JP5517160B2 - Automatic analyzer - Google Patents

Description

  The present invention relates to an automatic analyzer that performs qualitative and quantitative analysis of biological samples such as blood and urine.

  In the automatic analyzer, a reagent corresponding to an analysis item to be performed is mounted in advance in a reagent container storage unit or the like, and registered, and an analysis process is performed on a sample using these reagents. It is desirable to install and register sufficient types and amounts of reagents in the automatic analyzer and start the analysis process. However, after the analysis process starts, the reagent runs out or an urgently unloaded or unregistered reagent is installed. There is a need for analysis to be used, and it may be necessary to newly load and register reagents.

  For example, Patent Document 1 (Japanese Patent Application Laid-Open No. 2006-337386) discloses a conventional technique related to reagent registration and replacement in an automatic analyzer, in addition to an analytical reagent storage means, a reagent storage means for replenishment, and a reagent bottle There is described a technique for automating reagent management such as reagent registration and reagent replacement during analysis processing by providing transport means and managing information on the reagents stored in these two reagent storage means.

JP 2006-337386 A

  Some of the reagents used in automatic analyzers require specific preparatory processing (reagent preparatory processing) before use, and operations such as performing all necessary preparatory processing before starting analysis processing It is carried out. However, when it becomes necessary to newly load and register a reagent after the start of the analysis process, it is also necessary to perform a preparatory process on the reagent before use. Therefore, just by performing reagent registration and reagent replacement work during analysis processing as in the above-described prior art, analysis processing cannot be performed immediately using newly registered reagents. Therefore, it is necessary to start the analysis process after the preparation process is completed, and there is room for improvement in the turnaround time of the analysis process.

  The present invention has been made in view of the above, and an object of the present invention is to provide an automatic analyzer capable of improving the turnaround time when a reagent requiring preparation processing is newly loaded and registered.

To achieve the above object, the present invention includes one or more processing steps plurality of types coercive tube a plurality of reagent container containing a corresponding reagent, respectively for the analytical item of possible reagent container storage portion consisting of the processing A reagent container loader mechanism capable of carrying a new reagent container into the reagent storage unit during execution, a preparation processing mechanism for executing a reagent preparation process for stirring the reagent in the reagent container held in the reagent container storage unit, and A measurement processing mechanism for performing a measurement process on a reagent container held in the reagent container storage unit, and performing an automatic analysis in which the plurality of types of analysis items are performed in a preset order on a sample to be analyzed an apparatus, the reagent container the reagent container storage portion reagent container containing a magnetic particle reagent as new reagent by the loader mechanism is saved, and the analysis item corresponding to the reagent is performed preferentially If set as the priority implementation functions and the reagent carrying out the already shifting the start timing of the measurement process of the analysis items that are asked you the reagents available for use the reagent prepare processed priority the reagent preparation process performed, at least one other processing steps performed before the measurement process performed on the reagent as one of the analysis items of processing steps corresponding to the reagent and against and that a control unit having a parallel processing function performed by parallel.

  According to the present invention, it is possible to improve the turnaround time of an emergency test when it is necessary to newly load and register a reagent that requires a reagent preparation process.

1 is a diagram schematically showing an overall configuration of an automatic analyzer according to an embodiment of the present invention. It is a figure which extracts and shows the reagent container disk which is the reagent container storage part which concerns on one embodiment of this invention with the periphery structure. It is a figure which shows the priority item registration screen which concerns on one embodiment of this invention. It is a figure which shows the unit designation | designated screen which concerns on one embodiment of this invention. It is a figure which shows the same Caribbean use condition setting screen. It is a figure which shows the reagent registration execution screen displayed on the display part of a control part at the time of the additional registration of a reagent. It is a flowchart which shows the processing content of the reagent registration process by a control part. It is a figure which shows the reagent registration process which concerns on one embodiment of this invention. It is a figure shown about the detail of the reagent preparation process which concerns on one embodiment of this invention. It is a figure which shows the mode of the reagent registration process of a normal item in time series. It is a figure which shows the mode of the reagent registration process of a priority item in time series.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings.

  FIG. 1 is a diagram schematically showing an overall configuration of an automatic analyzer according to an embodiment of the present invention.

In FIG. 1, an automatic analyzer 100 includes a sample container rack 2 in which a plurality of sample containers 1 for storing biological samples such as blood and urine (hereinafter referred to as samples) are stored, and a rack that carries the sample container rack 2. A transport line 3, a reagent container storage unit which is a reagent container disk 5 in which a plurality of reagent containers 4 containing various reagents used for sample analysis are stored and kept warm and covered with a reagent disk cover 7; An incubator disk 9 containing a plurality of reaction containers 8 for mixing reagents, a sample dispensing nozzle 10 for dispensing a sample from the sample container 1 to the reaction container 8 of the incubator disk 9 by rotational driving or vertical driving; Through the reagent disk cover opening 7 a provided in the reagent disk cover 7, the reagent container 4 can be inserted from the reagent container 4 by rotation or vertical driving. A reagent dispensing nozzle 11 for dispensing the reagent into the reaction vessel 8 of the incubator disk 9, a reaction vessel stirring mechanism 14 for stirring the reaction solution contained in the reaction vessel 8, and a luminescence induction reagent containing the luminescence induction reagent The container 22, the cleaning reagent container 23 containing the cleaning reagent, and the reaction liquid mixed in the reaction container 8 of the incubator disk 9, the luminescence inducing reagent container 22, or the cleaning reagent container 23 by rotation driving and vertical driving A nozzle 17 for aspirating the contained reagent, an electric signal detector 18 for performing a measurement process (electric signal measurement or the like) using the reaction liquid or reagent aspirated by the nozzle 17, a reagent preparation process performed before the analysis process, A control unit 19 that controls the entire operation of the automatic analyzer 100 including the dispensing operation of each unit and the measurement processing by the electric signal detector 18 is roughly provided. The reagent container disk 5 stores a reagent container that contains a reagent containing a luminescent label, a reagent container that contains a reagent containing magnetic particles, and the like. In the present embodiment, electric signal measurement is shown and described as an example of measurement processing.

  The automatic analyzer 100 also includes a reaction container / sample dispensing tip storage unit 13 in which a plurality of unused reaction vessels 8 and sample dispensing tips 10a are accommodated, and a standby reaction for replacement / replenishment thereof. A container / sample dispensing tip storage unit 12, a disposal hole 15 for discarding the used sample dispensing tip 10a and the reaction vessel 8, and a conveyance mechanism for grasping and conveying the sample dispensing tip 10a and the reaction vessel 8. 16. The transport mechanism 16 is provided so as to be movable in the X-axis, Y-axis, and Z-axis directions (not shown), and transports the reaction container 8 stored in the reaction container / sample dispensing tip storage unit 13 to the incubator disk 9. Or, the used reaction container 8 is discarded in the disposal hole 15, or the unused sample dispensing tip 10a is transported to the tip mounting position 16a.

  FIG. 2 is a diagram showing a reagent container disk, which is a reagent container storage unit, extracted along with its peripheral configuration.

As shown in FIG. 2, a plurality of reagent containers 4 are mounted on the reagent container disk 5, and reagent dispensing for dispensing the reagent from the reagent container 4 to the reaction container 8 of the incubator disk 9 is provided around the reagent container disk 5. a nozzle 11, a reagent stirring mechanism 20 for stirring the reagent contained in the reagent container 4 mounted on the reagent container disk 5, or mounted reagent containers 4 in a predetermined position of the reagent container disk 5, from the reagent container disk 5 A reagent container loader 21 for collecting the reagent container 4 is provided.

  Each reagent container 4 is provided with a bar code 4d which is an individual identification mark. The reagent container 4 is individually managed by reading and registering the bar code 4d with a reading device (not shown). . Note that the individual identification label is not limited as long as the individual identification of the reagent container 4 is possible, and an RFID tag or the like may be used. The reagent container 4 includes containers 4a to 4c that contain a plurality of (three in the present embodiment) types of reagents. Each reagent container 4 includes a corresponding type of analysis process (analysis item). A set of reagents necessary for (1) is contained. Examples of the reagent accommodated in each of the containers 4a to 4c of the reagent container 4 include a reagent containing a luminescent label (luminescent label reagent) and a reagent containing magnetic particles (magnetic particle reagent).

The control unit 19 controls the overall operation of the automatic analyzer 100, and performs an analysis process based on a preset program or a command from an operator input by the input unit 19b or the like.

  Next, an example of analysis processing in the present embodiment will be shown, and the procedure will be described with reference to the drawings.

  First, various settings are made as preparations in the analysis process. 3 to 5 are diagrams illustrating screens for performing various settings before the execution of the analysis process, which is displayed on the display unit 19a of the control unit 19. FIG.

FIG. 3 is a diagram showing the priority item registration screen 30. A priority item is a reagent that can be used when the automatic analyzer 100 is in an operation state, that is, when an analysis process including other analysis items is being performed, for loading or registering a reagent corresponding to the analysis item. The reagent preparation process for setting the state is performed with priority over the operation related to the other analysis items. In FIG. 3, a priority item registration screen 30 includes a settable item display unit 31 that displays analysis items that can be set as priority items, and a priority item display unit 32 that displays analysis items selected for setting as priority items. In the settable item display unit 31, an analysis item designated by means such as a cursor (not shown) is displayed on the priority item display unit 32 as a priority item registration target, and a cursor (not shown) is displayed on the priority item display unit 32. The cancel button 34 for canceling the analysis item designated by the means from the priority item registration target, the cancel button 36 for canceling and invalidating the setting currently displayed on the priority item registration screen 30, and the setting contents on the priority item registration screen 30 An update button 37 newly registered in the storage unit (not shown) of the control unit 19 is provided as valid. Further, when the automatic analysis apparatus 100 is configured to use a plurality of analysis units 90, the priority item registration screen 30 designates the analysis unit 90 targeted for the setting displayed on the priority item registration screen 30. A unit designation button 35 for displaying a unit designation screen 40 (see FIG. 4) is provided.

  FIG. 4 is a diagram showing the unit designation screen 40. The unit designation screen 40 displays a list of names assigned to the analysis units 90 constituting the automatic analyzer 100, and is provided with radio buttons for selecting each. In FIG. 4, as an example, a unit designation screen 40 in the case where four analysis units from unit 1 to unit 4 are used in the automatic analyzer 100 is shown. On the unit designation screen 40, a cancel button 41 for canceling and invalidating the settings displayed on the unit designation screen 40 and the setting contents on the unit designation screen 40 are validated and stored in a storage unit (not shown) of the control unit 19. And an update button 42 to be newly registered. By selecting a radio button in the name of any analysis unit 90 and selecting the update button 42, the setting in the priority item registration screen 30 is set to be reflected in the desired analysis unit 90.

  FIG. 5 is a diagram showing the same calib use condition setting screen 50. The same calibra use condition setting screen 50 displays the calibration of the reagent that has been loaded and registered in advance in the automatic analyzer 100 and calibrated when the loading and registration of the reagent is performed when the automatic analyzer 100 is in the operation state. It is a screen which sets the range conditions of the object which uses data. In the same calibrate use condition setting screen 50, if the calibration data already registered in the automatic analyzer 100 is of the same lot as the newly loaded / registered reagent, the same inspection item is used. If there is a lot, it is provided so that it can be selected with a radio button regardless of the lot. By selecting the radio button of any condition and selecting the update button 52, the range condition of the target using the reagent calibration data is set.

  In this state, the analysis process is started by the operator based on a command to execute the analysis process by the input unit 19b or the like to the control unit 19. Here, the case where the analysis process using what stir-processed as a reagent preparation process is performed to the reagent containing a magnetic particle as an example is demonstrated. In the analysis processing in the present embodiment, first, sample sampling is performed in which a sample is dispensed from the sample container 1 to the reaction container 8 of the incubator disk 9 by the sample dispensing nozzle 10. Next, the reagent dispensing nozzle 11 performs first-stage reagent suction / addition for dispensing the reagent from the reagent container 4 to the reaction container 8 of the incubator disk 9. In this state, after incubation, magnetic particle reagent suction / addition for dispensing the reagent from the reagent container 4 to the reaction container 8 of the incubator disk 9 is performed by the reagent dispensing nozzle 11. In the magnetic particle reagent suction / addition, a reagent stirring process by the reagent stirring mechanism 20 is performed immediately before the suction. Next, the reaction solution in the reaction vessel 8 is stirred by the reaction vessel stirring mechanism 14 and further incubated. Then, the reaction liquid subjected to such processing, the reagent contained in the light emission induction reagent container 22, and the cleaning reagent container 23 are aspirated by the nozzle 17, and the electric signal detector 18 performs measurement processing such as electric signal measurement. Do.

  During the operation of the analysis process as described above, if the reagent runs out or there is an urgent sample analysis request, there is an urgent need for analysis using an unloaded / unregistered reagent. The case of registration will be described.

  FIG. 6 is a reagent registration execution screen 60 displayed on the display unit 19a of the control unit 19 when the reagent is additionally registered. In the reagent registration execution screen 60, a check box 61 for selecting whether or not the analysis item corresponding to the reagent to be added is processed as a priority item, and the setting displayed on the reagent registration execution screen 60 are canceled and additional registration of the reagent is performed. There is provided a No button 62 for canceling and a Yes button 63 for validating the setting contents on the reagent registration execution screen 60 and instructing the controller 19 to execute a reagent registration. A reagent registration process is executed by mounting a reagent to be added to the reagent container loader 21 and selecting the Yes button 63.

  FIG. 7 is a flowchart showing the contents of the reagent registration process performed by the control unit 19, and FIG. 8 is a diagram for explaining the details of the reagent registration process.

  As shown in FIG. 7, the control unit 19 firstly has a mechanism that operates in the operation state of the automatic analyzer 100 (for example, a mechanism related to sample dispensing) and a mechanism that operates in the reagent preparation process (for example, a mechanism related to reagent agitation). If the determination result is NO, a reagent preparation process is performed (step S50), and the process ends. If the determination result in step S10 is YES, it is determined whether the analysis item corresponding to the reagent to be registered is a priority item (step S20). If the determination result is YES, sample dispensing is temporarily performed. Stop (step S30), perform the reagent preparation process (step S50), and end the process. If the determination result in step S20 is NO, sample dispensing is continued (step S40), and then reagent preparation processing is performed (step S50), and the processing is terminated.

  Here, the difference between normal item processing and priority item processing in the reagent registration processing will be described. FIG. 8 illustrates a case where the reagent registration process for the normal item α is performed and a case where the reagent registration process for the priority item β is performed. As shown in FIG. 8, when the reagent registration process of the normal item α is performed, the reagent preparation process of the normal item α is performed after the already requested analysis process (for example, request A to request Z) is completed. This does not depend on the reagent registration execution timing of the normal item α. On the other hand, when the reagent registration process of the priority item β is performed, the reagent preparation process of the item β immediately after the end of the request (request A in FIG. 8) being performed at the timing of reagent registration execution among the already requested analysis processes. Is done. In this way, among the requested analysis processes, the requests B to Z have a priority processing function for temporarily stopping and preferentially performing the reagent preparation processing of the priority item β.

  Next, details of the reagent preparation process will be described with reference to FIG. In FIG. 9, step a to step g and step Z indicate the respective processing steps in the analysis processing, and the execution state of each step is schematically shown for the processing sequence A for normal items and the processing sequence B for priority items. Show.

  Step a is sample sampling, in which a sample is dispensed from the sample container 1 to the reaction container 8 of the incubator disk 9 by the sample dispensing nozzle 10. Step b is a first-step reagent aspiration / addition, in which a luminescent labeling reagent or the like is dispensed from the reagent container 4 to the reaction container 8 of the incubator disk 9 by the reagent dispensing nozzle 11. Step c is suction / addition of magnetic particle reagent, and is a step of dispensing magnetic particle reagent and the like from the reagent container 4 to the reaction container 8 of the incubator disk 9 by the reagent dispensing nozzle 11. In step c, a reagent stirring operation (not shown) is performed immediately before magnetic particle reagent suction. Step d is reaction solution stirring, which is a step of stirring the reaction solution stored in the reaction vessel 8 by the reaction vessel stirring mechanism 14. Step e is an electric signal measurement, in which the reaction liquid and other reagents mixed in the reaction vessel 8 of the incubator disk 9 are sucked by the nozzle 17 and the electric signal detector 18 performs the electric signal measurement as a measurement process. It is. Steps f and g are incubations, and are steps for promoting the reaction by subjecting the reaction solution in the reaction vessel 8 to a heating treatment or a constant temperature treatment. Step Z is magnetic particle initial stirring, and is a step of performing stirring as a reagent preparation process for making the reagent usable.

  As shown in FIG. 9, in the sequence A of the reagent preparation process for the normal items, after the reagent registration is executed, the process Z is first performed (time 1), and then the process a (time 2), the process b (time 3), Processes are performed in the order of step f (time 4, 5), step c (time 6), step d (time 7), step g (time 8, 9), step e (time 10). In contrast, in the sequence B of the reagent preparation process for the priority item, first, the process a (time 1) and the process b (time 2) are performed, and the process Z (time 3) is performed at the same time as the process f (time 3 and 4). Then, the process is performed in the order of step c (time 5), step d (time 6), step g (time 7, 8), step e (time 9). As described above, the control unit 19 performs in parallel the reagent preparation process (process Z) and at least one of the process steps performed before the process step using the reagent (step f in this example). It has a parallel processing function.

  Details of the reagent registration process will be further described with reference to the drawings.

  FIG. 10 is a diagram showing the normal item reagent registration processing, and FIG. 11 is a time series diagram showing the priority item reagent registration processing. 10 and 11 show a case where the measurement 6 having the analysis item B is added to the five measurements 1 to 5 having the analysis items A and C. FIG. 10 and 11, steps a to g and step Z are the same as those shown in the description of FIG. 9, and each processing step in the analysis processing is shown.

  As shown in FIG. 10, in the analysis processing of normal items, when analysis item B is registered between time 3 and time 4 for measurement 1 to measurement 6, already requested measurement 1 to measurement 6 are completed. The timing after which the operation of the mechanism operating in the operation state of the automatic analyzer 100 (magnetic particle reagent suction / addition item c) and the mechanism operating in the reagent preparation process (item Z of magnetic particle initial stirring) do not interfere with each other. At (time 10), the reagent preparation process for analysis item B, which is a normal item, is performed. Subsequently, processing is performed in the order of step a to step e. At this time, the turnaround time, which is the time from the registration of the analysis item B to the end of the step e (measurement process: electrical signal measurement), is the elapsed time t1.

  As shown in FIG. 11, in the priority item analysis process, when the analysis item B is registered between the time 3 and the time 4 for the measurement 1 to the measurement 5 as in the normal item, the measurement 1 already requested. After the measurement 4 (analysis item A) is completed, a mechanism that operates in the operation state of the automatic analyzer 100 (magnetic particle reagent suction / addition item c) and a mechanism that operates in the reagent preparation process (magnetic particle initial stage) The reagent preparation process for the analysis item B, which is a normal item, is performed at a timing (time 9) at which the operation of the stirring item Z) does not interfere. Accordingly, measurement 5 (analysis item C) and measurement 7 (analysis item B: priority item) start processing from step a to step e at times 6 and 7, respectively. At this time, the turnaround time, which is the time from the registration of the analysis item B to the end of the step e (measurement processing: electrical signal measurement), is the elapsed time t2. Therefore, the turnaround time t2 in the priority item analysis process can be made shorter than the turnaround time t1 in the normal item analysis process.

  The effect in this Embodiment comprised as mentioned above is demonstrated.

  Some reagents used in automatic analyzers require the execution of a prescribed reagent preparation process before use, and the necessary reagent preparation processes must be performed together before starting the analysis process. Therefore, if it becomes necessary to newly load and register a reagent after the start of the analysis process, it is necessary to perform a reagent preparation process on the reagent before use. However, as in the prior art, simply by performing reagent registration and reagent replacement during analysis processing, the newly registered reagent cannot be used to perform analysis processing immediately. It is necessary to start the analysis process after performing the reagent preparation process, for example, after the completion, and therefore there is room for improvement in the turnaround time of the emergency test.

  On the other hand, in the present embodiment, the priority execution function for performing the reagent preparation process with respect to the reagent of the priority item in preference to other preset analysis items, the reagent preparation process, and the analysis item Since it is configured to have a parallel processing function for performing at least one of the processing steps performed before the processing step using the reagent in parallel among the processing steps, a reagent that requires reagent preparation processing is newly installed. The turnaround time when registering can be improved.

  In addition, since the priority reagent is individually set for each of the plurality of analysis units 90, it is possible to select the reagent preparation processing to be performed in the same manner as the reagent of the priority item other than pre-registration. The flexibility of the operation mode of the laboratory can be improved.

  In the present embodiment, the case where the target reagent for the reagent preparation process is a magnetic particle reagent and the stirring process is performed as the reagent preparation process has been described as an example. The present invention can be applied to a case where necessary reagent preparation processing is performed on a reagent that requires reagent preparation processing.

DESCRIPTION OF SYMBOLS 1 Sample container 2 Sample container rack 3 Rack conveyance line 4 Reagent container 4a-4c Container 4d Bar code 5 Reagent container disk 7 Reagent disk cover 7a Reagent disk cover opening 8 Reaction container 9 Incubator disk 10 Sample dispensing nozzle 10a Sample dispensing Chip 11 Reagent dispensing nozzles 12, 13 Reaction container / sample dispensing chip storage unit 14 Reaction container stirring mechanism 15 Disposal hole 16 Transport mechanism 16a Chip mounting position 17 Nozzle 18 Electric signal detector 19 Control unit 19a Display unit
19b Input unit 20 Reagent stirring mechanism 21 Reagent container loader 22 Luminescence induction reagent container 23 Cleaning reagent container 30 Priority item registration screen
31 Settable item display section
32 Priority item display area
33 Registration button
34 Release button
35 Unit designation button
36, 41, 51 Cancel button
37, 42, 52 Update button 40 Unit designation screen 50 Same calibra usage condition setting screen 60 Reagent registration execution screen
61 check box
62 No button
63 Yes button 90 Analysis unit 100 Automatic analyzer

Claims (4)

And one or more processing steps plurality of types coercive tube a plurality of reagent container containing a corresponding reagent, respectively for the analytical item of possible reagent container storage section consisting of,
A reagent container loader mechanism capable of carrying a new reagent container into the reagent storage unit during the process;
A preparation processing mechanism for executing a reagent preparation process for stirring the reagent in the reagent container held in the reagent container storage unit;
A measurement processing mechanism for performing a measurement process on the reagent container held in the reagent container storage unit ,
An automatic analyzer that performs the plurality of types of analysis items on a sample to be analyzed in a preset order,
When the reagent container storing a magnetic particle reagent as a new reagent is stored in the reagent container storage unit by the reagent container loader mechanism , and the analysis item corresponding to the reagent is set to be preferentially performed,
A priority enforcing function implementing already said reagent Preparation process you the reagents usable state by shifting the start timing of the measurement process of the analysis item being requested by priority
At least one of the other processing steps performed before the measurement processing performed on the reagent as one of the processing steps of the analysis item corresponding to the reagent, the reagent preparation processing performed on the reagent One the automatic analyzer, wherein the parallel processing function performed by parallel, further comprising a control unit having a. The automatic analyzer according to claim 1, wherein
An automatic analyzer characterized in that storage of the reagent container containing a new reagent and reagent preparation processing can be performed during execution of other analysis items. The automatic analyzer according to claim 1, wherein
An automatic analyzer comprising setting means for setting whether the analysis item is a priority item or a normal item. The automatic analyzer according to claim 1, wherein
A plurality of analysis units each having the reagent container holding unit;
An automatic analyzer comprising: setting means for setting whether the analysis item is a priority item or a normal item in each of the plurality of analysis units.

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