JP2009069100A - Specimen analyzer - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a specimen analyzer capable of preventing an analysis result having low reliability from being approved (validated) automatically. <P>SOLUTION: This urinary physical component analyzer (specimen analyzer) 1 is equipped with a measuring part 2 for measuring a urinary physical component by using a reagent; a reagent exchange screen SC4 for receiving input of Reagent Code 100a; and a CPU 31a for determining whether the reagent is suitable for measuring the urinary physical component by the measuring part 2 or not, based on the received Reagent Code 100a, approving (validating) automatically the analysis result when determined to be suitable for measurement, and not approving the analysis result when determined to be not suitable for the measurement. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a sample analyzer, and more particularly, to a sample analyzer that analyzes a sample using a reagent.

  Conventionally, specimen analysis using a reagent is widely known. In such a sample analysis, even if the same analysis item is analyzed, the reagent to be used may differ depending on the analysis principle, the analysis method, the configuration of the analyzer, and the like. For example, Patent Document 1 discloses the use of a dedicated urine sediment analysis reagent in a predetermined analysis method for urinary sediment analysis.

  Conventionally, a sample analyzer that analyzes a sample using a dedicated reagent is known (see, for example, Patent Document 2).

  Patent Document 2 discloses a blood analyzer (sample analyzer) that analyzes blood using a dedicated reagent. In this blood analyzer, it is possible to select a plurality of measurement modes with different measurement items, and it is possible to facilitate reagent management by sharing a dedicated reagent used in each measurement mode. is there.

  Conventionally, in a sample analyzer for screening a sample, an examination engineer determines whether or not the obtained analysis result may be output for use in diagnosis, and approves (validates) it. It was general. In recent years, there is also a sample analyzer having an automatic approval (validate) function capable of automatically approving an analysis result in order to reduce the burden on the laboratory technician.

JP-A-8-170960 JP 2006-292738 A

  In the dedicated reagent as described above, the components of the reagent are optimized in the sample analyzer so that a highly accurate analysis result can be obtained in the sample analyzer. In addition, in the sample analyzer using the dedicated reagent as described above, an evaluation experiment is performed so that it can be guaranteed that a highly accurate analysis result can be obtained when the analysis is performed using the dedicated reagent (genuine reagent). The sample analyzer has been designed repeatedly. Therefore, if the sample analyzer uses a reagent other than a dedicated reagent that guarantees performance (non-dedicated reagent) and the sample is analyzed with the sample analyzer, there is no guarantee that an accurate analysis result can be obtained. Therefore, the reliability of the analysis result is low. However, in the sample analyzer having the automatic approval function as described above, even when a non-dedicated reagent with low measurement accuracy is used by enabling the automatic approval function, a dedicated reagent with high measurement accuracy can be obtained. Similar to the case where it is used, there is an inconvenience that the analysis result is approved (validated). That is, there is a problem that an analysis result with low reliability is automatically approved (validated).

  The present invention has been made in order to solve the above-described problems, and one object of the present invention is to prevent an analysis result with low reliability from being automatically approved (validated). Is to provide a simple sample analyzer.

Means for Solving the Problems and Effects of the Invention

  In order to achieve the above object, a sample analyzer according to the first aspect of the present invention is received by an analysis unit that analyzes a sample using a reagent, a reception unit that receives input of information about the reagent, and a reception unit. Based on the information, analysis is performed when the determination unit determines whether the reagent is appropriate for the analysis of the sample by the analysis unit and the determination unit determines that the reagent is appropriate for the analysis of the sample by the analysis unit. Automatic approval means for automatically approving the results and not approving the analysis results when the determination means determines that the reagent is not appropriate for the analysis of the sample by the analysis means.

  In the sample analyzer according to the first aspect of the present invention, with the above configuration, when a non-dedicated reagent that is not appropriate for analysis is used, the determination means determines that the reagent is not appropriate, and automatically The approval unit does not automatically approve the analysis result. As a result, it is possible to prevent an analysis result with low reliability from being automatically approved (validated).

  The sample analyzer according to the first aspect preferably further includes a manual approval unit capable of accepting a user's manual approval of the analysis result when the automatic approval unit does not automatically approve the analysis result. . If comprised in this way, even if it restrict | limits so that approval of an analysis result may not be performed automatically, a user can approve an analysis result manually.

  In the sample analyzer according to the first aspect, preferably, when the determination unit determines that the reagent is appropriate for the analysis of the sample by the analysis unit, the analysis result is automatically output, and the reagent is the sample by the analysis unit. And an automatic output means that does not output the analysis result when the determination means determines that the analysis is not appropriate. If comprised in this way, it can prevent that an analysis result with low reliability is output automatically.

  In this case, it is preferable that the automatic output unit further includes a manual output unit capable of accepting a manual analysis result output instruction from the user when the analysis result is not automatically output. If comprised in this way, even if it restrict | limits so that the output of an analysis result may not be performed automatically, a user can output an analysis result manually.

  In the configuration including the automatic output unit and the manual output unit, the automatic output unit and the manual output unit are preferably configured to output the analysis result to the host computer or the printer, respectively. . With this configuration, the analysis result can be automatically reported to the host computer, or the analysis result report form can be automatically printed on paper.

  In the configuration including the automatic output means, preferably, the automatic output means can be set to either a valid setting in which the analysis result is automatically output or an invalid setting in which the analysis result is not automatically output. In the case where the setting is set, if the determination unit determines that the reagent is not appropriate for the analysis of the sample by the analysis unit, the setting is changed to the invalid setting. With this configuration, when the automatic output means is set to the valid setting, it is changed to the invalid setting when the reagent is not appropriate, so that the analysis result with low reliability is automatically output. It can be surely prevented.

  In the sample analyzer according to the first aspect, preferably, the automatic approval unit can be set to either a valid setting in which the analysis result is automatically approved or an invalid setting in which the analysis result is not automatically approved. When the valid setting is set and the determination means determines that the reagent is not appropriate for the analysis of the sample by the analysis means, the setting is changed to the invalid setting. With this configuration, when the automatic approval means is set to the valid setting, it is changed to the invalid setting when the reagent is not appropriate, so that the analysis result with low reliability is automatically approved. It can be surely prevented.

  In the sample analyzer according to the first aspect, preferably, when the determination unit determines that the display device and the reagent are not appropriate for the analysis of the sample by the analysis unit, the analysis result is not automatically approved. Display control means for controlling display by the display device so as to display a warning to that effect. With this configuration, when a non-dedicated reagent is used, the user can easily recognize that the analysis result is not automatically approved.

  In this case, preferably, the display control means is configured to control the display device so as to display a warning at least at the time of activation. With this configuration, the user can recognize that the analysis result is not automatically approved before the analysis is started.

  In the sample analyzer according to the first aspect, preferably, when the reagent is exchanged, input of information about the reagent is received by the receiving unit, and the determination unit is configured to analyze the reagent based on the received information. It is configured to determine whether or not it is appropriate for the analysis of the sample. With this configuration, when a reagent is replaced, it is determined whether or not the reagent after replacement is appropriate. Therefore, whether the analysis result using the reagent is automatically approved immediately after the reagent is replaced. Whether or not can be set appropriately.

  The sample analyzer according to the first aspect preferably further includes a remaining amount measuring unit that measures the remaining amount of the reagent, and the determination unit includes information about the reagent received by the receiving unit and a measurement result by the remaining amount measuring unit. Based on both, it is configured to determine whether or not the reagent is appropriate for the analysis of the sample by the analyzing means. For example, a dedicated reagent that puts a non-dedicated reagent into a reagent container of a genuine reagent that has been used once, or enters information about a reagent of a dedicated reagent that was previously used, and actually uses a non-dedicated reagent instead of a dedicated reagent. The act of using a non-dedicated reagent can be considered. Therefore, with this configuration, the above-described action can be monitored based on the remaining amount of the reagent, and it can be accurately determined whether the reagent is a dedicated reagent appropriate for analysis.

  In the sample analyzer according to the first aspect, preferably, the analysis means is configured to process a measurement value obtained by optically measuring the sample with a flow cytometer and obtain an analysis result. In fully automatic sample analyzers using flow cytometers such as multi-item automated blood cell analyzers, each manufacturer uses its own analysis method, and each manufacturer's sample analyzer uses a dedicated reagent. It is configured as follows. Therefore, if configured as described above, in a sample analyzer using a flow cytometer, it is possible to prevent an analysis result with low reliability from being automatically approved when a non-dedicated reagent is used.

  In this case, preferably, the analysis means is configured to process a measurement value obtained by optically measuring a formed component contained in urine with a flow cytometer and obtain an analysis result. This configuration automatically approves unreliable analysis results when a non-dedicated reagent is used in a urine sediment analyzer using a flow cytometer that employs a manufacturer's original analysis method. Can be prevented.

  According to a second aspect of the present invention, there is provided a sample analyzer comprising: an analysis unit that analyzes a sample using a reagent; a reception unit that receives input of information about the reagent; and a reagent that is analyzed based on information received by the reception unit Determination means for determining whether or not the analysis of the sample by the means is appropriate, automatic approval means for automatically approving the analysis result, and determination means for determining that the reagent is not appropriate for the analysis of the sample by the analysis means And the prohibiting means for prohibiting the automatic approval of the analysis result by the automatic approval means.

  In the sample analyzer according to the second aspect of the present invention, with the configuration as described above, when a non-dedicated reagent that is not appropriate for analysis is used, the determination means can determine that the reagent is not appropriate. In addition, the prohibition unit can prohibit the automatic approval of the analysis result of the automatic approval unit. As a result, it is possible to prevent an analysis result with low reliability from being automatically approved (validated).

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

  FIG. 1 is a perspective view showing a urine particle analyzer according to an embodiment of the present invention. 2-9 is a figure for demonstrating the structure of the urine sediment analyzer by one Embodiment shown in FIG. First, with reference to FIGS. 1-9, the structure of the urine particle | grain formation analyzer 1 by one Embodiment of this invention is demonstrated.

  As shown in FIG. 1, the urine particle analyzer 1 according to an embodiment of the present invention includes a measurement unit 2 that optically measures a component contained in urine with a flow cytometer, and a measurement unit 2. And a data processing unit 3 that processes the measurement values output from the data processing unit 3 to obtain analysis results.

  As shown in FIG. 2, the measurement unit 2 includes a sample distribution unit 21, a sample preparation unit 22, an optical detection unit 23, and an analog signal processing circuit 24 that performs output amplification and filter processing by the optical detection unit 23. And an A / D converter 25 that converts the output of the analog signal processing circuit 24 into a digital signal, and a digital signal processing circuit 26 that performs predetermined waveform processing on the digital signal. Further, the measurement unit 2 includes a memory 27 connected to the digital signal processing circuit 26, a CPU 28 connected to the analog signal processing circuit 24 and the digital signal processing circuit 26, and a LAN adapter 29 connected to the CPU 28. It has been. The data processing unit 3 is connected to the measurement unit 2 via a LAN adapter 29 via a LAN. Further, the analog signal processing circuit 24, the A / D converter 25, the digital signal processing circuit 26, and the memory 27 constitute a signal processing circuit 30 for the electrical signal output from the optical detection unit 23.

  The sample distribution unit 21 is configured to dispense urine (sample) to the sample preparation unit 22 in a predetermined distribution amount. Further, the sample preparation unit 22 prepares a measurement sample from the urine (sample) and reagent dispensed by the sample distribution unit 21, and the prepared measurement sample together with the sheath liquid is placed in a sheath flow cell 23c of the optical detection unit 23 described later. It is configured to supply.

  As shown in FIG. 3, the optical detection unit 23 includes a light emitting unit 23a that emits laser light, an irradiation lens unit 23b, a sheath flow cell 23c that emits laser light, and laser light that is emitted from the light emitting unit 23a. The condensing lens 23d, the pinhole 23e and the PD (photodiode) 23f arranged on the extension line in the traveling direction, and the condensing arranged in the direction intersecting with the traveling direction of the laser light emitted from the light emitting unit 23a. It includes a lens 23g, a dichroic mirror 23h, an optical filter 23i, a pinhole 23j and a PD 23k, and an APD (avalanche photodiode) 23l arranged on the side of the dichroic mirror 23h.

  The light emitting unit 23a is provided to emit light to the sample flow including the measurement sample passing through the inside of the sheath flow cell 23c. Moreover, the irradiation lens unit 23b is provided in order to make the light radiate | emitted from the light emission part 23a into parallel light. The PD 23f is provided to receive forward scattered light emitted from the sheath flow cell 23c.

  The dichroic mirror 23h is provided to separate side scattered light and side fluorescence emitted from the sheath flow cell 23c. Specifically, the dichroic mirror 23h is provided to allow the side scattered light emitted from the sheath flow cell 23c to be incident on the PD 23k and to cause the side fluorescence emitted from the sheath flow cell 23c to be incident on the APD 23l. The PD 23k is provided to receive side scattered light. The APD 231 is provided to receive side fluorescence. Each of the PDs 23f and 23k and the APD 231 has a function of converting the received optical signal into an electrical signal.

  As shown in FIG. 3, the analog signal processing circuit 24 includes amplifiers 24a, 24b, and 24c. The amplifiers 24a, 24b, and 24c are provided to amplify and waveform-process electric signals output from the PDs 23f, 23k, and the APD 23l, respectively.

  The memory 27 is configured to store information (determination result information) indicating whether or not the replaced new reagent is a dedicated reagent (genuine product). Specifically, the memory 27 is configured to determine whether or not a CPU 31a of the data processing unit 3 described later is a dedicated reagent and store determination result information based on the determination result.

  As shown in FIG. 1, the data processing unit 3 is composed of a personal computer (PC) or the like. The data processing unit 3 includes a control unit 31, a display unit 32, and an input device 33. The data processing unit 3 receives a user operation, transmits an operation command to the measurement unit 2, receives measurement data (measurement value) from the measurement unit 2, processes the measurement data, and displays an analysis result. Have. As shown in FIG. 4, the control unit 31 includes a CPU 31a, a ROM 31b, a RAM 31c, a hard disk 31d, a reading device 31e, an input / output interface 31f, an image output interface 31g, and a communication interface 31i. Has been. The CPU 31a, ROM 31b, RAM 31c, hard disk 31d, reading device 31e, input / output interface 31f, image output interface 31g, and communication interface 31i are connected by a bus 31h.

  The CPU 31a is provided for executing computer programs stored in the ROM 31b and computer programs loaded in the RAM 31c. The ROM 31b is configured by a mask ROM, PROM, EPROM, EEPROM, or the like, and stores a computer program executed by the CPU 31a, data used for the same, and the like.

  The CPU 31a processes the measurement value measured by the measurement unit 2 to obtain an analysis result, and displays an analysis result screen SC1 (see FIG. 5), a setting screen SC2 (see FIG. 6), and SC3 for displaying the analysis result. (See FIG. 7) and a function of outputting a video signal to the image output interface 31g. The analysis result screen SC1 includes a display area SC1a for displaying numerical data for basic items, a display area SC1b for displaying numerical data for research items, the number of particles in the measurement sample in the basic items, A display area SC1c for displaying a scattergram showing a distribution such as a size is included. Here, the basic item is a measurement item with high importance used for diagnosis, and the research item is an auxiliary measurement item that is used as a reference for diagnosis and is less important than the basic item. In addition, in the analysis result screen SC1, analysis results of RBC (red blood cells), WBC (white blood cells), EC (epithelial cells), CAST (cylindrical) and BACT (bacteria) are shown as basic items. TAL (crystal), YLC (yeast-like fungus), SRC (small round cell), Path. CAST (pathological cylinder containing cellular components, etc.), MUCUS (mucus thread), SPERM (sperm) and Cond. The analysis result of (urine conductivity) is configured to be shown.

  Here, in the urine particle analyzer 1 according to the present embodiment, when the validate button SC1d of the analysis result screen SC1 is pressed, the Validated display (approved display) is displayed in the display area SC1e. The validation button SC1d is pressed when the laboratory technician determines whether or not the analysis result may be output for use in diagnosis, and determines that the analysis result may be output. As shown in FIG. 5, when the validate button SC1d is not pressed, Not Validated display is displayed in the display area SC1e.

  Further, the urine particle analyzer 1 according to the present embodiment outputs an analysis result by pressing the output button SC1f when the Validated display is displayed in the display area SC1e shown in FIG. The Further, the user arbitrarily selects whether to output the analysis result to the host computer 40 (see FIG. 4), the slip printer 50 (see FIG. 4), or the graphic printer 60 (see FIG. 4). It is possible to select. Further, as shown in FIG. 5, when the Not Validated display is displayed in the display area SC1e, the user cannot press the output button SC1f.

  The setting screens SC2 and SC3 shown in FIGS. 6 and 7 are displayed on the display unit 32 when a setting icon on a menu screen (not shown) is selected by the user.

  As shown in FIG. 6, when the automatic validation item SC2b in the menu tree display area SC2a is selected by the user, the automatic validation target menu is displayed in the display area SC2c on the right side of the menu tree display area SC2a. In the automatic validation target menu, the user can select three targets “not automatically validated”, “all samples”, and “normal samples”. When the user selects “Do not auto-validate”, the user needs to manually validate all samples. That is, the setting of the automatic validation function that the urine particle analyzer 1 has becomes invalid. When “all samples” is selected, all the samples are automatically validated by the CPU 31a without manual validation by the user. When “normal sample” is selected, the CPU 31a performs automatic validation only for a normal sample whose analysis result value is within a predetermined range. After selecting the automatic validation target, the automatic validation function is set so that the selected automatic validation target specimen is automatically validated by pressing the application button SC2d and the OK button SC2e.

  Also, as shown in FIG. 7, the automatic output condition setting menu is displayed in the display area SC3c when the user selects the automatic output item SC3b in the menu tree display area SC3a. In the automatic output condition setting menu, it is possible to select three output destinations “DP (slip printer 50)”, “GP (graphic printer 60)”, and “HC (host computer 40)”. It is possible to select the type of specimen to be output to the output destination. Specifically, there are five types of specimens: normal specimens, abnormal specimens, REVIEW specimens, ERROR specimens, and QC specimens (Quality Control) specimens. It is possible to select whether or not to output each specimen. An abnormal sample is a sample that shows an abnormal value whose analysis result value is not within a predetermined range, and a REVIEW sample is a sample that is preferably re-examined by a laboratory technician. Further, the ERROR sample is a sample in which an error has occurred during analysis, and the QC sample is a sample for use in quality control of the urine particle analyzer 1. After the output destination and the type of sample to be output are selected, the application button SC3d and the OK button SC3e are pressed, so that the analysis result of the selected type of sample is output to the selected output destination. The automatic output function is set to. In this embodiment, the user can enable the automatic output function only when the automatic validation function is enabled.

  Further, when the reagent used in the measurement unit 2 is replaced by the user, the CPU 31a outputs a video signal to the image output interface 31g so that the reagent replacement screen SC4 shown in FIG. The reagent replacement screen SC4 is configured so that the user can input a unique Reagent Code (reagent code) 100a (see FIG. 9) consisting of 27 digits attached to the reagent container 100 (see FIG. 9). Has been. The urine particle analyzer 1 also inputs the Reagent Code 100a by reading the barcode 100b displayed at the top of the Reagent Code 100a (see FIG. 9) using a barcode reader (not shown). Is possible. Here, the Reagent Code is an encrypted 27-digit code that stores information unique to a dedicated reagent (genuine product) appropriate for measurement by the measurement unit 2, for example, an expiration date and a lot number for traceability. This is the reagent code. This Reagent Code 100a is encrypted using a hash function such as MD (Message Digest Algorithm) 5, and is suitable for use in the measurement unit 2 based on the encrypted 27-digit alphanumeric characters. The CPU 31a can determine whether or not the reagent is a dedicated reagent (genuine product).

  When replacing the reagent, the CPU 31a measures the remaining amount of the reagent in use, and stores the remaining amount information in the RAM 31c together with the reagent code 100a of the reagent. The RAM 31c stores information on the reagent code and the remaining amount of a plurality of reagents used in the past as a reagent replacement history. Further, the CPU 31a determines whether or not the replaced new reagent is a dedicated reagent (genuine product) based on both the Reagent Code 100a and the remaining amount information.

  Further, the CPU 31a can update flags J1 and J2, which will be described later, so as to be in an ON state or an OFF state. Since the non-dedicated reagent (non-genuine product) is used, the flags J1 and J2 are switched between the ON state and the OFF state when the automatic validation function and the automatic output function are disabled. The flags J1 and J2 are stored in the RAM 31c.

  The RAM 31c is configured by SRAM, DRAM, or the like. The RAM 31c is used to read out computer programs recorded in the ROM 31b and the hard disk 31d. Further, when these computer programs are executed, they are used as a work area of the CPU 31a.

  The hard disk 31d is installed with various computer programs to be executed by the CPU 31a, such as an operating system and application programs, and data used for executing the computer programs. An application program 34a described later is also installed in the hard disk 31d.

  The reading device 31e is configured by a flexible disk drive, a CD-ROM drive, a DVD-ROM drive, or the like, and can read a computer program or data recorded on the portable recording medium 34. The portable recording medium 34 stores an application program 34a for causing the computer to realize a predetermined function. The computer as the data processing unit 3 reads the application program 34a from the portable recording medium 34, The application program 34a can be installed in the hard disk 31d.

  Note that the application program 34a is not only provided by the portable recording medium 34, but also from the external device communicatively connected to the data processing unit 3 by an electric communication line (whether wired or wireless). It can also be provided through a communication line. For example, the application program 34a is stored in the hard disk of a server computer on the Internet, and the data processor 3 accesses the server computer to download the application program 34a and install it on the hard disk 31d. Is also possible.

  In addition, an operating system that provides a graphical user interface environment, such as Windows (registered trademark) manufactured and sold by Microsoft Corporation, is installed in the hard disk 31d. In the following description, it is assumed that the application program 34a according to the present embodiment operates on the operating system.

  The input / output interface 31f includes, for example, a serial interface such as USB, IEEE1394, RS-232C, a parallel interface such as SCSI, IDE, IEEE1284, and an analog interface including a D / A converter, an A / D converter, and the like. Has been. An input device 33 including a keyboard and a mouse is connected to the input / output interface 31f, and the user can input data to the data processing unit 3 by using the input device 33. The input device 33 has a function of receiving measurement value data. Further, the input / output interface 31 f can output the analysis result to the slip printer 50 and the graphic printer 60.

  The communication interface 31i is an Ethernet (registered trademark) interface, and the data processing device 3 communicates with the measurement unit 2 connected by a LAN cable using a predetermined communication protocol (TCP / IP) by the communication interface 31i. Data can be sent and received between them. In addition, the host computer 40 is connected to the communication interface 31 i, and the communication interface 31 i can transmit (output) the analysis result to the host computer 40.

  The image output interface 31g is connected to a display unit 32 constituted by an LCD or a CRT, and outputs a video signal given from the CPU 31a to the display unit 32. The display unit 32 displays an image (screen) according to the input video signal.

  FIG. 10 is a flowchart for explaining an operation of determining whether or not the replaced reagent is a dedicated reagent (genuine product) in the urine particle analyzer according to the embodiment of the present invention. FIG. 11 is a diagram showing a Reagent Code warning screen of the urine particle analyzer according to the embodiment shown in FIG. Next, referring to FIGS. 8 to 11, in the urine particle analyzer 1 according to one embodiment of the present invention, it is determined whether or not the replaced reagent is a dedicated reagent (genuine product). The genuine product determination operation will be described.

  First, in step S1 of FIG. 10, the reagent replacement screen SC4 shown in FIG. 8 is displayed, and the user is prompted to input a reagent code (reagent code). The reagent replacement screen SC4 is displayed on the display unit 32 when a user double-clicks a reagent replacement icon on a menu screen (not shown). In step S2, the 27-digit Reagent Code 100a (see FIG. 9) attached to the reagent by the user is input on the reagent replacement screen SC4, and it is determined whether or not the execution button SC4a is pressed. This determination is repeated when the execution button SC4a is not pressed. When the execution button SC4a is pressed, it is determined in step S3 whether or not the input Reagent Code is correct. Specifically, it is determined whether or not it is a 27-digit alphanumeric character correctly created according to the MD5 algorithm used at the time of encryption. If the entered Reagent Code is correct, the lot number and expiration date encrypted and stored in 27-digit alphanumeric characters are decoded and displayed in each column of the reagent replacement screen SC4. If the inputted Reagent Code is correct, the operation proceeds to step S4.

  On the other hand, if the Reagent Code is wrong, a Reagent Code warning screen SC5 is displayed in step S7 as shown in FIG. The Reagent Code warning screen SC5 displays warnings that the Reagent Code has not been entered correctly, that the automatic validation and automatic output functions do not work, and that analysis results cannot be guaranteed, and that reagent replacement is required. Is displayed to confirm with the user whether or not to execute the process. This is due to the following reason. In the dedicated reagent, the components of the reagent and the like are optimized in the urine particle analyzer so that a highly accurate analysis result can be obtained in the urine particle analyzer. In addition, in the urine particle analyzer according to the present embodiment, an evaluation experiment is performed so as to ensure that a highly accurate analysis result can be obtained when an analysis is performed using a dedicated reagent (pure reagent). Repeatedly, the urine sediment analyzer has been designed. Therefore, the sample of the urine particle analyzer is analyzed using a reagent (non-dedicated reagent) other than the dedicated reagent that guarantees performance by the supplier of the urine particle analyzer according to the present embodiment. In such a case, there is no guarantee that an accurate analysis result will be obtained, and the reliability of the analysis result will be low.

  In step S8, it is determined which button of the OK button SC5a or the cancel button SC5b of the Reagent Code warning screen SC5 is pressed. If the cancel button SC5b is pressed, the process proceeds to step S1. If the OK button SC5a is pressed, determination result information indicating that the reagent is a non-dedicated reagent (non-genuine product) is stored in the RAM 31c in step S9, and the operation ends.

  If the Reagent Code is correct, whether or not the Reagent Code of the plurality of reagents used in the past stored in the RAM 31c as the reagent replacement history is the same as the input Reagent Code in step S4. Is judged. If there is no identical one, determination result information indicating that the reagent is a dedicated reagent (genuine product) is stored in the RAM 31c in step S5, and the operation is terminated.

  If the entered Reagent Code is the same as any of the Reagent Codes of the plurality of reagents stored in the RAM 31c, the remaining amount information of the reagent stored in the RAM 31c together with the Reagent Code is confirmed in Step S6. Is done. Thus, if it is stored in the RAM 31c that there is no reagent remaining amount corresponding to the input Reagent Code, it means that all the reagents have already been used and replaced. Another reagent (non-genuine product) is refilled and used, or the Reagent Code attached to the dedicated reagent (genuine product) used before is input, and the replaced reagent is a non-genuine product. For example, it is possible to determine that this is an act of using a non-dedicated reagent as a dedicated reagent. Therefore, in step S6, when the reagent remaining amount stored in the RAM 31c is not present, the process proceeds to step S7, and the Reagent Code warning screen SC5 is displayed. If there is a reagent remaining amount, it is determined that the reagent is a dedicated reagent (genuine product), and the process proceeds to step S5. When the reagent is exchanged in this way, by performing a genuine product determination operation, the replaced reagent is used for measurement and analysis in a state where it is unknown whether it is a dedicated reagent (genuine product) or not. Can be suppressed.

  FIG. 12 is a flowchart for explaining an operation of updating information on whether or not the product is genuine in the urine particle analyzer according to the embodiment of the present invention. Next, with reference to FIG. 10 and FIG. 12, a genuine product flag update operation for updating information on whether or not the product is genuine in the urine particle analyzer 1 according to one embodiment of the present invention will be described.

  First, in step S101 of FIG. 12, it is determined on the data processing unit 3 side whether or not reagent replacement has been executed. If not, this determination is repeated. Specifically, it is determined whether reagent replacement has been executed based on whether the genuine product determination operation of the flow shown in FIG. 10 has been completed. If it has been completed, it means that reagent replacement has been executed. In step S102, a signal of the determination result information is transmitted to the measurement unit 2, and the operation is terminated.

  On the measurement unit 2 side, in step S201, a signal of determination result information transmitted from the data processing unit 3 is received. In step S202, sequence control in reagent replacement is executed. The sequence control in the reagent replacement is a preparatory operation for performing the next measurement. More specifically, when the reagent is exchanged, air enters the tube through which the reagent flows, or there is no reagent in the space in the tube where the reagent must originally exist. Therefore, in sequence control in reagent replacement, a reagent is aspirated from a newly set reagent container, and the reagent is filled in the tube. Next, in step S <b> 203, information on whether or not the reagent is a dedicated reagent (genuine product) is stored in the memory 27 based on the received determination result information signal. Specifically, when the reagent is a dedicated reagent (genuine product), the genuine product flag stored in the memory 27 is updated so as to be turned on, and the reagent is a non-dedicated reagent (non-genuine product). Is updated so that the genuine product flag is turned off. Thereafter, the operation of the measurement unit 2 is terminated.

  FIG. 13 is a flowchart for explaining the operation at the start-up of the urine particle analyzer according to one embodiment of the present invention. FIG. 14 is a diagram showing a warning screen of the urine particle analyzer according to the embodiment shown in FIG. Next, with reference to FIG. 13 and FIG. 14, the operation | movement at the time of start-up of the urine sediment analyzer 1 by one Embodiment of this invention is demonstrated.

  First, in step S211 of FIG. 13, a reagent information signal is transmitted to the data processing unit 3 based on the state of the genuine product flag stored in the memory 27 of the measuring unit 2. Specifically, when the genuine product flag is ON, a signal notifying that the reagent to be used is a dedicated reagent (genuine product) is transmitted to the data processing unit 3 and the genuine product flag is OFF. If it is, a signal notifying that it is a non-dedicated reagent (non-genuine product) is transmitted, and the operation is terminated.

  In step S111, the data processing unit 3 receives the reagent information signal transmitted from the measurement unit 2. In step S112, the data processing unit 3 determines whether the reagent is a dedicated reagent (genuine product) based on the received reagent information signal. It is confirmed. If the reagent is a dedicated reagent (genuine product), the operation is terminated as it is. If the reagent is a non-dedicated reagent (non-genuine product), the warning screen SC6 is displayed in step S113 as shown in FIG. Is displayed. On the warning screen SC6, warnings are displayed that the Reagent Code has not been correctly input at the time of reagent replacement, that the analysis result cannot be guaranteed, and that the automatic validation function and automatic output function will not work. In this way, by displaying the warning screen SC6 at the start-up (start-up), the user has low reliability of the analysis result obtained before the measurement and analysis are started, and the automatic validation function and automatic output. It is possible to recognize that the function is disabled. Thereafter, the operation of the data processing unit 3 is terminated.

  FIG. 15 is a flowchart for explaining the measurement and analysis operations of the urine particle analyzer according to the embodiment of the present invention. Next, with reference to FIG. 5 to FIG. 7, FIG. 13 and FIG. 15, the measurement and analysis operations of the urine particle analyzer 1 according to one embodiment of the present invention will be described.

  First, in step S221 of FIG. 15, the measurement unit 2 starts measuring the formed component in urine, and in step S222, it is determined whether or not the measurement is completed. If the measurement has not been completed, this determination is repeated while continuing the measurement. When the measurement is completed, in step S223, the measurement value data is transmitted to the data processing unit 3 via the LAN adapter 29, and the operation on the measurement unit 2 side is ended.

  On the data processing unit 3 side, the measurement value data transmitted from the measurement unit 2 is received in step S121, and in step S122, measurement value processing (analysis processing) is performed based on the received measurement value data. In step S123, it is determined whether or not the used reagent is a dedicated reagent (genuine product) based on the confirmation result of the reagent information signal confirmed in step S112 of the startup operation shown in FIG. Is done.

  If it is determined in step S123 that the reagent is a non-dedicated reagent (non-genuine product), it is determined in step S124 whether or not the automatic validation function and the automatic output function are both set to be disabled. To be judged. Specifically, when “no automatic validation” is selected from the automatic validation target menu shown in FIG. 6 and no “output” is selected in the automatic output condition setting menu shown in FIG. Both the automatic validation function and the automatic output function are disabled, and the operation proceeds to step S128. On the other hand, if both are not invalid or one of them is not invalid, it is determined in step S125 whether or not only the automatic output function is set to invalid. In other words, if no “output” is selected in the automatic output condition setting menu and an item other than “no automatic validation” is selected from the automatic validation target menu, only the automatic output function is disabled. It has been set, and the process proceeds to step S126. In step 127, since the automatic validation function is set to valid, the automatic validation function is changed to an invalid state by the CPU 31a so as not to be automatically validated. If both the automatic validation function and the automatic output function are enabled by the user, in step S127, both the automatic validation function and the automatic output function are executed by the CPU 31a so that the validation and output are not automatically performed. Changed to invalid state. In this case, the validation and output of the analysis result is not automatically performed, but the user can manually validate by pressing the validation button SC1d and manually by pressing the output button SC1f. It is possible to output the analysis result.

  In step S128, the invalidation flag update processing operation for storing that the automatic validation function and the automatic output function are invalidated by the setting by the user by the CPU 31a is invalidated in FIG. This is performed in accordance with the flag update processing operation flow. In step S129, the analysis result in the state where the display is restricted in step S124 is displayed.

  If it is determined in step S123 that the reagent is a dedicated reagent (genuine product), it is determined in step S130 whether or not the flag J1 stored in the RAM 31c is ON. Here, in steps S <b> 130 to S <b> 133, the setting by the user was effective for at least one of the automatic validation function and the automatic output function because a non-dedicated reagent (non-genuine product) was previously used. This is an operation for returning to the original valid state set by the user that the CPU 31a has changed the above to the invalid state. The flag J1 being in the ON state means that the states of both the current automatic validation function and the automatic output function match the setting state set by the user. That is, neither the automatic validation function nor the automatic output function is changed to an invalid state by the CPU 31a. If it is determined in step S130 that the flag J1 is in the ON state, there is no need to return to the original state set by the user, and the process directly proceeds to step S134.

  If the flag J1 is not ON, it is determined in step S131 whether or not the flag J2 is ON. Here, the flag J2 being in the ON state is a state in which the CPU 31a has changed the valid setting by the user to both the automatic validation function and the automatic output function. If the flag J2 is in the ON state, the invalid state of both the automatic validation function and the automatic output function is canceled so that both the validation and the output are automatically performed in step S132, and the flag J1 of the RAM 31c is canceled. Is turned on, and the flag J2 is updated to be turned off. The default values of the flags J1 and J2 are that J1 is ON and J2 is OFF. Accordingly, the flags J1 and J2 are returned to the default values in step S132. If the flag J2 is not in the ON state, the process proceeds to step S133. Here, the flag J1 is not in the ON state and the flag J2 is not in the ON state. Both the flags J1 and J2 are in the OFF state, and the setting by the user is effective only for the automatic validation function. Regardless, the CPU 31a has been changed to an invalid state. Therefore, in step S133, the invalidation state of the automatic validation function is canceled, the flag J1 is turned on, and the flag J2 is updated so as to be turned off so that the validation is automatically performed.

  In steps S130 to S133, after both the automatic validation function and the automatic output function are processed so as to match the setting state set by the user, in step S134, the setting state of the automatic validation function set by the user It is determined whether or not is valid. If not valid, the analysis result screen SC1 is displayed in step S129 as shown in FIG. 5, and the operation is terminated.

  If the automatic validation function is valid, in step S135, an automatic validation process is performed on the sample to be automatically validated selected by the user. In step S136, it is determined whether or not the automatic output function is effective. If the automatic output function is not effective, the process directly proceeds to step S129. If the automatic output function is valid, in step S137, automatic output processing is performed based on the automatic output condition set by the user, and the process proceeds to step S129.

  FIG. 16 is a flowchart for explaining the operation of the invalidation flag update process in step S128 of the measurement and analysis operation shown in FIG. Next, the invalidation flag update processing operation in step S128 of the measurement and analysis operation shown in FIG. 15 will be described with reference to FIG. 15 and FIG.

  First, in step S128a, whether or not the setting by the user is valid for both the automatic validation function and the automatic output function is determined by the CPU 31a. When both are changed, in step S128b, the flag J1 is updated so as to be turned on, and the flag J2 is updated so as to be turned off. Thereafter, the operation is terminated. If either the automatic validation function or the automatic output function has been changed, it is determined in step S128c whether only the automatic validation function has been changed. If only the automatic validation function is used, in step S128e, both the flags J1 and J2 are updated to be in the OFF state, and the operation is terminated. When both the automatic validation function and the automatic output function are changed, in step S128d, the flag J2 is updated to be turned on, and the flag J1 is updated to be turned off. Thereafter, the process is returned to step S129 of the measurement / analysis operation flow.

  In the present embodiment, as described above, whether or not the reagent is appropriate for the measurement of the sample by the measurement unit 2 based on the Reagent Code 100a received by the reagent replacement screen SC4 by executing the application program 34a by the CPU 31a. The function is limited so that the analysis result is not automatically approved when it is determined that the reagent is not appropriate for the measurement of the sample by the measurement unit 2. Thereby, it is possible to prevent the analysis result with low reliability due to the non-dedicated reagent (non-genuine product) not suitable for measurement from being automatically approved (validated).

  In the present embodiment, the CPU 31a executes the application program 34a to automatically output the analysis result. When it is determined that the reagent is not appropriate for the measurement of the sample by the measurement unit 2, the analysis result Restrict the function so that is not automatically output. With this configuration, it is possible to prevent an analysis result with low reliability from being automatically output.

  The embodiment disclosed this time should be considered as illustrative in all points and not restrictive. The scope of the present invention is shown not by the above description of the embodiments but by the scope of claims for patent, and further includes all modifications within the meaning and scope equivalent to the scope of claims for patent.

  For example, in the above-described embodiment, an example in which the present invention is applied to a urine sediment analyzer that is an example of a sample analyzer has been described. However, the present invention is not limited thereto, and a sample is analyzed using a dedicated reagent. If it is a sample analyzer that performs the above, it may be applied to other sample analyzers such as a multi-item blood cell analyzer, a blood coagulation measuring device, and an immune analyzer.

  Moreover, although the example of the structure which displays a warning screen at the time of starting was shown in the said embodiment, this invention is not limited to this, You may make it display a warning screen whenever it displays an analysis result screen.

  In the above embodiment, the invalidation flag update process is performed in the measurement and analysis operations, and the invalid state function is returned to the valid state based on the invalidation flag mode. However, the present invention is not limited to this, and as shown in FIG. 17, the operations of steps S124 to S128 and steps S130 to S133 of FIG. 15 may not be performed. Thus, as in the above embodiment, when a non-dedicated reagent is used, the automatic validation function and the automatic output function can be prevented from working.

  In the above embodiment, an example in which the present invention is applied to a sample analyzer that analyzes a sample using one reagent has been described. However, the present invention is not limited to this, and a sample is analyzed using a plurality of reagents. The present invention may be applied to a sample analyzer that performs the above. In this case, when a non-dedicated reagent (non-genuine product) is used as one of a plurality of reagents, the automatic validation function and the automatic output function are changed to an invalid state. Alternatively, when a non-dedicated reagent (non-genuine product) is used for one predetermined reagent or a plurality of predetermined reagents, the automatic validation function and the automatic output function may be changed to an invalid state.

  In the above embodiment, when a non-dedicated reagent is used, an example is shown in which both the automatic validation function and the automatic output function are changed to an invalid state. However, the present invention is not limited thereto, and the automatic output function is not limited thereto. The automatic validation function may be changed to the invalid state without changing the state to the invalid state.

  In the above embodiment, the analysis result can be output to the host computer, slip printer, and graphic printer. However, the present invention is not limited to this. For example, the analysis result is digitized into a PDF file or the like. You may make it do.

  Further, in the above mobile phone, the encryption algorithm used for the Reagent Code is MD5. However, the present invention is not limited to this, and other encryption algorithms such as SHA and MD4 may be used.

  In the above-described embodiment, it is configured to determine whether the reagent is a dedicated reagent (genuine product) or a non-dedicated reagent (non-genuine product). However, the present invention is not limited to this. In addition to determining whether or not the reagent is a dedicated reagent, the expiration date of the reagent may be compared with the date of measurement to determine whether or not the reagent has expired. When the reagent is not expired, the automatic validation process and the automatic output process are executed without restriction. When the reagent is expired, at least one of the automatic validation process and the automatic output process is restricted. be able to.

It is the perspective view which showed the urine particle | grain component analyzer by one Embodiment of this invention. It is the block diagram which showed the structure of the measurement part of the urine particle | grain formation analyzer by one Embodiment shown in FIG. It is a figure for demonstrating the structure of the measurement part of the urine particle | grain formation analyzer by one Embodiment shown in FIG. It is the block diagram which showed the structure of the data processing part of the urine particle | grain formation analyzer by one Embodiment shown in FIG. It is the figure which showed the analysis result screen of the urine particle | grain formation analyzer by one Embodiment shown in FIG. It is the figure which showed the setting screen of the urine particle | grain formation analyzer by one Embodiment shown in FIG. It is the figure which showed the setting screen of the urine particle | grain formation analyzer by one Embodiment shown in FIG. It is the figure which showed the reagent replacement | exchange screen of the urine particle | grain formation analyzer by one Embodiment shown in FIG. It is the perspective view which showed the reagent container used for the urine particle | grain formation analyzer by one Embodiment shown in FIG. 6 is a flowchart for explaining an operation of determining whether or not a replaced reagent is a dedicated reagent (genuine product) in the urine particle analyzer according to the embodiment of the present invention. It is the figure which showed the Reagent Code warning screen of the urine particle | grain formation analyzer by one Embodiment shown in FIG. 6 is a flowchart for explaining an operation of updating information on whether or not the product is genuine in the urine particle analyzer according to the embodiment of the present invention. It is a flowchart for demonstrating the operation | movement at the time of start-up of the urine particle | grain formation analyzer by one Embodiment of this invention. It is the figure which showed the warning screen of the urine particle | grain formation analyzer by one Embodiment shown in FIG. It is a flowchart for demonstrating the operation | movement of a measurement and analysis of the urine sediment analyzer by one Embodiment of this invention. 16 is a flowchart for explaining an operation of an invalidation flag update process in step S128 of the measurement and analysis operation shown in FIG. It is a flowchart for demonstrating the modification of the operation | movement of a measurement and analysis of the urine sediment analyzer by one Embodiment of this invention.

Explanation of symbols

1 Urine material analyzer (sample analyzer)
2 Measurement unit (analysis means)
3 Data processing section (analysis means)
31a CPU (determination means, display control means, remaining amount measurement means, automatic approval means, automatic output means)
32 Display unit (display device)
40 host computer 50 slip printer (printer)
60 Graphic printer (printer)
100a Reagent Code (information on reagents)
SC1d Validate button (manual approval means)
SC1f output button (manual output means)
SC4 Reagent replacement screen (reception means)
SC6 Warning screen (warning)

Claims (14)

An analysis means for analyzing a sample using a reagent;
Accepting means for accepting input of information about the reagent;
Determination means for determining whether or not the reagent is appropriate for analysis of the sample by the analysis means based on the information received by the reception means;
When the determination unit determines that the reagent is appropriate for the analysis of the sample by the analysis unit, the analysis result is automatically approved, and the reagent is not appropriate for the analysis of the sample by the analysis unit. And an automatic approval unit that does not approve the analysis result when determined by the determination unit.   The sample analyzer according to claim 1, further comprising a manual approval unit capable of accepting a manual approval of the analysis result by a user when the automatic approval unit does not automatically approve the analysis result.   When the determination unit determines that the reagent is appropriate for the analysis of the sample by the analysis unit, the analysis result is automatically output, and the reagent is not appropriate for the analysis of the sample by the analysis unit. The sample analyzer according to claim 1, further comprising an automatic output unit that does not output the analysis result when determined by the determination unit.   The sample analyzer according to claim 3, further comprising a manual output unit capable of receiving a manual output instruction of the analysis result by a user when the automatic output unit does not automatically output the analysis result.   The sample analyzer according to claim 4, wherein the automatic output unit and the manual output unit are configured to output the analysis result to a host computer or a printer, respectively.   The automatic output means can be set to either an effective setting in which the analysis result is automatically output and an invalid setting in which the analysis result is not automatically output, and when the effective setting is set to the effective setting, 6. The apparatus according to claim 3, wherein when the determination unit determines that the reagent is not appropriate for the analysis of the sample by the analysis unit, the setting is changed to the invalid setting. The sample analyzer according to item.   The automatic approval means can be set to either an effective setting in which the analysis result is automatically approved and an invalid setting in which the analysis result is not automatically approved. The setting is changed to the invalid setting when the determination unit determines that the reagent is not appropriate for the analysis of the sample by the analysis unit. 2. The sample analyzer according to item 1. A display device;
When the determination unit determines that the reagent is not appropriate for the analysis of the sample by the analysis unit, the display device displays a warning that the analysis result is not automatically approved. The sample analyzer according to any one of claims 1 to 7, further comprising display control means for controlling the control.   The sample analyzer according to claim 8, wherein the display control unit is configured to control the display device so that the warning is displayed at least at the time of activation.   When the reagent is exchanged, input of information related to the reagent is received by the receiving means, and the determination means is suitable for analyzing the sample by the analyzing means based on the received information. The sample analyzer according to any one of claims 1 to 9, wherein the sample analyzer is configured to determine whether or not. Further comprising a remaining amount measuring means for measuring the remaining amount of the reagent,
The determination means determines whether the reagent is appropriate for the analysis of the sample by the analysis means based on both the information on the reagent received by the reception means and the measurement result by the remaining amount measurement means. The sample analyzer according to claim 1, wherein the sample analyzer is configured to make a determination.   The sample analyzer according to any one of claims 1 to 11, wherein the analysis means is configured to process a measurement value obtained by optically measuring the sample with a flow cytometer and obtain an analysis result. .   The sample analyzer according to claim 12, wherein the analysis unit is configured to process a measurement value obtained by optically measuring a formed component contained in urine with a flow cytometer and obtain an analysis result. An analysis means for analyzing a sample using a reagent;
Accepting means for accepting input of information about the reagent;
Determination means for determining whether or not the reagent is appropriate for analysis of the sample by the analysis means based on the information received by the reception means;
Automatic approval means capable of automatically approving the analysis result;
A sample analyzer comprising: a prohibiting unit that prohibits automatic approval of the analysis result by the automatic approval unit when the determination unit determines that the reagent is not appropriate for the analysis of the sample by the analysis unit.

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