Automated analyzer

Abstract

An automatic analysis device is provided with: an image acquisition unit (203) that acquires an image of a specimen container (105); a specifying unit (204) that specifies information on the type or diameter of the specimen container (105) on the basis of information on the distance from the opening of the specimen container (105) to the specimen liquid level and the image; a storage unit (205) that stores a threshold value for the distance corresponding to the type of the specimen container (105); and a determination unit (206) that determines, on the basis of the distance specified by the specification unit (204) and the threshold value stored in the storage unit (205), whether or not to dispense the specimen from which the image has been acquired. As a result, it is possible to improve the reliability of the test results by implementing sample dispensing with a lower risk, and to further improve the test efficiency by reducing sample containers that cannot be used in a specific analysis module.

Description

Technical Field

[0001] The present invention relates to an automatic analyzer for performing qualitative or quantitative analysis on a biological specimen (hereinafter referred to as a specimen) such as blood or urine. Background Art

[0002] Patent document 1 records the following: it comprises: an image acquisition unit, which acquires an upper image, which is an image obtained by photographing a container containing a collection object including a specimen, a reagent, and a reaction solution from above using a photographing unit; an area calculation unit, which calculates an edge area of ​​the container or an upper surface area of ​​the collection object based on the upper image; and a state determination unit, which determines the state of the container or the collection object based on the edge area or the upper surface area.

[0003] Prior art literature

[0004] Patent Literature

[0005] Patent Document 1: Japanese Patent Application Publication No. 2020-173101 Summary of the invention

[0006] Problems to be solved by the invention

[0007] In the field of clinical testing represented by biochemical testing, automatic analyzers are generally used. Automatic analyzers add specific reactive reagents to specific components contained in samples such as blood and urine to react, and measure the absorbance and luminescence of the reaction solution to perform qualitative and quantitative analysis.

[0008] In an automatic analyzer, in order to save unnecessary inspections and reduce the consumption of consumables and reagents, or to improve the reliability of inspection results, it is desirable to determine in advance whether a specimen is in a state suitable for inspection. Therefore, a method of detecting the liquid level position of a specimen by image processing and estimating the amount of the specimen based on the detected liquid level position, and a method of estimating the degree of hemolysis or turbidity of the specimen have been proposed.

[0009] For example, Patent Document 1 describes an example of an automatic analysis system that determines the amount of a specimen contained in a specimen container based on an image obtained by a camera. In Patent Document 1, when the type of specimen container and the amount of the specimen are determined based on the image and it is determined that the amount of the dispensing target does not reach a predetermined amount, the dispensing probe is stopped, etc. According to Patent Document 1, even when the amount of the specimen is insufficient, dispensing abnormalities can be avoided.

[0010] In recent years, the use of specimen containers with diameters smaller than the conventional diameter of 13 mm has increased. In such specimen containers with a smaller diameter, the probe may come into contact with the specimen adhering to the inner wall of the specimen container due to vibration when the probe is lowered, and the risk of carryover caused by the unintended adhesion of the specimen due to such contact increases.

[0011] The thickness of the probe and the degree of vibration when it is lowered are different for each analysis module. Therefore, the sample containers that can be used by each analysis module are determined and made known to the customer. However, the situation where there are sample containers that cannot be used by some analysis modules may greatly reduce the customer's inspection efficiency. In addition, there is also a concern that customers may mistakenly use unapproved sample containers, and there is a possibility that the reliability of the inspection results will be reduced due to the generation of residues.

[0012] According to the research conducted by the present inventors, the prior art described in Patent Document 1 described above has room for avoiding the above-mentioned residual risk and reduction in customer inspection efficiency, and thus has room for improvement.

[0013] The present invention has been completed in view of the above-mentioned problems, and its purpose is to provide an automatic analysis device that can improve the reliability of test results by realizing sample dispensing with lower risks, and improve test efficiency by reducing sample containers that cannot be used in specific analysis modules.

[0014] Means for solving problems

[0015] The present invention includes multiple means for solving the above-mentioned problems. If an example is cited, it is an automatic analysis device for analyzing a specimen, comprising: an image acquisition unit, which acquires an image of a specimen container containing the specimen; a determination unit, which determines information on the type or diameter of the specimen container based on the distance from the opening of the specimen container to the specimen liquid surface and the image; a storage unit, which stores a threshold value for the distance corresponding to the type of the specimen container; and a judgment unit, which determines whether to perform aliquoting of the specimen whose image has been acquired based on the distance determined by the determination unit and the threshold value stored in the storage unit.

[0016] Effects of the Invention

[0017] According to the present invention, the reliability of the test results can be improved, and the test efficiency can be improved by reducing the sample containers that cannot be used in a specific analysis module. Other problems, structures and effects than those described above will become clear from the following description of the embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 This is a plan view showing a schematic structure of the automatic analyzer of Example 1.

[0019] Figure 2 This is a functional block diagram showing details of the control unit in the automatic analyzer of Example 1.

[0020] Figure 3 This is a schematic diagram showing the distance from the opening of the specimen container to the specimen liquid surface determined by the control unit in the automatic analyzer of Example 1.

[0021] Figure 4 This is a flowchart of a series of processes performed by the control unit in the first embodiment.

[0022] Figure 5 This is a functional block diagram showing details of a control unit in the automatic analyzer of the second embodiment.

[0023] Figure 6 This is a flowchart of a series of processes performed by the control unit in the second embodiment. DETAILED DESCRIPTION

[0024] Hereinafter, embodiments of the automatic analyzer of the present invention will be described using the accompanying drawings. In addition, in the following embodiments, the constituent elements (including element steps, etc.) are not necessarily necessary except for the cases that are specifically indicated and the cases that are obviously considered to be necessary in principle. In addition, in the drawings used in this specification, the same or corresponding constituent elements are marked with the same or similar symbols, and sometimes repeated descriptions of these constituent elements are omitted.

[0025] <Example 1>

[0026] use Figures 1 to 4 , Example 1 of the automatic analysis device of the present invention is described.

[0027] First, use Figures 1 to 4 The overall structure of the automatic analyzer will be described. Figure 1 It is a plan view showing the outline of the automatic analyzer.

[0028] Figure 1 The automatic analyzer 1 for analyzing a sample shown includes a sample supply unit 102 having a sample supply port 102 a and a sample discharge port 102 b , an analysis module 103 for dispensing a certain amount of the sample 101 for measurement, and a transport unit 104 for transferring the sample 101 .

[0029] In the automatic analyzer 1, in order to protect the specimen 101 and improve the workability, the specimen container 105 containing the specimen 101 is transferred in a state of being stored in the specimen rack 106. The specimen rack 106 may be transferred in multiple racks or in a single rack. Figure 1 The arrow D in shows the transfer direction of the specimen rack 106 .

[0030] The transport unit 104 includes an in-carrying rack transport path 104a for transporting the sample rack 106 from the sample supply unit 102 to the analysis module 103, an out-carrying rack transport path 104b for transporting the sample rack 106 from the analysis module 103 to the sample supply unit 102, and a connecting transport path 104c for connecting the in-carrying rack transport path 104a and the out-carrying rack transport path 104b. A sample dispensing position 104d is provided in an area of ​​the in-carrying rack transport path 104a for performing sample dispensing in the analysis module 103.

[0031] Next to the incoming rack transport path 104 a , a camera 107 focusing on the incoming rack transport path 104 a and a lighting 108 illuminating the incoming rack transport path 104 a are fixed near the exit from the specimen supply unit 102 to the analysis module 103 .

[0032] The control device 109 is connected to each device in the automatic analyzer 1 via a wired or wireless connection to control the operation of each device in the automatic analyzer 1. The control of the operation of each device by the control device 109 is performed based on various programs recorded in a storage device (not shown). In addition to various programs for measuring the specimen, the storage device also stores programs that are input via the input device 201 (see Figure 2 ) input various parameters, information of the specimen to be measured (specimen type information, etc.), measurement results, etc. In addition, the control processing of the actions executed by the control device 109 can be summarized into one program, or can be divided into multiple programs, or can be a combination of them. In addition, part or all of the program can be implemented by dedicated hardware, or can be modularized.

[0033] The above is the overall structure of the automatic analyzer 1 .

[0034] Next, use Figure 2 The function of the control device 109 in the automatic analyzer 1 of this embodiment will be described in detail. Figure 2 It is a functional block diagram showing the detailed functions of the control device 109 .

[0035] like Figure 2 As shown, the control device 109 includes various functional blocks such as an image acquisition unit 203, a determination unit 204, a storage unit 205, a determination unit 206, and an operation control unit 207 for controlling the operation of various mechanisms, in addition to an input device 201 and a display device 202.

[0036] The image acquisition unit 203 acquires an image of the specimen container 105 containing the specimen, which is captured by the camera 107 .

[0037] The identification unit 204 identifies the type or diameter of the sample container 105 containing the sample based on the image of the sample container 105 acquired by the image acquisition unit 203. The type or diameter of the sample container 105 is preferably identified based on image information obtained by a camera photographing the target sample container 105 from the side or above, but is not limited to this method.

[0038] In addition, the determination unit 204 determines the distance from the opening of the specimen container 105 to the specimen liquid surface. The method for determining the distance from the opening to the specimen liquid surface is preferably performed based on the image of the specimen container 105 obtained by the image acquisition unit 203, but other methods such as laser may be used. However, in order to detect the liquid surface of the specimen, it is preferable not to use an electrostatic capacitance method in which the specimen dispensing probe directly enters the specimen container 105.

[0039] Figure 3 This is a schematic diagram showing the distance from the opening of the specimen container to the specimen liquid surface. It shows an example of a case where the specimen is divided into three layers, namely, a serum layer 101a, a separating agent layer 101b, and a blood clot layer 101c. In this case, the distance from the opening of the specimen container 105 to the upper end of the serum layer 101a is determined.

[0040] The storage unit 205 stores, in addition to various parameters for the operation of each mechanism of the automatic analysis device 1, information on the specimen, various information required for analysis of the specimen, etc., a threshold value for distance corresponding to the type of the analysis module 103 and the category of the specimen container 105 or the diameter of the opening of the specimen container 105 .

[0041] The value of the "threshold value for distance" can be different, for example, depending on the diameter of the sample dispensing probe. Specifically, a sample dispensing probe with a large diameter has a small vibration accompanying the descent, so the possibility of accidental contact between the sample container 105 and the inner wall is small, so the threshold value can be increased, and the smaller the diameter of the sample dispensing probe, the greater the vibration, and the higher the possibility of contact, so the threshold value can be reduced. In addition, since the possibility of contact is small, the threshold value can be set to be larger when the diameter of the opening of the sample container 105 is larger, and the threshold value can be set to be smaller when the diameter of the opening with a high possibility of contact is smaller.

[0042] The determination unit 206 determines whether to perform aliquoting of the sample whose image has been acquired based on the distance determined by the determination unit 204 and the threshold value stored in the storage unit 205. For example, the determination unit 206 determines to cancel aliquoting of the sample when the distance determined by the determination unit 204 is greater than the threshold value stored in the storage unit 205, and determines to perform aliquoting of the sample when the distance is less than the threshold value.

[0043] Next, refer to Figure 4 The processing contents of this embodiment which are preferably executed in the above-mentioned automatic analyzer 1 will be described. Figure 4 This is a flowchart of a series of processes of the control unit in the automatic analyzer of this embodiment. The control subject of the operations is preferably the control device 109 .

[0044] First, when the start of analysis is instructed from the input device 201 by a user operation, the image acquisition unit 203 of the control device 109 transports the sample rack 106 through the operation control unit 207 and acquires image information of the sample container 105 captured by the camera 107 (S1).

[0045] 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).

[0046] Next, the determination unit 206 of the control device 109 compares the distance from the opening of the specimen container 105 determined in S2 to the specimen liquid surface with a threshold value corresponding to the type of the specimen container 105 determined in S2 or the diameter of the opening stored in the storage unit 205, and makes a determination (S3).

[0047] If it is determined in S3 that the distance from the opening of the specimen container 105 to the specimen liquid surface is greater than the threshold and is not suitable for dispensing, the process proceeds to S4, the dispensing of the specimen is canceled (S4), and it is determined whether there is a next specimen (S6).

[0048] When the aliquoting of the sample is canceled in S4 , it is preferable that the determination unit 206 issues an alarm notifying the cancellation and displays the alarm on the display device 202 .

[0049] This "warning" is recorded as a system alarm on the screen of the display device 202, and it is considered to make an annotation to the analysis result accompanied by cancellation. In this case, it is preferable not to interrupt the analysis, but to stop analyzing the specimen contained in the corresponding specimen container 105, and continue the analysis of other specimens. However, in the case where there is no other specimen container 105 on the same rack or in the case of one rack, it is preferable to directly transport it to the removal port. In addition, after returning, it is considered to transfer to a micro cup or a container with a rough shape, or to take measures such as re-collection according to the use environment of the user of the automatic analyzer 1.

[0050] If the determination result in S6 is "yes", that is, if there is a next sample, the process returns to S1. On the other hand, if the determination result is "no", that is, if there is no sample for which analysis is requested, the process ends.

[0051] On the other hand, if it is determined in S3 that the distance from the opening of the specimen container 105 to the specimen liquid surface is less than the threshold value and is suitable for dispensing, the process proceeds to S5, dispensing of the specimen is determined (S5), and whether there is a next specimen is determined (S6).

[0052] Next, the effects of this embodiment will be described.

[0053] The automatic analysis device 1 for analyzing a specimen of the above-mentioned embodiment 1 of the present invention comprises: an image acquisition unit 203, which acquires an image of a specimen container 105 containing the specimen; a determination unit 204, which determines information on the type or diameter of the specimen container 105 based on the distance from the opening of the specimen container 105 to the specimen liquid surface and the image; a storage unit 205, which stores a threshold value for the distance corresponding to the type of the specimen container 105; and a determination unit 206, which determines whether to perform aliquoting of the specimen whose image has been acquired based on the distance determined by the determination unit 204 and the threshold value stored in the storage unit 205.

[0054] Therefore, in response to the recent demand for making the dispensing probe thinner, it is possible to solve the improvement points in the previous technology such as the increased risk of collision between the inner wall of the specimen container 105 and the dispensing probe when the dispensing probe descends a large amount, and the concern that the specimen adheres to unexpected parts of the dispensing probe and cannot be cleaned, resulting in residue.

[0055] Therefore, the automatic analyzer 1 of the first embodiment can improve the reliability of the test results by realizing sample dispensing with lower risks, and can further reduce the types of sample containers 105 that cannot be used in a specific analysis module compared with the past, thereby improving the test efficiency compared with the past.

[0056] In addition, the judgment unit 206 decides to cancel the dispensing of the specimen when the distance determined by the determination unit 204 is larger than a threshold value stored in the storage unit 205, and decides to implement the dispensing of the specimen when the distance is below the threshold value. Therefore, the dispensing can be canceled when there is a strong concern about the contact between the dispensing probe and the inner wall of the specimen container 105, thereby achieving specimen dispensing with lower risk.

[0057] Furthermore, when the determination unit 206 determines to cancel, by notifying an alarm, the user can understand that the analysis has been canceled due to inability to dispense, and can therefore determine whether to take action, thereby preventing the time required to finally obtain the analysis result from being prolonged.

[0058] Furthermore, since the identification unit 204 identifies the distance based on the image of the specimen container 105, the image used to identify the type or diameter information can be used directly, and thus a structure and operation for further acquiring information are unnecessary, and the load before identification can be further reduced.

[0059] Furthermore, the threshold value varies depending on the diameter of the sample dispensing probe. The larger the diameter of the opening, the larger the threshold value, and the smaller the diameter of the opening, the smaller the threshold value. This enables more stable sample dispensing.

[0060] <Example 2>

[0061] use Figure 5 as well as Figure 6 , an automatic analysis device according to Example 2 of the present invention is described. Figure 5 is a functional block diagram showing details of the control unit in the automatic analyzer of the second embodiment. Figure 6 This is a flowchart of a series of processes performed by the control unit in the automatic analyzer according to the second embodiment.

[0062] In the first embodiment, the distance from the opening of the sample container 105 to the sample liquid surface is determined to determine the processing content in the automatic analyzer 1 connected to a single analysis module 103. In contrast, the automatic analyzer of the second embodiment is a method in which a plurality of analysis modules 103 are connected.

[0063] In a configuration having a plurality of analysis modules 103 , it is preferable to compare the distance from the opening of the sample container 105 to the sample liquid surface calculated based on the sample consumption in each analysis module 103 with a threshold value to optimize the transport order.

[0064] Specifically, the determination unit 206A determines whether there is an analysis module 103 that performs injection at a time when the distance becomes larger than the threshold due to the consumption of samples in other analysis modules 103. When there is an analysis module 103 whose distance becomes larger than the threshold due to the consumption of samples in other analysis modules 103, the analysis priority changing unit 501 can increase the priority of injection in the analysis module 103, and postpone the injection in the analysis modules 103 that do not exceed the threshold after the injection in other analysis modules 103.

[0065] The structure of the automatic analyzer in Example 2 is the same as that of the automatic analyzer 1 in Example 1 except that a plurality of analysis modules 103 are connected, and therefore illustration and detailed description are omitted.

[0066] Figure 5 The functional block diagram of the control device 109A in the second embodiment shown in FIG. Figure 2 The functional block diagram of the control device 109 shown in FIG. 1 is different in that the structure of the determination unit 206A is partially different. Figure 2 An analysis priority changing unit 501 is added to the structure.

[0067] As described above, when the determination unit 206A determines that there is an analysis module 103 whose distance from the opening of the sample container 105 to the sample liquid surface exceeds the threshold value due to sample consumption in other analysis modules 103, Figure 5 The analysis priority order changing unit 501 in the control device 109A shown in the figure determines to change the analysis order in the corresponding analysis module 103 to be prioritized over the normal order based on the determination result of the determination unit 206A.

[0068] Next, refer to Figure 6 The processing contents of this embodiment which are preferably executed in the above-mentioned automatic analyzer 1 will be described.

[0069] Figure 6 S11 and Figure 4 S1 is the same as shown, S12 is the same as Figure 4 The same as S2 shown.

[0070] Next, the determination unit 206A of the control device 109A compares the distance from the opening of the specimen container 105 determined in S12 to the specimen liquid surface with the threshold value for each analysis module 103 according to the type of the specimen container determined in S2 and stored in the storage unit 205 by container type, and makes a determination (S13).

[0071] When it is determined in S13 that there is an analysis module 103 that is not suitable for dispensing because the distance from the opening of the sample container 105 to the sample liquid surface is greater than a threshold, the process proceeds to S14, and only the dispensing (S14) in the analysis module 103 that is greater than the corresponding threshold is canceled, and the process proceeds to S15.

[0072] When the aliquoting of the sample is canceled in S14 , it is preferable that the determination unit 206 issues an alarm notifying the cancellation and displays the alarm on the display device 202 .

[0073] In contrast, when it is determined in S13 that there is no analysis module 103 that is not suitable for aliquoting because the distance from the opening of the specimen container 105 to the specimen liquid surface is greater than the threshold, the processing enters S15 to confirm whether there is an analysis module 103 whose distance from the opening of the specimen container 105 to the specimen liquid surface exceeds the threshold due to specimen consumption in other analysis modules 103 (S15).

[0074] If there is no analysis module 103 whose number is greater than the threshold due to consumption in other analysis modules 103, the aliquoting of the sample in each analysis module 103 is determined according to the normal priority order (S16), and it is determined whether there is a next sample (S18).

[0075] On the other hand, when there is an analysis module 103 whose consumption exceeds the threshold due to consumption in other analysis modules 103, a change is made to give priority to the analysis in the analysis module 103 over the normal analysis (S17), and it is determined whether there is a next sample (S18).

[0076] If the result of determination in S18 is "yes", that is, if there is a next sample, the process returns to S11. On the other hand, if the result of determination is "no", that is, if there is no sample for which analysis is requested, the process ends.

[0077] The other structures and operations are substantially the same as those of the automatic analyzer 1 of the first embodiment, and detailed description thereof will be omitted.

[0078] The automatic analyzer according to the second embodiment of the present invention can also achieve substantially the same effects as those of the automatic analyzer 1 according to the first embodiment described above.

[0079] In addition, the determination unit 206A determines whether there is an analysis module 103 that performs dispensing at a time when the distance becomes larger than a threshold due to sample consumption in other analysis modules 103. If there is an analysis module 103 whose distance becomes larger than the threshold, the dispensing in the analysis module 103 is prioritized, thereby changing the analysis order as needed, thereby enabling efficient inspection.

[0080] <Others>

[0081] The present invention is not limited to the above-described embodiments, and includes various modifications. The above-described embodiments are examples described in detail to explain the present invention in an easy-to-understand manner, and are not necessarily limited to having all the described configurations.

[0082] Explanation of symbols

[0083] 1…Automatic analysis device

[0084] 101… specimen

[0085] 101a…Serum layer

[0086] 101b…Separating agent layer

[0087] 101c…Blood clot layer

[0088] 102…Specimen supply unit

[0089] 102a…Move in

[0090] 102b…Move out

[0091] 103…Analysis module

[0092] 104…Transportation unit

[0093] 104a…Rack transport path for loading

[0094] 104b…Export rack transport path

[0095] 104c…Transport path for connection

[0096] 104d…Specimen dispensing position

[0097] 105…sample container

[0098] 106…Specimen rack

[0099] 107…Camera

[0100] 108…Lighting

[0101] 109, 109A…Control device

[0102] 201…Input device

[0103] 202…Display device

[0104] 203 ...Image acquisition unit

[0105] 204…Determination

[0106] 205…Storage

[0107] 206, 206A…Judgment unit

[0108] 207…Motion Control Department

[0109] 501…Analysis priority change department.

Claims

1. An automatic analysis device for analyzing a specimen, characterized in that: have: an image acquisition unit that acquires an image of a specimen container containing the specimen; a determination unit that determines information on the type or diameter of the specimen container based on the distance from the opening of the specimen container to the specimen liquid surface and the image; a storage unit storing a threshold value for the distance corresponding to the type of the sample container; as well as A determination unit determines whether to perform aliquoting of 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.

2. The automatic analysis device according to claim 1, characterized in that The determination unit determines to cancel aliquoting of the sample when the distance determined by the determination unit is greater than the threshold value stored in the storage unit, and determines to perform aliquoting of the sample when the distance is less than the threshold value.

3. The automatic analysis device according to claim 1, characterized in that When the automatic analyzer has a plurality of analysis modules for analyzing the sample, The determination unit determines whether there is an analysis module that performs dispensing at a time when the distance is greater than the threshold due to sample consumption in other analysis modules, and if there is an analysis module whose distance is greater than the threshold, prioritizes dispensing in the analysis module.

4. The automatic analysis device according to claim 2, characterized in that: The determination unit notifies an alarm when determining the cancellation.

5. The automatic analysis device according to claim 1, characterized in that The determining unit determines the distance based on the image of the specimen container.

6. The automatic analysis device according to claim 1, characterized in that The value of the threshold value varies depending on the diameter of the sample dispensing probe.

7. The automatic analysis device according to claim 1, characterized in that: The threshold value increases as the diameter of the opening increases, and the threshold value decreases as the diameter of the opening decreases.

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