WO2023090017A1 - Analysis device and method - Google Patents

Abstract

An analysis device (600) comprises: a first storage unit (321) which stores three pieces of first reagent information and three pieces of second reagent information; a control device (354) which determines a reagent pair on the basis of the three pieces of first reagent information and the three pieces of second reagent information; and an analysis mechanism (300) which uses a first reagent and a second reagent included in the reagent pair determined by the control device (354) to analyze an unknown sample, wherein when the control device (354) has determined a first reagent pair and has received a prescribed operation from a user, the control device (354) determines a second reagent pair that includes a first reagent and a second reagent to used next by the analysis mechanism (300) after the first reagent pair.

Description

Analyzer and method

The present disclosure relates to an analyzer and method.

　Conventionally, analyzers that analyze samples using reagents have been proposed. For example, the analyzer disclosed in Japanese Patent Application Laid-Open No. 2011-227048 (Patent Document 1) includes a plurality of types of reagents (for example, a first reagent and a second reagent) to analyze a sample.

JP 2011-227048 A

Below, the reagent container is also referred to as a reagent bottle. Also, hereinafter, a combination of a plurality of types of reagents used is also referred to as a "reagent bottle combination". In general, when the analyzer analyzes a large number of samples, the amount of reagents used is large. Therefore, when the analyzer analyzes a large amount of samples, a configuration is conceivable in which a combination of a plurality of reagent bottles to be used in sequence is determined. Specifically, the analyzer selects, for example, a first reagent bottle combination, a second reagent bottle combination to be used next to the first reagent bottle combination, and a third reagent bottle combination to be used next to the second reagent bottle combination. decide.

However, in an analyzer adopting such a configuration, after the analyzer has determined a plurality of reagent bottle combinations, the plurality of reagent bottle combinations cannot be changed. Therefore, a problem may arise that user convenience cannot be improved.

The present disclosure has been made to solve such problems, and its purpose is to provide an analysis device and an analysis method that improve the user's convenience in determining reagent bottle combinations.

The analysis device of the present disclosure includes an arrangement section, a first storage device, a control device, and an analysis mechanism. A plurality of reagent bottles are arranged in the arrangement section. The first storage device stores reagent bottle information of a plurality of reagent bottles. The controller determines a combination of reagent bottles to be used for analysis items based on reagent bottle information of a plurality of reagent bottles. The analysis mechanism uses the reagent bottle combination determined by the controller to analyze the unknown sample. A controller determines a first reagent bottle combination containing a first reagent and a second reagent for the assay item. Further, when receiving a predetermined operation by the user, the control device determines a second reagent bottle combination containing the first reagent and the second reagent to be used next to the first reagent bottle combination by the analysis mechanism.

The analysis device of the present disclosure includes an arrangement section, a first storage device, a control device, and an analysis mechanism. A plurality of reagent bottles are arranged in the arrangement section. The first storage device stores reagent bottle information of a plurality of reagent bottles. The controller determines a combination of reagent bottles to be used for analysis items based on reagent bottle information of a plurality of reagent bottles. The analysis mechanism uses the reagent bottle combination determined by the controller to analyze the unknown sample. A controller determines a first reagent bottle combination containing a first reagent and a second reagent for the assay item. In addition, the control device determines that the amount of the first reagent contained in the first reagent-bottle combination is less than the necessary amount for use with the second reagent contained in the first reagent-bottle combination due to the occurrence of the abnormality. If so, the analysis mechanism determines a second reagent bottle combination containing the first and second reagents to be used next to the first reagent bottle combination.

The control method of the present disclosure is a control method for an analyzer. The analysis device includes an arrangement section, a first storage device, and an analysis mechanism. A plurality of reagent bottles are arranged in the arrangement section. The first storage device stores reagent bottle information of a plurality of reagent bottles. The analysis mechanism analyzes the unknown sample using the reagent bottle combination determined by the control method. The control method comprises determining a first reagent bottle combination containing a first reagent and a second reagent for the assay item. Also, the control method comprises determining a second reagent bottle combination containing the first reagent and the second reagent to be used next to the first reagent bottle combination by the analysis mechanism when a predetermined operation by the user is received. .

The control method of the present disclosure is a control method for an analyzer. The analysis device includes an arrangement section, a first storage device, and an analysis mechanism. A plurality of reagent bottles are arranged in the arrangement section. The first storage device stores reagent bottle information of a plurality of reagent bottles. The analysis mechanism analyzes the unknown sample using the reagent bottle combination determined by the control method. The control method comprises determining a first reagent bottle combination containing a first reagent and a second reagent for the assay item. Further, the control method is such that the amount of the first reagent contained in the first reagent bottle combination is less than the necessary amount for use with the second reagent contained in the first reagent bottle combination due to the occurrence of the abnormality. If so, determining a second reagent bottle combination containing the first reagent and the second reagent to be used next to the first reagent bottle combination by the analysis mechanism.

The analyzer of the present disclosure improves user convenience in determining the combination of reagent bottles.

1 is a diagram functionally showing the overall configuration of an analyzer according to the present embodiment; FIG. FIG. 4 is a plan view showing a configuration example of an analysis mechanism; It is a figure which shows an example of the reagent arrangement|positioning part of this Embodiment. It is a functional block diagram of a control device. It is a figure which shows an example of reagent information. It is a figure which shows an example of an input screen. Fig. 3 shows a first situation; Fig. 2 shows a second situation; FIG. 13 illustrates storage of reagent pairs and calibration curves; 4 is a flowchart showing an example of main processing of the analyzer; It is an example of main processing of main interrupt processing of the analyzer. 4 is a flow chart showing an example of main processing of the analyzer in decision mode; 4 is a flowchart showing an example of main processing of the analyzer in analysis mode;

Hereinafter, embodiments of the present disclosure will be described in detail with reference to the drawings. The same or corresponding parts in the drawings are denoted by the same reference numerals, and the description thereof will not be repeated.

[overall structure]
The overall configuration of the blood coagulation analyzer of the present disclosure (hereinafter simply referred to as "analyzer 600") will be described. The analyzer 600 is configured to dispense a sample and reagent into a cuvette with a probe (nozzle) and optically measure the reaction state in the cuvette. The sample is, for example, a subject's blood component (serum or plasma) or urine. Also, the analyzer 600 can analyze a sample using multiple types of reagents. In the present embodiment, the multiple types of reagents are the first reagent and the second reagent.

FIG. 1 is a diagram functionally showing the overall configuration of analysis device 600 according to the present embodiment. Analyzer 600 described in the first embodiment is an example of a blood coagulation analyzer.

Referring to FIG. 1, this analyzer 600 includes a cuvette supply device 110, a cuvette transfer device 120, a stirring device 200, a control device 354, and a cuvette disposal container 400. The cuvette supply device 110, the cuvette transfer device 120, and the cuvette disposal container 400 are hereinafter simply referred to as "supply device 110," "transfer device 120," and "disposal container 400," respectively.

The analyzer 600 further includes a sample dispensing port P1. The supply device 110 includes a cuvette storage section 111 (hereinafter simply referred to as “storage section 111 ”) and a supply mechanism 112 . The storage section 111 is configured to be able to store a large number of cuvettes (for example, 1000 cuvettes at maximum). The supply mechanism 112 supplies the cuvette housed in the housing portion 111 to the sample dispensing port P1. The details of the container 111 and the supply mechanism 112 will be described later with reference to FIG.

The sample pipetting port P1 is arranged at a position where the sample can be pipetted into the cuvette by a sample pipetting device (not shown). When a cuvette is set in the sample dispensing port P1, the sample dispensing device dispenses the sample into the cuvette.

The transfer device 120 includes an arm 121 with a chuck (hereinafter simply referred to as "arm 121") and a drive device 122. The arm 121 has a chuck (chuck 121a, which will be described later) that can grip a cuvette. Arm 121 is configured to detachably hold the cuvette by means of a chuck. Drive 122 is configured to actuate arm 121 to change the position of the chuck. Details of the arm 121 and the drive device 122 will also be described later with reference to FIG.

The analysis device 600 further includes a plurality of ports capable of transferring cuvettes by the transfer device 120, specifically, a stirring port P2, a photometry port P3, a waste port P5, a suction port P11, and a suction port P12. The photometric ports P3 include multiple coagulation ports P3a and multiple colorimetric ports P3b. Each of the sample dispensing port P1, stirring port P2, photometric port P3, disposal port P5, suction port P11, and suction port P12 is provided with a port sensor that detects the presence or absence of a cuvette.

The stirring port P2 is arranged at the stirring position of the stirring device 200 . The stirrer 200 is configured to stir the contents of the cuvette under predetermined conditions (eg, stirring speed and stirring time) when the cuvette is set in the stirring port P2.

Each of the coagulation port P3a and the colorimetric port P3b is arranged in a photometric section (not shown). Each of the coagulation port P3a and the colorimetric port P3b is provided with a photodetector (not shown) for detecting the irradiated light, which is irradiated with light from the light source.

The controller 354 receives the detection results of the amount of light from the photodetectors of the coagulation port P3a and the colorimetric port P3b, and performs predetermined measurements on the contents of the cuvettes set in each port. That is, for the coagulation port P3a, the controller 354 uses the amount of scattered light detected by the photodetector to measure the coagulation time of the sample in the cuvette. For the colorimetric port P3b, the controller 354 measures the absorbance of the sample in the cuvette based on the colorimetric method using the amount of transmitted light detected by the photodetector.

The control device 354 has a CPU (Central Processing Unit) 360, a memory 361, and a communication I/F 362 as main components. Each component is interconnected by a data bus. The memory 361 is composed of, for example, ROM (Read Only Memory), RAM (Random Access Memory), HDD (Hard Disk Drive), and the like.

The ROM stores programs executed by the CPU 360 . The RAM temporarily stores data generated by executing programs in the CPU 360 . RAM can function as a temporary data memory that is used as a working area. HDD 166 is a non-volatile storage device. Also, instead of the HDD 166, a semiconductor storage device such as a flash memory may be employed.

Also, the program stored in the ROM may be stored in a storage medium and distributed as a program product. Alternatively, the program may be provided by an information provider as a downloadable program product via the so-called Internet. The control device 354 reads a program provided by a storage medium, the Internet, or the like. Control device 354 stores the read program in a predetermined storage area (for example, ROM). CPU 360 executes the above-described display processing by executing the stored program.

Storage media are not limited to DVD-ROM (Digital Versatile Disk Read Only Memory), CD-ROM (compact disc read-only memory), FD (Flexible Disk), hard disk, magnetic tape, cassette tape, optical disk (MO (Magnetic Optical Disc) / MD (Mini Disc) / DVD (Digital Versatile Disc), optical card, mask ROM, EPROM (Electronically Programmable Read-Only Memory), EEPROM (Electronically Erasable Programmable Read-Only Memory), semiconductor memory such as flash ROM The recording medium is a non-transitory medium in which the program and the like can be read by the computer.

A communication I/F 362 is an interface for communicating with other devices. Other equipment includes, for example, an analysis mechanism 300, which will be described later, a group of quantity sensors S1-S6, which will be described later, a display device 358, and an input device 356.

The input device 356 is, for example, a pointing device such as a keyboard or a mouse, and receives commands from the user. The display device 358 is composed of, for example, a liquid crystal display (LCD) panel, and displays information to the user. When a touch panel is used as the user interface, the input device 356 and the display device 358 are integrally formed.

The waste port P5 is configured to collect used cuvettes. The waste port P5 is connected to the waste container 400 through piping, for example. When the cuvette is introduced into the disposal port P5, the cuvette is led to the disposal container 400. FIG.

The N (N is an integer equal to or greater than 2) first reagents are accommodated in N first reagent bottles, respectively. The N first reagent bottles containing the first reagent are held by the first reagent placing portion 311a. The aspiration spot P11 is configured to aspirate the first reagent from any one of the N first reagent bottles.

The M (M is an integer equal to or greater than 2) second reagents are each contained in a plurality of second reagent bottles. The M second reagent bottles containing the second reagents are held by the second reagent placement portion 312a. The aspiration spot P12 is configured to aspirate the second reagent from any one of the M second reagent bottles. In this embodiment, N=M=3. The reagent placement section may also be referred to as a "reagent holding area" or a "reagent holding mechanism."

FIG. 2 is a plan view showing a configuration example of the analysis mechanism 300 of the analysis device 600. FIG. Analysis mechanism 300 analyzes an unknown sample or a known sample under the control of control device 354 . Also, the analysis mechanism 300 analyzes unknown samples using reagent bottle combinations used for analysis items. Here, "using a reagent bottle combination" typically means "consuming a plurality of reagents constituting the reagent bottle combination". FIG. 2 shows three mutually orthogonal axes (X-axis, Y-axis and Z-axis). , indicates the vertical direction (ie, the up-down direction). The direction indicated by the Z-axis arrow is upward, and the opposite direction is downward (ie, the direction of gravity).

With reference to FIGS. 1 and 2, a large number of cuvettes 100 are accommodated in the accommodation section 111 . A user can replenish the cuvette 100 into the containing portion 111 from an inlet (not shown) of the containing portion 111 . The cuvette 100 can be made of any material as long as it can transmit light, and for example, a transparent acrylic material can be used.

The supply mechanism 112 is configured to take out the cuvettes 100 one by one from the container 111 and supply them to the sample dispensing port P1. A transfer method of the cuvette 100 in the supply mechanism 112 is arbitrary, and may be, for example, a slide method (self-weight method), a belt conveyor method, a roller method, or a slide method. The supply mechanism 112 is configured to receive the detection result of the port sensor of the sample dispensing port P1 and supply the next cuvette 100 to the port P1 when the sample dispensing port P1 becomes empty. However, the supply mechanism 112 is not limited to this, and may be configured to supply the cuvette 100 to the sample dispensing port P1 according to an instruction from a control device, which will be described later.

The arm 21 is a device (sample dispensing device) for dispensing the sample aspirated from the sample aspiration port P21 into the cuvette 100 set in the sample dispensing port P1. The arm 21 includes a probe 21a and an arm body 21b. The arm body 21b is configured to be rotatable around a rotation shaft 23a, and by rotating the arm body 21b, the probe 21a provided at the tip of the arm body 21b draws an arc-shaped trajectory L2 on the XY plane. You can move like

By rotating the arm main body 21b, the probe 21a moves to the sample dispensing port P1, the sample suction port P21, the S port P22 (more specifically, the ports P22a to P22i), and the washing port provided on the track L2. It is possible to move to each of P23. Regarding the S port P22, for example, ports P22a and P22b are detergent ports, ports P22c, P22d and P22e are buffer ports, and ports P22f, P22g, P22h and P22i are diluent ports.

Although not shown, a movable sample rack is provided below the sample suction port P21. A plurality of sample containers containing samples are placed on the sample rack. is placed directly below the sample aspiration port P21. The CTS mechanism 24 is provided near the sample aspiration port P21, and is configured to pierce the cap with a piercer when the sample container to be dispensed has a cap.

The photometry unit 130 has a plurality of photometry ports P3 (a plurality of coagulation ports P3a and colorimetric ports P3b) arranged in an arc. In this example, a plurality (14 in this embodiment) of coagulation ports P3a and a plurality of (6 in this embodiment) of colorimetric ports P3b are arranged. The arm 11 is a device for dispensing the reagent aspirated from the aspiration port P11 or the aspiration P12 into the target cuvette 100 set in the photometry port P3, and includes a probe 11a and an arm body 11b. The arm body 11b is configured to be rotatable around a rotation shaft 13a, and by rotating the arm body 11b, the probe 11a provided at the tip of the arm body 11b draws an arc-shaped trajectory L1 on the XY plane. You can move like

By rotating the arm body 11b, the probe 11a can move to each of the coagulation ports P3a, colorimetric ports P3b, suction ports P11 and P12, and recovery port P13 provided on the track L1. Although not shown, the probe 11a is actually composed of two probes in order to avoid contamination between reagents. The reagent placement section 31a (reagent tray) has an outer peripheral tray and an inner peripheral tray. The reagent (or washing liquid) on the outer peripheral tray and the reagent on the inner peripheral tray can be sucked from the suction ports P11 and P12 by two probes, respectively. The recovery port P13 is a port for recovering the used washing liquid. Although not shown, a water reservoir for collecting water discharged from the probe 11a to wash the outer surface of the tip of the probe, and a waste port for discarding the liquid. including the part.

The reference port P4 is provided at a different location from the photometry port P3 (photometry unit 130). As mentioned above, the reference port P4 has the same configuration as each colorimetric port P3b, but is located inside the analyzer 600 rather than on the analyzer 300, for example, because it does not require the cuvette 100 to be set.

A first reagent placement portion 311a (reagent placement portion 31a) is placed below the suction port P11. The first reagent placement portion 311a holds a plurality of first reagent bottles each containing a first reagent. A second reagent placement portion 312a (reagent placement portion 31a) is arranged below the suction port P12. A plurality of second reagent bottles each containing a second reagent are held by the second reagent placement portion 312a. The reagent placement unit 31a is composed of a disk-shaped turntable, and by driving the turntable, a desired reagent (first reagent or second reagent) detergent container 1a can be placed directly below the suction ports P11 and P12. can be done. A first reagent or a second reagent is aspirated by the probe 11 a and transported to a predetermined position by the arm 11 . For example, a first reagent or a second reagent is delivered into a cuvette (a cuvette containing an unknown or known sample) of sample dispensing port P1. An unknown sample is a reagent to be analyzed by analyzer 600 . A known sample is a sample for which the item analyzed by analyzer 600 (for example, the concentration of the component to be analyzed) is known.

The arm 121 includes a chuck 121a and an arm body 121b. The chuck 121a is configured to be able to grip the cuvette 100 . The method by which the chuck 121a holds the cuvette 100 is arbitrary, and the chuck 121a may be a mechanical chuck, a magnetic chuck, or a vacuum chuck. The arm main body 121b is configured to be able to turn around the rotary shaft 13a together with the rotating body 122a. When the rotating body 122a rotates, the arm body 121b rotates integrally with the rotating body 122a, and the chuck 121a provided at the tip of the arm body 121b moves so as to draw an arc-shaped trajectory L1 on the XY plane. can be done.

As described above, the pivot centers of the arms 11 and 121 are the same. On the trajectory L1 are a sample pipetting port P1, a stirring port P2, a waste port P5, a plurality of photometric ports P3 (a plurality of coagulation ports P3a and a plurality of colorimetric ports P3b), and suction ports P11 and P12. , and a recovery port P13. The arm 121 can move the chuck 121a to the sample dispensing port P1, the agitation port P2, each photometric port P3, and the disposal port P5. The probe 11a can be moved to the port P2 and each photometric port P3.

Also, the analyzer 600 acquires the first parameter by executing a predetermined process on the unknown sample. Then, the analyzer 600 calculates the second parameter by applying the first parameter to the calibration curve. The second parameter is a parameter for the analysis purpose of analysis device 600 of the present embodiment. A second parameter is the concentration of the target substance contained in the unknown sample.

A specific explanation is provided below. The analyzer 600 analyzes the sample by executing a predetermined process over a predetermined measurement time. The measurement time starts, for example, when light from a light source (not shown) hits a cuvette containing a sample and reagents (eg, first reagent and second reagent). Further, the predetermined process is a process of exposing the unknown sample to light. Analysis device 600 calculates the absorbance of the unknown sample by executing a predetermined process. An example of the predetermined processing described above corresponds to the processing of exposing an unknown sample to light for a predetermined measurement time. Furthermore, the analyzer 600 calculates the slope of the absorbance during the measurement time. This "slope of absorbance" corresponds to an example of the "first parameter". In addition, the analysis device 600 creates a calibration curve by executing the predetermined process on a known sample having a known concentration of the target substance in advance. In the calibration curve, the slope of the absorbance is associated with the concentration of the target substance. After calculating the slope of the absorbance difference, the analyzer 600 refers to the calibration curve and outputs the concentration of the target substance corresponding to the calculated slope of the absorbance as a measurement result. The "concentration of the target substance" corresponds to an example of the "second parameter". Note that the predetermined process may be another process, and the first parameter and the second parameter may be other parameters.

[Reagent placement part]
FIG. 3 is a diagram showing an example of the reagent placement portion (first reagent placement portion 311a, second reagent placement portion 312a) of the present embodiment. In the present embodiment, the multiple types of reagents include a first reagent A and a second reagent B different in type from the first reagent A. Therefore, the components of the first reagent A and the second reagent B are different.

The first reagent placement section 311a can hold M1 (M1 is an integer equal to or greater than 2) first reagents. The second reagent placement section 312a can hold M2 (M2 is an integer equal to or greater than 2) second reagents. In the example of FIG. 3, it is assumed that M1=M2=3. That is, the first reagent placement portion 311a can hold three first reagents, namely, the first reagent A1, the first reagent A2, and the first reagent A3. In addition, the second reagent placement section 312a can hold three second reagents, that is, a second reagent B1, a second reagent B2, and a second reagent B3. That is, the reagent placement section can hold six reagents. Also, M1 and M2 are preferably 2 or 3. Thus, by setting M1 and M2 to relatively small numbers, the size of the analyzer 600 can be reduced. As a modification, M1 and M2 may be 2 or an integer of 4 or more.

Also, each of the six reagents is contained in six reagent bottles. Before the reagent bottle is used, the lid is attached to the reagent bottle. When the reagent bottle is used, the analysis device 600 uses a piercer (not shown) to open the lid (penetrate through the lid) and remove the reagent contained in the reagent bottle. Absorb and use (consume).

The analyzer 600 also has six quantity sensors that detect reagent information for each of the six reagents. The reagent information corresponds to "reagent bottle information" of the present disclosure. The six quantity sensors are quantity sensor S1, quantity sensor S2, quantity sensor S3, quantity sensor S4, quantity sensor S5 and quantity sensor S6. Amount sensor S1 detects the amount of first reagent A1. Amount sensor S2 detects the amount of first reagent A2. Amount sensor S3 detects the amount of first reagent A3. Amount sensor S4 detects the amount of second reagent B1. Amount sensor S5 detects the amount of second reagent B2. Amount sensor S6 detects the amount of second reagent B3. Six quantity sensors are connected to controller 354 . Information detected by the six quantity sensors is output to the controller 354 . In the following, the six quantity sensors are also referred to as "quantity sensor groups S1 to S6".

[Functional block diagram of control device]
FIG. 4 is a functional block diagram of the control device 354. As shown in FIG. The control device 354 has an acquisition unit 302 , a processing unit 304 , a control unit 306 and a storage unit 310 . Storage unit 310 has a first storage unit 321 and a second storage unit 322 . In the example of FIG. 4, controller 354 is connected to analysis mechanism 300, input device 356, display device 358, and quantity sensors S1-S6.

The acquisition unit 302 acquires the analysis result of an unknown sample or a known sample by the analysis mechanism 300 from the analysis mechanism 300 . Acquisition unit 302 also acquires a signal indicating that the input device 356 has been operated by the user (for example, a predetermined operation described later). Further, the acquiring unit 302 acquires the reagent information detected by each quantity sensor of the quantity sensor groups S1 to S6. The information acquired by the acquisition unit 302 is output to the processing unit 304 .

When the processing unit 304 acquires the analysis result of the known sample from the acquisition unit 302, it creates a calibration curve. The calibration curve is stored in the second storage unit 322 (see FIG. 9). When the processing unit 304 acquires the analysis result (first parameter) of the unknown sample from the acquisition unit 302, the processing unit 304 refers to the prepared calibration curve to derive the analysis result (second parameter). . The processing unit 304 then generates image data representing the second parameter and outputs the image data to the control unit 306 . The control unit 306 causes the display device 358 to display an image based on the image data.

Further, when the processing unit 304 acquires the reagent information detected by each quantity sensor of the quantity sensor groups S1 to S6 from the acquisition unit 302, the processing unit 304 stores the reagent information in the first storage unit 321 (see FIG. 5). In other words, the processing unit 304 updates the reagent information stored in the first storage unit 321 to the reagent information newly detected by each quantity sensor of the quantity sensor groups S1 to S6.

[Reagent information]
Next, reagent information will be explained. The reagent information includes at least one of a reagent position in a reagent bottle corresponding to the reagent information, an amount of reagent corresponding to the reagent information, an expiration date of the reagent, and an onboard stability of the reagent. In this embodiment, the reagent information includes all of the reagent position corresponding to the reagent information, the amount of reagent corresponding to the reagent information, the expiration date of the reagent, and the onboard stability of the reagent.

The expiration date is the date set by the reagent manufacturer, and is the date when the reagent can be used properly. The more the current date and time is earlier than the expiration date, the higher the freshness of the reagent corresponding to the expiration date.

The on-board stability is the storage stability (or reactivity of the reagent) of the reagent placed in the reagent placement section 312 of the analyzer 600 . This is the number of days that have passed since the cap of the reagent bottle containing the reagent was opened by the piercer. The shorter the number of days that have passed, the higher the freshness of the reagent corresponding to the number of days that have passed. In other words, the fewer days that have passed, the higher the onboard stability.

The reagent position is information indicating the location within the analyzer 600 where the reagent bottle containing the reagent is arranged.

The amount sensor detects the amount of reagent in the reagent bottle at each predetermined interrupt time (for example, 1 minute). The quantity sensor is, for example, a liquid level sensor that detects the liquid level of the reagent. The amount of reagent detected by the amount sensor is output to controller 354 .

FIG. 5 is a diagram showing an example of reagent information stored in the first storage device of the control device 354. As shown in FIG. In the example of FIG. 5, each reagent (first reagent A1, first reagent A2, first reagent A3, second reagent B1, second reagent B2, second reagent B3) is associated with reagent information. remembered.

For example, for the first reagent A1, the reagent position P1, the amount X1 of the first reagent A1, the expiration date Y1 of the first reagent A1, and the onboard stability Z1 of the first reagent A1 correspond. attached. Thus, the first storage device stores reagent information. The reagent information of the first reagent is also referred to as "first reagent information". The reagent information of the second reagent is also referred to as "second reagent information". That is, the first storage device stores first reagent information (reagent information of the first reagent A1 to first reagent A3) of each of the plurality of first reagents and second reagent information of each of the plurality of second reagents (second reagent information of the reagent B1 to the second reagent B3).

Also, the control device 354 updates the reagent amount in the reagent information to the reagent amount output from the above-described amount sensor. As described above, the quantity sensor detects the quantity of reagent at each predetermined interrupt time (eg, one minute). Therefore, the reagent amount in the reagent information is updated every interrupt time. The controller 354 can grasp the amount of each reagent by such updating.

Next, I will explain the expiration date of the reagent information. Information including an expiration date (for example, a barcode) is attached to the reagent bottle. A barcode reader (not shown) detects the expiration date by reading the barcode. The detected expiration date is output to the control device 354 . Then, the control device 354 stores the expiration date in the first storage unit 321 . In this embodiment, controller 354 does not update the expiration date.

Next, we will explain the onboard stability of the reagent information. Controller 354 detects that the cap of the reagent bottle has been pierced by the piercer. Then, the control device 354 specifies the elapsed time (eg, the number of days elapsed) since the cap of the reagent bottle was pierced by the piercer. Controller 354 updates the onboard stability after a predetermined period of time (eg, one day).

[Mode of analyzer 600]
Next, modes of the analyzer 600 will be described. Modes of the analyzer 600 include an analysis mode and a determination mode. The analyzer 600 can be switched from the analysis mode to the determination mode while the processing of the analyzer 600 is stopped (the analyzer 600 is on standby), or can be switched from the determination mode to the analysis mode. can be switched.

The analysis mode is a mode in which the analysis device 600 analyzes an unknown sample. In analysis mode, analyzer 600 can analyze an unknown sample using one reagent (first reagent or second reagent). When analyzing an unknown sample using the one reagent, the analyzer 600 creates a calibration curve using the one reagent and a known sample (for example, a known sample corresponding to the unknown sample). allow. When the analysis device 600 permits the creation of the calibration curve, it may notify the user of the permission. If the user sets a known sample at a predetermined position in the analyzer 600 when the preparation of the calibration curve is permitted, the one reagent and the known sample are used to prepare the calibration curve. Analysis device 600 then derives the first parameter. Furthermore, the analyzer 600 calculates a second parameter based on the first parameter and the calibration curve (preliminarily created calibration curve).

In addition, in the analysis mode, when the user performs an operation for using two reagents on the input device 356, the analyzer 600 displays the reagent information (a plurality of first reagent information) shown in FIG. and a plurality of second reagent information), one first reagent is determined from three first reagents, and one second reagent is determined from three second reagents.

Next, an example of this decision method will be explained. Hereinafter, the amounts of the first and second reagents used that are necessary for analyzing a minimum unit sample (for example, a sample contained in one cuvette) are referred to as "required amounts." In other words, the analyzer 600 can analyze the sample using the first reagent and the second reagent when both the first reagent and the second reagent are in the necessary amount or more.

The processing unit 304 refers to the reagent amounts of the three pieces of first reagent information, and selects a first reagent having a required amount or more from the three first reagents A1 to A3 as a candidate. A first reagent that is less than the required amount is not used. Furthermore, the processing unit 304 refers to the expiration dates of the three pieces of first reagent information, and selects a first reagent within the expiration date as a candidate from among the candidate first reagents. Furthermore, the processing unit 304 refers to the onboard stability of the three pieces of first reagent information, and determines a first reagent with high onboard stability from among the candidate first reagents. As a modification, the processing unit 304 refers to the onboard stability of the three pieces of first reagent information, and determines the first reagent with the low onboard stability from among the candidate first reagents. good too.

Similarly, the processing unit 304 refers to the three pieces of second reagent information and determines the second reagent to be used from among the three second reagents B1 to B3. The determined first reagent and second reagent are also collectively referred to as a "reagent pair" or "combination". A "reagent pair" or "combination" corresponds to a "reagent bottle combination" in this disclosure.

Then, the controller 354 allows creating a calibration curve using the determined reagent pair (first reagent and second reagent) and a known sample (for example, a known sample corresponding to an unknown sample). When the preparation of the calibration curve is permitted and the user sets the known sample, the reagent pair (first reagent and second reagent) and the known sample are used to prepare the calibration curve. The calibration curve is also referred to as the "calibration curve corresponding to the reagent pair". Controller 354 then derives the first parameter. Furthermore, the control device 354 calculates a second parameter based on the first parameter and the calibration curve (preliminarily created calibration curve).

Also, the three first reagents may have different manufacturing lots or manufacturing dates. Therefore, although the three first reagents are of the same type, they may have slightly different characteristics. Similarly, the three second reagents may be of the same type but may have slightly different characteristics. In this way, even if the reagents are of the same type, in consideration of the case where the components are slightly different, when the analysis device 600 uses the first reagent A1 and the second reagent B1 for analysis, the first reagent A1 and the second reagent B1 are used. A calibration curve is prepared using reagent A1, the second reagent B1, and a known sample. Also, when the analyzer 600 performs analysis using the first reagent A2 and the second reagent B1, a calibration curve is created using the first reagent A2, the second reagent B1, and a known sample.

In this way, the control device 354 of the present embodiment creates calibration curves individually for reagents of the same type but in different reagent bottles. Therefore, the control device 354 can accurately analyze an unknown sample without being affected by slight differences in the properties of the sample.

Also, the analyzer 600 can analyze unknown samples for a plurality of analysis items. For example, for an unknown sample, the concentration of substance R1 can be analyzed as a first analysis item, and the concentration of substance R2 can be analyzed as a second analysis item.

Next, I will explain the decision mode. As described above, controller 354 determines a reagent pair when analyzing an unknown sample using a first reagent and a second reagent. The reagent pair is referred to as "first reagent pair", "first combination". The first reagent pair corresponds to the "first bottle combination" of the present disclosure. The determination mode is a mode for determining a reagent pair to be used next to the first reagent pair (hereinafter also referred to as a "second reagent pair") in a state where the first reagent pair has been determined. be. The second reagent pair corresponds to the "first bottle combination" of the present disclosure. In addition, at least one of the first reagent and the second reagent forming the first reagent pair is different from the first reagent and the second reagent forming the second reagent pair.

Also, the determination mode is shifted to the input device 356 by a predetermined operation by the user. Hereinafter, the first reagent and second reagent that constitute the first reagent pair and the calibration curve created with the known sample are referred to as "first calibration curve". Also, the calibration curve created with the first and second reagents constituting the second reagent pair and the known sample is referred to as a "second calibration curve".

Thus, the controller 354 controls the mode of the analyzer 600 to either the analysis mode (first mode) for analyzing an unknown sample or the determination mode (second mode) for determining the second reagent pair. do. Therefore, analyzer 600 can determine the second reagent pair while analyzing an unknown sample.

FIG. 6 is an example of an input screen for the user to perform a predetermined operation. The control device 354 displays the input screen of FIG. 6 at a predetermined timing, which will be described later. This input screen is displayed in a display area 358A of the display device 358. FIG. In the example of FIG. 6, a character image 411, a Yes button 412, and a No button 413 are displayed. The character image 411 in the example of FIG. 6 is an image showing the characters "Would you like to shift to the determination mode for determining the next reagent pair?"

When the user operates the Yes button 412 when the input screen of FIG. 6 is displayed, the mode of the analyzer 600 shifts to the decision mode. Thus, the predetermined operation for shifting to the decision mode is the operation of the Yes button 412 on the input screen of FIG. Further, the control device 354 permits the user's predetermined operation by displaying the input screen.

Next, a typical situation in which the determination mode of this embodiment is shifted will be described. First, the first situation will be explained. FIG. 7 is a diagram for explaining the first situation. FIG. 7A is a diagram showing a case where the analysis device 600 has determined the first reagent pair. FIG. 7A shows an example in which the analyzer 600 determines the pair of the first reagent A1 and the second reagent B1 as the first reagent pair. In addition, in the example of FIG. 7A, the analyzer 600 uses the first reagent A1 and the second reagent B1, which form the first reagent pair, and a known sample set by the user to create a calibration curve (first It is shown that a calibration curve) was created. Then, analyzer 600 analyzes the unknown sample using first reagent A1 and second reagent B1 while referring to the first calibration curve.

By the way, an unexpected imbalance between the amount of the first reagent and the amount of the second reagent may occur due to an abnormality occurring while the analyzer 600 is analyzing the unknown sample. Here, the imbalance means that the amount of the first reagent or the amount of the second reagent constituting the first reagent pair is less than the required amount. Moreover, the unbalance caused by the occurrence of the following abnormality is also called "abnormal unbalance". The example of FIG. 7(B) shows a case where abnormal imbalance causes the first reagent A1 to excessively decrease and the amount of the first reagent A1 to become less than the required amount.

There are three types of abnormalities that can cause abnormal imbalance. The first abnormality among the three abnormalities is the dispensing error of the first reagent A1. A dispensing error of the first reagent A1 occurs, for example, when the probe 11a aspirates an excessive amount of the first reagent A1. Also, the second abnormality is a dispensing error of the unknown sample when the unknown sample and the first reagent A1 are both dispensed. The pipetting error of the unknown sample is, for example, a case where a sample pipetting device (not shown) does not properly pipette the sample. In this case, the first reagent A1 is not used and is discarded, for example. Therefore, also in this case, the first reagent A1 is excessively decreased.

Also, in the present embodiment, the analyzer 600 dispenses the first reagent, and dispenses the second reagent after a predetermined period of time has elapsed. The third abnormality is an abnormality in which some abnormality occurs in the analysis device 600 during the predetermined period and the analysis device 600 is brought to an emergency stop. In this case, the dispensed first reagent is discarded, for example. Therefore, also in this case, the first reagent A1 is excessively decreased.

In addition to the first to third abnormalities, for example, when the first sample A1 is spilled due to external force applied to the analyzer 600, the first sample A1 is excessively reduced.

As described below, the control device 354 can identify the occurrence of abnormal imbalance based on the first reagent amount indicated by the first reagent information and the second reagent amount indicated by the second reagent information. As described above, the reagent amounts indicated by the six pieces of reagent information are updated at each interrupt time. Controller 354 also specifies the required amount of the first reagent and the required amount of the second reagent.

However, if an abnormal imbalance occurs, for example, the amount of the first reagent becomes less than the required amount due to excessive reduction of the first sample. If the amount of the first reagent becomes less than the required amount, the analyzer 600 cannot analyze the unknown sample using the first reagent (the first reagent that becomes less than the required amount) and the second reagent. In this way, the control device 354 determines that an abnormal imbalance has occurred when the amount of the first reagent is less than the required amount or when the amount of the second reagent is less than the required amount. . Therefore, the controller 354 can identify the occurrence of abnormal imbalance based on the first reagent amount indicated by the first reagent information and the second reagent amount indicated by the second reagent information.

When an abnormal imbalance occurs, the analysis device 600 allows the user's predetermined operation by displaying the input screen of FIG. Then, when the user performs the permitted predetermined operation (operation to the Yes button 412 in FIG. 6), the analyzer 600, as shown in FIG. A second combination is determined based on the plurality of pieces of second reagent information.

In this way, as shown in FIG. 7B, the amount of the reagent (the first reagent A1 in the present embodiment) contained in the predetermined first reagent pair is changed to , may be less than required. When an abnormal imbalance occurs, the conventional analyzer determines that the amount of the first reagent A1 is less than the required amount, and uses another reagent pair, the first reagent A2 and the second reagent B2. In this conventional analyzer, the second reagent B1 is not used even though the second reagent B1 remains sufficiently. Therefore, the second reagent B1 is wasted.

Therefore, the analyzer 600 of the present embodiment determines the second reagent pair based on the amounts indicated by the three pieces of first reagent information and the amounts indicated by the three pieces of second reagent information. As shown in FIG. 7B, the amount of the first reagent A1 is less than the required amount, while the second sample B1 remains sufficiently. Therefore, analyzer 600 selects second reagent B1 as the second reagent included in the second combination. Further, when determining the second combination, the analyzer 600 excludes the first reagent A1 from the candidates for the second combination because the amount of the first reagent A1 is less than the required amount. FIG. 7C shows an example in which the analyzer 600 selects the first reagent A2 as the first reagent included in the second combination. In other words, the analyzer 600 changes the reagent pair from the first reagent pair to the second reagent pair by the user's predetermined operation. Therefore, the analyzer 600 selects the sufficiently remaining second reagent B2 as the second reagent pair, excludes the first reagent A1 that is less than the required amount, and uses the other first reagent (first reagent A2). It can be selected as a second reagent pair. Therefore, waste of the second reagent B1 remaining in the pure content can be prevented.

In addition, after determining the second reagent pair, analyzer 600 creates a calibration curve (second calibration curve) using the first and second reagents that make up the second reagent pair and the known sample. allow.

Also, when the analysis device 600 detects an abnormal imbalance, it executes an alarm process. The warning process may include, for example, displaying warning information on the display device 358 . The warning information is, for example, information indicating that "the amount of the first reagent A1 is less than the required amount". The warning information is characters such as "the amount of the first reagent A1 is less than the required amount". Also, the warning process may include, for example, a process of outputting a warning sound from a speaker (not shown).

FIG. 8 is a diagram for explaining the second situation. As described above, in the present embodiment, when analyzer 600 creates a calibration curve, the user needs to set a known sample. In particular, when the analysis apparatus 600 needs to create a calibration curve during the analysis of an unknown sample, it is necessary to stop the analysis of the unknown sample and have the user set the known sample. Therefore, not only is the user's work increased, but the time required for analysis of the unknown sample is increased.

Therefore, the analyzer 600 can switch the mode to the determination mode before analyzing the unknown sample. FIG. 8A is a diagram showing a case where, for example, analysis device 600 determines the first reagent pair before analysis device 600 analyzes an unknown sample. FIG. 8A shows an example in which the analyzer 600 determines the pair of the first reagent A1 and the second reagent B1 as the first reagent pair. In the present embodiment, when the first reagent pair is determined, analyzer 600 displays the input screen of FIG. 6 to allow the user's predetermined operation. Then, when the user performs the permitted predetermined operation, as shown in FIG. 8(B), analyzer 600 performs a second 2 Determine the combination.

Thus, analyzer 600 determines a first combination, a first calibration curve corresponding to the first combination, a second combination, and a second calibration curve corresponding to the second combination prior to analysis of the unknown sample. can do. Therefore, analyzer 600 analyzes an unknown sample by using the first and second reagents included in the first combination and the first and second reagents included in the second combination to provide the user with a known sample. Unknown samples (a large amount of unknown samples) can be analyzed continuously without placing Hereinafter, the process of continuously analyzing an unknown sample using the first and second reagents contained in the first combination and the first and second reagents contained in the second combination is referred to as "seamless analysis." Also called By executing seamless analysis, the analyzer 600 can reduce the user's trouble of setting a known sample and the time required to analyze an unknown sample.

[Reagent pair and calibration curve storage]
Next, storage of reagent pairs and calibration curves by the second storage unit 322 will be described. FIG. 9 is a diagram showing storage of reagent pairs and calibration curves by the second storage unit 322. As shown in FIG. The maximum number of reagent pairs to be stored and the maximum number of calibration curves to be stored in the second storage unit 322 are both "2", and are configured not to store three or more reagent pairs and three or more calibration curves. As a result, an increase in the storage area of the second storage unit 322 can be suppressed. Further, as described above, since the number of first reagents and the number of second reagents that can be held by the reagent placement section 31a is originally a relatively small number of "3", the maximum storage number is set to "2". However, no particular inconvenience occurs.

In FIG. 9A, when the processing unit 304 determines the first reagent pair, which is the first reagent A1 and the second reagent B1, and creates the first calibration curve corresponding to the first reagent pair, , the first reagent pair information L1 indicating the first reagent pair and the first calibration curve are stored in the second storage unit 322. FIG. In the example of FIG. 9A, the first reagent pair information L1 is information indicating the first reagent A1 and the second reagent B1.

Next, as shown in FIG. 9B, the processing unit 304 determines a second reagent pair, which is the first reagent A2 and the second reagent B2, for seamless analysis, and , the second reagent pair information L2 indicating the second reagent pair and the second calibration curve are stored in the second storage unit 322 when the second calibration curve corresponding to is created. In the example of FIG. 9B, the second reagent pair information L2 is information indicating the first reagent A2 and the second reagent B2.

In this case, as shown in FIG. 9B, the processing unit 304 stores the second calibration curve in the second storage unit 322 while keeping the first calibration curve stored in the second storage unit 322. Therefore, the analyzer 600 can perform seamless analysis using the first calibration curve and the second calibration curve stored in the second storage unit 322 .

Next, we will explain the case where an abnormal imbalance occurs during the analysis of an unknown sample using the first calibration curve without creating the second calibration curve. In this case, as shown in FIG. 9C, the processing unit 304 determines the second reagent pair, which is the first reagent A2 and the second reagent B1, for seamless analysis, and When the second calibration curve corresponding to the pair is created, the second storage unit 322 stores the second reagent pair information L2 indicating the second reagent pair and the second calibration curve. In the example of FIG. 9C, the second reagent pair information L2 is information indicating the first reagent A2 and the second reagent B1.

In this case, the processing unit 304 stores the second calibration curve in the second storage unit 322 while keeping the first calibration curve stored in the second storage unit 322, as shown in FIG. 9(C).

In addition, the processing unit 304 deletes the unnecessary reagent pair information and the calibration curve corresponding to the reagent pair information. When the amount of the first reagent or the second reagent constituting the reagent pair becomes less than the required amount, the reagent pair information indicating the reagent pair and the calibration curve corresponding to the reagent pair become unnecessary. Therefore, the processing unit 304 deletes the reagent pair information and the calibration curve. In addition, when an abnormal imbalance occurs during the analysis of an unknown sample using the first calibration curve, the amount of any reagent of the first reagent pair corresponding to the first calibration curve becomes less than the required amount. That's what it was. Therefore, the processing unit 304 deletes the first reagent pair information of the first reagent pair and the first calibration curve. Thus, the processing unit 304 deletes unnecessary calibration curves. Therefore, the processing unit 304 can store other reagent pair information and calibration curves.

Thus, the processing unit 304 determines the second reagent pair to be used next to the first reagent pair. In the present embodiment, "the second reagent pair to be used next" means "a reagent pair newly determined while the first reagent pair is stored in the second storage unit 322 (second reagent pair)”.

[Flow chart of control device]
FIG. 10 is a flowchart showing an example of main processing of the analysis device 600. As shown in FIG. The flowchart of FIG. 10 starts when the user performs an operation to start the analysis of the unknown sample on the input device 356 . It is also assumed that the user sets the reagents used by the analyzer 600 in the reagent placement section 31a (the first reagent placement section 311a and the second reagent placement section 312a). Here, it is assumed that first reagents A1 to A3 and second reagents B1 to B3 are set by the user.

In step S2, the analyzer 600 acquires reagent information of the set reagent from the sensor groups S1 to S6. Analyzer 600 stores first reagent information for each of first reagents A1 to A3 and second reagent information for each of second reagents B1 to B3 in first storage section 321 (see FIG. 5).

Next, in step S4, the analyzer 600 determines the first reagent pair (see FIG. 7(A) or FIG. 8(A)) used in each analysis item of the unknown sample. Next, in step S5, the analysis device 600 allows creation of a first calibration curve corresponding to the first reagent pair. Next, in step S6, when a known sample is set for the user, the analyzer 600 uses the known sample and the first and second reagents configured by the determined first reagent pair. to create the first calibration curve.

Next, in step S8, the analysis device 600 displays the input screen of FIG. As a result, the analysis device 600 allows the user to perform a predetermined operation (operation to the Yes button 412). Then, in step S10, the analysis device 600 determines whether or not the Yes button 412 has been operated by the user. In step S10, if Yes button 412 is operated (YES in step S10), the process proceeds to step S10. Also, in step S10, when the No button 413 is operated (NO in step S10), the process proceeds to step S12.

At step S12, the analyzer 600 controls the mode to the determination mode. The determination mode is a mode for determining the second reagent pair, as described above. In this manner, analysis device 600 switches the mode of analysis device 600 between the analysis mode and the decision mode according to the user's operation on the input screen. Therefore, user convenience can be improved.

FIG. 11 is an example of main processing of interrupt processing executed by the analysis device 600. FIG. As shown in FIG. 11, in step S402, the analyzer 600 calculates the reagent amounts of three pieces of the first reagent information and three pieces of the reagent amounts of the second reagent information every interrupt time (for example, one minute). Update. In this way, analyzer 600 periodically updates reagent information (three pieces of first reagent information and three pieces of second reagent information). Note that the reagent information to be updated is the reagent information acquired in step S2 of FIG.

FIG. 12 is a flow chart showing an example of main processing of the analysis device 600 during the decision mode in step S12. First, in step S202, the analyzer 600 prohibits updating reagent information. This update of the reagent information is step S402 in FIG. Next, in step S204, analyzer 600 determines a second reagent pair based on the first reagent information and the second reagent information. Here, the reason why the update of the reagent information is prohibited in step S202 will be explained. If the process of step S202 is not executed, the first reagent information or the second reagent information may be updated during the process (calculation) of determining the second reagent pair in step S204. In this case, analyzer 600 may determine the wrong second reagent pair. Therefore, the analyzer 600 prohibits updating of the reagent information during the determination mode, thereby suppressing execution of the erroneous second reagent pair determination process.

Next, in step S206, the analyzer 600 permits creation of a second calibration curve corresponding to the second reagent pair. Further, in step S206, analysis device 600 allows quality control analysis. Quality control analysis will now be described. After step S206, a second calibration curve is created. Quality control analysis is a process of confirming whether or not an appropriate analysis can be performed with the prepared second calibration curve. Quality control analysis is performed using QC (Quality Control) samples. By permitting the execution of the quality control analysis in this way, the user can grasp whether or not the unknown sample can be appropriately analyzed with the first reagent and the second reagent included in the second combination.

Next, in step S208, when a known sample is set for the user, analyzer 600 uses the known sample and the first and second reagents configured by the determined second reagent pair. Create a second calibration curve for each item using Next, in step S210, the analysis device 600 determines whether or not the preparation of the second calibration curve has been completed for each analysis item. When it is determined that the second calibration curves have been created for all the analysis items (YES in step S210), the decision mode is terminated and the main processing of FIG. go to mode. In this way, the analyzer 600 automatically changes the mode of the analyzer 600 to the analysis mode when the second reagent pair is determined in the determination mode and the second calibration curve corresponding to the second reagent pair is created. to control. Therefore, it is possible to omit the trouble of causing the user to control to the analysis mode, and as a result, it is possible to improve the user's convenience.

If it is determined in step S210 that the preparation of calibration curves for all analysis items has not been completed (NO in step S210), the process proceeds to step S212. In step S212, the analyzer 600 displays all the second calibration curves created in step S208 on the display device 358. FIG. Through the process of step S212, the user can grasp the created second calibration curve and the second calibration curve that has not been created.

Next, in step S214, the analysis device 600 determines whether or not to recreate the second calibration curve. For example, in step S214, analyzer 600 displays on display device 358 a screen (not shown) that allows input of an operation for redoing the creation of the second calibration curve. If the user has performed an operation to redo the second calibration curve (YES in step S214), the process returns to step S208. On the other hand, if the user has performed an operation not to redo the second calibration curve (NO in step S214), the process proceeds to the analysis mode of step S14. As described above, the analysis device 600 has not generated the second calibration curves for all the analysis items (NO in step S210), but if the generation of the second calibration curves has not been redone (step S214 NO), the mode of the analyzer 600 is automatically controlled to the analysis mode. Therefore, it is possible to omit the trouble of causing the user to control to the analysis mode, and as a result, it is possible to improve the user's convenience.

FIG. 13 is a flowchart showing an example of main processing of the analysis device 600 in the analysis mode of step S14. In step S102, the analyzer 600 determines whether or not the reagent will run out during the analysis of the unknown sample based on the six pieces of reagent information.

In step S102, if the reagent runs out (YES in step S102), the analyzer 600 determines whether or not the next reagent for the running out reagent has already been determined. Here, if the second reagent pair for seamless analysis has been determined in step S12 prior to step S14 including step S102, YES is determined in step S104, and the process proceeds to step S108. . On the other hand, if the second reagent pair has not been determined, NO is determined in step S104, and the process proceeds to step S106. In step S106, the analysis item (analysis item corresponding to the insufficient reagent) that should have been analyzed with the "insufficient reagent" determined in step S104 is excluded from the analysis targets. As a result, analysis device 600 can analyze the sample with the determined reagent in subsequent step S112. After the process of step S106 ends, the process proceeds to step S112.

Also, in step S108, the analyzer 600 determines whether or not the calibration curve for the reagent pair containing the next reagent resulting from the determination of YES in step S104 has been obtained. At step S110, analyzer 600 facilitates the creation of the calibration curve that was determined not to have been obtained at step S108. For example, the analysis device 600 displays a character image such as “Please create a calibration curve” on the display device 358 . Then, the process ends without analyzing the unknown sample.

On the other hand, after the process of step S106 is completed, and if YES is determined in step S108, the process proceeds to step S112. In step S112, analyzer 600 starts analyzing the unknown sample. Also, in step S114, it is determined whether or not an abnormal imbalance has occurred during the analysis of the unknown sample. If it is determined that abnormal imbalance has not occurred, the process proceeds to step S116. In step S116, analyzer 600 determines whether the analysis of all unknown samples and the analysis of all analysis items of the unknown samples have been completed. In step S116, if all analyzes have not been completed (NO in step S116), the process returns to step S114. Further, in step S116, when all the analyzes have been completed (YES in step S116), the process ends.

Also, in step S114, if an abnormal imbalance occurs, in step S118, the analysis device 600 executes the warning process described above. Then, the process proceeds to step S12.

In the analytical device of the comparative example, after a plurality of reagent pairs have been determined before the analysis of the unknown sample, the plurality of reagent pairs cannot be changed. Therefore, there is a problem that user convenience cannot be improved.

In contrast, in the present embodiment, after determining the first reagent pair, analyzer 600 determines the second reagent pair when the user performs a predetermined operation in steps S8 and S10. can do. Therefore, user convenience can be improved.

Also, when the first reagent pair is determined (when the process of step S4 is executed), the analyzer 600 allows the user to perform a predetermined operation in step S8. In addition, the analyzer 600 allows the user to perform a predetermined operation in step S8 even when an abnormal imbalance occurs (NO in step S114). When the predetermined operation permitted when the first reagent pair is determined is accepted (hereinafter also referred to as "first case"), and when the abnormal imbalance occurs, the predetermined operation permitted is accepted. The second reagent pair is determined by executing the same processing in both cases (hereinafter also referred to as “second case”). The same processing is step S204 in FIG. 12, for example. Therefore, the analyzer 600 of the present embodiment can reduce the processing capacity (the number of processes) compared to an analyzer that determines the second reagent pair by different processes for the first case and the second case. .

[Modification]
(1) In the above-described embodiment, when the occurrence of abnormal imbalance is detected in step S114, analyzer 600 determines the second reagent pair when receiving the user's predetermined operation in step S8. I explained the configuration to do.

However, when the analyzer 600 detects the occurrence of abnormal imbalance in step S114, the analyzer 600 may automatically determine the second reagent pair without requiring a predetermined operation by the user. In other words, in FIGS. 10 and 13, if YES is determined in step S114, the warning process in step S118 is executed, and then the process proceeds to step S12 instead of step S8.

According to such a configuration, even after abnormal imbalance occurs, the second reagent pair can be determined without requiring user's operation. Therefore, even with such a configuration, user convenience can be improved.

(2) In the above embodiment, the number of types of reagents used for analyzing an unknown sample is two, that is, the reagents are the first reagent and the second reagent. However, a configuration in which the number of types of reagents is L (L is an integer equal to or greater than 3) may be adopted. That is, the first reagent combination (first reagent bottle combination) is a combination of L reagents (eg, first reagent, second reagent, and third reagent). The second reagent combination (second reagent bottle combination) is also a combination of L reagents (eg, first reagent, second reagent, and third reagent).

(3) In the above embodiment, if the reagent pair has been determined but the calibration curve corresponding to the reagent pair has not been created, the unknown sample is not analyzed and the process of FIG. 10 ends. explained the configuration. For example, if analysis device 600 determines NO in step S108 of FIG. 13, it ends the processing of FIG. 10 after executing the configuration of step S110.

However, when a reagent pair has been determined but a calibration curve corresponding to the reagent pair has not been created, analyzer 600 calculates the first parameter and stores the first parameter in a predetermined storage area. It may be stored (or held). In this case, the analyzer 600 calculates the second parameter by applying the reserved first parameter to the calibration curve after the calibration curve is created.

In FIG. 13, if NO is determined in step S108, the process proceeds to step S112. Then, the first parameter is calculated by the analysis of the unknown sample started in step S112. Each time, after the calibration curve is created, the analysis device 600 calculates the second parameter by applying the first parameter to the calibration curve.

(4) The configuration of the analyzer of this embodiment as a blood coagulation analyzer has been described. However, the analysis device may be another analysis device. Other analyzers are, for example, biochemical automated analyzers or immune item analyzers.

(5) In the analyzer 600 described above, the calibration curves (the first calibration curve and the second calibration curve) are used to analyze the unknown sample using the first reagent and the second reagent. However, a configuration in which the unknown sample is analyzed using the first reagent and the second reagent without using the calibration curve (the first calibration curve and the second calibration curve) may be adopted. An analysis apparatus employing such a configuration directly calculates the second parameter without calculating the first parameter.

(6) In the above-described embodiment, the reagent information includes all of the reagent position, the amount of the reagent, the expiration date of the reagent, and the on-board stability of the reagent. However, the reagent information may include at least one of reagent position, reagent quantity and expiration date of the reagent, on-board stability of the reagent. In the case of a configuration in which the reagent information does not include the amount of the reagent, the analyzer 600 detects the amount of the reagent by the above-described amount sensor or the like when determining the reagent to be used. Then, analyzer 600 identifies the remaining reagent based on the amount of the detected reagent and uses the remaining reagent.

[Aspect]
It will be appreciated by those skilled in the art that the multiple exemplary embodiments described above are specific examples of the following aspects.

(Section 1) An analysis device according to one aspect includes an arrangement unit, a first storage device, a control device, and an analysis mechanism. A plurality of reagent bottles are arranged in the arrangement section. The first storage device stores reagent bottle information of a plurality of reagent bottles. The controller determines a combination of reagent bottles to be used for analysis items based on reagent bottle information of a plurality of reagent bottles. The analysis mechanism uses the reagent bottle combination determined by the controller to analyze the unknown sample. A controller determines a first reagent bottle combination containing a first reagent and a second reagent for the assay item. Further, when receiving a predetermined operation by the user, the control device determines a second reagent bottle combination containing the first reagent and the second reagent to be used next to the first reagent bottle combination by the analysis mechanism.

According to such a configuration, after determining the first combination containing the first reagent and the second reagent used by the analysis mechanism, the first reagent used next to the first combination is determined at the user's desired timing. and a second reagent can be determined. Therefore, user convenience can be improved.

(Section 2) In the analysis apparatus described in Section 1, the control device causes the amount of the first reagent contained in the first reagent bottle combination to increase to the first 2 Allow routine manipulations when less than required for use with reagents.

According to such a configuration, even if the amount of the first reagent is excessively reduced due to the occurrence of an abnormality and the second reagent remains, the user can perform the permitted predetermined operation. , the second combination, which is the combination of the remaining second reagent and the new first reagent, is determined, so that waste of the second reagent can be avoided.

(Section 3) In the analyzer described in Section 2, the control device executes warning processing when the above-described abnormality occurs.

According to such a configuration, it is possible to notify the user that the amount of the first reagent contained in the first combination is less than the required amount.

(Section 4) In the analyzer according to any one of Sections 1 to 3, when the first reagent bottle combination is determined, the control device permits the predetermined operation, and the first reagent bottle combination and the known sample set by the user to create a first calibration curve, and use the second reagent bottle combination determined by accepting the permitted predetermined operation and the known sample set by the user to create a second calibration curve.

According to such a configuration, when the first combination is determined, when the user performs the permitted predetermined operation, the first calibration curve for the first combination and the second calibration curve for the second combination Both a second calibration curve and a second calibration curve can be generated. When creating a calibration curve for the analyzer, the user must set a known sample. Therefore, an unknown sample can be analyzed using the first and second reagents contained in the first combination and the first and second reagents contained in the second combination without requiring the user to place the known sample. , can continuously analyze unknown samples (a large number of unknown samples).

(Section 5) In the analyzer described in Section 2 or 3, the controller permits the predetermined operation when the first reagent bottle combination is determined, and allows the predetermined operation when an abnormality occurs. is received and the predetermined operation permitted when the first reagent bottle combination is determined is performed, thereby determining the second reagent bottle combination.

According to such a configuration, when the amount of the first reagent contained in the first combination becomes less than the required amount and when the predetermined operation permitted when the first combination is determined is accepted, the second Processing for determining combinations can be shared.

(Section 6) An analysis device according to one aspect includes an arrangement unit, a first storage device, a control device, and an analysis mechanism. A plurality of reagent bottles are arranged in the arrangement section. The first storage device stores reagent bottle information of a plurality of reagent bottles. The controller determines a combination of reagent bottles to be used for analysis items based on reagent bottle information of a plurality of reagent bottles. The analysis mechanism uses the reagent bottle combination determined by the controller to analyze the unknown sample. A controller determines a first reagent bottle combination containing a first reagent and a second reagent for the assay item. In addition, the control device determines that the amount of the first reagent contained in the first reagent-bottle combination is less than the necessary amount for use with the second reagent contained in the first reagent-bottle combination due to the occurrence of the abnormality. If so, the analysis mechanism determines a second reagent bottle combination containing the first and second reagents to be used next to the first reagent bottle combination.

According to such a configuration, even if the amount of the first reagent is excessively reduced due to the occurrence of an abnormality and the second reagent remains, the remaining second reagent and the new Since the second combination, which is the combination with the first reagent, is automatically determined, waste of the second reagent can be avoided without requiring user's operation.

(Section 7) In the analyzer according to any one of Sections 1 to 3, 5, and 6, the controller controls the combination of the first reagent bottle and the known A first calibration curve is generated using the samples and a second calibration curve is generated using a second reagent bottle combination and known samples set by the user.

According to such a configuration, the first calibration curve using the first reagent and the second reagent included in the first combination, and the second calibration curve using the first reagent and the second reagent included in the second combination A calibration curve can be created.

(Section 8) The analyzer described in Section 4 or 7 further includes a second storage device that stores the first calibration curve and the second calibration curve and does not store other calibration curves.

According to such a configuration, the second storage device stores at most two calibration curves, so an increase in the storage area of the second storage device can be suppressed.

(Item 9) In the analyzer according to any one of items 1 to 8, the controller determines the mode of the analyzer as the first mode for analyzing the unknown sample and the second combination. Control to either the second mode or the second mode.

According to such a configuration, it is possible to determine the second combination while analyzing the unknown sample.

(Item 10) In the analyzer described in Item 9, the control device switches the mode of the analyzer between the first mode and the second mode according to the user's operation.

According to such a configuration, user convenience can be improved.
(Item 11) In the analyzer described in Item 9 or 10, the controller prohibits update of the reagent bottle information during the second mode.

If updating of the first update information and updating of the second update information are permitted during the second mode, updating of the first update information and updating of the second update information are executed during the process of determining the second combination. may be In this case, the controller may determine the wrong second combination. Therefore, by prohibiting the update of the reagent bottle information during the second mode, it is possible to suppress execution of the erroneous determination process of the second combination.

(Item 12) In the analyzer according to any one of items 9 to 11, during the second mode, the controller controls the first reagent and the second reagent included in the second combination and the user It allows preparation of a second calibration curve using the set known samples, and quality control analysis using the second calibration curve.

According to such a configuration, since the preparation of the second calibration curve and the quality control analysis using the second calibration curve are allowed, the unknown sample is detected by the first reagent and the second reagent included in the second combination. The user can grasp whether the analysis can be performed appropriately.

(Item 13) In the analyzer according to any one of items 9 to 12, when the control device determines the second combination in the second mode and creates the second calibration curve, the analysis The mode of the device is automatically controlled to the first mode.

According to such a configuration, after the second calibration curve is created, it is possible to automatically control to the first mode for analyzing the unknown sample, so it is possible to improve the user's convenience.

(Section 14) In the analyzer according to any one of Sections 1 to 13, the reagent bottle information includes the amount of reagent, the expiration date of the reagent, and the onboard stability of the reagent. At least one.

According to such a configuration, the first combination and the second combination are determined based on at least one of the expiration date and onboard stability of the first reagent and at least one of the expiration date and onboard stability of the second reagent. can.

(Section 15) A control method according to one aspect is a control method for an analyzer. The analysis device includes an arrangement section, a first storage device, and an analysis mechanism. A plurality of reagent bottles are arranged in the arrangement section. The first storage device stores reagent bottle information of a plurality of reagent bottles. The analysis mechanism analyzes the unknown sample using the reagent bottle combination determined by the control method. The control method comprises determining a first reagent bottle combination containing a first reagent and a second reagent for the assay item. Also, the control method comprises determining a second reagent bottle combination containing the first reagent and the second reagent to be used next to the first reagent bottle combination by the analysis mechanism when a predetermined operation by the user is received. .

According to such a configuration, after determining the first combination containing the first reagent and the second reagent used by the analysis mechanism, the first reagent used next to the first combination is determined at the user's desired timing. and a second reagent can be determined. Therefore, user convenience can be improved.

(Section 16) A control method according to one aspect is a control method for an analyzer. The analysis device includes an arrangement section, a first storage device, and an analysis mechanism. A plurality of reagent bottles are arranged in the arrangement section. The first storage device stores reagent bottle information of a plurality of reagent bottles. The analysis mechanism analyzes the unknown sample using the reagent bottle combination determined by the control method. The control method comprises determining a first reagent bottle combination containing a first reagent and a second reagent for the assay item. Further, the control method is such that the amount of the first reagent contained in the first reagent bottle combination is less than the necessary amount for use with the second reagent contained in the first reagent bottle combination due to the occurrence of the abnormality. If so, determining a second reagent bottle combination containing the first reagent and the second reagent to be used next to the first reagent bottle combination by the analysis mechanism.

According to such a configuration, even if the amount of the first reagent is excessively reduced due to the occurrence of an abnormality and the second reagent remains, the remaining second reagent and the new Since the second combination, which is the combination with the first reagent, is automatically determined, waste of the second reagent can be avoided without requiring user's operation.

The embodiments disclosed this time should be considered illustrative in all respects and not restrictive. The scope of the present disclosure is indicated by the scope of the claims rather than the description of the above-described embodiments, and is intended to include all modifications within the meaning and scope equivalent to the scope of the claims.

110 cuvette supply device, 111 cuvette storage unit, 120 cuvette transfer device, 121 arm with chuck, 200 stirring device, 300 analysis mechanism, 302 acquisition unit, 304 processing unit, 306 control unit, 310 storage unit, 311 first storage unit, 311a first reagent placement unit, 312 second storage unit, 312a second reagent placement unit, 354 control device, 356 input device, 358 display device, 358A display area, 361 memory, 600 analyzer.

Claims (16)

an arrangement section in which a plurality of reagent bottles are arranged;
a first storage device that stores reagent bottle information of the plurality of reagent bottles;
a controller that determines a reagent bottle combination to be used for an analysis item based on the reagent bottle information of the plurality of reagent bottles;
an analysis mechanism that analyzes an unknown sample using the reagent bottle combination determined by the control device;
The control device is
determining a first reagent bottle combination containing a first reagent and a second reagent for the analytical item;
An analysis device that determines a second reagent bottle combination containing a first reagent and a second reagent to be used next to the first reagent bottle combination by the analysis mechanism when a predetermined operation by a user is received. The controller determines that the amount of the first reagent contained in the first reagent bottle combination is less than the necessary amount for use with the second reagent contained in the first reagent bottle combination due to the occurrence of the abnormality. 2. The analyzer according to claim 1, wherein said predetermined operation is permitted when The analysis device according to claim 2, wherein the control device executes warning processing when the abnormality occurs. The control device is
permitting the predetermined operation when the first reagent bottle combination is determined;
creating a first calibration curve using the first reagent bottle combination and a known sample set by a user;
A second calibration curve is created using the second reagent bottle combination determined by accepting the allowed predetermined operation and the known sample set by the user. 2. The analyzer according to item 1. The control device is
permitting the predetermined operation when the first reagent bottle combination is determined;
when the predetermined operation permitted when the abnormality occurs;
4. The second reagent bottle combination according to claim 2 or 3, wherein the second reagent bottle combination is determined by executing the same processing when the predetermined operation allowed when the first reagent bottle combination is determined is accepted. Analysis equipment. an arrangement section in which a plurality of reagent bottles are arranged;
a first storage device that stores reagent bottle information of the plurality of reagent bottles;
a controller that determines a combination of reagent bottles to be used for an analysis item based on the reagent bottle information of the plurality of reagent bottles;
an analysis mechanism that analyzes an unknown sample using the reagent bottle combination determined by the control device;
The control device is
determining a first reagent bottle combination containing a first reagent and a second reagent for the analytical item;
If the occurrence of an abnormality causes the amount of the first reagent contained in the first reagent bottle combination to become less than the necessary amount for use with the second reagent contained in the first reagent bottle combination, An analysis device for determining a second reagent bottle combination containing a first reagent and a second reagent to be used next to the first reagent bottle combination by the analysis mechanism. The control device is
creating a first calibration curve using the first reagent bottle combination and a known sample set by a user;
Any one of claims 1 to 3, 5, and 6, wherein a second calibration curve is created using the second reagent bottle combination and a known sample set by a user The analyzer described. The analysis device according to claim 4 or 7, further comprising a second storage device that stores the first calibration curve and the second calibration curve and does not store other calibration curves. 2. The analysis according to claim 1, wherein said controller controls the mode of said analyzer between a first mode for analyzing said unknown sample and a second mode for determining said second reagent bottle combination. Device. The analysis device according to claim 9, wherein the control device switches the mode of the analysis device between the first mode and the second mode according to a user's operation. The analyzer according to claim 9 or 10, wherein said control device prohibits update of reagent bottle information of said plurality of reagent bottles during said second mode. During the second mode, the control device creates a second calibration curve using the second reagent bottle combination and the known sample set by the user, and performs quality control analysis using the second calibration curve. The analysis device according to any one of claims 9 to 11, which allows. The controller automatically controls the mode of the analyzer to the first mode when the second reagent bottle combination is determined and the second calibration curve is created in the second mode. The analyzer according to any one of claims 9 to 12. The analyzer according to any one of claims 1 to 13, wherein the reagent bottle information includes at least one of reagent quantity, reagent expiration date, and reagent on-board stability. . A control method for an analyzer,
The analysis device is
an arrangement section in which a plurality of reagent bottles are arranged;
a first storage device that stores reagent bottle information of the plurality of reagent bottles;
an analysis mechanism that analyzes an unknown sample using the reagent bottle combination determined by the control method;
The control method is
determining a first reagent bottle combination containing a first reagent and a second reagent for the assay;
determining a second reagent bottle combination containing a first reagent and a second reagent to be used next to the first reagent bottle combination by the analysis mechanism when a predetermined operation by a user is received. Method. A control method for an analyzer,
The analysis device is
an arrangement section in which a plurality of reagent bottles are arranged;
a first storage device that stores reagent bottle information of the plurality of reagent bottles;
an analysis mechanism that analyzes an unknown sample using the reagent bottle combination determined by the control method;
The control method is
determining a first reagent bottle combination containing a first reagent and a second reagent for the assay;
If the occurrence of an abnormality causes the amount of the first reagent contained in the first reagent bottle combination to become less than the necessary amount for use with the second reagent contained in the first reagent bottle combination, determining a second reagent bottle combination containing a first reagent and a second reagent to be used next to said first reagent bottle combination by said analysis mechanism.

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