Urine analysis system, imaging device, cell imaging device, urine analysis method, management device and information processing method

Abstract

The urine analysis system (1) comprises: an inspection device (10) for measuring formed components contained in a urine sample by flow cytometry, a photographing device (20) for photographing formed components in the urine sample and obtaining a cell image, and a management device (30) for receiving the measurement results obtained by the inspection device (10) and the cell image obtained by the photographing device (20). The management device (30) generates a photographing instruction for the urine sample based on the measurement results obtained by the inspection device (10). After receiving the photographing instruction generated by the management device (30), the photographing device (20) performs photographing processing of the formed components in the urine sample and transmits the obtained cell image to the management device (30).

Description

[0001] This application is a divisional application of the Chinese invention patent application filed by the same applicant with application number 201680020462.7, application date January 29, 2016, and name “URINALYSIS SYSTEM, IMAGING DEVICE, CELL IMAGING DEVICE, URINALYSIS METHOD, MANAGEMENT DEVICE AND INFORMATION PROCESSING METHOD”. Technical Field

[0002] The present invention relates to a urine analysis system for analyzing a urine sample, a photographing device for photographing a urine sample, a cell photographing device for photographing cells contained in a liquid sample, a urine analysis method, a management device, and an information processing method. Background Art

[0003] There are known automatic analysis devices that analyze formed components in urine samples using flow cytometry (Patent Documents 1 to 3). Automatic analysis devices using flow cytometry can rapidly perform measurements and can process a large number of urine samples using a flow cytometer during measurement, thus having the advantage of being able to accurately analyze formed components in urine.

[0004] However, there are cases where urine contains aggregates of mucus, bacteria, salts, etc. that may resemble casts. Since the scattered light and fluorescence detected from these formed elements are similar to each other, these formed elements may not be correctly distinguished and detected using flow cytometry. Similarly, when there are crystalline components similar to red blood cells or yeast-like fungi in urine, these may not be correctly distinguished and detected.

[0005] The urine of patients with urinary tract cancer sometimes contains atypical cells. Atypical cells are malignant cells and suspected malignant cells that show atypical characteristics such as enlarged nuclei and increased chromatin accompanied by increased nucleic acid content. Detection of atypical cells in urine has very important clinical significance in the early detection of kidney disease and urinary tract cancer. However, the method using flow cytometry may not be able to correctly distinguish and detect atypical cells in urine from other formed elements in urine.

[0006] In this regard, the previous practice was to subject a portion of the samples to re-examination, concentrate them through centrifugation and staining, and after completing these pre-treatments, a smear specimen was prepared and examined by the inspection technician using a microscope and the naked eye.

[0007] Prior art literature

[0008] Patent Literature

[0009] Patent document 1: Japanese patent, Tokkai Hei 9-329596

[0010] Patent document 2: Japanese Patent, Tokukai 2002-188993

[0011] Patent document 3: Japanese Patent, Tokkai-Hei 8-136438. Summary of the invention

[0012] Problem that the invention aims to solve

[0013] Pre-treatment such as concentration by centrifugation and staining is time-consuming and labor-intensive, and the preparation of smear specimens is time-consuming and labor-intensive. In addition, visual inspection of the prepared smear specimens places a great burden on the inspection technician. It is desired to reduce these labors and burdens and to be able to efficiently and accurately distinguish the formed elements in urine.

[0014] Technical solutions to the problem

[0015] The first technical solution of the present invention relates to a urine analysis system. The urine analysis system involved in this technical solution comprises: an inspection device for measuring formed components contained in a urine sample by flow cytometry, a photographing device for photographing formed components in the urine sample and obtaining a cell image, and a management device for receiving the measurement results obtained by the inspection device and the cell image obtained by the photographing device. The management device generates a photographing instruction for the urine sample based on the measurement results obtained by the inspection device. After receiving the photographing instruction generated by the management device, the photographing device performs photographing processing of the formed components in the urine sample and transmits the obtained cell image to the management device.

[0016] A second technical solution of the present invention relates to a photographing device. The photographing device according to the technical solution comprises: an aspirating unit for aspirating a urine sample, a photographing unit for photographing formed elements in the urine sample aspirated by the aspirating unit and acquiring a cell image, and a control unit for controlling the aspirating unit and the photographing unit. The control unit controls the aspirating unit to aspirate the urine sample based on the measurement result of formed elements in the urine sample measured by flow cytometry, and controls the photographing unit to photograph the urine sample aspirated by the aspirating unit.

[0017] The third technical solution of the present invention relates to a cell photographing device. The cell photographing device involved in this technical solution has: a chamber for introducing a liquid sample containing cells, a photographing unit for photographing the liquid sample introduced into the chamber, and a processing unit for extracting a cell image of the components contained in the photographed image acquired by the photographing unit. The processing unit can implement a regular mode in which the photographing unit photographs a first number of photographed images of the liquid sample and obtains a cell image, and a detailed inspection mode in which the photographing unit photographs a second number of photographed images greater than the first number of photographed images of the liquid sample and obtains a cell image. One of the regular mode and the detailed inspection mode is implemented depending on whether the liquid sample as the processing object meets the first condition set for the regular mode or the second condition set for the detailed inspection mode.

[0018] The fourth technical solution of the present invention relates to a urine analysis method. The urine analysis method of this technical solution is to measure the formed components contained in a urine sample by flow cytometry, automatically aspirate the urine sample and photograph the formed components in the urine sample according to the measurement result of the formed components, obtain a cell image, and compare and display the measurement result obtained by the flow cytometry and the cell image.

[0019] The fifth technical solution of the present invention relates to a management device, which can be communicatively connected with: a first inspection device for measuring formed components in a urine sample by flow cytometry, a second inspection device for measuring chemical components in the urine sample by test paper, and a photographing device for photographing formed components in the urine sample and obtaining cell images. The management device involved in this technical solution has: a control unit and a display unit, wherein the control unit receives a first measurement result of formed components in the urine sample obtained by the first inspection unit, a second measurement result of chemical components in the urine sample obtained by the second inspection unit, and the cell image obtained by the photographing unit. The control unit causes the display unit to display the cell image plus at least one of the first measurement result and the second measurement result on the same interface.

[0020] The sixth technical solution of the present invention relates to an information processing method. The information processing method involved in this technical solution receives a first measurement result obtained by measuring a formed component in a urine sample by flow cytometry, a second measurement result obtained by measuring a chemical component in the urine sample by using a test paper, and a cell image obtained by photographing the formed component in the urine sample, and displays the cell image plus at least one of the first measurement result and the second measurement result on the same interface.

[0021] The seventh technical solution of the present invention relates to a management device, which is communicably connected to: an inspection device for classifying and counting formed elements in a urine sample by flow cytometry, and a photographing device for photographing the formed elements in the urine sample and obtaining a cell image. The management device involved in this technical solution has: a control unit, an input unit, and a display unit that receive the count values ​​of various formed elements in the urine sample obtained by the inspection device and the cell image obtained by the photographing device. The control unit causes the display unit to display the count values ​​of various formed elements and the cell image on the same interface, and receives information about the formed elements in the urine sample through the input unit. Regarding the types of formed elements classified by the inspection device, the control unit causes the display unit to display the count values ​​obtained by the inspection device as the inspection result when the information about the formed elements is not received through the input unit, and causes the display unit to display the count values ​​based on the information about the formed elements received through the input unit as the inspection result when the information about the formed elements is received through the input unit.

[0022] Effects of the Invention

[0023] According to the present invention, urine can be accurately diagnosed without complicated operations.

[0024] The effects and significance of the present invention will become more apparent through the following description of the embodiments. However, the embodiments shown below are only examples of the implementation of the present invention, and the present invention is not limited to the following embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 is a structural diagram of a urine analysis system according to the first embodiment;

[0026] Figure 2 A schematic diagram of the structure of a detector of the inspection device (flow cytometer) involved in the first embodiment;

[0027] Figure 3 (a) to (e) are graphs showing the measurement results of the formed components of the inspection device according to the first embodiment;

[0028] Figure 4 is a structural diagram of a photographing component involved in the first embodiment;

[0029] Figure 5 (a) and (b) are a plan view and a side view of the structure of the first chamber and the second chamber according to the first embodiment, respectively;

[0030] Figure 6 (a) and (b) are operation diagrams of the photographing component involved in the first embodiment;

[0031] Figure 7 (a) and (b) are diagrams showing a control method of a photographing component according to the first embodiment;

[0032] Figure 8 A timing diagram of a photographing operation according to the first embodiment;

[0033] Fig. 9 is a structural diagram of a control system of a urine analysis system according to the first embodiment;

[0034] Fig.10 (a) is a flowchart of a photographing instruction generation process of a management device according to the first embodiment. Fig.10 (b) and (c) are structural diagrams of the first and second condition tables respectively referred to when determining whether to generate a shooting instruction according to the first embodiment;

[0035] Fig.11 (a) is a flow chart of transport control of the transport device according to the first embodiment. Fig.11 (b) is a flowchart of the photographing process of the photographing device involved in the first embodiment;

[0036] Fig.12 It is a structural diagram of the management device browsing interface involved in the first implementation mode;

[0037] Fig.13 It is a structural diagram of the management device browsing interface involved in the first implementation mode;

[0038] Fig.14 is a structural diagram of a urine analysis system according to a second embodiment;

[0039] Fig.15 (a) and (b) are structural diagrams of the first and second condition tables respectively referred to when determining whether to generate a shooting instruction according to the second embodiment. Fig.15 (c) is a flowchart of a photographing instruction generation process of the management device according to the modification example;

[0040] Fig.16 This is a structural diagram of the overview interface involved in implementation mode 3;

[0041] Fig.17 This is a structural diagram of the overview interface after pressing the comprehensive tab involved in implementation mode 3;

[0042] Fig.18 This is a structural diagram of the overview interface after pressing the qualitative tab involved in implementation mode 3;

[0043] Fig.19 This is a structural diagram of the overview interface after pressing the FCM tab involved in implementation mode 3;

[0044] Fig. 20This is a structural diagram of the overview interface after pressing the chart tab involved in implementation mode 3;

[0045] Fig.21 This is a structural diagram of the overview interface after pressing the shooting tab involved in implementation mode 3;

[0046] Fig. 22 This is a structural diagram of the overview interface after pressing the naked eye observation tab involved in implementation mode 3;

[0047] Fig.23 This is a structural diagram of the overview interface after pressing the evaluation tab involved in implementation mode 3;

[0048] Fig.24 This is a structural diagram of the overview interface after pressing the comprehensive tab involved in implementation mode 3;

[0049] Fig.25 This is a structural diagram of the classification operation interface involved in implementation mode three;

[0050] Fig.26 This is a structural diagram of the classification result interface involved in implementation mode 3;

[0051] Fig. 27 This is a structural diagram of the overview interface after pressing the shooting tab involved in the fourth implementation mode;

[0052] Fig.28 A structural diagram of an overview interface after pressing the capture tab and a structural diagram of a dialog box for cutting a cell image involved in the fourth embodiment;

[0053] Fig.29 This is a structural diagram of the overview interface after pressing the shooting tab involved in the fourth implementation mode;

[0054] Fig.30 This is a structural diagram of the classification operation interface involved in the fourth implementation mode;

[0055] Fig.31 This is a structural diagram of the classification operation interface involved in the fourth implementation mode;

[0056] Fig.32 This is a structural diagram of the classification result interface involved in implementation mode 4;

[0057] Fig.33 This is a structural diagram of the classification operation interface involved in the fourth implementation mode;

[0058] Fig.34 A structural diagram of a classification operation interface and a structural diagram of a dialog box for simple input involved in the fourth implementation mode;

[0059] Fig.35A structural diagram of a classification operation interface and a structural diagram of a dialog box for cutting cell images involved in the fifth embodiment;

[0060] Fig.36 This is a structural diagram of the classification result interface involved in implementation mode five;

[0061] Fig.37 (a) is a structural diagram of a dialog box for simple input according to Embodiment 5; Fig.37 (b) is a structural diagram of a dialog box for direct input according to the fifth embodiment;

[0062] Fig.38 This is a structural diagram of the verification dialog box involved in implementation modes four and five.

[0063] However, the drawings are for illustration only and are not intended to limit the scope of the present invention. DETAILED DESCRIPTION

[0064] This embodiment is an application of the present invention to a urine analysis system for analyzing urine samples containing formed elements such as blood cells, bacteria, casts, epithelial cells, etc. The urine sample to be measured includes urine collected from a living body such as urine in the bladder in addition to urine excreted.

[0065] (Implementation Method 1)

[0066] like Figure 1 As shown, the urine analysis system 1 includes an inspection device (flow cytometer) 10, a photographing device 20, a management device 30, and a transport device 40. The inspection device 10 is a sediment device for classifying and counting components contained in a urine sample. The photographing device 20 is used to photograph cell images of components contained in a urine sample.

[0067] The management device 30 receives and manages the measurement results obtained by the inspection device 10 and the cell images obtained by the imaging device 20. The management device 30 also sends a measurement instruction to the inspection device 10 and sends a photographing instruction to the photographing device 20 according to the measurement results from the inspection device 10. The transport device 40 transports the urine sample to the inspection device 10 and the photographing device 20 according to the measurement instruction and the photographing instruction received from the management device 30. The urine sample is placed in a sample container 51. The transport device 40 transports a sample rack 50 in which a plurality of sample containers 51 are placed to the inspection device 10 and the photographing device 20.

[0068] Barcodes are attached to the sample rack 50 and the sample container 51. Each sample rack 50 is identified by the barcode attached to the sample rack 50. The urine sample contained in each sample container 51 is identified by the barcode attached to the sample container 51. The barcode attached to the sample container 51 carries the identification information of the urine sample.

[0069] The inspection device 10 includes a sample preparation unit 11 , an optical detector 12 , a signal processing unit 13 , a control unit 14 , and a storage unit 15 .

[0070] The sample preparation unit 11 has an aspiration unit 11a for aspirating a urine sample. The aspiration unit 11a is composed of a tubular aspirator. The sample preparation unit 11 aspirates the urine sample from the sample container 51 by the aspiration unit 11a. The sample preparation unit 11 mixes a reagent with the urine sample aspirated by the aspiration unit 11a to prepare a measurement sample. The reagent mixed with the urine sample is a dye solution or a diluent containing a pigment of a formed component in the dyed urine sample.

[0071] The staining solution used to stain the non-nucleic acid formed components (hereinafter referred to as "non-nuclear components") is a fluorescent dye that is more likely to bind to the lipids and proteins of the cell membrane rather than nucleic acids. It is preferable to select a dye that does not affect the morphology of red blood cells. The mixed diluent is a reagent with a buffer as the main component. The pH value of the buffer contained in the diluent can ensure that a stable fluorescent signal is obtained without dissolving red blood cells. These staining solutions and diluents are mixed in the urine sample, whereby the cell membrane or protein of the non-nuclear components in the urine sample is stained.

[0072] The dye used to stain the formed components with nucleic acid (hereinafter referred to as "nuclear components") is selected from fluorescent dyes that are more likely to bind to nucleic acid than lipids and proteins. The mixed diluent is a reagent that destroys the cell membrane and promotes the permeation of the dye through the membrane. The diluent contains a surfactant. The surfactant causes hemolysis of red blood cells and shrinks impurities such as red blood cell fragments. These dyes and diluents are mixed with the urine sample, thereby staining the formed components with nucleic acid in the urine sample.

[0073] The detector 12 is used to measure the measurement sample prepared by the sample preparation unit 11 .

[0074] like Figure 2 As shown, the detector 12 has a flow cell 101, a light source component 102, an optical system 103, and light receiving components 104 to 106. The flow cell 101 allows the measurement sample to flow in one direction in a state of being coated with a sheath liquid. The light source component 102 is composed of, for example, a laser diode, which emits light of a certain wavelength. The optical system 103 irradiates the light emitted by the light source component 102 to the sample flow in the flow cell 101. The optical system 103 guides the forward scattered light generated by the formed components in the flow cell 101 to the light receiving component 104. The optical system 103 guides the side scattered light and the side fluorescence generated by the formed components to the light receiving components 105 and 106, respectively.

[0075] The optical system 103 includes a collimator lens 111 , a cylindrical lens 112 , a condenser lens 113 , a collecting lens 114 , a beam stopper 115 , a pinhole 116 , a collecting lens 117 , a dichroic mirror 118 , and an optical filter 119 .

[0076] The collimator lens 111 converts the light emitted from the light source unit 102 into parallel light. The cylindrical lens 112 and the condenser lens 113 adjust the light transmitted through the collimator lens 111 into a shape with a larger width in the direction perpendicular to the measurement sample flow and irradiate the light to the sample flow in the flow cell 101. Thus, forward scattered light is generated in front of the formed components flowing through the flow cell 101, and side scattered light and fluorescence are generated to the sides of the formed components flowing through the flow cell 101.

[0077] The light collecting lens 114 collects the forward scattered light at the position of the pinhole 116. The beam stopper 115 blocks the light that passes through the flow cell 101 without irradiating the particles in the measurement sample. The light receiving component 104 receives the forward scattered light passing through the pinhole 116. The light receiving component 104 has, for example, a photodiode. The light receiving component 104 amplifies the detection signal with an amplifier, generates a forward scattered light signal based on the forward scattered light, and outputs the generated forward scattered light signal to the Figure 1 The signal processing component 13 is shown.

[0078] The light collecting lens 117 collects the side scattered light and the fluorescence respectively. The dichroic mirror 118 reflects the side scattered light transmitted through the light collecting lens 117. The light receiving component 105 receives the side scattered light reflected by the dichroic mirror 118. The light receiving component 105 has, for example, a photodiode or a photomultiplier tube. The light receiving component 105 amplifies the detection signal with an amplifier and generates a side scattered light signal based on the side scattered light, and outputs the generated side scattered light signal to the optical receiver. Figure 1 The signal processing component 13 is shown.

[0079] The dichroic mirror 118 allows the fluorescence transmitted through the light collecting lens 117 to pass through. The optical filter 119 removes light of a wavelength band that would become noise from the fluorescence transmitted through the dichroic mirror 118. The light receiving unit 106 receives the fluorescence transmitted through the optical filter 119. The light receiving unit 106 has, for example, a photomultiplier tube. The light receiving unit 106 amplifies the detection signal with an amplifier and generates a fluorescence signal based on the fluorescence, and outputs the generated fluorescence signal to the signal processing unit 13.

[0080] The light receiving components 104, 105, and 106 can switch the sensitivity of receiving light between low sensitivity and high sensitivity by switching the driving voltage during photoelectric conversion or by using an amplifier. The light receiving components 104 to 106 generate signals of each light when the sensitivity of receiving light is low sensitivity and signals of each light when the sensitivity of receiving light is high sensitivity during the flow cell 101 of the measurement sample, and output them to the Figure 1 The signal processing component 13 is shown.

[0081] return Figure 1The signal processing unit 13 processes the signals outputted by the light receiving units 104 to 106, and obtains the signal waveforms of the forward scattered light, the side scattered light and the fluorescence generated by the formed components passing through the flow cell 101. That is, the signal processing unit 13 obtains the signal waveforms corresponding to the formed components (red blood cells, white blood cells, epithelial cells, casts, bacteria, etc.) contained in the measurement sample. The signal processing unit 13 outputs the data of the obtained signal waveforms to the control unit 14.

[0082] The control unit 14 has a calculation processing circuit such as a CPU. The storage unit 15 has a memory such as a ROM, a RAM, and a hard disk. The storage unit 15 stores various information required for the control unit 14 to perform control. The storage unit 15 is also used as a work area when the control unit 14 performs control. The control unit 14 controls each component in the inspection device 10 according to the program stored in the storage unit 15. The control unit 14 stores the signal waveform data of the formed component obtained from the signal processing unit 13 in the storage unit 15. The control unit 14 calculates several characteristic parameters such as peak value, width and area for the signal waveform of forward scattered light, side scattered light and fluorescence. The control unit 14 causes the storage unit 15 to store the calculated characteristic parameters. The control unit 14 also classifies the formed components according to the calculated characteristic parameters and counts the number of each formed component contained in the measurement sample.

[0083] like Figure 3 As shown in (a) to (e), the control unit 14 classifies and measures the formed components in the sample based on a scatter plot with certain characteristic parameters as two axes.

[0084] In the following description, for convenience, the regions of each formed component are set on the scatter plot and the formed components are classified. However, the scatter plot and each region do not necessarily have to be in the form of a graph or chart. It is also possible to extract the formed components contained in each region through data processing, that is, to filter and extract only the formed components that belong to a specific numerical range.

[0085] exist Figure 3 In the scatter plots of (a) to (e), the vertical and horizontal axes are one of FSCP, FSCW, SSCP, FLLP, FLLW, FLLA, FLHP, FLHW and FLHA. FSCP is the forward scattered light intensity, that is, the peak value of the forward scattered light signal. FSCW is the pulse width of the forward scattered light signal. SSCP is the side scattered light intensity, that is, the peak value of the side scattered light signal. FLLP is the peak value of the low-sensitivity fluorescence signal. FLLW is the pulse width of the low-sensitivity fluorescence signal. FLLA is the pulse area of ​​the low-sensitivity fluorescence signal. FLHP is the peak value of the high-sensitivity fluorescence signal. FLHW is the pulse width of the high-sensitivity fluorescence signal. FLHA is the pulse area of ​​the high-sensitivity fluorescence signal.

[0086] exist Figure 3 In the scatter plot of (a), regions 121 and 122 contain red blood cells and crystals, respectively. Figure 3 In the scatter plot of (b), regions 123 and 124 contain casts and mucus threads, respectively. Figure 3 In the scatter plot of (c), regions 125 to 127 contain atypical cells, leukocytes, and epithelial cells, respectively. Figure 3 In the scatter plot of (d), regions 128 to 130 contain sperm, fungi, and Trichomonas, respectively. Figure 3 In the scattergram of (e), the region 131 contains bacteria. The control unit 14 counts the number of formed components contained in each region on each scattergram, and obtains the count value as the number of formed components of the corresponding category in each region.

[0087] return Figure 1 , the control unit 14 of the inspection device 10 sends optical information obtained from each formed component of the measurement sample, that is, characteristic parameters calculated based on the forward scattered light signal, the side scattered light signal and the fluorescent signal, and the number of formed components counted by category based on the optical information to the management device 30. The optical information includes characteristic parameters calculated based on the forward scattered light signal, the side scattered light signal and the fluorescent signal when the light receiving units 104 to 106 are set to low sensitivity and high sensitivity, respectively. The management device 30 stores the received information in association with the identification information of the urine sample.

[0088] The imaging device 20 includes a sample supply unit 21 , an imaging unit 22 , a control unit 23 , and a storage unit 24 .

[0089] The sample supply unit 21 includes an aspiration unit 21a for aspirating a urine sample. The aspiration unit 21a is composed of a tubular aspirator. The sample supply unit 21 supplies the urine sample aspirated by the aspiration unit 21a to the imaging unit 22. The imaging unit 22 images the supplied urine sample and sends the image to the control unit 23. The control unit 23 includes a calculation processing circuit such as a CPU. The storage unit 24 includes a memory such as a ROM, a RAM, and a hard disk. The storage unit 24 stores various information required for the control unit 23 to perform control. The storage unit 24 is also used as a workspace when the control unit 23 performs control.

[0090] The control unit 23 controls each unit in the photographing device 20 according to the program stored in the storage unit 24. The control unit 23 causes the storage unit 24 to store the photographed image obtained from the photographing unit 22. The control unit 23 cuts out a cell image from the photographed image, and classifies the cell image into eight levels according to the size of the cut cell image. The control unit 23 causes the storage unit 24 to store the cell image together with the level. The control unit 23 transmits the cell image together with the level to the control unit 33 of the management device 30. The following method can also be adopted: the control unit 23 automatically classifies the types of formed elements contained in the cell image by performing image processing on the cut cell image, and transmits the cell image together with the automatic classification result to the management device 30.

[0091] like Figure 4 As shown, the photographing component 22 includes: a first chamber 221 , a second chamber 222 , a light source 223 , an illuminating optical system 224 , an objective lens 225 , a photographing element 226 and a carrier stage 227 .

[0092] The first chamber 221 and the second chamber 222 are respectively cubic containers made of transparent materials such as quartz glass. The first chamber 221 and the second chamber 222 are fixed on a support platform 227. The support platform 227 transports the first chamber 221 and the second chamber 222 in the arrangement direction of the first chamber 221 and the second chamber 222.

[0093] like Figure 5 As shown in (a) and (b), the first chamber 221 and the second chamber 222 have inner spaces 221a and 222a of a cubic shape with a small thickness, respectively. The inner spaces 221a and 222a are of the same shape and size. Figure 5 As shown in (a), the internal spaces 221a and 222a are arranged at the same position in the left-right direction. Figure 5 As shown in (b), the internal spaces 221a and 222a are arranged at the same position in the up-down direction.

[0094] The first chamber 221 has an inlet 221b for allowing the urine sample to flow into the internal space 221a, and an outlet 221c for allowing the urine sample to flow out of the internal space 221a. The second chamber 222 has an inlet 222b for allowing the urine sample to flow into the internal space 222a, and an outlet 222c for allowing the urine sample to flow out of the internal space 222a. The bottom surface of the internal space 221a of the first chamber 221 and the bottom surface of the internal space 222a of the second chamber 222 are uniform planes with high surface accuracy.

[0095] return Figure 4, the light source 223 emits light of a certain wavelength. The light source 223 is, for example, a light emitting diode. The irradiation optical system 224 is composed of a plurality of lenses. The irradiation optical system 224 converts the light from the light source 223 into parallel light and irradiates it to the shooting area of ​​the objective lens 225. The objective lens 225 forms an image of the shooting area irradiated by the light on the light receiving surface of the shooting element 226. The shooting element 226 is, for example, a CCD image sensor or a CMOS image sensor. The objective lens 225 is driven in the direction of the optical axis to adjust the focus.

[0096] The inlet 221b of the first chamber 221 is connected to the suction part 21a through a tube and two electromagnetic valves. The outlet 221c of the first chamber 221 is connected to the pump 211 through a tube and two electromagnetic valves. The inlet 222b of the second chamber 222 is connected to the suction part 21a through a tube and two electromagnetic valves. The outlet 222c of the second chamber 222 is connected to the pump 211 through a tube and two electromagnetic valves.

[0097] The pump 211 is connected to a container 212 containing a buffer solution through a tube and an electromagnetic valve. The buffer solution is filled into the tube to introduce a urine sample. The container 212 is connected to a cleaning tank 213 through a tube and two electromagnetic valves. The buffer solution is supplied to the cleaning tank 213 and is also used as a cleaning liquid. A waste liquid container 214 is provided below the cleaning tank 213.

[0098] The pump 211 is operated while the electromagnetic valves are switched on and off, so that the urine sample contained in the sample container 51 is introduced into the first chamber 221 or the second chamber 222. The pump 211 is operated until the urine sample flows out of the outflow port 221c or the outflow port 222c. Thus, the internal space 221a of the first chamber 221 or the internal space 222a of the second chamber 222 is filled with the urine sample.

[0099] After the urine sample filled in the first chamber 221 or the second chamber 222 is photographed, the aspirating member 21a and the first chamber 221 or the second chamber 222 are cleaned. The aspirating member 21a is moved to the cleaning tank 213 for cleaning. The pump 211 operates, thereby supplying a buffer solution to the internal space 221a of the first chamber 221 or the internal space 222a of the second chamber 222, and cleaning the internal space 221a or the internal space 222a. The urine sample squeezed out of the internal space 221a of the first chamber 221 or the internal space 222a of the second chamber 222 due to the inflow of the buffer solution is discharged from the aspirating member 21a to the cleaning tank 213. The pump 211 further operates, thereby discharging the buffer solution from the aspirating member 21a, and cleaning the inside of the aspirating member 21a. The buffer solution is supplied from the container 212 to the cleaning tank 213 to clean the outside of the aspirating member 21a. The waste liquid from the cleaning tank 213 is stored in the waste liquid container 214.

[0100] like Figure 6As shown in (a) and (b), the first chamber 221 and the second chamber 222 are transported to the right by the carrier 227 during the shooting. During this period, the objective lens 225 is moved in the optical axis direction by the driving mechanism 228 to adjust the focus. During the transportation of the first chamber 221, the imaging element 226 photographs the urine sample filled in the first chamber 221 at a certain interval. In this way, a certain number of images of the first chamber 221 are photographed. For example, 40 images of the first chamber 221 are photographed.

[0101] After the first chamber 221 is photographed, the first chamber 221 and the second chamber 222 are transported to the right again. After the photographing area of ​​the objective lens 225 reaches the start position of the second chamber 222, the second chamber 222 begins to be photographed. As described above, a certain number of images are photographed for the second chamber 222. The number of images photographed for the second chamber 222 is the same as that for the first chamber 221.

[0102] like Figure 7 As shown in (a), the first chamber 221 is transported to the right during shooting. At this time, the first chamber 221 is transported in a direction inclined upward at a certain angle from the horizontal direction by the carrier 227, and the bottom surface of the internal space 221a is kept horizontal. The bottom surface of the first chamber 221 is provided with reference marks 221d and 221e in a certain pattern at the shooting start position and the shooting end position, respectively. The reference marks 221d and 221e are composed of, for example, a number of fine grooves processed by laser. The reference marks 221d and 221e are used to determine the focal position of the objective lens 225 during shooting as described below.

[0103] First, before the shooting operation starts, the buffer is filled into the first chamber 221. Then, as Figure 7 (a) The objective lens 225 is focused and the reference mark 221d is imaged on the imaging element 226. The position 229a of the objective lens 225 when the reference mark 221d is imaged on the imaging element 226 is acquired and used as the first focus position. Thereafter, the first chamber 221 is transported in a direction inclined upward at a certain angle from the horizontal direction as described above, and the first chamber 221 is placed Figure 7 (b) The objective lens 225 is in focus at this position and the reference mark 221e is imaged on the imaging element 226. The position 229b of the objective lens 225 when the reference mark 221e is imaged on the imaging element 226 is acquired and used as the second focal position. The slope of the linear function of the focal position with respect to the transport direction is calculated based on the difference between the first focal position and the second focal position and the distance between the reference marks 221d and 221e in the transport direction of the first chamber 221. The slope of the linear function is calculated similarly for the second chamber 222.

[0104] When photographing the first chamber 221 and the second chamber 222, the focus position of the objective lens 225 at each transport position of the first chamber 221 and the second chamber 222 is set by using the linear function whose slope is obtained as above. The selected buffer solution must satisfy the refractive index of the buffer solution and the refractive index of the urine sample. Therefore, by setting the position of the objective lens 225 by using the linear function whose slope is obtained as above, the focus of the objective lens 225 at each transport position of the first chamber 221 and the second chamber 222 is located near the bottom surface of the first chamber 221 and the second chamber 222. In this way, the tangible objects sunk to the bottom of the first chamber 221 and the second chamber 222 can be photographed correctly. In this way, the first chamber 221 and the second chamber 222 are photographed while adjusting the position of the objective lens 225.

[0105] like Figure 8 As shown, regarding the cycle of the photographing operation of the first chamber 221 and the second chamber 222, the four steps of aspiration, standing, photographing and cleaning constitute one cycle. The aspiration step is a step of filling the first chamber 221 or the second chamber 222 with a urine sample. The standing step is a step of allowing the formed components in the urine sample filled in the first chamber 221 or the second chamber 222 to settle on the bottom surface of the first chamber 221 or the second chamber 222. The photographing step is a step of photographing the urine sample filled in the first chamber 221 or the second chamber 222. The cleaning step is a step of cleaning the internal space 221a of the first chamber 221 or the internal space 222a of the second chamber 222.

[0106] During the static step of the first chamber 221, the second chamber 222 is photographed, cleaned, and pipetted. In addition, during the static step of the second chamber 222, the first chamber 221 is photographed, cleaned, and pipetted. In this way, the photographing, cleaning, and pipetting of each chamber can be smoothly performed. When the photographing operation is performed, the first chamber 221 and the second chamber 222 are repeatedly performed. Figure 8 of steps in a cycle.

[0107] return Figure 1 The management device 30 has an input unit 31, a display unit 32, a control unit 33 and a storage unit 34. The management device 30 is composed of, for example, a personal computer. The input unit 31 has a keyboard and a mouse. The display unit 32 is a display screen. The control unit 33 is composed of a calculation processing circuit such as a CPU, which is controlled according to a control program stored in the storage unit 34. The storage unit 34 has a memory such as a ROM, a RAM and a hard disk.

[0108] The transport device 40 includes two transport units 41 and 42, a collecting unit 43, and a control unit 44. The transport units 41 and 42 are respectively disposed in front of the inspection device 10 and the imaging device 20. The transport units 41 and 42 have the same structure.

[0109] The transport unit 41 includes a first transport path 411 for measuring the sample container 51 placed on the sample rack 50, and a second transport path 412 for transporting the sample rack 50 to the downstream side. The first transport path 411 and the second transport path 412 are lower than the upper side of the transport unit 41. The first transport path 411 is composed of a right groove 411a, a left groove 411b, and a straight part 411c connecting the right groove 411a and the left groove 411b. The second transport path 412 is a straight transport path. The second transport path 412 has a conveyor belt conveyor for transporting the sample rack 50 downstream.

[0110] When the sample rack 50 is transported by the first transport path 411, the push-out mechanism (not shown) pushes the front side of the sample rack 50 and pushes the sample rack 50 from the second transport path 412 to the right groove 411a of the first transport path 411. The conveying mechanism (not shown) conveys the sample rack 50 to the linear component 411c. The conveying mechanism causes the right groove 411a to extend protrusions from the left and right, and moves the protrusions toward the linear component 411c. At this time, the protrusions abut against the front side of the sample rack 50 and convey the sample rack 50 to the linear component 411c.

[0111] The linear component 411c has a conveyor belt. The sample rack 50 is transported to the left by the conveyor belt. The aspiration component 11a aspirates the urine sample from a certain sample container 51 placed on the sample rack 50. After the aspiration operation of the sample rack 50 is completed, the conveyor belt of the linear component 411c transports the sample rack 50 to the left end of the linear component 411c. The push-out mechanism (not shown) pushes the rear side of the sample rack 50 and pushes the sample rack 50 into the left groove 411b. The transport mechanism (not shown) pushes the rear side of the sample rack 50 in the direction of the second transport path 412 in the opposite direction to the right groove 411a and transports the sample rack 50 to the second transport path 412. The conveyor belt of the second transport path 412 transports the sample rack 50 downstream.

[0112] The transport unit 42 has a first transport path 421 and a second transport path 422 similarly to the transport unit 41. The first transport path 421 is composed of a right groove 421a, a left groove 421b, and a straight member 421c connecting the right groove 421a and the left groove 421b. The second transport path 422 is a straight transport path. Figure 1 As shown, the second transport path 422 of the transport unit 42 is connected to the second transport path 412 of the transport unit 41. In this way, the sample rack 50 is transferred from the transport unit 41 to the transport unit 42.

[0113] The collecting unit 43 is used to store the sample rack 50 after the measurement and imaging. The control unit 44 has a calculation processing circuit such as a CPU, and controls the transport units 41, 42 and the collecting unit 43 according to a control program.

[0114] When the urine sample in a certain sample container 51 placed on the sample rack 50 is to be photographed by the photographing device 20, the control unit 44 of the transport device 40 controls the transport unit 42 on the front side of the photographing device 20 to transport the sample container 51 containing the urine sample to be photographed to the aspiration position of the aspiration unit 21a through the first transport path 421. When the urine sample in any sample container 51 placed on the sample rack 50 does not need to be photographed by the photographing device 20, the control unit 44 of the transport device 40 controls the transport unit 42 on the front side of the photographing device 20 to transport the sample rack 50 to the collection unit 43 through the second transport path 422.

[0115] In the transport unit 41, the control of the right groove 411a and the straight member 411c in the first transport path 411 may also be performed by the control unit 14 of the inspection device 10. Similarly, in the transport unit 42, the control of the right groove 421a and the straight member 421c in the first transport path 421 may also be performed by the control unit 23 of the imaging device 20.

[0116] like Fig. 9 As shown, the transport unit 41 on the front side of the inspection device 10 has a driving component 413, a detection component 414, a barcode reader 415 and a control component 416. The driving component 413 includes Figure 1 The first and second transport paths 411 and 412 are shown to transport the sample rack 50 using a conveyor belt, a transport mechanism, and a push mechanism. The detection component 414 includes sensors for detecting the sample rack 50 and the sample container 51 at certain positions on the first and second transport paths 411 and 412.

[0117] The barcode reader 415 reads the barcode of the sample rack 50 and the barcode of the sample container 51 placed on the sample rack 50. The barcode is read at a certain position between the right end of the straight part 411c of the first transport path 411 and the aspiration position of the aspiration part 11a. The control part 416 includes a calculation processing circuit such as a CPU and controls according to a control program. The control part 416 includes a memory for storing a shooting instruction described later.

[0118] The transport unit 42 on the front side of the imaging device 20 also has a driving unit 423, a detecting unit 424, a barcode reader 425, and a control unit 426, similarly to the transport unit 41. The barcodes of the sample rack 50 and the sample container 51 are read at a certain position between the right end of the straight part 421c of the first transport path 421 and the aspiration position of the aspiration part 21a.

[0119] The measurement of the urine sample starts when the sample rack 50 is placed in the right groove 411a of the transport unit 41 on the front side of the inspection device 10. The control unit 416 causes the driving unit 413 to transport the sample rack 50 from the right groove 411a to the linear unit 411c, and transports the sample rack 50 to the reading position of the barcode reader 415. The control unit 416 causes the barcode reader 415 to read the barcode of the sample rack 50 and the barcode of the sample container 51. In this way, the control unit 416 obtains the identification information of the sample rack 50 and the identification information of the sample container 51.

[0120] The control unit 416 sends the acquired identification information to the control unit 44. The control unit 44 transmits the received identification information and the request to transmit the measurement instruction of the urine sample in the sample container 51 placed on the sample rack 50 to the management device 30. The control unit 33 of the management device 30 extracts the measurement instruction from the storage unit 34 according to the received identification information. The user pre-enters the measurement instruction of each urine sample in the management device 30. The control unit 33 transmits the extracted measurement instruction to the control unit 44 of the transport device 40. At this time, the control unit 33 also transmits the extracted measurement instruction to the control unit 14 of the inspection device 10.

[0121] The control unit 44 of the transport device 40 transmits a transport instruction to the control unit 416 according to the received measurement instruction. The control unit 416 sequentially transports the sample containers 51 of the sample rack 50 to the aspiration position of the aspiration unit 11a of the inspection device 10 according to the received transport instruction. Whenever the transport of each sample container 51 to the aspiration position is completed, the control unit 416 notifies the control unit 14 of the inspection device 10 of the transport completion through the control unit 44. This notification includes the identification information of the sample container 51 transported to the aspiration position. After receiving the notification, the control unit 14 refers to the measurement instruction of the sample container 51 located at the aspiration position and processes according to the measurement instruction.

[0122] When the measurement instruction indicates that the urine sample in the sample container 51 needs to be measured, the control unit 14 causes the aspiration unit 11a to aspirate the urine sample and perform the measurement process. When the measurement instruction indicates that the urine sample in the sample container 51 does not need to be measured, the control unit 14 skips the aspiration operation of the urine sample. After the aspiration process of the sample container 51 transported to the aspiration position is completed, the control unit 14 notifies the control unit 416 of the completion of the aspiration process through the control unit 44 of the transport device 40. In the case of skipping the aspiration process of the sample container 51, the control unit 14 also issues a notification of the completion of the aspiration process. In response, the control unit 416 transports the next sample container 51 to the aspiration position of the aspiration unit 11a. In this way, the control unit 416 of the transport unit 41 transports all the sample containers 51 placed on the sample rack 50 to the aspiration position of the aspiration unit 11a of the inspection device 10 in sequence.

[0123] In the measurement performed by the inspection device 10, a certain amount of urine sample, for example, about 8μL, is aspirated from the sample container 51 to prepare a measurement sample. The prepared measurement sample flows into the flow chamber 101 for measurement. That is, the measurement amount of each urine sample in the inspection device 10 is, for example, about 8μL. In contrast, the volume of urine sample that can be filled in the first chamber 221 and the second chamber 222 of the imaging device 20 is, for example, 1μL respectively. The amount of urine sample measured by the inspection device 10 is much larger than that of the imaging device 20, so a high-precision measurement result can be obtained even when the amount of components contained in the urine sample is small.

[0124] The control unit 14 of the inspection device 10 transmits the measurement results of the urine samples in each sample container 51 placed on the sample rack 50 together with the identification information of the urine samples to the control unit 33 of the management device 30. The measurement results include: characteristic parameters calculated based on the optical information (i.e., forward scattered light signal, side scattered light signal, and fluorescent signal) obtained from each formed component contained in the urine sample, and the number of formed components counted by category based on the optical information. Based on this, the control unit 33 of the management device 30 determines whether to take a picture of the urine sample for which the measurement results have been received.

[0125] like Fig.10 As shown in (a), the control unit 33 of the management device 30 determines in step S101 whether the measurement result and urine sample identification information are received from the inspection device 10. If the determination in S101 is yes, then in S102, the control unit 33 causes the storage unit 34 to store the received measurement result in association with the urine sample identification information. A database for storing the measurement results is constructed in the storage unit 34. The control unit 33 enters the measurement result and identification information received from the inspection device 10 into the database. In S103, the control unit 33 determines whether to take a picture through the photographing device 20 based on the received measurement result. In the determination, the control unit 33 refers to Fig.10 (b) and (c) show the first condition table and the second condition table.

[0126] In the management device 30, the user can set whether to use the imaging device 20 to capture images only in the normal mode or to use the close inspection mode in addition to the normal mode. When it is set to capture images only in the normal mode, the control unit 33 of the management device 30 refers to Fig.10 (b) The first condition table is used to perform the determination in S103. When the control unit 33 of the management device 30 refers to the first condition table 33 of the management device 30, the control unit 33 of the management device 30 refers to the first condition table 33 of the management device 30. Fig.10 The second condition table shown in (c) is used to perform the determination in S103.

[0127] Normal mode refers to only Figure 4The mode shown is that one of the first chamber 221 and the second chamber 222 is filled with a urine sample aspirated from a sample container 51 and photographed. At this time, the number of images taken of the urine sample is a certain number, such as 40. In the normal mode, the image analysis of the formed components of this number of images is performed. The detailed inspection mode refers to the Figure 4 The first chamber 221 and the second chamber 222 are filled with urine samples aspirated from a sample container 51 and photographed. At this time, the number of images taken of the urine sample is twice that of the normal mode, such as 80. In the detailed inspection mode, the image analysis of the formed components is performed on the images twice as many as the normal mode.

[0128] like Fig.10 As shown in (b), the first condition table sets the threshold for taking photos for each formed component. When the first condition table is used, the control unit 33 of the management device 30 compares the count value of each formed component contained in the measurement result of the inspection device 10 with the threshold value of each formed component in the first condition table. The control unit 33 determines that it is necessary to take photos of the urine sample by the photography device 20 when the count value of at least one formed component exceeds the threshold value in the first condition table. When the count values ​​of all formed components do not exceed the threshold value in the first condition table, the control unit 33 determines that it is not necessary to take photos of the urine sample by the photography device 20.

[0129] like Fig.10 As shown in (c), the second condition table sets the threshold for taking photos for each formed component. In addition, the second condition table also sets the conditions for executing the detailed inspection mode for certain formed components. When the second condition table is used, the control unit 33 of the management device 30 first compares the count value of each formed component contained in the measurement result of the inspection device 10 with the threshold value of each formed component in the second condition table. When the count value of at least one formed component exceeds the threshold value in the second condition table, the control unit 33 determines that it is necessary to take photos of the urine sample by the photographing device 20. When the count values ​​of all formed components do not exceed the threshold value in the second condition table, the control unit 33 determines that it is not necessary to take photos of the urine sample by the photographing device 20.

[0130] When the threshold value determines that shooting is necessary, the control component 33 further refers to the conditions of the detailed inspection mode to determine whether the detailed inspection mode is required. Fig.10In case (c), when the count value of at least one of the epithelial cells and casts exceeds the threshold used to determine whether shooting is required, the control unit 33 determines that shooting is required in the detailed inspection mode. When the count values ​​of both the epithelial cells and casts do not exceed the threshold used to determine whether shooting is required but the count value of the red blood cells is above the condition of the detailed inspection mode, that is, above 60 / µL, the control unit 33 also determines that shooting is required in the detailed inspection mode. When any condition of the detailed inspection mode is not met, the control unit 33 determines that shooting is not required in the detailed inspection mode and chooses to shoot in the normal mode.

[0131] The user may be allowed to arbitrarily set the threshold value of the first condition table, the threshold value of the second condition table, and the conditions of the close inspection mode.

[0132] In S104, the control unit 33 determines whether a determination result indicating that the urine sample for which the measurement result is received is obtained by the imaging device 20. If the determination in S104 is yes, in S105, the control unit 33 generates an imaging instruction for the urine sample, and causes the storage unit 34 to store the generated imaging instruction in association with the identification information of the urine sample. The imaging instruction includes information on which mode, the normal mode or the detailed inspection mode, is used to image and analyze the urine sample. If the determination in S104 is no, the control unit 33 does not generate an imaging instruction for the urine sample and ends the processing.

[0133] like Fig.11 As shown in (a), when the sample rack 50 is to be transported from the transport unit 41 on the front side of the inspection device 10 to the transport unit 42 on the front side of the imaging device 20, in S201, the control unit 44 of the transport device 40 transmits a request for transmitting an imaging command to the management device 30 together with the identification information of each sample container 51 placed on the sample rack 50 to be transported. The control unit 33 of the management device 30 extracts the imaging command of each urine sample from the storage unit 34 based on the received identification information. When the imaging command is extracted for a certain urine sample, the control unit 33 transmits the extracted imaging command and the identification information associated with the imaging command to the control unit 44 of the transport device 40 and the control unit 23 of the imaging device 20. When no imaging command is extracted for a certain urine sample, the control unit 33 transmits a notification indicating this result to the control unit 44 of the transport device 40.

[0134] In S202, the control unit 44 of the transport device 40 determines whether a photographing instruction has been received for the urine sample in the sample container 51 placed on the transport target sample rack 50. If the determination in S202 is yes, in S203, the control unit 44 transmits a transport instruction to transport the urine sample to be photographed to the aspiration position of the aspiration unit 21a via the first transport path 421 to the control unit 426 of the transport unit 42 disposed on the front side of the imaging device 20. The control unit 426 transports the sample container 51 containing the sample to be photographed to the aspiration position of the aspiration unit 21a according to the received transport instruction.

[0135] When the transport of the sample container 51 to the aspiration position is completed, the control unit 426 transmits a transport completion notification to the control unit 23 of the imaging device 20 through the control unit 44. The transport completion notification includes the identification information of the sample container 51 transported to the aspiration position. After receiving this notification, the imaging device 20 aspirates the urine sample from the sample container 51. After the aspiration is completed, the control unit 23 of the imaging device 20 transmits a notification indicating this to the control unit 426 of the transport unit 42 through the control unit 44 of the transport device 40.

[0136] In S205, the control component 426 determines whether all the urine samples of the object to be photographed placed on the sample rack 50 of the transport object have completed the aspiration operation in the photographing device 20. The control component 426 sequentially transports the urine samples of the object to be photographed to the aspiration position until the aspiration operation of all the urine samples of the object to be photographed is completed. If the judgment in S205 is yes, in S206, the control component 426 transports the sample rack 50 of the transport object to the recovery component 43. In this way, the control components 44 and 426 end the processing of the sample rack 50 of the transport object.

[0137] If the result of S202 is negative, then in S204, the control unit 44 transmits a transport instruction to the control unit 426 of the transport unit 42 to transport the transport target sample rack 50 to the recovery unit 43 via the second transport path 422. In S206, the control unit 426 transports the transport target sample rack 50 to the recovery unit 43 according to the received transport instruction. The processing of the transport target sample rack 50 by the control units 44 and 426 ends here.

[0138] like Fig.11 As shown in (b), in S301, the control unit 23 of the photographing device 20 determines whether a photographing instruction has been received. Fig.11In S201 of (a), the photographing instruction is transmitted to the control unit 23 of the photographing device 20. That is, the control unit 33 of the management device 30 extracts the photographing instruction of the sample container 51 placed on the transport target sample rack 50 according to the photographing instruction transmission request of the control unit 44 of the transport device 40. The control unit 33 of the management device 30 transmits the extracted photographing instruction to the control unit 44 of the transport device 40 and then to the control unit 23 of the photographing device 20. Then, after the control unit 23 of the photographing device 20 receives the photographing instruction, S301 is judged as yes. The control unit 23 of the photographing device 20 causes the storage unit 24 to store the received photographing instruction.

[0139] In S302, the control unit 23 determines whether the sample container 51 containing the urine sample of the imaging subject has reached the aspiration position of the aspiration unit 21a. Fig.11 In S203 of (a), the control unit 44 of the transport device 40 transmits a transport completion notification of the sample container 51 to the control unit 23 of the imaging device 20. After receiving the transport completion notification, the control unit 23 of the imaging device 20 determines yes in S302. As described above, the transport completion notification includes the identification number of the sample container 51 transported to the aspiration position.

[0140] If the judgment in S302 is yes, the control unit 23 of the photographing device 20 refers to the photographing instruction corresponding to the identification information included in the transport completion notification among the photographing instructions stored in the storage unit 24. In S303, the control unit 23 determines whether the photographing instruction referred to includes the mode information of the detailed inspection mode. When the photographing instruction referred to includes the mode information of the detailed inspection mode, the judgment in S303 is yes. When the photographing instruction referred to includes the mode information of the normal mode, the judgment in S303 is no.

[0141] When S303 is judged as yes, in S304, the control component 23 performs shooting and analysis in the detailed inspection mode. When S303 is judged as no, in S305, the control component 23 performs shooting and analysis in the normal mode. The control component 23 continues to process S302~S305 until it is judged in S306 that the processing of all urine samples of the shooting objects placed on the sample rack 50 is completed. After S306 is judged as yes, in S307, the control component 23 transmits the shooting results including the cell images of each formed component obtained by analysis, the level of the cell image, and the urine sample identification information to the management device 30, and then ends the processing. The control component 33 of the management device 30 records the received shooting results in association with the corresponding identification information of the database built in the storage component 34.

[0142] When the mode of the imaging device 20 is set to use only the normal mode, S303 and S304 are omitted, and the process of S305 is performed on all urine samples that are imaging targets.

[0143] In S304 and S305, the control unit 23 cuts out the cell images from the captured images. The control unit 23 classifies the cell images into eight levels according to the size of the cut cell images. In the normal mode, for example, 40 captured images are cut and graded for the cell images. In the detailed inspection mode, twice as many captured images as in the normal mode are cut and graded for the cell images, for example, 80 images. In the detailed inspection mode, the analysis and processing is more time-consuming than in the normal mode, but more cell images can be cut and acquired.

[0144] The management device 30 can display, on the display unit 32 , an interface including both the measurement results of the inspection device 10 and the imaging results of the imaging device 20 recorded in the database as described above, for each urine sample.

[0145] for example Fig.12 The reading interface is displayed on the display unit 32. The reading interface includes: an area 301 for displaying the measurement results of the inspection device 10, an area 302 for displaying the shooting results of the shooting device 20, and operation buttons 303 to 306. The counting results of each formed component are displayed in the form of count values ​​per unit volume in the upper part of the area 301. The scatter plot corresponding to each formed component is displayed in the lower part of the area 301. In the scatter plot, points are plotted in different colors according to each formed component.

[0146] The upper part of area 302 displays cell images in different levels. The number of cells in each level is indicated below the label. The lower part of area 302 displays the total number of extracted cell images and whether the images were taken and analyzed in the detailed inspection mode or the normal mode. Fig.12 In the example of , the detailed inspection mode is shown. When the user clicks the label of each level through the input component 31, the interface will be switched to display all cell images included in the level. This interface is appropriately provided with a scroll bar.

[0147] Cell images are displayed at each level according to their size, for example, level 1 displays cell images of sizes equivalent to bacteria, level 2 displays cell images of sizes equivalent to red blood cells, crystals, and fungi, level 3 displays cell images of sizes equivalent to white blood cells, crystals, and fungi, level 4 displays cell images of sizes equivalent to small round epithelial cells, level 5 displays cell images of sizes equivalent to flat epithelial cells, level 6 displays cell images of sizes equivalent to casts and flat epithelial cells, level 7 displays cell images of sizes equivalent to casts and epithelial cell masses, and level 8 displays cell images of sizes equivalent to casts and epithelial cell masses larger than level 7. Therefore, the user can refer to each level to infer the type of formed element shown in the cell image.

[0148] exist Fig.12In the previous interface of the reading interface, the measurement results and photographing results entered into the database are listed in a list corresponding to the urine sample identification number. The list is associated with the identification number and is marked with the examination date and time, the name of the examinee, gender, age, and the type and name of the institution where the urine sample was collected. The so-called institution type refers to the diagnosis and treatment department of the institution such as urology department and pediatrics department that will use the urine measurement results. After selecting a certain identification number in the list displayed at a glance through the input component 31, the display Fig.12 To return to the list, the user can press button 306 through input component 31.

[0149] exist Fig.12 The interface allows inspection technicians and others to perform editing operations and classify the cell images contained in each level according to each formed element. The user can edit by pressing button 304 through the input component 31. For example, after the user selects a level through the input component 31 and presses button 304, an interface including all cell images contained in the selected level and storage boxes of each formed element will be displayed. The user drags the displayed cell images into the storage boxes of the corresponding formed elements to classify the cell images. The cell images of formed elements that are not classified objects are dragged into the non-object storage box. After the editing work is completed, the user presses button 303 through the input component 31. In this way, the classification of the cell image is determined, and the classified information is stored in the database. According to the classified information, for example Fig.13 The reading interface is shown.

[0150] exist Fig.13 The reading interface shown, area 301 and Fig.12 The reading interface is the same as Fig.13 In the interface, Fig.12 The area 302 is changed to area 308. In area 308, the cell images are classified for each formed element on the left side, and the number of cell images of each formed element is displayed on the right side. The user can reclassify the cell images by pressing button 307 through input unit 31 as appropriate. Buttons 303, 305, and 306 are Fig.12 Same.

[0151] reading Fig.12 or Fig.13When the user finds that the urine sample is abnormal and determines that the subject needs to be re-examined, the user presses button 305 through input component 31. When salt precipitation occurs in the urine sample and the cell image cannot be classified, or when there are many mucus threads in the urine sample and the cell image cannot be classified, the user also presses button 305 through input component 31. In this way, the information indicating the need for re-examination is marked on the identification information of the urine sample being browsed in the database. The subject corresponding to the identification information marked with this information is subjected to a detailed inspection such as microscopic observation again. In this way, after the information indicating the need for re-examination is marked in the database, the user can appropriately and easily confirm whether to re-examine.

[0152] Reference Fig.12 or Fig.13 With the interface, the user can easily and accurately judge a disease that is difficult to correctly diagnose based on the measurement results of the inspection device 10 by referring to the cell image.

[0153] For example, in the measurement performed using the detector 12, it is sometimes impossible to distinguish between mucus threads, bacteria, salt aggregates, etc. that are shaped like casts, and sometimes it is impossible to distinguish between crystalline components and yeast-like fungi that are shaped like red blood cells. In addition, the method implemented using the detector 12 is sometimes unable to distinguish and correctly detect atypical cells in urine from other formed elements in urine. Fig.12 or Fig.13 In this way, when the user suspects that the urine sample contains casts and atypical cells that affect diagnosis based on the measurement results displayed in area 301, the user can refer to the cell image in area 302 to confirm whether the urine sample contains these formed elements. Therefore, this embodiment can perform high-precision urine diagnosis without complicated operations such as centrifugation.

[0154] <Implementation Method 2>

[0155] like Fig.14 As shown, the urine analysis system 1 of the second embodiment adds a second inspection device 60 upstream of the inspection device 10. A transport unit 45 is arranged in front of the second inspection device 60. The second inspection device 60 is a urine qualitative device for applying a urine sample to a test strip to perform a urine protein, urine sugar, etc. inspection. The transport unit 45 has the same structure as the transport units 41 and 42. The transport unit 45 is controlled by the control unit 44 of the transport device 40. When the urine sample is measured by the second inspection device 60, the transport unit 45 transports the sample rack 50 by the first transport path 451. When the urine sample is not measured by the second inspection device 60, the transport unit 45 transports the sample rack 50 to the transport unit 41 by the second transport path 452. The second transport path 452 is connected to the second transport path 412 of the transport unit 41.

[0156] The second inspection device 60 includes a sample supply unit 61 , a measurement unit 62 , a control unit 63 , and a storage unit 64 .

[0157] The sample supply part 61 has an aspiration part 61a for aspirating a urine sample. The aspiration part 61a is composed of a tubular straw. The sample supply part 61 supplies the urine sample aspirated by the aspiration part 61a to the measuring part 62. The measuring part 62 takes out the test paper required for measurement from the test paper holder and spots the urine sample on the taken test paper. The measuring part 62 detects the color of the test paper on which the urine sample is spotted using a color sensor and transmits the detection result to the control part 63. The control part 63 has a calculation processing circuit such as a CPU. The storage part 64 has a memory such as a ROM, a RAM, and a hard disk. The storage part 64 stores various information required for the control part 63 to perform control. The storage part 64 is also used as a working area when the control part 63 performs control.

[0158] The control unit 63 controls each unit in the second inspection device 60 according to the program stored in the storage unit 64. The control unit 63 causes the storage unit 64 to store the detection result from the measurement unit 62. The control unit 63 analyzes the detection result from the measurement unit 62 and obtains the quantitative level of each measurement item contained in the urine sample as the measurement result. The control unit 63 causes the storage unit 64 to store the obtained measurement result, and transmits the measurement result to the control unit 33 of the management device 30 together with the urine sample identification information.

[0159] The control unit 33 of the management device 30 performs comparison with the measurement result received from the second inspection device 60. Fig.10 (a) Same processing. After receiving the measurement result in S101, in S102, the control unit 33 enters the received measurement result into the database in the storage unit 34 in association with the identification information. In S103, the control unit 33 determines whether to photograph the urine sample corresponding to the received identification number through the photographing device 20 based on the received measurement result. If it is determined in S104 that photography is required, the control unit 33 generates a photography instruction and causes the storage unit 34 to store the photography instruction in association with the identification number. When it is determined in S104 that photography is not required, the control unit 33 does not generate a photography instruction and ends the processing.

[0160] The measurement results received from the second inspection device 60 are processed Fig.10 In the process shown in (a), the control unit 33 of the management device 30 refers to Fig.15 (a) and (b) are the first condition table and the second condition table. For example, when the image capture processing mode of the image capture device 20 is set to the normal mode only, the control unit 33 refers to the first condition table and the second condition table in the process of S103. Fig.15(a) First condition table. When the imaging processing mode of the imaging device 20 is set to the concurrent close inspection mode, the control unit 33 refers to the first condition table in the process of S103. Fig.15 (b) The second condition table.

[0161] When referring to the first condition table, the control unit 33 compares the quantity level of each measurement item contained in the urine sample with the threshold value of each measurement item recorded in the first condition table. When the level of at least one measurement item exceeds the threshold value, the control unit 33 determines that it is necessary to perform a photographing process through the photographing device 20 and generates a photographing instruction. At this time, the control unit 23 of the photographing device 20 performs photographing and analysis processing in a normal mode on the urine sample for which the photographing instruction is generated. When the levels of all measurement items do not exceed the threshold value, the control unit 33 determines that it is not necessary to perform a photographing process through the photographing device 20.

[0162] In addition, the following method can be adopted: the control unit 33 determines whether there is at least one pathological cast that does not generally appear in the urine sample of a healthy person in accordance with the measurement results obtained by the inspection device 10, and generates a shooting instruction as long as it is determined that there is a pathological cast, even if there is only one. The user can confirm the captured image, and when there is no pathological cast, the microscopic observation can be omitted. In addition, when a large number of flat epithelial cells are present in the male urine sample, urethritis may be caused by Trichomonas or Chlamydia, so it can be set that the control unit 33 generates a shooting instruction when it determines that there are flat epithelial cells above a certain value in the male urine sample according to the measurement results obtained by the inspection device 10. It can also be set that the control unit 33 generates a shooting instruction when it determines that there are epithelial cells in the female urine sample according to the measurement results obtained by the inspection device 10. For women, even if there is no abnormality in the urinary tract system, the flat epithelial cells derived from the external genitalia and vagina are easily mixed with red blood cells, white blood cells, etc. Therefore, the user can confirm the captured image, and when the epithelial cells are flat epithelial cells, the microscopic observation can be omitted.

[0163] Furthermore, it can be set that when the measurement result of the inspection device 10 shows abnormal classification of formed elements, for example, abnormal classification between red blood cells and crystals, the control unit 33 generates a photographing instruction. The conditions for generating the photographing instruction can be appropriately set in the management device 30 according to the operation conditions of the user's organization. By analyzing the formed elements in the urine sample based on both the measurement results obtained by the inspection device 10 through flow cytometry and the image obtained by the photographing device 20, the number of times of microscope observation, which is a heavy burden, can be reduced, and the inspection efficiency during microscope observation can be improved.

[0164] When referring to the second condition table, the control component 33 first compares the quantity level of each measurement item contained in the urine sample with the threshold value of each measurement item recorded in the second condition table. When the level of at least one measurement item exceeds the threshold value, the control component 33 determines that it is necessary to perform a photographing process through the photographing device 20. The control component 33 further examines whether the measurement item whose level exceeds the threshold value contains "protein". If the measurement item whose level exceeds the threshold value contains "protein", the control component 33 sets the mode of photographing and analyzing processing to the detailed inspection mode. If the measurement item whose level exceeds the threshold value does not contain "protein", the control component 33 sets the mode of photographing and analyzing processing to the normal mode. At this time, the control component 23 of the photographing device 20 performs photographing and analyzing processing in the detailed inspection mode or the normal mode on the urine sample for which the photographing instruction is generated. When the levels of all measurement items do not exceed the threshold value, the control component 33 determines that it is not necessary to perform a photographing process through the photographing device 20.

[0165] The same method as in the first embodiment can also be used, that is, Fig.15 The first condition table and the second condition table of (a) and (b) allow the user to arbitrarily set the threshold value and the condition of the detailed inspection mode. The condition of the detailed inspection mode can be set such that the threshold value for the detailed inspection mode is greater than the threshold value required for imaging, and when the level of the measurement item is greater than the threshold value for the detailed inspection mode, the imaging and analysis mode of the imaging device 20 is set to the detailed inspection mode.

[0166] In the second embodiment, the control unit 44 of the transport device 40 also obtains a photographing instruction based on the measurement result of the second inspection device 60 from the management device 30. Fig.11 In S201 of (a), the photographing instruction of the urine sample in the sample container 51 placed on the sample rack 50 to be transported is inquired. In S202, even if all the urine samples do not have a photographing instruction based on the measurement result of the inspection device 10, as long as at least one urine sample has a photographing instruction based on the measurement result of the second inspection device 60, in S203 the control unit 44 transports the sample rack 50 to be transported along the first transport path 421. Thus, the urine sample to be photographed on the sample rack 50 is sucked by the suction unit 21a to the imaging device 20. The imaging device 20 photographs and analyzes the urine sample according to the mode included in the photographing instruction.

[0167] When the second inspection device 60 performs the measurement, it is preferred that Fig.12 The browsing interface includes an area for displaying the measurement results of the second inspection device 60. Alternatively, the measurement results displayed in the area 301 may be switched between the measurement results of the inspection device 10 and the measurement results of the second inspection device 60 by using a switching button.

[0168] According to the second embodiment, the user can simply and correctly diagnose a disease that is difficult to correctly diagnose based on the measurement results of the second inspection device 60 by referring to the cell image. In particular, in the second embodiment, a urine sample that is determined not to require imaging and analysis based on the urine sediment measurement results of the inspection device 10 may be determined to require imaging and analysis based on the urine qualitative measurement results of the second inspection device 60. Therefore, the user can more appropriately diagnose a urine sample with a suspicious disease by confirming the cell image.

[0169] <Change example>

[0170] exist Fig.10 In the determination process of S103 of (a), Fig.10 (b) and (c) the first and second condition tables and Fig.15 The first and second condition tables of (a) and (b) can also be changed according to the gender, age, and type of institution that collects urine samples of the subject. For example, the threshold for judging whether to take a photo is lower for infants and young children than for adults. Epithelial cells from the vagina are easier to detect in women, so the threshold for epithelial cells is higher than that for men. For urine samples collected by the urology department and pediatrics department, in order to achieve more accurate examinations, the threshold for judging whether to take a photo is lower than that of other institutions, and it is easier to generate shooting instructions. Regarding the second condition table, the conditions for the detailed inspection mode of infant urine samples are lower than those of adults, and it is easier to photograph and analyze through the detailed inspection mode. The conditions of the detailed inspection mode are also changed according to gender and institution in the same way as above. Such changes are arbitrarily set by the user, for example. Another method that can be adopted is: for each subject, for example, according to the subject's condition, the threshold for judging the need for shooting and the conditions of the detailed inspection mode are set for each measurement item.

[0171] At this time Fig.15 (c) shows the process of changing the management device 30. Fig.15 In the flowchart of (c), S111 is added between S102 and S103, and the other contents outside S111 are the same as Fig.10 (a) is the same. In S111, the control unit 33 of the management device 30 refers to the database to determine the gender and age of the subject who collected the urine sample and the type of the institution that collected the urine sample. The control unit 33 changes the threshold for determining the need for imaging and the conditions of the detailed examination mode in the first and second tables to the contents preset by the user based on the determined gender, age and type of institution. The control unit 33 uses the first and second tables that have been changed in this way to perform the determination in S103. The processing after S103 is the same as Fig.10 (a) The same.

[0172] The modified example can be appropriately photographed and analyzed according to individual specific events and situations. Therefore, users can refer to the reading interface to make a more accurate diagnosis.

[0173] <Implementation Method 3>

[0174] In the third embodiment, the structure of the interface displayed on the display unit 32 of the management device 30 is exemplified when the second inspection device 60 is added upstream of the inspection device 10 as shown in the second embodiment.

[0175] By performing certain operations on the input component 31, the Fig.16 This overview interface includes a list display area 310 , a measurement result display area 320 , and a button area 330 .

[0176] The list display area 310 displays the inspection status of each sample at a glance. The measurement result display area 320 can switchably display several types of information based on the measurement results of the inspection device 10, the measurement results of the second inspection device 60, and the image captured by the imaging device 20 according to the input of the input unit 31. As described later, the display in the measurement result display area 320 is switched by operating the tab 321. Various buttons are arranged in the button area 330.

[0177] The list display area 310 includes a sample number item 311 , a qualitative item 312 , an FCM item 313 , an image item 314 , a visual observation item 315 , a measurement date item 316 , a measurement time item 317 , and an evaluation item 318 .

[0178] The identification number of the urine sample is displayed in the sample number item 311. The qualitative item 312 displays whether the urine sample corresponding to the identification number indicated in the sample number item 311 has been subjected to a urine qualitative measurement by the second inspection device 60. The FCM item 313 displays whether the urine sample corresponding to the identification number indicated in the sample number item 311 has been subjected to a urine sediment measurement by the inspection device 10. The image item 314 displays whether the urine sample corresponding to the identification number indicated in the sample number item 311 has been photographed by the photographing device 20.

[0179] The macroscopic observation item 315 indicates whether the urine sample corresponding to the identification number indicated in the sample number item 311 has been subjected to macroscopic observation. In the third embodiment, after the urine sample has been subjected to macroscopic observation by microscopic observation, the result is input to the management device 30 and stored in the database. The measurement date item 316 and the measurement time item 317 respectively indicate the date and time when the urine sample corresponding to the identification number indicated in the sample number item 311 was measured by the inspection device 10.

[0180] The evaluation item 318 displays the evaluation of the urine sample corresponding to the identification number shown in the sample number item 311. As described later, this evaluation can be arbitrarily input by a user such as a testing technician, and also includes the evaluation received from the testing device 10. For example, when there is a formed component with abnormal classification in the urine sample, the testing device 10 transmits information indicating the formed component with abnormal classification and its abnormal classification content to the management device 30 together with the measurement result.

[0181] The following is an example of a classification anomaly, such as Figure 3 In the scatter plots shown in (a) to (e), the boundaries of several tangible components overlap, and these tangible components cannot be correctly divided. At this time, together with the information of the tangible components indicating the classification abnormality, the information indicating "division abnormality" is transmitted from the inspection device 10 to the management device 30 as the content of the classification abnormality. The management device 30 Fig.16 The abnormally classified formed elements and the expression "division abnormality" are displayed in the evaluation item 318. For example, when red blood cells and crystals are not correctly divided, the text column "RBC / X'TAL division abnormality" is displayed in the evaluation item 318.

[0182] The list displayed in the list display area 310 can be scrolled up and down using a scroll bar arranged at the right end of the list display area 310 .

[0183] A field for inputting a range of acceptance dates and a field for inputting a term for filtering and sorting are arranged on the upper side of the list display area 310. These fields are used to filter the urine samples displayed in the list display area 310 by the acceptance date range or term or to rearrange the urine samples displayed in the list display area 310 by term.

[0184] The measurement result display area 320 can switch the display content through the tabs 321. The tabs 321 are composed of seven items: comprehensive, qualitative, FCM, graph, photography, visual observation, and evaluation. Fig.16 , the display contents when the comprehensive tab 321 is selected by the input unit 31 are shown. At this time, in the measurement result display area 320, the qualitative result area 322 and the sediment result area 323 are arranged one above the other, and a graph area 324 is arranged below them.

[0185] The qualitative result area 322 is an area for displaying the qualitative measurement results of the second inspection device 60. The sediment result area 323 is an area for displaying the sediment measurement results of the inspection device 10. The graph area 324 is an area for displaying the measurement results of the inspection device 10 using various graphs such as scattergrams and histograms. Fig.12 Similarly, in the scatter plot, each component is plotted in a different color.

[0186] The measurement result display area 320 displays the measurement result of the urine sample selected in the list display area 310. The qualitative result area 322, the sediment result area 323, and the graph area 324 can scroll the display contents up and down by means of the scroll bar arranged at the right end.

[0187] If an evaluation of abnormal classification is received from the inspection device 10 regarding the urine sample selected in the list in the list display area 310, a mark indicating abnormal classification, such as an asterisk, is placed in the column of the result value of the abnormally classified formed component among the formed components displayed in the sediment result area 323. In this way, the user can know that the abnormal classification has occurred in the formed component without referring to the evaluation item 318 in the list display area 310.

[0188] The button area 330 includes operation buttons 331 to 335. The operation button 331 is a button used for classifying cell images as described later. The operation button 332 is used to display the cell image of the urine sample selected in the list display area 310. The operation button 333 is used to save the classification result of the cell image and the evaluation described in the evaluation item 318 at any time. The operation button 334 is a button for moving the urine sample. When the user presses the up and down arrows of the operation button 334 through the input component 31, the urine sample selected in the list display area 310 is switched up and down, and the display content of the measurement result display area 320 is switched to the corresponding information of the newly selected urine sample. The operation button 35 is a button for closing the interface.

[0189] The user selects a urine sample from the list in the list display area 310 through the input unit 31 and presses the operation button 332, and the interface of the display unit 32 switches to Fig.17 The interface shown is referred to as the overview interface below.

[0190] About the overview interface, Fig.16 In the interface shown, the list display area 310 is replaced by a cell image display area 350. In the cell image display area 350, the cell images obtained by the camera 20 are distinguished and displayed according to certain indicators. Here, the cell images are distinguished into eight levels according to the size of the formed elements and displayed in the cell image display area 350. The indicators used to distinguish the cell images are not limited to the size, and may also be other parameters for a specific shape, etc.

[0191] The level area includes area 351, label 352 and operation button 353. Area 351 displays the cell image of the level. Label 352 displays a text string for identifying the level. Operation button 353 is operated to classify the cell image of the level into a specific type of shaped component. Cell images can also be classified by pressing the operation button 331 of the button area 330 through the input part 31. The user can classify the cell images from level 1 in sequence by operating the operation button 331 through the input part 31. The cell image classification operation performed by the user will be referred to later. Fig.25 Please explain.

[0192] The number of cell images that can be displayed in the area 351 is determined according to each level. For example, only four cell images can be displayed in the area 351 of level 4, and the fifth and subsequent cell images cannot be displayed. The following function can also be designed: when the user clicks the label 352 of each level through the input component 31, the display content of the cell image display area 350 is switched to the display content used to display all cell images included in the level. At this time, a scroll bar for scrolling the cell images is appropriately added to the cell image display area 350.

[0193] exist Fig.17 The overview interface shown, Fig.16 The operation button 333 in the interface is replaced by the operation button 336. The operation button 336 is used to switch the overview interface before the classification of the cell image and the overview interface after the classification of the cell image (classification result interface: refer to Fig.26 ).

[0194] Fig.17 In the overview interface shown, the urine sediment measurement result of the testing device 10 and the urine qualitative measurement result of the second testing device 60 are displayed side by side in the measurement result display area 320. The user can cross-check the two measurement results to understand the items that differ greatly between the two measurement results.

[0195] For example, if the result value of casts in the measurement results displayed in the sediment result area 323 is high, but the result value of protein in the measurement results displayed in the qualitative result area 322 is low, it means that casts may not be correctly measured in the inspection device 10. At this time, the user can carefully check the cell images of the level corresponding to the casts in the cell image display area 350 by visual observation, and more consciously confirm whether the urine sample contains casts. In this way, it is possible to more efficiently and accurately confirm whether the urine sample contains casts.

[0196] exist Fig.17 In the overview interface shown, the qualitative tab 321 is selected through the input component 31, and the measurement result display area 320 switches to Fig.18 The display content. Fig.18As shown in FIG. 1 , if the qualitative tab 321 is selected, only the qualitative result area 322 is set in the measurement result display area 320. The qualitative result area 322 displays the measurement item name and the result value item indicating the measurement result. The unit item displays the unit of the result value. Fig.18 The overview interface shown here allows users to evaluate cell images at each level based solely on qualitative measurement results.

[0197] exist Fig.18 In the overview interface shown, the FCM tab 321 is selected through the input component 31, and the measurement result display area 320 is switched to Fig.19 The display content. Fig.19 As shown, when the FCM tab 321 is selected, only the sediment result area 323 is set in the measurement result display area 320. The sediment result area 323 displays the measurement item name and the result value item indicating the measurement result. The unit item displays the unit of the result value. Fig.19 The overview screen shown allows users to evaluate cell images at each level based only on the sediment measurement results.

[0198] As mentioned above, the result value column of the abnormal shaped component is marked with a mark indicating abnormal classification, such as "*". Fig.19 The display content of the overview interface shown can also tell that a certain formed element has been classified abnormally. In this way, for example, the user can take countermeasures and more carefully examine the cell images of the corresponding level of the formed element with classification abnormality.

[0199] exist Fig.19 The overview interface is shown. By selecting the chart tab 321 through the input component 31, the measurement result display area 320 switches to Fig. 20 The display content. Fig. 20 As shown, when the chart tab 321 is selected, only the chart area 324 is set in the measurement result display area 320. In the chart area 324, the charts are distinguished and displayed according to each formed component. As described above, each formed component changes the color of the dot plot in the scatter plot. The user can grasp the measurement status of each formed component by referring to the chart area 324. When grasping the measurement results that need attention, the user can take corresponding countermeasures, such as more carefully checking the cell image of the level corresponding to the measurement result.

[0200] exist Fig. 20 The overview interface is shown. By selecting the shooting tab 321 through the input component 31, the measurement result display area 320 switches to Fig.21 The display content. Fig.21As shown, when the photographing tab 321 is selected, a photographed image area 325 a , an operation button 325 b , an image number 325 c , and a count result area 325 d are set in the measurement result display area 320 .

[0201] As described above, when photographing in the normal mode, 40 photographic images are acquired for one urine sample by changing the photographing position. When photographing in the detailed examination mode, 80 photographic images are acquired for one urine sample. One of the photographic images acquired in this way is displayed in the photographic image area 325a.

[0202] The photographing device 20 transmits the 40 photographed images taken in the normal mode or the 80 photographed images taken in the detailed examination mode, the cell images cut out from these photographed images, and the information indicating the cut out position of the cell images on the photographed images together with the sample number of the urine sample to the management device 30. The management device 30 enters the received information into the database. The management device 30 also enters the classification result of each cell image input by the user into the database in correspondence with the cell image through the classification operation described later.

[0203] The operation button 325b is used to move the captured image displayed in the captured image area 325a in the forward direction or the reverse direction. The uppermost and lowermost operation buttons 325b are used to display the first and last captured images, respectively. The middle two operation buttons 325b are used to move the captured images one by one. The second operation button 325b from the top and the second operation button 325b from the bottom are used to fast forward and fast rewind the captured images, respectively.

[0204] The denominator of image number 325c represents the Fig.16 The number of images captured by the urine sample selected in the list display area 310 is shown in FIG. 325. When shooting in the normal mode, the denominator of the image number 325c is the number of images captured in the normal mode, that is, 40. When shooting in the detailed inspection mode, the denominator of the image number 325c is the number of images captured in the detailed inspection mode, that is, 80. By referring to the denominator of the image number 325c, it can be known whether the shooting operation is performed in the normal mode or the detailed inspection mode.

[0205] The numerator of the image number 325c indicates the order of the captured images displayed in the captured image area 325a. When the first captured image captured for the urine sample is displayed in the captured image area 325a, the numerator of the image number 325c is 1. By operating the operation button 325b to move the captured image displayed in the captured image area 325a, the numerator of the image number 325c changes.

[0206] The user can grasp the status and tendency of the formed elements contained in the urine sample by operating the operation button 325b to move the captured image through the input part 31. Based on the information thus grasped, the user can more appropriately evaluate the cell image displayed in the cell image display area 350. For example, when formed elements such as casts or atypical cells that affect diagnosis are found in a series of captured images, corresponding countermeasures can be taken, that is, the cell images of the levels corresponding to these formed elements are carefully examined to confirm their status in more detail. In this way, the formed elements contained in the urine sample can be confirmed more efficiently and accurately.

[0207] exist Fig.21 In the overview interface, the number of cell images obtained for the urine sample is displayed in the counting result area 325d of the measurement result display area 320 at each level, and the total number of cell images obtained for the urine sample is displayed. With reference to these displayed contents, the user can grasp the general trend of the components contained in the urine sample. The user can efficiently and appropriately evaluate the captured images displayed in the captured image area 325a or the cell images of each level displayed in the cell image display area 350 based on the grasped trend.

[0208] The measurement result display area 320 includes two check boxes 325e and 325f. When the check box 325e is selected through the input component 31, the area of ​​the cut cell image in the captured image displayed in the captured image area 325a is marked with a frame. When the check box 325f is selected through the input component 31, a text column indicating the classification result of the cell image appears directly below the cell image cut area. This text column is displayed when the cell image has been classified. By displaying the box and text column in this way, the user can more smoothly confirm the cell image contained in the captured image. When there are many cell images contained in the captured image and it is difficult to see the cell image after the box and text column are displayed, the user can appropriately cancel the selection of the check boxes 325e and 325f through the input component 31. In this way, the user can well confirm the cell image contained in the captured image.

[0209] exist Fig.21 In the overview interface shown, the naked eye observation tab 321 is selected through the input component 31, and the measurement result display area 320 is switched to Fig. 22 The display content. Fig. 22 As shown in FIG. 3 , when the macroscopic observation tab 321 is selected, the macroscopic observation result area 326 is set in the measurement result display area 320. The macroscopic observation result area 326 displays the results of the macroscopic observation inspection using the microscope observation method. The macroscopic observation result area 326 displays the inspection item name and the result value item indicating the inspection result. The unit item displays the unit of the result value. Fig.21 The overview interface shown above allows users to further evaluate cell images at each level based on visual observation results.

[0210] exist Fig. 22 In the overview interface shown, by selecting the evaluation tab 321 through the input component 31, the measurement result display area 320 switches to Fig.23 The display content. Fig.23 As shown in FIG. 1 , when the evaluation tab 321 is selected, the evaluation column 327 is set in the measurement result display area 320. The user such as the testing technician can appropriately input the evaluation related to the urine sample in the evaluation column 327. That is, the management device 30 accepts the new evaluation input through the input unit 31 in the state where the evaluation column 327 is displayed in the measurement result display area 320. Fig.23 In this example, the character string “blood and urine sample” input by the user is displayed in the evaluation field 327 .

[0211] In addition, the evaluation column 327 also displays the evaluation received from the inspection device 10. For example, as described above, the tangible components classified abnormally by the inspection device 10 and the contents of the classified abnormality are displayed in the evaluation column 327. For example, a string of characters indicating the contents of the classified abnormality is displayed in the evaluation column 327.

[0212] exist Fig.23 The overview interface allows the user to efficiently and appropriately evaluate the cell image according to the evaluation content displayed in the evaluation column 327.

[0213] For example, when the evaluation column 327 includes the display content "RBC / X'TAL classification abnormality", the user can understand that there is an abnormality in the classification of red blood cells and crystals in the inspection device 10. At this time, the user carefully checks the cell images corresponding to the level of red blood cells and crystals in the cell image display area 350 by naked eye observation, and confirms these captured images with particular awareness. In this way, red blood cells and crystals can be classified efficiently and accurately, and when the cell images of these levels contain cell images of other cells such as atypical cells, their existence can be smoothly confirmed. In addition, the user can add evaluations to the evaluation column 327 at will. For example, the user can add items determined by observing the overview interface to the evaluation column 327 at any time through the input component 31. This can make subsequent diagnosis smoother.

[0214] like Figure 17 to Figure 23 As shown, the overview interface includes: a cell image display area 350 for displaying the cell image of the selected urine sample, and a measurement result display area 320. The cell image display area 350 displays the cell image obtained by the photographing device 20 in a certain size. The measurement result display area 320 displays several types of information such as the sediment measurement result of the inspection device 10 and the qualitative measurement result of the second inspection device 60, and the information can be switched with the operation of the tab 321.

[0215] Thus, in the overview interface, one interface includes the cell image display area 350 and the measurement result display area 320. Thus, by switching the display content of the measurement result display area 320, the user can smoothly grasp various information that should be paid attention to in the cell image evaluation, and appropriately and efficiently evaluate the cell image in the cell image display area 350 based on the grasped information. The user can grasp various viewpoints with reference to the measurement result display area 320 and evaluate and analyze the cell image accordingly. In this way, the user can more efficiently and accurately judge the condition that is difficult to make a correct diagnosis from the measurement results of the inspection device 10 and the second inspection device 60.

[0216] Generally speaking, when the formed components in urine samples are used as the analysis object, urine has its own unique conditions, such as a wide variety of formed components that may appear, and the number of formed components varies greatly when they appear, and the degree of damage is different. The morphology of the formed components varies greatly, and factors such as bacterial proliferation, the progress of red blood cell hemolysis and crystal precipitation will cause the morphology and number of the formed components to change easily with the time elapsed from collection. Therefore, the measurement results obtained by the inspection device 10 are not easy to classify and analyze the formed components.

[0217] In this regard, in the third embodiment, Figure 17 to Figure 23 As shown, the cell image of the urine sample is displayed together with the urine sediment measurement result of the inspection device 10 in one interface, and this interface also includes the urine qualitative measurement result of the second inspection device 60. The measurement result display area 320 displays several types of information such as the measurement result of the inspection device 10 and the measurement result of the second inspection device 60, and can be switched at any time with the operation of the tab 321. Therefore, the user can evaluate and analyze the cell image from multiple perspectives according to the information displayed in the measurement result display area 320. In addition, the formed components unique to urine that may have various forms can be properly evaluated. Since the cell image and the measurement results are displayed in the same interface, the user can easily compare and contrast the two. In addition, the evaluation of the cell image can be performed more smoothly and efficiently.

[0218] In addition, the tab 321 in the measurement result display area 320 is not only Figure 17 to Figure 23 The overview interface shown is operated. Fig.16 The overview display interface can also be operated. In the overview display interface, the comprehensive, qualitative, FCM, chart, photography, visual observation or evaluation tab 321 can be operated by the input component 31. Fig.16 The display content of the measurement result display area 320 in the interface shown will switch to Figure 17 to Figure 23 For example, in Fig.16 The interface shown in FIG. 31 displays the evaluation tab 321 by operating the evaluation tab 321 through the input component 31. Fig.24 interface.

[0219] exist Figure 17 to Figure 23 In the overview interface shown, the user can classify the cell images of the target level displayed in the cell image display area 350 .

[0220] For example, in the overview interface where the capture tab 321 is selected, if the level 4 operation button 353 in the cell image display area 350 is pressed through the input component 31, the display Fig.25 This interface is referred to as the classification operation interface below.

[0221] like Fig.25 As shown, the classification operation interface includes, in addition to the measurement result display area 320, a classification object display area 361, a classification result display area 362, a sample ID display area 363, a level display area 364, a capacity display area 365, a large classification selection area 366, and a small classification selection area 367. Operation buttons 337 to 339 are added to the button area 330.

[0222] Operation buttons 337 to 339 are used to make classification operations easier. Operation button 337 is a button for declassifying all particles contained in the classification target level and restoring them to an unclassified state. Operation button 338 is a button for declassifying classified cell images and restoring them to an unclassified state. Operation button 339 is a button for classifying all unclassified cell images contained in the classification target level into the currently selected major and minor categories.

[0223] The cell images of the level selected as the classification target are displayed in the classification target display area 361. If the number of cell images of the selected level is too large to be displayed in the classification target display area 361, a scroll bar is added to the right end of the classification target display area 361.

[0224] The counting result of each tangible component after classification is displayed in the classification result display area 362. The classification result display area 362 includes an item indicating the type of tangible component and a result value item indicating the counting result thereof. The counting result of each tangible component after classification is displayed in the result value item. The unit item displays the unit of the result value.

[0225] Each time a cell image is classified, the result value item in the classification result display area 362 is updated. More specifically, as described later, when the user operates the selection button in the large classification selection area 366 and the selection button in the small classification selection area 367 through the input unit 31 and then operates the cell image to be classified, the classification of the cell image is determined. As the classification is determined, the result value item in the classification result display area 362 is updated.

[0226] The identification number of the urine sample is displayed in the sample ID display area 363. The level of the selected classification object is displayed in the level display area 364. The number of cell images of the selected classification object level corresponding to each 1µL is displayed in the volume display area 365. In the normal mode, the total volume of the urine sample corresponding to all the captured images is about 1µL, so the number of cell images of the selected classification object level is displayed in the volume display area 365. On the other hand, in the detailed inspection mode, the total volume of the urine sample corresponding to all the captured images is about 2µL, so the number of cell images of the selected classification object level divided by 2 is displayed in the volume display area 365.

[0227] The large classification selection area 366 includes several selection buttons. These selection buttons correspond to the classification candidates of the cell image respectively. These selection buttons are marked with marks indicating the classification candidates, such as "Casts", "Bacteria", "Crystal" and other marks indicating the types of formed components. The large classification selection area 366 also includes a selection button selected when the cell image cannot be classified into any type of formed component. This selection button is marked with "other" or "other2" and the like. The right end of the large classification selection area 366 also includes a change button for changing the selection button group. By pressing this change button through the input component 31, the combination of the selection button group in the large classification selection area 366 is changed to a combination of other formed components.

[0228] The sub-classification selection area 367 includes several selection buttons for further sub-classifying the formed elements selected in the large classification selection area 366. These selection buttons correspond to the sub-classification candidates of the cell image, respectively. These selection buttons are marked with marks indicating the sub-classification candidates, such as: "Caoxm" (oxalic acid ca), "UA X'TAL" (uric acid crystals), "CaPhX'TAL" (phosphate ca), "Ammmoni" (phosphate AmMg, uric acid Am) and other sub-classification contents. The button at the left end of the sub-classification selection area 367 is the selection button selected when sub-classification is not possible. The right end of the sub-classification selection area 367 also includes a change button for changing the selection button group. By pressing this change button through the input component 31, the combination of the selection button group of the sub-classification selection area 367 is changed to a combination of other sub-classifications.

[0229] In the classification object display area 361, each cell image is marked according to the classification situation. For example, the cell image classified as a formed element is marked with an orange frame, and the unknown cell image that cannot be classified as any formed element is marked with a blue frame. The unclassified cell image is not marked with a frame, and the cell image selected as the classification object is marked with a yellow frame.

[0230] The marking method on the cell image is not limited to the above-mentioned method of changing the frame color, and any method can be used as long as the classification of the cell image can be grasped. Fig.25 In the example, for convenience, the classification of cell images is indicated by the thickness of the frame and the type of frame line. A thick frame indicates a cell image that has been selected as a classification object, and a solid line frame thinner than the thick frame indicates a cell image that has been classified as a formed element. A dotted line frame indicates an unknown cell image that cannot be classified as any formed element. There is no frame on an unclassified cell image.

[0231] exist Fig.25 In the classification operation interface shown in FIG. 3 , the user selects a cell image displayed in the classification object display area 361 by clicking on the input unit 31, and the captured image used to cut out the cell image is displayed in the captured image area 325a of the measurement result display area 320. That is, the captured image including the selected cell image and its surroundings is displayed in the captured image area 325a. At this time, if the check box 325e of the measurement result display area 320 is checked, Fig.25 As shown, a region corresponding to the selected cell image in the captured image is framed. This frame is the same as the frame marked on the selected cell image in the classification target display region 361. By marking the captured image displayed in the captured image region 325a with a frame, the cell image selected in the classification target display region 361 can be identified in the captured image. Therefore, the user can easily grasp the region of the classification target cell image in the captured image.

[0232] In addition, when the captured image also includes other cell images, the corresponding areas of the other cell images are also marked with frames. The frames of the other cell images are also the same as the frames marked with the other cell images in the classification object display area 361. Therefore, the user can clearly distinguish and grasp the area of ​​the classification object cell image and the area of ​​the other cell images on the captured image displayed in the captured image area 325a.

[0233] If the check box 325f of the measurement result display area 320 is checked, Fig.25 As shown, the content for indicating the classification of the cell image corresponding to the frame is displayed below the frame in the captured image of the captured image area 325a. The classification corresponding to the currently selected selection button is marked in the large classification selection area 366 on the corresponding frame of the classified cell image.

[0234] In this way, the captured image including the classification target cell image is displayed in the captured image area 325a, and the user can understand the surrounding situation of the classification target cell image in the urine sample. In this way, the user can smoothly and efficiently classify the cell image.

[0235] Some formed elements included in urine samples have a tendency to exist close to each other. For example, when a urine sample contains crystals, other crystals often exist around one crystal. Therefore, in the captured image displayed in the captured image area 325a, if there are other formed element cell images around the classification target cell image, sometimes it is possible to smoothly determine whether the classification target cell image belongs to the same type as the other formed elements by comparing the cell images of the other formed elements with the classification target cell image.

[0236] For example, in some cases, when the resolution of the classification target cell image is low and it is difficult to accurately determine that the formed element in the cell image is a crystal, if there are other crystal cell images with high resolution around it, it can be determined that the formed element on the classification target cell image is a crystal by comparing with the other crystal cell images. Therefore, since the captured image containing the classification target cell image is displayed in the captured image area 325a, the user can smoothly and efficiently classify the cell image.

[0237] exist Fig.25 In the classification operation interface, the captured image displayed in the captured image area 325a is not necessarily one of the 40 or 80 captured images acquired by the photographing device 20. For example, an image with a certain range centered on the classified cell image can be generated based on the captured image of the classified cell image cut out and the captured images before and after it from the 40 or 80 captured images, and the generated image can be displayed in the captured image area 325a. In this way, even if there is a cell image at the edge of the captured image acquired by the photographing device 20, the cell image and its surrounding parts can be well displayed in the captured image area 325a.

[0238] The user selects a cell image displayed in the classification object display area 361 as a classification object and observes the cell image. Through observation, the user determines the major classification of the cell image, selects and presses the corresponding selection button of the determined major classification from the major classification selection area 366 through the input component 31. Then, the user determines the minor classification of the cell image, selects and presses the selection button corresponding to the determined minor classification from the minor classification selection area 367 through the input component 31. The user then presses the cell image selected as the classification object through the input component 31. Thus, the classification of the cell image is determined. Then, the result value of the classification result display area 362 is updated.

[0239] After the cell images are classified in this way, if there are still unclassified cell images, the user performs the same operation as above to classify the unclassified cell images. After the classification of all the captured images displayed in the captured image area 325a is completed, a certain operation is performed to enter the classification results into the database.

[0240] For example, when the user operates the operation button 334 through the input component 31 to change the displayed urine sample, a dialog box appears to remind the user to save the classification result. By pressing the save button contained in this dialog box through the input component 31, the classification result is entered into the database. Fig.25 Return to the classification operation interface Fig.16 After the overview interface is displayed, the operation button 333 is pressed through the input component 31, and the classification result is entered into the database. The operation used to save the classification result can also be other operations.

[0241] like Fig.25 As shown, the classification operation interface includes: a classification object display area 361 for displaying the cell images contained in the level of the existing classification indication input, a measurement result display area 320, and also includes a classification operation area for inputting the type of formed elements shown in the cell image displayed in the classification object display area 361 through the input component 31, namely a large classification selection area 366 and a small classification selection area 367. Therefore, the user can correctly evaluate the cell image displayed in the classification object display area 361 based on the various information mastered by the reference measurement result display area 320, and can classify the cell image efficiently and appropriately. Moreover, the cell image and the measurement result are displayed on the same interface, so the user can easily compare and contrast the two. In this way, the evaluation and classification of the cell image can be carried out smoothly and efficiently.

[0242] The classification operation interface includes a classification result display area 362 for displaying the classification result in addition to the classification object display area 361 and the measurement result display area 320. In this way, the user can confirm the count value of each material component while performing classification. Therefore, the user can more quickly and smoothly grasp the diagnosis result of the disease.

[0243] exist Fig.25 The classification operation interface shown in FIG. 1 is switched to the classification operation interface by pressing the operation button 335 through the input component 31. Fig.26 The classification result interface shown. This interface includes a classification image display area 371 and a classification result display area 372. The classification image display area 371 distinguishes and displays the classification results. Fig.25 The cell image is displayed in the classification object display area 361. Fig.26 In the example of , the cell images are displayed as "Crystals" and "Unknown". Fig.25 The classification result display area of ​​​​the cell image also displays the classification results.

[0244] The captured images including the cell image selected in the classified image display area 371 are displayed in the captured image area 325a of the measurement result display area 320. When the selection of the cell image is changed in the classified image display area 371, the captured images displayed in the captured image area 325a are changed. In the classified image display area 371, a box indicating that the selected cell image is marked.

[0245] exist Fig.26 In the classification result interface of FIG. 31 , the user can also operate the tab 321 through the input component 31 and thereby Figure 17 to Figure 23 Similarly, the display content of the measurement result display area 320 is switched. Fig.26 The classification result interface is displayed, and the cell images are distinguished in the classification image display area 371 based on the classification result as an indicator. At this time, the user can also evaluate the cell images displayed in the classification image display area 371 from various perspectives based on various information obtained from the display content of the measurement result display area 320.

[0246] exist Fig.16 In the interface of Fig.26 The classification result interface is arranged in the same way. At this time, the classification image display area 371 distinguishes and displays the cell images according to all the classified formed elements. At this time, the user can operate the tab 321 through the input component 31 to Figure 17 to Figure 23 The display content of the measurement result display area 320 is similarly switched. Therefore, the user can evaluate the classified cell image displayed in the classification image display area 371 from various perspectives based on various information grasped from the display content of the measurement result display area 320.

[0247] <Implementation Method 4>

[0248] Compared with the third embodiment, in the fourth embodiment, the user can manually cut out the cell images and classify the cut out cell images in the management device 30 through the input unit 31. The differences from the third embodiment are described below.

[0249] In the fourth implementation mode, Fig.21 The overview interface shown is Fig. 27 Specifically, in Fig.16 After selecting a urine sample in the list display area 310 through the input component 31, pressing the operation button 332, and then selecting the shooting tab 321, the interface of the display component 32 is switched to Fig. 27 The overview interface is shown. Fig. 27 The overview interface shown is similar to Fig.21The overview interface shown has an additional area "Level M" corresponding to manually cut cell images in the cell image display area 350. The Level M area also includes an area 351, a label 352, and an operation button 353, similar to the Level 1 to Level 8 areas.

[0250] The user needs to perform the following operations to manually cut the cell image. First, the user operates the operation button 325b through the input component 31 to display the captured image where the cell to be cut is located in the captured image area 325a. Then, the user sets the area to be cut on the captured image. For example, the user specifies two opposite vertices of a rectangle through the input component 31 or drags between two opposite vertices to set the area corresponding to the cell.

[0251] exist Fig. 27 In the overview interface shown, after setting the area on the captured image of the captured image area 325a, as shown in FIG. Fig.28 As shown, a dialog box 510 pops up. The dialog box 510 has an area 511, a check box 512, a cut button 513, and a close button 514. The area 511 enlarges and displays the image in the area set on the captured image. The check box 512 is used to set whether to display the scale of the image displayed in the area 511.

[0252] When the user presses the cut button 513 through the input unit 31, the control unit 33 of the management device 30 acquires the image within the area set on the captured image of the captured image area 325a. Specifically, the control unit 33 enters the image within the area set on the captured image of the captured image area 325a into the database constructed in the storage unit 34 as an image corresponding to level M. Then, the control unit 33 Fig.29 As shown, the area 351 corresponding to the level M displays the image within the area set on the captured image of the captured image area 325a as a cut-out image, and closes the dialog box 510. When the user presses the close button 514 through the input unit 31, the control unit 33 cancels the area set on the captured image of the captured image area 325a and closes the dialog box 510.

[0253] After setting the area on the captured image of the captured image area 325 a , the control unit 33 may acquire the image within the captured image area as the cell image without displaying the dialog box 510 .

[0254] Here, if Fig. 27 As shown in the captured image area 325a of FIG. 1 , when the brightness difference between the cell and the background area in the captured image is small and the cell recognition is low, the camera 20 sometimes cannot correctly obtain the cell image from the captured image. However, by manually obtaining the cell image from the captured image as described above, the cell image that the camera 20 failed to obtain can be re-obtained.

[0255] Secondly, in Fig.29 The user can classify the level M cell images in the same way as the level 1 to 8 cell images. The user presses the level M operation button 353 in the cell image display area 350 through the input component 31, and the display Fig.30 The classification operation interface is shown.

[0256] and Fig.25 Compared with the classification operation interface shown in Fig.30 In the classification operation interface shown, "Class M" is displayed in the level display area 364, and the cell image manually acquired as above is displayed in the classification object display area 361. As in the third embodiment, for example, a mark corresponding to the classification situation is marked on the cell image in the classification object display area 361, such as a frame of a certain color. The user double-clicks the cell image in the classification object display area 361 through the input component 31, so that the enlarged cell image can pop up.

[0257] In addition, users Fig.30 In the classification operation interface shown, it is also possible to set a region and cut out a cell image from the captured image displayed in the captured image region 325 a as described above.

[0258] In addition, Fig.30 In the classification operation interface shown, Fig.25 Compared with the classification operation interface shown in the figure, a classification result display area 521 is added and replaced by the classification result display area 362. Fig.25 Compared with the classification result display area 362, the items indicating the UF value and the items indicating the count value are added. As described above, the inspection device 10 performs measurements on several measurement items and obtains the urine sediment measurement results. The items indicating the UF value display the measurement results obtained by the inspection device 10. The items indicating the count value display the count value of the formed components calculated by classifying the cell images. Before starting the cell image classification, the UF value is used as the final result value for all the formed components. Therefore, Fig.30 As shown, “U” is displayed for all shaped components at the right end of the classification result display area 521 .

[0259] When the user selects a cell image in the classification target display area 361 through the input unit 31, the classification of the cell image begins in the same manner as in the third embodiment. That is, the user determines the major classification and minor classification of the selected cell image, and selects and presses the selection button corresponding to the determined major classification and minor classification from the major classification selection area 366 and the minor classification selection area 367 through the input unit 31. The classification of the cell image is determined, and the display content of the classification result display area 521 is updated according to the determined classification.

[0260] For example, Fig.31 As shown in the figure, after selecting "Casts" (casts) and "Hy.Casts" (transparent casts) as the major and minor categories of the selected cell image, the corresponding count value of "Hy.Casts" in the classification result display area 521 is updated to "1.0", for example. As the count value is updated to "1.0", the result value of "Hy.Casts" is updated from "0.00" to "1.00". In addition, "P" indicating that the count value is used is displayed at the right end of the classification result display area 521, thereby replacing "U" indicating that the UF value is used.

[0261] In addition, when a cell image of level M is classified as a certain formed element, the count value of this formed element is updated to a value increased by 1 / µL for the normal mode and updated to a value increased by 0.5 / µL for the detailed inspection mode.

[0262] exist Fig.31 In the example of , the count values ​​of the items for which the inspection device 10 failed to obtain measurement results, i.e., "RBCCasts" (red blood cell casts), "WBCCasts" (white blood cell casts), and "s / cCasts" (salt crystal casts) whose UF values ​​are empty, are also updated. Moreover, as these count values ​​are updated, the result values ​​are also updated, and "P" is displayed at the right end of the classification result display area 521. In addition, as the count values ​​of "Hy.Casts", "RBCCasts", "WBCCasts", and "s / cCasts" are updated, the count value of "Casts" is also updated to "5.0", and "P" is displayed at the right end of the classification result display area 521, and the result value is updated to "6.80".

[0263] At this point, the classification of the cell images of level M is completed, and after a certain operation related to saving is performed, the classification results obtained based on the cell images and the result values ​​of the classification result display area 521 are entered into the database. In addition, after the cell images of levels 1 to 8 are classified through the input component 31, the content of the classification result display area 521 is updated in the same way as the cell images of level M, and the classification results obtained based on the cell images and the result values ​​of the classification result display area 521 are entered into the database.

[0264] like Fig.31 As shown in the figure, when the cell image is classified as "Hy.Casts" by the input unit 31, although the UF value of "Hy.Casts" obtained by the inspection device 10 is "0.00", the count value of "Hy.Casts" calculated after the cell image is classified by the input unit 31 is adopted as the result value. That is, after the cell image is classified by the input unit 31, the count value is reflected in the result value regardless of the UF value.

[0265] In other words, when the type of the formed component is not received through the input unit 31 regarding the type of the formed component classified by the inspection device 10, the control unit 33 displays the UF value obtained by the inspection device 10 as the result value on the interface. When the type of the formed component is received through the input unit 31 regarding the type of the formed component classified by the inspection device 10, the control unit 33 displays the count value calculated based on the type of the formed component received through the input unit 31 as the result value on the interface. For example, Fig.31 In this example, for "N-hyal.Casts" (non-transparent casts) whose UF values ​​have been acquired, the cell images have not been classified and the count values ​​have not been acquired. Therefore, for "N-hyal.Casts", the UF value "1.80" is displayed as the result value. On the other hand, for "Hy.Casts" (transparent casts) whose UF values ​​have been acquired, the cell images have been classified and the count values ​​have been acquired. Therefore, for "Hy.Casts", the count value "1.0" acquired by classifying the cell images is displayed as the result value.

[0266] Thus, when the reliability of the measurement result obtained by the inspection device 10 is considered to be low, the reliability of the result value can be improved by classifying the cell image through the input unit 31.

[0267] For example, Fig.16 As shown, when "RBC / X`TAL classification is abnormal" is displayed in the evaluation item 318 for the urine sample, the user carefully observes the red blood cells and crystals on the captured image. At this time, if the cell images for the red blood cells and crystals are not correctly generated, the user manually cuts the corresponding cell images of the red blood cells and crystals, and classifies the cut cell images. In this way, for the items corresponding to the red blood cells and crystals in the classification result display area 521, even if the UF value, which may have a lower reliability, is used as the result value, the count value based on the cell image classification will still be adopted as the result value. In this way, the reliability of the result value can be improved. In the case where it is believed that the measurement result obtained by the inspection device 10 is highly reliable, the UF value can be used as the result value instead of the count value based on the cell image classification.

[0268] Manually cropping cell images and classifying the cropped cell images is also useful when a certain disease is suspected.

[0269] For example, when urine protein is detected by the second inspection device 60, chronic nephritis, glomerulonephritis, pyelonephritis, etc. will be suspected. At this time, in order to speculate the degree and location of the disease, the user will carefully observe the casts on the captured image. If pathological casts (cellular casts) other than transparent casts such as red blood cell casts and white blood cell casts formed by red blood cells and white blood cells leaked from the glomerulus and protein components forming a columnar shape in the renal tubules appear in the captured image, it can be judged that the possibility of glomerulonephritis is high. In the case where the cell image of the pathological cast cannot be correctly generated, the user manually cuts the cell image corresponding to the pathological cast and classifies the cut cell image. In this way, if Fig.31 As shown in the figure, the result values ​​of "RBC Casts" and "WBC Casts" with empty UF values ​​will also be displayed. In this way, when a certain disease is suspected, the cell image can also be manually cut appropriately and the necessary result values ​​can be obtained, so the disease can be accurately judged.

[0270] exist Fig.31 The classification operation interface shown in the figure, after the user presses the operation button 335 through the input component 31, the interface switches to Fig.32 The classification result interface is shown. Fig.26 Compared with the classification result interface shown in Fig.32 The classification result interface shown in FIG. 1 has a classification result display area 531 added thereto and replaced with the classification result display area 372. The classification result display area 531 has a similar structure to the classification result display area 372. Fig.31 The classification result display area 521 is the same as shown. The classification image display area 371 displays both the cell images cut by the shooting device 20 and the cell images cut manually. The manually cut cell images are marked with a mark to indicate manual cutting. For example, a frame of a certain color is marked on the manually cut cell images.

[0271] In this way, in the fourth embodiment, the classification results of the cell images can be displayed at a glance in the same manner as in the third embodiment. When the count value based on the classification of the cell images is displayed as the result value, "P" is displayed at the right end of the classification result display area 521, 531. In this way, the user can clearly understand that the displayed result value is based on the classification of the cell images.

[0272] In the fourth embodiment, the user can display the designated value of the simple input at the result value of the classification result display area 521, 531. The simple input performed on the classification result display area 521, 531 is the same, and for convenience, the following description will only be made on the case of simple input performed on the classification result display area 521.

[0273] Fig.33 It is the classification operation interface corresponding to level 4, which is Fig.30When the user wants to use the specified value of the simple input as the result value, he double-clicks the tangible component item that he wants to change in the classification result display area 521 through the input component 31. In this way, the tangible component to be changed is determined, such as Fig.34 As shown, a dialog box 540 for changing the result value pops up. Fig.34 In this example, the row corresponding to "Bacteria" is double-clicked, and a dialog box 540 for changing the result value of "Bacteria" is displayed.

[0274] like Fig.34 As shown, the dialog box 540 has 14 buttons 541, a text box 542, a direct value input button 543, and a close button 544. The 14 buttons 541 include: buttons 1 to 8 for inputting semi-quantitative values, and buttons 9 to 14 for inputting quantitative values. Fig.34 In the example shown, the number of HPF (High Power Field) can be input as a semi-quantitative value, and the degree of existence of a formed element can be input as a quantitative value. Depending on the value that you want to input easily, more buttons 541 can be configured in the dialog box 540, such as the number of LPF (Low Power Field) and WF (Whole Field).

[0275] For example, if the user presses button 541 marked with "12" through input component 31, the result value of the changed object becomes "(2+)". If the user enters a value in text box 542 through input component 31 and presses direct value input button 543, the result value of the changed object becomes the value of text box 542. After the result value is changed through simple input using dialog box 540, "D" indicating simple input is displayed at the right end of the change object row. And the unit of classification result display area 521 becomes the unit of simple input value. Fig.34 In the example shown, the result value of “Bacteria” is changed to “(2+)”. The result value after the change is a quantitative value, so the unit of “Bacteria” is changed to zero. If the user wants to close the dialog box 540 , he presses the close button 544 through the input unit 31 .

[0276] In this way, the user does not need to follow the above-mentioned steps of cutting each cell image and classifying it, and can directly change the result value of the classification result display area 521, 531. This can improve the inspection efficiency. In addition, when a simple input is performed, "D" is displayed at the right end of the classification result display area 521, 531, so that the user can clearly understand at a glance that the displayed result value is a simple input.

[0277] After the simple input is performed, the count value of the simple input is reflected in the result value regardless of the UF value. In other words, regarding the type of formed component classified by the inspection device 10, if the count value of the formed component is not received through the input component 31, the control component 33 displays the UF value obtained by the inspection device 10 as the result value on the interface. Regarding the type of formed component classified by the inspection device 10, when the count value of the formed component is received through the input component 31, the control component 33 displays the count value of the formed component received through the input component 31 as the result value on the interface. In this way, when the reliability of the measurement result obtained by the inspection device 10 is considered to be low, the reliability of the result value can be improved by changing the result value through simple input.

[0278] <Implementation Method Five>

[0279] Embodiment 5 has a different interface design from embodiment 3. This embodiment can manually cut and classify cell images like embodiment 4. In the following figures, for convenience, parts having the same functions as embodiments 3 and 4 are marked with the same numbers as embodiments 3 and 4.

[0280] The user performs the following operations to manually crop and classify cell images. First, the user Fig.17 The same overview interface is used to press the operation button 353 through the input component 31, and then press the capture image tab 321 through the input component 31. Fig.35 The classification operation interface of the display level is shown.

[0281] Fig.35 The classification operation interface shown is the same as Fig.25 The classification operation interface shown in the figure corresponds to the following. Fig.35 In the example, the tab 321 is arranged at the bottom of the interface and is composed of items such as comprehensive display, captured images, re-examination results, and home page. Fig.35 In the figure, a large category selection area 366 and a small category selection area 367 are arranged at the bottom of the interface. Fig.35 The result items in the classification result display area 362 are shown as Fig.25 The result value item of the classification result display area 362 is the same as that of the classification result display area 362, and the result value is also displayed.

[0282] Next, the user operates the operation button 325b through the input unit 31 to display the captured image of the cell to be cut in the captured image area 325a. Then, after the user determines the major classification and minor classification of the cell, the user operates the selection button of the major classification selection area 366 and the selection button of the minor classification selection area 367 through the input unit 31 to select the classification. In this way, the control unit 33 of the management device 30 receives the classification of the cell to be cut. Fig.35The exemplary state is that the cells to be cut appear in the captured image area 325a, and the selection button corresponding to "Casts" (casts) in the large classification selection area 366 and the selection button corresponding to "Hy.Casts" (transparent casts) in the small classification selection area 367 are pressed.

[0283] Then, the user sets the area to be cut out on the captured image through the input unit 31 in the same manner as in the fourth embodiment. After setting the area on the captured image of the captured image area 325a, as shown in FIG. Fig.35 As shown, a dialog box 610 pops up. The dialog box 610 has an area 611, a save button 612, and a close button 613. The area 611 enlarges and displays the image within the area set on the captured image. The area 611 is near the scale of the image.

[0284] When the user presses the save button 612 through the input unit 31, the control unit 33 of the management device 30 records the image in the area set on the captured image of the captured image area 325a as an image corresponding to the level M in the database constructed by the storage unit 34. In addition, the control unit 33 also records the cell classifications accepted by the large classification selection area 366 and the small classification selection area 367 into the database. Then, the control unit 33 closes the dialog box 610.

[0285] After the cell images are cut and classified, the control unit 33 updates the classification of the manually cut cells as in the fourth embodiment. Fig.35 The result value of the classification result display area 362 is shown. In addition, in the fifth embodiment, the manually cut cell image is internally entered into the database as level M, but the level M area is not displayed in the overview interface.

[0286] After the dialog box 610 is displayed, if the user does not want to enter the cut target cell image and the classification of the cell in the database, the user presses the close button 613 through the input unit 31. In this way, the control unit 33 abandons the area set on the captured image and the cell classification accepted through the large classification selection area 366 and the small classification selection area 367, and closes the dialog box 610.

[0287] exist Fig.35 The classification operation interface shown in the figure, after pressing the operation button 335 through the input component 31, the interface switches to Fig.36 The classification result interface is shown. Fig.36 The classification result interface shown is the same as Fig.26 The classification result interface shown in the figure corresponds to the one shown in the figure. Fig.36 In the classification image display area 371 shown, a mark is also added to the manually cut cell image to indicate manual cutting, for example, a frame of a certain color is added to the manually cut cell image.

[0288] In the fifth embodiment, as in the fourth embodiment, the user can update the result value of the classification result display area 362, 372 to a specified value by simple input. Specifically, the user double-clicks the tangible component item that he wants to change in the classification result display area 362, 372 through the input component 31. Fig.37 As shown in (a), a dialog box 620 for changing the result value pops up.

[0289] like Fig.37 As shown in (a), the dialog box 620 has 16 buttons 621, 2 display change buttons 622, a clear button 623, and a cancel button 624. When the user presses the button 621 for inputting semi-quantitative values ​​and quantitative values ​​through the input component 31, the result value of the changed object is changed to the value corresponding to the pressed button 621. When the user presses the button 621 corresponding to direct input through the input component 31, a pop-up window appears. Fig.37 (b) shows a dialog box 630. After the user inputs a value in the text box 631 of the dialog box 630 through the input component 31 and presses the OK button 632, the result value of the changed object becomes the value of the text box 631, and the dialog box 630 is closed. Fig.37 In the dialog box 630 shown in (b), the cancel button 633 is pressed through the input unit 31.

[0290] To clear the result value to be changed, the user presses the clear button 623 in the dialog box 620 through the input unit 31. To switch the button 621 arranged in the dialog box 620 to a button 621 for inputting another value, the user presses the display change button 622 through the input unit 31.

[0291] <Verification of Implementation Methods 4 and 5>

[0292] The control unit 33 of the management device 30 can set verification, which is used to make the sediment measurement results of the inspection device 10, the qualitative measurement results of the second inspection device 60, the visual inspection results, and the classification results based on the cell image in a state that can be reported to the outside. To perform verification, the user operates a certain operation button in the button area 330 through the input unit 31 to display Fig.38 Verification dialog box 640 is shown.

[0293] like Fig.38 As shown, the verification dialog box 640 has areas 641 to 644, an OK button 645, and a cancel button 646. Areas 641 to 644 include check boxes for setting and canceling verification for qualitative measurement results, sediment measurement results, macroscopic inspection results, and results of classification based on cell images, respectively.

[0294] To verify and make the result reportable, the user selects the checkbox for setting verification in areas 641 to 644 through the input unit 31. To cancel verification, the user selects the checkbox for canceling verification in areas 641 to 644 through the input unit 31. Regarding areas 643 and 644, only the checkbox in one of the areas can be operated. In this way, only one of the visual observation result and the cell image classification result can be set or canceled.

[0295] When the user presses the OK button 645 through the input unit 31, the result of setting the verification checkbox being checked is verified, and the result of canceling the verification checkbox being checked is canceled. When the user presses the Cancel button 646 through the input unit 31, the state of the checkbox is abandoned and the verification dialog box 640 is closed.

[0296] After verifying the qualitative test results, sediment test results, and visual inspection results, Fig.18 The result values ​​shown in the qualitative result area 322 are shown. Fig.19 The result value shown in the sediment result area 323 is shown. Fig. 22 The result values ​​of the macroscopic observation result area 326 are verified respectively. After the result of classification based on the cell image is verified, the result values ​​displayed in the classification result display areas 362, 372, 521, and 531 are verified. Specifically, the control unit 33 of the management device 30 enters the contents indicating the setting and release of the verification into the database constructed in the storage unit 34 in correspondence with the result value.

[0297] The result value thus verified and set can be reported to a doctor or can be read by the doctor. For example, the control unit 33 transmits the verified result value to a host computer that can accept a reading request from other computers. Alternatively, the control unit 33 displays the verified result value on the display unit 32 in response to a reading request from a doctor or the like.

[0298] Number Description

[0299] 1 ... Urine analysis system

[0300] 10 …… Inspection device

[0301] 12 …… Detector

[0302] 101 …… Flow Chamber

[0303] 102 ... Light source components

[0304] 104~105 ... Light receiving component

[0305] 20 …… Camera

[0306] 21a ... Pipetting parts

[0307] 22 ... Shooting parts

[0308] 23 …… Control components

[0309] 221 ... Room 1

[0310] 222 ... Room 2

[0311] 30 …… Management Device

[0312] 31 ... Input components

[0313] 32 ... Display components

[0314] 33 …… Control components

[0315] 40 ... Transport device

[0316] 421 ... First delivery route

[0317] 422 ... Second delivery route

[0318] 60 ... Second inspection device

[0319] 320 ... Measurement result display area

[0320] 321 ... Tab

[0321] 322 ... Qualitative results area

[0322] 323 ... Sediment results area

[0323] 325a …… Image capture area

[0324] 327 ... Evaluation column

[0325] 350 …… Cell image display area

[0326] 361 ... Classification object display area

[0327] 362 ... Classification results display area

[0328] 366 ... Large category selection area

[0329] 367 ... Small category selection area

Claims

1. A method for displaying formed elements in a urine sample, comprising the following steps: Photograph several formed elements in urine samples; Displaying a plurality of images of the formed component for each level corresponding to the size of the formed component; Among the plurality of displayed formed component images, information for identifying the formed component images classified according to the types of the formed components is displayed.

2. The method for displaying formed elements in a urine sample according to claim 1, further comprising the following steps: Among the plurality of displayed shaped component images, information for identifying the shaped component images that cannot be classified into the types of shaped components is also displayed.

3. The method for displaying formed elements in a urine sample according to claim 1, further comprising the following steps: For at least one of the displayed shaped component images, a classification corresponding to the type of shaped component performed by a user is accepted.

4. The method for displaying formed elements in a urine sample according to claim 1, further comprising the following steps: photographing the urine sample to generate at least one photographed image, and extracting respective formed component images of the plurality of formed components from the at least one photographed image; In the step of displaying the plurality of formed component images, the plurality of formed component images and the captured image are displayed on the same interface.

5. The method for displaying formed elements in a urine sample according to claim 1, characterized in that: In the step of displaying the plurality of formed component images, the plurality of formed component images, a plurality of items representing the types of formed components, and count values ​​corresponding to the items are displayed on the same interface; The method further comprises the following steps: For at least one of the plurality of shaped component images displayed in the interface, after accepting the classification of the shaped component type by the user, the count value of the associated item is updated according to the accepted classification.

6. A method for displaying formed elements in a urine sample, comprising the following steps: photographing a urine sample containing a plurality of formed elements to generate at least one photographed image; extracting respective shaped component images of the plurality of shaped components from the at least one captured image; A plurality of shaped component images belonging to at least one of a plurality of levels corresponding to the size of the shaped component and the captured image are displayed on the same interface.

7. The method for displaying formed elements in a urine sample according to claim 6, further comprising the following steps: For at least one of the plurality of shaped component images displayed in the interface, a classification corresponding to the type of shaped component performed by a user is accepted.

8. The method for displaying formed elements in a urine sample according to claim 6, characterized in that: In the step of generating the at least one captured image, a plurality of regions of the urine sample that are different from each other are captured to generate a plurality of the captured images; The method further comprises the following steps: After at least one of the formed component images is selected from the plurality of formed component images displayed on the interface, the captured image from which the selected formed component image has been extracted is displayed on the interface.

9. The method for displaying formed elements in a urine sample according to claim 8, further comprising the following steps: The captured image displayed on the interface is changed according to the change in the selection of the shaped component image.

10. The method for displaying formed elements in a urine sample according to claim 6, further comprising the following steps: After at least one of the shaped component images is selected from the plurality of shaped component images displayed in the interface, the selected shaped component image is identifiably displayed in the captured image displayed in the interface.

11. The method for displaying formed elements in a urine sample according to claim 6, further comprising the following steps: The type of the corresponding shaped component is displayed near the shaped component image included in the captured image displayed in the interface.

12. The method for displaying formed elements in a urine sample according to claim 6, characterized in that: The interface displays the plurality of formed component images, the captured image, a plurality of items representing types of formed components, and count values ​​corresponding to each item; The method further comprises the following steps: For at least one of the plurality of shaped component images displayed in the interface, after accepting the classification of the shaped component type by the user, the count value of the associated item is updated according to the accepted classification.

13. A method for displaying formed elements in a urine sample, comprising the following steps: Photograph several formed elements in urine samples; Displaying on the same interface a plurality of images of formed components belonging to at least one of a plurality of levels corresponding to the size of the formed components, a plurality of items indicating the types of the formed components, and a count value corresponding to each item; For at least one of the plurality of shaped component images displayed in the interface, after accepting the classification of the shaped component type by the user, the count value of the associated item is updated according to the accepted classification.

14. The method for displaying formed elements in a urine sample according to claim 13, characterized in that: In the step of updating the count value, each time the classification according to the type of the tangible component by the user is accepted, the count value of the associated item is updated according to the classification.

15. The method for displaying formed elements in a urine sample according to claim 13, further comprising the following steps: photographing the urine sample to generate at least one photographed image, and extracting respective formed component images of the plurality of formed components from the at least one photographed image; The interface displays the plurality of formed component images, the plurality of items, count values ​​corresponding to the items, and the captured image.

16. The method for displaying formed elements in a urine sample according to any one of claims 1 to 15, further comprising the following steps: Determining the chemical components in the urine sample to obtain a qualitative result of the urine sample; in, The plurality of shaped component images and the qualitative results are displayed on the same interface.

17. The method for displaying formed elements in a urine sample according to any one of claims 1 to 15, characterized in that: In the step of photographing, the urine sample filled in the storage container is photographed.

18. The method for displaying formed elements in a urine sample according to any one of claims 1 to 15, characterized in that: The plurality of formed component images are displayed in an arranged manner according to their resolution.

19. A method for displaying formed elements in a urine sample, comprising the following steps: Determining the chemical components in the urine sample to obtain a qualitative result of the urine sample; photographing several formed elements in the urine sample; A plurality of shaped component images belonging to at least one of a plurality of levels corresponding to the size of the shaped component and the qualitative result are displayed on the same interface.

20. The method for displaying formed elements in a urine sample according to claim 19, characterized in that: For at least one of the plurality of shaped component images displayed in the interface, a classification corresponding to the type of shaped component performed by a user is accepted.

Images