Patent ID: 12216134

DESCRIPTION OF EMBODIMENTS

Hereinafter, a preferred embodiment for implementing the invention will be described with reference toFIGS.1to9. In the present description, there are different measurement items, that is, a short measurement item that requires a short period of time for a reaction (hereinafter, referred to as a short measurement item), and a standard measurement item that requires a standard period of time fora reaction (hereinafter, referred to as a standard measurement item) as types of a measurement sequence. The latter may be called a normal item.

First Embodiment

The first embodiment is an embodiment of an automatic analyzer including: an incubator that includes a plurality of holding portions holding a plurality of reaction containers and promotes a reaction of a mixed solution of a sample and a reagent, the reaction containers containing the mixed solution; a receiving unit that receives analysis information relating to a measurement item of the sample; a transport unit that transports each of the reaction containers to the holding portion; an analyzing unit that performs analysis by operating a measurement sequence of a predetermined reaction time on each of the reaction containers containing the mixed solution to which a predetermined reagent is added at a predetermined timing based on the analysis information; a planning unit that creates an analysis schedule to be performed by the analyzing unit based on the analysis information. In an analysis of a plurality of different measurement items, the planning unit estimates and creates the analysis schedule according to a plurality of different measurement sequences such that the different measurement sequences are capable of being performed.

In addition, the first embodiment is an embodiment of an automatic analysis method of an automatic analyzer, the automatic analyzer including: an incubator that includes a plurality of holding portions holding a plurality of reaction containers and promotes a reaction of a mixed solution of a sample and a reagent, the reaction containers containing the mixed solution; and an analyzing unit that performs analysis on the mixed solution contained in each of the reaction containers by installing the reaction container, in which the predetermined reagent is added to the sample at a predetermined timing based on analysis information relating to a measurement item of the sample, in the holding portion and operating a measurement sequence at a predetermined reaction time. In a case where an analysis schedule to be performed by the analyzing unit based on analysis information of the sample that is requested to be measured is created, in order to analyze a plurality of different measurement items, an analysis schedule of an analysis target is estimated and created according to a plurality of different measurement sequences of the measurement items such that the different measurement sequences are capable of being performed.

FIG.1is a system block diagram illustrating an overall configuration example of an automatic analyzer according to the first embodiment. The automatic analyzer includes a sample rack loading unit1-1, an identifier (ID) reading unit1-2, a transport line1-3, a reexamination transport line1-4, an analysis module1-7, a sample rack collecting unit1-5, and a computer for overall management1-8.

The sample rack loading unit1-1is a unit that loads a plurality of sample racks into the automatic analyzer. A calibrator storing unit1-6is a mechanism that can store a reagent used for calibration and automatically load a calibrator upon a request. The analysis module1-7is located along the transport line1-3and is detachably connected to the transport line1-3.

The analysis module1-7includes a computer1-10for an analysis module that functions as a control unit that performs a necessary processing control inside thereof. In addition, the sample rack loading unit1-1includes a computer1-9that performs a necessary control on the sample rack loading unit1-1, the transport line1-3, the reexamination transport line1-4and the sample rack collecting unit1-5. These computers1-9and1-10, and the ID reading unit1-2are connected to the computer for overall management1-8. The computer for overall management1-8is connected to an operation unit1-12that inputs further necessary information, a display unit1-11that displays an analysis result, and an external network1-13. The computer for overall management1-8, and the computers1-9and1-10each have a normal computer configuration, and include a central processing unit (CPU), a storage unit (memory), an input/output unit, a network interface, etc. In addition, the computer for overall management1-8and the computers1-9and1-10may implement functions of all control units with one computer without preparing three independent computers.

Next, a configuration example of the analysis module of the present embodiment will be described with reference toFIG.2. Inside an analysis module2-1corresponding to the analysis module1-7inFIG.1, a rack2-2, on which a sample container2-3for holding a sample is erected, is moved by a rack transport line2-18to a sample dispensing position near a sample dispensing nozzle2-4.

An incubator2-5is installed with a plurality of reaction containers2-6, and has a configuration capable of rotational movement for moving each of the reaction containers2-6installed in the circumferential direction to a predetermined position.

A sample dispensing tip and reaction container transport mechanism2-7can move in three directions of an X-axis, a Y-axis, and a Z-axis, and move within a predetermined range of a sample dispensing tip and reaction container holder member2-8, a reaction container stirring mechanism2-9, a sample dispensing tip and reaction container waste hole2-10, and a sample dispensing tip mounting position2-11, and the incubator2-5to transport a sample dispensing tip and a reaction container.

A plurality of unused reaction containers and sample dispensing tips are installed on the sample dispensing tip and reaction container holder member2-8. The sample dispensing tip and reaction container transport mechanism2-7moves to above the sample dispensing tip and reaction container holder member2-8and descends in the Z direction to grip an unused reaction container, and then rises and further moves to a predetermined position above the incubator2-5, and descends to install the reaction container2-6at a corresponding position.

Next, the sample dispensing tip and reaction container transport mechanism2-7moves to above the sample dispensing tip and reaction container holder member2-8and descends to grip an unused sample dispensing tip, and then rises and moves to above the sample dispensing tip mounting position2-11, and descends to install the sample dispensing tip at a corresponding position.

The sample dispensing nozzle2-4can rotate and move up and down, and rotates and moves to above the sample dispensing tip mounting position2-11, and then descends to press-fit and load the sample dispensing tip into a tip of the sample dispensing nozzle2-4. The sample dispensing nozzle2-4loaded with the sample dispensing tip moves to above the sample container2-3mounted on the transport rack2-2, and then descends to aspirate a predetermined amount of a sample held in the sample container2-3. The sample dispensing nozzle2-4that aspirated the sample moves to above the incubator2-5, and then descends to discharge the aspirated sample into an unused reaction container2-6held in the incubator2-5. When the sample discharge to the reaction container2-6is completed, the sample dispensing nozzle2-4moves to above the sample dispensing tip and reaction container waste hole2-10, and drops an used sample dispensing tip into a disposal hole and discards it.

A plurality of reagent containers2-19are installed on a reagent disk2-12. A reagent disk cover2-13is provided above the reagent disk2-12, and an inside of the reagent disk2-12is kept at a predetermined temperature. A reagent disk cover opening portion2-14is provided in a part of the reagent disk cover2-13. A reagent dispensing nozzle2-15can rotate and move up and down, and rotates and moves to above the opening portion2-14of the reagent disc cover2-13and descends to immerse a tip of the reagent dispensing nozzle2-15in a reagent in a predetermined reagent container2-19to aspirate a predetermined amount of the reagent. Then, the reagent dispensing nozzle2-15rises, and then rotates and moves to a predetermined position above the incubator2-5to discharge an aspirated reagent into the predetermined reaction container2-6.

The reaction container2-6to which the sample and the reagent are discharged is moved to a predetermined position by rotation of the incubator2-5, and is transported to the reaction container stirring mechanism2-9by the sample dispensing tip and reaction container transport mechanism2-7. The reaction container stirring mechanism2-9stirs and mixes the sample and the reagent in the reaction container by applying a rotary motion to the reaction container2-6. The reaction container2-6after stirring is returned to a predetermined position of the incubator2-5by the sample dispensing tip and reaction container transport mechanism2-7.

A reaction solution aspiration nozzle2-16can rotate and move up and down, and moves to above the reaction container2-6after the sample and the reagent are dispensed and stirred and a predetermined reaction time has passed in the incubator2-5, and descends and aspirates a reaction solution in the reaction container2-6. The reaction solution aspirated by the reaction solution aspiration nozzle2-16is analyzed by at least one detecting unit2-17.

The reaction container2-6from which the reaction solution is aspirated is moved to a predetermined position by the rotation of the incubator2-5, and is moved from the incubator2-5to above the sample dispensing tip and reaction container waste hole2-10by the sample dispensing tip and reaction container transport mechanism2-7, and then is discarded from the disposal hole.

In the analysis module shown inFIG.2, in order to be able to operate a plurality of different measurement sequences, in addition to an operation of one position counterclockwise, operation patterns such as one position clockwise and three positions counterclockwise may be prepared as operation patterns of the incubator2-5, for example, as shown in FIG. 5 of Patent Literature 2.

FIG.3is a block diagram illustrating various functions of the computer1-10for the analysis module in the present embodiment. These various functions can be implemented by the central processing unit (CPU) built in the computer that executes a predetermined program stored in the storage unit, etc. Arrows in the figure denote a transmission direction of information between functional blocks. Information transmission is, for example, message communication. A request input unit3-1has a function in which the analysis module2-1shown inFIG.2receives a measurement request for a sample on a sample rack. A rack managing unit3-2manages the measurement request received by an input unit3-1. A planning unit3-3schedules a measurement of the sample in analysis module2-1. A mechanism control unit3-4operates various mechanisms of the analysis module according to the schedule planned by the planning unit3-3. A result output unit3-5notifies a host system such as the computer for overall management1-8of a measurement result corresponding to the measurement request. A request analyzing unit3-6receives the measurement request input to the request input unit3-1, classifies whether the measurement item is a short measurement item or a standard measurement item, and obtains a ratio of the short measurement item and the standard measurement item in the measurement request. Here, the ratio is a proportion of the short measurement item to the standard measurement item. Unique functions of the automatic analyzer of the present embodiment are functions of the request analyzing unit3-6and the planning unit3-3inFIG.3.

Hereinafter, details of the two functions of the request analyzing unit and the planning unit will be described with reference toFIGS.4and5.FIG.4is a flowchart illustrating processing flows of the request analyzing unit3-6. First, the measurement request is received from the request input unit3-1(step4-1).

It is confirmed whether a measurement item of a measurement sequence of the received measurement request is a short measurement item or a standard measurement item, and based on a result thereof, the ratio of the short measurement item and the standard measurement item is calculated (step4-2). Then, it is confirmed whether the calculated ratio has changed (step4-3), and if there is a change, the ratio is recorded as an empty cycle setting for the short measurement, and the empty cycle setting for the short measurement is updated (step4-4). If there is no change, the processing flows end immediately and wait for a next request reception. By updating this setting, the request analyzing unit3-6outputs an updated empty cycle ratio for the short measurement. Here, an empty cycle means a cycle without measurement in the analysis schedule, and a cycle set to shorten a turnaround time of a STAT item is referred to as an empty cycle for the short measurement.

FIG.5is a flowchart illustrating processing flows of the planning unit3-3. First, a measurement request collated with the rack2-2is received from the rack managing unit3-2(step5-1). Then, the above-mentioned empty cycle ratio for the short measurement, which is an analysis result of the processing flows shown inFIG.4of the request analyzing unit3-6, is acquired (step5-2). Depending on the empty cycle ratio for the short measurement and a current number of schedules, it is determined whether a next analysis schedule is an empty cycle (step5-3).

If the next analysis schedule is an empty cycle (yes in step5-4), the empty cycle for the short measurement is scheduled (step5-8). If the next analysis schedule is not an empty cycle (no), a measurement item based on the measurement request is scheduled (step5-5) and the number of the schedules in the analysis schedule is counted up (step5-6). Then, it is confirmed whether all schedules of received measurement requests have been completed (step5-7), and if it has been not completed (no), the same process is executed from step5-3to process a next schedule. If all the schedules of the received measurement requests have been completed (yes), the processing flows end.

Next, an effect of the automatic analyzer of the present embodiment will be described in comparison with the related art.FIG.6shows a comparison of measurement sequences of an automatic analyzer in the related art and the automatic analyzer of the present embodiment in upper and lower stages. That is,FIG.6is an example of, when a measurement item A which is a standard measurement item is measured continuously, comparing an elapsed time until a measurement result of a measurement item B which is a short measurement item is output when an empty cycle without measurement is scheduled according to the configuration of the present embodiment with an elapsed time according to the related art when the measurement item B which is the short measurement item is measured. In both cases, an examination request contains 5 items, examination1to examination5. Contents of analysis processes a to e of the measurement items A and B are shown in a lower right portion.

As described above, the measurement item A shown inFIG.6is an example of the measurement sequence of the standard measurement item, and the measurement item B is an example of the measurement sequence of the short measurement item. Regarding the analysis processes a to e, a denotes sample sampling, b denotes first-stage reagent aspiration/addition, c denotes magnetic particle reagent aspiration/addition, d denotes reaction solution stirring, e denotes electrical signal measurement, and f and g denote incubation. By making different combinations of these analysis processes, the measurement sequences of the measurement item A and measurement item B are configured. In the figure, z denotes empty cycle (no measurement). One operation of the analysis processes a to e cannot be operated at the same timing for a plurality of measurement items.

As shown in the upper stage ofFIG.6, in the case of the related art, in the measurement item B of the examination4, there is a waiting time until time6on a horizontal axis is reached. That is, when the measurement item A which is the standard measurement item is continuously measured, a start of a measurement of the measurement item B which is a short measurement item may be awaited. However, as shown in the lower stage ofFIG.6, in the case of the configuration of the present embodiment, by a schedule without measurement due to an empty cycle (z) before a start of the measurement item A of the examination3, the measurement item B of the examination4can start the measurement from time5earlier than time6on the horizontal axis, and thus an elapsed time t2 until the measurement result of the measurement item B is output is shorter than an elapsed time t1 in the case of the related art (t2<t1).

As described above, the automatic analyzer and the automatic analysis method of the present embodiment can shorten the turnaround time of the short measurement item and contribute to an early diagnosis.

Subsequently, examples of an empty cycle schedule proportion setting, priority setting, and presence/absence setting screen of the automatic analyzer of the present embodiment will be described with reference toFIGS.7-9. These setting screens can be displayed as a Graphical User Interface (GUI) on the display unit1-11under control of the computer for overall management1-8inFIG.1, for example.

FIG.7is an example of an empty cycle schedule proportion setting screen. On an empty cycle schedule proportion setting screen7-1, a proportion of an empty cycle can be input in a text box7-2using a cancel button7-3and an update button7-4. It is also possible to determine the empty cycle schedule proportion based on a condition of the proportion (%) of the empty cycle set on a GUI screen regardless of instructions from the computer for overall management1-8.

FIG.8is an example of an empty cycle schedule priority setting screen. On an empty cycle schedule priority setting screen8-1, a priority condition in a priority condition8-2is selected by a condition selection radio button8-3. It is also possible to determine whether to prioritize an empty cycle schedule based on the priority condition set by a user on such a GUI screen regardless of the instructions from the computer for overall management1-8.

FIG.9is an example of an empty cycle schedule presence/absence setting screen for each measurement item. On an empty cycle schedule presence/absence setting screen9-2, a measurement item name9-2, a combo box for selection9-3, a cancel button9-4, and an update button9-5are displayed. In the measurement item name9-2, measurement items A to E can be selected. In this way, presence/absence of empty cycle schedules for the measurement items may be determined based on conditions set on such a GUI screen regardless of the instructions of the computer for overall management1-8.

Although the preferred embodiment of the invention has been described in detail with reference to the drawings, the invention is not limited to the above-described embodiment and includes various modifications. For example, the embodiment described above has been described in detail for better understanding of the invention, and the invention is not necessarily limited to those including all configurations described above.

In addition, for example, as shown inFIG.2, the analysis module serving as the analyzing unit includes a plurality of detection units2-17that operate the measurement sequence to perform analysis, and can set the analysis schedule for different measurement sequences for each of the plurality of detection units. That is, different analysis schedules can be set for a first reaction container to be transported to a first detecting unit and a second reaction container to be transported to a second detecting unit. For example, an analysis schedule may be set for the first reaction container and no analysis schedule may be set for the second reaction container. In addition, the number of physical detection units in the analysis module is not limited, and the first detecting unit and the second detecting unit may be logically assigned and different analysis schedules may be set for each. In other words, the analyzing unit of the automatic analyzer includes the plurality of detection units, it is possible to specify that the analysis schedule of the different measurement sequences is executed for each of the plurality of detecting units, and contents of the specified measurement sequences are saved in the storage unit of the computer1-10.

Furthermore, although the explanation is based on an example of creating a program of the CPU for implementing a part or all of the configurations, functions, and computer for overall management described above, it is needless to say that a part or all of them may be implemented by hardware, for example, by designing an integrated circuit. In other words, all or a part of functions of a processing unit may be implemented by an integrated circuit such as an application specific integrated circuit (ASIC) or a field programmable gate array (FPGA) instead of the program.

REFERENCE SIGN LIST

1-1: sample rack loading unit1-2: ID reading unit1-3: transport line1-4: reexamination transport line1-5: sample rack collecting unit1-6: calibrator storing unit1-7,2-1: analysis module1-8: computer for overall management1-9,1-10: computer1-11: display unit1-12: operation unit1-13: external network2-2: rack2-3: sample container2-4: sample dispensing nozzle2-5: incubator2-6: reaction container2-7: sample dispensing tip and reaction container transport mechanism2-8: sample dispensing tip and reaction container holder member2-9: reaction container stirring mechanism2-10: sample dispensing tip and reaction container waste hole2-11: sample dispensing tip mounting position2-12: reagent disk2-13: reagent disk cover2-14: reagent disk cover opening portion2-15: reagent dispensing nozzle2-16: reaction solution aspiration nozzle2-17: detecting unit2-18: rack transport line2-19: reagent container7-1: empty cycle schedule proportion setting screen7-2: text box for inputting empty cycle proportion7-3,8-4,9-4: cancel button7-4,8-5,9-5: update button8-1: empty cycle schedule priority setting screen8-2: priority condition8-3: radio button for condition selection8-5: update button9-1: empty cycle schedule presence/absence setting screen9-2: measurement item name9-3: combo box for selection