Automatic analysis device

Abstract

The present invention comprises: an image acquisition unit 203 that acquires an image of a sample container 105; a specifying unit 204 that specifies information on the distance from an opening in the sample container 105 to the liquid surface of a sample, and specifies, from the image, information on the type or the diameter of the sample container 105; a storage unit 205 that stores a threshold for the distance, according to the type of the sample container 105; and a determination unit 206 that determines, on the basis of the distance specified by the specifying unit 204 and the threshold stored in the storage unit 205, whether or not to dispense the sample for which the image was acquired. Due to this configuration, an automatic analysis device is provided which, by implementing lower-risk sample dispensing, improves test result reliability and, by minimizing sample containers which are unusable in a specific analysis module, enables improved testing efficiency.

Description

[Technical Field]

[0001] The present invention relates to an automatic analyzer that performs qualitative or quantitative analysis of biological specimens such as blood and urine (hereinafter referred to as specimens). [Background technology]

[0002] Patent document 1 describes that the device includes an image acquisition unit that acquires an upper image, which is an image obtained by capturing an image of a container containing a collection target including a specimen, a reagent, or a reaction solution from above using an imaging unit; an area calculation unit that calculates the edge area of ​​the container or the top surface area of ​​the collection target from the upper image; and a state determination unit that determines the state of the container or the collection target based on the edge area or the top surface area. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Publication No. 2020-173101 Summary of the Invention [Problem to be solved by the invention]

[0004] Automated analyzers are commonly used in the field of clinical testing, including biochemical testing. Automated analyzers perform qualitative and quantitative analysis by adding and reacting reagents that react specifically with specific components contained in samples such as blood or urine, and measuring the absorbance or luminescence of the reaction solution.

[0005] In automated analyzers, it is desirable to quickly determine whether a sample is in an appropriate state for testing in order to eliminate unnecessary tests, reduce consumption of consumables and reagents, and improve the reliability of test results. For this purpose, methods have been proposed that use image processing to detect the liquid level of the sample and estimate the sample volume based on the detected liquid level, as well as the degree of hemolysis and turbidity of the sample.

[0006] For example, Patent Document 1 describes an example of an automatic analysis system that determines the amount of specimen contained in a specimen container from an image acquired by a camera. In Patent Document 1, the type of specimen container and the amount of specimen are obtained from the image, and if it is determined that the amount of specimen to be dispensed does not reach a predetermined amount, the dispensing probe or the like is stopped. According to Patent Document 1, it is possible to avoid abnormal dispensing even when the amount of specimen is insufficient.

[0007] In recent years, the use of sample containers with diameters smaller than the conventional 13 mm has been increasing. With such small-diameter sample containers, there is a concern that the vibrations caused by the probe descending could cause the probe to come into contact with sample adhering to the inner wall of the sample container, increasing the risk of carryover due to unintentional sample adhesion.

[0008] Each analysis module has a different probe diameter and the degree of vibration during descent. For this reason, the sample containers that can be used for each analysis module are determined and communicated to customers. However, if some sample containers cannot be used in some analysis modules, this could significantly reduce the testing efficiency of customers. There is also the risk that customers may mistakenly use sample containers that are not approved for use, which could lead to carryover and reduce the reliability of test results.

[0009] The inventors' investigations have revealed that the prior art described in the above-mentioned Patent Document 1 has room for improvement, and there is room to avoid the aforementioned carryover risk and the decrease in testing efficiency for customers.

[0010] The present invention has been made in consideration of the above-mentioned problems, and aims to provide an automatic analyzer that can improve the reliability of test results by realizing sample dispensing with lower risk, and can also improve test efficiency by reducing the number of sample containers that cannot be used in specific analysis modules. [Means for solving the problem]

[0011] The present invention includes multiple means for solving the above-mentioned problems. One example is an automatic analyzer for analyzing samples, comprising: an image acquisition unit that acquires an image of a sample container containing a sample; an identification unit that identifies the distance from the opening of the sample container to the sample liquid surface and information on the type or diameter of the sample container from the image; a memory unit that stores a threshold value for the distance according to the type of the sample container; and a judgment unit that determines whether or not to dispense the sample for which the image has been acquired, based on the distance identified by the identification unit and the threshold value stored in the memory unit. [Effects of the Invention]

[0012] According to the present invention, it is possible to improve the reliability of test results and further improve test efficiency by reducing the number of sample containers that cannot be used in a specific analysis module. Problems, configurations, and effects other than those described above will become clear from the following description of the examples. [Brief explanation of the drawings]

[0013] [Figure 1] 1 is a top view showing a schematic configuration of an automatic analyzer according to Example 1. FIG. [Figure 2] FIG. 2 is a functional block diagram showing details of a control unit in the automatic analyzer according to the first embodiment. [Figure 3] 3 is a schematic diagram showing the distance from the opening of a specimen container to the specimen liquid surface, which is determined by a control unit in the automatic analyzer according to the first embodiment. FIG. [Figure 4] 4 is a flowchart illustrating a series of processes performed by a control unit in the first embodiment. [Figure 5] FIG. 10 is a functional block diagram showing details of a control unit in the automatic analyzer according to the second embodiment. [Figure 6] 10 is a flowchart illustrating a series of processes performed by a control unit in the second embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0014] Examples of the automated analyzer of the present invention will be described below with reference to the drawings. It goes without saying that in the following embodiments, the components (including element steps, etc.) are not necessarily essential unless specifically stated otherwise or considered to be clearly essential in principle. In the drawings used in this specification, identical or corresponding components are designated by the same or similar reference numerals, and repeated explanations of these components may be omitted.

[0015] Example 1 A first embodiment of the automatic analyzer of the present invention will be described with reference to FIGS. 1 to 4. FIG.

[0016] First, the overall configuration of the automatic analyzer will be described with reference to Figures 1 to 4. Figure 1 is a top view showing an outline of the automatic analyzer.

[0017] The automatic analyzer 1 shown in Figure 1 for analyzing a sample has a sample supply unit 102 equipped with an inlet 102a and an outlet 102b for the sample 101, an analysis module 103 that dispenses a fixed amount of the sample 101 and performs measurement, and a transport unit 104 that transports the sample 101.

[0018] Within the automated analyzer 1, to protect the samples 101 and to improve workability, the sample containers 105 containing the samples 101 are transported in a state where they are stored in a sample rack 106. The sample rack 106 may be a multi-sample rack or a single-sample rack. Arrow D in Figure 1 indicates the transport direction of the sample rack 106.

[0019] The transport unit 104 has an input rack transport path 104a that transports the sample rack 106 from the sample supply unit 102 to the analysis module 103, an output rack transport path 104b that transports the sample rack 106 from the analysis module 103 to the sample supply unit 102, and a connecting transport path 104c that connects the input rack transport path 104a and the output rack transport path 104b. A sample dispensing position 104d is provided in an area of ​​the input rack transport path 104a where sample dispensing is performed in the analysis module 103.

[0020] A camera 107 focused on the input rack transport path 104a and a light 108 illuminating the input rack transport path 104a are fixed to the side of the input rack transport path 104a near the exit from the sample supply unit 102 to the analysis module 103.

[0021] The control device 109 is connected to each device in the above-described automatic analyzer 1 by wire or wirelessly, and controls the operation of each device in the automatic analyzer 1. The control of the operation of each device by this control device 109 is executed based on various programs recorded in a storage device (not shown). In addition to the various programs used for measuring samples, the storage device stores various parameters input via the input device 201 (see FIG. 2), information on the sample to be measured (such as information on the sample type), measurement results, etc. Note that the control processing of the operations executed by the control device 109 may be integrated into a single program, or each may be separated into multiple programs, or a combination of these. Furthermore, some or all of the programs may be realized by dedicated hardware, or may be modularized.

[0022] The above is the overall configuration of the automatic analyzer 1.

[0023] Next, the details of the functions of the control device 109 in the automatic analyzer 1 of this embodiment will be described with reference to Fig. 2. Fig. 2 is a functional block diagram showing the details of the functions of the control device 109.

[0024] As shown in FIG. 2, the control device 109 includes various functional blocks such as an input device 201, a display device 202, an image acquisition unit 203, an identification unit 204, a memory unit 205, a determination unit 206, and an operation control unit 207 that controls the operation of various mechanisms.

[0025] The image acquisition unit 203 acquires an image of the sample container 105 containing the sample, which is captured by the camera 107.

[0026] The identification unit 204 identifies information about the type or diameter of the specimen container 105 containing the specimen from the image of the specimen container 105 acquired by the image acquisition unit 203. The type or diameter of the specimen container 105 is preferably identified based on image information captured by a camera from the side or above the specimen container 105, but is not limited to this method.

[0027] Furthermore, the identification unit 204 identifies the distance from the opening of the specimen container 105 to the specimen liquid level. This distance from the opening to the specimen liquid level is preferably determined from an image of the specimen container 105 acquired by the image acquisition unit 203, but other methods such as laser light can also be used. However, it is preferable not to employ a capacitance method in which the specimen dispensing probe directly accesses the inside of the specimen container 105 to detect the specimen liquid level.

[0028] 3 is a schematic diagram showing the distance from the opening of a specimen container to the specimen liquid surface. This shows an example in which the specimen is separated into three layers: serum layer 101a, separating agent layer 101b, and clot layer 101c. In this case, the distance from the opening of specimen container 105 to the top of serum layer 101a is specified.

[0029] The memory unit 205 stores various parameters for the operation of each mechanism of the automatic analyzer 1, sample information, various information necessary for sample analysis, and also stores threshold values ​​for distance according to the type of analysis module 103 and the type of sample container 105 or the diameter of the opening of the sample container 105.

[0030] This "threshold value for distance" can vary depending on, for example, the diameter of the sample dispensing probe. Specifically, a sample dispensing probe with a larger diameter vibrates less as it descends, reducing the risk of accidental contact with the inner wall of the sample container 105, so the threshold can be set larger. Conversely, a sample dispensing probe with a smaller diameter vibrates more and the possibility of contact increases, so the threshold can be set smaller. Furthermore, since the risk of contact is smaller, the threshold can be set larger for larger diameter openings of the sample container 105, and smaller diameter openings, which increase the risk of contact.

[0031] The determination unit 206 determines whether or not to dispense the sample for which an image has been acquired, based on the distance identified by the identification unit 204 and the threshold value stored in the memory unit 205. For example, the determination unit 206 determines to cancel dispensing of the sample when the distance identified by the identification unit 204 is greater than the threshold value stored in the memory unit 205, and determines to dispense the sample when the distance is equal to or less than the threshold value.

[0032] Next, the processing content according to this embodiment that is preferably executed in the above-described automatic analyzer 1 will be described with reference to Fig. 4. Fig. 4 is a flowchart showing a series of processing steps of the control unit in the automatic analyzer according to this embodiment, and the main body that controls the operations is preferably the control device 109.

[0033] First, when a user operates the input device 201 to instruct the start of analysis, the image acquisition unit 203 of the control device 109 causes the operation control unit 207 to transport the sample rack 106 and acquires image information of the sample container 105 photographed by the camera 107 (S1).

[0034] Next, the identification unit 204 of the control device 109 identifies the type of the specimen container 105 and the distance from the opening of the specimen container 105 to the specimen liquid surface based on the image information acquired in S1 (S2).

[0035] Next, the judgment unit 206 of the control device 109 compares the distance from the opening of the sample container 105 identified in S2 to the sample liquid surface with a threshold value corresponding to the type of sample container 105 identified in S2 or the diameter of its opening, which is stored in the memory unit 205, and makes a judgment (S3).

[0036] If it is determined in S3 that the distance from the opening of the sample container 105 to the sample liquid surface is greater than the threshold value and is therefore unsuitable for dispensing, the process proceeds to S4, where dispensing of the sample is canceled (S4), and it is determined whether there is a next sample (S6).

[0037] When the dispensing of the sample is canceled in S4, it is desirable that the determination unit 206 issues an alarm to notify the cancellation and that the alarm be displayed on the display device 202.

[0038] This "warning" may be displayed as a system alarm on the screen of the display device 202, and a note may be added to the analysis results accompanying the cancellation. In this case, it is desirable not to interrupt the analysis, but to continue the analysis of other samples without performing only the analysis of the sample contained in the sample container 105 in question. However, if there are no other sample containers 105 placed on the same rack, or if it is a single-tube rack, it is desirable to transport the sample directly to the removal port. After returning the sample, it may be possible to transfer the sample to a micro-cup or a thicker container, or to take measures such as re-collecting the sample, depending on the user's environment of the automatic analyzer 1.

[0039] If the determination result in S6 is YES, i.e., if there is a next sample, the process returns to S1. On the other hand, if the determination result is NO, i.e., if there is no sample for which an analysis request has been made, the process ends.

[0040] On the other hand, if it is determined in S3 that the distance from the opening of the sample container 105 to the sample liquid surface is smaller than the threshold value and suitable for dispensing, the process proceeds to S5, where it is decided to dispense the sample (S5) and it is determined whether there is a next sample (S6).

[0041] Next, the effects of this embodiment will be described.

[0042] The automatic analyzer 1 for analyzing a sample according to the first embodiment of the present invention described above includes an image acquisition unit 203 for acquiring an image of a sample container 105 containing a sample, an identification unit 204 for identifying the distance from the opening of the sample container 105 to the sample liquid surface and information on the type or diameter of the sample container 105 from the image, a memory unit 205 for storing a threshold value for the distance according to the type of sample container 105, and a judgment unit 206 for determining whether or not to dispense the sample whose image has been acquired based on the distance identified by the identification unit 204 and the threshold value stored in the memory unit 205.

[0043] This solves the problems with conventional technology, such as the increased risk of the dispensing probe colliding with the inner wall of the sample container 105 when the dispensing probe descends a long distance, and the risk of sample adhering to unexpected places on the dispensing probe and not being able to be completely cleaned, raising concerns about carryover, in response to recent demands for thinner dispensing probes.

[0044] Therefore, the automatic analyzer 1 of this embodiment 1 can improve the reliability of test results by realizing sample dispensing with lower risk, and can also reduce the number of types of sample containers 105 that cannot be used in specific analysis modules compared to conventional methods, thereby improving test efficiency compared to conventional methods.

[0045] Furthermore, if the distance identified by the identification unit 204 is greater than the threshold value stored in the memory unit 205, the judgment unit 206 decides to cancel the dispensing of the sample, and if the distance is equal to or less than the threshold value, the judgment unit 206 decides to carry out the dispensing of the sample. Therefore, dispensing can be canceled under conditions where there is a strong concern about contact between the dispensing probe and the inner wall of the sample container 105, thereby achieving even lower-risk sample dispensing.

[0046] Furthermore, when the judgment unit 206 decides to cancel, it notifies the user with an alarm, so that the user can understand that the analysis has been canceled due to an inability to dispense, and can decide whether or not to take action, thereby avoiding a long time until the final analysis results are obtained.

[0047] Furthermore, by determining the distance from the image of the specimen container 105, the identification unit 204 can use the image used to identify the type or diameter information as is, eliminating the need for further configuration or operation to acquire information, thereby further reducing the burden of identification.

[0048] Furthermore, the threshold value varies depending on the diameter of the sample dispensing probe, being larger for larger diameter openings and smaller for smaller diameter openings, thereby enabling more stable sample dispensing.

[0049] <Example 2> An automatic analyzer according to a second embodiment of the present invention will be described with reference to Fig. 5 and Fig. 6. Fig. 5 is a functional block diagram showing details of a control unit in the automatic analyzer according to the second embodiment, and Fig. 6 is a flowchart showing a series of processes performed by the control unit in the automatic analyzer according to the second embodiment.

[0050] In Example 1, the automatic analyzer 1 connected to a single analysis module 103 determines the processing content by identifying the distance from the opening of the sample container 105 to the sample liquid surface. In contrast, the automatic analyzer of Example 2 is configured in such a way that multiple analysis modules 103 are connected.

[0051] In a configuration having multiple analysis modules 103, it is desirable to optimize the transport order by comparing the distance from the opening of the sample container 105 to the sample liquid surface, which is calculated from the sample consumption amount in each analysis module 103, with a threshold value.

[0052] Specifically, the judgment unit 206A determines whether there is an analysis module 103 that will perform dispensing at a time when the distance will become greater than the threshold due to sample consumption in other analysis modules 103, and if there is an analysis module 103 where the distance will become greater than the threshold due to sample consumption in other analysis modules 103, the analysis priority change unit 501 can raise the priority of dispensing in that analysis module 103 and postpone dispensing in analysis modules 103 that will not exceed the threshold even after dispensing in other analysis modules 103.

[0053] The configuration of the automatic analyzer in the second embodiment is the same as that of the automatic analyzer 1 in the first embodiment except that a plurality of analysis modules 103 are connected, and therefore illustrations and detailed descriptions thereof will be omitted.

[0054] The functional block diagram of the control device 109A in the second embodiment shown in FIG. 5 differs from the functional block diagram of the control device 109 in the first embodiment shown in FIG. 2 in that the configuration of the determination unit 206A is partially different and that an analysis priority change unit 501 is added to the configuration of FIG. 2.

[0055] As described above, when the judgment unit 206A judges that there is an analysis module 103 in which the distance from the opening of the sample container 105 to the sample liquid surface exceeds a threshold due to sample consumption in another analysis module 103, the analysis priority change unit 501 in the control device 109A shown in Figure 5 decides to change the analysis order in that analysis module 103 to a higher priority than usual based on the judgment result of the judgment unit 206A.

[0056] Next, the processing content according to this embodiment that is preferably executed in the above-described automatic analyzer 1 will be described with reference to FIG.

[0057] S11 in FIG. 6 is the same as S1 shown in FIG. 4, and S12 is the same as S2 shown in FIG.

[0058] Next, the judgment unit 206A of the control device 109A compares the distance from the opening of the sample container 105 identified in S12 to the sample liquid surface with a threshold value for each analysis module 103 according to the type of sample container identified in S2, which is stored in the memory unit 205 by container type, and makes a judgment (S13).

[0059] If it is determined in S13 that there is an analysis module 103 where the distance from the opening of the sample container 105 to the sample liquid surface is greater than the threshold and is therefore unsuitable for dispensing, the process proceeds to S14, where only dispensing at the analysis module 103 where the distance is greater than the corresponding threshold is canceled (S14), and the process proceeds to S15.

[0060] When the dispensing of the sample is canceled in S14, it is desirable that the determination unit 206 issues an alarm to notify the cancellation and that the alarm be displayed on the display device 202.

[0061] On the other hand, if it is determined in S13 that there is no analysis module 103 for which the distance from the opening of the sample container 105 to the sample liquid surface is greater than the threshold value and therefore it is determined that the analysis module 103 is not suitable for dispensing, the process proceeds to S15, and it is confirmed whether there is any analysis module 103 for which the distance from the opening of the sample container 105 to the sample liquid surface exceeds the threshold value due to sample consumption in another analysis module 103 (S15).

[0062] If there is no analysis module 103 whose consumption exceeds the threshold due to consumption in other analysis modules 103, it is decided to dispense the sample in each analysis module 103 in accordance with normal priority (S16), and it is determined whether there is a next sample (S18).

[0063] On the other hand, if there is an analysis module 103 whose consumption exceeds the threshold due to consumption in other analysis modules 103, a change is decided to give priority to analysis in that analysis module 103 over normal (S17), and it is determined whether there is a next sample (S18).

[0064] If the determination result in S18 is YES, that is, if there is a next sample, the process returns to S11. On the other hand, if the determination result is NO, that is, if there is no sample for which an analysis request has been made, the process ends.

[0065] The other configurations and operations are substantially the same as those of the automatic analyzer 1 of the first embodiment described above, and the details are omitted here.

[0066] The automatic analyzer of the second embodiment of the present invention also provides substantially the same effects as the automatic analyzer 1 of the first embodiment described above.

[0067] In addition, the judgment unit 206A determines whether there is an analysis module 103 that will perform dispensing at a time when the distance will become greater than the threshold due to sample consumption in other analysis modules 103, and if there is an analysis module 103 that will cause the distance to become greater than the threshold, it prioritizes dispensing in that analysis module 103, thereby changing the analysis order as necessary and allowing the test to be performed efficiently.

[0068] <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. [Explanation of symbols]

[0069] 1…Automatic analyzer 101...Specimen 101a... Serum layer 101b...separating agent layer 101c…blood clot layer 102...Sample supply unit 102a…Carry-in entrance 102b...Exit 103...Analysis module 104...Transport unit 104a...Loading rack transport path 104b...Export rack transport path 104c...Connecting transport path 104d...Sample dispensing position 105...Specimen container 106...Sample rack 107...Camera 108...Lighting 109, 109A...Control device 201...input device 202...Display device 203...Image acquisition unit 204…Specific section 205...Storage section 206,206A…Judgment section 207...Motion control unit 501...Analysis priority change section

Claims

1. An automated analyzer for analyzing a sample, an image acquisition unit that acquires an image of a sample container containing a sample; an identification unit that identifies the distance from the opening of the sample container to the sample liquid surface and information on the type or diameter of the sample container from the image; a storage unit that stores a threshold value for the distance according to the type of the sample container; a determination unit that determines whether or not to dispense the sample for which the image has been acquired, based on the distance determined by the determination unit and the threshold value stored in the storage unit. Automatic analyzer.

2. The automatic analyzer according to claim 1, The determination unit determines to cancel dispensing of the sample when the distance specified by the specification unit is greater than the threshold value stored in the storage unit, and determines to perform dispensing of the sample when the distance is equal to or less than the threshold value. Automatic analyzer.

3. The automatic analyzer according to claim 1, When the automated analyzer has a plurality of analysis modules for analyzing the sample, The determination unit determines whether there is an analysis module that will perform dispensing at a timing when the distance will become larger than the threshold due to sample consumption in another analysis module, and if there is an analysis module that will become larger than the threshold, prioritizes dispensing in that analysis module. Automatic analyzer.

4. The automatic analyzer according to claim 2, When the determination unit determines the cancellation, an alarm is issued. Automatic analyzer.

5. The automatic analyzer according to claim 1, The identification unit identifies the distance from the image of the sample container. Automatic analyzer.

6. The automatic analyzer according to claim 1, The threshold value varies depending on the diameter of the sample dispensing probe. Automatic analyzer.

7. The automatic analyzer according to claim 1, The threshold value is larger as the diameter of the opening increases, and is smaller as the diameter of the opening decreases. Automatic analyzer.

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