JP2015135282A - Automatic analysis device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an automatic analysis device capable of performing accuracy management with still higher reliability by performing accuracy management at predetermined intervals.SOLUTION: The automatic analysis device comprises one or more analysis units 6-8 for performing qualitative and quantitative analyses of a sample to be analyzed, the analysis units 6-8 being disposed along transport devices 9, 10 for transporting a sample rack for placing thereon a sample container 17 in which the sample to be analyzed is accommodated, and a rack storage unit 2 for temporarily storing the sample rack 18 transported by the transport devices. A preparation process for preparing the sample to be analyzed to make it usable in qualitative and quantitative analyses by the analysis unit is executed on the basis of a preparation protocol in which a condition for the preparation process is preset, and the preparation process is started so that an accuracy management sample which is one of the samples to be analyzed is in a usable state at the preset start time of an accuracy management process for managing analysis accuracy using the result of analysis by the analysis unit of the accuracy management sample.

Description

  The present invention relates to an automatic analyzer that performs qualitative and quantitative analysis of samples such as blood and urine.

  Automatic analyzers add and react with reagents that react specifically with specific components in samples such as blood and urine (hereinafter referred to as specimens), and measure the absorbance, luminescence, etc. of the reaction solution. Qualitative and quantitative analysis is performed.

  In such an automatic analyzer, in order to ensure the reliability of the analysis results, calibration, which is a calibration curve calibration operation for obtaining a calibration curve, and accuracy for confirming that the calibration curve is appropriate Although management etc. are carried out as necessary, management is complicated because there are so many types of methods and samples (calibration samples, quality control samples) to be used.

  As a technique related to the management of a sample used for calibration and accuracy management, for example, Patent Document 1 (Japanese Patent Laid-Open No. 2013-24691) defines conditions for a preparation process for making a sample to be analyzed usable for analysis. An automatic analyzer that performs a preparation process of a sample to be analyzed based on a setting of a preparation protocol setting screen in which an operator sets a preparation protocol is described.

JP 2013-24691 A

  By the way, quality control samples used for quality control of automatic analyzers are purchased from reagent manufacturers, or procured by creating and storing pooled serum as quality control samples independently at facilities that use automatic analyzers. ing. In addition, since the quality control sample also serves as a reference for checking the device status in the automatic measuring device, the quality control sample of the same lot (which means the same sample in the pooled serum) is stored for a long time while maintaining the quality. It is required to do. Therefore, the quality control sample is often stored by a method such as freezing storage or freeze-drying storage.

  Since the quality control sample stored by freezing or freeze-drying cannot be used for measurement in the quality control as it is, it is used for measurement after being prepared by performing a preparation process. At this time, depending on the state of the quality control sample after the preparation process is performed, the measurement results will be affected. Therefore, in order to perform highly accurate quality control, the state of the sample used every time quality control is performed must be kept constant. Need to keep.

  In order to make the state of the quality control sample after the preparation process constant, it is necessary to make various conditions in the preparation process constant. However, there are many types of quality control samples, the preparation methods are different, and the timing to use differs depending on the target items, so the labor and time required for the operator to perform all preparation processes is It will be enormous. In particular, in clinical settings such as large facilities with a large number of specimens, it is necessary to perform preparation work between regular operations in order to perform accuracy control, and it is difficult to secure the effort and time required for preparation work. It was also difficult to maintain accuracy by performing accuracy control at predetermined intervals.

  The present invention has been made in view of the above, and an object of the present invention is to provide an automatic analyzer that can perform accuracy management with higher reliability by performing accuracy management at predetermined intervals.

  In order to achieve the above object, the present invention is arranged along a transport device for transporting a sample rack for placing a sample container in which a sample to be analyzed is accommodated, the transport means, and One or more analysis units for performing qualitative / quantitative analysis, a rack storage unit for temporarily storing a sample rack transported by the transport device, and an analysis result of the sample to be analyzed by the analysis unit are displayed. A preparation process control unit that performs a preparation process for preparing the display device and the sample to be analyzed in a state usable for qualitative / quantitative analysis by the analysis unit based on a preparation protocol in which the conditions for the preparation process are set in advance. In addition, a predetermined opening of the accuracy management process for managing the analysis accuracy using the analysis result of the accuracy control sample, which is one of the analysis target samples, in the analysis unit. Time the quality control sample is assumed that a preparation processing control unit for starting the preparation process so as to be used state.

  According to the present invention, it is possible to perform accuracy management with higher reliability by performing accuracy management at predetermined intervals.

1 is a diagram schematically showing an overall configuration of an automatic analyzer according to a first embodiment. It is a flowchart which shows the flow of the whole analysis process of the sample and quality control sample in 1st Embodiment. It is a flowchart which shows the preparation process of the quality control sample in 1st Embodiment. It is a figure which shows the display screen which displays the various information in an automatic analyzer, and is a figure which shows the state which displayed as a list the process required for the input quality control sample, and the execution time of a process. It is a figure which shows the state which made the alarm display of the expiration date of use of a quality control sample in the state of the screen which displayed the list of the required process and the execution time of a process required for the supplied quality control sample.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings.

<First Embodiment>
A first embodiment of the present invention will be described with reference to FIGS.

  FIG. 1 is a diagram schematically showing an overall configuration of an automatic analyzer according to the present embodiment.

  In FIG. 1, the automatic analyzer according to the present embodiment includes a sample rack loading unit 1 for loading a sample rack 18 on which a sample container 17 in which a sample to be analyzed (sample to be analyzed) is accommodated, and a sample rack. Each of the transport lines 9 and 10 (transport device) on the sending side and the return side for transporting the sample rack 18 loaded in the loading unit 1 to each part of the automatic analyzer, and the sample rack transported by the transport lines 9 and 10 A sample rack storage unit 2 for temporarily storing 18, a cold storage buffer 3 that is arranged along the transfer lines 9 and 10 and that stores the sample to be analyzed stored in the sample container 17, and the analysis target A storage unit 4 that performs a preparation process on a sample and stores the sample until the analysis process is performed, a measurement preparation unit 5 that performs a preparatory process such as an agitation process on the analysis target sample, and a conveyance La 1 or more (three in this embodiment) analysis units 6 to 8 that are arranged along the lines 9 and 10 and perform qualitative / quantitative analysis processing of a sample to be analyzed, and a sample container 17 that has been analyzed. A sample rack collection unit 16 for collecting the sample rack 18, a control unit 12 for controlling the operation of the entire automatic analyzer, a setting screen for performing various settings relating to analysis processing, preparation processing, preparation processing, and analysis results The display unit 15 that displays a result display screen that displays and the like, and the operation unit 14 that performs various operations by performing an input operation based on the display content of the display unit 15 are roughly configured.

  In this embodiment, the sample to be analyzed is a general sample (for example, serum, whole blood, urine, or a test solution obtained by subjecting these samples to dilution treatment, hereinafter referred to as a sample), and used for accuracy control. Means a quality control sample. The accuracy control sample is a sample having a known concentration used for measurement (accuracy control) for confirming whether the calibration curve is appropriate.

  The sample rack loading unit 1 is a portion for loading a sample rack 18 on which a sample container 17 is loaded into an automatic analyzer. The operator places a plurality of sample racks 18 at the same time, and transport lines 9 and 10 (transport device). It is configured so that it can be automatically entered in sequence. The sample rack loading unit 1 is provided with a sample identification information acquisition unit 11 that reads identification information from identifiers attached to the sample rack 18 and the sample container 17 in the form of barcodes or RF tags 17a and 18a, respectively. The identification information is read for each sample rack 18 and sample container 17 input by the operator and sent to the control unit 12. The sample rack 18 and the sample container 17 for which the identification information has been read are sequentially sent to the transport lines 9 and 10. In the present embodiment, the RF tags 17a and 18a are indicated by parenthesized symbols in FIG.

  The sample identification information acquisition unit 11 writes various information in addition to reading identification information from the RF tags 17a and 18a based on RFID (Radio Frequency Identification) technology. The information written (recorded) on the RF tags 17a and 18a includes, for example, the sample container 17 in the storage unit 4, the centrifuge processing unit 5a and the stirring unit 5b of the measurement preparation unit 5, an opening unit (not shown), Date and time of loading and unloading of each processing unit including the analysis units 6 to 8, necessity of each processing such as preparation processing and analysis processing, processing procedure such as preparation protocol, start date and time, end date and time, temperature of the processing unit There are measurement date and value of environmental conditions. Furthermore, when any processing step is interrupted due to some trouble, information indicating where the processing step is interrupted, the date and time of occurrence of the interruption, and the like are recorded in the RF tags 17a and 18a.

  The transport lines 9 and 10 (transport device) pass the sample rack 18 from the sample rack input unit 1 through the sample rack storage unit 2, the cold buffer 3, the storage unit 4, the measurement preparation unit 5, and the analysis units 6 to 8. And a return-side transfer line 10 that returns the sample rack 18 to the starting point of the transfer line 9. The transport lines 9 and 10 transport the sample container 17 and the sample rack 18 to various parts of the automatic analyzer based on an instruction from the control unit 12.

  The sample rack storage unit 2 temporarily stores the sample rack 18 that is input from the sample rack input unit 1 and transferred by the transfer lines 9 and 10. It has a sample rack moving mechanism 2a for carrying out to the line 9 and moving to a plurality of storage positions 2b provided in the sample rack storage unit 2. The information on the storage position 2b of each sample rack 18 and the sample information are managed in association with each other, and the information is stored in the storage unit 13.

  The cold insulation buffer 3 is used to keep the sample to be analyzed contained in the sample container 17 in a cold state and to store the sample rack 18 from the conveyance line 9, to the conveyance line 9, and in the cold insulation buffer 3. A sample rack moving mechanism 3a for moving the rack 18 and the like, a sample loading unit 3c for loading a sample container 17 that is not suitable for loading from the sample rack loading unit 1, a sample rack loading unit 1 and a sample loading port 3c are provided. In addition to reading the identification information from the RF tags 17a and 18a of the sample container 17 and the sample rack 18 held in the cold storage buffer 3, a sample identification information acquisition unit 3b for writing various information is provided. In the cold buffer 3, the sample container 17 containing the sample to be analyzed that does not require preparation is kept cold until the start of analysis, and when a sample that requires preparation (such as a quality control sample) is mounted, preparation is started. Until it is stored.

  The sample container 17 and the sample rack 18 that are transported or put into the cold buffer 3 through the sample rack loading part 1 and the sample loading port 3c are stored together with the identification information stored in the RF tags 17a and 18a. Whether or not the preparation process is necessary and the preparation protocol are read.

  When a sample container having a shape that cannot be mounted on the sample rack 18 is loaded from the sample loading unit 3c, and the quality control sample before the preparation process is accommodated in the sample container, the quality control sample preparation process is performed. Then, since it is necessary to transport to the analysis units 6 to 8, a dispensing mechanism for dispensing from the original sample container to another container (sample container 17) having a shape that can be mounted on the sample rack 18 (see FIG. (Not shown), and transported to the analysis units 6 to 8 after performing the dispensing by the dispensing mechanism.

  The storage unit 4 performs a preparation process on the sample to be analyzed, and further stores the sample until the analysis process is performed, and includes a sample preparation unit 4a. In the sample preparation unit 4a, a preparation process for making the analysis target sample in an analyzable state is performed based on a predetermined preparation protocol according to the type of the analysis target sample. In the preparation process, for example, a pretreatment solution such as a lysate is added to a quality control sample (analyzed sample) stored frozen or freeze-dried by the dispensing unit 4b and stirred by pipetting or the like. State. Samples to be analyzed, such as quality control samples that have been prepared, are prepared immediately in order to be transported to and used by the analysis unit or to make the quality of the quality control sample as the sample to be analyzed uniform. There is a case where it is left in the storage unit 4 for a predetermined time after processing.

  The storage unit 4 including the sample preparation unit 4a has a function of keeping the sample container 17 being stored cold. The storage unit 4 has a function of reading and writing information with respect to the RF tags 17a and 17b, and when the quality control sample that has been prepared is transported to the analysis units 6 to 8, the time is the RF tag 17a. , 18a.

  The measurement preparation unit 5 performs a preparatory process such as a stirring process on the sample to be analyzed before the analyzing process, and includes a stirring unit 5b that stirs the sample stored in the sample container 17 and a centrifugal separation that performs centrifugation. Part 5a. In the present embodiment, the stirring unit 5b and the centrifugal separation unit 5a are independent from each other. However, an integrated type may be used.

  The analysis units 6 to 8 are provided along the transport line 9 on the feed side, and have functions of taking the sample rack 18 from the transport line 9, placing it at the sampling position, and sending it to the feed transport line 9. The sampling line, the sample rack 18 and the identification information acquisition units 6a to 8a for reading and writing the identification information with respect to the RF tags 17a and 18a of the sample container 17, and the sample to be analyzed and the reagent corresponding to the analysis item are reacted. A reaction unit for optical measurement and a CPU for controlling the analysis units 6 to 8 are provided.

  The control unit 12 includes a storage unit 13 that stores information such as reagents and samples, analysis results, various programs, protocols, and the like, an operation unit 14 for an operator to input various data and instructions, and various types of information. Is connected to a display unit 15 for displaying. In addition to the sample and reagent information associated with the identification information and the analysis result, the storage unit 13 executes a preparation process such as a preparation protocol and a control program for executing analysis processing of the sample to be analyzed, and a quality control sample. A preparation control program and the like are stored. The control unit 12 controls the operation of the entire automatic analyzer, and in the preparation processing and measurement preparation unit 5 that are performed on the sample to be analyzed in the storage unit 4 based on various programs and information stored in the storage unit 13. Processing such as preparation processing performed on the analysis target sample and analysis processing (qualitative / quantitative analysis processing) performed on the analysis target sample in the analysis units 6 to 8 is performed.

  In the present embodiment, in order to write each information to the RF tags 17a and 18a, it is desirable that each part of the automatic analysis process has an information transmitting part in addition to the above-described ones. That is, when the information transmission unit is provided in the individual processing unit, for example, the sample rack 18 is provided in the vicinity of the transfer lines 9 and 10 for carrying in these processing units. However, from the viewpoint of complexity of control of the information transmission unit or cost reduction, if the sample container 17 or the subdivided sample container is moved by the sample transfer line 9 or 10 or the like, it will be connected to any processing unit or transfer path. It is good also as information writing in only one place or the minimum place. In addition, an information receiving unit is required to read information from the RF tags 17a and 18a. However, when the reception and transmission are configured with a common antenna or the like, when an independent receiving unit is provided, or as a transmission / reception unit. There may be cases.

  Furthermore, the transmission / reception unit in the sample transport unit of the host system including the automatic analysis system of the present embodiment may be used without using the transmission / reception unit in the RFID technology in each processing unit as described above. The information is recorded by the control unit of the host system, the record can be referred to or confirmed by the display unit, and further printed when printing is necessary. This information indicates that each process is performed by the set process, and if the process is interrupted due to a trouble, it will be known that the required process of the sample has not been performed. This shows that preparation and measurement are performed based on sufficient management control of the sample.

  FIG. 2 is a flowchart showing the entire flow of the analysis processing of the specimen and the quality control sample in the present embodiment, and FIG. 3 is a flow chart showing the preparation process of the quality control sample.

  In FIG. 2, when the sample stored in the sample container 17 mounted on the sample rack 18 is loaded into the sample rack loading unit 1 (step S110), the control unit 12 causes the sample identification information acquisition unit 11 to perform the RF tag 17a. , 18a (step S120), and the analysis time of the sample is calculated (step S130).

  Subsequently, the identification information obtained from the RF tags 17a and 18a of the quality control sample accommodated in the sample container 17 mounted on the sample rack 18 and put in the automatic analysis is inquired (Step S140). The sample analysis time is calculated (step S150), and the quality control sample preparation process is performed (step S160).

  Here, it is determined whether or not the sample container 17 containing the specimen has a shape that can be mounted on the sample rack 18 used in the automatic analyzer (step 170). If the determination result is NO, the cold insulation unit 4 is determined. The sample in the sample container is dispensed into the sample container 17 that can be mounted on the sample rack 18 (step S175), and the analysis of the sample is started (step S180). If the determination result in step S170 is YES, sample analysis is started (step S180).

  When the analysis of the sample in step S180 is performed, the analysis of the quality control sample is subsequently started (step S190), and the sample container 17 and the sample rack 18 containing the sample that has been analyzed and the quality control sample are stored in the sample. It is conveyed to the rack collection unit 16 (step 200), and the process is terminated.

  In FIG. 3, the control unit 12 reads and stores the analysis time recorded in the RF tags 17a and 18a when the quality control sample is loaded into the cold insulation buffer 3 via the sample rack loading unit 1 or the sample loading unit 3c. Is implemented (step S10).

  Next, it is determined whether or not the preparation start time calculated based on the time necessary for preparation has been reached so that the preparation is completed at the analysis start time (step S20). Wait until the time (step S25), and then read and store the time for the FR tags 17a and 18a and carry them out of the cold insulation buffer 3 (step S30). When the determination result in step S20 is YES, the time reading and storage are performed for the FR tags 17a and 18a, and the FR tags 17a and 18a are taken out from the cold insulation buffer 3 (step S30).

  In step S30, when the sample rack 18 carrying the sample container 17 containing the quality control sample is carried out, time reading and storage are performed for the FR tags 17a and 18a, and sample preparation is started (step S40). . Here, it is determined whether or not the sample container 17 in which the quality control sample is accommodated has a shape that can be mounted on the sample rack 18 used in the automatic analyzer (step 50). In section 4, the quality control sample of the sample container is dispensed into the sample container 17 that can be mounted on the sample rack 18 (step S55), and the time reading and storage are performed on the FR tags 17a and 18a. (Step S60). If the determination result in step S50 is YES, the time reading and storage are performed for the FR tags 17a and 18a, and the quality control sample is put into the analysis units 6 to 8 (step S60). In step 60, when the quality control sample is put into the analysis units 6-8, the time reading and storage are performed for the FR tags 17a and 18a, the quality control sample is analyzed (step S70), and the process is terminated. To do.

  The analysis process and the preparation process described above will be described in more detail.

  When a new rack is loaded into the sample rack loading unit 1, the ID information is read by the sample identification information acquisition unit and the RFID acquisition unit. It is recognized that the sample stored in the RF tags 17a and 18a is a sample that needs to be subjected to the preparation protocol as a measurement preparation. After obtaining the preparation protocol information, the sample is transported to the cold buffer 3. The time when it is carried into the cold buffer 3 is stored in the RF tags 17a and 18a.

  An inquiry with other measurement order information is made, and the execution time of the quality control process is calculated so that the quality control process (that is, analysis of the quality control sample) is performed at predetermined intervals. In each preparation protocol, the time that is required until the quality control sample is allowed to stand after dispensing of the lysate is set as the analysis possible time. Thereafter, the time (preparation start time) for starting the preparation work in the sample preparation unit 4a of the storage unit 4 is calculated by calculating backward from the analysis possible time. The control unit 12 checks whether or not it is the preparation start time, and waits in the cold insulation buffer 3 when the preparation start time is not reached. When the preparation start time is reached, the quality control sample is taken out of the cold buffer 3 and the sample preparation protocol is executed. At this time, the time when the sample container 17a is carried out of the cold buffer 3 is stored in the RF tags 17a and 18a. Further, the time when the sample preparation protocol is executed and the processing contents are stored in the RF tags 17a and 18a.

  After preparing the sample (specimen, quality control sample) in the sample preparation unit 4a, the sample preparation unit 4 stands by until the analysis is started. In addition, the preparation in a present Example means making it a usable state by adding a pretreatment liquid with respect to the quality control sample preserve | saved frozen or freeze-dried, for example. The prepared quality control sample may be transported to the analysis unit and used immediately thereafter. However, in order to make the quality control sample uniform, it is left in the sample preparation unit 4a for a predetermined time. There is also.

  In addition, when the opening of the sample container 17 is closed with a cap at the time of standing, in order to keep the quality of the quality control sample uniform in the measurement preparation unit 5, the container is rotated by the stirring unit 5b to perform non-contact stirring. In addition, the centrifuge 5a is centrifuged to prevent scattering of the sample at the time of opening. Thereafter, the bottle is opened and conveyed to the conveying line from 9 and 10, and analysis is performed in the analysis units 6 to 8. The sample rack 18 that has been analyzed is sent to the sample rack recovery unit 16 and the analysis process is completed.

  The quality control sample that has been prepared is transported to the analysis units 6-8. At this time, the time conveyed to the analysis units 6 to 8 is stored in the RF tags 17a and 18a. When the sample container 17 containing the quality control sample before preparation has a shape that cannot be mounted on the sample rack 18, the sample container 17 may be directly loaded from the sample loading unit 3 c provided in the cold buffer 3. In this case, the RF tags 17a and 18a are read by the sample identification information acquisition unit 3b. In such a case, in order to transport the quality control sample that has been prepared to the analysis units 6 to 8, for dispensing from the original sample container to another sample container 17 having a shape that can be mounted on the sample rack 18. A dispensing mechanism 4b is provided, and the dispensing mechanism 4b transports it to the analysis units 6 to 8 after performing dispensing.

  4 and 5 are diagrams showing display screens for displaying various types of information in the automatic analyzer, and are diagrams showing a state in which processing required for the input quality control sample and the execution time of the processing are displayed as a list.

  In FIG. 4, a screen 400 has tabs 401 to 405 for displaying screens related to routine operations, reagents, calibration, accuracy management, and utilities. FIG. 4 shows a state where the accuracy management tab 404 is selected. The screen 400 also includes a stop button 421 for instructing to stop the operation, a sample stop button 422 for instructing to stop the analysis of the sample, an alarm button 423 for informing various abnormal states, and printing of display contents. There are arranged a print button 424 for instructing a start button 425, a start button 425 for instructing the start of analysis processing, and the like.

  A screen 410 displayed by selection of the accuracy management tab 404 has tabs 411 to 415 for displaying screens related to status, date, day difference, control, and setting. FIG. 4 shows the situation tab 411 being selected.

  In the screen displayed by selecting the status tab 411, the display screen of the status tab 411 includes a measuring button 431 for displaying information being measured, a status management button 432 for displaying a status management status, and a refrigerator. A cool box button 433 for displaying the state of the quality control sample that has been cooled is disposed. Here, the situation management button 432 is selected. In addition, the screen displayed by selecting the status tab 411 includes control, type, lot number, ID / rack number, cool buffer input time, cool buffer transport time as information on the quality control sample input to the automatic analyzer. The stirring completion time and dispensing completion time are listed for each quality control sample.

  That is, on the screen 400, when the quality control sample is put into the automatic analyzer, processing and processing necessary for the quality control sample obtained based on the preparation protocol information acquired by reading the RF tags 17a and 18a. Execution time is listed.

  For example, the quality control sample can be input on a date other than the measurement date, and a sample for a certain period of time can be input in advance, and measurement at a predetermined interval can be automatically performed. On the screen 400, by selecting the status tab 411, it is possible to check the preparation status and measurement status of the quality control sample currently put in the automatic analyzer. On the screen 400, the dispensing completion time of each quality control sample calculated from the requested analysis item is displayed. In order to complete the preparation and dispensing of the quality control sample by this time, the quality control sample is displayed. You may comprise so that the time which should be thrown in may be displayed.

  FIG. 5 is a diagram showing a state in which the expiration date for use of the quality control sample is displayed as an alarm in the state of a screen displaying a list of processes necessary for the supplied quality control sample and the execution time of the process.

  As shown in FIG. 5, when the identification information of the sample is read, the expiration date (storage period) of the quality control sample is stored in the storage unit 13, and the sample whose storage period is close (for example, two weeks before the expiration date) For example, the color of a column (for example, column 500) in which an alarm or expiration date is displayed is changed to a color such as yellow (indicated by a double line in FIG. 5) and displayed on the display unit 15, etc. A state that the operator can grasp at a glance is displayed without checking the storage deadline described on the label or the like of the quality control sample container stored in the cold buffer 4.

  The effect of the present embodiment configured as described above will be described.

  Quality control samples used for quality control of automatic analyzers are procured by purchasing them from reagent manufacturers or by creating and storing pooled serum as quality control samples independently at facilities that use automatic analyzers. . In addition, since the quality control sample also serves as a reference for checking the device status in the automatic measuring device, the quality control sample of the same lot (which means the same sample in the pooled serum) is stored for a long time while maintaining the quality. It is required to do. Therefore, the quality control sample is often stored by a method such as freezing storage or freeze-drying storage. Since the quality control sample stored by freezing or freeze-drying cannot be used for measurement in the quality control as it is, it is used for measurement after being prepared by performing a preparation process. At this time, depending on the state of the quality control sample after the preparation process is performed, the measurement results will be affected. Therefore, in order to perform highly accurate quality control, the state of the sample used every time quality control is performed must be kept constant. Need to keep. In order to make the state of the quality control sample after the preparation process constant, it is necessary to make various conditions in the preparation process constant. However, there are many types of quality control samples, the preparation methods are different, and the timing to use differs depending on the target items, so the labor and time required for the operator to perform all preparation processes is It will be enormous. In particular, in clinical settings such as large facilities with a large number of specimens, it is necessary to perform preparation work between regular operations in order to perform accuracy control, and it is difficult to secure the effort and time required for preparation work. It was also difficult to maintain accuracy by performing accuracy control at predetermined intervals.

  On the other hand, in the present embodiment, the qualitative / quantitative analysis of the sample to be analyzed is arranged along the transport device for transporting the sample rack for placing the sample container in which the sample to be analyzed is placed, and the transport means. One or more analysis units for performing analysis, a rack storage unit for temporarily storing a sample rack transported by a transport device, and a display device for displaying an analysis result of a sample to be analyzed by the analysis unit, The preparation process to prepare the sample to be analyzed in a state that can be used for qualitative and quantitative analysis by the analysis unit is performed based on a preparation protocol in which the conditions of the preparation process are set in advance, and accuracy control is one of the samples to be analyzed Preparation process so that the quality control sample is ready for use at the preset start time of the quality control process that manages the analysis accuracy using the analysis result of the sample analysis unit Since it is configured to start, by performing quality control at predetermined intervals, it is possible to perform a more reliable quality control.

  That is, according to the present embodiment, since the preparation protocol information is stored in the RF tags 17a and 18a for each quality control sample, the analysis of the quality control sample can be started based on this preparation protocol information. Preparation of quality control sample can be started properly.

  In addition, since the RF tag 17a, 17b can store the information regarding the progress of the preparation protocol of the quality control sample and the use status, the user can objectively evaluate the quality control status.

<Second Embodiment>
An embodiment of subject 2 of the present invention will be described.

  In the first embodiment, the analysis result of the sample to be analyzed is further corrected based on the analysis result of the quality control sample by the analysis unit in the first embodiment. In the present embodiment, the same reference numerals are used for the same members as in the first embodiment, and the description thereof is omitted.

  First, the correction process for the analysis result of the sample to be analyzed in the control unit 12 of the automatic analyzer according to the present embodiment will be described for each situation.

  In this embodiment, the following corrections are made for the following cases (1) to (4) based on the measurement value (A) of the quality control sample using the reagent bottle of the new reagent lot. Do.

(1) When the run is different If the measurement value (B) of the quality control sample in the run is obtained, the measurement value of the specimen or clinical sample in the run is multiplied by (A / B). The measurement of the specimen or clinical sample is corrected by A.

(2) When the measurement date is different Once the measurement value (C) of the quality control sample on that day is obtained, the measurement value of the sample or clinical sample on that day is multiplied by (C / B), The measurement of the specimen or clinical sample is corrected by A.

(3) When the reagent lots are different Once the measurement value (D) of the quality control sample in the reagent lot is obtained, the measurement value of the specimen or clinical sample using the reagent of the lot is multiplied by (D / B). In other words, the measurement of the specimen or clinical sample of the reagent lot is corrected by A.

(4) When the reagent bottles are different Once the measured value (E) of the quality control sample in the reagent bottle is obtained, the measured value of the specimen or clinical sample using the reagent in the bottle is multiplied by (E / B). In other words, the measurement of the specimen or clinical sample in the reagent bottle is corrected by A.

  In addition, the measured value of said AD may use the value which measured the quality control sample single, and may measure several times and may use the average value. Furthermore, for examples other than (1) to (4), for example, values before and after system maintenance may be used. Further, for example, if there is a deterioration of the reagent with time, the value of the deterioration with time may be added to A and the measured value of the specimen or clinical sample at that time may be corrected.

  The effect of the present embodiment configured as described above will be described.

  There is a difference between measurement values based on various devices and reagents, which may impair sample measurement accuracy or measurement accuracy. Although these provide a sufficiently reliable measurement value by being in the prescribed range, it may be considered that the determination result is affected for a sample showing a value near a cutoff value that requires strict analysis.

  Even if the quality control sample shows almost no difference between measurements within the measurement, it can be measured even if it is within the acceptable range for quality control, for example, by comparing morning and evening measurements and measurements on different days. Differences may be observed (intra-measurement difference, daily difference).

  The value obtained by analyzing the quality control sample gives reliability to the measured value of the specimen or clinical sample of the measurement run for a certain period of time or shows the variation, deviation, or trend of the measured value across the period or run. Therefore, measurement of a quality control sample and a specimen or clinical sample is always performed in parallel.

  According to the present embodiment, since the quality control sample is preprocessed or prepared under sufficient control management and used for measurement, the difference between the quality control sample pretreatment or preparation can be greatly reduced. This indicates that this sample can also be a standard sample. If the measured value of this sample has variations or deviations between measurements or between days, this does not depend on the sample, but rather on the reagent, device or system. It can be assumed that there is a great deal of variation.

  The difference between runs before and after the process, such as when the run is different, the system is restarted by turning the system switch On / Off, or the system is started at the start of measurement the next day after the measurement is completed. Or there is a daily difference. Similarly, there is a difference between reagent lots or a difference between reagent bottles due to a change in a reagent lot that is necessary because the reagent to be used reaches the use guarantee period, or a reagent bottle replacement due to the reagent bottle being used up. Usually, the measurement of the quality control sample is often measured more frequently than the calibrator or the priced sample, and the use added to the quality control of the measurement value has an advantage of expanding the effectiveness of the sample measurement.

  In the present embodiment, the quality control sample is provided with a method of use similar to that of a standard sample or a calibrator, and further the accuracy of sample or clinical sample measurement can be increased.

  Further, in the automatic analyzer according to the present embodiment, a function is provided in which a flag or the like is provided for the sample to be analyzed whose measurement result is close to the cutoff value boundary, and the correction value of the reading value is displayed on the display unit 15. Is provided. As a result, the operator can be alerted to a sample suspected of being false positive or false negative.

DESCRIPTION OF SYMBOLS 1 Sample rack input part 2 Sample rack storage part 2a Sample rack movement mechanism 3 Cold storage buffer 3a Sample rack movement mechanism 3b Sample identification information acquisition part 3c Sample input part 4 Storage part 4a Sample preparation part 4b Dispensing part 5 Measurement preparation part 5a Centrifugation Processing unit 5b Stirring unit 6-8 Analysis unit 9, 10 Conveyance line (conveyance device)
DESCRIPTION OF SYMBOLS 11 Sample identification information acquisition part 12 Control part 13 Memory | storage part 14 Operation part 15 Display part 16 Sample rack collection | recovery part 17 Sample container 17a RF tag 18 Sample rack 18a RF tag 400 Screen

Claims (8)

A transport device for transporting a sample rack on which a sample container in which a sample to be analyzed is stored is placed;
One or more analysis units arranged along the transport means for performing qualitative and quantitative analysis of the sample to be analyzed;
A rack storage unit for temporarily storing the sample rack transported by the transport device;
A display device for displaying the analysis result of the sample to be analyzed by the analysis unit;
A preparation process control unit for performing a preparation process for preparing the analysis target sample in a state usable for qualitative and quantitative analysis by the analysis unit based on a preparation protocol in which conditions for the preparation process are set in advance, The quality control sample is ready for use at a preset start time of a quality control process for managing the quality of analysis using the analysis result of the quality control sample, which is one of the samples to be analyzed, in the analysis unit. And a preparation process control unit for starting the preparation process. The automatic analyzer according to claim 1, wherein
An automatic analyzer comprising an analysis result correction unit that corrects an analysis result of the analysis target sample based on an analysis result of the quality control sample by the analysis unit. The automatic analyzer according to claim 2,
When the analysis result of the sample to be analyzed is within a predetermined range for determining whether or not the analysis result is in the vicinity of a threshold value for comparison with the analysis result, the analysis result indicates that the analysis result is in the vicinity of the threshold value. The automatic analysis apparatus is characterized by adding boundary information to be displayed and displaying the content of correction of the analysis result by the analysis result correction unit on the display device. The automatic analyzer according to claim 2,
The automatic analysis apparatus, wherein the analysis result correction unit corrects the measurement result (reading value) based on a target value of the measurement result (reading value) predetermined for each quality control sample. The automatic analyzer according to claim 1, wherein
An automatic analyzer comprising a cold-retaining buffer for keeping the quality control sample before carrying out the preparation process. The automatic analyzer according to claim 1, wherein
An RF tag that is installed in a sample container in which the quality control sample is stored and in which a preparation protocol of the quality control sample is recorded;
An automatic analysis apparatus comprising: an RF tag reading device that reads out the recorded content of the RF tag and sends the read content to the preparation processing control unit. The automatic analyzer according to claim 1, wherein
An RF tag that is installed in a sample container in which the quality control sample is stored and in which the timing of analyzing the quality control sample by the analysis unit is recorded;
An automatic analysis apparatus comprising: an RF tag reading device that reads out the recorded content of the RF tag and sends the read content to the preparation processing control unit. The automatic analyzer according to claim 1, wherein
An agitation device for agitating the quality control sample before measurement in the quality control process;
A centrifuge for performing a centrifuge process for removing the quality control sample attached to the stopper of the sample container in the sample container of the quality control sample that has been closed after the preparation process has been performed. An automatic analyzer characterized by that.

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