measurement unit 2. It is mainly composed of a certain control device 400 (see FIG. 3).

  As shown in FIG. 2, the measurement unit 2 includes a sample transport unit (sampler) 10, an emergency sample / chip transport unit 20, a pipette chip supply device 30, a chip detachment unit 40, and a sample dispensing arm 50. , Reagent installation units 60a and 60b, primary reaction unit 80a and secondary reaction unit 80b, reagent dispensing arms 90a, 90b and 90c, primary B / F separation unit 100a and secondary B / F separation unit 100b, a detection unit 120, and a measurement control unit 140 that controls the operation of each mechanism included in the measurement unit 2 such as the sample transport unit (sampler) 10 and the sample dispensing arm 50. In the immunological analyzer 1 according to the present embodiment, the sample is aspirated and discharged in order to prevent the sample such as blood aspirated and discharged by the sample dispensing arm 50 from being mixed with other samples. Every time, disposable pipette tips are replaced.

[Configuration of each mechanism of the analyzer]
As the structure of each mechanism of the analyzer 1, known structures can be adopted as appropriate, but these will be briefly described below.
The sample transport unit 10 is configured to transport the rack 4 on which a plurality of test tubes (sample containers) 3 containing samples are placed to a position corresponding to the suction position of the sample dispensing arm 50.

  The sample transport unit 10 has a rack setting unit 10a for setting the rack 4 on which the test tubes 3 containing unprocessed samples are placed, and a test tube 3 containing the dispensed samples. The rack storage part 10b for storing the rack 4 made is provided. Then, the test tube 3 containing the unprocessed sample is transported to a position corresponding to the suction position of the sample dispensing arm 50, whereby the sample such as blood in the test tube 3 is aspirated by the sample dispensing arm 50. Then, the rack 4 on which the test tube 3 is placed is stored in the rack storage unit 10b.

Here, in the analyzer 1 of the present embodiment, about 5 to 30 racks are used as regular racks. Each of these racks 4 is assigned a rack number (rack identification information; rack ID). A barcode (barcode label) 4a is attached to each rack 4 so that the analyzer 1 can read the rack number (see FIG. 4).
Each test tube 3 is attached with a barcode (barcode label) 3a for identifying the specimen (see FIG. 4).

The analyzer 1 is provided with a barcode reader (identification information reading unit) 150 for reading the barcodes 4a and 3a printed on the barcode label.
The barcode reader 150 reads the barcode 4a of the rack 4 set in the rack setting unit 10a and each barcode 3a (sample identification information; sample ID) of the plurality of test tubes 3 held in the rack 4. be able to.

  The barcode reader 150 is accommodated in the sensor housing 6. The sensor housing 6 is also provided with an optical sensor (sample container detection unit) 160 that detects the presence or absence of the test tube 3 in the rack 4. The optical sensor 160 emits light toward the test tube (sample container) 3 and detects the presence or absence of the test tube (sample container) 3 based on the presence or absence of the reflected light.

The sample transport unit 10 can transport the rack 4 so that the sample containers 3 held in the rack 4 sequentially face the barcode reader 150 and the optical sensor 160. The barcode reader 150 and the optical sensor 160 confirm the presence or absence of the test tube (sample container) 3 at each holding position of the rack 4, and if the barcode 3a is attached to the test tube 3, the barcode 3a. To obtain specimen identification information (identification information of specimen contained in test tube; specimen number).
In order to sequentially read the barcode 4a of the rack 4 and the barcode 3a of the sample container 3 held by the rack 4, the sensor housing 6 is not a rack 4 but is driven along the rack 4 by driving means (not shown). You may make it slide.

  Here, as a sample container held in the rack 4, a calibrator (calibration curve sample) for creating a calibration curve is used in addition to a test tube 3 (see FIG. 4) containing a normal sample obtained from a subject. The accommodated sample cup 3b (see FIG. 5) is included. Since the sample cup 3b is not in a shape suitable for attaching the barcode 3a, the barcode 3a is not attached.

Therefore, when the barcode reader 150 and the optical sensor 160 detect the presence / absence of the sample containers 3 and 3b and read the barcodes 4a and 3a, the rack number (rack identification information) and the sample container at each holding position of the rack. Although the information indicating the presence or absence of 3, 3b can be acquired, the sample number (sample identification information) may or may not be acquired.
For this reason, when a sample in a sample container to which a barcode is not attached is sometimes measured, rack ID operation is required. Therefore, in the present embodiment, the sample ID operation is used complementarily so as not to impair the convenience of the sample ID operation while using the rack ID operation as a basis.

  The measurement control unit 140 recognizes the position where the sample containers 3 and 3b exist in the rack 4 (the position of the sample container) based on the detection result of the optical sensor 160. Then, the measurement control unit 140 transmits the position where the sample containers 3 and 3b exist in the rack (the position of the sample container) to the control device 400 together with the acquired rack number. When the sample number can be acquired, the sample number is also transmitted to the control device 400.

The urgent sample / chip transport unit 20 transports the test tube 3 containing the urgent sample that needs to be tested by interrupting the sample transported by the sample transport unit 10 to the mounting position of the sample dispensing arm 50. It is configured.
The pipette chip supply device 30 has a function of placing the inserted pipette chips one by one on the chip setting section 23 a of the transport rack 23 of the emergency sample / chip transport section 20.
The tip detachment unit 40 is provided to detach a pipette tip attached to a sample dispensing arm 50 described later.

  The sample dispensing arm 50 transfers the sample in the test tube 3 transferred to the suction position by the sample transfer unit 10 in the cuvette 8 held by the holding unit 81a of the rotary table unit 81 of the primary reaction unit 80a described later. Has the function of dispensing. The sample dispensing arm 50 dispenses the same sample into the first cuvette 8 as a first aliquot for antibody measurement and also dispenses it into the second cuvette 8 as a second aliquot for antigen measurement of the sample. Note.

  The sample dispensing arm 50 is configured so that the arm portion 51 can be rotated about a shaft 52 and can be moved in the vertical direction (Z direction). The tip of the arm 51 is provided with a nozzle for aspirating and discharging the sample. The tip of the nozzle is provided by a transport rack (not shown) of the emergency sample / chip transport unit 20. A pipette tip to be transported is attached.

The reagent installing unit 60a is provided with a reagent container that stores the R1 reagent and a reagent container that stores the R3 reagent.
On the other hand, a reagent container for storing the R2 reagent is installed in the reagent installing unit 60b.
In the reagent installation sections 60a and 60b, a reagent container containing R1 to R3 reagents for antibody measurement and a reagent container containing R1 to R3 reagents for antigen measurement are set, respectively.

The primary reaction unit 80a rotates and transfers the cuvette 8 held by the holding unit 81a of the rotary table unit 81 by a predetermined angle every predetermined period, and stirs the specimen, R1 reagent, and R2 reagent in the cuvette 8. It is provided for.
The primary reaction unit 80a agitates the sample, the R1 reagent, and the R2 reagent in the cuvette 8, the rotary table unit 81 for transporting the cuvette containing the sample, the R1 reagent, and the R2 reagent in the rotation direction. The container transport unit 82 transports the stirred sample, the cuvette 8 containing the R1 reagent and the R2 reagent to the primary B / F separation unit 100a described later.

  The container transport unit 82 is rotatably installed at the center portion of the rotary table unit 81. The container transport unit 82 has a function of holding the cuvette held by the holding unit 81 a of the rotary table unit 81 and stirring the sample in the cuvette 8. Furthermore, the container transport unit 82 also has a function of transporting the cuvette 8 containing the sample, the sample obtained by stirring and incubating the R1 reagent and the R2 reagent, to the primary B / F separation unit 100a.

  The reagent dispensing arm 90a has a function of sucking the R1 reagent in the reagent container installed in the reagent installing unit 60a and dispensing the sucked R1 reagent into the cuvette of the primary reaction unit 80a. ing. The reagent dispensing arm 90a is configured such that the arm portion 91b can be rotated about a shaft 91c and can be moved in the vertical direction. In addition, a nozzle for aspirating and discharging the R1 reagent in the reagent container is attached to the tip of the arm portion 91b.

  The reagent dispensing arm 90b has a function for dispensing the R2 reagent in the reagent container installed in the reagent installing unit 60b into the cuvette 8 into which the sample of the primary reaction unit 80a and the R1 reagent are dispensed. ing. The reagent dispensing arm 90b is configured such that the arm 92b can be rotated about a shaft 92c and moved in the vertical direction (Z direction). A nozzle for aspirating and discharging the R2 reagent in the reagent container is attached to the tip of the arm portion 92b.

In the present embodiment, the primary B / F separation unit 100a is provided to perform B / F separation (washing) of the sample in the cuvette 8 conveyed by the container conveyance unit 82 of the primary reaction unit 80a. Yes.
The cuvette 8 of the primary B / F separation unit 100a is transported by the transport mechanism 96 to the holding unit 83a of the rotary table unit 83 of the secondary reaction unit 80b. The transport mechanism 96 is configured to be capable of rotating an arm portion 96a having a cuvette gripping portion (not shown) at the tip thereof about the shaft 96b and moving in the vertical direction (Z direction). Yes.

The secondary reaction unit 80b has the same configuration as the primary reaction unit 80a, and rotates and conveys the cuvette held by the holding unit 83a of the rotary table unit 83 by a predetermined angle every predetermined period. It is provided for stirring the specimen, R1 reagent, R2 reagent, R3 reagent, R4 reagent, and R5 reagent in the cuvette 8.
The secondary reaction unit 80b includes a rotary table unit 83 for transporting the sample, R1 reagent, R2 reagent, R3 reagent, R4 reagent, and R5 reagent in the rotation direction, a sample in the cuvette 8, From the container transport unit 84 that stirs the R1 reagent, R2 reagent, R3 reagent, R4 reagent, and R5 reagent and transports the cuvette 8 containing the stirred specimen and the like to the secondary B / F separation unit 100b described later. It is configured. Further, the container transport unit 84 has a function of transporting the cuvette 8 processed by the secondary B / F separation unit 100 b to the holding unit 83 a of the rotary table unit 83 again.

  The reagent dispensing arm 90c sucks the R3 reagent in the reagent container installed in the reagent installing unit 60a, and the sample of the secondary reaction unit 80b, the R1 reagent, and the R2 reagent are dispensed to the sucked R3 reagent. The cuvette 8 has a function for dispensing into the cuvette 8. The reagent dispensing arm 90c is configured such that the arm portion 93b can be rotated about the shaft 93c and moved in the vertical direction. In addition, a nozzle for aspirating and discharging the R3 reagent in the reagent container is attached to the tip of the arm portion 93b.

The secondary B / F separation unit 100b has the same configuration as the primary B / F separation unit 100a, and has not reacted from the sample in the cuvette 8 conveyed by the container conveyance unit 84 of the secondary reaction unit 80b. The R3 reagent (unnecessary component) is separated from the magnetic particles.
The R4 reagent supply unit 94 and the R5 reagent supply unit 95 are provided to supply the R4 reagent and the R5 reagent into the cuvette 8 held in the holding unit 83a of the rotary table unit 83 of the secondary reaction unit 80b, respectively. .

The detection unit 120 is provided to perform measurement on a specimen by acquiring the amount of chemiluminescence from the specimen (sample) that has been subjected to the predetermined processing using a photomultiplier tube. The detection unit 120 includes a transport mechanism unit 121 for transporting the cuvette 8 held by the holding unit 83a of the rotary table unit 83 of the secondary reaction unit 80b to the detection unit 120.
The used cuvette in which the measured sample has been sucked is discarded through a disposal hole 130 into a dust box (not shown) disposed at the lower part of the analyzer 1.

  Using the above configuration, the chemiluminescence amount is output as a measurement result from the detection unit 120 and provided to the control device 400.

[Configuration of control device]
The control device 400 includes a personal computer 401 (PC) or the like, and includes a control unit 400a, a display unit 400b, and an input unit 400c such as a keyboard and a mouse, as shown in FIG. The control unit 400a controls the operation of each mechanism in the measurement unit 2 and has a function for analyzing optical information of the specimen obtained by the measurement unit 2. The control unit 400a includes a CPU, a ROM, a RAM, and the like. The display unit 400b is used to display information such as analysis results obtained by the control unit 400a.

Next, the configuration of the control device 400 will be described. As shown in FIG. 3, the control unit 400a includes a CPU 401a, a storage unit including a ROM 401b, a RAM 401c, and a hard disk 401d, a reading device 401e, an input / output interface 401f, a communication interface 401g, and an image output interface 401h. Is mainly composed of
The CPU 401a, ROM 401b, RAM 401c, hard disk 401d, reading device 401e, input / output interface 401f, communication interface 401g, and image output interface 401h are connected by a bus 401i.

The CPU 401a can execute computer programs stored in the ROM 401b and computer programs loaded in the RAM 401c. The computer 401 functions as the control device 400 when the CPU 401a executes an application program 404a described later.
The ROM 401b is configured by a mask ROM, PROM, EPROM, EEPROM, or the like, and stores a computer program executed by the CPU 401a, data used for the same, and the like.

  The RAM 401c is configured by SRAM, DRAM, or the like. The RAM 401c is used to read out computer programs recorded in the ROM 401b and the hard disk 401d. Further, when these computer programs are executed, they are used as a work area of the CPU 401a.

  The hard disk 401d is installed with various computer programs 404a to be executed by the CPU 401a, such as an operating system and application programs, and data used for executing the computer programs. For example, an application program for registering a measurement order (details will be described later) and an application program for counting the number of measurements and displaying the counting result are installed in the hard disk 401d.

  The reading device 401e is configured by a flexible disk drive, a CD-ROM drive, a DVD-ROM drive, or the like, and can read a computer program or data recorded on the portable recording medium 404. The portable recording medium 404 stores the application program 404a in the present embodiment, and the computer 401 reads the application program 404a from the portable recording medium 404 and installs the application program 404a on the hard disk 401d. Is possible.

  The application program 404a is not only provided by the portable recording medium 404, but also from an external device that is communicably connected to the computer 401 via a telecommunication line (whether wired or wireless). It is also possible to provide through. For example, the application program 404a is stored in a hard disk of a server computer on the Internet, and the computer 401 can access the server computer to download the application program 404a and install it on the hard disk 401d. It is.

  An operating system that provides a graphical user interface environment, such as Windows (registered trademark) manufactured and sold by Microsoft Corporation, is installed in the hard disc 401d. In the following description, it is assumed that the application program 404a in the present embodiment operates on the operating system.

  The input / output interface 401f includes, for example, a serial interface such as USB, IEEE1394, RS-232C, a parallel interface such as SCSI, IDE, IEEE1284, and an analog interface including a D / A converter, an A / D converter, and the like. Has been. A keyboard 400c is connected to the input / output interface 401f, and the user can input data to the computer 401 by using the keyboard 400c.

The communication interface 401g is, for example, an Ethernet (registered trademark) interface. The computer 401 can transmit and receive data to and from the measurement unit 2 using a predetermined communication protocol through the communication interface 401g.
The image output interface 401h is connected to a display unit 400b configured by an LCD, a CRT, or the like, and outputs a video signal corresponding to the image data given from the CPU 401a to the display unit 400b. The display unit 400b displays an image (screen) according to the input video signal.

[Analysis processing]
Hereinafter, the analysis process by the analyzer 1 will be described. The following processing is executed by the computer program (application program 404a) included in each of the measurement unit 2 and the control device 400.
As shown in FIG. 6, when the analyzer 1 is activated, the measurement unit 2 and the control device 400 are initialized (steps S1-1 and S2-1).

[Register Order]
Then, in the control device 400, the measurement order is registered (step S2-2).
The measurement order can be registered on the order registration screen (first screen) 500 shown in FIG.
The order registration screen 500 is for registering a measurement order (first information) in units of racks, and includes a selection button 501 for selecting a rack number to be registered. The rack number selected by operating the selection button 501 is displayed on the rack number display unit 502.

In addition, the order registration screen 500 has a setting area (setting screen) 503 for setting (inputting) the measurement items and the like of each sample held in the rack of the selected rack number.
The setting area 503 includes setting items such as “registration”, “position”, “sample number”, “setA”, “routine”, “HBsAg”, “HBsAb”, “HBeAg”, “HBeAb”, and the like. Yes.
The “position” is a numerical value (1 to 10) indicating the holding position of the sample container in the rack, and a sample number, a measurement item, and the like can be set for each “position”. The “sample number” is sample identification information. In FIG. 7, samples whose “positions” are registered in 5 to 10 are calibrators for creating a calibration curve.

“SetA”, “Routine”, “HBsAg”, “HBsAb”, “HBeAg”, and “HBeAb” are measurement items that can be set for each specimen, and items that are checked are set as measurement items. The measurement items are not limited to those shown in FIG. 7, and more measurement items can be set.
The “registration” is an item for confirming whether or not the registration has been made with the set contents, based on the presence or absence of the check.
“SetA” and “Routine” are items for setting a plurality of predetermined measurement items as a set. When “setA” is checked, “HBsAg” and “HBsAb” are automatically set as measurement items. When “Routine” is checked, “HBsAg”, “HBsAb”, “HBeAg”, and “HBeAb” are automatically set as measurement items.

  Using the order registration screen 500, an order can be registered based on rack ID operation. That is, on the order registration screen 500, the first information (first order information) in which the rack number, the position of the sample in the rack, the sample number, and the measurement item are associated can be registered.

As shown in FIG. 8, N setting areas (setting screens) 503 on the order registration screen 500 are prepared, where N is the number of racks (ordinary racks). Note that the number N of racks (ordinary racks) is set in advance by the user.
When the rack number is switched by the selection button 501, a setting screen for registering the order of the rack corresponding to the rack number is switched and displayed in the setting area 503.

Therefore, the user can switch the rack number with the selection button 501 and perform order registration for a desired rack.
The input to each item in the setting area 503 may be manual input, or information registered in the control device 400 or other computer (host computer) is called and registered as order registration. Also good.

[Worklist]
In addition to the registration on the order registration screen 500, the user can perform registration using a work list. Registration by the work list is performed by a work list screen (second screen) 600 shown in FIG. The work list screen 600 is displayed by selecting the “work list” button (startup display) 505 a displayed on the order registration screen 500 by selecting the “option” button 505 on the order registration screen 500.

  That is, as shown in FIG. 10, when a work list screen activation instruction is issued from the order registration screen 500, the work list screen 600 is displayed. This work list screen 600 is displayed as a dialog. When the “close” button 601 is selected on the work list screen 600 and the work list screen is instructed to be completed, the work list screen 600 is deleted and the order registration screen 500 is displayed again.

  Unlike the order registration screen 500, the work list 600 is an order list mainly composed of sample numbers, and is used for holding a measurement order without considering the rack number and the sample holding position (sample setting position) in the rack. Is.

  The work list screen 600 has a work list setting area 602. The setting area 602 includes items such as “registration”, “sample number”, “SetA”, “Route”, “HBsAg”, “HCVAb”, and “additional date / time”.

In order to add a new order to the work list, the sample number is input to the sample number input unit 603a of the new order addition unit 603. Then, the sample number is added to the setting area 602 by selecting the add button 603b. Then, the measurement item (“SetA”, “Route”, “HBsAg”, “HCVAb”, etc.) to be measured for the added specimen number may be selected. The sample number is also automatically added to the setting area 602 by reading a barcode indicating the sample number with a handy barcode reader.
Thus, using the work list screen 600, order registration based on the sample ID operation can be performed. That is, in the work list screen 600, the second information in which the sample number and the measurement item are associated can be registered.

  In the work list screen 600, as shown in FIG. 11, a function for preventing double registration of orders in the work list works. That is, when an order is newly entered in the work list (step S100), whether or not the entered specimen number is the same as the specimen number already registered on the work registration screen 500 or the work list screen 600. A determination is made (step S101).

  If the newly entered sample number has already been registered, registration of the sample number in the work list is rejected (step S102). As described above, double registration of orders in the work list is prevented.

Returning to the flowchart of FIG. 6, after the measurement order registration (step S2-2) is completed, when the control device 400 receives a measurement start instruction (step S2-3), the control device 400 sends a measurement start signal to the measurement unit. 2 is transmitted to the second measurement control unit 140 (step S2-4).
When receiving the measurement start signal, the measurement control unit 140 of the measurement unit 2 moves the rack 4 to the position of the barcode reader 150 (step S1-3).

  The barcode reader 150 first reads the barcode (rack number) 4a of the rack 4 (step S1-4). The read rack number (rack identification information) is transmitted from the measurement control unit 140 of the measurement unit 2 to the control device 400 (step S1-5).

Upon receiving the rack number (step S2-5), the control device 400 changes the setting screen 503 corresponding to the rack number from an editable state to a state where the user cannot edit, as shown in FIG. To do.
Further, a new setting screen 503 is generated for the rack number setting screen 503 that is not editable. As the rack number of the newly generated setting screen 503, the rack number of the regular rack that has been applied to the setting screen 503 used for setting the rack number received in step S2-5 is automatically set. Even if the rack number has been changed on the setting screen 503 used for setting the rack number received in step S2-5, the rack number of the regular rack before the change is not the rack number after the change. Is automatically set. Therefore, after the control device 400 receives the rack number, when the rack number is selected by the selection button 501, a newly generated setting screen is displayed in the setting area 503. In the newly generated setting screen 503, the next measurement order (first information for later measurement) for the rack corresponding to the rack number (that is, the rack whose rack barcode has been read in the most recent step S 1-4). ) Can be registered first.

  As shown in FIG. 12, the setting screen 503 (order registration) in the edit disabled state is changed to an end state when all the samples in the corresponding rack are aspirated.

After reading the rack number, the measurement unit 2 further detects the position of the sample container 3 in the rack 4 and reads the barcode 3a attached to the sample container 3 (step S1-6).
Subsequently, the measurement control unit 140 of the measurement unit 2 makes an inquiry about the measurement order of the sample to the control device 400 (step S1-7). The measurement order inquiry is an inquiry as to what measurement items are to be measured and analyzed for each sample in the rack 4.

At the time of a measurement order inquiry, the read rack number (rack identification information), the position of the sample container 3 or 3b in the rack 4, and the sample number (sample identification information) if present are transmitted to the control device 400.
Upon receiving the measurement order inquiry (step S2-7), the control device 400 determines the order based on the order set on the order registration screen 500 and the order set on the work list screen 600 (step S2). -8) An order instruction based on the determined order is transmitted to the measurement unit 2 (step S2-9).
Details of order determination will be described later.

  When receiving the order instruction (Step S1-8), the measurement control unit 140 of the measurement unit 2 sucks the sample and performs measurement of the specified measurement item based on the order included in the order instruction (Step S1- 9).

When the measurement is completed, the measurement control unit 140 transmits the measurement result to the control device 400 (step S1-10). In this flowchart, the measurement result is transmitted before step S1-11. However, this is for convenience of explanation, and is transmitted as soon as the measurement result is generated. Accordingly, the measurement result may be transmitted after steps S1-11 and S1-12, or after step S1-13.
When receiving the measurement result (step S2-10), the control device 400 performs an analysis process on the measurement result (step S2-11).

In the measurement unit 2 and the control device 400, when the measurement result is transmitted or received, it is determined whether or not all the samples in the rack have been aspirated (steps S1-11 and S2-12).
If the suction of all the samples in the rack 4 has not been completed, the rack 4 is transported so that the next sample containers 3 and 3b face the barcode reader 150 and the optical sensor 160 (step 1-12). Then, steps S1-12, S1-6 to S1-11 and steps S2-7 to S2-12 are repeated until the suction of all the samples in the rack is completed.

  When the suction of all the samples in the rack is completed (steps S1-11 and S1-13), the rack 4 that has completed the suction is transported to the rack storage unit 10b, and the next rack 4 is positioned at the position of the barcode reader 150. (Step S1-3). And the process after step S1-4 is performed again.

  When the measurement of all the set racks 4 is finished (steps S1-13 and S2-13) and the control device 400 is instructed to shut down the device (step S2-14), the control device 400 sends a shutdown signal. Is transmitted to the measurement unit 2 (step S2-15), and a shutdown process is performed (step S2-16). Moreover, the measurement control part 140 of the measurement unit 2 will also perform a shutdown process, if a shutdown signal is received (step S1-14) (step S1-15).

[Order determination process]
Hereinafter, the order determination process (step S2-8) in FIG. 6 will be described in detail with reference to FIG.
In the order determination process, the control device 400 first searches the order registration area 510 in which the order registration information is stored using the rack number and the sample container position received from the measurement unit 2 as keys (step S201). In this search, the specimen number is not used.

  As shown in FIG. 14, the order registration information is stored in the order registration area 510 secured in the storage area of the control device 400. The order registration area 510 is an area for storing the order set on the order registration screen 500. The order registration information in the order registration area 510 is formed in units of racks and has an order for each rack. The order registration screen generation unit 520 generates the setting screen 503 based on the order registration information for each rack, thereby forming the number of setting screens 503 corresponding to the number of racks N as shown in FIG.

If there is a corresponding sample (sample having the same rack number and position) in the order registration information (step S202), the process proceeds to step S203. If there is no corresponding sample, the process proceeds to step S207.
In step S203, it is determined whether or not “matching determination” for determining whether or not the sample number of the corresponding sample in the order registration information matches the sample number read by the barcode reader 150 should be performed. Whether or not to perform “match determination” is set in advance by the user, and whether or not match determination is necessary is determined based on the setting.

When the coincidence determination is necessary (step S203), it is determined whether the sample number of the corresponding sample in the order registration information matches the sample number read by the barcode reader 150 (step S204).
If the read sample number does not match the sample number of the order registration information, the reliability of the order registration information is low, so that the sample is determined as “no order” (step 205). Therefore, measurement of the sample is prohibited.

  When the read sample number is registered as order registration information, or when it is determined that the coincidence determination is unnecessary, the measurement item registered in the order registration area 510 is determined as the measurement order (step S206). That is, the measurement item registered in the order registration area 510 that is information corresponding to rack ID operation is determined as the measurement order (rack ID mode).

  If a sample corresponding to the order registration area 510 is not found in step S202, in step S207, “worklist use determination” is performed to determine whether or not to use information in the worklist area 610 for order determination (step S207). S207). Whether or not to perform “worklist use determination” is set in advance by the user, and whether or not worklist use is necessary is determined based on the setting.

  When using the work list, the work list area 610 is searched using the read sample number as a key (step S208). The work list area 610 is an area for storing orders set on the work list screen 600. Based on the order stored in the work list area 610, the work list screen generation unit 620 generates a work list screen 600 (see FIG. 14).

  When the corresponding sample number is in the work list area 610 (step S209), the measurement item (order) of the sample number is added to the order registration area 510, and order information (sample number and measurement) for the sample number is added. (Including the item) is deleted from the work list area 610 (step S210).

The addition to the order registration area 510 is performed by adding the order of the work list area 610 to the order registration area 510 as a measurement order for the read rack number and sample container position.
Therefore, even if the sample is not registered on the order registration screen 500, if the sample is registered on the work list screen 600, the barcode 3a (sample number; sample identification information) of the sample container 3 is displayed. ) Is automatically transferred to the order registration area 510 in the order information in the work list area 610.
As a result, the sample number and the measurement item corresponding to the read rack number and sample container position are generated in the order registration area 510. The control device 400 determines an order based on the generated specimen number and measurement item (step S206).
That is, the measurement item registered in the Lark list area 610, which is information corresponding to the sample ID operation, is determined as the measurement order (sample ID mode).

Here, since the order registration screen 500 is based on the rack ID operation, the specimen can be specified by the rack number and the specimen container position, and the order registration is possible even for a specimen (such as a calibrator) to which the barcode 3a cannot be attached. . However, in the order registration screen 500, for a sample that has a sample number and can be attached with a barcode, it is necessary to specify the rack number and the sample container position even though the sample number exists, and the setting is complicated. .
Therefore, for the sample in the sample container 3 to which the barcode is attached, the sample number and the measurement item may be set on the work list screen 600 instead of the setting on the order registration screen 500. Since it is only necessary to set the sample number and the measurement item on the work list screen 600, the setting can be performed more easily than the setting on the order registration screen 500.
In the present embodiment, even if the corresponding sample is not registered in the order registration area 510, the corresponding sample is extracted from the work list and added to the order registration area 510. The order can be determined even if no order is set for.

Further, when it is determined that there is no sample corresponding to the order registration area 510 and the work list is not used (step S207), or when the work list is used but there is no sample corresponding to the work list (step S207). In step S209, a “host usage determination” is performed to determine whether or not to use information in the order storage area 800 of the host computer for order determination (step S211).
Whether or not to perform “host usage determination” is set in advance by the user, and the necessity of host usage determination is determined based on the setting.

When it is necessary to use the host computer, an order inquiry to the host computer is performed from the control device 400 via the network or by serial communication (step S212). At the time of order inquiry, the read sample number is transmitted. If there is a sample corresponding to the order storage area 800 of the host computer (step S213), the order of the sample is added to the order registration list (step S214). This addition is performed in the same manner as the addition from the work list to the order registration list.
Then, the control device 400 determines an order based on the added order information (S206).
That is, the order instruction unit 700 of the control device 400 determines an order by referring to the order registration area 510 based on the rack number and position, and issues an order instruction.

  When there is no corresponding sample even when the host computer is inquired (step S213), or when it is determined not to use the host computer (step S211), for the sample corresponding to the rack number and the sample container position, “No order” is determined (step S215).

In addition, this invention is not limited to the said embodiment, A various deformation | transformation is possible. For example, although the work list screen 600 is a screen for setting sample identification information of a plurality of samples, one screen may be displayed for one sample.
If sample identification information is input to the work list screen 600, the sample identification information is input to the work list screen 600 when the sample identification information matches the sample identification information input from the order registration screen 500. The order of the specimen identification information may be given priority, and the measurement item corresponding to this specimen identification information may be determined as the measurement order.
The sample identification information and the rack identification information need not be read by a common barcode reader, and a barcode reader may be provided for each of the sample identification information and the rack identification information.

It is a general view of an analyzer. It is detail drawing of a measurement part. It is a block diagram of a control apparatus. It is a perspective view of the rack holding the sample container. It is a perspective view of a sample cup. 4 is a flowchart showing processing of the measurement unit 2 and the control device 400. It is a figure which shows an order registration screen. It is explanatory drawing that there exist multiple setting screens of an order registration screen. It is a figure which shows a work list screen. It is a state transition diagram which shows switching between an order registration screen and a work list screen. It is a flowchart which shows the input process of a work list. It is a state transition diagram of the setting screen of the order registration screen. It is a flowchart of an order determination process. It is a block diagram of a control apparatus.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Immunoassay apparatus 2 Measuring part 140 Measurement control part 150 Bar code reader (identification information reading part)
160 Optical Sensor 400 Control Device

Claims (11)

An immunological analyzer capable of handling operations using rack identification information and operations using sample identification information,
A sample transport unit for transporting a rack capable of holding a plurality of sample containers;
A display unit;
As a registration screen for a measurement order for specifying a measurement item of a sample, a rack registration information, a first registration screen for registration in association with the holding position of the sample container in the rack, and registration in association with the sample identification information Order registration means for displaying one of the second registration screens on the display unit and receiving registration of the measurement order via the displayed registration screen;
An identification information reading unit configured to be able to read rack identification information of a rack conveyed by the sample conveyance unit and sample identification information of each sample container held in the rack ;
Position recognition means for recognizing the position of the sample container in the rack;
In response to said recognition result of the position by the reading result and the position recognition means of the identification information by the identification information reading unit, the first or reference to measurement order registered in the second registration screen, the measurement item of the specimen A measurement item determining means to be determined;
A measurement unit that performs measurement on the measurement item determined by the measurement item determination unit with respect to the sample conveyed by the sample conveyance unit ;
And a analysis section for analyzing the measurement result of the measuring unit,
The first registration screen includes an activation unit for activating the second registration screen,
The order registration means causes the display unit to display the first registration screen as an initial screen of the first and second registration screens, and when the activation means is operated on the first registration screen, An immune analyzer that displays a second registration screen on the display unit . The measurement item determination unit is configured to register the measurement order that matches the rack identification information read by the identification information reading unit and the position recognized by the position recognition unit via the first registration screen. is the measurement items specified by the measurement order, is determined as a measurement item of the measurements the measuring unit performs, according to claim 1 Symbol placement of the immune analyzer. It said first registration screen is a screen for setting the measurement order at the rack unit, the rack identification information of the rack is read, according to claim 1 or 2 prohibiting editing of the first registration screen for that rack The immunoassay device described. It said first registration screen, the specimen identification information for identifying the sample, and the rack identification information, it is possible to accept the registration of the measurement order in association with said position,
The rack identification information read by the identification information reading unit and the position recognized by the position recognition unit match the rack identification information and the position set on the first registration screen, and are read by the identification information reading unit. And a measurement prohibiting unit for prohibiting measurement by the measurement unit when the sample identification information does not match the sample identification information set in association with the rack identification information and the position on the first registration screen. Item 4. The immune analyzer according to any one of Items 1 to 3 . The measurement item determination means, the first or even by referring to the measurement order registered in the second registration screen, when it is not possible to determine the measurement item of the specimen, an inquiry of the measurement items to an external computer, wherein Item 5. The immunoassay device according to any one of Items 1 to 4 . The immune analyzer according to any one of claims 1 to 5 , wherein the second registration screen can accept registration of a measurement order in association with a plurality of pieces of specimen identification information. The measurement item determining means, the rack identification information read by the identification information reading unit and the position recognized by the position recognition means do not match the rack identification information and position registered in the first registration screen , When the sample identification information read by the identification information reading unit matches the sample identification information registered on the second registration screen, the measurement item is selected based on the measurement order corresponding to the matched sample identification information. determining immune analyzer according to any one of claims 1 to 6.   The second registration screen includes completion instruction means for accepting completion of the second registration screen,
  The immune analyzer according to any one of claims 1 to 7, wherein the order registration unit returns the registration screen from the second registration screen to the first registration screen when the completion instruction unit is operated. .   The immune analyzer according to claim 8, wherein the second registration screen is displayed as a dialog.   The immune analyzer according to claim 1, wherein the second registration screen does not include an area for inputting rack identification information and a holding position of the sample container in the rack. A method for immunoassay of a specimen,
A first display step for displaying a first registration screen for registering a measurement order specifying a measurement item of a sample in association with rack identification information and a holding position of the sample container in the rack;
A second display step for displaying a second registration screen for registering the measurement order in association with the specimen identification information when the activation display included in the first registration screen is operated;
An order receiving step for receiving registration of a measurement order via the first or second registration screen;
A transport step for transporting a rack holding a plurality of sample containers;
An identification information reading step of reading the rack identification information of the transported rack and the sample identification information of the sample held in the rack ;
A position recognition step for recognizing the position of the sample container in the rack;
According to the reading result of the identification information in the identification information reading step and the position recognition result in the position recognition step, the measurement order of the specimen is referred to by referring to the measurement order registered via the first or the second registration screen. Measuring item determination step for determining,
A measurement step for measuring the measurement item determined in the measurement item determination step with respect to the transported sample;
An analysis step for analyzing a measurement result in the measurement step;
An immunoassay method comprising:

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