Automatic analysis device and automatic analysis method

Abstract

The purpose of this invention is to provide an automatic analysis device and automatic analysis method that prevent a detergent usage amount and processing time from increasing as a result of excessive additional cleaning. This invention is an automatic analysis device comprising a dispensing mechanism that sucks in and discharges a sample, a cleaning unit that cleans the dispensing mechanism, and a control unit that determines whether to carry out additional cleaning in addition to normal cleaning that is carried out each time a sample is dispensed, characterized in that the control unit makes the determination on the basis of the purpose of a preceding sample that was dispensed before a following sample that is to be dispensed by the dispensing mechanism.

Description

[Technical field]

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

[0002] Automated analyzers are equipped with one or more dispensing mechanisms, and perform qualitative and quantitative analysis of biological samples such as blood and urine by repeatedly dispensing using the dispensing mechanism and cleaning the dispensing mechanism after dispensing. Since the nozzle of the dispensing mechanism comes into physical contact with multiple samples, if the previous sample is not cleaned sufficiently, the previous sample will be carried over into the next sample (carryover), which will cause measurement errors. To prevent such cross-contamination, in addition to the normal cleaning after dispensing, additional cleaning using a specified detergent is performed.

[0003] For example, Patent Document 1 discloses that it is determined whether or not to perform additional washing based on the types of the preceding and succeeding samples, that is, whether they are urine or feces. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2016-206186 A Summary of the Invention [Problem to be solved by the invention]

[0005] In the technology disclosed in Patent Document 1, the need for additional washing is determined based only on the type of sample, so the accuracy of the determination is low and additional washing may be performed even for analysis conditions that do not actually require it. In such cases, not only will the amount of detergent consumed increase, but the overall processing time will also be longer.

[0006] An object of the present invention is to provide an automatic analyzer and an automatic analysis method that suppress an increase in the amount of detergent used and processing time caused by excessive additional washing. [Means for solving the problem]

[0007] In order to solve the above problems, for example, the configurations described in the claims are adopted.

[0008] The present application includes multiple means for solving the above problems, and one example is an automatic analyzer comprising a dispensing mechanism for aspirating and dispensing a sample, a washing unit for washing the dispensing mechanism, and a control unit for determining whether or not to perform additional washing in addition to the normal washing performed each time a sample is dispensed, wherein the control unit makes a determination based on the purpose of a pre-sample dispensed before a post-sample dispensed by the dispensing mechanism. Effect of the Invention

[0009] According to the present invention, it is possible to provide an automatic analyzer and an automatic analysis method that suppress an increase in the amount of detergent used and processing time due to excessive additional washing.

[0010] Problems, configurations and effects other than those described above will become apparent from the following description of the embodiments. [Brief description of the drawings]

[0011] [Figure 1] FIG. 1 is a schematic diagram showing the configuration of an automatic analyzer according to an embodiment of the present invention. [Diagram 2] An example of the additional wash settings screen. [Diagram 3] 11 is a flowchart for explaining a procedure for determining whether or not additional cleaning is required. [Figure 4] 4 is an example of analysis request information related to Example 1. [Diagram 5] 13 is an example of analysis request information related to Example 2. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] Hereinafter, an embodiment of the present invention will be described with reference to the drawings.

[0013] Fig. 1 is a schematic diagram of an automatic analyzer according to the present embodiment. As shown in Fig. 1, the automatic analyzer includes a sample rack 101 capable of mounting a plurality of sample containers 100 for holding samples (specimens), a reagent disk 103 capable of mounting a plurality of reagent containers 102 for holding reagents on a concentric circumference, a reaction disk 105 on which a plurality of reaction containers 104 are arranged on the circumference, a sample dispensing mechanism 106 capable of dispensing samples from the sample rack 101 to the reaction disk 105, a reagent dispensing mechanism 107 capable of dispensing reagents from the reagent disk 103 to the reaction disk 105, a washing unit 108 for washing the dispensing mechanism, a detergent installation unit 109 in which a detergent for additional washing described later is installed, a computer 111, a display unit 114 for displaying and outputting analysis results, and an input unit 110 operated by an operator or the like when inputting analysis request information, etc. to the computer 111.

[0014] The sample dispensing mechanism 106 has a nozzle with its tip facing downward, and dispensing is performed by aspirating and discharging the sample through the nozzle. The computer 111 also has a control unit 112 that controls each mechanism according to input information, and a storage unit 113 that is a database that stores various information. Specific examples of the input unit 110 include a mouse and a keyboard.

[0015] During analysis, each mechanism of the automatic analyzer basically operates as follows. First, the sample rack 101 moves the sample container 100 to the position of the sample dispensing mechanism 106. Next, the sample dispensing mechanism 106 aspirates the sample in the sample container 100 and dispenses it into a reaction container 104 on the reaction disk 105. The reagent dispensing mechanism 107 aspirates the reagent from the reagent container 102 on the reagent disk 103 and dispenses it into a reaction container 104 also on the reaction disk 105. The nozzle of the dispensing mechanism that has completed dispensing is washed in a washing unit 108.

[0016] As described above, the nozzle of the specimen dispensing mechanism 106 comes into contact with the specimen when aspirating the specimen to be analyzed, and the outer and inner walls of the nozzle at the contacted portions become contaminated. If the nozzle in this state is used to aspirate the subsequent specimen to be analyzed next, the remaining pre-specimen from the previous dispensing may be mixed into the subsequent specimen, and the pre-specimen may also be mixed into the container containing the subsequent specimen. Therefore, the washing unit 108 prevents cross-contamination by washing the outer and inner walls of the nozzle contaminated with the pre-specimen with water (normal washing) after discharging the pre-specimen and before aspirating the subsequent specimen. However, depending on the condition of the pre-specimen and subsequent specimen, the normal washing performed each time of dispensing may not be enough to prevent cross-contamination, so additional washing is performed in addition to the normal washing.

[0017] The control unit 112 determines whether or not to perform additional washing after normal washing. Specifically, the control unit 112 acquires the preceding sample information (purpose of the preceding sample, number of aliquots, etc.) and the following sample information (test items of the following sample, sample type, etc.) stored in the memory unit 113, and by referring to preset conditions, determines not only whether additional washing is necessary, but also the washing pattern if necessary. Here, the sample purpose and number of aliquots of the preceding sample are registered in the memory unit 113 in advance by the input unit 110, so that the necessity of additional washing can be determined even before the analysis of the preceding sample is completed, and the additional washing and analysis of the following sample can be started immediately.

[0018] The additional cleaning in this embodiment is not limited to cleaning using a dedicated detergent, and may be cleaning using water as long as it is a cleaning performed additionally after normal cleaning. Additional cleaning using water is expected to be performed when there is a high possibility that carryover can be avoided even with normal cleaning, and the contamination is not so severe that a detergent is required.

[0019] The control unit 112 according to this embodiment determines the optimal washing pattern individually according to the pre-sample information and post-sample information, thereby preventing carryover reliably while suppressing increases in detergent usage and processing time due to excessive additional washing. For example, when the combination of the pre-sample information and post-sample information meets a predetermined condition and the pre-sample is considered to have little effect on the post-sample, it is possible to set the washing pattern for additional washing to water only, thereby reducing the amount of detergent usage. Examples of washing patterns include water only, alkaline detergent, acid detergent, and combinations of these. Therefore, it is possible to store multiple types of detergent in the detergent installation unit 109.

[0020] In this embodiment, the specimen use of the preceding specimen is set as a condition for the control unit 112 to determine the necessity and pattern of additional washing. The specimen use that is set includes a patient specimen (specimen sample) with an unknown concentration, a control specimen (quality control sample) with a known concentration, and a calibrator (calibration sample) with a known concentration. If the specimen use is not set as a condition, excessive additional washing may be performed to accommodate a patient specimen with an unknown concentration of the preceding specimen, in other words, to prevent carryover even if the concentration of the preceding specimen is high. For example, even if the preceding specimen is actually a control specimen with a known concentration or a patient specimen with an average concentration, additional washing that is actually unnecessary may be performed on the assumption that the preceding specimen is a patient specimen with a high concentration.

[0021] However, the control unit 112 in this embodiment determines the additional washing and pattern based on which sample the sample use of the previous sample corresponds to, so if the previous sample is a sample with a known concentration, such as a control sample, the level of additional washing can be lowered compared to when the previous sample is a patient sample, or the additional washing can be omitted altogether.

[0022] In this embodiment, the number of times the previous sample is dispensed is set as a condition for the control unit 112 to determine the necessity and pattern of additional cleaning. If the number of times the previous sample is dispensed is large, the number of times the nozzle comes into contact with the sample increases, and the degree of contamination of the nozzle increases accordingly, so the necessity of additional cleaning increases. On the other hand, if the number of times the previous sample is dispensed is small, the degree of contamination of the nozzle is small, so the necessity of additional cleaning is low. Therefore, the control unit 112 determines to perform additional cleaning of a predetermined pattern only when the number of times the previous sample is dispensed is a predetermined number or more.

[0023] As described above, the automated analyzer of this embodiment obtains in advance the sample use and number of dispenses of the previous sample as information that serves as an indication of the degree of contamination of the nozzle by the previous sample, and determines whether additional cleaning is necessary. Therefore, it is possible to reliably prevent carryover while suppressing increases in detergent usage and processing time that would result from excessive additional cleaning.

[0024] FIG. 2 is an example of the setting screen for additional washing. As shown in FIG. 2, the setting screen for additional washing has a setting area 301, a register button 302, and a cancel button 303. In FIG. 2, only information No. 1 to No. 3 is displayed in the setting area 301, but other information can be displayed by using a scroll button (not shown) or the like. When setting a new additional washing, an operator or the like uses the input unit 110 to select each piece of information that is a condition from a plurality of candidates using a pull-down menu, or directly inputs the information using a keyboard or the like. The register button 302 has a function of registering the setting for additional washing (saving it in the memory unit 113), and the cancel button 303 has a function of closing the setting screen without saving the setting for additional washing.

[0025] In addition, Fig. 2 shows an example in which, in addition to the washing pattern, test items and specimen type can be set as post-specimen information, and specimen use and number of aliquots can be set as pre-specimen information. Specimen type refers to the type of specimen, such as serum, urine, plasma, cerebrospinal fluid, etc. Furthermore, test items include occult blood and protein when the specimen type is urine, for example.

[0026] As for the sample use, for example, not only can the entire control sample be selected, but also multiple candidate control samples can be individually selected. Therefore, if the type of the specified control sample is of a standard concentration, excessive additional washing can be omitted, and if it is of a high concentration, appropriate additional washing can be performed, improving the accuracy of the additional washing judgment by the control unit 112. Similarly, not only can the entire calibrator be selected, but also multiple candidate calibrators can be individually selected. In No. 1 of FIG. 2, only the control sample AAA is set individually.

[0027] For each setting item other than the washing pattern, in addition to selecting one from multiple candidates, it is also possible to target all candidates (for example, the number of dispensings No. 1 in FIG. 2). The contents that can be set on the setting screen are not limited to the example in FIG. 2. For example, the sample type may be set as the previous sample information in addition to the sample use and the number of dispensings. By making it possible to set the conditions for performing additional washing in more detail, it is possible to accurately suppress excessive additional washing and prevent carryover.

[0028] FIG. 3 is a flow chart for explaining the flow of determining whether or not additional washing is required when the dispensing target is switched from a certain sample 1 (previous sample) to a next different sample 2 (next sample).

[0029] First, the sample dispensing mechanism 106 dispenses the sample 1 from the sample container 100 into the reaction container 104 on the reaction disk 105 (step S401).

[0030] Next, the sample dispensing mechanism 106 moves to the position of the washing unit 108, and normal washing is performed in the washing unit 108 (step S402).

[0031] The control unit 112 determines whether the specimen will be changed in the next dispensing based on the analysis request information registered in the memory unit 113 (step S403), and if it will not be changed, returns to step S401. At this time, the number of times that the process returns from step S403 to step S401 is stored in the memory unit 113 as the number of dispensings N.

[0032] When the sample to be dispensed is changed, the control unit 112 determines whether the test item of the sample 2 is set as a target for additional washing (step S404). If the condition of the test item is not satisfied, the sample dispensing mechanism 106 dispenses the sample 2 without performing additional washing (step S410).

[0033] If the condition of the test item in step S404 is met, the control unit 112 determines whether the sample type of the sample 2 is set as a target for additional washing (step S405). If the condition of the sample type is not met, the sample dispensing mechanism 106 dispenses the sample 2 without performing additional washing (step S410).

[0034] If the condition for the sample type in step S405 is met, the control unit 112 determines whether the sample use of the sample 1 is set as a target for additional cleaning (step S406). If the condition for the sample use is not met, the sample dispensing mechanism 106 dispenses the sample 2 without performing additional cleaning (step S410).

[0035] If the condition for the sample use in step S406 is met, the control unit 112 determines whether the number of times of dispensing the sample 1 is set to be subject to additional washing (e.g., whether the number of times of dispensing is equal to or greater than a predetermined value N) (step S407). If the condition for the number of times of dispensing is not met, the sample dispensing mechanism 106 dispenses the sample 2 without performing additional washing (step S410).

[0036] If the condition for the number of dispensing times in step S407 is satisfied, the control unit 112 determines which washing pattern corresponds to the additional washing (step S408). Then, after the additional washing is performed in the washing unit 108 according to the determined washing pattern (step S409), the sample dispensing mechanism 106 dispenses the sample 2 (step S410).

[0037] The additional cleaning may be performed in a location different from the cleaning unit 108 where the normal cleaning is performed. The determinations in steps S404 to S407 may be performed in a different order or simultaneously.

[0038] Next, a method for determining whether additional cleaning is required will be described with a specific example. As a premise, before an analysis request is made, an operator or the like sets the additional cleaning using the input unit 110, and the control unit 112 stores the setting information in the storage unit 113. Here, it is assumed that the conditions for additional cleaning shown in FIG. 2 are set. An operator or the like sets the analysis request using the input unit 110, and the control unit 112 stores the setting information in the storage unit 113. EXAMPLES

[0039] Fig. 4 is an example of analysis request information related to Example 1. In this example, a specific method for determining whether or not to perform additional cleaning when the analysis request information shown in Fig. 4 is set will be described with reference to Fig. 3. First, the sample dispensing mechanism 106 dispenses sample A corresponding to the first analysis request No. 1 (step S401), and then the cleaning unit 108 performs normal cleaning on the nozzle of the sample dispensing mechanism 106 (step S402).

[0040] In the next analysis request No. 2, the sample is switched from A to B, so step S403 returns Yes and the process proceeds to step S404. Here, test item X for sample B is registered in additional cleaning setting No. 1 (see FIG. 2), so the process proceeds to step S405. The sample type of sample B, serum, matches the conditions of setting No. 1 (see FIG. 2), so the process proceeds to step S406. However, the sample use of sample A is a calibrator, so it does not match the conditions of additional cleaning setting No. 1 (see FIG. 2). Therefore, additional cleaning is not performed between analysis requests No. 1 and No. 2, and dispensing of the next sample begins (step S410).

[0041] In the next analysis request No. 3, the sample is switched from B to C, so the answer is Yes in step S403 and the process proceeds to step S404. Here, the test item X of the sample C is registered in the setting No. 1 of additional washing (see FIG. 2), so the process proceeds to step S405. The sample type of the sample C, serum, matches the conditions of the setting No. 1 (see FIG. 2), so the process proceeds to step S406. Here, the sample use of the sample B is a control sample (control name AAA), so it matches the conditions of the setting No. 1 of additional washing (see FIG. 2), so the process proceeds to step S407. Furthermore, the condition of the number of dispensings (previous sample) in the setting No. 1 is all the number of dispensings (see FIG. 2), so it also matches the condition, so the process proceeds to step S408. The washing pattern corresponding to the setting No. 1 is additional washing using detergent A (see FIG. 2), so detergent A washing is performed in step S409. In this way, between analysis requests No. 2 and No. 3, additional washing is performed, and then dispensing of the next sample is started (step S410). Note that in the next analysis requests No. 4 and No. 5, as shown in FIG. 4, the sample remains as sample C and is not switched, so additional washing is not performed.

[0042] In the next analysis request No. 6, the sample is switched from C to D, so the answer is Yes in step S403, and the process proceeds to step S404. Here, the test item Y of the sample D is registered in the additional cleaning setting No. 2 (see FIG. 2), so the process proceeds to step S405. The sample type of the sample D, urine, matches the conditions of the setting No. 2 (see FIG. 2), so the process proceeds to step S406. Here, the target of the sample use (previous sample) in the setting No. 2 is all sample uses (see FIG. 2), so the sample C, which is a patient sample, is also a target, and the process proceeds to step S407. Furthermore, since the sample C has been dispensed three times in the analysis request Nos. 3 to 5, the condition of the number of dispensings in the setting No. 2, that is, the condition of the number of dispensings N≧3, is also met, and the process proceeds to step S408. The cleaning pattern corresponding to the setting No. 2 is additional cleaning using detergents A and B (see FIG. 2), so detergent A+B cleaning is performed in step S409. In this manner, between analysis requests No. 5 and No. 6, additional washing is performed, and then dispensing of the next sample is started (step S410).

[0043] In the next analysis request No. 7, the sample is switched from D to E, so the answer is Yes in step S403, and the process proceeds to step S404. Here, the test item Z of the sample E is registered in the additional cleaning setting No. 3 (see FIG. 2), so the process proceeds to step S405. Here, the target of the sample type (subsequent sample) in the setting No. 3 is all sample types (see FIG. 2), so the sample type of the sample E, plasma, is also a target, and the process proceeds to step S406. In addition, the sample use of the sample D is a patient sample, so it matches the condition of the additional cleaning setting No. 3 (see FIG. 2), and the process proceeds to step S407. Furthermore, the condition of the number of dispensings (previous sample) in the setting No. 3 is all dispensings (see FIG. 2), so it also matches this condition, and the process proceeds to step S408. The cleaning pattern corresponding to the setting No. 3 is additional cleaning using only water (see FIG. 2), so the system water cleaning is performed in step S409. EXAMPLES

[0044] In Example 1, when switching to a different sample, the necessity of additional washing is determined by considering information such as the sample use of the pre-sample immediately before switching and information such as the test item of the post-sample immediately after switching. In Example 2, when the same post-sample is used for multiple test items, the necessity of additional washing is determined by considering not only the post-sample dispensed for a specific test item immediately after switching, but also the post-sample dispensed for another test item thereafter. Therefore, in this example, even if the test item of the post-sample immediately after switching is not subject to additional washing, if the test item of the same post-sample dispensed thereafter includes a subject for additional washing, additional washing is performed before the first dispensing of the post-sample.

[0045] Fig. 5 is an example of analysis request information related to Example 2. In this Example, a specific method for determining whether or not to perform additional cleaning when the analysis request information shown in Fig. 5 is set will be described with reference to Fig. 3. First, the sample dispensing mechanism 106 dispenses sample A corresponding to the first analysis request No. 1 (step S401), and then the cleaning unit 108 performs normal cleaning on the nozzle of the sample dispensing mechanism 106 (step S402).

[0046] In the next analysis request No. 2, the sample is switched from A to B, so the answer in step S403 is Yes, and the process proceeds to step S404. Here, the test item X for sample B is registered in additional cleaning setting No. 1 (see FIG. 2), so the process proceeds to step S405. The sample type of sample B, serum, matches the conditions of setting No. 1 (see FIG. 2), so the process proceeds to step S406. However, the sample use of sample A is a patient sample, so it does not match the conditions of additional cleaning setting No. 1 (see FIG. 2). Therefore, in the case of Example 1, additional cleaning is not performed between analysis requests No. 1 and No. 2, and there is no change in sample between analysis requests No. 2 and No. 3, so additional cleaning is not performed.

[0047] Meanwhile, in this embodiment, the control unit 112 also determines whether analysis request No. 3, which uses the same subsequent sample B, meets the conditions for additional washing. Here, it is found that the test item Z and sample type serum of analysis request No. 3 are registered in additional washing setting No. 3 as shown in FIG. 2. In addition, the sample use of the previous sample (sample A before switching), which is a patient sample, and the number of aliquots of the previous sample (sample A before switching), which is 1, also meet the conditions for additional washing setting No. 3 as shown in FIG. 2. Therefore, in this embodiment, additional washing using only water is performed between analysis requests No. 1 and No. 2.

[0048] According to this embodiment, even if the effect of carryover from the previous sample is small for the test item immediately after switching samples, but the effect of carryover from the previous sample is large for subsequent test items using the same subsequent sample, additional cleaning is performed before switching samples, thereby more reliably preventing cross-contamination and improving analytical accuracy.

[0049] The present invention is not limited to the above-mentioned first and second embodiments, and includes various modified examples. For example, the control unit 112 may determine whether or not additional cleaning is required based on the amount of the previous sample dispensed, instead of or in addition to the number of times the previous sample is dispensed. If the amount of the previous sample dispensed is greater than a predetermined value, the sample will penetrate deep into the inner wall of the nozzle of the dispensing mechanism, increasing the risk of nozzle contamination, so that additional cleaning is set to be performed. Regarding the amount of the dispensed amount, for example, information on how many ml to dispense is registered in advance in the storage unit 113, so that the need for additional cleaning can be determined in preparation for the analysis of the subsequent sample before the analysis of the previous sample is completed, and a decrease in the processing capacity of the analyzer is suppressed.

[0050] Moreover, the above-mentioned first and second embodiments have been described in detail to clearly explain the present invention, and are not necessarily limited to those including all of the configurations described. Furthermore, it is possible to replace a part of the configuration of one embodiment with the configuration of another embodiment, and it is also possible to add the configuration of another embodiment to the configuration of one embodiment. Furthermore, it is also possible to add, delete, or replace a part of the configuration of each embodiment with another configuration. [Explanation of symbols]

[0051] 100: sample container, 101: sample rack, 102: reagent container, 103: reagent disk, 104: reaction container, 105: reaction disk, 106: sample dispensing mechanism, 107: reagent dispensing mechanism, 108: cleaning unit, 109: detergent installation unit, 110: input unit, 111: computer, 112: control unit, 113: memory unit, 114: display unit, 301: setting area, 302: registration button, 303: cancel button

Claims

1. A dispensing mechanism for aspirating and discharging a sample; A cleaning unit that cleans the dispensing mechanism; A control unit that determines whether to perform additional cleaning in addition to normal cleaning performed every time a sample is dispensed, The automatic analyzer according to claim 1, wherein the control unit performs a determination based on a purpose of a pre-sample dispensed before a post-sample dispensed by the dispensing mechanism.

2. 2. The automated analyzer according to claim 1, The automatic analyzer according to claim 1, wherein the control unit determines whether or not the additional cleaning is required based on the type of the control sample of the previous sample.

3. 2. The automated analyzer according to claim 1, The automatic analyzer according to claim 1, wherein the control unit determines whether or not the additional cleaning is required based on a type of a calibrator for the preceding sample.

4. 2. The automated analyzer according to claim 1, The automatic analyzer according to claim 1, wherein the control unit determines a predetermined pattern from a plurality of cleaning patterns for the additional cleaning.

5. 2. The automated analyzer according to claim 1, The automatic analyzer according to claim 1, wherein the control unit determines whether or not to perform the additional cleaning, taking into consideration the test items of the subsequent sample.

6. The automatic analyzer according to claim 5, When the sample is aliquoted multiple times and used for different test items, An automatic analyzer characterized in that, if a test item for which the additional cleaning is required is included, the additional cleaning is performed before the first dispensing of the subsequent sample.

7. a dispensing step in which a dispensing mechanism aspirates and discharges the sample; a normal cleaning step of cleaning the dispensing mechanism after each dispensing; and an additional cleaning step that is performed when the control unit determines that an additional cleaning step is necessary, The automatic analysis method, characterized in that the control unit determines whether or not the additional cleaning step is necessary based on the purpose of a pre-sample dispensed before a post-sample dispensed by the dispensing mechanism.

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