Automated Analysis System

Abstract

To provide an automatic analysis system with which the time required for accuracy management is suppressed, even when a large amount of accuracy management samples are needed.SOLUTION: Provided is an automatic analysis system comprising a plurality of analyzers, a transport unit to which the analyzers are connected, and an operation unit for operating the transport unit to transport a sample to the analyzers, the system further including a common storage cabinet for storing accuracy management samples suppliable to the plurality of analyzers. The operation unit operates the storage cabinet in accordance with rules preliminarily registered for each of the plurality of analyzers, so as to automatically transport the accuracy management samples to the analyzers.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to an automatic analysis system to which a plurality of analysis devices are connected. [Background technology]

[0002] 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 and luminescence intensity of the reaction solution.

[0003] In order to ensure the reliability of analytical results, such automatic analyzers perform calibration, which is a calibration operation to obtain a calibration curve, and quality control to confirm that the calibration curve is appropriate, as necessary. However, there are an extremely large number of methods and types of samples used (calibration samples, quality control samples), making handling and management cumbersome.

[0004] Furthermore, the following technologies are known for handling and managing quality control samples. For example, Patent Document 1 describes an automatic analyzer in which a plurality of functional modules are connected, and each module is provided with a refrigerated unit for storing quality control samples, and the quality control samples are used in each module as needed. Furthermore, Patent Document 2 describes an automatic analyzer that performs a preparation process so that quality control samples are available at a preset time, and is provided with a storage unit for storing the quality control samples after preparation. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2015-57617 [Patent Document 2] Japanese Patent Application Laid-Open No. 2015-135282 Summary of the Invention [Problem to be solved by the invention]

[0006] In conventional automated analysis systems such as those described in Patent Documents 1 and 2, the input of quality control samples into each module was always performed by an operator, which lengthened the overall work time required for quality control. In particular, depending on the type of quality control, a large amount of quality control samples may be required, which makes it difficult to store a large amount of quality control samples in each module or for the operator to input them.

[0007] An object of the present invention is to provide an automatic analysis system that reduces the time required for quality control even when a large amount of quality control samples is required. [Means for solving the problem]

[0008] In order to achieve the above object, the present invention Automated analysis system a plurality of analytical devices, a transport unit to which the analytical devices are connected, and an operation unit that operates the transport unit to transport samples to the analytical devices; a dispensing unit that dispenses the sample contained in the sample container into another empty sample container; A common repository for storing quality control samples that can be supplied to multiple analytical devices. and the dispensing unit dispenses the quality control sample contained in the sample container transported from the storage cabinet into the empty sample container, and the dispensed sample dispensed by the dispensing unit is transported to the analyzer. It is something. [Effects of the Invention]

[0009] According to the present invention, an automatic analysis system can be provided that reduces the time required for quality control even when a large amount of quality control samples is required. [Brief explanation of the drawings]

[0010] [Figure 1] 1 is a schematic diagram showing the overall configuration of an automatic analysis system according to an embodiment. [Figure 2] FIG. 2 is a plan view showing the configuration of a storage cabinet according to the embodiment. [Figure 3] FIG. 2 is a flowchart showing the operation of the automatic analysis system according to the first embodiment. [Figure 4] FIG. 10 is a diagram showing a table regarding storage conditions for quality control samples. [Figure 5] FIG. 1 is a flow chart showing steps for determining whether or not to store quality control samples. [Figure 6]FIG. 10 is a flowchart showing the operation of the automatic analysis system according to the second embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0011] 1 is a schematic diagram showing the overall configuration of an automatic analysis system according to an embodiment of the present invention. As shown in FIG. 1, the automatic analysis system according to this embodiment includes an input unit 110, a transport unit 120, a centrifugation unit 140, an uncap unit 150, a daughter sample container generation unit 160, a dispensing unit 170, a capping unit 180, a storage unit 130, a plurality of analyzers 190, an operation unit 101, and a storage cabinet 210.

[0012] Here, the input unit 110 is a unit for inputting a sample container 200 (test tube) containing a sample (specimen) such as blood or urine into the automated analysis system. Installed within the input unit 110 are a sample recognition unit 121, a stopper detection unit 122, and a carrier recognition unit 125. The sample recognition unit 121 reads the barcode attached to the sample container 200 to identify the sample being transported. The stopper detection unit 122 captures an image of the sample container 200 and analyzes the captured image to identify the type of sample container 200 and the presence or absence and type of stopper. The carrier recognition unit 125 reads ID information attached to the carrier holding the sample container 200, and carrier recognition units 135, ..., 175, 185, 215 corresponding to this carrier recognition unit 125 are provided in each section of the automated analysis system.

[0013] Next, the transport unit 120 is a mechanism that transports the sample container 200 loaded from the loading unit 110 and the sample container (child container) dispensed in the dispensing unit 170 to various units, such as the centrifuge unit 140, the dispensing unit 170, and the analyzer 190. The centrifuge unit 140 is a unit that performs centrifugation on the loaded sample container 200 to separate the sample into serum components and blood clot components. The uncapper unit 150 is a unit that removes the stopper from the loaded sample container 200. The child sample container generation unit 160 is a unit that performs preparations necessary for dispensing the sample contained in the loaded sample container 200 in the next dispensing unit 170, such as preparing a new sample container (child container) and attaching a barcode label or the like to the prepared sample container 200. The dispensing unit 170 is a unit that distributes the centrifuged serum components into other empty sample containers (child containers) for analysis in the analyzer 190, which will be described later. The capping unit 180 is a unit for capping the treated sample containers 200 and secondary containers. The storage unit 130 is a unit for storing the sample containers 200 and secondary containers capped by the capping unit 180.

[0014] The analyzer 190 is a unit to which samples processed in each section of the automatic analysis system are transported and which performs correction and quantitative analysis of sample components. The analyzer 190 has a sample dispensing mechanism 191, a reagent dispensing mechanism 192, a reagent disk 193, a reaction disk 194, a detection mechanism 195, and a transport line 196 which constitutes part of the transport section 120.

[0015] Here, the sample dispensing mechanism 191 aspirates and dispenses the sample in the sample container 200. The reagent disk 193 stores reagents necessary for analyzing the components of the sample. The reagent dispensing mechanism 192 aspirates and dispenses the reagents. The detection mechanism 195 measures the optical properties of the mixture in the reaction cell of the reaction disk 194 and transmits the measured data to the operation unit 101.

[0016] The operation unit 101 is composed of a processor such as a CPU (Central Processing Unit), a storage device, a communication device, an input device, a display device, etc. This operation unit 101 controls the operation of each unit in the automatic analysis system and analyzes the measurement data in the analyzer 190. In particular, the control of the operation of each unit in the automatic analysis system may be configured, for example, as shown in FIG. 6, so that the operation unit 101 also has the function of issuing instructions to cause the pre-processing units, such as the aforementioned input unit 110, transport unit 120, and centrifuge unit 140, to operate, and the storage cabinet 210. Furthermore, when the number of analyzers 190 is large, the operation unit 101 may be configured so that each unit is controlled by a plurality of operation units 101 installed separately for the analyzer 190 and the pre-processing unit.

[0017] The storage cabinet 210 is a unit for storing prepared quality control samples and pooled serum (hereinafter referred to as "quality control samples") in a refrigerated state, separate from a refrigerator for reagents required for analysis.

[0018] In the automated analysis system according to this embodiment, quality control is performed to maintain the accuracy of the analysis results of each analyzer 190 at a certain level or higher. Here, rules are pre-registered for each analyzer 190 regarding the conditions under which quality control should be performed. One possible rule is a time interval for performing quality control, such as performing quality control every two hours. Another possible rule is a number of measurements of general samples, which is a condition for performing quality control, such as performing quality control every 100 general samples. Furthermore, if multiple types of samples are used for quality control, information identifying the type of quality control sample is also included in the rule. The pre-registered rules are not necessarily the same for each analyzer 190; they may be different for each analyzer 190.

[0019] Furthermore, the automated analysis system according to this embodiment is connected to multiple analyzers 190. When there are many general samples to be measured, each analyzer 190 performs the same test. In this case, each analyzer 190 typically starts its measurement process at approximately the same time, so quality control may also be required at approximately the same time. Therefore, if an operator were to individually load quality control samples into each automated analyzer, as in the past, it would be difficult to load many quality control samples at approximately the same time, lengthening the time required for quality control. However, in this embodiment, the operation unit 101 operates the storage 210 according to rules pre-registered for each of the multiple analyzers 190, automatically transporting quality control samples to a specific analyzer, thereby reducing the time required for quality control.

[0020] Here, the storage 210 of this embodiment is a common storage for storing quality control samples that can be supplied to multiple analyzers 190. FIG. 2 is a plan view showing the configuration of the storage 210 of this embodiment. As shown in FIG. 2, the storage 210 of this embodiment has a tray 210A for quality control samples that can hold a large number of sample containers 200, and a disposal box 210B for disposing of unusable quality control samples together with the sample container 200. Note that the sample containers 200 stored in the storage 210 have a one-dimensional barcode or an RFID tag on which an identification code is recorded, so that the quality control samples inside can be identified.

[0021] If an individual storage cabinet were provided for each analyzer 190, it would be difficult to secure the space to place a large storage cabinet for each analyzer 190, which would inevitably limit the number of quality control samples that could be stored. In contrast, the storage cabinet 210 of this embodiment can efficiently store quality control samples that can be supplied to multiple analyzers 190 in one place. In particular, depending on the type of quality control, a large amount of quality control samples may be required for a single analyzer 190, but this can be handled by storing a large amount of quality control samples in a dedicated storage cabinet 210, as in this embodiment.

[0022] Furthermore, if a large number of quality control samples need to be input, multiple repositories 210 may be provided, and each repositories 210 may supply quality control samples to multiple analyzers 190. This allows a certain number of quality control samples to be stored by combining multiple repositories 210, even if a large repositories 210 is not available. Furthermore, when quality control samples are transported from one repositories 210 to multiple analyzers 190 simultaneously, the transport unit 120 downstream of the repositories 210 may become congested, making transport difficult. However, if multiple repositories 210 transport quality control samples from each repositories 210 to their respective analyzers 190 so that the transport routes of the multiple repositories 210 do not overlap, congestion in the transport unit 120 can be alleviated, and the time required for quality control can be reduced.

[0023] Next, the operation of the automatic analysis system according to this embodiment will be described. [Example]

[0024] 3 is a flow diagram showing the operation of the automatic analysis system according to Example 1. First, the operator fills the sample container 200 with quality control samples and sets the sample container 200 on the tray 210A for quality control samples in the storage cabinet 210. The number and installation positions of the quality control samples to be set are registered in advance by the operation unit 101, and the operator performs the work in accordance with the registered contents.

[0025] Then, based on rules pre-registered in each analyzer 190, each analyzer 190 notifies the operation unit 101 of information that triggers quality control as quality control sample request information (step S101). At this time, the operation unit 101 waits for 10 minutes after receiving the first quality control request information so that it can receive the same type of quality control request information from other analyzers 190, and determines whether one quality control sample can be used for quality control of multiple analyzers 190. The request waiting time during which the operation unit 101 waits for quality control requests from multiple analyzers 190 can be set by the operation unit 101 for each type of quality control (see FIG. 4).

[0026] When the request waiting time has elapsed, the operation unit 101 instructs the storage 210 to remove the sample container 200 filled with the target quality control sample based on the quality control request information from the analysis device 190 (step S102). In response to this, the storage 210 removes the target sample container 200, and the transport unit 120 transports the sample container 200 (quality control sample) to the analysis device 190 that notified the request (step S103). The analysis device 190 then measures the transported quality control sample.

[0027] If the operation unit 101 receives the same type of request from other analyzers 190, the quality control sample used for quality control in one analyzer 190 is transported in sequence to the other analyzers 190 by the transport unit 120, and is also used for measurements in the other analyzers 190. Therefore, there is no need to individually feed quality control samples into each analyzer 190. Here, in conventional automatic analysis systems, even for the same type of quality control, the operator must individually feed quality control samples into each analyzer, whereas this embodiment reduces the operator's workload.

[0028] Then, when the measurement by the analyzer 190 is completed, the transport unit 120 returns the quality control sample from the analyzer 190 to the storage 210 (step S104). When the quality control sample arrives at the storage 210, the storage 210 notifies the operation unit 101 that the quality control sample has arrived (step S105).

[0029] Next, the operation unit 101 refers to a pre-registered table for the quality control sample returned to the storage 210, checks whether each parameter satisfies the conditions, and if all conditions are met, issues an instruction to the storage 210 to store the sample in the storage 210 (step S106). The operation unit 101 also checks the remaining capacity of the quality control sample, and if the remaining capacity is low, issues an instruction to the storage 210 to discard the quality control sample in the disposal box 210B, etc.

[0030] Here, the operation unit 101 counts various parameters for each quality control sample, such as the time elapsed since it was first placed in the storage cabinet 210 (storage time), the number of times it has been taken out of the storage cabinet 210 (number of uses), and the time it was taken out of the storage cabinet 210 (usage time). Note that if one quality control sample is used for measurement by multiple analyzers 190 from the time it leaves the storage cabinet 210 until it returns, this is counted as multiple times.

[0031] FIG. 4 shows a table of storage conditions for quality control samples. This table lists the maximum storage time, maximum usage time, and maximum number of uses for each type of quality control sample. The maximum storage time indicates the maximum length of time the quality control sample can be stored in the storage cabinet 210. The maximum usage time indicates the maximum length of time the quality control sample can maintain its quality even when stored in a room-temperature environment. If the time the quality control sample spends in a room-temperature environment during a single use is approximately constant, the maximum number of uses may be used instead of the maximum usage time. For example, if it takes five minutes for a quality control sample to be transported from the storage cabinet 210 and returned to the storage cabinet 210 via multiple analyzers 190, a maximum usage time of 20 minutes corresponds to a maximum number of uses of four. The maximum number of uses may be set separately from the maximum usage time, taking into account the increased risk of contamination associated with the measurement of quality control samples.

[0032] 5 is a flow diagram showing the steps for determining whether or not to store a quality control sample. As shown in FIG. 5, the operation unit 101 compares the time that the quality control sample has been refrigerated in the storage 210 with the maximum storage time for the quality control sample that has returned to the storage 210 (step S201), and if the maximum storage time has been exceeded, instructs the storage 210 to transport the quality control sample to the storage unit 130 (step S205). Instead of transporting the quality control sample to the storage unit 130, the operation unit 101 may instruct the storage 210 to discard the quality control sample in the disposal box 210B. When transporting the quality control sample from the storage 210 to the storage unit 130, the transport unit 120 is used.

[0033] If it is within the maximum storage time, the operation unit 101 compares the counted usage time with the maximum usage time (step S202), and if it exceeds the maximum usage time, it instructs the storage unit 210 to transport the quality control sample to the storage unit 130 or to discard it in the disposal box 210B (step S205).

[0034] If it is within the maximum usage time, the operation unit 101 compares the counted number of uses with the maximum number of uses (step S203), and if it exceeds the maximum number of uses, it instructs the storage 210 to transport the quality control sample to the storage unit 130 or to discard it in the disposal box 210B (step S205). If it is within the maximum number of uses, the operation unit 101 instructs the storage 210 to store the quality control sample (step S204).

[0035] In this way, in this embodiment, if at least one of the maximum storage time of the quality control sample, the maximum usage time of the quality control sample, or the maximum number of times the quality control sample is used is exceeded, the quality control sample will not be stored, making it possible to guarantee a certain level of quality control accuracy.

[0036] In the automated analysis system of this embodiment, even if a quality control sample request is not received from the analysis device 190, the operation unit 101 ensures the quality of the quality control samples by checking at predetermined confirmation intervals whether any quality control samples have exceeded the maximum storage time. If the check finds that any quality control samples have exceeded the maximum storage time, the storage cabinet 210 transports the quality control samples to the storage unit 130 or discards them in the disposal box 210B.

[0037] In conventional automated analysis systems, quality control samples that have been measured by each analyzer are left at room temperature in the storage section of each analyzer, so if the quality control sample deteriorates after being left for a long period of time, the operator must discard it and replace it with a new quality control sample. However, according to this embodiment, quality control samples that have been measured by analyzer 190 are returned to storage 210 and stored in a refrigerated environment, so they spend less time in a room temperature environment and can be used for repeated measurements. Furthermore, in this embodiment, quality control samples that have been returned to storage 210 are not all stored, but only those that meet certain conditions are stored, so the quality of the quality control samples can be guaranteed.

[0038] In this embodiment, the analytical device 190 notifies the operation unit 101 of quality control request information at a predetermined timing according to its own rules, but the rules of each analytical device 190 may be aggregated in advance in the operation unit 101, and the operation unit 101 may issue an instruction to the storage facility 210 to transport quality control samples without receiving a notification from the analytical device 190. [Example]

[0039] When one quality control sample is transported sequentially to different analyzers 190 as in Example 1, if the transport unit 120 is congested, it may take time to transport the quality control sample that has completed measurement in the first analyzer 190 to the second or subsequent analyzer 190. Therefore, in Example 2, unlike Example 1, the dispensing unit 170 dispenses the quality control sample into different empty sample containers 200, and the dispensed multiple dispensed samples are transported individually to different analyzers 190.

[0040] 6 is a flow diagram showing the operation of the automatic analysis system according to the second embodiment. First, similar to the first embodiment, each analyzer 190 notifies the operation unit 101 of quality control sample request information based on rules pre-registered therein (step S301). Next, the operation unit 101 instructs the storage 210 to retrieve the target quality control sample (step S302). In response to this, the storage 210 retrieves the target quality control sample, and the transport unit 120 transports the quality control sample to the dispensing unit 170 (step S303).

[0041] The dispensing unit 170 then dispenses the quality control sample into an empty sample container 200 that is different from the sample container containing the transported quality control sample. A barcode label is affixed to each empty sample container 200 by the child specimen container generation unit 160. This barcode label contains information indicating that the sample is a dispensed quality control sample, information about the quality control sample from which it was dispensed, and the like, recorded as a one-dimensional barcode. Furthermore, this barcode label contains attribute information, such as characters, that allows the operator to identify the sample as a quality control sample.

[0042] Thereafter, the quality control sample to be dispensed is transported to the storage 210 by the transport unit 120 (step S304). When the quality control sample to be dispensed arrives at the storage 210, the storage 210 notifies the operation unit 101 that the quality control sample has arrived (step S306). Next, the operation unit 101 refers to a pre-registered table for the quality control sample to be dispensed, and if each parameter satisfies the conditions, issues an instruction to the storage 210 to store the sample in the storage 210 (step S307).

[0043] Meanwhile, the dispensing sample is transported by the transport unit 120 to the analyzer 190 that sent the quality control request information (step S305). When the measurement in the analyzer 190 is completed, the transport unit 120 returns the dispensing sample from the analyzer 190 to the storage 210 (step S308). Note that the dispensing sample may also be transported sequentially to multiple analyzers 190 and used for measurement in each of the analyzers 190. When the dispensing sample arrives at the storage 210, the storage 210 notifies the operation unit 101 that the dispensing sample has arrived (step S309). Next, the operation unit 101 refers to a pre-registered table for the dispensing sample, and if each parameter satisfies the conditions, issues an instruction to the storage 210 to store the dispensing sample in the storage 210 (step S310).

[0044] According to this embodiment, even if multiple analyzers 190 notify the operation unit 101 of quality control request information at approximately the same time, the quality control sample can be dispensed by the dispensing unit 170 and the dispensed sample can be transported to each analyzer 190, thereby suppressing an increase in the time required for quality control due to congestion in the transport unit 120. Furthermore, not only the original quality control sample but also the dispensed sample is stored in the storage cabinet 210 only when predetermined conditions are met, so the accuracy of quality control can also be guaranteed.

[0045] Note that, because the dispensed sample is usually produced in the amount to be used by the target analyzer 190, even if it is returned to the storage 210, there may not be enough remaining capacity, so it is discarded in the disposal box 210B or transported to the storage unit 130. However, it is desirable to temporarily store the dispensed sample in the storage 210 until the measurement of the quality control sample in the analyzer 190 is completed and the measurement data is obtained. The reason for this is that, if the quality control results are inappropriate, it is possible to determine whether the quality control sample or the analyzer 190 was at fault. Therefore, the quality control sample including the dispensed sample that has returned to the storage 210 is temporarily stored in the storage 210, even if it is to be discarded, and the operation unit 101 waits until the quality control results are obtained. When the analytical device 190 notifies the operation unit 101 that the quality control results have been obtained (step S311), the operation unit 101 instructs the storage unit 210 to discard the quality control sample that was temporarily stored, and the storage unit 210 transports the quality control sample to the storage unit 130 or discards it in the disposal box 210B.

[0046] Furthermore, 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 part of the configuration of one embodiment with the configuration of another embodiment, or to add the configuration of another embodiment to the configuration of one embodiment. Furthermore, it is also possible to add, delete, or replace part of the configuration of each embodiment with other configurations. [Explanation of symbols]

[0047] 101:Operation unit 110: Input section 120: Transport unit 121: Sample recognition unit 122: Plug detection unit 125, 135, 175, 185, 215: Carrier recognition section 130: Storage area 140: Centrifugal section 150: Opening section 160: Sub-sample container generation unit 170: Dispensing section 180: Cap section 190: Analyzer 191: Sample dispensing mechanism 192: Reagent dispensing mechanism 193: Reagent disk 194: Reaction disc 195:Detection mechanism 196: Conveyor line 200: Sample container 210: Storage 210A: Tray for quality control samples 210B: Disposal box

Claims

1. a plurality of analytical devices; a transport unit to which the analysis device is connected; an operation unit that operates the transport unit to transport the sample to the analysis device; a dispensing unit that dispenses the sample contained in the sample container into another empty sample container; a common storage cabinet for storing quality control samples that can be supplied to the plurality of analytical devices; The dispensing unit dispenses the quality control sample contained in the sample container transported from the storage cabinet into the empty sample container, The dispensed sample dispensed by the dispenser is transported to the analyzer, The dispensed sample used in the analyzer is transported to the storage facility, The storage cabinet stores the dispensed sample when predetermined conditions are met, including the remaining volume of the dispensed sample being sufficient.

2. The automated analysis system according to claim 1, An automatic analysis system in which a plurality of dispensed samples dispensed by the dispenser are transported to different analyzers.

3. The automated analysis system according to claim 1, Further provided is an input section into which a sample container containing a sample is input, The dispensing unit dispenses the sample contained in the sample container loaded from the loading unit into the empty sample container.

4. The automated analysis system according to claim 1, The quality control sample from which the sample was dispensed is transported to the storage facility. The storage facility is an automatic analysis system that stores the quality control sample from the source of dispensing when predetermined conditions are met.

5. The automated analysis system according to claim 1, The storage is an automatic analysis system that, when the remaining volume of the dispensed sample is insufficient, discards the dispensed sample or transports it to a storage unit outside the storage.

6. In the automatic analysis system according to claim 5, The storage facility is an automatic analysis system that temporarily stores the dispensed sample even if there is insufficient remaining volume of the dispensed sample until the results of quality control are available, and then discards the dispensed sample or transports it to a storage unit outside the storage facility.

7. The automated analysis system according to claim 1, The automated analysis system wherein the storage facility further includes a disposal box for disposing of quality control samples.

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