JP2009068979A - Specimen analyzer - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a specimen analyzer capable of suppressing provision of an analysis result having low reliability. <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 display part 32 for displaying an analysis result, a reagent exchange screen SC7 for receiving input of Reagent Code 100a, and a CPU 31a for controlling operation on analysis based on the received Reagent Code 100a. <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.

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, with a conventional sample analyzer, even when a non-dedicated reagent with low measurement accuracy is used, the sample is analyzed in the same manner as when a dedicated reagent with high measurement accuracy is used, and the analysis results are displayed. There was a problem of doing.

  The present invention has been made to solve the above-described problems, and one object of the present invention is to provide a sample analyzer that can suppress the provision of analysis results with low reliability. It is.

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. A determination unit that determines whether the reagent is appropriate for the analysis of the sample by the analysis unit based on the information, and a control unit that controls an operation related to the analysis based on the determination result by the determination unit.

  In the sample analyzer according to the first aspect of the present invention, as described above, based on the information received by the receiving unit, the determining unit that determines whether the reagent is appropriate for the analysis of the sample by the analyzing unit; And a control means for controlling the operation related to the analysis based on the determination result by the determination means, and when the non-dedicated reagent that is not appropriate for the analysis is used, the determination means determines that the reagent is not appropriate. In addition, the control unit can control the operation related to the analysis, and can suppress providing the analysis result with low reliability to the user.

  The sample analyzer according to the first aspect preferably further includes a display device that displays an analysis result by the analysis unit, and the control unit controls display by the display device based on the determination result by the determination unit. It is configured. If comprised in this way, when it determines with a reagent not being appropriate, a display apparatus is controlled so that a user may recognize that it is an analysis result with low reliability, for example. be able to. As a result, the user can recognize that the analysis result has low reliability when an appropriate reagent is not used.

  In this case, preferably, when the determination unit determines that the reagent is not appropriate, the control unit displays a display on the display device so that the analysis result by the analysis unit is low in reliability. Configured to control. If comprised in this way, the user can recognize reliably that it is an analysis result with low reliability.

  In the configuration in which the control means controls display by the display device, preferably, the analysis means is configured to analyze the specimen containing particles and obtain numerical data and a distribution map of the particles contained in the specimen. When the determination unit determines that the reagent is appropriate, the control unit controls display by the display device so as to display both the numerical data and the distribution chart, and the determination unit determines that the reagent is not appropriate. In such a case, the display by the display device is controlled so as to display the numerical data without displaying the distribution map. When a doctor diagnoses a patient, the analysis result of the sample collected from the patient is referred to.Depending on the doctor, more detailed diagnosis is performed by referring not only to numerical data but also to distribution diagrams such as scattergrams and histograms. There may be. However, an analysis result using a non-dedicated reagent is low in reliability, and even if a detailed diagnosis is performed using such an analysis result, the diagnosis itself is low in reliability. Therefore, with the above-described configuration, since a distribution map used when performing a detailed diagnosis is not displayed, it is possible to prevent a detailed diagnosis from being performed based on an analysis result with low reliability.

  In the configuration in which the control unit controls display by the display device, preferably, the analysis unit analyzes the first analysis item and the second analysis item, and acquires the first numerical data as the analysis result of the first analysis item. The second numerical data is obtained as the analysis result of the second analysis item, and the control means determines that the first numerical data and the second numerical data when the determination means determines that the reagent is appropriate. The display by the display device is controlled so as to display both analysis results, and when the determination means determines that the reagent is not appropriate, the first numerical data is displayed without displaying the second numerical data. The display by the display device is controlled. With this configuration, when displaying analysis results with low reliability, the display is controlled so as not to display the second numerical data, so the display is limited so that analysis results with low reliability are not displayed as much as possible. can do. As a result, the amount of analysis results with low reliability acquired by the user can be reduced as much as possible.

  In this case, preferably, the first numerical data is basic data used for diagnosis, and the second numerical data is auxiliary data used as a reference for diagnosis. When a doctor diagnoses a patient, the analysis result of a sample collected from the patient is referred to. Depending on the doctor, more detailed diagnosis may be performed by referring not only to basic data but also to auxiliary data. However, an analysis result using a non-dedicated reagent is low in reliability, and even if a detailed diagnosis is performed using such an analysis result, the diagnosis itself is low in reliability. Therefore, with the above-described configuration, auxiliary data used when performing a detailed diagnosis is not displayed, so that a detailed diagnosis can be prevented from being performed based on an analysis result with low reliability.

  In the configuration in which the control unit controls display by the display device, preferably, the control unit displays a warning that the analysis result is low in reliability when the determination unit determines that the reagent is not appropriate. The display by the display device is controlled. If comprised in this way, a user can recognize easily that the reliability of an analysis result is low.

  In this case, preferably, the control means is configured to control the display device so as to display a warning at least when the sample analyzer is activated. With this configuration, the user can recognize that the reliability of the analysis result is low before the analysis is started.

  In the sample analyzer according to the first aspect, preferably, the control unit is configured to prohibit the analysis operation by the analysis unit when the determination unit determines that the reagent is not appropriate. If comprised in this way, when it determines with a reagent not being appropriate, analysis operation | movement will not be performed but it can suppress that an analysis result with low reliability is provided to a user.

  In the sample analyzer according to the first aspect described above, preferably, when the reagent is replaced, input of information regarding the reagent is received by the receiving unit, and the determination unit analyzes the reagent based on the received information. It is configured to determine whether or not it is appropriate to analyze the sample by the means. According to this configuration, when the reagent is replaced, it is determined whether or not the reagent after replacement is appropriate. Therefore, immediately after the reagent is replaced, the operation related to the analysis using the reagent is performed as a result of the determination. Can be controlled according to.

  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, when configured as described above, in a sample analyzer using a flow cytometer, it is possible to suppress a user from being provided with an analysis result with low reliability 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. With this configuration, in the urine sediment analyzer using a flow cytometer that employs a manufacturer's original analysis method, a non-reliable analysis result is provided to the user when a non-dedicated reagent is used. Can be suppressed.

  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. 2-12 is a figure for demonstrating the structure of the urine particle | grain formation analyzer by one Embodiment shown in FIG. First, with reference to FIGS. 1-12, 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.

  Here, in this embodiment, CPU31a processes the measured value measured by the measurement part 2, obtains an analysis result, The analysis result screen SC1-SC6 for displaying the analysis result (refer FIGS. 5-10) ) 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.

  In addition, as shown in FIG. 6, the asterisk display (*) in the display area SC2a of the analysis result screen SC2 corresponds to the measurement item that is preferably re-inspected by the inspection engineer as a result of processing the measurement value by the data processing unit 3. It is comprised so that it may be attached. In addition, the asterisk display is configured to be attached even when the reliability of the analysis result is low. Further, the REVIEW display in the display area SC2b is conspicuous in the vicinity of the upper left of the analysis result screen SC2 so that the user can easily recognize that the sample is desired to be retested when the asterisk display is added. Are displayed in red.

  The analysis result screen SC3 shown in FIG. 7 is a screen for displaying a list of analysis results for basic items of a plurality of samples. The asterisk display of the display area SC3a on the analysis result screen SC3 is also configured to be attached to a measurement item that is preferably re-inspected by an inspection engineer as described above. Further, the analysis result screen SC4 shown in FIG. 8 is a screen for displaying a list of analysis results for the research items of a plurality of samples. An analysis result screen SC5 shown in FIG. 9 is a screen for displaying red blood cell morphology information as a research item. An analysis result screen SC6 shown in FIG. 10 is a screen for displaying urine concentration information and the like as research items.

  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 SC7 shown in FIG. This reagent replacement screen SC7 is configured so that the user can input a unique Reagent Code (reagent code) 100a (see FIG. 12) consisting of 27 digits attached to the reagent container 100 (see FIG. 12). Has been. The urine particle analyzer 1 also inputs the Reagent Code 100a by reading the barcode 100b displayed on the top of the Reagent Code 100a (see FIG. 12) using a barcode reader (not shown). Is configured to be 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).

  Further, the CPU 31a is configured to measure the remaining amount of the reagent in use and store the remaining amount information in the RAM 31c together with the reagent code 100a of the reagent. In addition, the RAM 31c can store information on reagent codes and remaining amounts of a plurality of reagents used in the past as a reagent replacement history. The CPU 31a is configured to determine 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.

  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.

  The application program 34a is not only provided by the portable recording medium 34, but also from an external device that is communicably connected to the computer via an electric communication line (whether wired or wireless), through the electric communication line. It is also possible to provide. For example, the application program 34a is stored in the hard disk of a server computer on the Internet. The computer can access the server computer, download the application program 34a, and install it on the hard disk 31d. is there.

  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 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.

  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. 13 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. 14 is a view showing a Reagent Code warning screen of the urine particle analyzer according to the embodiment shown in FIG. Next, referring to FIG. 11 to FIG. 14, 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. 13, the reagent replacement screen SC7 shown in FIG. 11 is displayed, and the user is prompted to input a Reagent Code (reagent code). The reagent replacement screen SC7 is displayed on the display unit 2 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. 12) attached to the reagent by the user is input on the reagent replacement screen SC7, and it is determined whether or not the execution button SC7a has been pressed. This determination is repeated when the execution button SC7a is not pressed. When the execute button SC7a 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 SC7. 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 SC8 is displayed in step S7 as shown in FIG. On the Reagent Code warning screen SC8, a warning that the Reagent Code has not been correctly input and that the analysis result cannot be guaranteed is displayed, and the user is asked to determine whether or not to perform reagent replacement. Is displayed. 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 SC8a or the cancel button SC8b on the Reagent Code warning screen SC8 is pressed. If the cancel button SC8b is pressed, the process proceeds to step S1. If the OK button SC8a 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 SC8 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. 15 is a flowchart for explaining an operation of updating information as to whether or not the product is genuine in the urine particle analyzer according to one embodiment of the present invention. Next, with reference to FIG. 13 and FIG. 15, 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. 15, it is determined whether or not reagent replacement has been executed on the data processing unit 3 side. 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. 13 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. 16 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. 17 is a diagram showing a warning screen of the urine particle analyzer according to the embodiment shown in FIG. Next, with reference to FIG. 16 and FIG. 17, the operation | movement at the time of start-up of the urine particle | grain formation analyzer 1 by one Embodiment of this invention is demonstrated.

  First, in step S211 of FIG. 16, 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 SC9 is displayed in step S113 as shown in FIG. Is displayed. On the warning screen SC9, warnings are displayed indicating that the Reagent Code has not been correctly input at the time of reagent replacement, and that the analysis result cannot be guaranteed. In this way, by displaying the warning screen SC9 at the start-up (start-up), the user can recognize that the reliability of the obtained analysis result is low before the measurement and analysis are started. Become. Thereafter, the operation of the data processing unit 3 is terminated.

  FIG. 18 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. 10, FIG. 16, and FIG. 18, 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. 18, the measurement unit 2 starts measurement of 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 reagent used 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.

  Here, in this embodiment, when it is determined in step S123 that the reagent is a dedicated reagent (genuine product), an analysis result screen SC1 is displayed in step S125 as shown in FIG. The analysis result screen SC1 is a display in a state where the main tab SC1d is selected. Any one of the numerical data for the basic items in the display area SC1a, the numerical data for the research items in the display area SC1b, and the scattergram in the display area SC1c. Analysis results are also displayed. That is, when a dedicated reagent (genuine product) is used, all analysis results of basic items and research items that can be analyzed by the urine particle analyzer 1 are displayed. Even when the research 1 tab SC1e and the research 2 tab SC1f are selected, all analysis results are displayed.

  If it is determined in step S123 that the reagent is a non-dedicated reagent (non-genuine product), the output of the analysis result is limited in step S124. Specifically, as shown in FIG. 6, in the analysis result screen SC2 in a state where the main tab SC2c is selected, an asterisk display (*) of the display area SC2a is attached to all the basic item columns. This is because the measurement is performed using a non-dedicated reagent (non-genuine product) and the reliability of the analysis result is low, so that re-inspection by an inspection engineer is desirable. Further, by adding an asterisk display, a REVIEW display of the display area SC2b is also added. Further, since the reliability of the analysis result is low, all the numerical data for the research items in the display area SC2d with low importance are hidden by the hyphen symbol (−), and the scattergram in the display area SC2e is also not displayed. It becomes. Further, in the analysis result screen SC3 shown in FIG. 7, an asterisk display indicating low reliability is added to the display area SC3a for the analysis result of the basic item of the sample measured by the non-dedicated reagent (non-genuine product). . Further, in the analysis result screen SC4 shown in FIG. 8, the numerical data on the research item in the sample display area SC4a measured by the non-dedicated reagent (non-genuine product) is hidden by the hyphen symbol. Further, as shown in FIG. 9, in the analysis result screen SC5 in a state where the research 1 tab SC5a is selected, all the red blood cell morphology information in the display area SC5b is hidden by the hyphen symbol, and the display area SC5c associated therewith is displayed. The scattergram is also hidden. Further, as shown in FIG. 10, in the analysis result screen SC6 in a state where the research 2 tab SC6a is selected, all the urine concentration information and the like in the display area SC6b are hidden. Thus, when measured with a non-dedicated reagent (non-genuine product), in the analysis result screens SC2 to SC6 (see FIGS. 6 to 10), the asterisk indicating low reliability is displayed in the numerical data of the basic items. A display (see FIGS. 6 and 7) is attached, and all analysis results other than the numerical data of the basic items are hidden. Thereby, when the reliability of the analysis result is low, the analysis result is limited so as not to be displayed as much as possible. When a doctor diagnoses a patient, he refers to the analysis result of the sample collected from the patient, but depending on the doctor, not only the numerical data of the basic items, but also the distribution diagrams such as scattergrams and histograms and the numerical data of the research items More detailed diagnosis may be performed by referring to it. However, an analysis result using a non-dedicated reagent is low in reliability, and even if a detailed diagnosis is performed using such an analysis result, the diagnosis itself is low in reliability. Therefore, by preventing the analysis results of scattergrams and research items used when performing detailed diagnosis as described above from being displayed, it is possible to prevent detailed diagnosis from being performed with low-reliability analysis results. Can do.

  In the present embodiment, as described above, based on the display unit 32 that displays the analysis result and the Reagent Code 100a received by the reagent replacement screen SC7, the reagent is appropriate for the measurement of the urine formed component by the measurement unit 2. The CPU 31a is provided when a non-dedicated reagent (non-genuine product) that is not appropriate for analysis is used by determining whether or not there is a CPU 31a that controls display by the display unit 32 based on the determination result. By controlling the display unit 32 so as to display an asterisk display (*) that allows the user to recognize that the analysis result is low in reliability. Can do. As a result, the user can recognize that the analysis result has low reliability.

  In the present embodiment, when the CPU 31a determines that the reagent is a non-dedicated reagent (non-genuine product) that is not appropriate, the display by the display unit 32 is controlled so as to display the warning screen SC9. By configuring, the user can easily recognize that the reliability of the analysis result is low.

  Further, in the present embodiment, the CPU 31a determines that the reagent is appropriate for the analysis of the urine formed component by the measuring unit 2 based on both the reagent code 100a received on the reagent replacement screen SC7 and the information on the reagent remaining amount. By determining whether or not the reagent (genuine product) is used, the CPU 31a can make a determination based not only on the reagent code 100a but also on the measurement result of the remaining amount of the reagent. It is possible to accurately determine whether the product is a product.

  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, 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 for any one of the plurality of reagents, the display of the analysis result may be limited, or a predetermined 1 When a non-dedicated reagent (non-genuine product) is used for one reagent or a plurality of predetermined reagents, the display of analysis results may be limited.

  Moreover, in the said embodiment, although the encryption algorithm used for Reagent Code was MD5, it is not limited to this, You may use other encryption algorithms, such as SHA and MD4.

  In the above embodiment, the display of the analysis result is limited when it is determined that the reagent is not appropriate (non-genuine product). However, the present invention is not limited to this, and the reagent is appropriate. If it is determined that the reagent is not suitable, the analysis operation may be prohibited. Also by this, it is possible to prevent the analysis result with low reliability from being provided to the user.

  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. If the reagent has not expired, an analysis operation is executed. If the reagent has expired, a warning screen notifying that the reagent has expired is displayed and the analysis operation is prohibited. it can.

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 analysis result screen 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 analysis result screen 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 analysis result 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.

Explanation of symbols

1 Urine material analyzer (sample analyzer)
2 Measurement unit (analysis means)
3 Data processing section (analysis means)
31a CPU (determination means, control means, remaining amount measurement means)
32 Display unit (display device)
100a Reagent Code (information on reagents)
SC7 Reagent replacement screen (reception means)
SC9 Warning screen (warning)

Claims (13)

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;
A sample analyzer comprising: control means for controlling an operation related to analysis based on a determination result by the determination means. A display device for displaying an analysis result by the analysis means;
The sample analyzer according to claim 1, wherein the control unit is configured to control display by the display device based on a determination result by the determination unit.   When the determination unit determines that the reagent is not appropriate, the control unit displays a display by the display device so as to display that the reliability of the analysis result by the analysis unit is low together with the analysis result. The sample analyzer according to claim 2, wherein the sample analyzer is configured to be controlled. The analysis means is configured to analyze a specimen containing particles and obtain numerical data and a distribution map of particles contained in the specimen.
The control means controls the display by the display device so as to display both the numerical data and the distribution chart when the determination means determines that the reagent is appropriate, and the determination means 4. The display device according to claim 2, wherein when the reagent is determined to be inappropriate, the display by the display device is controlled so as to display the numerical data without displaying the distribution chart. 5. Sample analyzer. The analysis means analyzes the first analysis item and the second analysis item, acquires the first numerical data as the analysis result of the first analysis item, and acquires the second numerical data as the analysis result of the second analysis item. Configured as
The control means displays the display by the display device so as to display the analysis results of both the first numerical data and the second numerical data when the determination means determines that the reagent is appropriate. And when the determination means determines that the reagent is not appropriate, the display by the display device is controlled to display the first numerical data without displaying the second numerical data. The sample analyzer according to any one of claims 2 to 4, wherein the sample analyzer is configured. The first numerical data is basic data used for diagnosis,
6. The sample analyzer according to claim 5, wherein the second numerical data is auxiliary data used as a reference for diagnosis.   The control means is configured to control the display by the display device so as to display a warning that the reliability of the analysis result is low when the determination means determines that the reagent is not appropriate. The sample analyzer according to any one of claims 2 to 6.   8. The sample analyzer according to claim 7, wherein the control unit is configured to control the display device so that the warning is displayed at least when the sample analyzer is activated.   The sample analyzer according to claim 1, wherein the control unit is configured to prohibit an analysis operation by the analysis unit when the determination unit determines that the reagent is not appropriate.   When the reagent is exchanged, input of information related to the reagent is received by the receiving means, and the determination means is configured to analyze 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 it is appropriate. 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.

Images