Automatic analysis device and automatic analysis method

The automatic analyzer enables parallel processing of biochemical and immunoassay steps using common units and controlled cycle times, improving efficiency and throughput while maintaining analytical performance.

JP7725621B2Active Publication Date: 2025-08-19HITACHI HIGH TECH CORP
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Patent Information

Application Number
JP2023576835
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2022-01-28
Filing Date
2023-01-18
Publication Date
2025-08-19
Estimated Expiration
2043-01-18

AI Technical Summary

Technical Problem

Existing automatic analyzers face reduced throughput due to the need to schedule biochemical and immunoassay steps separately, as simultaneous performance of these steps is not possible, leading to inefficiencies in device configuration and analytical performance.

Method used

An automatic analyzer with a control unit that allows parallel performance of first and second analytical steps using common analytical units, with distinct cycle times and time charts to manage operations, ensuring non-overlapping use of mechanisms for different analysis processes.

Benefits of technology

This configuration simplifies device setup, enhances throughput by allowing simultaneous testing of multiple items without performance degradation, and reduces maintenance and consumable usage.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention: comprises at least one common analysis unit which is commonly used in a first analyzing step and a second analyzing step, and a control unit 3 which controls the operation of the common analysis unit; and has a first time chart configured such that the first analyzing step can be repeatedly executed every first cycle time, the second analyzing step can be repeatedly executed every second cycle time, the second cycle time is positive integer times as large as the first cycle time, the first cycle time includes a first time slot and a second time slot which does not overlap the first time slot, the common analysis unit is caused to operate, in the first time slot, for a specific operation in the first analyzing step, and the common analysis unit is caused to operate, in the second time slot, for a specific operation in the second analyzing step.
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Description

[Technical Field]

[0001] The present invention relates to an automatic analyzer and an automatic analysis method. [Background technology]

[0002] As an example of an automatic analyzer that reacts a sample, such as blood, with an analytical reagent that reacts specifically with the component to be measured in the sample, and measures the resulting reaction product primarily by spectroscopic techniques, Patent Document 1 describes how the device configuration can be simplified by performing biochemical tests and immunoassays in a single device, and by sharing some of the mechanisms used for the analysis in both the biochemical analysis and the immunoassay processes. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] International Publication No. 2010 / 117044 Summary of the Invention [Problem to be solved by the invention]

[0004] According to Patent Document 1, the analytical processes for biochemical tests and immunoassays, which require pre-processing, are carried out on an intermediate disk, and the pre-processing dispensing mechanism and the immunoassay reagent dispensing mechanism are shared, thereby simplifying the device configuration.

[0005] However, since resampling of pretreated samples to the biochemical analysis section and resampling to the immunoanalysis section cannot be performed simultaneously, it is necessary to schedule the timing so that the steps do not overlap, which poses the problem of reduced throughput when these analysis steps are performed simultaneously.

[0006] The present invention provides an automatic analyzer and an automatic analysis method that can efficiently perform tests on multiple items while simplifying the device configuration and preventing a decrease in analytical performance. [Means for solving the problem]

[0007] The present invention includes a plurality of means for solving the above-mentioned problems. One example thereof is an automatic analyzer capable of performing a first analytical step and a second analytical step in parallel, each of which has different items, the automatic analyzer comprising one or more common analytical units used in common in the first analytical step and the second analytical step, and a control unit that controls the operation of the common analytical unit, the first analytical step being repeatedly performed every first cycle time, the second analytical step being repeatedly performed every second cycle time, the second cycle time being composed of a positive integer multiple of the first cycle time, the first cycle time including a first time period and a second time period that does not overlap with the first time period, and a first time chart configured to operate the common analytical unit for an operation specific to the first analytical step in the first time period, and to operate the common analytical unit for an operation specific to the second analytical step in the second time period. and a second time chart configured to use the common analysis unit for operations specific to the second analysis step during both the first time period and the second time period. With and when a measurement request is made for a measurement item in the first analysis step or a measurement item in the second analysis step, the control unit executes the operation of the common analysis unit in the first time period or the second time period of the first time chart, and when the second time chart is used, the control unit does not execute the first analysis step in the time period in which the first time chart is to be used. It is characterized by: [Effects of the Invention]

[0008] According to the present invention, it is possible to simplify the device configuration, efficiently perform tests on multiple items, and prevent a decline in analytical performance. Problems, configurations, and effects other than those described above will become clear from the following description of the examples. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a diagram showing a schematic configuration of an automatic analyzer according to a first embodiment. [Figure 2] FIG. 2 is a diagram showing the analysis cycle of the first analysis step in the automatic analyzer of the first embodiment. [Figure 3] FIG. 3 is a diagram showing the analysis cycle of the second analysis step in the automatic analyzer of the first embodiment. [Figure 4] FIG. 3 is a diagram showing a first time chart in the automatic analyzer of the first embodiment. [Figure 5]FIG. 3 is a first time chart for the automatic analyzer of the first embodiment, showing a time chart for executing a first analysis step and a second analysis step. [Figure 6] FIG. 4 is a first time chart for the automatic analyzer of the first embodiment, showing a time chart for executing only the first analysis step. [Figure 7] FIG. 4 is a diagram showing a second time chart in the automatic analyzer of the first embodiment. [Figure 8] FIG. 10 is a diagram showing a schematic configuration of an automatic analyzer according to a second embodiment. [Figure 9] FIG. 10 is a diagram showing the flow path configuration in the automatic analyzer of the second embodiment. [Figure 10] FIG. 10 is a first time chart for the automatic analyzer of the second embodiment. [Figure 11] FIG. 10 is a first time chart for the automatic analyzer of the second embodiment, showing a time chart for executing the first analysis step and the second analysis step. [Figure 12] FIG. 10 is a first time chart for the automatic analyzer of the second embodiment, showing a time chart for executing only the first analysis step. DETAILED DESCRIPTION OF THE INVENTION

[0010] Hereinafter, an embodiment of the automatic analyzer and the automatic analysis method will be described with reference to the drawings.

[0011] The embodiments described below are merely examples, and modifications can be made without departing from the spirit of the invention. Furthermore, features shown or described in connection with one exemplary embodiment may be combined with features of other embodiments.

[0012] Furthermore, in the drawings used in this specification, identical or corresponding components are denoted by the same or similar reference numerals, and repeated description of these components may be omitted.

[0013] Example 1 A first embodiment of an automatic analyzer and an automatic analysis method will be described with reference to FIGS. 1 to 7. FIG.

[0014] First, the overall configuration of the automatic analyzer will be described with reference to Fig. 1. Fig. 1 is a diagram showing an example of the configuration of the automatic analyzer.

[0015] The automatic analyzer 1 is an apparatus for analyzing a sample using a reagent corresponding to a predetermined analysis item, and is composed of an analysis unit 2 and a control unit 3.

[0016] The analysis unit 2 includes a sample holding unit 12, a sample dispensing mechanism 50, a reagent holding unit 23, a first reagent dispensing mechanism 51, a second reagent dispensing mechanism 52, a first incubator 41, a reagent stirring mechanism 53, a first transport mechanism 34, a second incubator 42, a second stirring mechanism 44, a reaction vessel tray 33, a second transport mechanism 35, a second measurement unit 62, a first stirring mechanism 43, a first measurement unit 61, a cleaning mechanism 45, etc.

[0017] The specimen holding unit 12 is structured to be able to hold a plurality of specimen containers 11 in a ring shape, each containing a specimen to be analyzed in the first and second analysis steps. During specimen dispensing, the specimen holding unit 12 rotates to transport the specimen container 11 to an access position of the specimen dispensing mechanism 50. The specimen holding unit 12 has a specimen suction position 13, and just before the specimen dispensing mechanism 50 aspirates the specimen to be analyzed, the specimen holding unit 12 rotates to transport the specimen container 11 to the specimen suction position 13.

[0018] The specimen holder 12 may be configured so that two specimen holders 12 can be physically swapped for use. For example, the two specimen holders 12 may be configured to be swappable alternately, or a small window provided in the specimen holder 12 may be provided to allow specimens to be added or replaced mid-use. However, the specimen holder 12 does not have to be configured to be installed by the user, and may be transported using a transport mechanism or the like. Furthermore, the specimen holder 12 is not limited to a disk system that transports specimen containers by rotating as shown in the figure, but may be a rack system that transports multiple specimen containers together. Furthermore, a specimen information acquisition unit 14 for acquiring (reading) specimen information assigned to specimen container 11 may be provided near the specimen holder 12, and the specimen information may be acquired immediately before specimen dispensing to verify whether the specimen container is a specimen to be analyzed.

[0019] The sample dispensing mechanism 50 is composed of a rotation drive mechanism, a vertical drive mechanism, and a dispensing probe so that it can access each position when the first reaction container 31 and the second reaction container 32 are in their predetermined positions for sample dispensing. The rotation drive mechanism and the vertical drive mechanism move between a sample suction position and a sample discharge position, and the sample is dispensed at the sample suction position 13 and discharged into the first reaction container 31 and the second reaction container 32. As shown in the figure, the configuration may be such that each position is accessed by a rotational movement, or may be such that each position is accessed by a linear movement.

[0020] The reagent holding unit 23 is a mechanism for holding a plurality of first reagent containers 21 containing a reagent to be used in a first analysis step that is to be reacted in a first reaction container 31, and a plurality of second reagent containers 22 containing a reagent to be used in a second analysis step that is to be reacted in a second reaction container 32, and has a reagent disk and a reagent container holding unit (both of which are omitted for convenience of illustration). The reagent holding unit 23 has a cooling function.

[0021] Reagent container holders are arranged in a double ring on the reagent disk, and are configured to be able to hold a plurality of first reagent containers 21 and second reagent containers 22. The reagent disk has a rotation drive mechanism, and by rotation, moves each of the first reagent containers 21 and second reagent containers 22 to a predetermined position on the circumference.

[0022] If the reagent holding unit 23 is a disk type, the reagent holding unit 23 rotates before dispensing the reagent and transports the appropriate reagent container to the first reagent aspirating position 24 or the second reagent aspirating position 25, allowing the first reagent dispensing mechanism 51 and the second reagent dispensing mechanism 52 to aspirate the reagent required for analysis. The first reagent container 21 and the second reagent container 22 may each be composed of a plurality of different reagent bottles. If the first reagent container 21 and the second reagent container 22 have different shapes, dedicated positions for holding each reagent container may be provided, or the first reagent container 21 and the second reagent container 22 may be shaped so that both reagent containers can be held in one position.

[0023] The automated analyzer 1 of this embodiment is provided with a first reagent dispensing mechanism 51 for biochemical analysis that dispenses a reagent from a first reagent container 21 into a first reaction container 31, and a second reagent dispensing mechanism 52 for immunological analysis that dispenses a reagent from a second reagent container 22 into a second reaction container 32. The first reagent dispensing mechanism 51 and the second reagent dispensing mechanism 52 have a common configuration, and are each composed of a rotation drive mechanism, a vertical drive mechanism, and a dispensing probe.

[0024] The first reagent dispensing mechanism 51 and the second reagent dispensing mechanism 52 rotate and descend to the position of a predetermined type of first reagent container 21 or second reagent container 22 in the reagent holding unit 23, and aspirate a predetermined amount of reagent. After aspirating the reagent, the first reagent dispensing mechanism 51 and the second reagent dispensing mechanism 52 rise. Next, they rotate and descend to dispense the reagent to a predetermined first reaction container 31 in the first incubator 41 in the case of the first reagent dispensing mechanism 51 for biochemical analysis, or to a second reaction container 32 for analysis of an immune item installed in the reagent dispensing position in the case of the second reagent dispensing mechanism 52 for immune analysis, and dispense the respective reagent.

[0025] A reagent stirring mechanism 53 (also called a stirrer) is set above the reagent holding unit 23 as stirring means for stirring the reagent contained in the second reagent container 22. This reagent stirring mechanism 53 moves to the upper region of the first reagent container 21 or the second reagent container 22 containing the magnetic particle solution to be stirred, lowers the magnetic particle stirring element of the reagent stirring mechanism 53, and stirs the magnetic particle solution by rotating this stirring element. To prevent spontaneous precipitation of the magnetic particles in the solution, the reagent stirring mechanism 53 stirs the magnetic particles immediately before the reagent is dispensed.

[0026] The immunoassay flow will be explained below in the order of processing.

[0027] The first transport mechanism 34 has drive mechanisms for the X-axis, Y-axis, and Z-axis directions, and a reaction vessel gripping mechanism, and moves above the reaction vessel disposal hole, the second incubator 42, the second stirring mechanism 44, and the reaction vessel tray 33.

[0028] The second transport mechanism 35 has a rotation drive mechanism, an up-down drive mechanism, and a reaction vessel gripping mechanism, and has the function of moving the second reaction vessel 32 containing a reaction liquid obtained by mixing a sample and a reagent in the second analysis process to each reaction vessel installation position, such as the second stirring mechanism 44 provided on the rotation orbit or the sample ejection position.

[0029] The first transport mechanism 34 moves the second reaction container 32 from a reaction container tray 33 that stores multiple second reaction containers 32 to the sample dispensing position. The sample dispensing mechanism 50 dispenses a predetermined amount of sample into the second reaction container 32 placed at the sample dispensing position. The second reaction container 32 into which the sample has been dispensed is then moved by the second transport mechanism 35 to the reagent dispensing position.

[0030] The second reagent dispensing mechanism 52 dispenses a predetermined amount of reagent into the second reaction vessel 32 placed at the reagent discharge position. After that, the second reaction vessel 32 is moved by the second transport mechanism 35 to the position of the second stirring mechanism 44, and the mixed liquid in the second reaction vessel 32 is stirred.

[0031] After the reaction solution is stirred, the second reaction vessel 32 is moved to the second incubator 42 by the first transport mechanism 34. The second incubator 42 is regulated to an appropriate temperature for the purpose of holding the second reaction vessel 32 and promoting the reaction between the specimen and the reagent, and when the reaction process between the specimen and the reagent in the second incubator 42 is completed, the second reaction vessel 32 is moved to the specimen discharge position by the first transport mechanism 34.

[0032] Thereafter, the second reaction container 32 is moved by the second transport mechanism 35 to a reaction liquid suction position provided below the second measurement unit 62, which measures the reaction liquid in the second analysis step to analyze the immune items of the specimen. Thereafter, the reaction liquid is suctioned into the detection unit in the second measurement unit 62, and the reaction signal is measured.

[0033] After the signal measurement, the second reaction vessel 32 is moved to the sample discharge position by the second transport mechanism 35, and then discarded into the reaction vessel disposal hole by the first transport mechanism .

[0034] Next, the flow of biochemical analysis will be explained in the order of processing.

[0035] The first incubator 41 is a mechanism for holding the reaction liquid for analysis by the first measurement unit 61, which measures the reaction liquid in the first analysis step, i.e., the first reaction vessel 31, and, like the second incubator 42, is regulated to an appropriate temperature in order to promote the reaction between the sample and the reagent.

[0036] First, the specimen dispensing mechanism 50 dispenses a predetermined amount of specimen into a predetermined first reaction vessel 31 on the first incubator 41, which contains a reaction liquid in which the specimen and reagent are mixed in the first analysis step. After that, the first incubator 41 rotates, and moves the first reaction vessel 31 into which the specimen has been discharged to an access position for the first reagent dispensing mechanism 51, and the first reagent dispensing mechanism 51 dispenses a predetermined amount of reagent into the first reaction vessel 31 into which the specimen has been discharged.

[0037] Next, the first incubator 41 rotates, and the first reaction vessel 31 into which the specimen and reagent have been discharged is moved to the installation position of the first stirring mechanism 43, and the specimen and reagent in the first reaction vessel 31 are stirred by the first stirring mechanism 43.

[0038] When the reaction process between the sample and the reagent in the first incubator 41 is completed, the first incubator 41 rotates and moves the first reaction container 31 containing the reaction liquid after the reaction is completed to the installation position of the first measurement unit 61, which analyzes the biochemical items of the sample.

[0039] Thereafter, the reaction signal is measured by the detection unit in the first measurement unit 61. After the signal measurement, the reaction liquid is discharged from the first reaction container 31 in the first incubator 41 by the washing mechanism 45.

[0040] The above-described mechanism of the automatic analyzer 1 is referred to as an analysis operation unit.

[0041] Furthermore, the automatic analyzer 1 includes a control unit 3 that controls the operation of each device in the automatic analyzer 1, including the sample holder 12 and the sample dispensing mechanism 50, in addition to the analysis operation unit.

[0042] The control unit 3 can be configured as a computer having a display unit such as an LCD display, an input device, a storage device, a CPU, memory, etc., and may be configured as a single computer or as separate computers, and is not particularly limited.

[0043] In this embodiment, when a request for measurement of a measurement item in the first analysis step or a measurement item in the second analysis step is received, the control unit 3 executes the operation of the common analysis unit in the first time slot or the second time slot of the first time chart, as will be described in detail later.

[0044] The control of the operation of each device by the control unit 3 is executed based on various programs recorded in a storage device. The control processing of the operation executed by the control unit 3 may be integrated into one program, or may be separated into multiple programs, or a combination thereof. Furthermore, some or all of the programs may be realized by dedicated hardware or may be modularized.

[0045] The above is the configuration of the automatic analyzer 1 of this embodiment.

[0046] The configuration of the automatic analyzer is not limited to the configuration shown in FIG. 1 in which different reaction vessels are used for the first analysis step, the first reaction vessel 31, and the second reaction vessel 32 for the second analysis step, but may be a configuration in which a common reaction vessel is used for the first analysis step and the second analysis step.

[0047] Furthermore, although the first analysis step is a biochemical item and the second analysis step is an immunological item, other analysis items may be used as long as they are different from each other.

[0048] Furthermore, different reagents (first reagent container 21 and second reagent container 22) are used in the first analysis step and the second analysis step, but a common reagent may also be used, and there is no particular limitation.

[0049] Furthermore, the automatic analyzer is not limited to a configuration with a single analysis module as shown in Figure 1, but may be configured with two or more analysis modules capable of measuring various identical or different analysis items and preprocessing modules that perform preprocessing connected by a transport device.

[0050] Next, the characteristic configuration of this embodiment will be described with reference to FIG. 2 and subsequent figures.

[0051] The automatic analyzer 1 is configured to be able to carry out a first analysis step and a second analysis step in parallel, each step having different items.

[0052] The mechanisms within the configuration can be classified into a first analysis unit that is used only in the first analysis process, a second analysis unit that is used only in the second analysis process, and a common analysis unit that is used in both the first analysis process and the second analysis process.

[0053] The units used as the common analysis unit in the first analysis step and the second analysis step include the sample holder 12, the reagent holder 23, and the sample dispensing mechanism 50. The first analysis unit basically corresponds to the units other than the common analysis unit among the mechanisms described in the biochemical analysis flow section above, and the second analysis unit basically corresponds to the units other than the common analysis unit among the mechanisms described in the immunological analysis flow section above.

[0054] In order to optimize the device configuration, it is possible to freely select which analytical units are to be shared as needed, and the configuration is not limited to that of this embodiment.

[0055] For example, in the case of an automatic analyzer that uses a common reaction vessel for the first and second analysis steps as described above, among the mechanisms of the automatic analyzer shown in Figure 1, in addition to the sample holding section 12, the reagent holding section 23, and the sample dispensing mechanism 50, the mechanisms corresponding to the first reagent dispensing mechanism 51, the first incubator 41, and the first stirring mechanism 43 are further classified as a common analysis unit.

[0056] The following describes the details of the analysis flow, with the first analysis step being a biochemical analysis and the second analysis step being an immunological analysis, focusing on the operation of the common analysis unit.

[0057] 2 is a diagram showing an analysis cycle of biochemical analysis. The cycle time of biochemical analysis is a first cycle time T1, and the operation of each analysis unit is repeatedly carried out using this first cycle time T1 as a basic unit.

[0058] First, the specimen dispensing mechanism 50 aspirates the specimen from the specimen container 11 (S501) and dispenses the specimen into the first reaction container 31 held in the first incubator 41 (S502). At this time, the specimen dispensing mechanism 50 is used in time period 101, and the specimen holder 12 is used in time period 102.

[0059] Next, after a predetermined number of cycles have elapsed, the first incubator 41 rotates so that the first reaction container 31 moves to the reagent dispensing position, and the first reagent dispensing mechanism 51 aspirates the first reagent from the first reagent container 21 (S511) and dispenses the reagent into the first reaction container 31 (S512). At this time, the reagent holding unit 23 is used in time period 111. The number of elapsed cycles can be set arbitrarily, but it is preferable to set it to 0 cycles or as few cycles as possible in order to start the reaction between the sample and the reagent as soon as possible.

[0060] After a predetermined number of cycles have elapsed, the first incubator 41 rotates so that the first reaction vessel 31 moves to the reagent dispensing position, and the first reagent dispensing mechanism 51 aspirates the second reagent from the first reagent vessel 21 (S521) and dispenses the reagent into the first reaction vessel 31 (S522). At this time, the reagent holding unit 23 is used during time period 112.

[0061] Here, it is desirable that the time period 111 and the time period 112 are configured so as not to overlap.

[0062] While dispensing the specimen and reagent as described above, the first incubator 41 repeatedly rotates as appropriate, the first stirring mechanism 43 stirs the first reaction vessel 31, and the first measurement unit 61 measures the absorbance inside the first reaction vessel 31. Once the measurement is complete, the cleaning mechanism 45 cleans the used first reaction vessel 31. After cleaning, the first reaction vessel 31 can be used again for the next analysis operation.

[0063] 3 is a diagram showing the analysis cycle of the immunoassay. The cycle time of the immunoassay is the second cycle time T2, and the operations of each analysis unit related to the immune item are repeatedly performed using this second cycle time T2 as a basic unit.

[0064] First, the sample dispensing mechanism 50 aspirates the sample from the sample container 11 (S601) and dispenses the sample into the second reaction container 32 that has been transported from the reaction container tray 33 to the sample dispensing position in advance by the first transport mechanism 34 (S602). At this time, the sample dispensing mechanism 50 is used in time period 201, and the sample holder 12 is used in time period 202.

[0065] Next, after a predetermined number of cycles have elapsed, the second transport mechanism 35 transports the second reaction container 32 to the reagent discharge position, and the second reagent dispensing mechanism 52 aspirates the first reagent from the second reagent container 22 (S611) and discharges the reagent into the second reaction container 32 (S612). At this time, the reagent holding unit 23 is used during time period 211. The number of elapsed cycles can be set arbitrarily, but it is preferable to set it to 0 cycles or as few cycles as possible in order to start the reaction between the sample and the reagent as soon as possible.

[0066] After a further predetermined number of cycles have elapsed, the second transport mechanism 35 transports the second reaction container 32 to the reagent dispensing position, and the second reagent dispensing mechanism 52 aspirates the second reagent from the second reagent container 22 (S621) and dispenses the reagent into the second reaction container 32 (S622). At this time, the reagent holding unit 23 is used during time period 212.

[0067] After a further predetermined number of cycles have elapsed, the second transport mechanism 35 transports the second reaction container 32 to the reagent dispensing position, and the second reagent dispensing mechanism 52 aspirates the third reagent from the second reagent container 22 (S631) and dispenses the reagent into the second reaction container 32 (S632). At this time, the reagent holding unit 23 is used during time period 213. Immediately before the dispensing operation, the reagent stirring mechanism 53 stirs the third reagent as needed. It is desirable that the above-mentioned time periods 211, 212, and 213 are configured so as not to overlap within the frame of the second cycle time T2.

[0068] While the sample and reagent are being dispensed as described above, the first transport mechanism 34 and the second transport mechanism 35 transport the second reaction vessel 32 to the second stirring mechanism 44 and the second incubator 42, where the reaction liquid is mixed and the reaction is promoted. After a predetermined number of cycles have elapsed and the reaction process is completed, the second reaction vessel 32 is transported to the second measurement unit 62, where optical measurement is performed. After the measurement is completed, the second reaction vessel 32 is discarded.

[0069] FIG. 4 is a diagram showing an analysis cycle when biochemical analysis and immunoassay are carried out simultaneously.

[0070] The second cycle time T2 for the immunoassay is configured to be a positive integer multiple of the first cycle time T1 for the biochemical assay. Figure 4 shows the case where T1 = T2 / 5, i.e., the second cycle time T2 is five times the first cycle time T1, and shows the analysis cycle in Figure 2 repeated five times superimposed on the analysis cycle in Figure 3.

[0071] Here, the operation of the common analysis unit when multiple analyses are performed consecutively will be described.

[0072] Taking the sample dispensing mechanism 50 as an example, if the first cycle time T1 of biochemical analysis is used as a reference, the sample dispensing mechanism 50 is used every cycle in biochemical analysis, but in immunological analysis, the sample dispensing mechanism 50 is used only once every five cycles of the first cycle of biochemical analysis.

[0073] Here, since there is a possibility that the sample dispensing mechanism 50 will be used in both analyses once every five cycles in terms of the first cycle, the time periods 101 and 201 in which the sample dispensing mechanism 50 is used in each process are configured so that they do not overlap. This prevents the sample dispensing operation for biochemical analysis and the sample dispensing operation for immunological analysis from overlapping even when the analyses are repeated. Therefore, the sample dispensing operations for biochemical analysis and immunological analysis can be performed completely independently.

[0074] Similarly, the specimen holder 12 and the reagent holder 23 are configured so that the time periods in which they are used for both the biochemical analysis and the immunological analysis do not overlap.

[0075] This also applies to the configurations corresponding to the first reagent dispensing mechanism 51, the first incubator 41, and the first stirring mechanism 43 in an automatic analyzer configured to use a common reaction vessel for the first analysis step and the second analysis step. For example, the mechanism corresponding to the first reagent dispensing mechanism 51 basically has the same chart as the reagent holding unit 23, and the mechanisms corresponding to the first incubator 41 and the first stirring mechanism 43 basically have the same chart as the specimen dispensing mechanism 50, so details thereof will be omitted.

[0076] It should be noted that time periods 211, 212, and 213 correspond to the dispensing operations of the first, second, and third reagents for the immunoassay, respectively, and it is desirable that all of these operate at the same timing within the first cycle time T1. This is because time period 210 used for the reagent dispensing operation for the immunoassay in Fig. 5, which will be described later, must be configured to include all of time periods 211, 212, and 213.

[0077] As shown in Figure 4, the first time chart is configured so that during the first time period, i.e., time periods 101, 102, 111, and 112, the common analysis unit operates for operations specific to the first analysis process, which is biochemical analysis, and during the second time period, i.e., time periods 201, 202, 211, 212, and 213, the common analysis unit operates for operations specific to the second analysis process.

[0078] Fig. 5 shows a case where biochemical analysis and immunoassay are performed in parallel during the first cycle time T1 of the first time chart, while Fig. 6 shows a case where only biochemical analysis is performed during the first cycle time T1, and immunoassay is not performed.

[0079] In Figure 4, the operations of the sample dispensing mechanism 50, the sample holding unit 12, and the reagent holding unit 23 are shown together as a first time chart, but whether the operation for biochemical analysis or the operation for immunological analysis is to be performed for each common analysis unit can be selected appropriately depending on the analysis situation.

[0080] For example, in the third and fourth cycles of the first cycle time T1 in Figure 4, only the biochemical analysis operation is performed on the sample dispensing mechanism 50 and the sample holder 12, and both the biochemical analysis and immunoanalysis operations are performed on the reagent holder 23, so that the operations required for both analyses can be performed without any problems.

[0081] Furthermore, although the above description has been given of a case where a large number of analyses are carried out continuously, when analyses are carried out intermittently, if the operation of a certain analysis unit is unnecessary, the operation may simply not be carried out.

[0082] By configuring the first time chart as described above, even when biochemical analysis and immunological analysis are performed simultaneously and consecutively, it is possible to prevent the operation timings of the common analysis units from interfering with each other, thereby avoiding a decrease in throughput.

[0083] Furthermore, it is preferable to further include a second time chart configured to use the common analysis unit for operations specific to the second analysis step in both the first time period and the second time period. Figure 7 shows the second time chart for each common analysis unit.

[0084] As shown in FIG. 7, when the control unit 3 uses the second time chart, it is desirable that the control unit 3 not perform the first analysis process, which requires the use of the first time chart, during the time period in which the second time chart is executed.

[0085] FIG. 7 shows an example in which the sample dispensing mechanism 50 and the sample holder 12 are assigned time slots 203 and 204, respectively, during which only immunoassays can be used.

[0086] Time slot 203 encompasses time slot 101 and time slot 201, and similarly time slot 204 encompasses time slot 102 and time slot 202. This shows a special operation of performing an immunoassay operation using the time allocated for biochemical analysis as well.

[0087] One example of this is when a large amount of sample is dispensed for an immune item, and the sample is dispensed twice.

[0088] When such a special operation is performed, the second time chart is performed instead of the first time chart, and biochemical analysis in which the operation timing overlaps is canceled or the operation is not assigned in advance.

[0089] Next, the effects of this embodiment will be described.

[0090] The automated analyzer 1 of the first embodiment described above is an apparatus capable of performing a first analysis process and a second analysis process, each of which has different items, in parallel, and is equipped with one or more common analysis units used in common for the first analysis process and the second analysis process, and a control unit 3 that controls the operation of the common analysis unit, wherein the first analysis process can be repeatedly performed every first cycle time, and the second analysis process can be repeatedly performed every second cycle time, the second cycle time being composed of a positive integer multiple of the first cycle time, the first cycle time including a first time period and a second time period that does not overlap with the first time period, and having a first time chart configured to operate the common analysis unit for operations specific to the first analysis process in the first time period and to operate the common analysis unit for operations specific to the second analysis process in the second time period.

[0091] This allows the device configuration to be simplified by sharing the mechanisms used for different analysis processes, and even when tests for multiple items are performed simultaneously, it is possible to avoid interference with the timing of using the common mechanisms in each analysis process, making it possible to perform tests for multiple items efficiently.

[0092] Furthermore, when a request is made to measure a measurement item in the first analysis process or a measurement item in the second analysis process, the control unit 3 executes the operation of the common analysis unit during the first time period or the second time period of the first time chart, thereby preventing unnecessary operations from being executed, suppressing wear on each mechanism, reducing the frequency of maintenance of the device, and suppressing consumption of consumables.

[0093] Furthermore, by further having a second time chart configured to use a common analysis unit for operations specific to the second analysis process in both the first time period and the second time period, and in particular, when using the second time chart, the control unit 3 does not perform the first analysis process, which requires the use of the first time chart, in the time period in which the second time chart is executed, it is possible to prioritize special operations that require longer operating times while minimizing the reduction in throughput.

[0094] <Example 2> Second Embodiment An automatic analyzer and an automatic analysis method according to a second embodiment will be described with reference to FIGS.

[0095] First, an outline of the automatic analyzer of this embodiment will be described with reference to Figures 8 and 9. Figure 8 is a diagram showing the automatic analyzer of Example 2, and Figure 9 is a diagram showing the connection relationship between a cleaning liquid supply unit 74 and cleaning tanks 70, 71, 72, and 73.

[0096] The automatic analyzer 1A shown in FIGS. 8 and 9 is configured with an analysis unit 2A and a control unit 3A, similar to the automatic analyzer 1 of the first embodiment.

[0097] In addition to the analysis unit 2 of the automatic analyzer 1 shown in Figure 1, the analysis unit 2A includes a washing tank 70 and a vacuum tank 90 for the sample dispensing mechanism 50, a washing tank 71 and a vacuum tank 91 for the first reagent dispensing mechanism 51, a washing tank 72 and a vacuum tank 92 for the second reagent dispensing mechanism 52, a washing tank 73 for the reagent stirring mechanism 53, a washing liquid supply unit 74 that supplies washing liquid to these washing tanks 70, 71, 72, and 73, and a vacuum supply unit 93 that reduces the pressure inside the vacuum tanks 90, 91, and 92.

[0098] The control unit 3A has basically the same configuration as the control unit 3, except that the first and second time charts stored therein are different.

[0099] As shown in Figure 9, the cleaning liquid supply unit 74 and the cleaning tanks 70, 71, 72, and 73 are connected by a flow path, and solenoid valves 80, 81, 82, and 83 and a pump 84 are provided along the connecting flow path. Each of the cleaning tanks 70, 71, 72, and 73 discharges a cleaning liquid onto the corresponding dispensing nozzle or stirring rod in the analytical unit 2A, thereby cleaning their external surfaces. Alternatively, the cleaning liquid discharged by the cleaning liquid supply unit 74 may be sucked into the dispensing nozzle to clean the inside of the dispensing nozzle. Furthermore, the cleaning liquid supply unit 74 may be directly connected to a flow path inside the dispensing nozzle, thereby cleaning the inside of the dispensing nozzle.

[0100] The discharge operation of the cleaning solution in the cleaning tanks 70, 71, 72, and 73 can be controlled to start and stop by opening and closing the electromagnetic valves 80, 81, 82, and 83, respectively. The driving force for discharging the cleaning solution is the pressure from the pump 84. Here, the operating principle of the pump is not important. The water used in the analysis section may be used as the cleaning solution, or it may be supplied in a separate reagent bottle or the like.

[0101] Vacuum tanks 90, 91, and 92 for vacuum drying are provided near the cleaning tanks 70, 71, and 72, respectively. Vacuum tanks 90, 91, and 92 are connected to a vacuum supply unit 93, and like the cleaning tanks 70, 71, 72, and 73, vacuum suction and stopping can be controlled by opening and closing solenoid valves 95, 96, and 97. The structures of the vacuum tanks 90, 91, and 92 and the vacuum supply unit 93 are similar to the flow path structures of the cleaning tanks 70, 71, 72, and 73 and the cleaning liquid supply unit 74, and provide the same effects as those of the invention described below using a cleaning tank as an example.

[0102] Generally, it is necessary to ensure a sufficient discharge flow rate of the cleaning solution, especially when cleaning the external surfaces of a dispensing nozzle or the like. Therefore, if multiple cleaning tanks 70, 71, 72, and 73 simultaneously discharge the cleaning solution, there is a concern that the discharge flow rate of each cleaning tank 70, 71, 72, and 73 will decrease, resulting in a decrease in cleaning efficiency. While it is possible to increase the discharge amount in advance in anticipation of a decrease in the discharge flow rate, if only a single cleaning tank 70, 71, 72, and 73 is used, excessive cleaning solution will be discharged, resulting in inefficient use of the cleaning solution. Furthermore, depending on the structure of the cleaning tanks 70, 71, 72, and 73, this could cause the cleaning solution to overflow.

[0103] Fig. 10 shows an analysis cycle when biochemical analysis and immunoassay are performed simultaneously. Here, the second cycle time T2 of the immunoassay is configured to be a positive integer multiple of the first cycle time T1 of the biochemical analysis. Fig. 10 shows the case where T1 = T2 / 5, as in Example 1.

[0104] During time period 300, the washing tank 70 discharges a washing liquid to wash the sample dispensing mechanism 50. During time period 301, the washing tank 71 discharges a washing liquid to wash the first reagent dispensing mechanism 51. During time period 302, the washing tank 72 discharges a washing liquid to wash the second reagent dispensing mechanism 52. During time period 303, the washing tank 73 discharges a washing liquid to wash the reagent stirring mechanism 53.

[0105] Fig. 11 shows a case where the cleaning operation for biochemical analysis and the cleaning operation for immunoassay are performed in parallel during the first cycle time T1 of the first time chart, while Fig. 12 shows a case where only the cleaning operation for biochemical analysis is performed during the first cycle time T1 of the first time chart, without performing the cleaning operation for immunoassay.

[0106] During time period 304, the cleaning tank 72 ejects cleaning liquid to clean the second reagent dispensing mechanism 52, and the cleaning tank 73 ejects cleaning liquid to clean the reagent stirring mechanism 53, so the timing is determined so that these times do not overlap.

[0107] Here, the timings for discharging the cleaning liquid in biochemical analysis, i.e., for using the cleaning liquid supply unit 74, are time period 300 and time period 301, and the timings for using the cleaning liquid supply unit 74 in immunoassay are time period 300, time period 302, and time period 303. Time periods 300, 301, 302, and 303 are configured so as not to overlap with each other. Therefore, the required cleaning liquid discharge operations can be performed completely independently for biochemical analysis and immunoassay.

[0108] The same is true for the vacuum tanks 90, 91, and 92, and the timing at which they are used is basically later than or immediately after the timing at which the cleaning tanks 70, 71, and 72 are used, and the timing chart is approximately the same as that for the cleaning tanks 70, 71, and 72, so details are omitted.

[0109] In this embodiment, the time period 300 is configured to be shared by both biochemical analysis and immunological analysis. This is because the sample dispensing mechanism 50 is used as a common analytical unit, allowing the same cleaning operation to be applied. However, the time period 300 may be divided or the timing may be changed so that cleaning of the sample dispensing mechanism 50 is used only for each analysis. In this case, the time periods in which the cleaning solution is discharged for each analysis should be configured so as not to overlap, as described above.

[0110] As in Example 1, whether to perform the biochemical analysis operation or the immunological analysis operation for each common analysis unit can be selected appropriately depending on the analysis situation. Furthermore, when performing analysis intermittently, if the cleaning operation is not required, the operation may simply not be performed.

[0111] The other configurations and operations are substantially the same as those of the automatic analyzer and automatic analysis method of the first embodiment, and details thereof will be omitted.

[0112] The automatic analyzer and automatic analysis method of Example 2 also achieve substantially the same effects as the automatic analyzer and automatic analysis method of Example 1 described above, and even when biochemical analysis and immunological analysis are performed simultaneously and consecutively, it is possible to prevent a decrease in cleaning efficiency due to mutual interference between the timing of use of the cleaning liquid supply unit 74, and to suppress adverse effects on analytical performance.

[0113] <Other> It should be noted that the present invention is not limited to the above-described embodiment, and includes various modifications. The above-described embodiment has been described in detail to clearly explain the present invention, and the present invention is not necessarily limited to an embodiment having all of the described configurations.

[0114] It is also possible to replace part of the configuration of one embodiment with the configuration of another embodiment, or to add the configuration of another embodiment to the configuration of one embodiment, or to add, delete, or replace part of the configuration of each embodiment with the configuration of another embodiment. [Explanation of symbols]

[0115] 1,1A: Automatic analyzer 2,2A:Analysis Department 3, 3A: Control unit 11: Sample container 12: Sample holder 13: Sample aspiration position 14: Sample information acquisition unit 21: First reagent container 22: Second reagent container 23: Reagent holding section 24: First reagent aspiration position 25: Second reagent aspiration position 31: First reaction vessel 32: Second reaction vessel 33: Reaction vessel tray 34: First transport mechanism 35: Second transport mechanism 41: First Incubator 42: Second Incubator 43: First stirring mechanism 44: Second stirring mechanism 45: Cleaning mechanism 50: Sample dispensing mechanism (first dispensing mechanism, second dispensing mechanism) 51: First reagent dispensing mechanism (first dispensing mechanism) 52: Second reagent dispensing mechanism (second dispensing mechanism) 53: Reagent stirring mechanism 61: 1st measurement section 62:Second measurement section 70: Washing tank for sample dispensing mechanism (first washing tank, second washing tank) 71: Washing tank for first reagent dispensing mechanism (first washing tank) 72: Washing tank for second reagent dispensing mechanism (second washing tank) 73: Cleaning tank for reagent stirring mechanism 74: Cleaning liquid supply unit 80, 81, 82, 83, 95, 96, 97: Solenoid valves 84: Pump 90: Vacuum chamber for sample dispensing mechanism (first vacuum chamber, second vacuum chamber) 91: Vacuum chamber for first reagent dispensing mechanism (first vacuum chamber) 92: Vacuum chamber for second reagent dispensing mechanism (second vacuum chamber) 93: Vacuum supply section 101: Time period when the sample dispensing mechanism is used in biochemical analysis 102: Time period when the specimen holder is used in biochemical analysis 111: Time period when the reagent holding unit is used in the first reagent dispensing operation of biochemical analysis 112: Time period when the reagent holding unit is used in the second reagent dispensing operation of biochemical analysis 201: Time period when the sample dispensing mechanism is used in immunoassay 202: Time period when the sample holder is used in immunoassay 203: Time period when the sample dispensing mechanism is used in special operations of immunoassay 204: Time period when the sample holder is used in special operations of immunoassay 210: Time period during which the reagent holding unit is used in any one of the first, second, and third reagent dispensing operations for immunoassay 211: Time period in which the reagent holding section is used in the first reagent dispensing operation of the immunoassay 212: Time period when the reagent holding section is used in the second reagent dispensing operation of the immunoassay 213: Time period when the reagent holding section is used in the third reagent dispensing operation of the immunoassay 300: Time period during which cleaning fluid is used in the cleaning tank for the sample dispensing mechanism 301: Time period during which cleaning solution is used in the cleaning tank for the first reagent dispensing mechanism 302: Time period during which cleaning solution is used in the cleaning tank of the second reagent dispensing mechanism 303: Time period when cleaning solution is used in the cleaning tank for the reagent mixing mechanism 304: Time period during which cleaning solution is used in the cleaning tank for the second reagent dispensing mechanism and the reagent stirring mechanism

Claims

1. An automatic analyzer capable of performing a first analysis step and a second analysis step in parallel, each step having different items, one or more common analysis units used in common in the first analysis step and the second analysis step; a control unit that controls the operation of the common analysis unit; The first analyzing step can be repeatedly performed every first cycle time; The second analyzing step can be repeated every second cycle time; the second cycle time is a positive integer multiple of the first cycle time; the first cycle time includes a first time period and a second time period that does not overlap with the first time period; a first time chart configured to operate the common analysis unit for operations specific to the first analysis step in the first time period and to operate the common analysis unit for operations specific to the second analysis step in the second time period; and a second time chart configured to use the common analysis unit for operations specific to the second analysis step in both the first time period and the second time period, The control unit When a measurement request is made for a measurement item in the first analysis step or a measurement item in the second analysis step, the common analysis unit performs an operation in the first time period or the second time period of the first time chart; When the second time chart is used, the first analysis step, which requires the use of the first time chart, is not performed during the time period in which the second time chart is performed. An automatic analyzer characterized by:

2. The automatic analyzer according to claim 1, The common analysis unit further includes a specimen dispensing mechanism that dispenses specimens into reaction vessels used in the first analysis step and the second analysis step. An automatic analyzer characterized by:

3. The automatic analyzer according to claim 1, The common analysis unit further includes an incubator mechanism for holding reaction vessels used in the first analysis step and the second analysis step. An automatic analyzer characterized by:

4. The automatic analyzer according to claim 1, The common analysis unit further includes a stirring mechanism for stirring the reaction solution in the reaction vessels used in the first analysis step and the second analysis step. An automatic analyzer characterized by:

5. The automatic analyzer according to any one of claims 2 to 4, The reaction vessels used in the first analysis step and the second analysis step are different vessels. An automatic analyzer characterized by:

6. The automatic analyzer according to any one of claims 2 to 4, The same reaction vessel is used in the first analysis step and the second analysis step. An automatic analyzer characterized by:

7. The automatic analyzer according to claim 1, The common analysis unit further includes a specimen holding section that holds a specimen container containing a specimen to be analyzed in the first analysis step and the second analysis step. An automatic analyzer characterized by:

8. The automatic analyzer according to claim 1, The common analysis unit further includes a specimen information acquisition unit that acquires specimen information attached to a specimen container containing a specimen to be analyzed in the first analysis step and the second analysis step. An automatic analyzer characterized by:

9. The automatic analyzer according to claim 1, The common analysis unit further includes a reagent dispensing mechanism that dispenses reagent from a reagent container used in the first analysis step and the second analysis step. An automatic analyzer characterized by:

10. The automatic analyzer according to claim 1, The common analysis unit further includes a reagent holding unit that holds reagent containers to be used in the first analysis step and the second analysis step. An automatic analyzer characterized by:

11. The automatic analyzer according to claim 9 or 10, Different reagents are used in the first analysis step and the second analysis step. An automatic analyzer characterized by:

12. The automatic analyzer according to claim 1, a first dispensing mechanism used in the first analysis step; a second dispensing mechanism used in the second analysis step; a first washing tank for washing the first dispensing mechanism; a second washing tank for washing the second dispensing mechanism; The common analysis unit further includes a cleaning liquid supply unit that supplies cleaning liquid to the first cleaning tank and the second cleaning tank. An automatic analyzer characterized by:

13. The automatic analyzer according to claim 1, a first dispensing mechanism used in the first analysis step; a second dispensing mechanism used in the second analysis step; a first vacuum tank for vacuum-drying the first dispensing mechanism; a second vacuum tank for vacuum-drying the second dispensing mechanism; The common analysis unit further includes a vacuum supply unit that reduces the pressure inside the first vacuum chamber and the second vacuum chamber. An automatic analyzer characterized by:

14. An automatic analysis method capable of performing a first analysis step and a second analysis step in parallel, each step having different items, The first analyzing step can be repeatedly performed every first cycle time; The second analyzing step can be repeated every second cycle time; the second cycle time is a positive integer multiple of the first cycle time; the first cycle time includes a first time period and a second time period that does not overlap with the first time period; Execute either a first time chart in which one or more common analytical units used in common in the first analytical step and the second analytical step are operated for an operation specific to the first analytical step in the first time period, and the common analytical units are operated for an operation specific to the second analytical step in the second time period, or a second time chart in which the common analytical units are used for an operation specific to the second analytical step in both the first time period and the second time period; When a measurement request is made for a measurement item in the first analysis step or a measurement item in the second analysis step, the common analysis unit performs an operation in the first time period or the second time period of the first time chart; When the second time chart is used, the first analysis step, which requires the use of the first time chart, is not performed during the time period in which the second time chart is performed. An automatic analysis method characterized by:

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