Automatic analyzer and control method thereof

By controlling the analysis module in the automated analysis equipment, it is prohibited to analyze measurement items that require calibration or accuracy control, which solves the problem of reduced analysis processing speed and realizes rapid analysis and efficient processing of biological samples.

JP7673216B2Active Publication Date: 2025-05-08HITACHI HIGH TECH CORP
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Patent Information

Application Number
JP2023546797
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2021-09-08
Filing Date
2022-06-30
Publication Date
2025-05-08
Estimated Expiration
2042-06-30

AI Technical Summary

Technical Problem

When existing automated analytical equipment analyzes biological samples, if multiple measurement items include items that require calibration or accuracy control, it may lead to reduced analysis processing speed.

Method used

Through the control analysis module, the analysis of measurement items that require calibration or accuracy control is prohibited, and only the analysis of items that do not require these measurements is allowed, thereby increasing the speed of analysis processing.

Benefits of technology

Improve the analysis processing speed of automated analysis equipment, ensure rapid analysis of biological samples, while avoiding analysis bottlenecks due to calibration or accuracy control delays.

✦ Generated by Eureka AI based on patent content.

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Abstract

The objective of the present invention is to provide an automated analyzing device which enables an improvement in analysis processing speed. This automated analyzing device is provided with an analysis module for analyzing a sample, and a control unit for controlling the analysis module, characterized in that the control unit controls the analysis module such that, among a plurality of measurement items registered in the analysis module, analysis of a biological sample supplied from a subject is prohibited with respect to measurement items for which calibration or accuracy control measurement is indicated, and analysis of the biological sample is permitted with respect to measurement items for which calibration and accuracy control measurement are not indicated.
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Description

[Technical field]

[0001] The present invention relates to an automatic analyzer for analyzing biological samples such as blood and urine. [Background technology]

[0002] In an automatic analyzer that automatically performs qualitative or quantitative analysis of specific components contained in a biological sample such as a subject's blood or urine, calibrators and quality control samples, which are samples with known concentrations, are periodically analyzed to maintain analytical accuracy. In addition, to prevent the calibrators and quality control samples from being mixed with biological samples provided by subjects, the analyzer is generally controlled so that the biological samples are not analyzed until the analysis of the calibrators and quality control samples is completed.

[0003] However, in an automated analyzer equipped with multiple analytical modules, if an analytical module that has finished analyzing calibrators and quality control samples and is capable of analyzing biological samples is controlled so that biological samples are not analyzed, the analytical processing speed may decrease.

[0004] Patent document 1 discloses that in order to avoid slowing down the analytical processing speed of an automatic analyzer, the transport of biological samples to analysis modules to which calibrators and quality control samples are transported is prohibited, and the transport of biological samples to other analysis modules is permitted. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Patent No. 4919677 Summary of the Invention [Problem to be solved by the invention]

[0006] However, in Patent Document 1, there is insufficient consideration given to the case where the multiple measurement items registered in the analysis module of the automatic analyzer include a measurement item that can be used to analyze a biological sample after the analysis of a calibrator or quality control sample has been completed. In other words, even if the analysis of a calibrator or quality control sample has been completed, the measurement items registered in the analysis module to which the calibrator or quality control sample is transported may not be performed, resulting in a decrease in the analysis processing speed.

[0007] SUMMARY OF THE PRESENT EMBODIMENTS An object of the present invention is to provide an automatic analyzer that enables an improvement in the analysis processing speed. [Means for solving the problem]

[0008] In order to achieve the above-mentioned object, the present invention provides an automatic analysis device comprising an analysis module for analyzing a sample and a control unit for controlling the analysis module, wherein the control unit controls the analysis module to prohibit analysis of a biological sample provided by a subject for measurement items for which calibration or quality control measurement is instructed among a plurality of measurement items registered in the analysis module, and to permit analysis of the biological sample for measurement items for which calibration or quality control measurement is not instructed.

[0009] The present invention is also characterized by a control method for an automatic analyzer equipped with an analysis module for analyzing samples, which controls the analysis module so as to prohibit analysis of a biological sample provided by a subject for a measurement item for which calibration or quality control measurement is instructed among a plurality of measurement items registered in the analysis module, and to permit analysis of the biological sample for a measurement item for which calibration or quality control measurement is not instructed. Effect of the Invention

[0010] According to the present invention, it is possible to provide an automatic analyzer that enables an improvement in the analysis processing speed. [Brief description of the drawings]

[0011] [Figure 1] FIG. 1 is a diagram showing an example of the configuration of an automatic analyzer. [Diagram 2] FIG. 13 is a diagram showing an example of an analysis module table. [Diagram 3] FIG. 2 is a diagram showing a processing flow of the first embodiment. [Figure 4] FIG. 13 is a diagram showing an example of a sample ID table. [Diagram 5] FIG. 4 is a diagram showing a part of the processing flow of the first embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] Hereinafter, an embodiment of an automatic analyzer according to the present invention will be described with reference to the accompanying drawings. EXAMPLES

[0013] An example of the configuration of the automatic analyzer will be described with reference to Fig. 1. The automatic analyzer includes an input unit 103, an ID reader 104, a transport line 105, three analysis modules 110, a branch unit 108, a waiting unit 109, a discharge unit 106, and a control unit 101. Note that the number of analysis modules 110 is not limited to three, and may be one or more. Each unit will be described below.

[0014] The input section 103 is input with a sample container 102 that contains a biological sample such as blood or urine provided by a subject, a calibrator that is a sample with a known concentration, and a quality control sample. The sample container 102 may be placed on a dish-shaped carrier and input into the input section 103. The sample container 102 may be input into the input section 103 manually by a user or automatically by an external transport system. The sample container 102 input into the input section 103 is transported to the ID reader 104, the analysis module 110, the branch section 108, the standby section 109, and the discharge section 106 by the transport line 105 and the return line 107. The return line 107 is a transport path that transports the sample container 102 from downstream to upstream of the transport line 105.

[0015] The ID reader 104 is a device, such as a barcode reader or an RFID reader, that reads the sample ID, which is an identifier given to the sample container 102. The sample ID is associated in advance with attribute information relating to the sample contained in the sample container 102, such as a reception number, the subject's name, and requested measurement items, which are requested measurement items.

[0016] The analysis module 110 is a device that dispenses and analyzes the sample contained in the sample container 102 based on the requested measurement items. Since there are a wide variety of measurement items, several measurement items are registered for each of the multiple analysis modules 110 and stored in an analysis module table 201 illustrated in Fig. 2. The analysis module table 201 has columns for analysis module name 202 and measurement item 203, and stores which measurement items have been registered for each analysis module. In the analysis module table 201 in Fig. 2, measurement item A and measurement item D are registered in analysis module α, measurement item B in analysis module β, and measurement item C in analysis module γ.

[0017] Furthermore, in each of the analysis modules 110, in order to maintain the analytical accuracy of the registered measurement items, calibration using a calibrator and quality control measurement using a quality control sample are periodically performed. When a calibration or quality control measurement is instructed, the contents stored in the analysis module table 201 are updated to, for example, "calibration in progress." Furthermore, when the calibration or quality control measurement is completed, the measurement items registered in each analysis module become measurable, and the contents stored in the analysis module table 201 are updated to "measurable."

[0018] Branching section 108 is provided at the connection between transport line 105 and return line 107, and sets the transport destination of sample container 102 to either return line 107 or discharge section 106 based on the implementation status of the requested measurement items associated with the sample ID of sample container 102. In other words, if all requested measurement items associated with the sample ID have been implemented, sample container 102 is transported to discharge section 106, and if there are requested measurement items that have not been implemented, sample container 102 is transported to return line 107.

[0019] The waiting section 109 is provided in the middle of the return line 107 and allows the transported sample container 102 to wait. When a predetermined condition is satisfied, the sample container 102 waiting in the waiting section 109 is transported upstream on the transport line 105.

[0020] The sample container 102 for which all requested measurement items have been performed is discharged from the discharge unit 106. The sample container 102 may be discharged from the discharge unit 106 manually by a user or automatically by an external transport system.

[0021] The control unit 101 is a device, such as a computer, that controls the operation of each unit included in the automatic analyzer and executes processes related to analysis.

[0022] The flow of the process executed in the first embodiment will be described step by step with reference to FIG.

[0023] (S301) Sample containers 102 containing biological samples, calibrators, and quality control samples are placed in the loading section 103. A sample ID is assigned to the sample containers 102. The sample containers 102 placed in the loading section 103 are transported to an ID reader 104 by a transport line 105.

[0024] (S302) The ID reader 104 reads the sample ID of the sample container 102. The read sample ID is transmitted to the control unit 101.

[0025] (S303) The control unit 101 acquires the requested measurement items by checking the received sample ID against a sample ID table 401 illustrated in Fig. 4. The sample ID table 401 has columns of sample ID 402, sample type 403, and requested measurement items 404. That is, the sample ID table 401 stores what sample type the sample contained in the sample container 102 of each sample ID is, and what measurement items have been requested for that sample. The sample ID table 401 in Fig. 4 stores that a calibrator is contained in the sample container 102 with a sample ID of 1 and measurement item A has been requested, and that a biological sample is contained in the sample container 102 with a sample ID of 2 and measurement items A to D have been requested.

[0026] (S304) The control unit 101 determines whether the sample type is a biological sample. If the sample type is a biological sample, the process proceeds to S305. If the sample type is not a biological sample but a calibrator or quality control sample, the process proceeds to S313, and the analysis module 110 is instructed to perform calibration or quality control measurement.

[0027] (S305) The control unit 101 determines whether or not the requested measurement items acquired in S303 include any requested measurement items for which calibration or quality control measurement is instructed. If there are any requested measurement items for which calibration or quality control measurement is instructed, the process proceeds to S306, and if there are no requested measurement items for which calibration or quality control measurement is instructed, the process proceeds to S307. For example, the analysis module table 201 is referenced to determine whether or not there are any requested measurement items for which calibration or quality control measurement is instructed.

[0028] (S306) The control unit 101 prohibits the execution of the requested measurement items for which calibration or quality control measurement has been instructed.

[0029] (S307) The control unit 101 causes the analysis module 110 to carry out the requested measurement items. However, the requested measurement items that are prohibited in S306 are not carried out. In other words, the requested measurement items that are not prohibited are allowed to be carried out.

[0030] (S308) The control unit 101 determines whether or not all of the requested measurement items of the biological sample have been performed. If all of the requested measurement items have been performed, the process proceeds to S309, and if there are any requested measurement items that have not been performed, the process proceeds to S310.

[0031] (S309) The control unit 101 causes the sample container 102 to be transported to the discharge unit 106 via the branch unit 108 and the transport line 105 .

[0032] (S310) The control unit 101 causes the sample container 102 to be transported to the waiting unit 109 via the branch unit 108 and the return line 107 .

[0033] (S311) The control unit 101 judges whether or not the requested measurement items that were prohibited in S306 have been permitted. If any of the requested measurement items have been permitted, the process proceeds to S312, and if no of the requested measurement items have been permitted, the process of S311 is repeated.

[0034] (S312) The control unit 101 transfers the sample container 102 to the analysis module 110 via the return line 107 and the transfer line 105. Thereafter, the requested measurement item is carried out in S307.

[0035] (S313) When calibration or quality control measurement is instructed, the control unit 101 updates the status of the analysis module. Specifically, the content stored in the analysis module table 201 is updated to, for example, "calibration in progress." Note that the content is updated only for the measurement item for which calibration or quality control measurement is instructed. After the update, the process proceeds to S309.

[0036] The control unit 101 performs the process of FIG. 5 in parallel with the process of FIG.

[0037] (S501) The control unit 101 determines whether the instructed calibration or quality control measurement has been completed. If the instructed calibration or quality control measurement has been completed, the process proceeds to S502, and if not, the process of S501 is repeated.

[0038] (S502) The control unit 101 updates the status of the analysis module when calibration or quality control measurement is completed. Specifically, the content stored in the analysis module table 201 is updated to, for example, "measurable." Note that the content is updated only for measurement items for which calibration or quality control measurement has been completed.

[0039] The above-described process flow can improve the analysis processing speed. That is, only the measurement items for which calibration or quality control measurement is instructed are prohibited, and the measurement items for which calibration or quality control measurement is not instructed are permitted, so that the sample containers 102 that can be measured are analyzed without delay.

[0040] Furthermore, in an automatic analyzer equipped with multiple analysis modules, sample containers 102 for which the requested measurement item is prohibited from being performed are stored together in the waiting section 109, so that there is no need to provide space in each analysis module 110 for storing sample containers 102 on standby, and the automatic analyzer can be made smaller.

[0041] Note that even if the requested measurement item is prohibited from being performed in S306, it may be permitted to be performed for the measurement item having the past measurement results of calibration or quality control measurement. By permitting the performance of the measurement item having the past measurement results, the biological sample can be analyzed promptly without waiting for the completion of the calibration or quality control measurement. However, whether or not to use the past measurement results of the calibration or quality control measurement may be switched by the user via the setting screen of the control unit 101. Also, the control unit 101 may switch whether or not to use the past measurement results depending on the priority of the biological sample. For example, the past measurement results may be used preferentially in order to quickly obtain the measurement results of a biological sample with high urgency and high priority.

[0042] Furthermore, even if calibration or quality control measurement is not instructed, the measurement item may be prohibited from being performed if there is no calibration or quality control measurement result. By prohibiting the performance of a measurement item for which there is no calibration or quality control measurement result, it is possible to prevent erroneous analysis from being performed.

[0043] The above describes the embodiments of the present invention. The present invention is not limited to the above embodiments, and the components may be modified without departing from the scope of the invention. In addition, the components disclosed in the above embodiments may be appropriately combined. Furthermore, some components may be deleted from all the components shown in the above embodiments. [Explanation of symbols]

[0044] 101: control unit, 102: sample container, 103: input unit, 104: ID reader, 105: transport line, 106: discharge unit, 107: return line, 108: branch unit, 109: standby unit, 110: analysis module, 201: analysis module table, 202: analysis module name, 203: measurement item, 401: sample ID table, 402: sample ID, 403: sample type, 404: measurement request item

Claims

1. An automated analyzer comprising an analysis module for analyzing a sample and a control unit for controlling the analysis module, The control unit controls the analysis module to prohibit analysis of biological samples provided by a subject for measurement items for which calibration or quality control measurements are instructed among a plurality of measurement items registered in the analysis module, and to permit analysis of the biological samples for measurement items for which calibration or quality control measurements are not instructed.

2. The automated analyzer according to claim 1 , The automatic analyzer according to claim 1, wherein the control unit causes a biological sample for which analysis is prohibited to wait in a waiting unit.

3. The automated analyzer according to claim 2, The automatic analyzer according to claim 1, wherein the control unit, when the calibration or the quality control measurement is completed, transports a biological sample for which analysis is prohibited from the standby unit to the analysis module.

4. The automated analyzer according to claim 1 , The control unit controls the analysis module to allow analysis of the biological sample for measurement items that have past measurement results of the calibration or the quality control measurement, even if the measurement items are instructed to be calibrated or the quality control measurement.

5. The automated analyzer according to claim 1 , The control unit controls the analysis module to prohibit analysis of the biological sample for measurement items that do not have measurement results for the calibration or quality control measurement, even if the calibration or quality control measurement is not instructed for the measurement item.

6. A method for controlling an automated analyzer including an analysis module for analyzing a sample, comprising the steps of: A control method characterized by controlling the analysis module so as to prohibit analysis of biological samples provided by a subject for measurement items for which calibration or quality control measurement is instructed among a plurality of measurement items registered in the analysis module, and to permit analysis of the biological samples for measurement items for which calibration or quality control measurement is not instructed.

Citation Information

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