JP5726239B2 - Sample analyzer and program for sample analyzer - Google Patents

Description

The present invention, as the blood cell counter, relates to a sample analyzer and a program for a sample analyzer for analyzing a sample such as blood with a reagent.

  In hospitals and testing institutions, sample analyzers that measure items about the properties of samples (samples) such as blood collected from a living body are used (for example, see Patent Document 1). Such a sample analyzer is usually recommended to use a dedicated reagent (genuine product) designated by a supplier (manufacturer). This is because the dedicated reagent is optimized so that high-precision analysis results can be obtained by repeatedly conducting evaluation experiments, while samples other than genuine products (non-genuine products) are used. This is because the same highly accurate analysis result may not be obtained when the above analysis is performed, and the reliability of the analysis result decreases. This also applies to, for example, a slide glass in a smear preparation apparatus. If a non-genuine slide glass is used, the observed component in the specimen may be destroyed, and the reliability of the prepared specimen is high. descend. Further, if a non-genuine staining solution is used in the smear preparation apparatus, blood cells cannot be stained well, and the observation result may be adversely affected.

  However, there are cases where the user does not recognize that the reliability of the analysis result or the like is low if a non-genuine product is used, or the user uses the product without knowing that it is a non-genuine product. In such a case, if a patient's medical care or the like is performed based on an unreliable analysis result or the like, there is a possibility that the patient may be adversely affected by inappropriate treatment or medication.

JP 2006-292738 A

The present invention is a reagent when the reagent replacement of the sample analyzer is equal to or genuine, the fact that the analysis result of the use of reagents non-genuine specimen can not be guaranteed after the user has recognized reliably It is an object of the present invention to provide a sample analyzer and a program for a sample analyzer that can determine whether to use a non-genuine reagent .

The sample analyzer of the present invention is a sample analyzer for analyzing a sample collected from a living body, and is an analysis unit that analyzes a sample using a reagent, a display unit, and a reagent that is genuine when the reagent is replaced. When the reagent is not a genuine product, the user inputs information that the analysis result of the sample is not guaranteed if the reagent is used and an input that the reagent determined to be not the genuine product is used. And an input means for performing control, and a control means configured to cause the display means to display a warning screen on which is displayed.

According to this configuration, when it is determined that the reagent used for analyzing the sample is not a genuine product, it is determined that the analysis result of the sample is not guaranteed if the reagent is used and that the reagent is not a genuine product. A warning screen displaying input means for the user to input whether or not to use the reagent is displayed on the display means. Therefore, it is possible to prevent erroneous analysis without knowing that the reagent to be used is not a genuine product. Further, the user can surely recognize that the reagent to be used is not a genuine product and can decide whether or not to use it.

The sample analyzer program of the present invention, analyzing means for analyzing the collected analyte from the biological, and display means, a computer equipped to a sample analyzer having a reagent during the reagent exchange is a genuine product with a reagent If the reagent is not a genuine product, information indicating that the analysis result of the sample is not guaranteed if the reagent is used and input means for the user to input whether the reagent is used or not Are displayed on the display means. The display means functions as a means for displaying the warning screen .

The present invention is, to decide whether to use the reagents non-genuine when using reagents non-genuine when replacement of the reagent of the sample analyzer of the fact that the analysis result of the sample can not be guaranteed after the user has recognized reliably Can do.

1 is a perspective view showing a blood cell counter according to a first embodiment of the present invention. It is a block diagram which shows the structure of the measurement part in the blood cell counter of FIG. It is a block diagram which shows the structure of the data processor in the blood cell counter of FIG. It is a figure for demonstrating the flow of RBC / PLT measurement in the blood cell counter of FIG. It is a figure for demonstrating the flow of the HGB measurement in the blood cell counter of FIG. It is a figure for demonstrating the flow of WBC / BASO measurement in the blood cell counter of FIG. It is a figure for demonstrating the flow of the DIFF measurement by the blood cell counter of FIG. It is a figure for demonstrating the structure of the optical detection part in the blood cell counter of FIG. It is a figure which shows the reagent replacement | exchange screen displayed on the data processor in the blood cell counter of FIG. It is a perspective view which shows the reagent container used for the blood cell counter of FIG. 2 is a flowchart for explaining control for determining whether or not a replaced reagent is a dedicated reagent (genuine product) in the blood cell counter of FIG. 1. It is a figure which shows the Reagent Code warning screen displayed on the data processor of the blood cell counter of FIG. 2 is a flowchart for explaining control for updating information on whether or not a reagent is a genuine product in the blood cell counter of FIG. 1. It is a flowchart for demonstrating the control at the time of start-up in the blood cell counter of FIG. It is a figure which shows the warning screen displayed on the data processor of the blood cell counter of FIG. 3 is a flowchart for explaining control of measurement / analysis operation in the blood cell counter of FIG. 1. 3 is a flowchart for explaining analysis result display control of the blood cell counter of FIG. 1. 6 is a flowchart for explaining screen display control with warning of the blood cell counter of FIG. 1. It is a figure for demonstrating the content of the database which shows the relationship between the measurement item and the genuine reagent used which are memorize | stored in the blood cell counter of FIG. 6 is a flowchart for explaining analysis result printing control of the blood cell counter of FIG. 1. It is a figure which shows an example of the analysis result display screen displayed on the data processor of the blood cell counter of FIG. 1 when a pure reagent is used. It is a figure which shows an example of the analysis result display screen displayed on the data processor of the blood cell counter of FIG. 1 when a non-pure reagent is used. It is a figure which shows the modification of the analysis result display screen displayed on the data processor of the blood cell counter of FIG. 1 when a non-pure reagent is used. It is a figure which shows the modification of the analysis result display screen displayed on the data processor of the blood cell counter of FIG. 1 when a non-pure reagent is used. It is a figure which shows the modification of the analysis result display screen displayed on the data processor of the blood cell counter of FIG. 1 when a non-pure reagent is used. It is a figure which shows the reagent information screen displayed on the data processor of the blood cell counter of FIG. It is a figure which shows the reagent information screen displayed on the data processor of the blood cell counter of FIG. It is a figure which shows the reagent information screen displayed on the data processor of the blood cell counter of FIG. It is a figure which shows an example of the analysis result printed by the printer of the blood cell counter of FIG. 1 when a non-pure reagent is used. It is a block diagram which shows the structure of the smear preparation apparatus based on the 2nd Embodiment of this invention. It is a perspective view of the slide glass used for the smear preparation apparatus of FIG. It is a figure for demonstrating the reliability information printed by the smear preparation apparatus of FIG.

[First Embodiment]
FIG. 1 is a perspective view showing a blood cell counter which is a sample processing apparatus according to the first embodiment of the present invention. The blood cell counter 1 of the present embodiment includes a measurement unit 2 that performs blood cell count measurement, a data processing device 3 that processes measurement values output from the measurement unit 2 and obtains an analysis result (processing result), and an analysis It is comprised by the printing apparatus (printer) 4 which prints a result.

[Configuration of Measuring Unit 2]
As shown in FIG. 2, the measurement unit 2 includes a specimen (sample) distribution unit 21 that sucks and distributes blood in a blood collection tube, a sample preparation unit 22 that prepares a distributed sample, and a plurality of samples that measure a sample. Detection units 23A to 23C, an analog signal processing circuit 24 that performs amplification and filtering of outputs from the detection units 23A to 23C, 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 device 3 is LAN-connected to the measurement unit 2 via the LAN adapter 29. 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 signals output from the detection units 23A to 23C.

  The sample distribution unit 21 is configured to dispense blood into the sample preparation unit 22 in a predetermined distribution amount. The sample preparation unit 22 is configured to prepare a measurement sample from the blood and reagent dispensed by the sample distribution unit 21 and supply the prepared measurement sample to the detection units 23A to 23C. The detectors 23A to 23C include an RBC / PLT detector 23A, an HGB detector 23B, and an optical detector 23C.

(Measurement content by the RBC / PLT detector 23A)
The RBC / PLT detection unit 23A performs red blood cell count measurement (RBC measurement) and platelet count measurement (PLT measurement). FIG. 4 is an explanatory diagram showing the flow of measurement by the RBC / PLT detector 23A. The blood in the blood collection tube 51 is sucked into the sampling valve 52 from the suction pipette and is quantified to a predetermined amount by the sampling valve 52. The quantified blood is diluted with the first reagent for RBC / PLT measurement and sent to the RBC sample chamber 53 as a diluted sample. Thereafter, the diluted sample and the second reagent are fed into the RBC / PLT detection unit 23A, and the RBC / PLT detection unit 23A counts RBC and PLT by the sheath flow DC detection method. At the same time, HCT (hematocrit value) is calculated by the red blood cell pulse peak value detection method.

(Measurement content by the HGB detector 23B)
The HGB detector 23B measures the amount of hemoglobin in the blood (HGB measurement). FIG. 5 is an explanatory diagram showing the flow of measurement by the HGB detector 23B. The blood in the blood collection tube 51 is sucked into the sampling valve 52 from the suction pipette, and is quantified to a predetermined amount by the sampling valve 52. The quantified blood is diluted with the third reagent for HGB measurement, and sent to the flow cell 54 of the HGB detection unit 23B as a diluted sample. At the same time, a fourth reagent for HGB measurement is added, the diluted sample is further diluted with the fourth reagent, red blood cells of this diluted sample are hemolyzed, and hemoglobin is converted into SLS-hemoglobin.

Then, the HGB detection unit 23B applies the light emitted from the light emitting diode 55 to the diluted sample through the lens, measures the concentration of SLS-hemoglobin as the absorbance, and determines the absorbance of only the diluted solution measured before the sample enters. HGB measurement is performed by comparison.
The RBC and HCT measured by the RBC / PLT detection unit 23A and the HGB measured by the HGB detection unit 23B are also used for calculating the average red blood cell volume (MCV) and the average red blood cell pigment concentration (MCHC).

(Measurement content by optical detector 23C)
The optical detection unit 23C is capable of fraction measurement of white blood cell count (WBC measurement), fraction measurement of basophils in white blood cells (BASO measurement), and neutrophils in white blood cells (NEUT), lymphocytes (LYMPH). , Monocyte (MONO), eosinophil (EO), and basophil (BASO) fraction measurement (DIFF measurement). FIG. 6 is an explanatory diagram showing the flow of WBC measurement and BASO measurement by the optical detection unit 23C. The blood in the blood collection tube 51 is sucked into the sampling valve 52 from the suction pipette and quantified to a predetermined amount. The quantified blood is diluted with the fifth reagent and sent to the reaction chamber 56 as a diluted sample. In this state, the red blood cells of the diluted sample are hemolyzed by reacting for 10 seconds or more.
The diluted sample and the sixth reagent are fed into the optical detection unit 23C, and WBC measurement and BASO measurement are performed by a flow cytometry method using a semiconductor laser.

FIG. 7 is an explanatory diagram showing the flow of DIFF measurement by the optical detection unit 23C. The blood in the blood collection tube 51 is sucked into the sampling valve 52 from the suction pipette, and a predetermined amount is quantified. The quantified blood is diluted with the seventh reagent for DIFF measurement and sent to the reaction chamber 56 as a diluted sample, and at the same time, the eighth reagent is added and further diluted. By reacting for several tens of seconds in this state, the red blood cells of the diluted sample are hemolyzed and the white blood cells are stained.
The diluted sample and the ninth reagent are sent to the optical detection unit 23C, and DIFF measurement is performed by the flow detection method using a semiconductor laser by the optical detection unit 23C.

  As shown in FIG. 8, the optical detection unit 23C 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 a laser beam that is emitted from the light emitting unit 23a. The condensing lens 23d, the pinhole 23e, and the PD (photodiode) 23f arranged on an extension line in the direction in which the light travels, and the light collection disposed in a direction crossing the direction in which the laser light emitted from the light emitting unit 23a travels. It includes an optical lens 23g, a dichroic mirror 23h, an optical filter 23i, a pinhole 23j, and a PD 23k, and an APD (avalanche photodiode) 23l disposed 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 the side scattered light and the 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.

  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.

(Reagent used for each measurement)
Various reagents (first to ninth reagents) such as a diluted solution, a sheath solution, a hemolyzing agent, and a staining solution are used for measurement in each of the detection units 23A to 23C, and these reagents are supplied from the blood cell counter 1 It is recommended to use a dedicated reagent (genuine product) guaranteed by the supplier. This is due to the following reason. The reagent components of the dedicated reagent are optimized for the blood cell counter 1 so that a highly accurate analysis result can be obtained in the blood cell counter 1. In addition, the blood cell counter 1 according to the present embodiment repeatedly performs evaluation experiments to ensure that a highly accurate analysis result can be obtained when analysis is performed using a dedicated reagent. Has been done. Therefore, when the blood cell counter 1 according to the present embodiment analyzes the sample with the blood cell counter 1 using a reagent (non-genuine product) other than the dedicated reagent that guarantees the performance, This is because there is no guarantee that an accurate analysis result can be obtained, and the reliability of the analysis result is low. The dedicated reagent only needs to be guaranteed by the supplier, and it does not matter whether the reagent can be used in another company's apparatus.

  In the blood cell counter 1 of the present embodiment, “Cell Pack (registered trademark) (II)” (manufactured by Sysmex Corporation) as a genuine product of the first reagent, and “SE sheath (registered trademark) as a genuine product of the second reagent. ) (II) "(manufactured by Sysmex Corporation)," Cell Pack (II) "similar to the first reagent as a genuine third reagent, and" Sulfolyzer (registered trademark) "(Sysmex Corporation) as a genuine fourth reagent “Stomatolizer (registered trademark) -FB (II)” (manufactured by Sysmex Corporation) as a genuine product of the fifth reagent, “Cell Pack (same as the first and third reagents as a genuine product of the sixth reagent) II) ". “Stomatolizer-4DL” (manufactured by Sysmex Corporation) as a genuine product of the seventh reagent, “Stomatolizer-4DS” (manufactured by Sysmex Corporation) as a genuine product of the eighth reagent, “Cell Pack (II) ) "Can be used.

The hard disk 31d (see FIG. 3) of the data processing device 3 stores a database in which measurement items performed in the detection units 23A to 23C are associated with information on dedicated reagents used in the measurement items. Yes. FIG. 19 shows the relationship between measurement items and reagents in this database.
In addition, the memory 27 (see FIG. 2) of the measurement unit 2 is configured to store information (determination result information) indicating whether or not the replaced new reagent is a dedicated reagent. Specifically, the memory 27 is configured to determine whether or not a CPU 31a of the data processing device 3 to be described later is a dedicated reagent and store determination result information based on the determination result. Details of this will be described later.

[Configuration of Data Processing Device 3]
As shown in FIG. 1, the data processing device 3 is composed of a personal computer (PC) or the like. The data processing device 3 includes a control unit 31, a display unit 32, and an input device 33. The data processing device 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. Further, as shown in FIG. 3, the control unit 31 includes a storage unit including a CPU 31a, a ROM 31b, a RAM 31c, and a hard disk 31d, a reading device 31e, an input / output interface 31f, an image output interface 31g, and a communication interface 31i. It is comprised by. 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 to execute a computer program stored in the ROM 31b and a computer program 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 RAM 31c is configured by SRAM, DRAM, or the like. The RAM 31c is used for reading 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 for causing the data processing device 3 to perform predetermined functions (a reagent determination function, a screen display function, a printing function, etc. as 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. A computer as the data processing apparatus 3 reads the application program 34a from the portable recording medium 34 and installs the application program 34a on the hard disk 31d. It is possible.

  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 a 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 US Microsoft Co. 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 is, for example, a serial interface such as USB, IEEE 1394, or RS-232C, a parallel interface such as SCSI, IDE, or IEEE 1284, and an analog interface including a D / A converter, an A / D converter, or the like. Etc. 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 device 3 by using the input device 33.

The communication interface 31i is, for example, an Ethernet (registered trademark) interface, and the data processing apparatus 3 is connected to 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 printer 4 is connected to the data processing device 3 via the communication interface 31i.
The image output interface 31g is connected to a display unit 32 constituted by an LCD, a CRT, or the like, 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.

  In the present embodiment, the CPU 31a processes the measurement value measured by the measurement unit 2 to obtain an analysis result, and outputs a video signal corresponding to the analysis result display screen for displaying the analysis result to the image output interface 31g. It has a function to output. FIG. 21 is a diagram illustrating an example of the analysis result display screen SC1 displayed on the display unit 32 of the data processing device 3. The analysis result display screen SC1 shows a display area SC1a for displaying numerical data for each measurement item, and a distribution such as the number and size of particles in predetermined items (WBC, RBC, PLT, DIFF, etc.). A display area SC1b for displaying a scattergram and a particle size distribution diagram (hereinafter referred to as “scattergram or the like”) is included.

  In the present embodiment, when the reagent used in the measurement unit 2 is replaced by the user, the CPU 31a displays a video signal as an image output interface so that the reagent replacement screen SC3 shown in FIG. Output to 31g. This reagent replacement screen SC3 is configured so that the user can input a unique Reagent Code (reagent code) 60a consisting of 27 digits attached to the reagent container 60 (see FIG. 10). In addition, the blood cell counter 1 is configured to be able to input the Reagent Code 60a by reading the barcode 60b displayed on the upper part of the Reagent Code 60a using a barcode reader (not shown). . 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 measuring unit 2, such as an expiration date and a lot number for traceability. This is the reagent code. The Reagent Code 60a is encrypted using a predetermined function, and whether or not the reagent code 60a is a dedicated reagent (genuine product) appropriate for use in the measurement unit 2 based on the encrypted alphanumeric characters. The CPU 31a can be determined.

  The CPU 31a is configured to measure the remaining amount of the reagent in use and store the remaining amount information together with the reagent code 60a of the reagent in a storage unit such as the hard disk 31d or the RAM 31c. Further, the storage unit 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 60a and the remaining amount information.

[Dedicated reagent judgment procedure]
FIG. 11 is a flowchart for explaining an operation of determining whether or not the replaced reagent is a dedicated reagent (genuine product) in the blood cell counter 1 of the present embodiment. FIG. 12 is a diagram showing a Reagent Code warning screen in the blood cell counter 1 of the present embodiment shown in FIG. Next, with reference to FIG. 9 to FIG. 12, a genuine product determination operation for determining whether or not the replaced reagent is a dedicated reagent (genuine product) in the blood cell counter 1 of the present embodiment will be described. To do. The operations described below are operations controlled by the CPU 31a of the data processing device 3.

  In step S1 of FIG. 11, the reagent replacement screen SC3 shown in FIG. 9 is displayed, and the user is prompted to input a Reagent Code (reagent code). The reagent replacement screen SC3 is displayed on the display unit 32 when the user double-clicks a reagent replacement icon on a menu screen (not shown). In step S2, the 27-digit Reagent Code 60a (see FIG. 10) attached to the reagent by the user is input on the reagent replacement screen SC3, and it is determined whether or not the execution button SC3a is pressed (selected). This determination is repeated when the execution button SC3a is not pressed. When the execution button SC3a is pressed, it is determined in step S3 whether or not the input Reagent Code is correct. Specifically, it is determined whether or not the alphanumeric character is correctly created according to the algorithm used for encryption. If the entered Reagent Code is correct, the lot number and expiration date encrypted and stored in alphanumeric characters are decoded and displayed in each column of the reagent replacement screen SC3. If the inputted Reagent Code is correct, the operation proceeds to step S4.

  On the other hand, if the Reagent Code is incorrect, a Reagent Code warning screen SC4 is displayed in step S7 as shown in FIG. The Reagent Code warning screen SC4 displays a warning that the Reagent Code has not been entered correctly and that the analysis result cannot be guaranteed, and confirms whether or not to perform reagent replacement with the user. Is displayed.

  In step S8 of FIG. 11, it is determined which button of the OK button SC4a or the cancel button SC4b on the Reagent Code warning screen SC4 is pressed. If the cancel button SC4b is pressed, the operation returns to step S1. When the OK button SC4a is pressed, determination result information indicating that the reagent is a non-dedicated reagent (non-genuine product) is stored in the storage unit such as the RAM 31c in step S9, and the operation ends.

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

  If the input Reagent Code is the same as any of the Reagent Codes of the plurality of reagents stored in the storage unit, information on the remaining amount of the reagent stored in the storage unit together with the Reagent Code in step S6 Is confirmed. Thus, if it is stored in the storage unit 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 used by being refilled in the container, or the reagent code attached to the dedicated reagent (genuine product) used before is input, and the replaced reagent is a non-genuine product. It is possible to judge that this is an act of using a non-dedicated reagent as a dedicated reagent. Therefore, in step S6, when there is no reagent remaining amount stored in the storage unit, the process proceeds to step S7, and the Reagent Code warning screen SC4 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.

[Reagent information update procedure]
FIG. 13 is a flowchart for explaining an operation of updating information on whether or not a reagent is a genuine product in blood cell counter 1 according to the present embodiment. Next, with reference to FIGS. 11 and 13, a genuine product flag update operation for updating information on whether or not a reagent is a genuine product in the blood cell counter 1 according to the present embodiment will be described. The operations described below are operations controlled by the CPU 31a of the control unit 31 and the CPU 28 of the measurement unit 2 of the data processing device 3.

  First, in step S101 of FIG. 13, it is determined on the data processing device 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. 11 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 device 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 a reagent is exchanged, there is air in the tube in which the reagent flows, or there is no reagent in the space in the tube where the reagent should 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 S203, information on whether or not the reagent is a dedicated reagent (genuine product) is stored in the memory 27 (see FIG. 2) 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.

[Operation procedure at startup of blood cell counter]
FIG. 14 is a flowchart for explaining the operation at start-up of the blood cell counter 1 of the present embodiment. FIG. 15 is a diagram showing a warning screen of the blood cell counter 1 shown in FIG. Next, with reference to FIG. 14 and FIG. 15, the operation at the start-up of the blood cell counter 1 of the present embodiment will be described. The operations described below are operations controlled by the CPU 31a of the control unit 31 and the CPU 28 of the measurement unit 2 of the data processing device 3.

  First, in step S211 of FIG. 14, a reagent information signal is transmitted to the data processing device 3 based on the state of the genuine product flag stored in the memory 27 of the measurement 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 device 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 the data processing device 3, the reagent information signal transmitted from the measurement unit 2 is received in step S111, and in step S112, based on the received reagent information signal, whether or not the reagent is a dedicated reagent (genuine product). It is confirmed. When the reagent is a dedicated reagent (genuine product), the operation is terminated as it is. On the other hand, when the reagent is a non-dedicated reagent (non-genuine product), as shown in FIG. SC5 is displayed. On the warning screen SC5, warnings are displayed that the Reagent Code has not been correctly input at the time of reagent replacement, and that the analysis result cannot be guaranteed. Thus, by displaying the warning screen SC5 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 device 3 is terminated.

[Measurement and analysis procedure of blood cell counter]
FIG. 16 is a flowchart for explaining the measurement and analysis operations in blood cell counter 1 according to the present embodiment. Next, the measurement and analysis operations of the blood cell counter 1 according to the present embodiment will be described including the display of analysis results by the display unit 32 and the operation of printing analysis results by the printing device 4.

  First, when the start of measurement is instructed on the data processing device 3 side, in step S120, it is determined whether or not the reagent used for the analysis is a genuine product. If the reagent is a genuine product, the process proceeds to step S121. If the reagent is not a genuine product, in step S129, the display unit 32 displays a warning screen indicating that the reagent is not a genuine product and selecting whether to start or cancel the measurement. Is displayed, the process proceeds to step S130. In step S130, if measurement start is selected on the warning screen, the process proceeds to step S121. If measurement cancellation is selected, the measurement is canceled and the process ends (step S130). ). This prevents accidental measurement using non-genuine reagents when the user does not know that the reagent is not genuine and the user does not want to measure with a non-genuine product. Can do.

  On the other hand, on the measurement unit 2 side, blood measurement by the measurement unit 2 is started in step S221, 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 device 3 via the LAN adapter 29 (see FIG. 2), and the operation on the measurement unit 2 side is ended.

  On the data processing device 3 side, in step S121, it is determined whether or not the measurement value data transmitted from the measurement unit 2 is received. If received, in step S122, based on the received measurement value data, Processing of measured values (analysis processing) is performed. In step S123, an operation for displaying the analysis result on the display unit 32 is performed.

(Analysis result display processing procedure)
FIG. 17 is a flowchart for explaining analysis result display control of the blood cell counter 1 according to the present embodiment. In step S131, the data processing device 3 determines whether or not the reagent used for the analysis is a genuine product. This determination is made based on the confirmation result confirmed in step S112 of the startup operation shown in FIG.
If the reagent used for the analysis is a genuine product, the process proceeds to step S132, and the normal analysis result display screen SC1 shown in FIG. The analysis result display screen SC1 is a display in a state where the main tab SC1d is selected. Numerical data is displayed in the display area SC1a, and a scattergram or the like is displayed in the display area SC1b.

  If the reagent used for the analysis is a non-genuine product, the process proceeds to step S133, and an analysis result display screen SC2 with a warning as shown in FIG. This analysis result display screen SC2 is obtained by adding a note SC2c to the normal analysis result display screen SC1 of FIG. In this note SC2c, information (reliability information) indicating that the reagent used in the analysis is a non-genuine product and that the analysis result cannot be guaranteed as a supplier of the blood cell counter 1 is displayed in text. Therefore, the user can surely recognize that the analysis result has low reliability by viewing the reliability information of the note SC2c together with the analysis result.

On the other hand, on the analysis result display screen SC2 of FIG. 22, it is impossible to identify which measurement item the analysis result is of low reliability. Therefore, as a modification, reliability information as shown in FIGS. 23 to 25 can be displayed.
FIG. 23 shows an example in which reliability information is assigned to each measurement item in the numerical data display area SC2a. Specifically, warning marks (icons) IC1a to IC1f for calling attention are used as reliability information, and the warning marks IC1a to IC1f are attached corresponding to the measurement item names and numerical data. The warning marks IC1a to IC1f can be attached before (IC1a, IC1d) or after (IC1b, IC1e) of the text representing the measurement item name or numerical data, or can be attached to the background (IC1c, IC1f). In any pattern, the user can accurately recognize which measurement item analysis result has low reliability by looking at the numerical data display area SC2a.

  FIG. 24 shows an example in which reliability information is attached to the display area SC2b such as a scattergram. Also in this example, warning marks IC2a to IC2d for calling attention are used as the reliability information. The warning mark can be attached before (IC2b) or after (IC2a) the text representing the item name such as a scattergram, or can be attached to the background. It can also be added to the background of a scattergram or the like (IC2c, IC2d).

  FIG. 25 is similar to the example shown in FIG. 23, in which reliability information is added to the numerical data display area SC2a, but is different in that the reliability information includes reagent information. That is, as a warning mark indicating reliability information, icons IC3a to IC3c marked with “x” are used in different reagent container diagrams for each reagent, and this warning mark corresponds to the text representing the measurement item name. It is attached. Therefore, in the example of FIG. 25, in addition to which measurement item analysis result has low reliability, the user selects which reagent is a non-genuine product among a plurality of reagents used for measurement items with low reliability. Can be recognized. The icons IC3a to IC3c may be attached to text representing numerical data.

  As described above, when the reliability information is attached to the numerical data or scattergram of each measurement item, the following control is performed in step S133 in FIG. FIG. 18 is a flowchart for explaining screen display control with warning. In step S141, the data processing device 3 determines whether or not the reagent used for each measurement item, scattergram, and the like is a genuine product. If the reagent used for each measurement item and scattergram is a genuine product, it is determined in step S143 whether or not the determination has been completed for all measurement items and scattergrams. The operation is returned to step S141. If the reagent used for the predetermined measurement item, scattergram, etc. is not a genuine product, in step S142, the measurement item, scattergram, etc. are determined as items to which a warning mark (reliability information) is added, and the operation is stepped. The process proceeds to S143.

  If it is determined in step S143 that all the measurement items, scattergrams, and the like have been determined, warning marks are added to the measurement items, scattergrams, and the like that are determined to be added in step S144. The analysis result display screen SC2 (SC2a and SC2b in FIGS. 23 to 25) is displayed on the display unit 32. Thereafter, the operation proceeds to step S124 in FIG.

  In FIG. 16, it is determined whether or not the display of the reagent information screen has been instructed in step S124. If instructed, the reagent information screen is displayed on the display unit 32 in step S125. Specifically, the reagent information screen SC6 as shown in FIG. 26 is displayed when the user clicks the note SC2c as reliability information shown in FIG. 22 or the warning marks IC1a to IC3c in FIGS. The This reagent information screen SC6 shows the parts (reaction chamber and detection unit) to which the reagent is supplied, along with the name, lot number, and expiration date of the genuine reagent used for a predetermined measurement item (here, WBC). For the reagent that is displayed and the genuine product is not used, a warning mark IC4 that is reliability information is attached and the lot number or expiration date is displayed as unknown or displayed. The field is left blank. Therefore, the user can recognize at a glance which part of the reagent to be supplied is a non-genuine product by looking at the reagent information screen SC6.

  As another example of the reagent information screen, as shown in FIG. 27, a reagent information tab SC2d is provided on the analysis result display screen SC2, and the reagent information screen SC2e can be displayed by selecting this tab SC2d. . This reagent information screen SC2e displays the name of the genuine reagent, its lot number, and the expiration date. Reagents for which genuine products are not used are listed as unknown in the lot number and expiration date display fields, or the display fields are blank, and the reliability information is displayed along with the warning mark IC5. Information indicating that the analysis results cannot be guaranteed for the measurement items used is displayed in text. Therefore, the user can recognize not only which reagent is a non-genuine product but also a measurement item with low reliability of the analysis result by looking at the reagent information screen SC2e.

  As another example of the reagent information screen, for example, when the user clicks the note SC2c as the reliability information shown in FIG. 22 or the warning marks IC1a to IC3c shown in FIGS. An information screen SC7 can also be displayed. On the reagent information screen SC7, information on genuine reagents, for example, information on the performance and advantages of genuine products, and how to obtain them is displayed in text. By displaying such information, the user can recognize the superiority and importance of using a genuine product, and can obtain a genuine product smoothly.

  In step S126 of FIG. 16, it is determined whether or not an instruction to print the analysis result has been issued. As shown in FIGS. 21 and 22, the printing instruction is performed when the user clicks a print button (print icon) IC6 provided on the toolbar of the analysis result display screens SC1 and SC2. When the printing instruction is given, the operation proceeds to step S127, and the analysis result is printed on the sheet by the printing apparatus 4.

FIG. 20 is a flowchart for explaining analysis result printing control. In step S151, it is determined whether the used reagent is a genuine product. This determination is made based on the confirmation result confirmed in step S112 of the startup operation shown in FIG. If the reagent is a genuine product, the analysis result is printed in a normal format in step S152, and then the process proceeds to step S128 in FIG. If the reagent is a non-genuine product, the analysis result is printed in a format with a warning in step S153.

  FIG. 29 is a diagram illustrating an analysis result printed in a format with a warning. In this figure, various types of information relating to inspection, for example, measurement item names, numerical data, scattergrams, and the like are printed on the paper S. Then, the reliability information Sa that the reagent used in the background is a non-genuine product and the provider of the blood cell counter 1 cannot guarantee the analysis result is printed so as to overlap these information. Therefore, the user can surely recognize the reliability information together with the analysis result without missing it. Further, it is possible to prevent the reliability information Sa from being cut off when the printed analysis result is presented to a patient or the outside.

  The printed analysis results may be printed with the reliability information (warning marks IC1a to IC3c) shown in FIGS. 23 to 25 corresponding to the display of measurement item names, numerical data, scattergrams, and the like. Good. In addition, it is not necessary to display both the analysis result and the warning on one sheet as shown in FIG. 29, and the analysis result and the warning may be printed on different sheets.

  In step S128 of FIG. 16, it is determined whether or not an instruction to end screen display has been issued. If the instruction has been issued, the operation is terminated, and if not, the operation returns to step S124. It is.

  As described above, the blood cell counter 1 according to the present embodiment determines whether or not the reagent is appropriate for the measurement of the sample by the measurement unit 2 based on the Reagent Code 60a received on the reagent replacement screen SC3. Based on the determination result, since the reliability information indicating that the reliability of the analysis result is low is output together with the analysis result, the user can recognize the reliability of the analysis result together with the analysis result. Therefore, it is possible to prevent the patient from receiving inappropriate treatment or medication based on the analysis result with low reliability.

  In the present embodiment, when it is determined that the reagent is a non-dedicated reagent that is not appropriate for analysis (non-genuine product), the warning screen SC5 is displayed on the display unit 32 at the start-up of the blood cell counter 1. Therefore, the user can recognize that the reliability of the analysis result is low before the analysis is performed.

  In the present embodiment, the reagent is a dedicated reagent (genuine product) suitable for analyzing the sample by the measuring unit 2 based on both the reagent code 60a received on the reagent replacement screen SC3 and the information on the remaining amount of the reagent. Since it is configured to determine whether or not there is a dedicated reagent (genuine product), it can be accurately determined.

[Second Embodiment]
FIG. 30 is a block diagram showing a configuration of a smear preparation apparatus 100 as a sample processing apparatus according to the second embodiment of the present invention. The smear preparation apparatus 100 is installed adjacent to the blood cell counter 1 described above, for example, and prepares a smear for a sample that requires reexamination with a smear based on the analysis result of the blood cell counter 1. It is said. Reagents such as a staining solution and a diluted solution are also used for the preparation of the smear.

  The smear preparation apparatus 100 includes a control unit 101, a display operation unit 102, a cassette storage unit 103, a cassette transport unit 104, a sample preparation unit 105, a staining unit 106, and a storage unit 107. The control unit 101 includes a CPU 101a, a memory 101b such as a ROM and a RAM, and the like, and has a function of controlling the operation of the smear preparation apparatus 100. The display operation unit 102 includes a touch panel, and can input various settings of the smear preparation apparatus 100 and display a status.

  The cassette housing unit 103 has a function of housing a cassette (not shown) that can house the slide glass 110 (see FIG. 31) and a staining solution for staining inside and feeding the cassette into the cassette transport unit 104. The cassette transport unit 104 has a function of transporting the cassette sent from the cassette housing unit 103 to the specimen preparation unit 105 and the staining unit 106.

  The specimen preparation unit 105 includes a suction / dispensing mechanism unit 105a, a smearing unit 105b, and a slide glass insertion unit 105c. The suction / dispensing mechanism unit 105a has a function of sucking blood from a blood collection tube automatically supplied by a conveyance device (not shown) or a manual blood collection tube and dropping the blood on the slide glass 110. The smearing unit 105b has a function of smearing and drying blood dropped on the slide glass 110 and printing it by the printing unit 105b1. As shown in FIG. 31, the slide glass 110 includes a specimen preparation area 110b and a frost portion (information display area) 110a provided on one side of the specimen preparation area 110b. The printing section 105b1 includes the frost section. Information about the smear is printed on the section 110a.

As illustrated in FIG. 30, the slide glass insertion unit 105 c has a function of inserting the smeared slide glass 110 into the cassette conveyed by the cassette conveyance unit 104. The slide glass 110 inserted into the cassette is conveyed to the staining unit 106 by the cassette conveyance unit 104.
The staining unit 106 stains the smeared slide glass 110 by supplying a staining solution (reagent) into the cassette conveyed by the cassette conveyance unit 104. The storage unit 107 has a function of storing the cassette in which the slide glass 110 stained by the staining unit 106 is stored. The stained slide glass 110 stored in the storage unit 107 is used for analysis by visual observation or the like. Provided. Therefore, the smear preparation apparatus 100 processes the blood using the reagent and outputs a smear as a processing result.

  As shown in FIG. 31, the date, patient name, specimen number, etc. can be printed on the frosted part 110a of the slide glass 110 as information about the smear. The printing unit 105b1 is configured to print reliability information on the frost unit 110a for a smear prepared using a reagent that is not a genuine product. Note that the determination as to whether or not the reagent is a genuine product and the control for printing the reliability information are performed by the CPU 101a of the control unit 101 in the same manner as in the first embodiment.

FIG. 32 is a diagram showing a print example of reliability information. FIG. 32A shows that three lines of text can be printed on the frosted part 110a. For example, the date is displayed on the first line and the sample is displayed on the second line. The reliability information 120 such as “use of non-genuine reagent” is printed on the third line such as a number.
In FIG. 32B, text printing can be performed on the uppermost and lowermost portions of the frosted part 110a, and a one-dimensional barcode can be printed on the central part. The reliability information 120 “Use of non-genuine reagent” is printed above or below the bar code. The barcode may be a two-dimensional barcode.
In FIG. 32 (c), three lines can be printed on the frost portion 110a in the same manner as shown in FIG. 32 (a), but the reliability information 120 shows “× ”Is printed, and from this image, it is possible to recognize that the reagent is not a genuine product and which reagent is not a genuine product. In the examples shown in FIGS. 32A and 32B, the type of reagent using a non-genuine product may be printed as text or a figure.

  Each embodiment disclosed this time must 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 embodiment but by the scope of claims for patent, and further includes meanings equivalent to the scope of claims for patent and all modifications within the scope.

  For example, in the above-described embodiment, the example in which the present invention is applied to the blood cell counter 1 and the smear preparation apparatus 100 as the sample processing apparatus has been described. However, the present invention is not limited thereto, and the sample processing is performed using a dedicated reagent. As long as it is a sample processing apparatus to be used, it may be applied to other medical sample processing apparatuses such as a blood pseudo-solid measuring apparatus, an immune analyzer, and a urine sediment analyzer.

  In the first embodiment, the example of the configuration in which the warning screen is displayed at the start-up is shown. However, the present invention is not limited to this, and the warning screen is displayed every time the analysis result display screen is displayed. May be.

  In the above-described embodiment, it is configured to determine whether a 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 the measurement date to determine whether or not the reagent has expired. When the reagent has not expired, normal screen display or printing can be performed. When the reagent has expired, reliability information for notifying that the reagent has expired can be displayed or printed.

  In the above 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. It may be configured to determine whether it is a genuine product or a non-genuine product with respect to other auxiliary materials used for processing, and output reliability information when the product is a non-genuine product. For example, it may be configured to determine whether the slide glass 110 used in the second embodiment is a genuine product or a non-genuine product, and output reliability information when the slide glass 110 is a non-genuine product. Further, it may be configured to determine whether a cuvette used in a blood coagulation measuring apparatus or an immunoassay apparatus is a genuine product or a non-genuine product, and output reliability information when the cuvette is a non-genuine product.

DESCRIPTION OF SYMBOLS 1 Blood cell counter 2 Measuring part 3 Data processing apparatus 4 Printing apparatus 100 The smear preparation apparatus 101 Control part 105 Sample preparation part 105b1 Printing part

Claims (13)

A sample analyzer for analyzing a sample collected from a living body,
Analytical means for analyzing a sample using a reagent,
Display means, and
When the reagent is replaced , it is determined whether or not the reagent is a genuine product. When the reagent is not a genuine product, information indicating that the analysis result of the sample is not guaranteed if the reagent is used is determined to be a genuine product. Control means configured to cause the display means to display a warning screen displaying the input means for the user to input whether or not to use the reagent,
A sample analyzer. A storage means;
The said control part is comprised so that the determination result that the said reagent is not a genuine product may be memorize | stored in the said memory | storage means, when a user inputs that the said reagent is used via the said input means. 2. The sample analyzer according to 1.   When it is stored in the storage means that the reagent is not a genuine product, the control means causes the display means to display information indicating that the analysis result of the sample is not guaranteed if the reagent is used at start-up. The sample analyzer according to claim 2, configured as described above. Said control means, a reagent replacement screen for inputting the reagent code when the user to replace or supplement the reagent is displayed on the display means, reagent genuine product based on the input code through which the reagent replacement screen The sample analyzer according to any one of claims 1 to 3, wherein the sample analyzer is configured to determine whether or not. A reading means for reading the reagent code;
The sample analyzer according to any one of claims 1 to 4, wherein the control unit is configured to determine whether or not the reagent is a genuine product based on a code input from the reading unit. The control means is configured to display, on the warning screen , information indicating that the code of the reagent is not correctly input together with information indicating that the analysis result of the sample is not guaranteed if the reagent is used. The sample analyzer according to any one of 1 to 5. Said control means is configured to display the input means for whether the input to perform the replacement or replenishment of reagent user to the reagent replacement screen, the sample analyzer according to claim 4 . When the reagent is not a genuine product, the control means adds to the button for the user to perform replacement or replenishment of the reagent, and inputs to the user not to perform replacement or replenishment of the reagent. to display a button for performing within the reagent replacement screen, if the user performs an input to the effect that not perform replacement or replenishment of the reagent, and is configured so as to prohibit the exchange or replenishment of the reagent, in claim 7 The sample analyzer described above. The control means displays on the reagent replacement screen input means for a user to input whether or not to perform replacement or replenishment of the reagent, and inputs that the user performs replacement or replenishment of the reagent. The sample analyzer according to claim 7, configured to permit execution of reagent replacement or replenishment when performed. The control means is configured to cause the analysis means to perform analysis of a sample using the reagent when the user inputs that the reagent is used via the input means displayed on the warning screen. The sample analyzer according to any one of claims 1 to 3. The control means is configured to receive an instruction to start analyzing the sample, and when the reagent is not a genuine product, when the instruction to start analyzing the sample is received, the control means displays the warning screen on the display means. The sample analyzer according to any one of claims 1 to 3, wherein the sample analyzer is configured. When the analysis unit executes sample analysis when the reagent is not a genuine product, the control unit displays the analysis result screen displaying information indicating that the sample analysis result is not guaranteed together with the sample analysis result. The sample analyzer according to any one of claims 1 to 11, wherein the sample analyzer is configured to be displayed on a means. A computer provided in a sample analyzer having an analysis means for analyzing a sample collected from a living body using a reagent and a display means,
Determine whether the reagent is genuine when replacing the reagent,
When the reagent is not a genuine product, a warning screen displaying information that the analysis result of the sample is not guaranteed if the reagent is used, and input means for the user to input whether or not to use the reagent the display on the display means,
A program for a sample analyzer that functions as a means for the above.

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