Automated analysis system

Abstract

The object of the present invention is to provide an automated analysis system that minimizes the time required for precision management even in situations requiring a large number of precision-managed samples. Therefore, the automated analysis system of the present invention comprises: multiple analysis devices (190); a transport unit (120) connecting the analysis devices (190); and an operation unit (101) that operates the transport unit (120) to transport samples to the analysis devices (190). In this automated analysis system, a common storage container (210) is provided for storing precision-managed samples that can be supplied to the multiple analysis devices (190). The operation unit (101) operates the storage container (210) according to rules pre-registered for each of the multiple analysis devices (190), automatically transporting the precision-managed samples to the analysis devices (190).

Description

Technical Field

[0001] This invention relates to an automated analysis system that connects multiple analysis devices. Background Technology

[0002] The automated analysis device adds reagents that specifically react with certain components contained in samples such as blood and urine, and performs qualitative / quantitative analysis by measuring the absorbance and luminescence of the reaction solution.

[0003] In such automated analytical devices, to ensure the reliability of the analytical results, calibration curve correction operations (calibration) are performed as needed to obtain the calibration curve, and precision management is implemented to confirm the appropriateness of the calibration curve. However, this method and the types of samples used (calibration samples, precision management samples) are very diverse, making handling and management complicated.

[0004] Furthermore, regarding the handling and management of precision-managed samples, the following techniques are known. For example, Patent Document 1 describes an automatic analysis device that connects multiple functional modules, in which a cooling unit for storing precision-managed samples is provided in each module, and the precision-managed samples are used in each module as needed. Furthermore, Patent Document 2 describes an automatic analysis device that performs modulation processing to enable the use of precision-managed samples within a preset time, and includes a storage unit for storing the modulated precision-managed samples.

[0005] Prior technology documents

[0006] Patent documents

[0007] Patent Document 1: JP 2015-57617

[0008] Patent Document 2: JP 2015-135282 Summary of the Invention

[0009] The problem that the invention aims to solve

[0010] In the existing automated analysis systems mentioned in Patent Documents 1 and 2, the input of precision management samples for each module ultimately relies on operators, which increases the overall operation time required for precision management. In particular, depending on the type of precision management, there are situations requiring a large number of precision management samples, making it difficult to store large quantities of precision management samples in each module or for operators to input such large quantities.

[0011] The purpose of this invention is to provide an automated analysis system that reduces the time required for precision management, even in situations where a large number of samples need to be managed with high precision.

[0012] Methods for solving problems

[0013] To achieve the above objectives, the automatic analysis system of the present invention includes: a plurality of analytical devices; a transport unit connected to the analytical devices; and an operation unit that operates the transport unit to transport samples to the analytical devices. The automatic analysis system also includes: a common storage container for storing precision-managed samples that can be supplied to the plurality of analytical devices; the operation unit operates the storage container according to rules pre-registered for each of the plurality of analytical devices, automatically transporting the precision-managed samples to the analytical devices.

[0014] The effects of the invention

[0015] According to the present invention, an automated analysis system can be provided that reduces the time required for precision management, even in cases where a large number of samples require precision management. Attached Figure Description

[0016] Figure 1 This is a schematic diagram showing the overall structure of the automated analysis system involved in the implementation method.

[0017] Figure 2 This is a top view showing the structure of the vault involved in the implementation method.

[0018] Figure 3 This is a flowchart illustrating the actions in the automatic analysis system involved in Embodiment 1.

[0019] Figure 4 It is a table showing the storage conditions related to precision management samples.

[0020] Figure 5 This is a flowchart illustrating the steps involved in determining the suitability of storing samples for precision management.

[0021] Figure 6 This is a flowchart illustrating the actions in the automatic analysis system involved in Embodiment 2. Detailed Implementation

[0022] Figure 1 This is a schematic diagram showing the overall structure of the automated analysis system according to an embodiment of the present invention. The automated analysis system according to this embodiment is as follows: Figure 1 As shown, it includes an input section 110, a transport section 120, a centrifugation section 140, a plug opening section 150, a sample container generation section 160, a dispensing section 170, a plug closing section 180, a storage section 130, multiple analytical devices 190, an operation section 101, and a storage unit 210.

[0023] Here, the input unit 110 is a component used to input a sample container 200 (test tube) containing samples (examinees) such as blood and urine into the automated analysis system. The input unit 110 is equipped with a sample identification unit 121, an embolus detection unit 122, and a carrier identification unit 125. The sample identification unit 121 reads the barcode attached to the sample container 200 to identify the sample being transported. The embolus detection unit 122 takes an image of the sample container 200 and analyzes the image to determine the type of sample container 200, the presence or absence of an embolus, and its type. The carrier identification unit 125 reads the ID information of the carrier attached to the sample container 200. Carrier identification units 135, ..., 175, 185, and 215, corresponding to this carrier identification unit 125, are respectively located within the automated analysis system.

[0024] Next, the transport unit 120 is a mechanism that transports the sample container 200 fed from the input unit 110 and the sample containers (sub-containers) dispensed in the dispensing unit 170 to various parts such as the centrifugation unit 140, the dispensing unit 170, and the analysis device 190. The centrifugation unit 140 is a component that centrifuges the input sample container 200 and separates the sample into serum components and blood clot components. The plug-opening unit 150 is a component for opening the plug from the input sample container 200. The subsample container generation unit 160 is a component that prepares the sample contained in the input sample container 200 for dispensing in the subsequent dispensing unit 170, for example, for preparing new sample containers (sub-containers) and affixing barcode labels to the prepared sample containers 200. The dispensing unit 170 is a component that further subdivides the centrifuged serum components into other empty sample containers (sub-containers) for analysis in the analysis device 190, described later. The closing section 180 is an assembly used to close the processed sample container 200 and sub-containers. The storage section 130 is an assembly used to store the sample container 200 and sub-containers closed by the closing section 180.

[0025] The analytical apparatus 190 is the destination for transporting processed samples from various parts of the automated analytical system, and is a component used for corrective / quantitative analysis of the sample composition. The analytical apparatus 190 includes a sample dispensing mechanism 191, a reagent dispensing mechanism 192, a reagent tray 193, a reaction tray 194, a detection mechanism 195, and a transport line 196 that forms part of the transport section 120.

[0026] Here, the sample dispensing mechanism 191 draws in and dispenses the sample from the sample container 200. The reagent tray 193 stores the reagents required for the sample's compositional analysis. Additionally, the reagent dispensing mechanism 192 draws in and dispenses the reagents. Furthermore, the detection mechanism 195 measures the optical properties of the mixture within the reaction unit of the reaction tray 194 and sends the measured data to the operation unit 101.

[0027] The operation unit 101 comprises a processor such as a CPU (Central Processing Unit), storage devices, communication devices, input devices, and a display device. This operation unit 101 controls the operations of various components within the automatic analysis system and analyzes the measurement data from the analysis device 190. Specifically, the control of the operations of each component within the automatic analysis system is as follows: Figure 6 As shown, the operation unit 101 can also be configured to give instructions for performing actions related to the aforementioned input unit 110, transport unit 120, centrifugation unit 140 and storage unit 210. In addition, if the number of analysis devices 190 increases, it can also be configured to be controlled by multiple separately provided operation units 101 for analysis devices 190 and pre-processing units respectively.

[0028] Unlike the cold storage used for reagents required for analysis, storage room 210 is a component used for the cold storage of prepared precision management samples and mixed serum (hereinafter referred to as "precision management samples").

[0029] In the automated analysis system of this embodiment, accuracy management is performed to maintain the accuracy of the analysis results in each analysis device 190 above a certain level. Here, rules are pre-registered for each analysis device 190 regarding the conditions under which accuracy management will be performed. These rules include, for example, provisions related to the time interval for performing accuracy management, such as performing accuracy management every 2 hours. Furthermore, other rules include provisions related to the number of measurements of general samples that constitute the conditions for performing accuracy management, such as performing accuracy management every 100 measurements of general samples. Moreover, when there are multiple types of samples used in accuracy management, information on the types of samples for accuracy management is also included in these rules. Additionally, the pre-registered rules do not necessarily have to be the same for each analysis device 190; they can be set differently.

[0030] Furthermore, in the automated analysis system of this embodiment, when multiple analytical devices 190 are connected and there are many samples to be measured, each analytical device 190 performs the same test. In this case, since each analytical device 190 typically starts measurement processing approximately simultaneously, there is a possibility that the timing required for accuracy management will also be approximately simultaneous. Therefore, when operators individually add accuracy management samples to each automated analytical device as in the past, it is difficult to add many accuracy management samples approximately simultaneously, and the time required for accuracy management will increase. However, in this embodiment, since the operation unit 101 operates the storage tank 210 according to rules pre-registered for each of the multiple analytical devices 190, automatically transporting the accuracy management samples to the given analytical device, the time required for accuracy management can be suppressed.

[0031] Here, the storage container 210 of this embodiment serves as a common storage container for storing precision-managed samples that can be supplied to multiple analytical devices 190. Figure 2 This is a top view showing the structure of the vault 210 according to this embodiment. The vault 210 of this embodiment is as follows... Figure 2 As shown, the system includes: a precision management sample tray 210A capable of holding a large number of sample containers 200; and a waste bin 210B for discarding unusable precision management samples per sample container 200. Furthermore, the sample containers 200 stored in the storage facility 210 are equipped with one-dimensional barcodes, RFID tags recording identification codes, etc., to enable identification of the precision management samples inside.

[0032] Assuming each analytical apparatus 190 has its own storage container, the number of precision-managed samples that can be stored is inevitably limited because it is difficult to ensure sufficient space for a large storage container in each analytical apparatus 190. In contrast, the storage container 210 of this embodiment can efficiently store precision-managed samples that can be supplied to multiple analytical apparatuses 190 in one place. In particular, depending on the type of precision management, there may be cases where a large number of precision-managed samples are needed even in a single analytical apparatus 190, but this can be addressed as long as a large number of precision-managed samples are stored in a dedicated storage container 210 as in this embodiment.

[0033] Furthermore, when a large number of precision-managed samples are required, multiple storage bins 210 can be set up, each supplying precision-managed samples to multiple analytical devices 190. Thus, even without a large storage bin 210, a certain number of precision-managed samples can be stored by combining multiple storage bins 210. Moreover, when precision-managed samples are simultaneously transported from one storage bin 210 to multiple analytical devices 190, there is a possibility that the downstream transport section 120 of the storage bin 210 may become congested, making transport difficult. However, if multiple storage bins 210 transport precision-managed samples from each storage bin 210 to each analytical device 190, ensuring that the transport paths of other storage bins 210 do not overlap, congestion in the transport section 120 can be alleviated, and the time required for precision management can be reduced.

[0034] The operation of the automatic analysis system involved in this embodiment will now be explained.

[0035] Example 1

[0036] Figure 3This is a flowchart illustrating the operations of the automated analysis system described in Embodiment 1. First, the operator fills the sample container 200 with precision management samples and places the sample container 200 into the precision management sample tray 210A in the storage room 210. Furthermore, the number of precision management samples to be placed and their placement positions are pre-registered via the operation unit 101, and the operator follows this registration information to perform the operation.

[0037] Then, each analysis device 190, based on its pre-registered rules, notifies the operation unit 101 as a precision management sample request information, which will trigger precision management (step S101). At this time, the operation unit 101 waits for 10 minutes after receiving the initial precision management request information to ensure it can also receive similar precision management request information from other analysis devices 190, and to determine whether one precision management sample can be used in the precision management of multiple analysis devices 190. Furthermore, the waiting time for the operation unit 101 to receive precision management requests from multiple analysis devices 190 can be set by the operation unit 101 according to the type of precision management (see reference). Figure 4 ).

[0038] If the waiting time has elapsed, the operation unit 101 instructs the storage unit 210 based on the precision management request information from the analysis device 190 to retrieve the sample container 200 of the precision management sample of the object being filled (step S102). Upon receiving this instruction, the storage unit 210 retrieves the sample container 200 of the object, and the transport unit 120 transports the sample container 200 (precision management sample) to the analysis device 190 that has notified the request (step S103). Then, the analysis device 190 performs measurements on the transported precision management sample.

[0039] Furthermore, when the operation unit 101 receives the same type of request from other analytical devices 190, the precision management sample used in the precision management of one analytical device 190 is also transported sequentially to the other analytical devices 190 via the transport unit 120 for use in the determinations in the other analytical devices 190. Therefore, it is not necessary to individually feed precision management samples to each analytical device 190. Here, in existing automated analysis systems, even for the same type of precision management, the operator must individually feed the precision management sample to each analytical device. According to this embodiment, the operator's work can be simplified.

[0040] Then, if the measurement in the analysis device 190 is completed, the transport unit 120 will send the precision management sample back from the analysis device 190 to the storage unit 210 (step S104). If the precision management sample arrives at the storage unit 210, the storage unit 210 will notify the operation unit 101 that the precision management sample has arrived (step S105).

[0041] Next, the operation unit 101 checks the parameters of the precision management sample returned to the storage room 210 against a pre-registered table to confirm whether they meet the conditions. If all conditions are met, the operation unit 101 instructs the storage room 210 to store the sample there (step S106). Additionally, the operation unit 101 checks the remaining capacity of the precision management sample. If the remaining capacity is low, the operation unit 101 instructs the storage room 210 to discard the precision management sample into the waste bin 210B.

[0042] Here, the operation unit 101 counts various parameters for each precision-managed sample, including the elapsed time (storage time) since it was initially set in the storage silo 210, the number of times it has been taken out of the storage silo 210 (usage times), and the time taken out of the storage silo 210 (usage time). Furthermore, if a precision-managed sample is used in multiple analytical devices 190 for measurement from the time it is taken out of the storage silo 210 until it is returned, the count is repeated multiple times.

[0043] Figure 4 This is a table showing the storage conditions related to precision-managed samples. In this table, the maximum storage time, maximum usage time, and maximum number of uses are recorded for each type of precision-managed sample. The maximum storage time represents the upper limit for the time the precision-managed sample can be stored in storage 210. The maximum usage time represents the upper limit for the time the quality of the precision-managed sample can be guaranteed even when it is at room temperature. If the time the precision-managed sample is at room temperature during a single use is approximately fixed, the maximum number of uses can be used instead of the maximum usage time. For example, if the time from when the precision-managed sample is transported from storage 210 to when it is returned to storage 210 via multiple analytical devices 190 is 5 minutes, the maximum usage time of 20 minutes is equivalent to a maximum of 4 uses. Furthermore, the maximum number of uses can be set separately from the maximum usage time, taking into account the increased risk of contamination during the measurement of the precision-managed sample.

[0044] Figure 5 This is a flowchart illustrating the steps involved in determining the suitability of storing samples for precision management. For example... Figure 5 As shown, for precision management samples returned to storage 210, operation unit 101 compares the current storage time in storage 210 with the maximum storage time (step S201). If the maximum storage time has been exceeded, operation unit 101 instructs storage 210 to transport the precision management sample to storage unit 130 (step S205). Operation unit 101 may also instruct storage 210 to discard the precision management sample to waste bin 210B instead of transporting the precision management sample to storage unit 130. Furthermore, when transporting precision management samples from storage 210 to storage unit 130, transport unit 120 is used.

[0045] If the maximum storage time is reached, the operation unit 101 compares the counted usage time with the maximum usage time (step S202). If the maximum usage time is exceeded, the storage unit 210 is instructed to transport the precision management sample to the storage unit 130 or discard it in the waste bin 210B (step S205).

[0046] Within the maximum usage time, the operation unit 101 compares the counted number of uses with the maximum number of uses (step S203). If the maximum number of uses is exceeded, the operation unit 101 instructs the storage unit 210 to transport the precision management sample to the storage unit 130 or to discard it in the waste bin 210B (step S205). Within the maximum number of uses, the operation unit 101 instructs the storage unit 210 to store the precision management sample (step S204).

[0047] Thus, in this embodiment, since the precision management sample is not stored if at least one of the following conditions is exceeded: the maximum storage time of the precision management sample, the maximum usage time of the precision management sample, or the maximum number of times the precision management sample can be used, the precision management accuracy can be guaranteed to be above a certain level.

[0048] Furthermore, in the automated analysis system of this embodiment, even if no precision management sample request is notified from the analysis device 190, the operation unit 101 ensures the quality of the precision management samples by checking at given time intervals whether there are any precision management samples that have exceeded the maximum storage time. If the check results show that there are precision management samples that have exceeded the maximum storage time, the storage unit 210 transports the precision management sample to the receiving unit 130 or discards it in the waste bin 210B.

[0049] In existing automated analysis systems, precision management samples from each analytical apparatus are stored at room temperature in their respective storage compartments after measurement. Therefore, samples that deteriorate due to prolonged storage must be discarded by the operator and replaced with new precision management samples. However, according to this embodiment, since the precision management samples from the analytical apparatus 190 are returned to the storage room 210 and refrigerated, they spend less time at room temperature and can be used in repeated measurements. Furthermore, in this embodiment, since not all precision management samples returned to the storage room 210 are stored, but only those meeting certain conditions are stored, thus ensuring the quality of the precision management samples.

[0050] In addition, in this embodiment, the analysis device 190 notifies the operation unit 101 of the precision management entrustment information at a given time according to its own rules. However, the rules of each analysis device 190 can also be pre-aggregated in the operation unit 101, and the operation unit 101 can make a precision management sample transportation instruction to the storage warehouse 210 without relying on the notification from the analysis device 190.

[0051] Example 2

[0052] As in Example 1, when a single precision management sample is sequentially transported to different analytical devices 190, there is a possibility that if the transport unit 120 becomes congested, it may take time to transport the precision management sample that has been measured in the first analytical device 190 to the second or subsequent analytical devices 190. Therefore, in Example 2, unlike Example 1, the precision management sample is dispensed into other empty sample containers 200 in the dispensing unit 170, and the multiple dispensed samples are transported individually to different analytical devices 190.

[0053] Figure 6 This is a flowchart illustrating the operations of the automated analysis system involved in Embodiment 2. First, similar to Embodiment 1, each analysis device 190 notifies the operation unit 101 of the precision management sample request information based on rules pre-registered in itself (step S301). Next, the operation unit 101 instructs the storage unit 210 to retrieve the precision management sample of the object (step S302). Upon receiving this instruction, the storage unit 210 retrieves the precision management sample of the object, and the transport unit 120 transports the precision management sample to the dispensing unit 170 (step S303).

[0054] Then, at the dispensing unit 170, the precision management sample is dispensed into empty sample containers 200, which are different from the sample containers into which the transported precision management sample was placed. Additionally, a barcode label is affixed to each empty sample container 200 at the sample container generation unit 160. This barcode label records information indicating that it is a precision management sample being dispensed, information about the precision management sample from which the dispensing originated, etc., as a one-dimensional barcode. Furthermore, the barcode label records attribute information, such as characters, that allows the operator to identify it as a precision management sample.

[0055] Next, the precision management sample of the injection source is transported to the storage warehouse 210 via the transport unit 120 (step S304). If the precision management sample of the injection source arrives at the storage warehouse 210, the storage warehouse 210 notifies the operation unit 101 of the arrival of the precision management sample (step S306). Next, for the precision management sample of the injection source, the operation unit 101 refers to a pre-registered table and, if all parameters meet the conditions, instructs the storage warehouse 210 to store it in the storage warehouse 210 (step S307).

[0056] On the other hand, the fractionated sample is transported via the transport unit 120 to the analysis device 190 that has sent the accuracy management request information (step S305). If the measurement in the analysis device 190 is completed, the transport unit 120 returns the fractionated sample from the analysis device 190 to the storage unit 210 (step S308). Furthermore, the fractionated sample can be transported sequentially to multiple analysis devices 190 for use in measurements in each analysis device 190. If the fractionated sample arrives at the storage unit 210, the storage unit 210 notifies the operation unit 101 of the arrival of the fractionated sample (step S309). Next, the operation unit 101 refers to a pre-registered form for the fractionated sample, and if all parameters meet the conditions, instructs the storage unit 210 to store it in the storage unit 210 (step S310).

[0057] According to this embodiment, even if multiple analysis devices 190 notify the operation unit 101 of accuracy management requests approximately simultaneously, the increased time required for accuracy management due to congestion in the transport unit 120 can be suppressed because the accuracy management samples can be dispensed in the dispensing unit 170 and the dispensed samples can be transported to each analysis device 190. Furthermore, since not only the original accuracy management samples but also the dispensed samples are stored in the storage room 210 only when given conditions are met, the accuracy of accuracy management can be guaranteed.

[0058] Furthermore, since the amount of dispensing sample typically only generated is the amount used in the analytical apparatus 190, even if it is returned to the storage silo 210, the remaining capacity is insufficient, and it is either discarded in the waste bin 210B or transported to the storage unit 130. However, it is desirable to temporarily store the dispensing sample in the storage silo 210 until the measurement of the precision management sample in the analytical apparatus 190 is completed and the measurement data is available. The reason for this is that if the precision management result is unsuitable, it can be determined whether the precision management sample is faulty or the analytical apparatus 190 is faulty. Therefore, even if the precision management sample containing the dispensing sample is discarded, it is temporarily stored in the storage silo 210, and the operation unit 101 remains on standby until the precision management result is available. If the analysis device 190 notifies the operation unit 101 of the result of the precision management (step S311), the operation unit 101 instructs the storage unit 210 to discard the temporarily stored precision management sample, etc. The storage unit 210 transports the precision management sample to the storage unit 130 or discards it in the waste box 210B.

[0059] Furthermore, while embodiments 1 and 2 have been described in detail for ease of understanding of the present invention, they are not necessarily limited to all the described structures. Moreover, a portion of the structure of one embodiment can be replaced with the structure of another embodiment; furthermore, structures of other embodiments can be added to the structure of one embodiment. Furthermore, other structures can be added to, deleted from, or replaced in relation to a portion of the structure of each embodiment.

[0060] Explanation of reference numerals in the attached figures

[0061] 101: Operation Section; 110: Input Section; 120: Transport Section; 121: Sample Identification Section; 122: Plug Detection Section; 125, 135, 175, 185, 215: Carrier Identification Section; 130: Storage Section; 140: Centrifugation Section; 150: Plug Opening Section; 160: Sub-sample Container Generation Section; 170: Dispensing Section; 180: Plug Closing Section; 190: Analytical Device; 191: Sample Dispensing Mechanism; 192: Reagent Dispensing Mechanism; 193: Reagent Tray; 194: Reaction Tray; 195: Detection Mechanism; 196: Transport Line; 200: Sample Container; 210: Storage Room; 210A: Precision Management Sample Tray; 210B: Waste Bin.

Claims

1. An automatic analysis system, comprising: Multiple analytical devices; a transport unit connected to the analytical devices; an operating unit that operates the transport unit to transport samples to the analytical devices; and a dispensing unit that dispenses samples with precision management capabilities. The automatic analysis system is characterized by the following features: The automated analysis system includes: a common storage facility for storing precision-managed samples that can be supplied to multiple analytical devices. The operating unit operates the storage facility according to pre-registered rules for each of the plurality of analytical devices, automatically transporting the precision-managed samples to the analytical devices. The aliquot sample dispensed in the aliquot section is transported to the analytical apparatus. The precision management sample, which is the dispensed sample after the measurement in the analytical device has been completed, is sent back to the storage unit via the transport unit. In order to determine whether the problem lies with the precision management sample or the analytical device if the precision management result is unsuitable, the precision management sample sent back to the storage unit is temporarily stored in the storage unit even if the remaining capacity is insufficient for disposal. After the precision management result is obtained, the storage unit will either discard the temporarily stored precision management sample or transport it to the receiving unit outside the storage unit. The storage facility stores the returned precision-managed sample provided that none of the maximum storage time, maximum usage time, or maximum number of uses of the precision-managed sample is exceeded.

2. The automatic analysis system according to claim 1, characterized in that, If the analysis device notifies the operation unit of the information that will trigger precision management, the operation unit instructs the storage unit to remove the precision management sample, and the transport unit transports the precision management sample to the analysis device.

3. The automatic analysis system according to claim 1, characterized in that, The rules include at least one of the following: the type of sample used in precision management, the time interval for implementing precision management, and the number of measurements of a general sample that constitutes the conditions for implementing precision management.

4. The automatic analysis system according to claim 1, characterized in that, Multiple samples dispensed in the dispensing unit are transported to different analytical devices.

5. The automatic analysis system according to claim 1, characterized in that, The precision management samples of the injection source are transported to the storage facility and stored thereunder, provided that given conditions are met.

6. The automatic analysis system according to claim 1, characterized in that, The automated analysis system includes: multiple vaults, Each storage facility supplies the precision-managed samples to multiple analytical devices.

7. The automatic analysis system according to claim 4, characterized in that, If the determination in the analytical device is completed, the transport unit will send the aliquot sample from the analytical device back to the storage facility, which will store the aliquot sample if given conditions are met.

Images