The present invention relates to an automatic analyzer.
In an automatic analyzer, in order to reduce the influence of specimen carryover (hereinafter, referred to as carryover) in analysis between specimens, there is a technology that classifies biochemistry and immunity within the same specimen and dispenses the analysis items of biochemistry first (refer to JP-A-2010-025587 (PTL 1)).
PTL 1: JP-A-2010-025587
According to the above-described PTL 1, since only the determination of a dispensing sequence for each specimen is considered, there is a problem that the reduction of carryover between specimens is insufficient.
Therefore, an object of the present invention is to provide an automatic analyzer capable of further reducing carryover between specimens.
According to an aspect of the present invention, there is provided an automatic analyzer including a first dispensing unit for dispensing a specimen related to a first analysis item group having a high possibility of carryover, a second dispensing unit for dispensing a specimen related to a second analysis item group having a low possibility of carryover, an input unit for receiving an input of analysis information related to a plurality of analysis items for the specimen, a classification unit for classifying the analysis information into the first analysis item group and the second analysis item group, and a determination unit for determining a dispensing sequence for each specimen for the first analysis item group and determining a dispensing sequence for each analysis item for the second analysis item group.
According to the present invention, it is possible to provide an automatic analyzer capable of further reducing carryover between specimens.
The automatic analyzer 100 includes an incubator 1, a reaction vessel 2, a common disk 3 for holding a reagent and a specimen in common, a reagent vessel 4, a specimen vessel 5, a first dispensing unit 8 for dispensing the specimen and the reagent for biochemistry using a first nozzle, a second dispensing unit 9 for dispensing the specimen and the reagent for immunity using a second nozzle, a first pump 10 that enables the rotation and vertical movement of the first dispensing unit 8, a second pump 11 that enables the rotation and vertical movement of the second dispensing unit 9, a first cleaning tank 12 for cleaning the first nozzle, the second cleaning tank 13 for cleaning the second nozzle, a reagent agitating unit 14, a spectrophotometer 15, a detection unit 16 such as a flow cell, a tip 17 used when dispensing a liquid for immunity, a transport unit 18 for transporting the tip 17 or the reaction vessel 2, a tray 19 for the tip 17, a tray 20 for the reaction vessel 2, a disposal box 21 for storing used tip 17 and reaction vessel 2, a mounting position 22 of the tip 17, a disposal position 23 of the tip 17, a waste tank 24 for storing the used liquid, a water supply tank 25 for biochemical measurement, a water supply tank 26 for immunoassay, a cleaning liquid container 27 for storing cleaning liquid, and a control device 30 for performing various controls of the automatic analyzer 100.
The incubator 1 holds the reaction vessel 2 for storing a mixed solution of the specimen and the reagent on the circumference thereof, and keeps the reaction vessel 2 at a constant temperature in order to promote the reaction of the mixed solution. The incubator 1 is controlled by a drive mechanism such as a motor to be rotated and driven by a distance corresponding to a predetermined number of reaction vessels 2 in one cycle.
The reaction vessel 2 is a vessel having common specifications for all reactions, and is disposable. Regarding the installation positions of the reaction vessels 2, the reaction vessels 2 are arranged alternately on the circumference, such that, for example, the vessels for biochemical analysis are at the odd-numbered positions and the vessels for immunoassay are at the even-numbered positions.
On the common disk 3, a plurality of reagent vessels 4 and specimen vessels 5 are placed on the circumference. Here, an example in which the reagent vessels 4 are arranged on the inner circumference of the specimen vessels 5 is shown, but the specimen vessels 5 may be arranged on the inner circumference of the reagent vessels 4, and may be arranged without distinguishing the inner circumference and the outer circumference from each other.
The first dispensing unit 8 performs reagent dispensing and specimen dispensing from the reagent vessel 4 and the specimen vessel 5 to the reaction vessel 2 while drawing an arc around the rotation axis. On the path of the first dispensing unit 8, there are a specimen aspiration position 7-1 and a reagent aspiration position 6-1 on the common disk 3, a first dispensing position and a second dispensing position on the incubator 1, and the first cleaning tank 12. Meanwhile, the second dispensing unit 9 performs reagent dispensing and specimen dispensing from the reagent vessel 4 and the specimen vessel 5 to the reaction vessel 2 while drawing an arc around the rotation axis. On the path of the second dispensing unit 9, there are a specimen aspiration position 7-2 and a reagent aspiration position 6-2 on the common disk 3, a third dispensing position and a fourth dispensing position on the incubator 1, and the second cleaning tank 13. Furthermore, in a case of immunoassay, precise measurement is required and it is highly necessary to prevent carryover between specimens. Therefore, the second dispensing unit 9 performs dispensing using the tip 17. Accordingly, there are the mounting position 22 and the disposal position 23 on the path of the second dispensing unit 9. Meanwhile, in a case of biochemical analysis, since precision is not required as much as in immunoassay, the first dispensing unit 8 performs dispensing while cleaning the first nozzle in the first cleaning tank 12 each time dispensing is performed without using the tip 17.
The first dispensing unit 8 and the second dispensing unit 9 are arranged such that the paths of the first nozzle and the second nozzle and the respective mechanisms thereof do not physically interfere with each other. The first dispensing unit 8 and the second dispensing unit 9 aspirate the specimen and the reagent, and then agitate and mix the specimen and the reagent in the reaction vessel 2 by an aspiration/discharge operation. For the specimen used for both biochemical and immunological analysis, both the first dispensing unit 8 and the second dispensing unit 9 access the specimen.
The spectrophotometer 15 arranged around the incubator 1 is used for biochemical analysis. The spectrophotometer 15 is provided with a light source or a detector (not shown), and measures the absorbance of the reaction solution by spectroscopically detecting the transmitted light obtained by irradiating the reaction solution in the reaction vessel 2 with light.
The detection unit 16 is used for immunoassay. The reaction solution of which reaction is promoted by the incubator 1 is sent to the detection unit 16 and analyzed by electrochemical luminescence or chemiluminescence. Reagents or labeling substances suitable for each case and the structure and physical properties of the detection region are selected, and the detector (for example, a photomultiplier tube) measures the amount of luminescence derived from the luminescence reaction of the labeling substance.
The transport unit 18 transports the reaction vessel 2, of which the measurement of absorbance is completed in the incubator 1, to the disposal box 21, and disposes of the reaction vessel 2. Further, the transport unit 18 transports the reaction vessel 2 containing the reaction solution, of which reaction has been promoted by the incubator 1, to the detection unit 16. Furthermore, the transport unit 18 transports the reaction vessel 2 analyzed by the detection unit 16 to the disposal box 21, and disposes of the reaction vessel 2.
The control device 30 is connected to each mechanism of the automatic analyzer 100 (the connection is not shown), and includes a control unit 31, a storage unit 32, an input unit 33, and a display unit 34. The control unit 31 controls the first dispensing unit 8 and the second dispensing unit 9 to perform dispensing in parallel, as well as the rotation drive of the incubator 1, the rotation operation of the common disk 3, the nozzle drive, the specimen aspiration and discharge, and the like. The storage unit 32 stores programs or various data of the classification unit 35 or the determination unit 36, which will be described later. The input unit 33 receives an instruction from the user. The display unit (display) 34 displays the result or the like obtained from the analysis result to the user. The input unit 33 and the display unit 34 may be integrated as a user interface. The control unit 31 reads and executes a program of the classification unit 35 or the determination unit 36 from the storage unit 32 to realize the embodiment, which will be described later. Furthermore, the classification unit 35 or the determination unit 36 may be realized by hardware.
One cycle of immunity is six device cycles. The reaction vessel 2 for immunity is installed in the incubator 1 in the first cycle of the device cycle and is taken out in the third cycle. The first dispensing is performed in the fourth cycle of the device cycle, and the second dispensing is performed in the sixth cycle. The time for the first dispensing is the time from the first to fourth cycles of the device cycle, but the time from the first to third cycles is used for mounting the tip and aspirating reagents and specimens. At this time, the first dispensing unit 8 for biochemistry also aspirates reagents and specimens, the reagents for biochemistry and immunity are mounted on the common disk 3, and thus the timings at which the first dispensing unit 8 and the second dispensing unit 9 perform the aspiration operation are controlled so as not to overlap each other.
The A mark in
Here, in JP-A-2010-025587 (PTL 1), analysis items are classified into biological analysis items and immunological analysis items in the same specimen, and dispensing is performed for biochemistry first before for immunity. Since the nozzle is cleaned each time dispensing is performed for one analysis item, when there are a plurality of biochemical analysis items, the nozzles are cleaned as the same number as the plurality of biochemical analysis items, and then the process moves to the dispensing for immunity. In other words, there is almost no influence of the previous specimen, and there is an effect that carryover that causes an analysis error can be reduced. Meanwhile, for a certain specimen, when there are a plurality of analysis items for biochemistry, the above-described effects can be obtained, but when there is only one biological analysis item (the number of items is small) or when there are only immunological analysis items, the dispensing for immunity is performed with the same nozzle immediately after the dispensing of the previous specimen. Therefore, there is also a problem that the possibility of causing carryover increases. Furthermore, in JP-A-2010-025587 (PTL 1), the dispensing related to biochemistry and immunity is performed using the same specimen dispensing unit. Therefore, it is also noted that the assumption in PTL 1 is different from that in this automatic analyzer that uses the specimen dispensing unit for biochemistry and the specimen dispensing unit for immunity separately.
Further, in WO2017/138285, for the purpose of shortening the analysis time, the dispensing is performed in descending order of the reaction time of the analysis items. However, when performing measurement in descending order of the reaction time of the analysis items for all the specimens, there is a high possibility that a certain specimen (pre-specimen) is dispensed and then a specimen (post-specimen) different from the pre-specimen is dispensed frequently. As a result, the pre-specimen attached to the first nozzle is likely to be mixed with the post-specimen, which increases the possibility of causing carryover. In particular, in a case of an automatic analyzer that shares reagents and specimens on the common disk 3, reagents or specimens cannot be added until the analysis operation of all specimens is completed, and thus, when the completion of analysis is delayed, the addition of reagents or specimens to be used in the next analysis will be delayed, and analysis efficiency will decrease.
Therefore, in the following, an embodiment related to an automatic analyzer that can further reduce carryover, in particular, an automatic analyzer that can achieve both reduction of carryover between specimens and shortening of analysis time by using different specimen dispensing units for different analysis items will be described. Furthermore, in the following, there is a description that the program is the control main body in some cases, but it is needless to say that this means that the control unit 31 reads the program from the storage unit 32 and executes the program.
First, the control unit 31 acquires information (hereinafter, referred to as analysis information) necessary for analyzing the target component contained in the specimen. More specifically, a table (hereinafter, referred to as Table 1) in which the types of the specimen shown in
A label (for example, a bar code, a two-dimensional code, or RFID) is attached to the specimen vessel 5, and the analysis items for the specimen is stored in the label. A reader (not shown) reads the analysis items from the label and transmits the analysis items to the control device 30. The control unit 31 collates the analysis items with the parameters registered by the user, and generates Table 1 based on the matching analysis items.
Next, the classification unit 35 classifies the analysis information into a first analysis item group and a second analysis item group. In other words, Table 1 is divided into each analysis item group (S302). In a case of biochemical analysis, the nozzle directly touches the reagent or specimen, and thus there is a high possibility of carryover. Meanwhile, in a case of immunoassay, since the nozzle has the tip 17 attached thereto to perform dispensing, the possibility of carryover is low. In this manner, Table 1 is divided with the analysis item group having a high possibility of carryover as the first analysis item group (biochemistry) and the analysis item group having a low possibility of carryover as the second analysis item group (immunity). In this manner, a table (hereinafter, referred to as Table 3) only for the first analysis item group and a table (hereinafter, referred to as Table 4) only for the second analysis item group are generated.
Next, the determination unit 36 determines the dispensing sequence for each specimen for the first analysis item group, and determines the dispensing sequence for each specimen for analysis item for the second analysis item group. More specifically, the determination unit 36 determines whether or not the priority item (which will be described later) is included in Table 4 (S303), and when the priority item is not included, the dispensing sequence is not rearranged for Table 3, and the dispensing sequence is rearranged in descending order of the reaction time for Table 4 (S304). Meanwhile, when the priority item is included, the determination unit 36 arranges the priority item to be positioned first in Table 4 and arranges the same specimen as the specimen having the priority item to be positioned last in Table 3, and rearranges the dispensing sequence in descending order of the reaction time of general items (which will be described later) in Table 4 (S305). When there is no specimen which is the same as the specimen having the priority item in Table 3, the dispensing sequence is not rearranged. Further, in Table 4, when a plurality of priority items are included, the dispensing sequence of the priority items is rearranged in descending order of the reaction time, after the priority items, the dispensing sequence of the general items is rearranged in descending order of the reaction time.
After S304 or S305, the control unit 31 starts dispensing related to the specimen which is the analysis request target according to the determined dispensing sequence.
Here, the priority item (also referred to as a high priority item) is one type of immunity items, and indicates an analysis item that requires particularly precise analysis among the immunity items. The general item indicates a normal immunity item (immunological analysis item that requires normal accuracy). In other words, the priority item has a higher priority than the general item.
For example, when the first nozzle accesses a specimen vessel A, there is a possibility that impurities attached to the first nozzle are mixed into the specimen vessel A. After that, when the second nozzle accesses the specimen vessel A, there is a possibility that the second nozzle aspirates the impurities. Since the first nozzle is cleaned each time dispensing is performed, this problem is trivial in a case of a general item, but it is necessary to consider even a trivial influence in a case of a priority item. Accordingly, the control unit 31 performs control to dispense the priority item first without influence of carryover.
Further, for example, there are a plurality of priority items, and it is necessary for the second nozzle to first access the specimen vessel A and then access a specimen vessel B. Here, when only the control of dispensing the priority item first is performed, a sequence in which the second nozzle accesses the specimen vessel A→4 the first nozzle accesses the specimen vessel A→4 the first nozzle accesses the specimen vessel B→4 the second nozzle accesses the specimen vessel B may also be adopted. Then, the impurities attached to the first nozzle that has accessed the specimen vessel A are mixed into the specimen vessel B, and then the second nozzle accesses the specimen vessel B, which affects the priority items. Accordingly, in the biochemical analysis, the control unit 31 performs control to dispense the same specimen as the specimen having the priority item lastly.
In this example,
In summary, the number of times of dispensing from one specimen to another is 3 in
Meanwhile, in a case of Example 1, the number of times of dispensing from one specimen to another is 3, and the analysis time is 54 minutes. In other words, the number of times of dispensing from one specimen to another can be reduced by 5 as compared with a case of simply dispensing in descending order of the reaction time, and the analysis time can be reduced by 4 minutes as compared with a case of simply dispensing according to the requested order.
As described above, in Example 1, both reduction of carryover and shortening of analysis time can be realized, and carryover of a priority item can be reduced even in immunity.
First, the control unit 31 stops the new specimen dispensing (S901), and as in
After that, the control unit 31 determines whether or not the dispensing of the reagents and the specimens has been completed (S905). Here, it is determined whether or not there are reagents and specimens in the middle of dispensing. When there are reagents and specimens, the process is repeated, and when there are no reagents and specimens, the common disk 3 is stopped and the process proceeds to the emergency specimen installation (S906). Then, when the installation of the emergency specimen on the common disk 3 is completed, the control unit 31 starts dispensing related to the emergency specimen according to the determined dispensing sequence.
Here, a case is shown in which interruption of 3 specimens, which are emergency specimens, occurs 2 minutes after the start of dispensing. For example, when the emergency specimen analysis button is pressed during the analysis of No. 5 of Table 3 and No. 2 of Table 4, the interruption of the emergency specimens No. 6 to 10 and No. 3 to 5 occurs between No. 5 and No. 6 in Table 3 and between No. 2 and No. 3 in Table 4, respectively. As shown in
Furthermore, when the emergency specimen analysis button is pressed during the analysis of No. 4 of Table 3, priority is given to the emergency specimen, and the emergency specimen may be analyzed immediately after the analysis of No. 4 is completed, and from the viewpoint of preventing carryover, interruption of the emergency specimen may occur after waiting for the completion of the analysis of No. 5.
In Examples 1 and 2, a case where the first analysis item group is for biochemistry and the second analysis item group is for immunity was described. Here, as shown in
The control unit 31 acquires a table (hereinafter, referred to as Table 8) shown in
Next, the determination unit 36 determines whether or not the priority item is included in Table 8 (S1203), and when the priority item is not included, the dispensing sequence is rearranged in descending order of one specimen analysis time (which will be described later) for Table 10 (S1204), and the dispensing sequence is rearranged in descending order of the reaction time for Table 11 (S1205). Furthermore, as a result of rearrangement, when there are a plurality of specimens having the same length of one specimen analysis time, an order in which the analysis is requested is adopted.
Here, the one specimen analysis time indicates the time from the start of dispensing of the first analysis item to the end of the analysis of the last analysis item in the analysis of only one certain specimen. For example, a specimen S1 has 2 analysis items of the first analysis item group, and the analysis times of each analysis item is 7 minutes and 10 minutes, respectively. Further, a specimen S2 has 3 analysis items of the first analysis item group, and the analysis time of all 3 analysis items is 10 minutes. Then, there is a deviation of 20 seconds in the analysis start time for each analysis item. In this case, in S1, the analysis item of 10 minutes is started first, and the analysis item of 7 minutes is started 20 seconds later, but the analysis time of S1 as a whole is only 10 minutes. Meanwhile, in S2, the analysis time of all the analysis items is 10 minutes, and thus, when the dispensing is started with the time shifted by 20 seconds each, the analysis time as S2 becomes 10 minutes and 40 seconds. In other words, when comparing the one specimen analysis times of S1 and S2 with each other, S2 is longer. Accordingly, in the first analysis item group, S2, in which one specimen analysis time is long, may be dispensed before S1.
According to the above-described embodiments, in the automatic analyzer including the first dispensing unit for dispensing the specimen related to the first analysis item group having a high possibility of carryover and the second dispensing unit for dispensing the specimen related to the second analysis item group having a low possibility of carryover, the dispensing sequence is determined for each specimen for the first analysis item group, and the dispensing sequence is determined for each analysis item for the second analysis item group. Therefore, the carryover can be reduced more reliably than in the technology of the related art in which the dispensing sequence is determined only for each specimen. Further, for the second analysis item group, when the dispensing sequence is determined in descending order of the reaction time, both reduction of carryover and shortening of overall analysis time can be achieved.
100: automatic analyzer
1: incubator
2: reaction vessel
3: common disk
4: reagent vessel
5: specimen vessel
6: reagent aspiration position
7: specimen aspiration position
8: first dispensing unit
9: second dispensing unit
10: first pump
11: second pump
12: first cleaning tank
13: second cleaning tank
14: reagent agitating unit
15: spectrophotometer
16: detection unit
17: tip
18: transport unit
19, 20: tray
21: disposal box
22: tip mounting position
23: tip disposal position
24: waste tank
25, 26: water supply tank
27: cleaning liquid container
30: control device
Number | Date | Country | Kind |
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2019-185620 | Oct 2019 | JP | national |
Filing Document | Filing Date | Country | Kind |
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PCT/JP2020/034242 | 9/10/2020 | WO |