WO2015019880A1 - 自動分析装置 - Google Patents
自動分析装置 Download PDFInfo
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- WO2015019880A1 WO2015019880A1 PCT/JP2014/069762 JP2014069762W WO2015019880A1 WO 2015019880 A1 WO2015019880 A1 WO 2015019880A1 JP 2014069762 W JP2014069762 W JP 2014069762W WO 2015019880 A1 WO2015019880 A1 WO 2015019880A1
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- automatic analyzer
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/0092—Scheduling
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00594—Quality control, including calibration or testing of components of the analyser
- G01N35/00712—Automatic status testing, e.g. at start-up or periodic
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00722—Communications; Identification
- G01N35/00871—Communications between instruments or with remote terminals
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00594—Quality control, including calibration or testing of components of the analyser
- G01N35/00613—Quality control
- G01N35/00623—Quality control of instruments
- G01N2035/00643—Quality control of instruments detecting malfunctions in conveying systems
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00594—Quality control, including calibration or testing of components of the analyser
- G01N35/00613—Quality control
- G01N35/00663—Quality control of consumables
- G01N2035/00673—Quality control of consumables of reagents
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00722—Communications; Identification
- G01N2035/00891—Displaying information to the operator
- G01N2035/0091—GUI [graphical user interfaces]
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/0092—Scheduling
- G01N2035/0094—Scheduling optimisation; experiment design
Definitions
- the present invention relates to an automatic analyzer that analyzes components of biological samples such as plasma, serum, and urine.
- Automatic analyzers add and react reagents that specifically react with specific components contained in biological samples such as serum, plasma, and urine (hereinafter, simply referred to as samples) to transmit light, scattered light, and chemiluminescence. And quantitative and qualitative analysis of specific components of the sample by measuring electrochemiluminescence.
- a preparation operation is performed to make the state of the analyzer suitable for analysis before the analysis operation, and a termination operation is performed to put the analyzer in an appropriate standby state after the analysis operation.
- Patent Document 1 International Publication No. 2011/078118 automatically performs for the purpose of shortening TAT.
- the automatic analyzer according to which the designated preparation operation is performed during the initial processing at the time of powering on of the device or after the start of the analysis Technology is disclosed.
- the present invention has been made in view of the above, and it is an object of the present invention to provide an automatic analyzer that can shorten the time required for analysis processing by improving the efficiency of various operations related to the analysis processing.
- the present invention performs the analysis operation from the end of the startup process of the analyzer to the start of the analysis preparation operation for preparing the analysis operation and from the end of the analysis end operation.
- a device state monitoring unit that monitors the state of the automatic analyzer before the start of the analysis preparation operation for preparing the plurality of preparations set as the analysis preparation operation based on the monitoring results of the device state monitoring unit; It is assumed that an analysis preparation operation item determination unit for determining one or more preparation operation items to be executed among operation items is provided.
- the time required for analysis processing can be shortened by streamlining various operations related to the analysis processing.
- FIG. 1 is a view schematically showing an overall configuration of an automatic analyzer according to the present embodiment.
- FIG. 4 is a view schematically showing a flow path configuration regarding system reagents.
- the automatic analyzer 100 holds a plurality of sample containers 102 for containing a sample and a plurality of sample containers 102.
- Rack 101 a rack transport line 117 for transporting the rack 101, an incubator disk 104 for holding the reaction vessel 105, a sample dispensing nozzle 103 for dispensing a sample from the sample vessel 102 to the reaction vessel 105, and a reagent.
- the reaction reaction suction nozzle 115 for suctioning the reaction liquid and sending it to the detection unit 116, the detection reaction auxiliary reagent reservoir 123 holding the detection reaction auxiliary reagent sucked by the reaction liquid suction nozzle, and the detection reaction auxiliary to
- the automatic analyzer 100 includes a sample dispensing tip / reaction container transport mechanism 106, a sample dispensing tip / reaction container holding unit 107, a sample dispensing tip / reaction container disposal hole 109, and a sample dispensing tip mounting unit 110. Is provided.
- the sample containers 102 are held by the rack 101 and conveyed along the rack conveyance line 117.
- the sample container 102 contains a biological sample (hereinafter referred to as a sample) such as plasma, serum, or urine to be analyzed.
- Sample dispensing positions are disposed on the rack transport line 117.
- Reagent disc 111 On the reagent disk 111, a plurality of reagent containers 118 containing reagents used for analysis processing are arranged in the circumferential direction.
- the reagent disc 111 conveys the reagent container 118 in the circumferential direction by being rotationally driven in the circumferential direction by a rotational driving device (not shown).
- the inner space of the reagent disc 111 in which the reagent container 118 is held is defined by the reagent disc cover 112 and maintained at a predetermined temperature. ing.
- the reagent disc cover 112 is provided with a reagent disc cover opening 113 for the reagent dispensing nozzle 114 to access the reagent container 118.
- a plurality of reaction containers 105 in which a mixed solution (reaction solution) of a sample and a reagent is stored are arranged side by side in the circumferential direction.
- the incubator disk 104 conveys the reaction vessel 105 in the circumferential direction by being rotationally driven in the circumferential direction by a rotational drive device (not shown).
- a reaction container installation position, a reagent dispensing position, a sample dispensing position, a detection position, a reaction container disposal position and the like are arranged.
- Sample dispensing nozzle 103, reagent dispensing nozzle 114 The sample dispensing nozzle 103 and the reagent dispensing nozzle 114 are configured to be able to rotate and move up and down in the horizontal direction, and the nozzle tip is used as a reagent / diluted solution in the reagent container 118 or a sample in the sample container 102.
- the liquid is brought into contact with the liquid, a suction of a predetermined amount is performed, and the liquid is discharged to the reaction container 105 of the incubator disk 104.
- the sample dispensing nozzle 103 dispenses a sample from the sample container 102 transported to the sample dispensing position of the rack transport line 117 to the reaction container 105 transported to the sample dispensing position of the incubator disk 104.
- the sample dispensing nozzle 103 moves above the sample dispensing tip mounting position 110 and descends, and mounts the sample dispensing tip on the tip of the sample dispensing nozzle 103.
- the sample dispensing tip is moved to the upper side of the sample dispensing tip and the reaction container disposal hole 109, and the used sample dispensing tip is discarded to the sample dispensing tip and the reaction container disposal hole 109.
- the reagent dispensing nozzle 114 suctions and discharges a predetermined amount of the cleaning reagent supplied to the cleaning reagent supply hole 122 in the reagent dispensing nozzle cleaning tank 121 for cleaning the reagent dispensing nozzle 114, thereby removing the reagent
- the reagent container 118 transported to the reagent dispensing position corresponding to the reagent disc cover opening 113 of the reagent disc 111, to the reagent dispensing position of the incubator disc 104
- the reagent is dispensed into the transported reaction container 105.
- the cleaning reagent is aspirated from the cleaning reagent bottle 154 by the cleaning reagent supply syringe 152 connected via the flow path and the switching valves 161, 162, 164, and discharged to the cleaning reagent supply hole 122.
- Sample dispensing tip / reaction vessel holding unit 107 holds an unused sample dispensing tip for attaching to the tip of the sample dispensing nozzle 103 and an unused reaction container 105 disposed on the incubator disk 104. It is done.
- sample dispensing tip / reaction container transport mechanism 106 The sample dispensing tip / reaction container transfer mechanism 106 is configured to be movable in three directions of the X-axis, Y-axis, and Z-axis.
- the sample dispensing tip is transported to the chamber, and the reaction vessel 105 is transported to the incubator disk 104.
- the sample dispensing tip / reaction container transport mechanism 106 transports the reaction container 105 into which the sample and the reagent have been dispensed from the incubator disk 104 to the stirring mechanism 108, and the liquid mixture (reaction liquid) contained in the reaction container 105. Stir.
- the sample dispensing tip and reaction container transfer mechanism 106 moves above the sample dispensing tip and reaction container holding member 107, descends, grips the unused reaction container 105, and ascends. Move to the top of the reaction vessel installation position and descend to install the reaction vessel.
- the sample dispensing tip / reaction container transport mechanism 106 transports the used reaction container 105 to the sample dispensing tip / reaction container disposal hole 109 and discards it.
- reaction liquid suction nozzle 115 is capable of rotating and moving up and down in the horizontal direction, moves to the reaction vessel 105 on which the reaction on the incubator disc 104 is completed, and sucks the reaction solution in the reaction vessel 105 to flow.
- the fluid is sent to a detection unit 116 connected via a channel.
- the reaction solution suction nozzle 115 moves to the detection reaction auxiliary reagent reservoir 123, sucks the detection reaction auxiliary reagent, and sends it to the detection unit 116.
- the detection reaction auxiliary reagent is aspirated from the detection reaction auxiliary reagent bottle 153 by the detection reaction auxiliary reagent supply syringe 151 connected via the flow path and the switching valves 156, 158, 159, 160, and the detection reaction auxiliary reagent supply nozzle 124 And stored in the detection reaction auxiliary reagent reservoir. Furthermore, similarly, the reaction solution suction nozzle 115 moves to the washing reagent reservoir 125 to suck the washing reagent and send it to the detection unit 116.
- the washing reagent is aspirated from the washing reagent bottle 154 by the washing reagent supply syringe 152 connected via the flow path and the switching valves 157, 161, 163, 164, and discharged from the washing reagent supply nozzle 126, and the washing reagent reservoir 125 To be stored.
- FIG. 2 is a functional block diagram for explaining the outline of the control unit.
- control unit 119 includes an input unit 130, a storage unit 131, an operation unit 132, and an output unit 133.
- Arithmetic unit 132 performs an analysis preparation operation (described later), which is an operation for making the state of the analyzer suitable for analysis before performing the analysis operation, and the sample to be analyzed based on the detection result by the detection unit 116.
- An analysis operation (to be described later) that performs analysis, an analysis end operation (to be described later) to put the analyzer into an appropriate standby state after the analysis operation, and the like are output. It memorizes in 131.
- the computing unit 132 is provided between the end of the start-up process of the analyzer, the start of the analysis preparation operation for preparing the analysis operation, and the end of the analysis end operation to the analysis preparation operation.
- Analysis preparation operation item for determining one or more preparation operation items to be executed among a plurality of preparation operation items set as analysis preparation operation based on the function as a device state monitoring unit that monitors the state and the monitoring result It has a function as a determination unit.
- the status of the automatic analyzer monitored by the operation unit 132 by the function as the device status monitoring unit there are abnormality during device startup processing, presence or absence of execution of maintenance after device startup, and types of maintenance items, There are access to the analysis unit, replacement of system reagent bottles, and so on.
- Alarm during activation processing for the device startup processing maintenance item history selected by the operator from the operation screen for maintenance execution, opening / closing of the top cover covering the analysis unit for the operator's access to the analysis unit Monitors the information about the sensor status that detects the presence of the system reagent bottle replacement and the input signal of the bottle replaced button by the operator, and sent to the control unit 119 from each part of the automatic analyzer and stored in the storage unit 131 or the like. Be done.
- Storage unit 131 In the storage unit 131, detection results by the detection unit 116, analysis results calculated from the detection results, settings such as analysis mode (described later), passwords set for each operator, display level of the screen, sample information Information related to the automatic analyzer such as reagent information, analysis parameters, analysis request items, calibration results, etc. is stored.
- the output unit 133 includes, for example, a display device such as a monitor, a printer, and the like, and displays or prints out the analysis result of the sample and various setting contents.
- the input unit 130 is configured by an operation device such as a keyboard or a mouse, for example, and performs various operations by using a GUI (Graphical User Interface) including a setting screen displayed on a monitor of the output unit 133 and the like. .
- GUI Graphic User Interface
- FIG. 3 is a view showing an example of an analysis mode selection screen which is one of setting screens displayed on the output unit 133. As shown in FIG.
- the analysis mode selection screen 140 has a check box 141 for selecting the quick start mode as an analysis mode, an OK button 142 for determining the setting contents in the check box 141, and a cancel button 143 for canceling. doing.
- the analysis mode selection screen 140 is a setting screen for setting the analysis mode in the automatic analyzer to either the normal mode or the quick start mode.
- the normal mode is a mode for executing all of the plurality of operation items prepared in each of the analysis end operation and the analysis preparation operation.
- the quick start mode (to be described in detail later) can be performed by selecting and executing an item to be executed and an item not to be executed from a plurality of operation items in the analysis end operation and the analysis preparation operation depending on the situation.
- the analysis preparation operation is optimized to shorten the time required for the operation and to shorten the time for analysis processing.
- the analysis preparation operation is an operation for making the state of the analyzer suitable for analysis before performing the analysis operation.
- a plurality of operation items (hereinafter referred to as preparation operation items) are prepared in advance, and some or all of the operation items are selected and executed from the plurality of preparation operation items.
- the preparation operation items include, for example, replacement of system reagents such as detection reaction auxiliary reagents and washing reagents, disposal of reaction containers, removal of air bubbles in the flow path, and detection sensor function confirmation.
- system reagents such as detection reaction auxiliary reagents and washing reagents
- disposal of reaction containers removal of air bubbles in the flow path, and detection sensor function confirmation.
- System reagent replacement system reagent replacement includes a detection reaction auxiliary reagent reservoir 123, a flow path connecting a detection reaction auxiliary reagent supply nozzle 124 and a detection reaction auxiliary reagent bottle 153, a washing reagent reservoir 125, washing A flow path connecting the reagent supply nozzle 126 and the cleaning reagent bottle 154, a reagent dispensing nozzle cleaning tank 121, and a flow path connecting the cleaning reagent supply hole 122 and the cleaning reagent bottle 154, respectively, detection reaction auxiliary reagent or cleaning It is an operation item to replace with a reagent.
- the system reagent is filled from each system reagent bottle into each system reagent supply nozzle and each system reagent reservoir to prepare for a detection process. Further, the cleaning reagent is supplied from the cleaning reagent bottle to the reagent dispensing nozzle cleaning tank to prepare for the reagent dispensing process.
- This system reagent replacement is to replace the solution remaining in each system reagent supply nozzle and each system reagent reservoir from each system reagent bottle of detection reaction auxiliary reagent and washing reagent and in the reagent probe washing tank with the system reagent concerned. Since it is necessary to supply the system reagent corresponding to the total volume of the flow path and the reservoir and the cleaning reagent supply hole of the reagent probe cleaning tank multiple times, it has the feature that the longest required time among the operation items of the analysis preparation operation is there.
- Reaction Container Disposal Reaction container disposal is an operation item for discarding the reaction container 105 remaining in the incubator disc 104 and the stirring mechanism 108.
- the presence or absence of the remaining reaction container 105 remaining in the incubator disc 104 and the stirring mechanism 108 is confirmed, and the disposal operation is performed.
- the reaction container 105 When the reaction container 105 remains in the incubator disc 104 and the stirring mechanism 108, the reaction container is discarded by the sample dispensing tip and the reaction container 105 by the sample dispensing tip and the reaction container transport mechanism 106.
- the container is characterized in that the time required for system reagent replacement is longer than that of the system reagent replacement because the container is transported to the exit and discarded.
- Removal of bubbles in the channel is an operation item for removing the bubbles in the channel in the reagent dispensing nozzle 114 and the sample dispensing nozzle 103.
- the system water is discharged from the syringes of the reagent dispensing nozzle 114 and the sample dispensing nozzle 103 to the respective dispensing nozzles via the flow path to remove bubbles in the syringe and the flow path. To ensure the accuracy of dispensing.
- the detection sensor function confirmation is an operation item for confirming the function of the detection sensor in the detection unit 116.
- the state of the detection sensor is confirmed using a system reagent (detection reaction auxiliary reagent), and the presence or absence of abnormality of the detection sensor is confirmed in advance when the analysis is performed.
- a system reagent detection reaction auxiliary reagent
- a plurality of sample containers 102 in which samples to be analyzed are stored are installed in a rack 101 and transported to a sample dispensing position by a sample dispensing nozzle 103 by a rack transport line 117.
- the reaction container 105 used for the analysis operation is transported to the sample dispensing position by the rotation of the incubator disk 104.
- the sample of the sample container 102 is aspirated by the sample dispensing nozzle 103 and discharged into the reaction container 105.
- the reaction vessel 105 from which the sample and the reagent are discharged is moved to the reaction vessel transport position by the rotation of the incubator disk 104, and is agitated by the sample dispensing tip and the reaction vessel transport mechanism 106. It is transported to the mechanism 108. In the stirring mechanism 108, rotational motion is added to the reaction vessel 102 to mix (stir) the sample and the reagent in the reaction vessel.
- the reaction container 102 after the stirring is returned to the reaction container transfer position of the incubator disk 104 by the sample dispensing tip and reaction container transfer mechanism 106.
- the reagent and the sample are dispensed and mixed, and the reaction vessel 105 on which a predetermined time has elapsed on the incubator disc 104 is transported to the detection position.
- the reaction liquid contained in the reaction container 105 is aspirated by the reaction liquid suction nozzle 115, and then the detection reaction aiding reagent contained in the detection reaction aiding reagent reservoir 123 is aspirated to react with the reaction liquid and the detection reaction.
- the auxiliary reagent is sent to the detection unit 116. In the reaction liquid sent to the detection unit 116, the component to be measured is detected, and the detection result is sent to the control unit 119.
- washing reagent filled in the washing reagent reservoir 125 is aspirated and sent to the detection unit 116 to wash the detection unit 116.
- system reagents detection counter reagent, washing reagent
- system reagents are replenished from each system reagent supply nozzle.
- the analysis end operation is an operation to put the analyzer in an appropriate standby state after performing the analysis operation.
- a plurality of operation items (hereinafter referred to as end operation items) are prepared in advance, and some or all of the operation items are selected and executed from the plurality of end operation items.
- the end operation items include, for example, water replacement of system reagents and disposal of reaction containers.
- Disposal of reaction container is an operation item for discarding the reaction container 105 remaining in the incubator disc 104 and the stirring mechanism 108.
- the reaction container 105 from which the reaction liquid has been sucked is transported to the reaction container disposal position by the rotation of the incubator disk 104, and the sample dispensing tip and the sample dispensing tip from the incubator disc 105 by the reaction container transport mechanism 106. And, it is conveyed above the reaction container disposal hole 109 and discarded from the sample dispensing tip and the reaction container disposal hole 109.
- FIGS. 5 and 6 are flowcharts showing the overall flow of analysis processing in the present embodiment.
- control unit 119 determines whether the setting of the analysis mode is set to the quick start mode (step S100), and the determination result is In the case of NO, all items in the analysis preparation operation are performed (step S151).
- step S100 it is determined whether or not the previous analysis process (or the automatic analyzer startup process) ended normally (step S110), and if the determination result is YES, the process continues And the analysis unit to perform some operation based on the monitoring of the state of the open / close sensor of the top cover of the analysis unit from the end of the analysis end operation in the previous analysis processing (or the start-up processing of the automatic analyzer). It is determined whether (incubator disk 104, reservoir, etc.) is accessed (step S120). If the determination result in step S110 is NO, or if the determination result in step S120 is YES, all items in the analysis preparation operation are performed (step S151).
- step S120 determines whether the system reagent bottle has been replaced (step S130), and if the determination result is YES, the item of reaction container disposal in the analysis preparation operation is not performed. That is, items other than reaction container disposal are implemented (step S153).
- step S130 determines whether maintenance has been performed (step S140), and if the determination result is YES, it is determined whether water substitution of the system reagent has been performed (step S130) S141). If both determinations in steps S140 and S141 are NO, items of system reagent substitution and reaction container disposal in the analysis preparation operation are not performed, that is, items other than the items of system reagent substitution and reaction container disposal It carries out (step S152).
- step S141 If the determination result in step S141 is YES, the item of reaction container disposal in the analysis preparation operation is not performed, that is, items other than reaction container disposal are performed (step S153).
- step S160 When the analysis preparation operation (steps S151, S152, S153) is completed, the analysis operation is subsequently performed (step S160), and among the operation items of the analysis end operation, the operation item according to the setting of the analysis mode is analysis completed It is implemented as an operation (step S170).
- step S180 it is determined whether the next analysis processing instruction has been issued (step S180), and if the determination result is NO, it is determined whether a predetermined time has elapsed from the analysis end operation (step S170) (step S181). If the determination result is YES, the system reagent is replenished (step S182), and the process returns to step S180. If the determination result in step S181 is NO, the process returns to step S180 without doing anything.
- step S180 If the determination result in step S180 is YES, the process ends and the next analysis process is performed.
- step S190 the elapsed time from the end of the previous analysis, or the elapsed time from the execution of the maintenance operation to replace or replenish the system reagent is constant. It is judged whether it is above or not (step S190). If the determination result is YES, the item of reaction container disposal in the analysis preparation operation is not performed, that is, items other than reaction container disposal are performed (step S153). If the determination result is NO, the items of system reagent substitution and reaction vessel disposal in the analysis preparation operation are not performed, that is, items other than the items of system reagent substitution and reaction vessel disposal are performed (step S152). Step S190 is a measure for evaporation or deterioration of the system reagent when a predetermined time has elapsed from the previous processing, and is positioned as a substitute for steps S180, 181, and 182 shown in FIG.
- the system reagent replacement operation of the flow path of the stem reagent supply nozzle having a long required time, the system reagent reservoir, and the cleaning reagent supply hole of the reagent nozzle cleaning tank, and remaining on the incubator disk 104 and the stirring mechanism 108 The waste operation of the reaction container 105 is omitted.
- the system reagent replacement operation of the flow channel of the system reagent supply nozzle, the system reagent reservoir, and the system reagent replacement operation of the cleaning reagent supply hole of the reagent nozzle cleaning tank may be implemented as a simple system reagent replenishment operation that can be performed in a shorter time.
- the system reagents in each system reagent dispensing nozzle and each system reagent reservoir are detected.
- a top cover of the analysis unit is provided with a sensor for detecting the open / close state, and the detection state of the sensor is monitored.
- the operation of cleaning the analysis unit such as the sample dispensing nozzle 103 or the reagent dispensing nozzle 114 or the reaction liquid suction nozzle 115 from the detection unit 116
- the operation of installing a cleaning liquid to the analysis unit there is an operation of installing a cleaning liquid to the analysis unit, and the like.
- the system reagent water replacement operation of the flow channel of the system reagent supply nozzle, the system reagent reservoir, or the cleaning reagent supply hole of the reagent nozzle cleaning tank is included If the maintenance item is performed, the flow path of the system reagent supply nozzle, the inside of the system reagent reservoir, or the cleaning reagent supply hole of the reagent nozzle cleaning tank is replaced with water, and the incubator disc 104 and the stirring mechanism It is determined that the reaction container 105 does not remain at 108. And, from the item of the analysis preparation operation, only the reaction container disposal remaining on the incubator disk 104 and the stirring mechanism 108 is omitted.
- the detection unit As a maintenance item that includes the water replacement operation of the system reagent of the flow path of the stem reagent supply nozzle, the system reagent reservoir, or the cleaning reagent supply hole of the reagent nozzle cleaning tank, for example, the detection unit There are maintenance for cleaning the flow path including 116, maintenance for replacing the detection sensor of the detection unit 116, and the like.
- the results of monitoring the presence / absence of abnormality at the previous analysis, the maintenance items executed after the previous analysis, the presence / absence of access to the analysis unit by the operator, and the presence / absence of replacement of system reagent bottles Select and execute the analysis preparation operation based on.
- the flow path of the stem reagent supply nozzle, the system reagent reservoir, and the system reagent replacement operation of the cleaning reagent supply hole of the reagent nozzle cleaning tank may be a simple system reagent replenishment operation that can be performed in a shorter time.
- the flow path of the system reagent supply nozzle, the inside of the system reagent reservoir, and the cleaning of the reagent nozzle cleaning tank The reagent supply hole needs to be filled with a new system reagent, and it is determined that the reaction container 105 does not remain on the incubator disk 104 and the stirring mechanism 108. And, from the item of the analysis preparation operation, only the reaction container disposal remaining on the incubator disk 104 and the stirring mechanism 108 is omitted.
- the system reagent supply nozzle flow path, system reagent reservoir, and system reagent water replacement operation of the cleaning reagent supply hole of the reagent nozzle cleaning tank are omitted from the items constituting the analysis end operation.
- the waste operation of the reaction vessel 105 remaining on the incubator disc 104 and the stirring mechanism 108 is performed.
- the flow path of the system reagent supply nozzle, the system reagent reservoir, and the cleaning reagent supply hole of the reagent nozzle cleaning tank maintain the system reagent.
- the reagent is in the cleaning reagent supply holes in each system reagent supply nozzle, each system reagent reservoir, and the reagent nozzle cleaning tank. Since there is a possibility of crystal precipitation due to evaporation and concentration, system reagent replacement operation and system reagent replenishment quantity optimization in preparation operation at the time of analysis restart depending on automatic replenishment of system reagents regularly or analysis restart time Is preferred.
- the shutdown operation is performed first and then shutdown (power off) is performed.
- the water replacement operation of the flow channel of the system reagent supply nozzle, the system reagent of the system reagent reservoir, and the cleaning reagent supply hole of the reagent nozzle cleaning tank is performed. This is to prevent crystals from being deposited by evaporation and concentration of reagents in the cleaning reagent supply holes of each system reagent supply nozzle, system reagent reservoir, and reagent nozzle cleaning tank when the apparatus is not in operation. It is a thing. In the normal analysis mode in which all analysis end operations and analysis preparation operations are performed, the above-described device end operation may not be performed at the time of a shutdown request.
- the preparation operation is performed to make the state of the analyzer suitable for analysis before the analysis operation, and the termination operation is performed to put the analyzer in the appropriate standby state after the analysis operation.
- one or more end operation items to be executed are determined among the plurality of end operation items set as the analysis end operation performed at the end of the analysis operation to analyze the sample to be analyzed. And a plurality of preparations set as the analysis preparation operation based on the monitoring result of monitoring the state of the automatic analyzer between the end of the analysis end operation and the start of the analysis preparation operation for preparing the analysis operation.
- one or more preparatory operation items to be executed are determined. Therefore, by rationalizing various operations related to the analysis processing, the time required for the analysis processing can be shortened.
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Abstract
Description
図1は、本実施の形態に係る自動分析装置の全体構成を概略的に示す図である。また、図4はシステム試薬に関する流路構成を概略的に示す図である
図1および図4において、自動分析装置100は、試料を収容する複数のサンプル容器102と、複数のサンプル容器102を保持するラック101と、ラック101を搬送するラック搬送ライン117と、反応容器105を保持するインキュベータディスク104と、サンプル容器102から反応容器105へ試料を分注するサンプル分注ノズル103と、試薬を収容する複数の試薬容器118と、複数の試薬容器118を保持する試薬ディスク111と、試薬容器118から反応容器105に試薬を分注する試薬分注ノズル114と、試薬分注ノズル114を洗浄する試薬分注ノズル洗浄槽121と、試薬ノズル洗浄槽121に洗浄試薬を供給する洗浄試薬供給孔122と、反応容器105に収容された試料と試薬の混合液(以降、反応液と称する)を攪拌する攪拌機構108と、反応液から特定成分の検出を行う検出ユニット116と、反応容器105から反応液を吸引して検出ユニット116に送る反応液吸引ノズル115と、反応液吸引ノズルによって吸引する検出反応補助試薬を保持する検出反応補助試薬リザーバ123と、検出反応補助試薬リザーバ123に検出反応補助試薬を供給する検出反応補助試薬供給ノズル124と、反応液吸引ノズルによって吸引する洗浄試薬を保持する洗浄試薬リザーバ125と、洗浄試薬リザーバ125に洗浄試薬を供給する洗浄試薬供給ノズル126と、分析部を覆うトップカバーの開閉を検知する為のセンサー127、自動分析装置全体の動作を制御する制御部119とから概略構成されている。また、自動分析装置100には、サンプル分注チップ・反応容器搬送機構106、サンプル分注チップ・反応容器保持部107、サンプル分注チップ・反応容器廃棄孔109及び、サンプル分注チップ装着部110が設けられている。
サンプル容器102は、ラック101に保持されてラック搬送ライン117に沿って搬送される。サンプル容器102には、分析対象の血漿や血清、尿などの生体サンプル(以下、試料と称する)が収容されている。ラック搬送ライン117上には、サンプル分注位置が配置されている。
試薬ディスク111には、分析処理に用いる試薬が収容された複数の試薬容器118が周方向に並べて配置されている。試薬ディスク111は、図示しない回転駆動装置によって周方向に回転駆動されることにより、試薬容器118を周方向に搬送する。
インキュベータディスク104には、試料と試薬の混合液(反応液)が収容される複数の反応容器105が周方向に並べて配置されている。インキュベータディスク104は、図示しない回転駆動装置によって周方向に回転駆動されることにより、反応容器105を周方向に搬送する。インキュベータディスク104による反応容器105の搬送経路上には、反応容器設置位置、試薬分注位置、サンプル分注位置、検出位置、反応容器廃棄位置などが配置されている。
サンプル分注ノズル103及び試薬分注ノズル114は、水平方向への回動及び上下移動可能に構成されており、ノズル先端を試薬容器118内の試薬・希釈液、或いはサンプル容器102内の試料に接液させて、所定量の吸引を行い、インキュベータディスク104の反応容器105に吐出する。
サンプル分注チップ・反応容器保持部107には、サンプル分注ノズル103の先端に装着するための未使用のサンプル分注チップと、インキュベータディスク104に配置される未使用の反応容器105とが保持されている。
サンプル分注チップ・反応容器搬送機構106は、X軸,Y軸,Z軸の3方向に移動可能に構成されており、サンプル分注チップ・反応容器保持部107からサンプル分注チップ装着位置110へのサンプル分注チップの搬送や、インキュベータディスク104への反応容器105の搬送を行う。また、サンプル分注チップ・反応容器搬送機構106は、試料と試薬が分注された反応容器105をインキュベータディスク104から攪拌機構108に搬送し、反応容器105に収容された混合液(反応液)を攪拌する。つまり、サンプル分注チップ及び反応容器搬送機構106は、サンプル分注チップ及び反応容器保持部材107の上方に移動し、下降して未使用の反応容器105を把持して上昇し、インキュベータディスク104の反応容器設置位置の上方に移動し、下降して反応容器を設置する。また、サンプル分注チップ・反応容器搬送機構106は、使用済みの反応容器105をサンプル分注チップ・反応容器廃棄孔109に搬送して廃棄する。
反応液吸引ノズル115は水平方向への回転移動と上下移動が可能であり、インキュベータディスク104上の反応を終えた反応容器105へと移動して、反応容器105内の反応液を吸引し、流路を介して連結される検出ユニット116へと送液する。また、反応液吸引ノズル115は、検出反応補助試薬リザーバ123へと移動して、検出反応補助試薬を吸引し、検出ユニット116へと送液する。検出反応補助試薬は、検出反応補助試薬ボトル153から、流路および切り替えバルブ156、158、159、160を介して連結される検出反応補助試薬供給シリンジ151によって吸引され、検出反応補助試薬供給ノズル124から吐出され、検出反応補助試薬リザーバへ貯蔵される。さらに同様に、反応液吸引ノズル115は、洗浄試薬リザーバ125へと移動して、洗浄試薬を吸引し、検出ユニット116へと送液する。洗浄試薬は、洗浄試薬ボトル154から、流路および切り替えバルブ157、161、163、164を介して連結される洗浄試薬供給シリンジ152によって吸引され、洗浄試薬供給ノズル126から吐出され、洗浄試薬リザーバ125へ貯蔵される。
図2は、制御部の概要を説明する機能ブロック図である。
演算部132は、分析動作を行う前に分析装置の状態を分析に適した状態にするための動作である分析準備動作(後述)や、検出ユニット116による検出結果に基づいて分析対象の試料の分析を行う分析動作(後述)、分析動作を行った後に分析装置を適切な待機状態にするための分析終了動作(後述)などを行い、分析結果等を出力部133に出力するとともに、記憶部131に記憶する。
記憶部131には、検出ユニット116による検出結果や、検出結果から演算された分析処理の結果、分析モード(後述)などの設定、オペレータ毎に設定されたパスワードや、画面の表示レベル、試料情報、試薬情報、分析パラメータ、分析依頼項目、キャリブレーション結果など、自動分析装置に係る情報が記憶されている。
出力部133は、例えば、モニター等の表示装置やプリンター等により構成されており、試料の分析結果や各種設定内容を表示したり、印刷出力したりする。また、入力部130は、例えば、キーボードやマウス等の操作装置により構成されており、出力部133のモニター等に表示される設定画面などを含むGUI(Graphical User Interface)により、種々の操作を行う。
本実施の形態における、分析準備動作、分析動作、分析終了動作の詳細について説明する。
分析準備動作は、分析動作を行う前に分析装置の状態を分析に適した状態にするための動作である。分析準備動作では、予め複数の動作項目(以降、準備動作項目と称する)が用意されており、これら複数の準備動作項目から一部又は全部の動作項目が選択されて実行される。準備動作項目としては、例えば、検出反応補助試薬や洗浄試薬などのシステム試薬置換や反応容器廃棄、流路内気泡除去、検出用センサー機能確認などがある。なお、準備動作項目のうち、システム試薬置換や反応容器廃棄に要する時間が比較的長いため、これらを最適化することにより得られる時間短縮効果は比較的大きい。
システム試薬置換は、検出反応補助試薬リザーバ123と、検出反応補助試薬供給ノズル124と検出反応補助試薬ボトル153を連結する流路、洗浄試薬リザーバ125と、洗浄試薬供給ノズル126と洗浄試薬ボトル154を連結する流路、および試薬分注ノズル洗浄槽121と、洗浄試薬供給孔122と洗浄試薬ボトル154を連結する流路を、各々、検出反応補助試薬または洗浄試薬に置換する動作項目である。
反応容器廃棄は、インキュベータディスク104及び攪拌機構108に残存する反応容器105を廃棄する動作項目である。
流路内気泡除去は、試薬分注ノズル114及びサンプル分注ノズル103における流路内の気泡を除去する動作項目である。
検出用センサー機能確認は、検出ユニット116内の検出用センサーの機能を確認する動作項目である。
分析動作では、以下の工程により分析対象試料の分析を行う。
試薬や希釈液が収容された複数の試薬容器118は、試薬ディスク111の回転により試薬分注ノズル114による試薬分注位置まで搬送される。インキュベータディスク104上に周方向に並べて配置された複数の反応容器105のうち、分析動作に用いる反応容器105は、インキュベータディスク104の回転により試薬分注位置まで搬送される。試薬分注位置では、試薬分注ノズル114により、試薬容器118の試薬が吸引され、反応容器105に吐出され。
試料と試薬とが吐出された反応容器105は、インキュベータディスク104の回転によって、反応容器搬送位置に移動され、サンプル分注チップ及び反応容器搬送機構106によって、攪拌機構108へと搬送される。攪拌機構108では、反応容器102に回転運動を加えて反応容器内のサンプルと試薬を混和(攪拌)する。攪拌の終了した反応容器102は、サンプル分注チップ及び反応容器搬送機構106によって、インキュベータディスク104の反応容器搬送位置に戻される。
試薬と試料とが分注・混和され、インキュベータディスク104上で所定時間が経過した反応容器105は、検出位置に搬送される。検出位置では、反応容器105に収容された反応液が、反応液吸引ノズル115により吸引され、次いで、検出反応補助試薬リザーバ123に収容された検出反応補助試薬が吸引されて、反応液と検出反応補助試薬が検出ユニット116に送液される。検出ユニット116に送られた反応液は、測定対象成分が検出され、検出結果が制御部119に送られる。その後、洗浄試薬リザーバ125に充填された洗浄試薬を吸引して検出ユニット116に送液して検出ユニット116を洗浄する。各システム試薬リザーバのシステム試薬(検出反補助試薬、洗浄試薬)が吸引された後、各システム試薬供給ノズルからシステム試薬が補充される。
分析終了動作は、分析動作を行った後に分析装置を適切な待機状態にするための動作である。分析終了動作では、予め複数の動作項目(以降、終了動作項目と称する)が用意されており、これら複数の終了動作項目から一部又は全部の動作項目が選択されて実行される。終了動作項目としては、例えば、システム試薬の水置換や反応容器廃棄などがある。
システム試薬の水置換は、システム試薬供給ノズルの流路、システム試薬リザーバ、および試薬プローブ洗浄槽の洗浄試薬供給孔のシステム試薬の水置換を行う動作項目である。
反応容器廃棄は、インキュベータディスク104及び攪拌機構108に残存する反応容器105を廃棄する動作項目である。
図5および図6は、本実施の形態における分析処理の全体の流れを示すフローチャートである。
以上のように構成した本実施の形態における動作を説明する。
以上のように構成した本実施の形態における効果を説明する。
101 ラック
102 サンプル容器
103 サンプル分注ノズル
104 インキュベータディスク
105 反応容器
106 サンプル分注チップおよび反応容器搬送機構
107 サンプル分注チップおよび反応容器保持部材
108 攪拌機構
109 サンプル分注チップおよび反応容器廃棄孔
110 サンプル分注チップ装着位置
111 試薬ディスク
112 試薬ディスクカバー
113 試薬ディスクカバー開口部
114 試薬分注ノズル
115 反応液吸引ノズル
116 検出ユニット
117 ラック搬送ライン
118 試薬容器
119 制御部
121 試薬プローブ洗浄槽
122 洗浄試薬供給孔
123 反応補助試薬リザーバ
124 反応補助試薬供給ノズル
125 洗浄試薬リザーバ
126 洗浄試薬供給ノズル
127 トップカバー開閉検知センサー
130 入力部
131 記憶部
132 演算部
133 出力部
140 分析モード選択画面
151 反応補助試薬シリンジ
152 洗浄試薬シリンジ
153 反応補助試薬ボトル
154 洗浄試薬ボトル
155 廃液受け
156 切り替えバルブ(反応補助試薬シリンジ)
157 切り替えバルブ(洗浄試薬供給ノズル)
158 切り替えバルブ(反応補助試薬供給ノズル)
159 切り替えバルブ(反応補助試薬ボトル)
160 切り替えバルブ(反応補助試薬廃液)
161 切り替えバルブ(洗浄試薬ボトル)
162 切り替えバルブ(試薬ノズル洗浄)
163 切り替えバルブ(洗浄試薬廃液)
164 切り替えバルブ(洗浄試薬シリンジ)
Claims (9)
- 前回の分析装置の起動処理終了から、分析動作の準備を行うための分析準備動作の開始までの間、および分析終了動作の終了から、次の分析動作の準備を行うための分析準備動作の開始までの間における自動分析装置の状態を監視する装置状態監視部と、
前記装置状態監視部の監視結果に基づいて、前記分析準備動作として設定された複数の準備動作項目のうち、実行する1つ以上の準備動作項目を決定する分析準備動作項目決定部を備えたことを特徴とする自動分析装置。 - 請求項1記載の自動分析装置において、
前記装置状態監視部は、監視する自動分析装置の状態として、少なくとも、前記自動分析装置の起動時の異常発生の有無、分析動作時の異常の有無、分析動作の終了から分析準備動作の開始までにおける操作者による分析部へのアクセスの有無、分析動作の終了から分析準備動作の開始までにおけるメンテナンスの実行の有無、実行された前記メンテナンスの種別、分析に用いる試薬の交換の有無、分析装置の起動処理終了時点あるいは前回の分析終了時点からの経過時間、システム試薬のメンテナンスを実行してからの経過時間、の少なくともいずれかを含むことを特徴とする自動分析装置。 - 請求項1記載の自動分析装置において、
前記分析準備動作の準備動作項目は、少なくとも、分析に用いる試薬を供給するための試薬供給流路に試薬を充填する動作項目と、前記分析動作に用いた前記反応容器を廃棄する動作項目と、を含むことを特徴とする自動分析装置。 - 請求項2記載の自動分析装置において、
前記装置状態監視部は、監視する自動分析装置の状態として、前記実行されたメンテナンス種別に基づいて判断される、分析に用いる試薬を供給するための試薬供給流路の試薬の水への置換の有無、を含むことを特徴とする自動分析装置。 - 予め定められた複数の分析準備動作項目を実行する通常モードと、前記通常モードよりも少ない数の分析準備動作項目を実行する時間短縮モードとから操作者が選択する動作モード設定部と、
前記分析装置の起動処理終了から、分析動作の準備を行うための分析準備動作の開始までの間、および分析終了動作の終了から、前記分析動作を行うための準備を行う分析準備動作の開始までの間における装置の状態を監視する装置状態監視部と、
前記動作モード設定部において設定された動作モードと、前記装置状態監視部の監視結果とに基づいて、前記分析準備動作として設定された複数の準備動作項目のうち、実行する1つ以上の準備動作項目を決定する分析準備動作項目決定部と
を備えたことを特徴とする自動分析装置。 - 請求項5記載の自動分析装置において、
前記動作モード設定部において設定された動作モードに基づいて、分析動作の終了時に行う分析終了動作として設定された複数の終了動作項目のうち、実行する1つ以上の終了動作項目を決定する分析終了動作項目決定部を備えたことを特徴とする自動分析装置。 - 前回の分析終了動作の終了から、次の分析動作を行うための分析準備動作の開始までの間における自動分析装置の状態監視結果、あるいは、操作者の指示に基づいて、複数の準備動作項目のうち、実行する1つ以上の準備動作項目を決定することを特徴とする自動分析装置の制御方法。
- 請求項8記載の自動分析装置の制御方法において、
前記操作者の指示は、予め定められた複数の分析準備動作項目を実行する通常モードと、前記通常モードよりも少ない数の分析準備動作項目を実行する時間短縮モードの、いずれかを選択することである、自動分析装置の制御方法。 - 請求項8記載の自動分析装置の制御方法において、
前記自動分析装置の状態監視結果は、自動分析装置の起動時の異常発生の有無、分析動作時の異常の有無、分析動作の終了から分析準備動作の開始までにおける操作者による分析部へのアクセスの有無、分析動作の終了から分析準備動作の開始までにおけるメンテナンスの実行の有無、実行された前記メンテナンスの種別、分析に用いる試薬の交換の有無、前回の分析終了時点からの経過時間、システム試薬のメンテナンスを実行してからの経過時間、のいずれかを含むことを特徴とする自動分析装置の制御方法。
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