JP6072450B2 - Automatic analyzer - Google Patents

Description

  The present invention relates to an automatic analyzer for performing quantitative or qualitative analysis of a predetermined detection target contained in a specimen such as blood or urine.

  In an automatic analyzer, in order to improve the inconvenience of qualitative / quantitative analysis inspection due to dry adhesion of diluted samples and alteration of diluted samples, the original sample container setting part for placing the original sample container into which the original sample is placed, and the original sample are diluted Automatic analysis that performs analysis and inspection of various samples including original sample, diluted sample, and combined sample in which the diluted sample and the original sample are used together. Some apparatuses have a function capable of discarding the remaining diluted sample dispensed in the analytical inspection from the diluted sample container or holding it in the diluted sample container (see Patent Document 1).

JP 2009-204409 A

When quantifying or qualitatively analyzing a detection target in a sample by an automatic analyzer, some analysis items have a narrow concentration range in which the analysis reagent can be analyzed with respect to the detection target concentration range in the sample. is there. When analyzing such items, the sample must be diluted to an appropriate concentration so that the detection target in the sample is within the analyzable range.
Therefore, for a sample whose concentration of the detection target is unknown, it is required to first analyze the sample diluted at a predetermined magnification, and to reanalyze the sample by optimizing the dilution factor based on the analysis result.

However, this reanalysis of the sample is generally performed after the determination of the first analysis result, the stock solution sample is transported again to the automatic analyzer, and an appropriate dilution rate is obtained from the previous analysis result to obtain the obtained dilution rate. An analysis plan is prepared in which a sample and a diluent are prepared and measurement is started.

However, in automatic analyzers, re-analysis is usually planned after the determination of the first analysis result. Therefore, if analysis of another sample is planned before the determination of the first analysis result, that plan is given priority. To implement.
For this reason, the reanalysis planned after the determination of the first analysis result is not carried out until the analysis result of another sample is obtained, and it takes a long time to obtain the reanalysis result, thereby extending the examination time. There is a problem that occurs.
Moreover, since the undiluted sample is transported again and used, there is a problem that the amount of the sample used increases.

  The present invention provides an automatic analyzer capable of suppressing an increase in the amount of specimen used while suppressing an increase in test time.

More in order to achieve the above object, the present invention provides an automatic analyzer for performing qualitative and quantitative analyzes of test samples, mixing of the sample and diluent, the reaction vessel row Utame mixing of the sample and reagent A reaction disc to be held, a sample dispensing mechanism for dispensing the sample and the diluted sample diluted with the diluent into a reaction vessel on the reaction disc, and dispensing the reagent and the diluted solution into the reaction vessel A reagent dispensing mechanism, a transport mechanism for transporting the reaction container to a predetermined position on the reaction disk or a disposal position of the reaction container, and a detection target in a reaction liquid held in the reaction container are detected. A detection mechanism; and a control device that controls the operation of each mechanism, wherein the reaction disk includes a first container containing the sample, and a sample dispensed from the first container by the sample dispensing mechanism. Part of the reagent dispensing A second container containing the first diluted specimen diluted with the diluent dispensed by the structure, and a part of the first diluted specimen dispensed from the second container by the specimen dispensing mechanism And a third container containing a first reaction liquid in which the reagent dispensed by the reagent dispensing mechanism is reacted, and the control device is used to prepare the first reaction liquid A step of performing a first analysis using the first reaction solution in a state where the sample and the first diluted sample are stored without being discarded, and a measurement value is determined in advance as a result of executing the first analysis. Based on the result of the step of determining whether it is within the threshold range and the step of determining, prepare a second diluted sample having a different dilution ratio based on the first diluted sample stored in the second container, First reacted with the second diluted sample and the reagent. Or preparing a reaction solution, or to prepare a third reaction mixture based on the accommodating analyte within the first container, or to end the analysis, and to execute the step of selecting, the a .

  According to the present invention, it is possible to suppress an increase in test time and an increase in the amount of specimen used.

It is a top view which shows schematic structure of embodiment of the automatic analyzer of this invention. It is a flowchart showing a part of sample analysis process among the control processing procedures of embodiment of the automatic analyzer of this invention. It is a flowchart showing a part of sample analysis process among the control processing procedures of embodiment of the automatic analyzer of this invention. It is a flowchart showing a part of sample analysis process among the control processing procedures of embodiment of the automatic analyzer of this invention. It is a flowchart showing a part of sample analysis process among the control processing procedures of embodiment of the automatic analyzer of this invention.

Embodiments of an automatic analyzer according to the present invention will be described below with reference to the drawings. 1 to 5, the case where the automatic analyzer is applied to an immune analyzer will be described as an example.
FIG. 1 is a plan view showing a schematic configuration of an embodiment of an automatic analyzer of the present invention, and FIGS. 2 to 5 are diagrams showing one of sample analysis steps in a control processing procedure of the embodiment of the automatic analyzer of the present invention. It is a flowchart showing a part.

  In FIG. 1, an automatic analyzer 100 includes a rack 101, a sample dispensing nozzle 103, an incubator disk 104, a transport mechanism 106, a holding member 107, a stirring mechanism 108, a disposal hole 109, a reagent disk 111, and the like. , A reagent dispensing nozzle 114, a reaction liquid suction nozzle 115, a detection unit 116, a rack transport line 117, and a control unit 119.

  The rack 101 is provided with a sample container 102 for holding a sample (specimen). The rack transport line 117 moves the sample container 102 installed on the rack 101 to a sample dispensing position near the sample dispensing nozzle 103.

  The sample dispensing nozzle 103 can rotate and move up and down, and is configured to suck the sample held in the sample container 102 and discharge the sucked sample to the reaction container 105 on the incubator disk 104.

  The incubator disc 104 is configured such that a plurality of reaction vessels 105 can be installed. The incubator disc 104 is used for moving the reaction container 105 installed in the circumferential direction to a predetermined position such as a reaction container installation position, a sample discharge position, a reagent discharge position, a detection position, a reaction container disposal position, and the like. Perform a rotational motion.

  The transport mechanism 106 is movable in three directions of the X axis, the Y axis, and the Z axis, and includes a holding member 107, a stirring mechanism 108, a waste hole 109, a tip mounting position 110 for sample dispensing tips, an incubator disk 104, and the like. The sample is moved within the range, and the sample dispensing tip and the reaction container 105 are transported.

  The holding member 107 is provided with a plurality of unused reaction vessels 105 and sample dispensing tips.

  The stirring mechanism 108 is a stirring mechanism for mixing the sample in the reaction container 105 or the diluted sample with the reagent by applying a rotational motion to the reaction container 105.

  The discard hole 109 is a hole for discarding the used sample dispensing tip and the reaction container 105.

  The reagent disk 111 is provided with a plurality of reagent containers 118 holding reagents and diluents. The inside of the reagent disk 111 is maintained at a predetermined temperature, and a cover 112 is provided above the reagent disk 111. A cover opening 113 is provided in a part of the cover 112.

  The reagent dispensing nozzle 114 can rotate and move up and down, sucks the reagent or diluent held in the reagent container 118 in the reagent disk 111, and draws the sucked reagent or diluent into the reaction container on the incubator disk 104. It is comprised so that it may discharge to 105.

  The reaction liquid suction nozzle 115 can rotate and move up and down, and is a mechanism for feeding the reaction liquid in the reaction vessel 105 on the incubator disk 104 to the detection unit 116.

  The detection unit 116 detects the concentration and the like of the detection target in the reaction liquid sent from the reaction liquid suction nozzle 115.

  The control unit 119 controls the overall operation of the automatic analyzer 100 such as an initial preparation operation performed before the analysis process, a dispensing operation of each part, and an analysis process of the detection result of the detection unit 116. The control unit 119 has a display 119a for displaying the analysis result.

In the automatic analyzer 100 as described above, the reaction disk of the present invention includes the incubator disk 104 and the stirring mechanism 108.
The sample dispensing mechanism of the present invention is configured by a sample dispensing nozzle 103.
The reagent dispensing mechanism of the present invention is constituted by a reagent dispensing nozzle 114.
The transport mechanism of the present invention is configured by the transport mechanism 106.
The detection mechanism of the present invention is constituted by the detection unit 116.
The control unit of the present invention is configured by the control unit 119.

  Next, operation in the above-described embodiment of the automatic analyzer of the present invention will be described.

The control unit 119 of the automatic analyzer 100 receives the measurement input signal from the operator and creates an analysis plan for sample analysis.
Specifically, when analyzing the sample, the control unit 119 performs the first step of analyzing the 400-fold diluted sample as the first analysis, the second step of analyzing the stock solution sample, and the analysis of the 4000-fold diluted sample. A second analysis in any of the third steps to be performed, and a fourth step in which analysis of a 40000-fold diluted sample is planned as the third analysis are planned in advance. In other words, after the first analysis, the second analysis is performed instead of the analysis of other samples, and the analysis plan is made so that the third analysis and the analysis of a specific sample are performed continuously after the second analysis. create.
During the first analysis, the stock solution sample and the 400-fold diluted sample are retained on the incubator disk 104 without being discarded, and during the third step, the 4000-fold diluted sample is retained on the incubator disk 104. In the fourth step, the 40000-fold diluted sample is held on the incubator disk 104.
Furthermore, when the analysis result in the first analysis falls within the analysis possible range in which the detection accuracy in the detection unit 116 can be guaranteed, the plans for the second analysis and the third analysis planned in advance are discarded. Furthermore, when the analysis result of the second analysis falls within the analysis possible range, the plan of the third analysis planned in advance is discarded.

  After creating the plan as described above, the control unit 119 outputs a control signal to each mechanism in the apparatus to perform analysis, and controls its operation.

  First, the transport mechanism 106 moves upward and lowers above the holding member 107, and grips and raises the unused reaction container 105. Thereafter, the transport mechanism 106 moves upward and lowers the reaction container installation position of the incubator disk 104, and installs an unused reaction container 105 on the incubator disk 104.

  Further, the transport mechanism 106 moves down above the holding member 107 and moves up while holding an unused sample dispensing tip. Thereafter, the transport mechanism 106 moves upward and lowers the tip mounting position 110, and places an unused sample dispensing tip on the tip mounting position 110. Thereafter, the sample dispensing nozzle 103 moves upward and lowers the tip mounting position 110 and mounts the sample dispensing tip at the tip of the sample dispensing nozzle 103.

  The reagent dispensing nozzle 114 is rotated and moved downward above the opening 113 of the reagent disk cover 112, and the tip of the reagent dispensing nozzle 114 is brought into contact with a reagent or a diluent in a predetermined reagent container to be a predetermined amount. Aspirate the reagent or diluent. Next, the reagent dispensing nozzle 114 rises and moves above the reagent discharge position of the incubator disk 104 and discharges the reagent or diluent to the reaction container 105 installed on the incubator disk 104.

Further, the sample dispensing nozzle 103 equipped with the sample dispensing tip moves down above the sample container 102 placed on the rack 101 and sucks a predetermined amount of the sample held in the sample container 102. Thereafter, the sample dispensing nozzle 103 that sucks the sample moves to the sample discharge position of the incubator disk 104 and descends, and discharges the sample into the reaction container 105 into which the reagent or diluent on the incubator disk 104 has been dispensed. After sample discharge, the sample dispensing nozzle 103 moves above the disposal hole 109 and discards the used sample dispensing tip into the disposal hole 109.
Thereafter, the sample dispensing nozzle 103 moves upward and lowers the tip mounting position 110 and mounts a new sample dispensing tip at the tip of the sample dispensing nozzle 103. The sample dispensing nozzle 103 equipped with a new sample dispensing tip moves to the diluted sample suction position on the incubator disk 104, and dilutes the sample from the reaction vessel 105 that holds the diluted sample in which the sample and the diluent are dispensed. A predetermined amount is aspirated, moved again to the sample discharge position, and the diluted sample is discharged into the reaction container 105 into which the reagent or diluent has been newly dispensed. By repeatedly performing such an operation, the sample is diluted in a plurality of stages.
Note that the order of dispensing of the reagent or diluent and the sample dispensing may be reversed.

  Thereafter, the control unit 119 rotates the incubator disk 104 to move the reaction vessel 105 from which the sample or the diluted sample and the reagent are discharged to the reaction vessel transfer position, and the transfer mechanism 106 moves the reaction vessel 105 to the stirring mechanism 108. And carry.

  The stirring mechanism 108 applies a rotational motion to the transported reaction container 105 to stir the sample or the diluted sample in the reaction container 105 and the reagent. Thereafter, the control unit 119 returns the stirred reaction container 105 onto the incubator disk 104 by the transport mechanism 106.

After a predetermined time has passed since the reaction vessel 105 that has been agitated is returned to the incubator disk 104 and sufficiently reacted, the control unit 119 moves the reaction solution suction nozzle 115 above the reaction vessel 105 and lowers it. After being lowered, the reaction liquid in the reaction container 105 is sucked, the reaction liquid sucked by the reaction liquid suction nozzle 115 is sent to the detection unit 116, and the detection target 116 detects the detection target.
The control unit 119 derives a measurement result (such as the concentration of the detection target in the sample) based on the detection value of the measurement target detected by the detection unit 116, and displays the result using the display 119a of the control unit 119 or the like.

The control unit 119, a reaction vessel 105 the reaction solution was aspirated is moved to the reaction vessel disposal position by rotation of the incubator disc 104 is moved from the incubator disk 104 above the disposal hole 109 by the transport mechanism 106, discards Discard from hole 109.

  The above-described control for planning the analysis of samples having different dilution ratios and actually executing the analysis planned in advance will be described in more detail with reference to FIGS.

<Plan: First analysis / First process>
First, as a first analysis / first step, the automatic analyzer 100 dispenses a stock solution sample from the sample container 102, prepares a 20-fold diluted sample from the stock solution sample, and a 400-fold diluted sample from the 20-fold diluted sample. In order to analyze the 400-fold diluted sample, the amount of the undiluted solution sample, the diluent and the reagent necessary for the analysis of the 400-fold diluted sample and the operation of each mechanism of the automatic analyzer 100 (for example, incubator) Which position of the disk 104 is to be used, installation and preparation of the reaction vessel 105, etc.) are planned in advance by obtaining by the control unit 119.
At this time, during the first step, it is necessary to carry out the second analysis after the first analysis, and determine whether the second step or the third step is carried out as the second analysis is carried out. Until this is done, the stock solution sample and the 400-fold diluted sample are kept on the incubator disk 104 without being discarded.

<Plan: Second analysis, second process and third process>
In addition, as the second analysis / second step, the automatic analyzer 100 determines that the control unit 119 determines that the analysis result of the first step is a low value (less than the analysis possible range) with respect to the analysis possible range. In order to analyze the stock solution sample, the amount and operation of the stock solution sample and reagent necessary for the analysis are obtained and planned in advance.
Furthermore, in the case where the automatic analysis apparatus 100 determines that the analysis result of the first process is a high value (greater than the analysis possible range) with respect to the analysis possible range by the control unit 119 as the second analysis / third process, Prepare a 4000-fold diluted sample from a 400-fold diluted sample, and determine the amount and operation of the 400-fold diluted sample, diluent, and reagent necessary for the analysis and plan in advance so that the 4000-fold diluted sample is analyzed. . At this time, in the third step, the 4000-fold diluted sample is held on the incubator disc 104 until it is determined whether the third analysis needs to be performed.

<Plan: Third analysis / fourth process>
As a third analysis / fourth step, the automatic analyzer 100 determines that the control unit 119 determines that the analysis result of the second step of the second analysis is a high value with respect to the analysis possible range. To prepare a 40,000-fold diluted sample and analyze the 40,000-fold diluted sample, the amount and operation of the 4000-fold diluted sample, diluent and reagent necessary for the analysis are determined and planned in advance.
At this time, in the fourth step, the 40000-fold diluted sample is held on the incubator disk 104 until it is determined whether the fourth analysis needs to be performed.

  Hereinafter, the control unit 119 of the automatic analyzer 100 plans in advance an analysis plan in which the same analysis as the third analysis is repeated a predetermined number of times.

<Analysis: First analysis / First process>
In FIG. 2, first, the automatic analyzer 100 transports the input sample to the vicinity of the sample dispensing nozzle 103 by the rack transport line 117 (step S101).

  Thereafter, the automatic analyzer 100 dispenses 60 μl of the stock solution sample in the sample container 102 into the first reaction container installed on the incubator disk 104 by the sample dispensing nozzle 103 (step S102).

  Next, the automatic analyzer 100 rotates the reagent disk 111 to move the reagent container 118 holding the diluted solution to the vicinity of the reagent dispensing nozzle 114 (step S103). Thereafter, the automatic analyzer 100 dispenses 6 μl of the stock solution sample from the first reaction container into the second reaction container installed on the incubator disk 104 by the sample dispensing nozzle 103 and 114 μl of the diluent by the reagent dispensing nozzle 114. To prepare a 20-fold diluted sample (step S104).

  Further, the automatic analyzer 100 rotates the reagent disk 111 to move the reagent container 118 holding the diluted solution to the vicinity of the reagent dispensing nozzle 114 (step S105).

  Thereafter, the automatic analyzer 100 dispenses 6 μl of a 20-fold diluted sample of the second reaction container into the third reaction container installed on the incubator disk 104 by the sample dispensing nozzle 103 and dilutes by the reagent dispensing nozzle 114. 114 μl of the liquid is dispensed to prepare a 400-fold diluted sample (step S106).

  Thereafter, the automatic analyzer 100 rotates the reagent disk 111 to move the reagent container 118 holding the reaction reagent to the vicinity of the reagent dispensing nozzle 114 (step S108).

  Thereafter, the automatic analyzer 100 dispenses 20 μl of a 400-fold diluted sample of the third reaction container into the fourth reaction container installed on the incubator disk 104 by the sample dispensing nozzle 103 and reacts by the reagent dispensing nozzle 114. 100 μl of reagent is dispensed, and then the fourth reaction vessel is stirred by the stirring mechanism 108 to prepare a 400-fold diluted reaction solution (step S109).

Thereafter, the automatic analyzer 100 sends the reaction solution prepared in step S109 to the detection unit 116 by the reaction solution suction nozzle 115, analyzes the detection target contained in the reaction solution by the detection unit 116, and controls the control unit 119. From this analysis result, the concentration of the measurement object in the sample is obtained (step S110).

  During this time, the automatic analyzer 100 performs re-analysis (second analysis / second step) with a stock solution sample planned in advance or re-dilution and re-analysis (second analysis / third step) from a 400-fold diluted sample. In addition, two of the first reaction container and the third reaction container are held on the incubator disk 104 until step S111 is completed. On the other hand, the second reaction container is discarded from the disposal hole 109 (step S107). This step S107 is performed between the end of step S106 and the end of step S111. The fourth reaction vessel is discarded after the reaction solution is fed in step S110 (step S118).

  Next, the automatic analyzer 100 immediately outputs the analysis result (concentration of the measurement target in the sample) of the detection target in the 400-fold diluted reaction solution in step S110 by the control unit 119, and outputs the analysis target range. It is determined whether the analysis result is appropriate, that is, whether the analysis result is within the analyzable range, a low value with respect to the analyzable range, or a high value with respect to the analyzable range (step S111). If it is within the analysis possible range, the process proceeds to step S112. If the analysis possible range is low, the process proceeds to step S114. If the analysis possible range is high, the process proceeds to step S116.

  When the analysis result is within the analysis possible range, the automatic analyzer 100 uses the first reaction container or the third reaction container held on the incubator disk 104, the second process, the third process, and the subsequent processes. The analysis plan is discarded (step S112), the first reaction container and the third reaction container are discarded from the discard hole 109 (step S113), and the sample analysis is completed.

  On the other hand, when the analysis result is lower than the analysis possible range, the automatic analyzer 100 determines the third process using the third reaction container held on the incubator disk 104 and the subsequent analysis plan. Discard (step S114) and discard the third reaction container from the disposal hole 109 (step S115). Thereafter, the automatic analyzer 100 performs the second analysis / second step using the stock solution sample planned in advance for the first reaction vessel held on the incubator disk 104 (step S200).

  If the analysis result is higher than the analysis possible range, the automatic analyzer 100 discards the analysis plan of the second process using the first reaction container held on the incubator disk 104 (step S116). Then, the first reaction container is discarded from the discard hole 109 (step S117). Thereafter, the automatic analyzer 100 performs the second analysis / third process using the diluted sample planned in advance for the third reaction vessel held on the incubator disk 104 (step S300).

<Analysis: Second analysis / second step>
In FIG. 3, when it is determined that the analysis result of the first analysis is a low value with respect to the analysis possible range, the automatic analyzer 100 first selects the first reaction container held on the incubator disk 104 as step S200. Immediately move to the diluted sample suction position (step S201).

  Next, the reagent container 118 holding the reaction reagent is moved to the vicinity of the reagent dispensing nozzle 114 (step S202).

  Thereafter, the automatic analyzer 100 dispenses 20 μl of the stock solution sample of the first reaction container into the fifth reaction container installed on the incubator disk 104 by the sample dispensing nozzle 103 and 100 μl of the reaction reagent by the reagent dispensing nozzle 114. Then, the fifth reaction vessel is stirred by the stirring mechanism 108 to prepare a stock reaction solution (step S203).

Thereafter, the automatic analyzer 100 sends the reaction solution prepared in step S203 to the detection unit 116 by the reaction solution suction nozzle 115, analyzes the detection target contained in the reaction solution by the detection unit 116, and controls the control unit 119. From this analysis result, the concentration of the measurement object in the sample is obtained (step S205).

  During this time, the automatic analyzer 100 discards the first reaction container after the stock solution sample is aspirated in step S203 (step S204). Further, the fifth reaction vessel held on the incubator disk 104 is discarded from the discard hole 109 after the reaction solution is sent in step S205 (step S206).

Thereafter, the automatic analyzer 100 determines whether the control unit 119 is suitable for the analysis possible range immediately after outputting the analysis result of the detection target in the stock reaction liquid held in the fifth reaction container (step S207).
When the analysis result matches the analysis possible range, the automatic analyzer 100 ends the analysis.
On the other hand, when the analysis result becomes incompatible with the analysis possible range, the automatic analyzer 100 reports to the operator as an invalid result due to a different cause from the inconsistency of the detection target concentration in the sample and the analysis possible range. (Step S208) and the analysis is terminated.

<Analysis: Second analysis / third process>
In FIG. 4, when it is determined that the analysis result of the first process is a high value with respect to the analysis possible range, the automatic analyzer 100 immediately uses the third reaction container held on the incubator disk 104 as step S300. Move to the diluted sample suction position (step S301).

  Next, the automatic analyzer 100 rotates the reagent disk 111 to move the reagent container 118 holding the diluted solution to the vicinity of the reagent dispensing nozzle 114 (step S302).

  Thereafter, the automatic analyzer 100 dispenses 12 μl of the 400-fold diluted sample in the third reaction container into the sixth reaction container installed on the incubator disk 104 by the sample dispensing nozzle 103 and the reagent dispensing nozzle 114. A dilution of 08 μl is dispensed to prepare a 4000-fold diluted sample (step S303).

  Thereafter, the automatic analyzer 100 rotates the reagent disk 111 to move the reagent container 118 holding the reaction reagent to the vicinity of the reagent dispensing nozzle 114 (step S305).

  Next, the automatic analyzer 100 dispenses 20 μl of a 4000-fold diluted sample of the sixth reaction container into the seventh reaction container installed on the incubator disk 104 by the sample dispensing nozzle 103 and also by the reagent dispensing nozzle 114. A reaction reagent is dispensed in 100 μl, and then the seventh reaction vessel is stirred by the stirring mechanism 108 to prepare a 4000-fold diluted reaction solution (step S306).

Thereafter, the automatic analyzer 100 sends the reaction liquid prepared in step S306 to the detection unit 116 by the reaction liquid suction nozzle 115, analyzes the detection target contained in the reaction liquid by the detection unit 116, and controls the control unit 119. From this analysis result, the concentration of the measurement object in the sample is obtained (step S307).

  During this time, the automatic analyzer 100 discards the third reaction container (step S304). In contrast, the sixth reaction vessel is held on the incubator disk 104 for re-dilution from the 4000-fold diluted sample and re-analysis (third analysis / fourth step). The seventh reaction vessel is discarded after the reaction solution is fed in step S307 (step S311).

  Next, the automatic analyzer 100 determines the suitability of the analysis possible range immediately after the output of the analysis result of the detection target in the 4000-fold diluted reaction solution in step S307 by the control unit 119 (step S308).

  If the analysis result matches the analysis possible range, the automatic analyzer 100 discards the third analysis planned in advance and the subsequent analysis plans (step S309). Further, the sixth reaction vessel held on the incubator disk 104 is discarded from the discard hole 109 (step S310), and the analysis is completed.

  On the other hand, when the analysis result is still a high value with respect to the analysis possible range, the fourth process which is the third analysis planned in advance is performed (step S400).

<Analysis: Third analysis / fourth process>
In FIG. 5, when it is determined that the analysis result of the second analysis / third process is a high value with respect to the analysis possible range, the automatic analyzer 100 starts with the sixth sixth held on the incubator disk 104 as step S400. The reaction container is immediately moved to the diluted sample suction position (step S401).

  Next, the automatic analyzer 100 rotates the reagent disk 111 to move the reagent container 118 holding the diluted solution to the vicinity of the reagent dispensing nozzle 114 (step S402).

  Thereafter, the automatic analyzer 100 dispenses 12 μl of the 4000-fold diluted sample in the sixth reaction container into the eighth reaction container installed on the incubator disk 104 by the sample dispensing nozzle 103 and also by the reagent dispensing nozzle 114. The diluted solution is dispensed into 108 μl to prepare a 40000-fold diluted sample (step S403).

  Thereafter, the automatic analyzer 100 rotates the reagent disk 111 to move the reagent container 118 holding the reaction reagent to the vicinity of the reagent dispensing nozzle 114 (step S405).

  Next, the automatic analyzer 100 dispenses 20 μl of a 40,000-fold diluted sample of the eighth reaction container into the ninth reaction container installed on the incubator disk 104 by the sample dispensing nozzle 103 and the reagent dispensing nozzle 114. Dispense 100 μl of the reaction reagent, and then stir the ninth reaction container by the stirring mechanism 108 to prepare a 40000-fold diluted reaction solution (step S406).

Thereafter, the automatic analyzer 100 sends the reaction solution prepared in step S406 to the detection unit 116 by the reaction solution suction nozzle 115, analyzes the detection target contained in the reaction solution by the detection unit 116, and controls the control unit 119. From this analysis result, the concentration of the measurement object in the sample is obtained (step S407).

  During this time, the automatic analyzer 100 discards the sixth reaction container (step S404). On the other hand, the eighth reaction vessel is held on the incubator disk 104 for an additional step (fourth analysis / fifth step not shown) which is re-dilution and re-analysis from a 40000-fold diluted sample. The ninth reaction container is discarded after the reaction solution is fed in step S407 (step S411).

  Next, the automatic analyzer 100 determines the suitability of the analysis possible range immediately after the output of the analysis result of the detection target in the 40000-fold diluted reaction solution in Step S407 by the control unit 119 (Step S408).

  If the analysis result matches the analysis possible range, the plan for the additional analysis process (fourth analysis, fifth analysis, sixth analysis,... After step S500) that has been planned in advance is discarded (step S409). Further, the eighth reaction vessel held on the incubator disk 104 is discarded (step S410), and the analysis is finished.

  On the other hand, when the analysis result is still high in the analysis possible range, the same analysis process as the third analysis / fourth process in step S500 is performed (step S500 and subsequent steps).

According to the above-described embodiment of the automatic analyzer of the present invention, the analysis of the second process of the second analysis, the third process, and the analysis of the fourth process of the third analysis are already planned at the start of the analysis of the first analysis. Yes.
Therefore, even when analyzing an item whose analysis reagent concentration range is narrower than the detection target concentration range in the sample, the automatic analysis device of this embodiment uses the second step or third step that is a reanalysis. Since the analysis of the process and the fourth process is carried out without being disturbed by the newly planned analysis after the start of the first analysis, it does not take a long time to obtain the analysis result of the reanalysis, and the inspection time is extended. Is suppressed.

In the second analysis, the reaction solution is prepared using the sample in the first reaction container or the third reaction container held on the incubator disk 104 at the time of the first analysis. Therefore, it is not necessary to carry out the preparation again, and it is possible to suppress an increase in the inspection time and an increase in the amount of sample used.

  With these effects, the analysis processing efficiency of the specimen is improved, and it is not necessary to collect more samples than necessary, and the burden on the sample collection target can be reduced.

Further, when a plurality of samples having different dilution ratios are prepared in advance, even if a plurality of samples prepared in advance occupy the incubator disk 104 and a plurality of detection units 116 are provided, other analysis is hindered. In addition, if it is within the analysis possible range in the first analysis, it is not necessary to carry out the subsequent analysis, so the prepared sample is discarded. Therefore, the sample, the diluent, and the reaction container are wasted, and problems such as an increase in waste occur.
However, by planning in advance a plurality of analyzes of samples with different dilution ratios as in this embodiment, the incubator disk 104 is not unnecessarily occupied as compared with the case of preparing in advance, and other hindrances to analysis Don't be. In addition, since the second analysis is performed based on the result of the first analysis, the third analysis is performed based on the result of the second analysis,... Thus, the sample can be used effectively without wasting the reaction vessel.

  Also, the first analysis and the second analysis are planned in advance, and the necessity of the second analysis and the dilution factor of the sample of the second reaction liquid in the second analysis are determined based on the analysis result of the first analysis ( For example, based on the result of the first analysis, it is determined whether the second analysis is the second step or the third step). It is possible to select and implement a plan with conditions that are most suitable to do. Therefore, accurate analysis of the sample can be performed at an early stage, and the inspection time can be shortened.

  Furthermore, when it is determined that the second analysis is unnecessary based on the analysis result of the first analysis, the plan after the second analysis is discarded, and the plan that has been retained until the analysis result of the first analysis is obtained. By discarding one reaction container or the third reaction container, analysis of the next sample is started promptly. For this reason, especially when it is necessary to analyze a plurality of samples, the analysis of the next sample is performed at an early stage, and it is possible to more reliably prevent the inspection time from extending for a long time.

  In addition, this invention is not restricted to said embodiment, A various deformation | transformation and application are possible.

For example, in the above-described embodiment, the analysis planned in advance is the first to third analysis, but the present invention is not limited to this, and the first to second analysis may be planned in advance. Many analysis plans can be planned in advance.
For example, as described above, the same steps as the third analysis / fourth step (<fourth analysis, fifth analysis, sixth analysis,...>) May be performed.
However, if the analysis result is determined to be higher than the analysis possible range even after a large number of dilutions and analyzes are repeated a predetermined number of times, there is a cause that is different from the inconsistency of the analyte concentration in the sample and the analysis possible range. It is therefore desirable to report invalid results.

Furthermore, in the above-described embodiment, when analyzing a certain sample, the first step of analyzing a 400-fold diluted sample as the first analysis, the second step of analyzing the stock solution sample as the second analysis, and the 4000-fold diluted sample The third step for performing the analysis of step 4 and the fourth step for performing the analysis of the 40000-fold diluted sample as the third analysis are planned in advance. Good.
For example, a step of analyzing a stock solution sample as a first analysis, a step of analyzing a 400-fold diluted sample as a second analysis, a step of analyzing a 4000-fold diluted sample as a third analysis, and a 40000-fold diluted sample as a fourth analysis And the analysis plan for simply reducing the concentration of the sample (increasing the dilution factor) can be planned and executed in advance. Furthermore, it is possible to increase the sample concentration.

Further, when obtaining the concentration of the detection target in the sample, it is possible to take into account evaporation of the sample (evaporation of the diluted solution, etc.) due to the holding on the incubator disk 104 for a certain period of time.
Taking the above embodiment as an example, it takes 18 minutes to complete the calculation of the analysis results of the first analysis and the first process. The 54 μl stock solution sample in the first reaction vessel held on the incubator disc 104 undergoes 2 μl evaporation during this time. For this reason, when obtaining the concentration of the detection target in the reaction solution in the second analysis / second step, the concentration of 1.04 times is considered in consideration of the evaporation of 2 μl. Similarly, sample concentration due to sample evaporation can be taken into consideration in the third step, the fourth step of the third analysis, and the subsequent analysis.
Thus, by considering the evaporation of the sample, it is possible to improve the reliability of the analysis of the concentration of the analyte in the sample, and to shorten the time until a desired test result is obtained. Moreover, it is not necessary to perform reanalysis from scratch, and an increase in the amount of sample used can be prevented.

  Furthermore, in the above-described embodiment, the immune analyzer is exemplified as the automatic analyzer, but the automatic analyzer is not limited to this. For example, the present invention can be applied to a biochemical automatic analyzer.

100 ... automatic analyzer,
101 ... Rack,
102 ... sample container,
103 ... Sample dispensing nozzle,
104 ... Incubator disc,
105 ... reaction vessel,
106 ... transport mechanism,
107 ... holding member,
108 ... stirring mechanism,
109: Waste hole,
110 ... chip mounting position,
111 ... Reagent disc,
112 ... cover,
113 ... cover opening,
114: Reagent dispensing nozzle,
115 ... reaction solution suction nozzle,
116 ... detection unit,
117: Rack transport line,
118 ... Reagent container,
119: control unit,
119a: Display.

Claims (4)

An automatic analyzer for performing qualitative and quantitative analyzes of test samples,
Mixing of sample and diluent, a reaction disk holding a plurality of reaction vessels mixture rows Utame of the specimen and the reagent,
A sample dispensing mechanism for dispensing the sample and the diluted sample diluted with the diluent into a reaction container on the reaction disk;
A reagent dispensing mechanism for dispensing the reagent and the diluent into the reaction vessel;
A transport mechanism for transporting the reaction container to a predetermined position on the reaction disk or a disposal position of the reaction container;
A detection mechanism for detecting a detection object in the reaction solution held in the reaction vessel;
A control device for controlling the operation of each mechanism,
The reaction disk is diluted with the first solution containing the sample, a part of the sample dispensed from the first container by the sample dispensing mechanism with the diluent dispensed by the reagent dispensing mechanism. A second container containing the first diluted specimen and a part of the first diluted specimen dispensed from the second container by the specimen dispensing mechanism and dispensed by the reagent dispensing mechanism Holding a third container containing a first reaction solution reacted with the reagent,
The controller is
Performing the first analysis using the first reaction solution in a state where the sample used for preparing the first reaction solution and the first diluted sample are stored without being discarded;
Determining whether the measurement value is within a predetermined threshold range as a result of performing the first analysis; and
Based on the result of the determination step, a second diluted sample having a different dilution ratio is prepared based on the first diluted sample stored in the second container, and the second diluted sample is reacted with the reagent. Selecting whether to prepare a second reaction solution, to prepare a third reaction solution based on the specimen contained in the first container, or to end the analysis. An automatic analyzer. The automatic analyzer according to claim 1,
The control apparatus executes the determination step and the selection step immediately after the step of executing the first analysis . The automatic analyzer according to claim 1 or 2 ,
The control device corrects the concentration by evaporation of the first diluted specimen with respect to the elapsed time from the preparation of the first reaction solution to the analysis of the second reaction solution, with respect to the analysis result of the second reaction solution, or for analysis of the third reaction mixture, and carrying out the correction, the concentration by evaporation of the specimen due to the time elapsed from the preparation of the first reaction liquid to the analysis of the third reaction mixture Automatic analyzer. The automatic analyzer according to claim 1,
The control device further includes:
Performing a second analysis for analyzing the second reaction solution;
A second determination step for determining whether the measurement value is within a predetermined second threshold range as a result of performing the second analysis,
Based on the result of the second determination step, a third diluted sample having a different dilution ratio is prepared based on the second diluted sample, and a third reaction solution is prepared by reacting the third diluted sample with the reagent. Or a second selection step for selecting whether to end the analysis.

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