Automatic analysis device

Abstract

To provide an automatic analyzer capable of improving analysis throughput while reducing the consumption of standard samples and reagents.SOLUTION: The automatic analyzer includes: a control unit that is configured so as to, when a quality control sample is introduced after a standard sample is fed, request to measure a measurement item identical to the measurement item that is requested for the standard sample for the quality control sample as well; and a selection screen 201 on which the timing of measurement of the quality control sample with the same items as the measurement request item of the standard sample can be selected. The control unit starts measurement of the quality control sample when the timing selected on the selection screen 201 has reached. With this, an automatic analyzer that is capable of improving the analysis throughput while reducing the consumption of standard sample and reagents compared to conventional art is achieved.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] The present invention relates to an automatic analyzer for qualitative and quantitative analysis of biological samples such as serum and urine (hereinafter referred to as specimens).

Background Art

[0002] As an example of an automatic analyzer that reduces the operator's wasteful restraint time and does not waste reagents, Patent Document 1 describes that when analyzing a standard sample or a quality control sample, it determines the presence or absence of abnormalities in the analysis results, and when it is determined that the analysis results are abnormal, it stops the analysis operation of the quality control sample or the specimen. It is provided with a control determination unit.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] In automatic analyzers such as biochemical automatic analyzers and immunoautomatic analyzers that perform qualitative and quantitative analysis of specimens, dedicated reagents are registered and used for each analysis item.

[0005] Regarding the analysis item, using the previously registered reagent, the physical properties such as the absorbance and the intensity of scattered light of a specimen (standard specimen / calibrator) having a known concentration are measured in advance, and calibration curve data representing the relationship between each concentration and the measured value is created. Then, based on the created calibration curve data and analysis parameters such as preset analysis conditions, the concentration of the patient specimen is calculated.

[0006] In conventional automated analyzers, if a quality control sample is added immediately after a standard sample for creating a calibration curve, the analyzer automatically generates a measurement request for the same parameters as those requested for the standard sample, and then performs measurements on both the standard sample and the quality control sample.

[0007] Of these, standard samples are generally specimens provided as part of a clinical diagnostic reagent by a supplier of clinical diagnostic reagents. Quality control samples, on the other hand, are specimens with predetermined acceptable concentrations, and the signal output can be predicted if the instrument is calibrated with an appropriate standard sample. The purpose of quality control is to confirm the reliability of the instrument based on the measurement results of the standard sample.

[0008] If, as in the conventional method, a request for quality control samples is automatically generated and measured before outputting the measurement results for the standard sample, regardless of the measurement status or results of the standard sample, then if the measurement of the standard sample fails, quality control cannot be performed using the invalid, failed measurement results. Therefore, it is necessary to remeasure the standard sample to ensure a successful measurement before performing quality control again, which leads to the problem of wasting quality control samples and reagents.

[0009] Furthermore, the automatic generation of measurement requests for quality control samples is limited to the reagents used and the items requested for standard samples. Therefore, for reagents that are frequently measured, it is necessary to measure the reagents inherited from the quality control samples once the original reagent runs out.

[0010] In this case, for copy-calibration items, since measurement requests are not made using standard samples, requests for quality control samples are not automatically generated. Copy-calibration is a mechanism that allows the results of a standard sample measured for an item measurable with a certain reagent to be used for other items measurable with the same reagent.

[0011] When an operator is responsible for determining the measurement results of a standard sample, they must wait until the measurement results for the standard sample are output, confirm the results, and then request measurement of the quality control sample. This means that the quality control sample cannot be placed into the instrument immediately after the standard sample, resulting in a longer time commitment for the operator.

[0012] Furthermore, because the measurement of the quality control sample is performed only after the success or failure of the standard sample measurement results is determined, there was a problem in that it took a long time for the measurement results of the quality control sample to be output.

[0013] In contrast, the technology described in Patent Document 1 determines whether the standard sample and quality control sample have been measured based on mechanical malfunctions or the success or failure of the measurement results. If successful, the quality control sample and the sample are measured, but if the measurement of the standard sample fails, the analysis operation stops until the problem is resolved, which presents a challenge in that throughput needs to be improved.

[0014] Furthermore, as in the case mentioned above, there was the problem that it took a long time to obtain the results.

[0015] This invention provides an automated analyzer that reduces the consumption of standard samples and reagents compared to conventional systems, while also improving analytical throughput. [Means for solving the problem]

[0016] The present invention includes multiple means for solving the above problems, but to give one example, an automated analyzer for analyzing a sample comprises an analysis unit that performs the analysis of the sample, and a control unit that controls the operation of the analysis unit, wherein the control unit determines the measurement items to be requested for a quality control sample based on the measurement items requested for a standard sample, and the control unit Whether or not an abnormality occurred in the aforementioned standard sample, At one or more of the following timings: when the rack of the standard sample is recognized, during the dispensing operation, or at the start of the analysis: judgment The method is characterized by determining the transport of the quality control sample based on the result of the determination.

Advantages of the Invention

[0017] According to the present invention, it is possible to suppress the consumption of standard samples and reagents compared with the prior art, and improve the analysis throughput. Problems, configurations, and effects other than those described above will be clarified by the description of the following examples.

Brief Description of the Drawings

[0018] [Figure 1] It is a diagram showing an example of the configuration of an automatic analyzer according to an embodiment of the present invention. [Figure 2] It is a diagram showing an example of a measurement timing setting screen for an accuracy control sample in the automatic analyzer of the embodiment. [Figure 3] It is a diagram showing an example of a measurement determination flow for an accuracy control sample based on the measurement result of a standard sample in the automatic analyzer of the embodiment. [Figure 4] It is a diagram showing an example of a measurement determination flow for an accuracy control sample based on the measurement result of a standard sample in the automatic analyzer of the embodiment. [Figure 5] It is a diagram showing an example of a measurement timing setting screen for an accuracy control sample in the automatic analyzer of the embodiment. [Figure 6] It is a diagram showing an example of a measurement determination flow for an accuracy control sample based on the measurement status of a standard sample in the automatic analyzer of the embodiment. [Figure 7] It is a diagram showing an example of an automatic request generation flow when an accuracy control sample is input in the automatic analyzer of the embodiment. [Figure 8] It is a diagram showing an example of a temporary waiting location setting screen for an accuracy control sample in the automatic analyzer of the embodiment. [Figure 9] It is a diagram showing an example of an accuracy control necessity setting screen for an inheritance destination in the automatic analyzer of the embodiment. [Figure 10] It is a diagram showing an example of an accuracy control necessity setting screen for a copy calibration destination in the automatic analyzer of the embodiment.

Modes for Carrying Out the Invention

[0019] An embodiment of the automated analyzer of the present invention will be described with reference to Figures 1 to 10.

[0020] First, an overview of the automated analyzer will be explained using Figure 1. Figure 1 is a schematic diagram showing the overall configuration of the automated analyzer according to the present invention.

[0021] The automated analyzer 100 shown in Figure 1 consists of an input / output unit 1, an ISE (Ion Selective Electrode) analysis unit 2a, a biochemical analysis unit 2b, an immunoassay unit 2c, a transport line 9, temporary rack storage units 3 and 5, and an operation unit PC 7.

[0022] The loading / unloading section 1 is the part that supplies racks for supplying samples to each of the analysis sections 2a, 2b, and 2c, which will be described later. It has a mechanism for detecting when a rack is loaded and a mechanism for identifying the type of sample loaded in the loaded rack. For example, if the rack has an information storage medium such as a barcode or RFID, it is equipped with a reading means for reading these information storage media to identify information such as the time the rack was loaded, the type of rack, and consequently, the type of sample loaded in the rack.

[0023] Each analytical unit 2a, 2b, and 2c that performs the analysis of the sample is located along the transport line 9 and has dispensing lines 4, 6, and 8 that transport the racks to which each sample is dispensed.

[0024] The ISE analysis unit 2a is an analysis unit that measures the electrolyte concentration in a sample using an ion-selective electrode.

[0025] The biochemical analysis unit 2b is an analysis unit that mixes and reacts the sample and reagents in a reaction vessel (not shown) mounted on the reaction disk 2b1, and measures the absorbance of the reaction solution with a photometer to analyze the biochemical components in the sample.

[0026] The immunoassay section 2c is an analytical section for highly sensitive analysis of trace components in blood, such as hormones, by mixing and reacting the sample and reagents in a reaction vessel (not shown) mounted on the incubator 2c1.

[0027] The configuration of each of these analysis units 2a, 2b, and 2c is not particularly limited and can be a known configuration.

[0028] The transport line 9 consists of a transport belt, motor, etc., and supplies racks loaded into the loading / unloading section 1 to the respective analysis sections 2a, 2b, and 2c according to the analysis request. It also transports racks containing samples that have been analyzed in the analysis sections 2a, 2b, and 2c to the temporary rack storage sections 3 and 5, and transports racks containing samples for which no analysis request has been made back to the loading / unloading section 1. The transport line 9 is not limited to a belt system, and various transport devices such as electromagnetic transport systems can be used.

[0029] The temporary rack storage units 3 and 5 are line mechanisms that temporarily hold racks containing general samples, standard samples, and quality control samples, and transport the racks back to the respective analysis units 2a, 2b, and 2c, or the loading / unloading unit 1, at any desired timing. The detailed configuration is not particularly limited and only needs to be able to store multiple samples and allow random access. For example, it could be a disk-type temporary storage unit that can store multiple racks, or it could be a type of temporary storage unit that houses multiple racks on each of the lines that carry racks, and allows for the loading and unloading of any rack.

[0030] The control unit PC7 is an overall control device that controls the operation of each of the above-mentioned parts, and is a computer composed of a monitor 7a, an input device 7b, a storage medium 7c, a control unit 7d, etc. This control unit PC7 is connected to a printer (not shown), a host system in the laboratory or hospital (not shown), an external management server from the manufacturer (not shown), etc.

[0031] Monitor 7a is a display device such as an LCD that displays various information, including input screens for various parameters and settings, analysis data for initial and re-examinations, and measurement results. It may also consist of a touch panel display device that also serves as the input device 7b, which will be described later.

[0032] In this embodiment, monitor 7a displays selection screens 201, 501 (see Figure 2 or Figure 5) that allow the user to select the measurement timing for quality control samples with the same measurement request items as the standard sample. Details of selection screens 201, 501 will be described later.

[0033] The input device 7b consists of a keyboard and mouse for inputting various data such as parameters, settings, analysis request information, and instructions to start the analysis.

[0034] The storage medium 7c is a semiconductor memory such as flash memory or a magnetic disk such as an HDD that records attribute information (sample ID, reception number, patient name, requested analysis items, etc.) related to the sample placed in the automated analyzer 100, as well as the measurement results of the sample. The storage medium 7c also records various parameters and settings for controlling the operation of each device in the automated analyzer 100, as well as various computer programs for executing various processes described later.

[0035] The control unit 7d controls the overall operation of the automated analyzer 100, including each analysis unit 2a, 2b, 2c, the transport line 9, and the temporary rack storage units 3, 5, and is composed of a CPU and other components.

[0036] In this embodiment, when a quality control sample is added after a standard sample has been added, the control unit 7d requests the same measurement items for the quality control sample as those requested for the standard sample. The control unit 7d then executes control to start measuring the quality control sample when the timing selected on selection screen 201,501 is reached. The details will be described later.

[0037] The above describes the configuration of the automated analyzer 100.

[0038] In the automated analyzer 100 shown in Figure 1, one module each of the ISE analysis unit 2a, biochemical analysis unit 2b, and immunoassay unit 2c are shown as an example, totaling three modules. However, an automated analyzer to which the present invention is suitably applied only needs to include at least one of each analysis unit 2a, 2b, and 2c, and its details are not particularly limited. Furthermore, modules for performing various pre- and post-processing steps may be provided as appropriate, and the transport line 9 and rack temporary storage units 3 and 5 may be omitted.

[0039] The analysis of samples by the automated analyzer 100 described above is generally performed in the following order.

[0040] A rack containing multiple samples to be analyzed by the automated analyzer 100 is placed in the loading / unloading section 1 by the user. After placement, the information storage medium, such as barcodes attached to the rack and samples, is read by a sample type identification mechanism located near the transport line 9, and the rack is recognized.

[0041] The control unit 7d confirms the requested information on the operation unit PC7 and the sample information on the rack. In accordance with the analysis request assigned to the sample, the control unit 7d transports the rack installed in the loading / unloading unit 1 via the transport line 9 to the dispensing lines 4, 6, or 8 of one of the analysis units 2a, 2b, or 2c.

[0042] Each analysis unit 2a, 2b, and 2c uses a sample probe to aspirate samples from sample containers on the supplied racks and performs the analysis. After all analysis is completed, the racks are transported along the transport line 9 and stored in the temporary rack storage units 3 and 5, or the loading / unloading unit 1.

[0043] Here, the types of samples analyzed by each analysis unit 2a, 2b, and 2c of the automated analyzer 100 include patient samples, standard samples, and quality control samples.

[0044] Patient samples are samples with unknown component concentrations for the analytical items, and the component concentrations of the target analytical items in the patient samples are determined in each analytical unit 2a, 2b, and 2c.

[0045] Standard samples and quality control samples are specimens whose component concentrations for the analytical items are known. Standard samples are used to calculate calibration curves, which are relationship formulas between absorbance or luminescence measured by a photometer or detector and component concentration. Quality control samples are used for quality control (condition management) of the analytical items or equipment.

[0046] Next, Figures 2 to 4 will explain the details of the selection screen displayed on the monitor 7a of this embodiment for selecting the measurement timing of quality control samples with the same measurement request items as the standard sample, and an example of the flow of analysis control based on the selection results.

[0047] Figure 2 shows an example of the measurement timing setting screen for quality control samples, and Figures 3 and 4 show an example of the flow chart for determining whether or not to measure quality control samples based on the measurement results of standard samples.

[0048] In this embodiment, the measurement timing for quality control samples can be selected from a selection screen 201 displayed on monitor 7a, as shown in Figure 2.

[0049] In Figure 2, if the "Not Specified" area 202 is selected, the control unit 7d automatically generates a measurable request for the same items as those requested for the standard sample when a quality control sample is loaded while a standard sample is being analyzed or scheduled for analysis in the instrument. The control unit 7d then transports the standard sample and the quality control sample to the dispensing lines 4, 6, and 8 of the analysis units 2a, 2b, and 2c, and performs measurements on the standard sample and the quality control sample. After the measurements are completed, the control unit 7d outputs the measurement results for the quality control sample using the measurement results for the standard sample.

[0050] In contrast, if the "Successful Measurement of Standard Sample" area 203 in Figure 2 is selected, the control unit 7d automatically generates a measurable request for the same items as those requested for the standard sample when a quality control sample is loaded while a standard sample is being analyzed or scheduled for analysis in the instrument. The control unit 7d then transports the quality control sample to the dispensing lines 4, 6, and 8 of the analysis units 2a, 2b, and 2c, which are for standard samples only, and temporarily stores the quality control sample in the temporary storage rack units 3 and 5 until the measurement of the standard sample is completed.

[0051] Subsequently, when it is determined that there are no problems with the measurement results of the standard sample, the control unit 7d transports the racks containing the quality control samples from the temporary rack storage units 3 and 5 to the dispensing lines 4, 6, and 8 of the target analysis units 2a, 2b, and 2c, and starts measuring the quality control samples in the target analysis units 2a, 2b, and 2c.

[0052] Conversely, if it becomes clear that there is a problem with the measurement results of the standard sample, the quality control sample, which has been temporarily held in the temporary storage racks 3 and 5, is transported to the loading / unloading unit 1 and discharged outside the device.

[0053] Next, we will explain the process for determining whether a quality control sample can be measured based on the standard sample measurement conditions shown in Figure 2, using Figures 3 and 4. In Figures 3, 4, and 6, "A" refers to the standard sample and "B" refers to the quality control sample.

[0054] As shown in Figure 3, first, when the control unit 7d recognizes the racks on which the quality control samples have been loaded after the standard samples have been loaded (step S301), it automatically generates measurement requests for the same items as those requested for the standard samples for the quality control samples as well (step S302).

[0055] Next, the control unit 7d determines whether the "Not Specified" area 202 is selected on the screen shown in Figure 2 (step S303).

[0056] If the "Not Specified" area 202 is selected on the screen in Figure 2, the process proceeds to step S304, and the control unit 7d starts dispensing the standard sample and quality control sample (step S304). This starts the analysis of the standard sample and quality control sample (step S305). Subsequently, the control unit 7d outputs the measurement results of the standard sample (step S306), and then outputs the measurement results of the quality control sample using the measurement results of the standard sample (step S307).

[0057] In contrast, if the "Successful Measurement of Standard Sample" area 203 is selected on the screen in Figure 2 instead of the "Not Specified" area 202, the control unit 7d places the quality control sample on standby in the temporary rack storage units 3 and 5.

[0058] Next, when dispensing of the standard sample begins (step S308), the control unit 7d checks to see if there are any abnormalities or problems when the standard sample rack is recognized (step S309). For example, this could be a case where the samples necessary for measuring the standard sample are not all on the rack.

[0059] If a problem is confirmed in step S309, the quality control samples that were waiting in the temporary rack storage units 3 and 5 are removed (step S314), and the process is terminated by notifying the monitor 7a or the like of the occurrence of an abnormality.

[0060] In contrast, if it is confirmed that no problems occurred in step S309, the process proceeds to step S310. Then, when the analysis of the standard sample begins (step S310), the control unit 7d checks whether any problems occurred during the dispensing of the standard sample (step S311). For example, this could be due to insufficient sample volume for the standard sample, or insufficient sample volume for another item requested for the standard sample.

[0061] If a problem is confirmed in step S311, the quality control samples that were waiting in the temporary rack storage units 3 and 5 are removed (step S314), and the process is terminated by notifying monitor 7a, etc., of the occurrence of the abnormality.

[0062] In contrast, if it is confirmed that no problems occurred in step S311, the process proceeds to step S312. Then, the control unit 7d outputs the analysis results of the standard sample (step S312) and checks whether any problems occurred at the start of the analysis of the standard sample (step S313). For example, this could be due to a shortage of reagents or diluents used to measure the standard sample, or a shortage of reagents occurring due to the dispensing of reagents.

[0063] If a problem is confirmed in step S313, the quality control samples that were waiting in the temporary rack storage units 3 and 5 are removed (step S314), and the process is terminated by notifying monitor 7a, etc., of the occurrence of the abnormality.

[0064] If it is confirmed that no problems occurred in step S313, the process proceeds to step S401 in Figure 4.

[0065] As shown in Figure 4, the control unit 7d then checks whether any problems have occurred in the measurement results of the standard sample (step S401). For example, if there is a problem with the standard sample, it may be that a calibration curve has not been created from the measurement results of the standard sample, or the created calibration curve is abnormal.

[0066] If a problem is found in the standard sample and this is confirmed in step S401, the quality control sample that was waiting in the temporary storage racks 3 and 5 is removed (step S405), and the process is terminated by notifying the monitor 7a or the like of the abnormality.

[0067] If it is confirmed that no problems occurred in step S401, the process proceeds to step S402, where the control unit 7d dispenses the quality control sample (step S402), and the analysis of the quality control sample begins (step S403).

[0068] Subsequently, the control unit 7d outputs the measurement results of the quality control sample using the measurement results of the standard sample (step S404), and terminates the process.

[0069] Next, we will explain in detail another example of the selection screen displayed on the monitor 7a of this embodiment, and the details of the analysis control flow based on the selection results, using Figures 5 and 6. Figure 5 shows an example of the measurement timing setting screen for quality control samples, and Figure 6 shows an example of the flow for determining whether or not to measure quality control samples based on the measurement status of standard samples.

[0070] In this embodiment, the screen for selecting the measurement timing of quality control samples can be a selection screen 501, as shown in Figure 5, in addition to the selection screen 201 shown in Figure 2. In the selection screen 501 shown in Figure 5, in addition to the "No specification" area 502 and the "Analysis completion" area 506 shown in Figure 2, it is possible to select from two or more timings, such as the "Analysis start" area 505, the "Sample dispensing" area 504, and the "Rack recognition" area 503.

[0071] In Figure 5, if the "No specification" area 502 is selected, the same processing will occur as when the "No specification" area 202 is selected in Figure 2. Also, in Figure 5, if the "Analysis complete" area 506 is selected, the same processing will occur as when the "Standard sample measurement successful" area 203 is selected in Figure 2.

[0072] In Figure 5, when the "Rack Recognition" area 503 is selected, the same measurable requests for the same items as those requested for the standard sample are automatically generated for the quality control sample, as is the case when the "No Specification" area 502 is selected. This is also the case when the "Sample Dispensing" area 504 or the "Analysis Start" area 505 shown below are selected.

[0073] The control unit 7d then transports the standard samples to the dispensing lines 4, 6, and 8 of the analysis units 2a, 2b, and 2c, which only handle standard samples, while the quality control samples are temporarily stored in the rack temporary storage units 3 and 5 until the rack recognition of the standard samples in the analysis units 2a, 2b, and 2c is completed.

[0074] Subsequently, once it is determined that there are no problems with rack recognition of the standard sample, the control unit 7d transports the racks containing the quality control samples from the temporary rack storage units 3 and 5 to the dispensing lines 4, 6, and 8 of the analysis units 2a, 2b, and 2c, and starts measuring the quality control samples in the target analysis units 2a, 2b, and 2c.

[0075] Conversely, if it becomes clear that there is a problem with the rack recognition of the standard sample, the quality control sample that has been temporarily held in the temporary rack storage section 3,5 is transported to the loading / unloading section 1 and discharged outside the device. This is also the case when the "sample dispensing" area 504 or the "analysis start" area 505 shown below is selected.

[0076] In Figure 5, if the "Sample Dispensing" area 504 is selected, the control unit 7d transports the standard samples to the dispensing lines 4, 6, and 8 of the analysis units 2a, 2b, and 2c, which are for standard samples only, and the quality control samples are temporarily held in the temporary storage racks 3 and 5 until the dispensing of standard samples in the analysis units 2a, 2b, and 2c is completed.

[0077] Subsequently, once it is determined that there are no problems with the dispensing operation of the standard sample, the control unit 7d transports the racks containing the quality control samples from the temporary rack storage units 3 and 5 to the dispensing lines 4, 6, and 8 of the analysis units 2a, 2b, and 2c, and starts measuring the quality control samples in the target analysis units 2a, 2b, and 2c.

[0078] Furthermore, if the "Analysis Start" region 505 is selected in Figure 5, the control unit 7d transports the standard samples to the dispensing lines 4, 6, and 8 of the analysis units 2a, 2b, and 2c, which are only for standard samples, and the quality control samples are temporarily stored in the rack temporary storage units 3 and 5 until the analysis of the standard samples in the analysis units 2a, 2b, and 2c begins.

[0079] Subsequently, when it is determined that there are no problems at the start of analysis of the standard sample, the control unit 7d transports the racks containing the quality control samples from the temporary rack storage units 3 and 5 to the dispensing lines 4, 6, and 8 of the analysis units 2a, 2b, and 2c, and starts measuring the quality control samples in the target analysis units 2a, 2b, and 2c.

[0080] Thus, in this embodiment, once a quality control sample is loaded, the control unit 7d can determine whether the timing selected on the selection screen 501 has been reached, and also determine whether there is an abnormality in the standard sample.

[0081] Furthermore, in this case, the control unit 7d can promptly start measuring the quality control sample when it determines that the timing has been reached and there are no abnormalities, and when it determines that the timing has not been reached, it can make the quality control sample wait in the temporary rack storage units 3 and 5 until the timing selected on the selection screen 501 is reached.

[0082] Furthermore, the control unit 7d can interrupt the analysis of the quality control sample or remove it from the device without performing the analysis if it determines that there is an abnormality in the standard sample, regardless of whether the timing has been reached or not.

[0083] Next, we will explain, using Figures 6 and 4, the process for determining whether or not a quality control sample can be measured based on the standard sample measurement status shown in Figure 5.

[0084] As shown in Figure 6, first, the control unit 7d recognizes the racks on which the quality control samples are loaded after the standard samples have been loaded (step S601), and then automatically generates requests for the same items as those requested for the standard samples for the quality control samples (step S602).

[0085] Next, the control unit 7d determines whether the "Not Specified" area 502 is selected on the screen shown in Figure 5 (step S603).

[0086] If the "Not Specified" area 502 is selected on the screen in Figure 5 (YES in step S603), the process proceeds to step S604, and the control unit 7d starts dispensing the standard sample and quality control sample (step S604). This starts the analysis of the standard sample and quality control sample (step S605).

[0087] Subsequently, the control unit 7d outputs the measurement results of the standard sample (step S606), and then outputs the measurement results of the quality control sample using the measurement results of the standard sample (step S607).

[0088] In contrast, if the "Not Specified" area 502 is not selected on the screen in Figure 5 (NO in step S603), the control unit 7d places the quality control sample on standby in the temporary rack storage units 3 and 5, and determines whether the "Rack Recognition" area 503 is selected on the screen in Figure 5 (step S608).

[0089] If the "Rack Recognition" area 503 is selected on the screen in Figure 5, the process proceeds to step S401 in Figure 4. Conversely, if the "Rack Recognition" area 503 is not selected on the screen in Figure 5, the process proceeds to step S609.

[0090] Next, the control unit 7d checks whether there are any abnormalities or problems when the rack of standard samples is recognized (step S609). Similar to step S309 in Figure 3, for example, cases where the samples necessary for measuring the standard samples are not all on the rack are possible.

[0091] If a problem occurs during rack recognition of the standard sample, and this is confirmed in step S609, the quality control samples that were waiting in the temporary rack storage units 3 and 5 are removed (step S617), and the process is terminated by notifying the monitor 7a or the like of the abnormality.

[0092] If it is confirmed that no problems occurred in step S609, the control unit 7d proceeds to step S610, leaving the quality control samples waiting in the temporary rack storage units 3 and 5. When the dispensing of the standard samples begins (step S610), the control unit 7d determines whether the "Sample Dispensing" area 504 is selected on the screen in Figure 5 (step S611).

[0093] If the "Sample Dispensing" area 504 is selected on the screen in Figure 5, the process proceeds to step S401 in Figure 4. Conversely, if the "Sample Dispensing" area 504 is not selected on the screen in Figure 5, the process proceeds to step S612.

[0094] Next, the control unit 7d checks whether any problems occurred during the dispensing of the standard sample (step S612). Similar to step S311 in Figure 3, possible cases include, for example, insufficient sample volume for the standard sample, or insufficient sample volume for another item requested for the standard sample.

[0095] If a problem occurs during sample dispensing of the standard sample, and this is confirmed in step S612, the quality control samples that were waiting in the temporary storage racks 3 and 5 are removed (step S617), and the process is terminated by notifying monitor 7a or the like of the occurrence of an abnormality.

[0096] If it is confirmed that no problems occurred in step S612, the control unit 7d proceeds to step S613, leaving the quality control sample waiting in the temporary rack storage units 3 and 5. When the analysis of the standard sample begins (step S613), the control unit 7d determines whether the "Analysis Start" area 505 is selected on the screen in Figure 5 (step S614).

[0097] If the "Start Analysis" area 505 is selected on the screen in Figure 5, the process proceeds to step S401 in Figure 4. Conversely, if the "Start Analysis" area 505 is not selected on the screen in Figure 5, the process proceeds to step S615.

[0098] Next, the control unit 7d checks whether any problems occurred at the start of the analysis of the standard sample (step S615). Similar to step S313 in Figure 3, possible cases include, for example, a shortage of reagents or diluents used for measuring the standard sample, or a shortage of reagents due to the dispensing of reagents.

[0099] If a problem is found in step S615 due to an issue at the start of analysis of the standard sample, the quality control sample that was waiting in the temporary rack storage section 3,5 is removed (step S617), and the process is terminated by notifying the monitor 7a, etc., of the occurrence of the abnormality.

[0100] In contrast, if it is confirmed that no problems occurred in step S615, the process proceeds to step S616. Then, when the analysis results of the standard sample are output (step S616), the control unit 7d proceeds to step S401 in Figure 4.

[0101] Figures 2 through 6 above illustrate the case where quality control samples are added immediately after standard samples. However, there are also cases where quality control samples are not added immediately after standard samples. Figure 7 illustrates the control mechanisms to address such cases. Figure 7 shows an example of the automated request generation flow when quality control samples are added.

[0102] As shown in Figure 7, when a standard sample is loaded (step S701), the rack of the standard sample is first recognized in the loading / unloading unit 1 (step S702), the standard sample is dispensed (step S703), the measurement of the standard sample is started (step S704), and the process from measuring the standard sample (step S705) to completing the measurement of the standard sample (step S706) is executed.

[0103] In various steps such as steps S702, S703, S704, and S705, when a quality control sample is loaded (step S707), the loading / unloading unit 1 recognizes the rack of quality control samples, and the control unit 7d determines whether the "Not Specified" area 502 is selected on the screen shown in Figure 5 (step S708).

[0104] If the "Not Specified" area 502 is selected on the screen in Figure 5, the control unit 7d performs measurements on the quality control sample for the items requested when the quality control sample was introduced (step S712).

[0105] In contrast, if an area other than the "Not Specified" region 502 is selected on the screen in Figure 5, the control unit 7d automatically requests measurement of the same items as those requested for the standard sample for the quality control sample (step S709).

[0106] Next, the control unit 7d determines whether the measurement timing of the quality control sample selected on the selection screen 501 in Figure 5 has passed the timing for introducing the quality control sample (step S707) (step S710).

[0107] If the measurement timing for the quality control sample selected on the selection screen 501 in Figure 5 has passed the quality control sample input timing, the process proceeds to step S401 in Figure 4.

[0108] In response to this, if the measurement timing of the quality control sample selected on the selection screen 501 in Figure 5 has not passed the quality control sample loading timing, the control unit 7d will have the quality control sample wait in the temporary rack storage units 3 and 5 until the selected timing, and will also perform other processing (step S711). After that, when the set timing is reached, the process proceeds to step S401 in Figure 4.

[0109] Furthermore, if a quality control sample is added after a standard sample has been introduced, and it is not possible to measure the same parameters as those requested for the standard sample or general sample, it is desirable to start the measurement without waiting, regardless of the set measurement timing, although waiting is also an option.

[0110] Furthermore, the measurement timing can be selected not only from the selection screens 201, 501 shown in Figures 2 and 5, but also through definition files, external devices, external communication from external terminals, and even by defining the parameters of registered standard samples.

[0111] For example, when setting measurement timing in a definition file, one could add a setting to the instrument's environment settings definition file, such as whether or not the measurement timing for quality control samples can be selected. It is also possible to specify quality control measurement timing for each standard sample or item within the definition file. Since it is a definition file, it cannot be changed by the instrument user, and it allows for restricting the use of functions.

[0112] Furthermore, when setting the measurement timing via external communication from an external device or terminal, it is possible to specify the measurement timing for the quality control sample by downloading parameters (measurement items, standard samples, quality control samples) via external communication. This allows the parameter provider to specify the measurement timing according to the items and reagents, rather than relying on the device user's judgment.

[0113] Furthermore, with external communication, even if the measurement timing needs to be changed due to changes in parameters or reagents, the timing can be adapted as long as the data is downloaded each time.

[0114] Next, we will explain the screen for setting the waiting location for quality control samples using Figure 8. Figure 8 shows an example of the screen for setting the temporary waiting location for quality control samples.

[0115] The temporary waiting location setting screen 801 shown in Figure 8 is a screen displayed on the monitor 7a, and allows the user to select which of the multiple waiting areas the sample rack on which the quality control sample is placed will be kept waiting, based on the control described above.

[0116] For example, when the "temporary rack storage" area 802 in Figure 8 is selected, the control unit 7d places quality control samples on standby in the temporary rack storage areas 3 and 5 shown in Figure 1. Also, when the "dispensing line" area 803 is selected, the control unit 7d places quality control samples on standby in the dispensing lines 4, 6, and 8 within the respective analysis units 2a, 2b, and 2c shown in Figure 1.

[0117] Note that the waiting locations shown in Figure 8 are merely examples, and the selectable waiting locations are not particularly limited as long as they are structurally suitable for waiting.

[0118] Next, using Figure 9, we will explain the screen for selecting whether or not to automatically generate a request for the successor reagent when automatically generating a request for the same measurable items as the standard sample for the quality control sample. Figure 9 shows an example of the screen for setting whether or not quality control is required for the successor reagent.

[0119] The quality control requirement setting screen 901 shown in Figure 9 is a screen that allows the user to select whether or not to automatically generate a measurement request for a quality control sample even for reagents that inherit the measurement results of a standard sample. When the "Do not perform quality control for inherited reagents" area 902 is selected, the control unit 7d generates an automatic request for a quality control sample only for the reagent for which the standard sample was requested. When the "Perform quality control for inherited reagents" area 903 is selected, the control unit 7d generates an automatic request for a quality control sample for both the reagent for which the standard sample was requested and the reagent for which the inherited reagent was requested.

[0120] Here, "inheritance" refers to a mechanism that allows the results of a standard sample measured with a particular reagent to be used with other reagents capable of measuring the same parameter. In this context, the reagent that actually measured the standard sample is referred to as the "source of inheritance," and the reagent to which the measurement results of the source standard sample are applied is referred to as the "recipient of inheritance."

[0121] Next, Figure 10 illustrates a screen that allows you to select whether or not to automatically generate a request for the copy-calibration target reagent when automatically generating a request for the same measurable items as the standard sample for the quality control sample. Figure 10 shows an example of the screen for setting whether or not quality control is required for the copy-calibration target.

[0122] The quality control requirement setting screen 1001 shown in Figure 10 is a screen that allows the user to select whether or not to automatically generate a measurement request for a quality control sample even for reagents on which the measurement results of a standard sample are copied. When the "Do not perform quality control for copy calibration target" area 1002 is selected, the control unit 7d generates an automatic request for a quality control sample only for items on which a standard sample has been requested.

[0123] Furthermore, when the "Perform quality control of the copy calibration destination" area 1003 is selected, the control unit 7d generates an automatic request for quality control samples in the items for requesting standard samples and the copy calibration destination.

[0124] Here, the reagent parameters used to actually measure the standard sample are referred to as the "copy-calib source," and the other parameters of the same reagent to which the measurement results of the copy-calib source standard sample are applied are referred to as the "copy-calib destinations."

[0125] Next, the effects of this embodiment will be described.

[0126] The automated analyzer 100 for analyzing the sample in the above-described embodiment comprises analysis units 2a, 2b, and 2c that perform the analysis of the sample, and a control unit 7d that controls the operation of each instrument in the apparatus, including the analysis units 2a, 2b, and 2c. The control unit 7d also includes a selection screen 201, 501 that allows the user to select the measurement timing for the quality control sample for the same measurement items requested for the standard sample when a quality control sample is introduced after a standard sample has been introduced, and a selection screen 201, 501 that allows the user to select the measurement timing for the quality control sample for the same measurement items as those requested for the standard sample. The control unit 7d starts measuring the quality control sample when the timing selected on the selection screen 201, 501 is reached.

[0127] With this configuration, users can arbitrarily select the timing of quality control sample measurements according to their operational policies and circumstances. For example, they can prioritize preventing the measurement of quality control samples after a standard sample measurement failure, or prioritize analytical throughput without considering the waste of quality control samples and reagents. In other words, compared to conventional automated analyzers, it is possible to choose whether to achieve a balance between reducing the consumption of standard samples and reagents and improving analytical throughput, based on operational conditions, thereby improving usability compared to conventional devices.

[0128] Furthermore, on the selection screen 501, users can choose from two or more timings for measurement, including the "Analysis Completion" area 506, the "Analysis Start" area 505, the "Sample Dispensing" area 504, and the "Rack Recognition" area 503. This allows the device user to freely set the measurement timing, enabling flexible operation according to the device user's policies.

[0129] In particular, by allowing users to select the timing of quality control sample measurement from rack recognition, sample dispensing, analysis start, and analysis completion, it is possible to eliminate waiting for the standard sample measurement results to be output and expedite the measurement of quality control samples. Furthermore, only quality control samples capable of measuring the same parameters as the standard sample are kept waiting during the analysis of the standard sample. If there is a problem with the standard sample, the measurement of only the waiting quality control sample is stopped, more reliably reducing the impact on subsequent measurements. In this way, it is possible to achieve both a reduction in waste of quality control samples and reagents and a reduction in the time operators are tied up with the task of requesting the measurement of quality control samples.

[0130] Furthermore, once a quality control sample is loaded, the control unit 7d determines whether the timing selected on the selection screen 201, 501 has been reached, and also determines whether there is an abnormality in the standard sample. This allows the control unit to handle cases where the quality control sample is not loaded immediately after the standard sample, further reducing operational constraints on the device and improving usability.

[0131] For example, even if a quality control sample is not added immediately after a standard sample, the system can automatically generate a request for the same parameters requested for the standard sample, allowing for measurement of the quality control sample. This has the effect of reducing the operator's time commitment.

[0132] Furthermore, when the control unit 7d determines that the timing has been reached and no abnormalities have been detected, it promptly starts measuring the quality control sample, thereby ensuring that the analysis is performed quickly and more reliably improving the analysis throughput.

[0133] Furthermore, if the control unit 7d determines that the timing has not been reached, it will have the quality control sample wait in the temporary rack storage units 3 and 5 until the timing selected on the selection screen 501 is reached, thereby enabling more reliable analysis based on the user's operational policy.

[0134] Furthermore, regardless of whether the timing has been reached or not, if the control unit 7d determines that there is an abnormality in the standard sample, it can interrupt the analysis of the quality control sample or remove it from the instrument without performing the analysis, thereby reliably preventing the unnecessary consumption of quality control samples and reagents.

[0135] Furthermore, the control unit 7d automatically generates measurement requests for quality control samples even for reagents that inherit the measurement results of standard samples, thereby eliminating the need for the user to perform detailed settings each time a quality control sample is added, and realizing a more user-friendly device.

[0136] Furthermore, by adding a quality control necessity setting screen 901 that allows users to select whether or not to automatically generate a measurement request for quality control samples even for reagents whose measurement results for standard samples are inherited, the system can more faithfully perform analyses tailored to the user's operational situation.

[0137] Furthermore, the control unit 7d can also automatically generate measurement requests for quality control samples for reagents on which the measurement results of standard samples are copied, thereby realizing a more user-friendly device.

[0138] Furthermore, the system includes a quality control requirement setting screen 1001 that allows users to select whether or not to automatically generate a measurement request for quality control samples even for reagents on which the measurement results of standard samples are copied, and a temporary waiting location setting screen 801 that allows users to select which of the multiple waiting units the quality control samples should be placed in, thereby enabling more accurate analysis tailored to the user's operational situation.

[0139] Furthermore, by selecting the measurement timing based on the instrument's definition file, communication from external devices or external terminals, or the definition of registered standard sample parameters, users unfamiliar with the instrument's operation can avoid having to perform detailed settings, thus enabling more reliable and simpler stable analysis.

[0140] <Other> It should be noted that the present invention is not limited to the embodiments described above, and various modifications and applications are possible. The embodiments described above are explained in detail for the purpose of clearly illustrating the present invention, and are not necessarily limited to those having all the configurations described.

[0141] For example, in the above embodiment, we described a case where the analysis plan for the quality control sample is created after reaching the timing set on selection screen 201,501. However, it is also possible to create the analysis plan for the quality control sample immediately after the quality control sample is introduced, postpone the execution of the plan until reaching the timing set on selection screen 201,501, and then quickly execute or discard the plan once the set timing is reached. [Explanation of symbols]

[0142] 1…Loading and unloading section 2a…ISE analysis department 2b…Biochemical analysis department 2b1...Reaction disk 2c…Immunology Analysis Department 2c1... Incubator 3,5... Rack temporary storage area (standby area) 4, 6, 8… Dispensing lines (standby area) 7…Operation PC (Control Unit) 7a…Monitor 7b...Input device 7c…Storage medium 7d... Control Unit 9…Conveyor line 100…Automatic analyzer 201...Selection screen (selection area) 202... "Unspecified" area 203... "When standard sample measurement is successful" area 501...Selection screen (selection area) 502... "Unspecified" area 503... "When rack is recognized" area 504... "During specimen dispensing" area 505…“At the start of analysis” area 506…“When analysis is completed” area 801...Temporary waiting location setting screen (waiting selection section) 802... "Temporary storage area for racks" area 803... "Dispensing Line" area 901...Quality control requirement setting screen (succession selection section) 902... Areas where "accuracy management of inherited data is not performed." 903... Area for "Managing the accuracy of inherited assets" 1001... Accuracy control requirement setting screen (copy selection section) 1002... Area where "accuracy control of the copy calibration target is not performed." 1003... "Performing accuracy control of copy calibration targets" area

Claims

1. An automated analyzer for analyzing samples, An analysis unit that performs the analysis of the aforementioned sample, The control unit controls the operation of the analysis unit and includes a control unit that determines the measurement items to be requested for the quality control sample based on the measurement items requested for the standard sample, The control unit, Whether or not an abnormality has occurred in the standard sample is determined at one or more of the following timings: when the standard sample is recognized in the rack, during the dispensing operation, or at the start of the analysis. Based on the result of the determination, the transport of the quality control sample is controlled. An automated analyzer characterized by the following features.

2. An automated analyzer according to claim 1, The control unit, If an abnormality is detected in the standard sample, the transport of the quality control sample is controlled so that it is not transported to the analysis unit. An automated analyzer characterized by the following features.

3. An automated analyzer according to claim 1, The system further includes an unloading section from which the quality control sample is unloaded. The control unit, When it is determined that there is an abnormality in the standard sample, the transport of the quality control sample is controlled to discharge the quality control sample from the discharge unit. An automated analyzer characterized by the following features.

4. An automated analyzer according to claim 3, The system further includes a storage section for storing the aforementioned quality control samples. The control unit, When it is determined that there is an abnormality in the standard sample, the transport of the quality control sample stored in the storage unit is transported and the transport of the quality control sample is controlled to be transported from the transport unit. An automated analyzer characterized by the following features.

5. An automated analyzer according to claim 1, The control unit will notify the system of the occurrence of an abnormality when it determines that an abnormality has occurred. An automated analyzer characterized by the following features.

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