Automatic 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 with 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 such automatic analyzers, in order to ensure the reliability of the analysis results, calibration, which is a calibration operation to obtain a calibration curve, and quality control to confirm that the calibration curve is appropriate are performed as necessary. However, there are a large number of methods and types of samples used (calibration samples, quality control samples), which make handling and management cumbersome.

[0004] Furthermore, the following techniques 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, in which each module is provided with a cooling section for storing quality control samples, and the quality control samples are used in each module as needed. 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 section for storing the quality control samples after preparation. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] JP 2015-57617 A [Patent Document 2] JP 2015-135282 A Summary of the Invention [Problem to be solved by the invention]

[0006] In conventional automatic analysis systems such as those described in Patent Documents 1 and 2, the input of quality control samples into each module was always done 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, and it was 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-mentioned object, the present invention provides an automatic analysis system comprising 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, and has a common storage cabinet for storing quality control samples that can be supplied to the plurality of analytical devices, and the operation unit operates the storage cabinet in accordance with rules pre-registered for each of the plurality of analytical devices to automatically transport the quality control samples to the analytical devices. Effect of the Invention

[0009] According to the present invention, it is possible 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. [Brief description of the drawings]

[0010] [Figure 1] 1 is a schematic diagram showing the overall configuration of an automatic analysis system according to an embodiment. [Diagram 2] FIG. 2 is a plan view showing the configuration of a repository according to the embodiment. [Diagram 3] FIG. 2 is a flow diagram showing the operation of the automatic analysis system according to the first embodiment. [Figure 4] FIG. 13 is a table showing storage conditions for quality control samples. [Diagram 5]FIG. 11 is a flow diagram showing the steps for determining whether or not to store a quality control sample. [Figure 6] FIG. 11 is a flow diagram showing the operation of the automatic analysis system according to the second embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] Fig. 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, a capping unit 150, a child 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 automatic analysis system. A sample recognition unit 121, a stopper detection unit 122, and a carrier recognition unit 125 are installed in the input unit 110. The sample recognition unit 121 reads a barcode attached to the sample container 200 to identify the sample to be transported. The stopper detection unit 122 images the sample container 200 and analyzes the captured image to identify the type of the sample container 200 and the presence or absence and type of a stopper. The carrier recognition unit 125 reads ID information added to a carrier that holds the sample container 200, and carrier recognition units 135, ..., 175, 185, 215 corresponding to this carrier recognition unit 125 are provided in each unit in the automatic analysis system.

[0013] Next, the transport unit 120 is a mechanism for transporting the sample container 200 introduced from the introduction unit 110 and the sample container (child container) dispensed in the dispensing unit 170 to each unit such as the centrifuge unit 140, the dispensing unit 170, and the analyzer 190. The centrifuge unit 140 is a unit for centrifuging the introduced sample container 200 and separating the sample into serum components and blood clot components. The capping unit 150 is a unit for removing the cap from the introduced sample container 200. The child specimen container generating unit 160 is a unit for making preparations necessary for dispensing the sample contained in the introduced sample container 200 in the next dispensing unit 170, for example, 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 for subdividing the centrifuged serum components into other empty sample containers (child containers) for analysis by the analyzer 190 described later. The capping unit 180 is a unit for capping the treated sample containers 200 and child containers. The storage unit 130 is a unit for storing the sample containers 200 and child containers capped by the capping unit 180.

[0014] The analyzer 190 is a unit to which samples processed in each part of the automatic analysis system are transported and which performs correction and quantitative analysis of the components of the sample. 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 a part of the transport unit 120.

[0015] Here, the sample dispensing mechanism 191 aspirates and discharges the sample in the sample container 200. The reagent disk 193 stores reagents necessary for component analysis of the sample. The reagent dispensing mechanism 192 aspirates and discharges the reagent. Also, 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, and a display device. The operation unit 101 controls the operation of each part in the automatic analysis system and analyzes the measurement data in the analysis device 190. In particular, the control of the operation of each part in the automatic analysis system may be configured, for example, as shown in FIG. 6, so that the operation unit 101 also has a function of issuing instructions for performing operations related to the pre-processing units such as the above-mentioned input unit 110, transport unit 120, and centrifugal unit 140 and the storage 210, or, when the number of analysis devices 190 is large, the analysis devices 190 and the pre-processing units may be controlled by multiple operation units 101 installed separately.

[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 automatic analysis system according to the present embodiment, quality control is performed to maintain the quality of the analysis results of each analyzer 190 at a certain level or higher. Here, rules are registered in advance in each analyzer 190 regarding the conditions under which quality control is performed. As this rule, for example, a time interval for performing quality control, such as performing quality control every two hours, is considered. In addition, as another rule, for example, a number of measurements of general samples, which is a condition for performing quality control, is considered, such as performing quality control every time 100 general samples are measured. Furthermore, when there are multiple types of samples used for quality control, information for identifying the type of quality control sample is also included in this rule. Note that the rules registered in advance are not necessarily the same for each analyzer 190, and may be set to be different.

[0019] In addition, in the automatic analysis system according to the present embodiment, multiple analyzers 190 are connected, and when there are many general samples to be measured, each analyzer 190 executes the same test. At this time, each analyzer 190 usually starts the measurement process almost simultaneously, so the timing when quality control is required may also be almost simultaneous. For this reason, when an operator individually inputs quality control samples into each automatic analyzer as in the conventional method, it is difficult to input many quality control samples almost simultaneously, and the time required for quality control becomes long. However, in the present embodiment, the operation unit 101 operates the storage 210 according to rules registered in advance for each of the multiple analyzers 190, and automatically transports the quality control samples to a specified analyzer, so that the time required for quality control can be reduced.

[0020] Here, the repository 210 of this embodiment is a common repository for storing quality control samples that can be supplied to a plurality of analysis devices 190. FIG. 2 is a plan view showing the configuration of the repository 210 of this embodiment. As shown in FIG. 2, the repository 210 of this embodiment has a tray 210A for quality control samples in which a large number of sample containers 200 can be set, and a disposal box 210B for disposing of quality control samples that can no longer be used together with the sample containers 200. Note that the sample containers 200 stored in the repository 210 have a one-dimensional barcode, an RFID tag on which an identification code is recorded, or the like, so that the quality control samples inside can be identified.

[0021] If an individual repository were provided for each analyzer 190, it would be difficult to secure space to place a large repository for each analyzer 190, and the number of quality control samples that can be stored would inevitably be limited. In contrast, the repository 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 providing a large amount of quality control samples in a dedicated repository 210 as in this embodiment.

[0022] Furthermore, when a large number of quality control samples need to be input, multiple storages 210 may be provided, and each storage 210 may supply quality control samples to multiple analysis devices 190. This allows a certain number of quality control samples to be stored by combining multiple storages 210, even if a large storage 210 is not required. In addition, when quality control samples are simultaneously transported from one storage 210 to multiple analysis devices 190, the transport unit 120 downstream of the storage 210 may become congested, making transport difficult. However, if quality control samples are transported from each storage 210 to each analysis device 190 so that the transport routes of multiple storages 210 do not overlap with those of other storages 210, the congestion of the transport unit 120 may be alleviated, and the time required for quality control may be reduced.

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

[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 quality control sample tray 210A 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 according to the registered contents.

[0025] Then, based on rules registered in advance in each analyzer 190, each analyzer 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. Note that 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 sent the request (step S103). The analysis device 190 then measures the transported quality control sample.

[0027] If the operation unit 101 has received 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 used for measurements in the other analyzers 190. Therefore, it is not necessary to individually feed quality control samples to 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 to each analyzer, whereas this embodiment can reduce the operator's workload.

[0028] Then, when the measurement by the analysis device 190 is completed, the transport unit 120 returns the quality control sample from the analysis device 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 preregistered table for the quality control sample returned to the storage 210, checks whether each parameter satisfies the conditions, and if all conditions are satisfied, issues an instruction to the storage 210 to store the quality control 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 discard box 210B, etc.

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

[0031] FIG. 4 is a diagram showing a table regarding storage conditions of quality control samples. In this table, the maximum storage time, maximum use time, and maximum number of uses are registered for each type of quality control sample. The maximum storage time indicates the upper limit of the time that the quality control sample can be stored in the storage 210. The maximum use time indicates the upper limit of the time that the quality control sample can be guaranteed even if it exists in a room temperature environment. If the time that the quality control sample exists in a room temperature environment in one use is almost constant, the maximum number of uses may be used instead of the maximum use time. For example, if the time it takes for the quality control sample to be taken out of the storage 210 and to return to the storage 210 via multiple analysis devices 190 is 5 minutes, the maximum use time of 20 minutes corresponds to the maximum number of uses of 4 times. Note that the maximum number of uses may be set separately from the maximum use time, taking into consideration the increased risk of contamination accompanying the measurement of the quality control sample.

[0032] 5 is a flow diagram showing steps for determining whether or not the quality control sample can be stored. 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 discard box 210B. When the quality control sample is transported 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 facility 210 to transport the quality control sample to the storage unit 130 or discard it in the discard 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 discard 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 manner, 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 notified from the analysis device 190, the operation unit 101 ensures the quality of the quality control sample by checking at a predetermined confirmation interval whether there is any quality control sample that has exceeded the maximum storage time. If the check reveals that there is a quality control sample that has exceeded the maximum storage time, the storage 210 transports the quality control sample to the storage unit 130 or discards it in the discard box 210B.

[0037] In the conventional automatic analysis system, the quality control samples that have been measured by each analyzer are left at room temperature in the storage section of each analyzer, so that the operator must discard the quality control samples that have deteriorated after being left for a long time and replace them with new quality control samples. However, according to this embodiment, the quality control samples that have been measured by the analyzer 190 are returned to the storage 210 and stored in a refrigerator, so that they are not left in a room temperature environment for long periods of time and can be used for repeated measurements. In addition, in this embodiment, the quality control samples that have been returned to the storage 210 are not all stored, but are stored only if certain conditions are met, so that 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 being notified by the analytical device 190. EXAMPLES

[0039] When one quality control sample is transported sequentially to different analyzers 190 as in the first embodiment, 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 analyzers 190. Therefore, in the second embodiment, unlike the first embodiment, the dispensing unit 170 dispenses the quality control sample into another empty sample container 200, and the dispensed multiple dispensed samples are transported individually to the different analyzers 190.

[0040] 6 is a flow diagram showing the operation of the automatic analysis system according to the second embodiment. First, similarly to the first embodiment, each analysis device 190 notifies the operation unit 101 of quality control sample request information based on a rule registered in advance therein (step S301). Next, the operation unit 101 instructs the storage 210 to take out the target quality control sample (step S302). In response to this, the storage 210 takes out the target quality control sample, and the transport unit 120 transports the quality control sample to the dispensing unit 170 (step S303).

[0041] Then, in the dispensing unit 170, the quality control sample is dispensed into an empty sample container 200 other than the sample container containing the transported quality control sample. A barcode label is attached to each empty sample container 200 by the child sample container generation unit 160. This barcode label has information indicating that it 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. Also, this barcode label has attribute information recorded in characters or the like that allows the operator to identify it as a quality control sample.

[0042] Thereafter, the quality control sample to be dispensed is transported by the transport unit 120 to the storage 210 (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 preregistered 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 quality control sample in the storage 210 (step S307).

[0043] On the other hand, the dispensing sample is transported by the transport unit 120 to the analysis device 190 that sent the quality control request information (step S305). When the measurement in the analysis device 190 is completed, the transport unit 120 returns the dispensing sample from the analysis device 190 to the storage 210 (step S308). Note that the dispensing sample may also be transported to a plurality of analysis devices 190 in sequence and used for measurement in each analysis device 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 table registered in advance 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 210 only when predetermined conditions are met, so the accuracy of the quality control can be guaranteed.

[0045] In addition, since the dispensed sample is usually produced in an amount to be used by the target analysis device 190, even if it is returned to the storage 210, the remaining capacity is insufficient and the dispensed sample 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 analysis device 190 is completed and the measurement data is obtained. The reason for this is that, if the result of the quality control is inappropriate, it is necessary to determine whether the quality control sample or the analysis device 190 is defective. 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 result of the quality control is 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] 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. Also, 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. Also, it is possible to add, delete, or replace a part of the configuration of each embodiment with another configuration. [Explanation of symbols]

[0047] 101:Operation unit 110: Input section 120: Transport section 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: Daughter sample container generating unit 170: Dispensing section 180: Cap section 190: Analyzer 191: Sample dispensing mechanism 192: Reagent dispensing mechanism 193: Reagent disk 194: Reaction disk 195:Detection mechanism 196: Conveyor line 200: Sample container 210: Storage 210A: Tray for quality control samples 210B: Disposal box

Claims

1. An automatic analysis system comprising a plurality of analysis devices, a transport unit to which the analysis devices are connected, and an operation unit that operates the transport unit to transport samples to the analysis devices, A common storage unit is provided for storing quality control samples that can be supplied to the plurality of analytical devices; the operation unit operates the storage unit in accordance with a rule registered in advance for each of the plurality of analytical devices, and automatically transports the quality control sample to the analytical device; An automatic analysis system in which the quality control sample, after measurement by the analytical device, is returned to the storage facility by the transport unit, and after the quality control results are available, the storage facility either discards the quality control sample that was temporarily stored or transports it to a storage unit outside the storage facility.

2. 2. The automated analysis system according to claim 1, When the analysis device notifies the operation unit of information that triggers quality control, The operation unit instructs the storage unit to remove the quality control sample, The transport unit is an automatic analysis system that transports the quality control sample to the analysis device.

3. 2. The automated analysis system according to claim 1, The rule includes at least one of the following: the type of sample used for quality control, the time interval for performing quality control, and the number of measurements of general samples that are a condition for performing quality control.

4. 2. The automated analysis system according to claim 1, The storage facility is an automatic analysis system that stores the returned quality control sample if none of the maximum storage time of the quality control sample, the maximum usage time of the quality control sample, or the maximum number of uses of the quality control sample has been exceeded.

5. 2. The automated analysis system according to claim 1, A dispensing unit that dispenses the quality control sample, An automatic analysis system in which a plurality of dispensed samples dispensed by the dispenser are transported to different analyzers.

6. 2. The automated analysis system according to claim 1, A dispensing unit that dispenses the quality control sample, The sample dispensed by the dispenser is transported to the analyzer, The quality control sample from which the sample is dispensed is transported to the repository, and if it satisfies predetermined conditions, it is stored in the repository.

7. 2. The automated analysis system according to claim 1, A plurality of the storage units are provided, An automated analysis system in which each repository supplies the quality control samples to a plurality of the analysis devices.

8. 6. The automated analysis system according to claim 5, When the measurement in the analyzer is completed, the transport unit returns the dispensed sample from the analyzer to the storage unit, and the storage unit stores the dispensed sample when a predetermined condition is satisfied.

Images