Sample analyzer and sample analysis method

Abstract

To provide a sample analyzer that, when an abnormality occurs in an analysis result, can efficiently grasp the cause of the abnormality.SOLUTION: A sample analyzer 1 as an example of an embodiment comprises: an imaging unit 20 that picks up images of test papers 100; a control unit 50 that analyzes test paper images 300; a display unit 30 that displays a result of the analysis of the test paper images 300; and an input unit 30 for inputting a predetermined instruction. The control unit 50 causes the display unit 30 to display a plurality of test paper images 300 selected by the input unit 30.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a sample analyzer and a sample analysis method for analyzing components in a sample using a test paper. [Background technology]

[0002] Conventionally, there are known sample analyzers that analyze components contained in a sample based on a reaction that occurs when a test paper is brought into contact with the sample, such as urine or saliva (see, for example, Patent Document 1). Such sample analyzers are classified into semi-automatic and fully automatic. In the case of semi-automatic devices, an operator immerses a test paper in the sample and places the test paper on the placement section of the device. In the case of fully automatic devices, the test paper is automatically placed on the placement section, and the sample is then applied to the test paper. In either case, the test paper placed on the placement section is imaged, and the resulting image is analyzed to analyze the components contained in the sample. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2017-72567 A Summary of the Invention [Problem to be solved by the invention]

[0004] In sample analyzers, when an abnormality occurs in the analysis results, it is an important issue to be able to grasp the cause of the abnormality. The causes of abnormalities in the analysis results are diverse, including deterioration of the test paper or adhesion of dust to the test paper, differences between lots of test paper or quality control samples, testing techniques (variations in techniques) or device operation, and deterioration of the device over time, such as a decrease in the sensitivity of the detection unit, so it is not easy to grasp the cause of the abnormality efficiently. [Means for solving the problem]

[0005] The sample analysis device (1, 2) of the present invention comprises an imaging unit (20) that images a test strip (100), a control unit (50) that analyzes a test strip image (300) obtained by imaging, a display unit (30) that displays the analysis results of the test strip image (300), and an input unit (30) for inputting predetermined instructions, and is characterized in that the control unit (50) causes the display unit (30) to display a plurality of test strip images (300) selected by the input unit (30).

[0006] According to the above configuration, since a plurality of test strip images (300) can be displayed on the display unit (30), the plurality of test strip images (300) on which the analysis results are based can be easily compared. For example, if an abnormality occurs in the analysis result of a quality control sample, the test strip image (300) relating to the abnormal analysis result and the test strip image (300) relating to the normal analysis result can be compared on the same screen, which is helpful in identifying the cause of the abnormality.

[0007] The sample analysis method according to the present invention is characterized in that it comprises the steps of photographing a test strip (100), analyzing the obtained test strip image (300), storing the test strip image (300), selecting a plurality of specific images from the stored plurality of test strip images (300), and displaying the plurality of specific images on a display unit (30). Effect of the Invention

[0008] According to the sample analyzer of the present invention, when an abnormality occurs in the analysis results, it is possible to efficiently grasp the cause of the abnormality. [Brief description of the drawings]

[0009] [Figure 1] 1 is a diagram showing a schematic configuration of a sample analyzer according to an embodiment; [Diagram 2] FIG. 1 is a perspective view showing the appearance of a sample analyzer. [Diagram 3] FIG. 2 is a perspective view showing the internal structure of the sample analyzer. [Figure 4] FIG. 2 is a side view showing the internal structure of the sample analyzer. [Diagram 5] FIG. 2 is a perspective view of a test paper holder. [Figure 6] FIG. 2 is a perspective view showing an example of a test paper. [Figure 7] 1 is a block diagram showing the configuration of a sample analyzer. [Figure 8] 13 is a flowchart showing an example of a sample analysis process. [Figure 9] FIG. 13 is a diagram showing an example of a display screen of a sample analysis result. [Figure 10] FIG. 13 is a diagram showing an example of a measurement screen. [Figure 11] FIG. 13 is a diagram showing an example of a selection screen for selecting a test strip image to be displayed on the screen. [Figure 12] FIG. 13 is a diagram showing an example of an enlarged display screen of a test paper image. [Figure 13] 10 is a flowchart showing an example of a display process of a test strip image. [Figure 14] FIG. 13 illustrates an example of an error display screen. [Figure 15] 13 is an example of a mark indicating a location where an abnormality has occurred. [Figure 16] 13 is a flowchart showing an example of an abnormality display process. [Figure 17] 13A and 13B are diagrams illustrating a function for detecting dirt on a test paper holder in a sample analyzer according to an embodiment of the present invention. [Figure 18] 13A and 13B are diagrams illustrating a function for detecting dirt on a test paper holder in a sample analyzer according to an embodiment of the present invention. [Figure 19] 13 is a diagram showing an example of a display screen for information regarding a test paper holder cleaning mode and stains on the holder. FIG. [Figure 20] FIG. 13 is a diagram showing an example of a judgment screen for determining the cleaning state of the test paper holder. [Figure 21] 13 is a flowchart showing an example of an automatic detection and cleaning process for a test paper holder. [Figure 22] 10 is a flowchart showing an example of a process for detecting stains on a test paper holder. [Diagram 23] FIG. 2 is a diagram showing a schematic configuration of a sample analyzer according to another embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Hereinafter, with reference to the drawings, an embodiment of a sample analysis device and a sample analysis method according to the present invention will be described in detail. The embodiment described below is merely an example, and the present invention is not limited to the following embodiment. Furthermore, the present invention includes forms that are formed by selectively combining the respective components of the multiple embodiments and modified examples described below.

[0011] FIG. 1 is a schematic diagram for explaining the schematic configuration of a sample analyzer 1 according to an embodiment of the present invention, and an outline of a sample analysis method. As shown in FIG. 1, the sample analyzer 1 is an apparatus for analyzing a sample 110 by capturing an image of a test paper 100 immersed in the sample 110, and includes a transport unit 10 and an imaging unit 20. The transport unit 10 has a test paper holder 11 as a placement unit on which the test paper 100 is placed by an operator. The transport unit 10 is provided with a plurality of test paper holders 11. The transport unit 10 moves the test paper holder 11 to transport the test paper 100 to an imaging position P3, and the imaging unit 20 captures an image of the test paper 100 at the imaging position P3. The imaging unit 20 includes a light source 21 and an imaging element 22.

[0012] The sample analyzer 1 further includes a test paper detection unit 40 that detects the test paper 100 placed on the test paper holder 11, and a collection unit 80 that collects the test paper 100 after its image has been captured. In the sample analyzer 1, a placement position P1 is defined where the operator places the test paper 100 on the test paper holder 11. A detection position P2 of the test paper 100 by the test paper detection unit 40 is set between the placement position P1 and the imaging position P3. In the sample analyzer 1, the test paper 100 is placed on the test paper holder 11 at the placement position P1, and is transported to the imaging position P3 via the detection position P2. The test paper 100 is imaged at the imaging position P3, and then collected by the collection unit 80.

[0013] The sample 110 analyzed by the sample analyzer 1 is a liquid in which the test strip 100 can be immersed, and is a liquid sample collected from a human, such as saliva, body cavity fluid, or urine. In the following description, the sample 110 is urine, and the sample analyzer 1 is used for a urine test. The sample 110 includes a test specimen and a quality control specimen. In the sample analyzer 1, an operator immerses the test strip 100 in urine, which is the sample 110, wipes off the urine adhering to the test strip 100, and then places the test strip 100 on the test strip holder 11 at the placement position P1. Specifically, the operator wipes off excess urine adhering to the test strip 100 with wiping paper 111, and places the test strip 100 on the test strip holder 11 with the reagent pad 102 facing upward.

[0014] The sample analyzer 1 automatically carries the test paper 100 placed on the test paper holder 11 from the placement position P1 to the imaging position P3, captures an image of the test paper 100, and analyzes the sample 110 based on the image of the test paper 100. As described above, the test paper 100 to be placed on the test paper holder 11, i.e., the test paper 100 that has been dipped in urine and wiped to remove excess urine, must be prepared by an operator. The sample analyzer 1 is called a semi-automatic device, in contrast to the sample analyzer 2 described below, which automatically places the test paper 100 on the placement section and applies the sample 110 onto the test paper 100.

[0015] The test paper detection unit 40 detects the test paper 100 placed on the test paper holder 11 at a detection position P2 between the placement position P1 and the imaging position P3. The imaging unit 20 performs imaging processing when the test paper 100 is detected by the test paper detection unit 40 in a normal measurement mode in which the automatic detection and cleaning mode described below is not executed. The imaging unit 20 images the test paper holder 11 so that the entire test paper holder 11 is captured. The test paper detection unit 40 is, for example, an optical sensor having a light emitting unit and a light receiving unit.

[0016] The structure of sample analyzer 1 will be described in detail below with reference to Figures 2 to 4. Figure 2 is a diagram showing the external appearance of sample analyzer 1. Figures 3 and 4 are diagrams showing the internal structure of sample analyzer 1, with Figure 3 showing the state with upper cover 71a of housing 70 removed.

[0017] In the following, for convenience of explanation, terms indicating directions will be used. In the XYZ Cartesian coordinate system shown in Figures 2 to 4, the X direction is the direction along the transport direction of the test paper 100, the Z direction is the direction along the vertical direction, and the Y direction is the direction perpendicular to the X and Z directions. The X direction may be called the left-right direction, the Y direction the front-rear direction, and the Z direction the up-down direction. The direction in which a drawer section 75 (described later) is pulled out is defined as the front, and left and right are defined as the left and right when the sample analyzer 1 is viewed from the front.

[0018] As shown in Figs. 2 to 4, the sample analyzer 1 includes a housing 70 that covers the internal structure of the device, such as the transport unit 10 and the imaging unit 20. The housing 70 includes an upper cover 70a, a lower cover 70b, and a front cover 70c, and forms the external appearance of the sample analyzer 1. An opening 71 is formed on the upper surface of the upper cover 70a to expose one of the test paper holders 11 that constitute the transport unit 10. The opening 71 in the upper cover 70a allows the operator to place a test paper 100 on the test paper holder 11 arranged inside the device. The position where the opening 71 is formed is the placement position P1 where the test paper 100 is placed on the test paper holder 11.

[0019] The sample analyzer 1 further comprises a display input unit 30. The display input unit 30 functions as a display unit that displays the analysis results of the sample 110, etc., and as an input unit for inputting predetermined instructions. The display input unit 30 is composed of a touch panel. It is also possible to provide the display unit and the input unit separately. The sample analyzer 1 also comprises a board 55 on which a microcomputer that constitutes the control unit 50 (see Figure 7 described below) is mounted, and a printing unit 60. The printing unit 60 is a printer that prints out the analysis results of the sample 110.

[0020] The sample analyzer 1 is longer in the X direction (left-right direction) than in the Y direction (front-back direction) and Z direction (up-down direction), with the right side of the device being one step higher than the left side. The imaging unit 20, display input unit 30, and printing unit 60 are located on the right side of the sample analyzer 1, and the display input unit 30 and printing unit 60 are located on the top surface of the sample analyzer 1. Placement position P1 for the test paper 100 is provided on the left side of the sample analyzer 1. Furthermore, the substrate 55 is located from the right side to the left side of the sample analyzer 1.

[0021] The sample analyzer 1 is a small-sized analyzer that can be placed on a table in an examination room, a consultation room, etc. and can be easily carried by one person, but is configured so that the test paper 100 can be transported to the imaging position P3 at any time. Because the transport unit 10 has multiple test paper holders 11, even while an image of one test paper 100 is being analyzed, the test paper 100 can be placed on the test paper holder 11 at the placement position P1, and the test paper holder 11 with the test paper 100 placed thereon can be transported toward the imaging position P3. The transport unit 10 is configured so that the multiple test paper holders 11 move cyclically in the X direction of the device.

[0022] The sample analyzer 1 is provided with a drawer section 75 including a tray 76 to which the transport section 10 is fixed, and is configured so that the transport section 10 can be drawn out forward. The tray 76 is fixed to a front cover 70c of the housing 70, and is drawn out by pulling the front cover 70c forward. The front cover 70c and the tray 76 form the drawer section 75. The front cover 70c is formed with a recess 77 into which a finger can be inserted as a handle. In addition, a lock lever 78 for locking the movement of the drawer section 75 is provided at a position adjacent to the recess 77. The provision of the drawer section 75 makes it possible to draw out the transport section 10 from inside the device for cleaning.

[0023] The transport unit 10 has a plurality of test paper holders 11 on which the test papers 100 are placed, a transport mechanism 12 for the test paper holders 11, and a drive unit 13. The test paper holders 11 are mounting units configured so that the test papers 100 are placed by an operator. Each test paper holder 11 has one test paper 100 placed at a mounting position P1. As described above, the position of the opening 71 formed in the upper cover 70a corresponds to the mounting position P1. The opening 71 is formed to be large enough to expose the entirety of one test paper holder 11.

[0024] The test paper 100 is placed on the test paper holder 11 with the gripping portion 104 of the test paper 100 protruding from the top of the holder (see Figures 5 and 6 described below). Furthermore, the gripping portion 104 of the test paper 100 protrudes from inside the housing 70 toward the front of the device. In this case, the operator can operate the gripping portion 104 from outside the device, making it easy to place the test paper 100 in an appropriate position on the test paper holder 11. The left side of the sample analyzer 1 is recessed further back than the right side, and a slit-shaped opening 72 is formed at the upper end of the front cover 70c to allow the gripping portion 104 to pass through.

[0025] The opening 71 in the upper cover 70a is formed as a slit extending from the front end of the upper cover 70a in the front-rear direction (Y direction). The opening 72 in the front cover 70c is formed continuous with the opening 71 from the placement position P1 to the part of the device that protrudes forward. In this case, even if the gripping portion 104 of the test paper 100 protrudes forward from inside the device, the test paper 100 can be prevented from coming into contact with the housing 70.

[0026] The transport mechanism 12 transports the test paper holder 11 and includes an endless belt 12a, a pulley 12b, and a pulley 12c. The endless belt 12a is a band-shaped body formed in a ring shape. A plurality of test paper holders 11 are attached to the endless belt 12a in a state in which they are independent of each other. Adjacent test paper holders 11 are arranged close to each other with a gap therebetween so that they do not come into contact with each other. The pulleys 12b and 12c are arranged with a gap in the X direction and with their respective rotation axes aligned in the Y direction. The pulley 12c is a drive pulley driven by the drive device 13, and the pulley 12b is a driven pulley.

[0027] The endless belt 12a is passed around pulleys 12b and 12c, and rotates when the pulley 12c is driven. As the endless belt 12a rotates, the test paper holder 11 attached to the endless belt 12a moves in a circular motion in the X direction, and the test paper 100 placed on the test paper holder 11 is transported from the placement position P1 on the left side of the device to the imaging position P3 on the right side of the device. After that, the test paper holder 11, having transported the test paper 100, returns to the placement position P1 again. The collection unit 80 (see FIG. 1) is disposed near the pulley 12c. When the test paper holder 11 turns around at the position of the pulley 12c, the imaged test paper 100 falls into the collection unit 80 and is collected.

[0028] As described above, the placement position P1 where the test paper 100 is placed on the test paper holder 11 and the imaging position P3 where the image of the test paper 100 is captured by the imaging unit 20 are spaced apart in the X direction. As will be described in detail later, the test paper 100 includes multiple types of reagent pads 102. When the test paper 100 moves from the placement position P1 to the imaging position P3, a predetermined component in the sample 110 reacts with a reagent contained in the reagent pad 101 of the test paper 100. For this reason, the time it takes for the test paper 100 to move from the placement position P1 to the imaging position P3 is set so that the reaction occurs just enough and the reagent pad 101 appropriately changes color.

[0029] The driving device 13 is a device that rotates the pulley 12c. The driving device 13 is, for example, a stepping motor, and drives the pulley 12c intermittently. This allows the test paper holder 11 attached to the endless belt 12a to move intermittently from the placement position P1 to the imaging position P3, and the test paper holder 11 can be stopped at the placement position P1 and the imaging position P3 for a predetermined time. This predetermined time, i.e., the operation interval of the driving device 13, is preferably short enough to allow the placement of the test paper 100 on the test paper holder 11 and the imaging of the test paper 100 to be performed without any problems. An example of the predetermined time is 5 to 10 seconds. An example of the driving time of the driving device 13 is 0.3 to 1 second.

[0030] The imaging section 20 includes a light source 21, an imaging element 22, and a support 23. The imaging section 20 illustrated in FIG. 4 includes a pair of light sources 21 arranged to face each other in the X direction and sandwich the imaging element 22. The two light sources 21 and the imaging element 22 are supported by the support 23 and arranged above the transport section 10. An imaging unit 20a constituted by the light source 21, the imaging element 22, and the support 23 is configured to be movable in the Y direction along a pair of guide rails 24 extending in the Y direction. The imaging section 20 includes a drive device 25 that moves the imaging unit 20a along the guide rails 24.

[0031] The light source 21 includes a light-emitting element for illuminating the imaging target. By arranging a pair of light sources 21 diagonally above the left and right of the imaging position P3 to illuminate the test paper 100, the test paper 100 can be illuminated more uniformly. There is no particular limitation on the type of light source 21, but it is preferable to use a small light-emitting diode (LED) that generates little heat for the light source 21. Since the sample analyzer 1 measures the degree of color development of the reagent pad 102 of the test paper 100, the light-emitting element constituting the light source 21 is a light-emitting element that outputs white light. The light source 21 may be provided with a diffusion plate for uniformizing the light output from the light-emitting element.

[0032] The imaging element 22 is an element for capturing a two-dimensional image of the test paper 100. The imaging element 22 is disposed above the transport unit 10 with its light receiving surface facing downward. In this embodiment, the imaging range of the imaging element 22 is set to a size that allows it to capture an image of a part of the test paper 100. Here, the imaging range means the range that can be captured with the imaging element 22 in a fixed position. The imaging element 22 captures an image of the test paper 100 while moving in the longitudinal direction (Y direction) of the test paper holder 11 along the guide rail 24. In this case, the imaging element 22 can be disposed close to the test paper 100, and the sample analyzer 1 can be made more compact.

[0033] The length in the Y direction of the imaging range of the imaging element 22 is shorter than the length of the test paper 100, for example set to about one-fourth the length of the test paper 100. The length in the X direction of the imaging range of the imaging element 22 is preferably equal to or greater than the width of the test paper holder 11, and may be long enough to image three test paper holders 11 including the adjacent test paper holders 11 on both sides. An example of the size of the imaging range of the imaging element 22 is 30 mm x 30 mm.

[0034] The imaging element 22 is, for example, a two-dimensional RGB color image sensor such as a CCD (charge-coupled device) image sensor or a CMOS (complementary metal-oxide semiconductor) image sensor. When light is incident on pixels arranged in a grid pattern, the imaging element 22 generates charges according to the intensity of the light, and detects the light intensity of each pixel by extracting the magnitude of the charges as an electrical signal. The imaging element 22 converts the detected light intensity into 256-level shading data (density value), for example, and generates an image based on this data.

[0035] The support 23 supports the light source 21 and the imaging element 22 without changing the positional relationship between the pair of light sources 21 and the imaging element 22. The support 23 is attached so as to be slidable in the Y direction relative to the pair of guide rails 24. Therefore, even if the support 23 moves in the Y direction along the guide rails 24, the illumination conditions when the imaging element 22 images the test paper 100 do not substantially change.

[0036] The driving device 25 is a motor that moves the imaging unit 20a along the guide rail 24. The driving device 25 may move the imaging unit 20a continuously, or may move the imaging unit 20a intermittently by repeatedly moving and stopping for a predetermined period of time. The imaging element 22 of the imaging unit 20a captures images of all the reagent pads 102 of the test paper 100 while moving in the Y direction. The imaging element 22 also captures images of the identification mark 103 of the test paper 100 (see FIG. 6 described later).

[0037] The display input unit 30 is a device that combines the functions of a display unit and an input unit. An example of a suitable display input unit 30 is a touch panel display. An opening 73 is formed in the upper cover 70a of the housing 70 to expose the surface of the display. The surface of the display is disposed on the right side of the sample analyzer 1, which is one step higher, and is substantially flush with the upper surface of the upper cover 70a. The type of display may be either a liquid crystal display or an organic electroluminescence display, and is not particularly limited. Details of the screen displayed on the display input unit 30 will be described later.

[0038] As described above, the board 55 is a printed circuit board on which a microcomputer constituting the control unit 50 is mounted, and is communicatively connected to the transport unit 10, the imaging unit 20, the display input unit 30, the test paper detection unit 40, and the printing unit 60. As will be described in detail later, the control unit 50 comprehensively controls the operation of the sample analyzer 1, analyzes the test paper image acquired by the imaging unit 20, and performs analysis of the sample 110. The control unit 50 also causes the display input unit 30 to display the test paper image, and performs control related to the detection of dirt on the test paper holder 11. The board 55 is disposed within the housing 70 behind the transport unit 10, but the shape and arrangement of the board 55 are not particularly limited.

[0039] The test paper holder 11 and the test paper 100 will be described in detail with reference to Figures 5 and 6. Figure 5 is a perspective view of the test paper holder 11. Figure 6 is a perspective view of the test paper 100.

[0040] As shown in Fig. 5, the test paper holder 11 is a tray-shaped holder having a bottom plate 11b that is rectangular in plan view and a pair of side walls 11c that stand on both ends of the bottom plate 11b in the width direction. The test paper holder 11 also has a pair of extensions 11d that protrude from the upper ends of each side wall 11c toward the outside in the width direction of the holder. The test paper holder 11 has a storage section 11a that is surrounded on three sides by the bottom plate 11b and the pair of side walls 11c. The storage section 11a is a recess on which the test paper 100 is placed. The top surface of the bottom plate 11b on which the test paper 100 is placed is lowered by one step, and side walls 11c are arranged on both the left and right sides of the bottom plate 11b, so that the test paper 100 can be prevented from falling off while the test paper holder 11 is moving.

[0041] Two rib-like protrusions 11e are formed on the upper surface of the bottom plate 11b. The two protrusions 11e are formed at a distance from each other in the longitudinal direction of the test paper holder 11, and each protrusion supports a test paper 100. That is, the test paper 100 is placed on the protrusions 11e. In this case, the test paper 100 is supported at two points, and even if the sample 110 is attached to the test paper 100, the test paper 100 can be prevented from sticking to the upper surface of the bottom plate 11b. The height of each protrusion 11e is lower than the height of the side wall 11c. The distance between each protrusion 11e may be any length that can stably support the test paper 100.

[0042] The shape of the protrusion 11e is not particularly limited, but it is preferable that the width of the protrusion 11e gradually narrows toward the tip of the protrusion 11e and that the cross section in the width direction has a triangular shape. In the example shown in FIG. 5, the protrusion 11e is formed across the side wall 11c and the extension 11d, but the protrusion 11e may be formed only on the bottom plate 11b. Since the protrusion 11e is the part that comes into contact with the test paper 100, if the determination area 120 for stain detection described later is limited to a part of the mounting surface of the test paper holder 11, the part where the protrusion 11e is formed may be the determination area. Here, the mounting surface of the test paper holder 11 is the surface on which the test paper 100 facing vertically upward at the mounting position P1 is placed, and includes not only the upper surface of the bottom plate 11b but also the upper surface of the extension 11d unless otherwise specified.

[0043] The width W1 of the storage section 11a is, for example, 1.5 to 3.0 times the width of the test paper 100 at the narrowest part where the protrusion 11e is formed. A specific example of the width W1 is 5 mm to 20 mm. Note that although the width W1 of the storage section 11a is sufficiently wider than the width of the test paper 100, when the test paper 100 is placed on the test paper holder 11, the test paper 100 may come into contact with the extending portion 11d, and the sample 110 may adhere to the extending portion 11d. The length of the test paper holder 11 may be shorter than the length of the test paper 100, and the test paper 100 is placed in a state where the gripping portion 104 protrudes from the test paper holder 11.

[0044] The color of the test paper holder 11 is preferably a dark color such as black. In this case, the contrast between the test paper holder 11 and the test paper 100 is high, making it easier to extract the image of the test paper 100 from the image captured by the imaging unit 20. Furthermore, if the test paper holder 11 is black, dirt adhering to the test paper holder 11 is also easier to detect.

[0045] As shown in FIG. 6, the test paper 100 has a base material 101 having a rectangular shape in a plan view and a reagent pad 102 provided on one side of the base material 101. In this embodiment, an operator immerses the test paper 100 in a sample 110, so that the sample 110 is impregnated into the reagent pad 102. The test paper 100 is a so-called multi-test piece in which a plurality of reagent pads 102 are arranged in the longitudinal direction of the base material 101. Therefore, a plurality of components contained in the sample 110 can be analyzed using one test paper 100. The reagent pad 102 contains a reagent that reacts with the component to be analyzed, and changes color when the component to be analyzed is contained in the sample 110 in which the test paper 100 is immersed. The sample analyzer 1 analyzes the image of the reagent pad 102 and performs semi-quantitative analysis of the components in the sample 110.

[0046] The test paper 100 has multiple types of reagent pads 102, each containing a reagent that reacts with, for example, occult blood, sugar, protein, ketone body, nitrite, creatinine, albumin, urobilinogen, and white blood cells contained in urine. Each reagent pad 102 changes color depending on the concentration of the target component contained in urine, and generally the higher the concentration, the darker the color. Therefore, the target component can be semi-quantified by analyzing the degree of coloring of the reagent pad 102. The test paper 100 may also have a reagent pad 102 that can analyze the pH of urine. The number of reagent pads 102 is not particularly limited, but is, for example, 10 to 15.

[0047] The test paper 100 has, for example, reagent pads 102 each having a rectangular shape when viewed from the front, arranged at a predetermined interval in the longitudinal direction of the base material 101. The reagent pads 102 are preferably arranged closely to each other at an interval that can sufficiently suppress bridging abnormalities, which will be described later. The predetermined interval is, for example, shorter than the length of one side of the reagent pad 102, and the intervals between the reagent pads 102 are substantially equal. In addition, an identification mark 103 is provided on the surface of the base material 101 on which the reagent pads 102 are provided. The identification mark 103 indicates identification information such as the type of the test paper 100 and the lot number, and is composed of a one-dimensional code such as a barcode, a two-dimensional code such as a QR code (registered trademark), or a combination of these.

[0048] The substrate 101 is, for example, a substrate having a length of 100 mm to 150 mm, a width of 3 mm to 7 mm, and a thickness of 0.1 mm to 1 mm. The reagent pad 102 is, for example, a rectangular shape in a plan view with a side of 3 mm to 7 mm, and has a thickness of 0.5 mm to 2 mm. On one side of the substrate 101, a plurality of reagent pads 102 are arranged in a range from a first end in the longitudinal direction of the substrate 101 to beyond the center in the longitudinal direction, and an identification mark 103 is provided between a second end in the longitudinal direction of the substrate 101 and the reagent pads 102. The surface of the substrate 101 in a portion where no reagent pads 102 are present is used as a reference value in image analysis of the reagent pads 102. One example of a suitable color of the substrate surface is white.

[0049] The range from the second longitudinal end of the base material 101 to the reagent pad 102 constitutes the gripping portion 104 of the test paper 100 that is gripped by the operator. The length of the gripping portion 104 is not particularly limited, but a suitable example is 30% to 45% of the overall length of the base material 101. When preparing the test paper 100 to be placed on the test paper holder 11, the operator holds the gripping portion 104 so as not to touch the reagent pad 102 with their hands, and immerses the entire reagent pad 102 in the sample 110.

[0050] The configuration of the control system of sample analyzer 1 will be described in detail with reference to Figure 7. Figure 7 is a block diagram showing the schematic configuration of sample analyzer 1.

[0051] As shown in Fig. 7, the sample analyzer 1 includes a control unit 50 that controls the overall operation of the device. The control unit 50 is communicably connected to the transport unit 10, the imaging unit 20, the display input unit 30, the test paper detection unit 40, and the printing unit 60, and is configured to transmit control signals to each device. The control unit 50 also acquires information required for control from each device. In this embodiment, the control unit 50 is mounted on a substrate 55 and housed in a housing 70, but some of the functions of the control unit 50 may be implemented by a server or the like outside the device.

[0052] The control unit 50 has a calculation unit 51 and a storage unit 52, and is configured, for example, by a microcomputer including a CPU, RAM, ROM, an interface, etc. The control unit 50 controls the operation of various devices constituting the sample analyzer 1 by the calculation unit 51 (CPU) executing a program stored in the storage unit 52. As will be described in detail later, the storage unit 52 stores the test strip image in association with at least one measurement information selected from measurement date and time information, operator information, identification information of the test strip 100, and identification information of the sample 110. The sample 110 includes a test specimen and a quality control specimen of a known concentration, and the identification information of the sample 110 includes identification information of the test specimen and identification information of the quality control specimen.

[0053] The control unit 50 controls the drive device 13 of the transport unit 10 to move the test paper holder 11 from the placement position P1 to the imaging position P3. When the test paper 100 placed on the test paper holder 11 is detected at the detection position P2, the image of the test paper 100 is captured by the imaging unit 20 at the imaging position P3. The control unit 50 controls the light source 21, the image sensor 22, and the drive device 25 of the imaging unit 20 to capture an image of the entire test paper 100 while moving the imaging unit 20a in the Y direction. The control unit 50 then analyzes the test paper image captured by the imaging unit 20 to analyze the sample 110.

[0054] When the control unit 50 acquires the detection information of the test paper 100 from the test paper detection unit 40, it starts capturing images while moving the imaging unit 20a in the Y direction from the origin position when the test paper 100 is transported to the imaging position P3. The imaging unit 20a may capture images of the test paper 100 while continuously moving, or may stop multiple times and capture images of the test paper 100 at each stop position. When the control unit 50 has completed capturing images of the test paper 100, it returns the imaging unit 20a to the origin position.

[0055] As will be described in detail later, the control unit 50 displays multiple test paper images selected by the display input unit 30 on one screen of the display input unit 30. The control unit 50 also detects the type of abnormality and the location of the abnormality appearing in the test paper image, and displays information indicating the type of abnormality and the location of the abnormality together with the test paper image on the display input unit 30. The control unit 50 also analyzes the image of the test paper holder 11 acquired by the imaging unit 20 to detect dirt on the test paper holder 11.

[0056] Prior to analyzing the test strip image, the control unit 50 performs image processing such as correction processing, synthesis processing, and extraction processing. Since the brightness within the imaging range of the imaging element 22 is generally non-uniform between the center and the periphery of the imaging range, the control unit 50 may perform correction processing using a brightness correction table. In addition, since the imaging element 22 captures the image of the test strip 100 while moving in the Y direction, the control unit 50 generates one test strip image by synthesizing multiple images acquired by the imaging element 22. Unless otherwise specified, in this specification, a test strip image means a composite image in which the entire test strip 100 is captured.

[0057] The extraction process is a process for extracting an image of the test paper 100 from the composite image. Since the composite image contains not only an image of the test paper 100 but also an image of the test paper holder 11, when analyzing the sample 110, only the image of the test paper 100 is extracted from the composite image. For example, the control unit 50 performs a Hough transform on the composite image to extract a rectangle showing the outer edge of the test paper 100, rotates the composite image to an appropriate angle based on the inclination of the extracted rectangle, and then detects the edges of the image of the test paper 100 to extract the image of the test paper 100. On the other hand, when detecting dirt on the test paper holder 11, the image of the test paper holder 11 is extracted from the composite image.

[0058] As described above, the control unit 50 analyzes the test strip image to analyze the sample 110. Specifically, the presence or absence of the target component in the sample 110 and, if the target component is present, the approximate content thereof are determined from the degree of coloration of the reagent pad 102 included in the test strip image. The operator immerses the test strip 100 in the sample 110, wipes off excess sample 110, and places the test strip on the test strip holder 11. However, by the time the test strip 100 is transported to the imaging position P3, the reagent in the reagent pad 102 reacts with the target component in the sample 110, causing the reagent pad 102 to color.

[0059] A reading device for reading the identification information of the sample 110 is generally connected to the sample analyzer 1. A barcode label containing the identification information of the sample 110 is attached to a container containing the sample 110, such as a urine collection cup or urine collection tube. The reading device reads this barcode label and transmits the sample ID, which is the identification information of the sample 110, to the control unit 50. A barcode reader can be used as the reading device. The sample ID is read, for example, before the test strip 100 is immersed in the sample 110.

[0060] Fig. 8 is a flow chart showing an example of a sample analysis method using the sample analyzer 1. Fig. 8 shows the control procedure from when an operator places the test strip 100 on the test strip holder 11 at the placement position P1 of the sample analyzer 1 until the test strip 100 is discarded.

[0061] As shown in Fig. 8, in step S1, the control unit 50 receives a detection signal of the test paper 100 from the test paper detection unit 40. When the test paper 100 is placed on the test paper holder 11 at the detection position P2, the test paper detection unit 40 outputs a detection signal of the test paper 100 to the control unit 50. The process of step S1 is performed for each test paper holder 11. If the control unit 50 receives a detection signal of the test paper 100 (Yes in step S1), the control unit 50 proceeds to step S2. On the other hand, if the control unit 50 does not receive a detection signal of the test paper 100 (No in step S1), the control unit 50 proceeds to step S8.

[0062] In step S2, the control unit 50 moves the test paper 100 to the imaging position P3. The control unit 50 intermittently drives the drive device 13 of the transport unit 10 under preset conditions to transport the test paper holder 11 on which the test paper 100 is placed from the detection position P2 to the imaging position P3. The transport unit 10 is configured so that multiple test paper holders 11 attached to the endless belt 12a move in a circular manner in the X direction. Therefore, the control unit 50 moves not only the test paper holder 11 on which the test paper 100 is placed, but all the test paper holders 11 from the placement position P1 to the detection position P2 and then to the imaging position P3.

[0063] In step S3, the control unit 50 controls the imaging unit 20 to capture an image of the test paper holder 11 on which the test paper 100 is placed. Specifically, when the test paper holder 11 in which the test paper 100 was detected in step S1 arrives at the imaging position P3, the imaging unit 20a is moved in the Y direction from the origin position to start imaging. Since the test paper holder 11 is transported under predetermined conditions, the control unit 50 can determine the timing when the test paper holder 11 in which the test paper 100 was detected at the detection position P2 arrives at the imaging position P3.

[0064] In step S4, the control unit 50 performs image processing on the test paper image captured by the imaging element 22 of the imaging unit 20. The image data captured by the imaging element 22 is transmitted to the control unit 50. Examples of image processing include correction processing, synthesis processing, and extraction processing, as described above. In step S3, the imaging element 22 captures images of the test paper 100 while moving in the Y direction, so that the control unit 50 synthesizes multiple images to generate one test paper image.

[0065] In step S5, the control unit 50 analyzes the image-processed test strip image to determine the presence or absence of the target component in the sample 110, and the approximate amount of the target component if the target component is present. The approximate amount of the target component in the urine determined by the urine test of this embodiment is generally called a semi-quantitative value. The control unit 50 also determines the presence or absence of a measurement abnormality. If the control unit 50 detects a measurement abnormality by analyzing the test strip image, it causes the display input unit 30 to display the type and location of the abnormality. The control unit 50 may control the printing unit 60 to print the analysis results including the semi-quantitative value of each target component for analysis for each sample 110.

[0066] In step S6, the control unit 50 stores the analysis results of the test strip image in the memory unit 52. The control unit 50 stores the semi-quantitative value, abnormality detection information, test strip image used in the analysis, etc. in the memory unit 52 in association with at least one measurement information selected from identification information of the sample 110 (specimen ID), identification information of the test strip 100 (test strip type, test strip lot), measurement date and time information, operator information, etc. As will be described in detail later, this allows the operator to display a desired test strip image on the display input unit 30 based on the specimen ID, operator information, etc.

[0067] In step S7, the control unit 50 moves the imaged test paper 100 from the imaging position P3 to the discarding position. The test paper holder 11 returns from the imaging position P3 to the placement position P1, and at that time, rotates inverted at the position of the pulley 12c. At this time, the imaged test paper 100 falls from above the test paper holder 11 into the recovery unit 80 and is discarded, and the empty test paper holder 11 is transported to the placement position P1.

[0068] In step S8, if the measurement mode continues, the control unit 50 repeats the processes of steps S1 to S7 (No in step S8). If the measurement mode is cancelled by the operator operating the display / input unit 30, the control unit 50 stops the transport unit 10 and ends the measurement (Yes in step S8). If the test paper 100 is not detected at the detection position P2 for a predetermined time, the control unit 50 may cancel the measurement mode, stop the transport unit 10, and end the measurement.

[0069] The processes in steps S1 to S7 are performed simultaneously. For example, while image analysis is being performed on the previous test piece 100, the next test piece 100 is transported to the imaging position P3 and is detected by the test piece detection unit 40.

[0070] Hereinafter, the display screen for the test strip image and the method for displaying the test strip image will be described in detail with reference to Figs.

[0071] 9 shows an example of (a) a display screen of a list of sample analysis results and (b) a display screen of a test strip image. Note that acquisition of operation signals of the touch panel which is the display input unit 30 and display of various screens based on the operation signals are performed under the control of the control unit 50.

[0072] As shown in FIG. 9(a), the result list screen 31a displays the index of the analysis results in list form. In the list 310 of the result list screen 31a, from the right side of the screen, the measurement date and time, the operator's identification information, the test strip 100's identification information, the sample ID, the sequence number, and the browsing history information are displayed. In the operator's identification information field, for example, the login ID to the sample analyzer 1 when the measurement was performed is displayed, but the operator's name, etc. may also be displayed. The operator's information is useful for correcting the testing technique. The "Rev" mark indicates that any of the measurement results was positive.

[0073] The list 310 displays the type of test paper 100 as identification information for the test paper 100. The sample analyzer 1 is capable of measuring multiple types of test paper 100, and this information is used when displaying the test paper image 300 for each type of test paper 100. The sample ID and sequence number are identification information for the sample 110. The sample ID is unique information assigned to each sample, and the sequence number indicates a sequential number (consecutive number) when the device is turned on. In the example shown in FIG. 9(a), the test sample is indicated by "No.", the quality control sample by "C.", and the emergency sample by "#".

[0074] The result list screen 31a further displays screen switching buttons 311a, 311b, a display condition switching button 312, a selection button 313, a scroll button 314, a result details display button 315, a refinement setting button 316, a search button 317, and an information share button 318. The result details display button 315 is a button for displaying details of the analysis results of the sample selected in the list 310. By pressing the result details display button 315, the screen of the display input unit 30 is switched to a result details screen 36 (see FIG. 14 described later) including the semi-quantitative value of the sample. In addition, the information share button 318 is a button for transmitting the analysis results to an external device connected to the sample analyzer 1 via a wired or wireless connection.

[0075] In the result list screen 31a, a list 310 is arranged in the center of the screen, and various buttons are arranged around the list 310. The list 310 is a table showing indexes of the analysis results of the sample 110. Since the analysis results of the sample 110 are obtained by analyzing the test strip image 300, the list 310 can be said to be a list of the analysis results. The list 310 displays the measurement information of each specimen in order according to the conditions selected by the display condition switching button 312. In the example shown in FIG. 9(a), the data is displayed in order of specimen ID, with the most recent measurement date and time at the top of the list 310.

[0076] The screen switching button 311a is a button for switching the screen from the second result list screen 31b to the first result list screen 31a. The screen switching button 311b is a button for switching the screen from the first result list screen 31a to the second result list screen 31b. For example, when the screen switching button 311b displaying "Strip" is pressed on the result list screen 31a, the screen of the display input unit 30 can be switched to the result list screen 31b. Providing the screen switching buttons 311a and 311b facilitates screen switching, improving usability.

[0077] The number of data items that can be simultaneously displayed in the list 310 on the result list screen 31a is limited to a predetermined number (for example, 7 to 15 items), but measurement information exceeding the predetermined number can be viewed by operating the scroll button 314. The number of test strip images 300 that can be simultaneously displayed on the result list screen 31b may be the same as the predetermined number in the list 310, but in the example shown in FIG. 9, the number of test strip images 300 is smaller. In this case, each test strip image 300 can be displayed larger, making comparison and reference easier. On the result list screen 31b as well, a large number of test strip images 300 that cannot all be simultaneously displayed can be viewed by operating the scroll button 314.

[0078] As shown in Fig. 9(b), the result list screen 31b displays multiple test strip images 300 in parallel instead of the list 310. The results list screens 31a and 31b display the same information on both screens except for the list 310 and the test strip images 300. The result list screen 31b displays multiple test strip images 300 along with the sample ID and sequence number. By displaying multiple test strip images 300 side by side on one screen, for example, if an abnormality occurs in the analysis results of a quality control sample, it becomes easier to identify the cause of the abnormality.

[0079] It is preferable that the control unit 50 displays the multiple test paper images 300 in the same orientation on the result list screen 31b so that the reagent pads 102 of the same type of test paper 100 are lined up in a row in the multiple test paper images 300. In this case, it becomes easy to compare and refer to the multiple test paper images 300. In the example shown in Fig. 9(b), images of all the same type of test paper 100 are displayed, and the test paper images 300 are aligned so that the reagent pads 102 of the same type are lined up in the vertical direction of the screen and the identification marks 103 are also lined up in the vertical direction. The number of test paper images 300 that can be displayed simultaneously on the result list screen 31b can be changed as appropriate depending on the size of the display input unit 30, etc., and is not particularly limited, but is, for example, 5 to 10.

[0080] When the screen switching button 311b is operated on the result list screen 31a as described above, the control unit 50 switches the screen of the display input unit 30 to the result list screen 31b and displays multiple test strip images 300 in parallel. The control unit 50 further has a function of displaying multiple test strip images 300 selected by operating the display input unit 30 on the display input unit 30. The control unit 50 displays a list 310 on the result list screen 31a and displays multiple test strip images 300 selected by the operator from the list 310. Note that when one display object is selected on the result list screen 31a, one test strip image 300 is displayed on the result list screen 31b.

[0081] In this embodiment, pressing the selection button 313 switches to a first selection mode in which the display target of the test strip image 300 can be selected. In the first selection mode, the display target can be selected by pressing the measurement information column of each sample in the list 310. Then, by pressing the screen switching button 311b with the sample selected, only the test strip image 300 of the sample selected by the operator from the list 310 is displayed on the result list screen 31b.

[0082] Although details will be described later, a motion button 340 (see FIG. 12 described later) may be displayed by operating the selection button 313. The motion button 340 is a button for moving to an enlarged display screen 34 that enables an enlarged display of the test paper image 300. Alternatively, the motion button 340 originally displayed on the result list screens 31a and 31b may be enabled by operating the selection button 313 and selecting a display target. The motion button 340 becomes operable when at least one display target is selected.

[0083] The list 310 includes measurement date and time information, operator information, identification information of the test strip 100, and sample identification information (including sequence numbers for identifying the test sample and the quality control sample), allowing the operator to select the test strip images 300 to be displayed based on this measurement information. The control unit 50 can further display the list 310 including only information on specific samples narrowed down from this measurement information. For example, the control unit 50 can display the list 310 including only information on the quality control samples, and display multiple test strip images 300 selected from the list.

[0084] In this embodiment, pressing the narrowing down setting button 316 switches to a second selection mode in which the test strip images 300 to be displayed can be selected based on the measurement information. When the control unit 50 receives an operation signal of the narrowing down setting button 316, it switches the screen of the display input unit 30 to a selection screen 33a (see FIG. 11 described later) and displays multiple test strip images 300 corresponding to the measurement information selected on the selection screen 33a. This function allows the operator to display only the desired test strip image 300 based on one or multiple pieces of measurement information.

[0085] The search button 317 is a button for searching for the analysis results of the target sample by inputting information such as the sample ID and the operator, etc. The operator can also use this search button 317 to select the test strip image 300 to be displayed from the measurement information.

[0086] Fig. 10 shows an example of a measurement screen. As shown in Fig. 10, an indicator 320, a list 321, and a measurement button 322 are displayed on the measurement screen 32. The measurement screen 32 is a screen that is displayed when measuring the sample 110. The operator can start or stop the measurement of the sample 110 by operating the measurement button 322. Note that the measurement screen 32 may be provided with a search button 317 or the like, similar to the result list screens 31a and 31b.

[0087] The indicator 320 is a guidance display that informs the operator of the timing to immerse the test paper 100 in the sample 110, to wipe off the sample 110 adhering to the test paper 100, and to place the test paper 100 on the test paper holder 11. When the operator presses the measurement start button 322, the guidance by the indicator 320 progresses, and the operator can follow the guidance to prepare the test paper 100 to be placed on the test paper holder 11. The list 321 displays the sample ID, etc. of the sample 110 that is being measured or has been measured. For example, when the sample ID is read by a barcode reader, the sample ID is displayed in the list 321.

[0088] Fig. 11 shows an example of a selection screen for narrowing down the display target of the analysis result from the measurement information. As shown in Fig. 11(a), a narrowed-down display selection button 330 for selecting whether or not to display a narrowed-down display of the analysis result is displayed at the top of the selection screen 33a. In addition, under the narrowed-down display selection button 330, a plurality of selection buttons for selecting the measurement information that is the narrowing-down condition of the display target are arranged.

[0089] The refined display selection buttons 330 include two buttons for "refined display" and "no refined display". The refined display selection buttons 330 are, for example, radio buttons. By selecting the "refined display" button, the other selection buttons can be operated, and the display target can be refined (selection of measurement information). The control unit 50 stores the refinement conditions, which are the selected measurement information, in the memory unit 52. Then, according to the refinement conditions, a list 310 of specific samples is displayed on the result list screen 31a, and specific test strip images 300 are displayed on the result list screen 31b. On the other hand, when the "no refined display" button is selected, the other selection buttons cannot be operated, and the test strip images 300 are displayed on the result list screen 31b in order of sample ID or sequence number.

[0090] The selection screen 33a displays six selection buttons for selecting measurement information. The first selection button 331 is a measurement date and time selection button. By operating the first selection button 331, any measurement date and time can be selected, such as today, yesterday, April 3, 2023, a specific date or period such as April 4 to 7, 2023, or a specific time period such as 9:00 to 11:00. The second selection button 332 is a sample ID selection button. By operating the second selection button 332, a specific sample can be selected from the test samples based on the sample ID, or a specific sample can be selected from the quality control samples.

[0091] The third selection button 333 is an operator selection button. By operating the third selection button 333, the operator who prepared the test strip 100 to be placed on the test strip holder 11 and measured the sample 110 can be selected. In the semi-automatic sample analyzer 1, the test technique may have a significant effect on the analysis results. In particular, if an operator with little experience performs the measurement, it is expected that, for example, the analysis results of the quality control sample may fall outside the appropriate range or measurement errors may occur easily. By narrowing down the operators and displaying the test strip image 300, it becomes easier to determine the cause when appropriate analysis results are not obtained. It is also effective for correcting the test technique and training.

[0092] The fourth selection button 334 is a button for selecting a quality control sample. Generally, a quality control sample is also called a control reagent, or simply a control. When the fourth selection button 334 is pressed, the screen of the display input unit 30 switches to a selection screen 33b shown in FIG. 11(b). As shown in FIG. 11(b), the selection screen 33b displays a type selection button 337b for selecting the type of the quality control sample, and a lot number selection button 338b for selecting the lot number of the quality control sample.

[0093] In the example shown in FIG. 11(b), three check boxes are displayed as type selection buttons 337b. The operator can select a specific quality control sample from among multiple types of quality control samples by checking the box of the quality control sample that the operator wants to display. When the operator presses lot number selection button 338b on selection screen 33b, the screen of display input unit 30 switches to selection screen 33c shown in FIG. 11(c). As shown in FIG. 11(c), selection screen 33c displays multiple check boxes corresponding to each lot number of the quality control samples.

[0094] As the identification information of the quality control sample, it may be possible to further select the identification information of each container (hereinafter referred to as "vial") filled with the quality control sample. Generally, quality control samples are prepared in the same lot in an amount that can fill multiple vials. In the memory unit 52, for example, the type of quality control sample, the lot number, and the identification information of each vial with the same lot number are stored. As will be described in more detail later, storing the vial identification information makes it easier to identify measurement abnormalities caused by immersing the same vial in more than the number of times it can be used.

[0095] The fifth selection button 335 is a button for selecting the test paper 100. When the fifth selection button 335 is pressed, the screen of the display input unit 30 switches to a selection screen 33d shown in FIG. 11(d). As shown in FIG. 11(d), the selection screen 33d displays a type selection button 337d for selecting the type of test paper 100, and a lot number selection button 338d for selecting the lot number of the test paper 100. In the example shown in FIG. 11(d), three check boxes are displayed as the type selection buttons 337d. The operator can select a specific test paper 100 from among multiple types of test papers 100 by checking the box of the test paper 100 that the operator wants to display.

[0096] When the lot number selection button 338d on the selection screen 33d is pressed, the screen of the display input unit 30 switches to a selection screen 33e shown in Fig. 11(e). As shown in Fig. 11(e), the selection screen 33e displays a number of check boxes corresponding to the lot numbers of the test paper 100. Note that in the example shown in Fig. 11(e), the check box for the lot number of the type "9A" of the test paper 100 that is not selected on the selection screen 33d is also displayed, but even if that lot number is selected, "9A" will not be displayed unless "9A" is selected on the selection screen 33d.

[0097] The sixth selection button 336 is a selection button for the sequence number of the sample and the classification of the analysis results. By operating the sixth selection button 336, the classification of the analysis results to be displayed for each sequence number can be selected. Specific examples include selecting a test sample or quality control sample in which a measurement error has occurred, or selecting samples in which a measurement error has occurred. In the example shown in FIG. 11(a), a list-format check box including a row of sequence numbers and a column of classification of the analysis results is displayed as the sixth selection button 336.

[0098] 12 is a diagram showing an example of an enlarged display screen of the test strip image 300. As shown in FIG. 12(a), the result list screen 31a displays a motion button 340 for switching to a motion mode in which the test strip image 300 of the selected sample can be enlarged. For example, the operator can narrow down the test strip image 300 to be displayed on the selection screen 33a, and then select the test strip image 300 to be enlarged on the first result list screen 31a or the second result list screen 31b. In the example shown in FIG. 12(a), two samples are selected on the result list screen 31a. When the motion button 340 is pressed in this state, the screen of the display input unit 30 is switched to the enlarged display screen 34 shown in FIG. 12(b) and (c).

[0099] FIG. 12(b) shows the state before the enlargement operation, and FIG. 12(c) shows the state after the enlargement operation. The enlarged display screen 34 displays the test strip image 300 corresponding to the sample selected on the result list screen 31a together with the sample ID, sequence number, and measurement date and time. The enlarged display screen 34 may also display operator information. Although the enlarged display screen 34 can display multiple test strip images 300, it is preferable that the maximum number of test strip images 300 displayed on the enlarged display screen 34 is limited to an appropriate number depending on the screen size of the display input unit 30, and is set to 2 to 5, for example. It is preferable that the multiple test strip images 300 are displayed in parallel in the same orientation so that the reagent pads 102 of the same type of each test strip 100 are lined up in a row.

[0100] A back button 341 is displayed on the enlarged display screen 34. The back button 341 is a button for returning to the original screen, and when the back button 341 is pressed, the screen of the display input unit 30 returns to the first result list screen 31a or the second result list screen 31b that was displayed immediately before moving to the enlarged display screen 34. In other words, the back button 341 is a button for canceling the motion mode.

[0101] The control unit 50 enlarges and displays a part of the test strip image 300 based on an enlargement instruction from the display input unit 30. The enlargement instruction is given, for example, by tapping on the part of the test strip image 300 that is to be enlarged. Alternatively, the enlargement instruction may be given by other operations such as a double tap operation, a long press operation, a pinch operation, etc., and the operation for inputting the enlargement instruction is not particularly limited. In addition, an operation for reducing the enlarged image may be set, and buttons for enlarging and reducing the test strip image 300 may be provided on the enlargement display screen 34.

[0102] When an operation is performed to enlarge a part of the test strip image 300, the control unit 50 enlarges and displays the part of the test strip image 300 including the part corresponding to the operation signal at a predetermined magnification. The magnification of the test strip image 300 is, for example, one or more predetermined fixed magnifications. When a part of the test strip image 300 is tapped, the part and its vicinity are enlarged and displayed at a predetermined magnification. The magnification may be changeable depending on the number of operations, so that the magnification increases with further tapping. The magnification may also be changeable arbitrarily.

[0103] It is preferable that the enlarged display of the test strip images 300 is synchronized for the multiple images. When the control unit 50 receives an instruction to enlarge one of the multiple test strip images 300 displayed on the enlarged display screen 34, it causes the control unit 50 to enlarge and display the same portion of all the images at the same magnification. When the control unit 50 receives an instruction to reduce one of the test strip images 300, it causes the control unit 50 to reduce and display the same portion of all the images at the same magnification. In this case, the desired portion of the multiple test strip images 300 can be compared and referenced quickly and easily.

[0104] The control unit 50 further enlarges and displays another part of the test strip image 300 based on an instruction to change the display area from the display input unit 30. On the enlarged display screen 34 shown in Fig. 11(c), a part of the test strip image 300 is enlarged, but the enlarged display area can be changed, for example, by a swipe operation in which a finger touching the screen is slid left and right. Note that the operation for inputting an instruction to change the display area is not limited to a swipe operation. When an operation to change the display area is performed on the enlarged display screen 34, the control unit 50 changes the part to be enlarged and displayed based on the operation signal.

[0105] Fig. 13 is a flow chart showing an example of the display process of the test strip image 300. Fig. 13 shows the control procedure from displaying the result list screen 31a on the display input unit 30, narrowing down the display targets on the selection screen 33a, to enlarging and displaying the test strip image 300, but the presence or absence of this narrowing down does not affect the enlarged display process itself.

[0106] 13, in step S11, the control unit 50 causes the display input unit 30 to display a result list screen 31a. The control unit 50 causes the result list screen 31a to be displayed based on, for example, an operation of the display input unit 30 by an operator, but may also cause the result list screen 31a to be displayed when the measurement of the sample 110 is completed. The result list screen 31a may also be set as a default screen when the sample analyzer 1 is started up. The result list screen 31a displays the measurement information of each specimen in list form as a list of analysis results, and also displays a screen switching button 311b.

[0107] When the control unit 50 receives an operation signal of the screen switching button 311b, it switches the screen of the display input unit 30 to a result list screen 31b, and displays multiple test strip images 300 in parallel. On the result list screen 31b, multiple test strip images 300 are displayed so that the same type of reagent pads 102 of each test strip 100 are lined up in a row, and the screen switching button 311a is also displayed. Furthermore, on the result list screen 31b, the sample ID, sequence number, etc. are displayed next to each test strip image 300 so that each test strip image 300 can be identified. Furthermore, information such as the number and name of the reagent pad 102 may be displayed on the result list screen 31b.

[0108] In step S12, the control unit 50 accepts an instruction to narrow down the display target. The narrow down instruction is input by operating the narrow down setting button 316 and each selection button on the selection screen 33a. When the control unit 50 acquires the narrow down instruction (Yes in step S12), the control unit 50 advances the process to step S13. On the other hand, when the control unit 50 does not acquire the narrow down instruction (No in step S12), the control unit 50 advances the process to step S14.

[0109] When the narrowing down setting button 316 is pressed on the first result list screen 31a or the second result list screen 31b, the control unit 50 switches the screen of the display input unit 30 to the selection screen 33a. Then, when the narrowing down display selection button 330 for "Yes" is selected on the selection screen 33a, the control unit 50 enables the operation of the first selection button 331 to the sixth selection button 336. The control unit 50 stores the narrowing down conditions selected by the operation of the first selection button 331 to the sixth selection button 336.

[0110] In step S13, the control unit 50 narrows down the display targets on the result list screens 31a, 31b in accordance with the above-mentioned narrowing conditions, and displays only the selected samples on the result list screens 31a, 31b. The result list screen 31a displays a list 310 including only the samples selected in step S12, and the result list screen 31b displays only the test strip image 300 selected in step S12. Note that it is possible to enlarge and display the test strip image 300 without narrowing down the display targets in steps S12 and S13, but it is preferable to proceed to step S14 via steps S12 and S13 in order to make it easier to search for the target to be enlarged and displayed.

[0111] In step S14, the control unit 50 receives an instruction to enlarge the test strip image 300. The enlargement instruction is input by, for example, tapping on the part of the test strip image 300 that is to be enlarged. In this embodiment, the enlargement instruction is input on the enlargement display screen 34. Therefore, as a prerequisite for enlarging the test strip image 300, the target to be enlarged must be selected on the result list screens 31a, 31b, and the screen must transition to the enlargement display screen 34 by operating the motion button 340. When the control unit 50 receives the operation signal of the motion button 340, it switches the screen of the display input unit 30 to the enlargement display screen 34.

[0112] In step S15, the control unit 50 enlarges and displays a part of the test strip image 300 in accordance with the enlargement instruction. For example, when a part of the test strip image 300 is tapped, the control unit 50 enlarges and displays a part of the test strip image 300 including the tapped part. At this time, it is preferable to synchronize the enlargement magnification and enlargement range for the multiple test strip images 300 displayed on the enlarged display screen 34. That is, when an enlargement instruction is obtained for one of the multiple test strip images 300, the same part is enlarged and displayed at the same magnification for all images. Furthermore, the control unit 50 changes the part to be enlarged when a swipe operation or the like is performed to change the display area on the enlarged display screen 34.

[0113] When the control unit 50 receives an operation signal of the back button 341 on the enlarged display screen 34, it returns the screen of the display input unit 30 to the first result list screen 31a or the second result list screen 31b that was displayed immediately before moving to the enlarged display screen 34, and cancels the motion mode. It is also possible to output the information displayed on the display input unit 30 to a display unit of an external device connected to the sample analyzer 1. In this case, a screen similar to that of the display input unit 30 can be displayed on the display unit of the external device.

[0114] Fig. 14 is a diagram showing an example of an error display screen. As shown in Fig. 14(a), if an abnormality in the measurement is detected by analyzing the test paper image during the measurement of the sample 110, an error display screen 35 notifying the user that an abnormality has occurred in the measurement is displayed on the display input unit 30. The error display screen 35 displays information indicating the nature of the abnormality, such as "wiping is insufficient." Also, an error code "5030a" indicating the type of abnormality may be displayed.

[0115] When an abnormality in the measurement is detected by analyzing the test strip image, the control unit 50 may switch the measurement screen 32 to an error display screen 35, or may display the error display screen 35 as a pop-up on the measurement screen 32. After the operator checks the details of the abnormality on the error display screen 35, the operator can return the screen of the display input unit 30 to the measurement screen 32 by pressing the "OK" button at the bottom right of the screen. In this case, when the measurement has reached a certain stage, the screen can be switched to the result list screen 31a to check the details of the abnormality. Alternatively, the measurement of the sample 110 can be interrupted and the details of the abnormality can be immediately checked by operating the search button 317.

[0116] As shown in FIG. 14(b), a mark indicating that a measurement abnormality has occurred is displayed in the list 310 of the result list screen 31a. In the example shown in FIG. 14(b), a mark "!" is added to the column of the sample in which a color abnormality has occurred. The list 310 may also display a mark "Err" indicating that a measurement error has occurred and no measurement result has been obtained. The control unit 50 may display a different mark in the list 310 for each type of abnormality. The mark displayed in the list 310 allows the operator to easily identify the sample in which a measurement abnormality has occurred. The operator can also display the result details screen 36 including the details of the abnormality by selecting a sample with a mark "!" and pressing the result details display button 315.

[0117] 14(c), the result details screen 36 displays a list 360 including the semi-quantitative value of the sample, as well as a first label 361 and a second label 362. The result details screen 36 also displays measurement information such as the sample ID, sequence number, measurement date and time, and type of test strip 100. The first label 361 is an indication that a measurement abnormality has occurred, and includes the word "Error" and an error code "5030a" indicating the type of abnormality. The second label 362 is an indication that indicates the location of the abnormality in the test strip 100, and is displayed superimposed on the test strip image 300.

[0118] The control unit 50 detects the type and location of the abnormality shown in the test strip image 300, and displays information indicating the type and location of the abnormality on the result details screen 36 together with the test strip image 300. Note that on the result details screen 36, the test strip image 300 may be displayed only for samples in which a measurement abnormality occurred, or may be displayed for all samples. The control unit 50 detects abnormalities in the analysis results by analyzing the test strip image 300, and stores the type and location of the abnormality in the memory unit 52.

[0119] The control unit 50 may display a different second label 362 for each type of abnormality. In the example shown in FIG. 14(c), a square frame-shaped mark spanning two reagent pads 102 is displayed as the second label 362, but the shape, size, and color of the mark may be changed for each type of abnormality, or different characters or symbols may be displayed. In this case, the type of abnormality can be ascertained from the second label 362. For example, the color of the mark may be changed for each type of abnormality, with color abnormality displayed in red, color unevenness abnormality displayed in orange, bridge abnormality displayed in green, and immersion abnormality displayed in blue. The details of these abnormalities will be described later.

[0120] FIG. 15 shows an example of a mark (second label 362) having a different shape for each type of anomaly. The shape of the mark indicating the location of an anomaly is not limited to the rectangular frame shape shown in FIG. 14(c), and may be a line, a circle (single circle), a double circle, or a polygon other than a rectangle, as shown in FIG. 15. For example, a line mark 362a indicates a bridge anomaly, and a single circle mark 362b indicates an anomaly due to the presence of a foreign substance such as dust. Also, a double circle mark 362c indicates an anomaly due to remaining sample 110. The second label 362 may be a filled or shaded mark, but is preferably a mark surrounding the location of an anomaly.

[0121] FIG. 16 is a flowchart showing an example of the abnormality display process.

[0122] 16, in step S21, the control unit 50 determines whether or not there is an abnormality by analyzing the test strip image 300. If the control unit 50 detects an abnormality in the test strip image 300 (Yes in step S21), the control unit 50 proceeds to step S22. On the other hand, if the control unit 50 does not detect an abnormality (No in step S21), the control unit 50 ends this series of abnormality display processes.

[0123] In step S22, the control unit 50 stores the type and location of the detected abnormality in association with measurement information such as a sample ID in the storage unit 52. The control unit 50 can determine the type of abnormality by analyzing the test strip image 300, and stores, for example, an error code corresponding to the determined type of abnormality.

[0124] In step S23, the control unit 50 displays an error message to inform the operator that an abnormality has been detected in the measurement. A specific example is to display an error display screen 35 on the display input unit 30. The error display screen 35 displays information indicating the type of abnormality, and may also display a method of dealing with the abnormality.

[0125] In step S24, the control unit 50 accepts an instruction to display details of the abnormality. The instruction to display details of the abnormality is input, for example, by operating the result details display button 315. When the control unit 50 acquires the instruction to display details (Yes in step S24), the control unit 50 advances the process to step S25. On the other hand, when the instruction to display details is not acquired (No in step S24), the control unit 50 skips step S25 and ends this series of abnormality display processes.

[0126] In step S25, the control unit 50 causes the display input unit 30 to display information indicating the type of abnormality and the location of the abnormality. When the control unit 50 receives an operation signal from the result details display button 315, the control unit 50 switches the screen of the display input unit 30 to a result details screen 36 including a first label 361 and a second label 362. The first label 361 prominently displays that an abnormality has occurred in the measurement. The second label 362 displays the location of the abnormality on the test strip image 300.

[0127] The control unit 50 may display a second label 362 with a mark of a different shape, size or colour for each type of abnormality, or may change the letters or symbols affixed to the mark. The operator can quickly check the location of the abnormality from the second label 362 displayed on the test strip image 300, and can also ascertain the type of abnormality from the first label 361, the second label 362, or the test strip image 300. By comparing the test strip image 300 containing the abnormality with a normal test strip image 300 side by side, the operator can efficiently ascertain the cause of the measurement abnormality.

[0128] Below, we will explain in detail the measurement abnormalities detected by analyzing the test strip image 300. We will also explain, with specific examples, how to identify the cause of the abnormality by comparing and referencing the test strip image 300, and how to identify the cause of the abnormality in the analysis results of a quality control sample.

[0129] Measurement abnormalities detected by analyzing the test strip image 300 include immersion abnormalities, bridging abnormalities, color unevenness abnormalities, and color development abnormalities. These abnormalities may be caused by the quality control sample, the test strip 100, the sample analyzer 1, or the testing procedure. These may cause the analysis results of the quality control sample to vary significantly. Among these, measurement abnormalities caused by the testing procedure are most likely to occur, and the testing procedure is likely to cause abnormal analysis results. By arranging multiple test strip images 300 in parallel for comparison, it becomes easier to identify the cause.

[0130] A test strip image 300 showing a normal analysis result may be stored in advance as a reference standard in the sample analyzer 1. Alternatively, a test strip image 300 that serves as a reference standard may be registered by the operator. If an abnormality occurs in the measurement or the analysis result of a quality control sample, the reference standard image may be used as one of the multiple test strip images 300 for comparison and reference, which may make it possible to more efficiently and accurately identify the abnormality or its cause, for example.

[0131] The above-mentioned immersion abnormality occurs when there is a reagent pad 102 that is not in sufficient contact with the sample 110. The color reaction does not proceed in the reagent pad 102 that is not immersed in the sample 110, and therefore a correct analysis result cannot be obtained. Insufficient immersion in the sample 110 is likely to occur in the reagent pad 102 close to the gripping portion 104, and the reflected light intensity of a dry reagent pad 102 is greater than the reflected light intensity of a wet reagent pad 102. Therefore, the immersion abnormality can be detected based on the color (reflected light intensity) of the reagent pad 102 close to the gripping portion 104.

[0132] The bridge abnormality occurs when adjacent reagent pads 102 are connected to each other via the sample 110. In this case, the reagents impregnated in the reagent pads 102 may be mixed together, which may affect the analysis results. Since the base material 101 of the test paper 100 is white, if the sample 110 is present between adjacent reagent pads 102, the reflected light intensity is smaller than when the sample 110 is not present. The bridge abnormality is detected based on this change in the reflected light intensity. Even if the reagent pads 102 are not connected to each other via the sample 110, if the sample 110 remains on the base material 101, this state can be detected as a wiping abnormality.

[0133] The color unevenness abnormality described above occurs when color unevenness occurs in the reagent pad 102. For example, color unevenness occurs in the reagent pad 102 due to the adhesion of powder from other reagent pads 102, other dirt and dust, sedimentary components in the sample 110, etc. to the reagent pad 102, or due to non-uniformity of the reagent pad 102, and this may affect the analysis results. Color unevenness abnormality is detected based on the variation in density values ​​of each pixel constituting the image data of the reagent pad 102, specifically, the difference or ratio between the maximum and minimum density values, the variance value, etc.

[0134] The color abnormality is a state in which the color of the reagent pad 102 deviates significantly from each reference color. Color abnormality is thought to be caused by deterioration of the test paper 100, color reaction inhibitors contained in the sample 110, over-immersion in the sample 110, etc., and in such cases, a correct analysis result cannot be obtained. Color abnormality in each reagent pad 102 is detected based on the magnitude of color difference between the RGB values ​​of the image data of the reagent pad 102 and each reference color in the color coordinate space.

[0135] For example, if discoloration defects or uneven coloring are found in the reagent pad 102 close to the gripping portion 104 of the test strip 100, if the reagent pad 102 is excessively discolored, if the sample 110 remains on the base material 101, or if bridging occurs, then measurement anomalies and abnormal analysis results due to the testing technique are suspected. In this case, it is preferable to compare the test strip image 300 in question with test strip images 300 under the following conditions. <Comparison target> 1) The lot numbers of the test strips 100 are the same. 2) The lot numbers of the quality control samples are the same 3) The operators are different

[0136] By comparing test strip images 300 obtained by measurements performed by different operators and under the same other conditions, the influence of the testing technique on the analysis results becomes clear. If poor discoloration or uneven coloring of the reagent pad 102 close to the gripping portion 104 is observed in the test strip images 300 related to a specific operator, it is presumed that the test strip 100 is not sufficiently immersed in the sample 110. Excessive discoloration of the reagent pad 102 is presumed to be due to over-immersion, and residual sample 110 on the base material 101 is presumed to be due to insufficient wiping of the test strip 100.

[0137] Furthermore, in a measurement using a quality control sample, if each reagent pad 102 discolors uniformly and no residual sample 110 is found on the base material 101, but the discoloration of a particular reagent pad 102 differs, it is suspected that the quality control sample in the same vial has been immersed more than the number of times it should have been used. Specifically, there is a case where the discoloration of the reagent pads 102 used to analyze occult blood (BLD), glucose (GLU), and pH differs, while the other reagent pads 102 discolor appropriately. In this case, it is preferable to compare the test strip image 300 in question with a test strip image 300 under the following conditions. <Comparison target> 1) The lot numbers of the test strips 100 are the same. 2) The lot number of the quality control sample is the same and it is from the same vial. 3) The operator is the same

[0138] The number of times the quality control sample can be used is set to, for example, five times, but there is a possibility that the test strip 100 may be immersed in the test strip more than the number of times it can be used by mistake. If only the test strip image 300 in question contains the above abnormality when compared with the test strip image 300 captured in the measurement of the quality control sample from the same vial, it is presumed that the quality control sample has been used more than the predetermined number of times. Note that if this problem occurs frequently in measurements by a specific operator, it is also effective to compare test strip images 300 based on measurements by different operators.

[0139] Furthermore, in measurements using quality control samples of the same lot number, if each reagent pad 102 is discolored uniformly and no residual sample 110 is found on the base material 101, but the degree of discoloration of the reagent pads 102 varies overall, or if one or two reagent pads 102 are discolored in spots, then the test paper 100 is suspected to be defective. In this case, it is preferable to compare the test paper image 300 in question with a test paper image 300 under the following conditions: <Comparison target> 1) The lot numbers of the test strips 100 are different / or the same 2) The lot numbers of the quality control samples are the same 3) The operator is the same

[0140] If a comparison with images of test papers 100 with different lot numbers reveals that the above problem occurs frequently when using test papers 100 with the same lot number as the test paper 100 of the problematic test paper image 300, it is presumed that there is a defect in the test paper 100 with that lot number. Furthermore, when comparing images of test papers 100 with the same lot number, if patchy discoloration of the reagent pad 102 is confirmed only in the problematic test paper image 300, it is presumed that the abnormality is specific to that test paper 100 due to the adhesion of powder from other reagent pads 102, other debris, dust, etc.

[0141] Furthermore, in measurements using test strips 100 of the same lot number, if the discoloration of each reagent pad 102 is uniform and no residual sample 110 is found on the base material 101, but the discoloration of the reagent pads 102 varies overall, the quality control sample may be defective. In this case, it is preferable to compare the problematic test strip image 300 with test strip images 300 under the following conditions: <Comparison target> 1) The lot numbers of the test strips 100 are the same. 2) The lot numbers of the quality control samples are different, or the lot numbers are the same but the vials are different. 3) The operator is the same

[0142] If a comparison with a test strip image 300 obtained using a quality control sample with a different lot number reveals that the above problem occurs more frequently when a quality control sample with the same lot number as the quality control sample of the problematic test strip image 300 is used, it is presumed that there is a defect in the quality control sample with that lot number. Also, when comparing test strip images 300 obtained using quality control samples with the same lot number but different vials, if the above problem is confirmed only in the problematic test strip image 300, it is presumed that the abnormality is specific to that vial.

[0143] As described above, by displaying multiple test strip images 300 in parallel on the display input unit 30 for comparison, for example, when a measurement abnormality occurs or an abnormality occurs in the analysis results of a quality control sample, the cause of the abnormality or large variation can be efficiently identified. In the semi-automatic sample analyzer 1, variations in the testing technique of the operator in particular can have a significant effect on the analysis results, but by comparing the test strip images 300 acquired by each operator, it becomes easy to find and correct problems in the testing technique. By comparing and referring to test strip images 300 acquired in measurements where only the operator is different and other conditions are the same, the effect of the testing technique on the analysis results becomes clear, so this function of the sample analyzer 1 is also suitable for training in testing techniques.

[0144] The function of being able to display multiple test strip images 300 side by side for comparison is useful not only for identifying the causes of measurement abnormalities and abnormalities in the analysis results of quality control samples, correcting and training testing techniques, and checking differences between lots of quality control samples and test strips 100, as described above, but also for monitoring the urinary components of the same patient.

[0145] Hereinafter, the configuration and method for detecting dirt on the test paper holder 11 will be described in detail with reference to Figs.

[0146] As shown in Figures 17 and 18, the sample analyzer 1 is configured so that the imaging unit 20 captures an image of the test paper holder 11 of the transport unit 10. The imaging unit 20 captures an image of the test paper 100 placed on the test paper holder 11, and in so doing, an image of the test paper holder 11 is obtained. The sample analyzer 1 analyzes the image of the test paper holder 11 to detect dirt on the test paper holder 11. The analysis of the image of the test paper holder 11 and the detection of dirt on the test paper holder 11 are performed by the functions of the control unit 50, which will be described in more detail below.

[0147] As described above, the sample analyzer 1 is a semi-automatic device in which an operator immerses the test paper 100 in the sample 110, wipes off the sample 110 adhering to the back and sides of the test paper 100, and then places the test paper 100 on the test paper holder 11. Therefore, if the sample 110 is not wiped off sufficiently, the sample 110 may adhere to the test paper holder 11 and cause the test paper holder 11 to become dirty. The sample analyzer 1 is provided with a pull-out section 75, and cleaning is performed by pulling out the entire transport section 10 from inside the device and immersing it in a cleaning solution, but it is required to be able to clean the test paper holder 11 efficiently and appropriately. When the transport section 10 is immersed in the cleaning solution, white limescale stains may occur due to insufficient wiping.

[0148] According to the sample analyzer 1, dirt on the test paper holder 11 is automatically detected, and the test paper holder 11 can be efficiently cleaned. In this embodiment, since the sample 110 is urine, there is a problem of odor, and it is preferable that the test paper holder 11 can be quickly cleaned when it becomes dirty. Although multiple test paper holders 11 are provided, dirt can be quickly and accurately detected by using the image of the test paper holder 11 acquired by the imaging unit 20.

[0149] The sample analyzer 1 has, for example, a manual cleaning mode, a continuous cleaning mode, and an automatic detection cleaning mode. The manual cleaning mode is a mode in which the test paper holder 11 is manually transported and cleaned, and the continuous cleaning mode is a mode in which the test paper holder 11 is automatically transported and cleaned continuously. In either case, the operator determines whether the test paper holder 11 is dirty. In contrast, in the automatic detection cleaning mode, dirt is automatically detected by image analysis of the test paper holder 11. The automatic detection cleaning mode may be executable during measurement of the sample 110.

[0150] From the viewpoint of miniaturization and cost reduction of the device, the sample analyzer 1 does not have a function for automatically cleaning the test paper holder 11. For this reason, the test paper holder 11 is cleaned by, for example, an operator wiping off dirt on the test paper holder 11 with a paper towel or the like. In other words, the automatic detection and cleaning mode of the sample analyzer 1 assists the cleaning work of the test paper holder 11.

[0151] In the automatic detection and cleaning mode, the sample analyzer 1 performs a cleaning support operation to automatically detect the test paper holder 11 that needs cleaning and place the test paper holder 11 in a cleaning position where cleaning is possible. In this embodiment, the cleaning position is the placement position P1 of the test paper 100 where the opening 71 of the housing 70 is formed. It is preferable that the sample analyzer 1 further performs, as the cleaning support operation, an operation to display the location where dirt is present on the test paper holder 11 on the display input unit 30 and an operation to recheck the dirt after cleaning.

[0152] When detecting contamination of the test paper holder 11 during measurement of the sample 110, the control unit 50 may control the imaging unit 20 to capture an image of the test paper holder 11 without a test paper 100 placed thereon, and analyze the image of the test paper holder 11 to detect contamination of the test paper holder 11. In this case, the test paper 100 does not get in the way of detecting contamination of the test paper holder 11. The test paper detection unit 40 can detect whether or not a test paper 100 is placed on the test paper holder 11. Since the test paper holder 11 is transported under predetermined conditions, the control unit 50 can determine the timing when a test paper holder 11 in which no test paper 100 is detected at the detection position P2 arrives at the imaging position P3.

[0153] When detecting dirt on the test paper holder 11 during measurement of the sample 110, the control unit 50 may control the imaging unit 20 to capture an image of the test paper holder 11 on which the test paper 100 is placed, and detect dirt on the test paper holder 11. In this case, the part of the test paper holder 11 is extracted by image processing. A test paper holder 11 on which no test paper 100 is placed may never have been used, whereas a test paper holder 11 on which the test paper 100 is placed has been used at least once and is highly likely to be dirty. In addition, if dirt detection is not performed on the test paper holder 11 on which the test paper 100 is placed, a problem of dirt accumulation may be expected when the same test paper holder 11 is used repeatedly.

[0154] The control unit 50 controls the imaging unit 20 to start imaging the test paper holder 11 while moving the imaging unit 20a in the Y direction when the target test paper holder 11 is transported to the imaging position P3. The imaging unit 20 is configured to be able to image the entire test paper holder 11. Since the test paper 100 is placed in the storage section 11a of the test paper holder 11, the imaging range of the imaging element 22 may be limited to the range of the storage section 11a. However, since the sample 110 may also adhere to the extension section 11d, it is preferable to image the entire test paper holder 11.

[0155] When detecting contamination of the test paper holders 11 during measurement of the sample 110, the control unit 50 may capture images of all the test paper holders 11 regardless of whether or not a test paper 100 is present, to detect contamination of the test paper holders 11.

[0156] If the length in the X direction of the imaging range of the imaging element 22 is equivalent to three test paper holders 11 including the adjacent test paper holders 11 as described above, dirt detection may be performed using images of the adjacent test paper holders 11 that are captured when the test paper 100 is imaged. For example, when the test paper holder 11 on which the test paper 100 is placed arrives at the imaging position P3, the control unit 50 captures images of the test paper holder 11 and three test paper holders 11 on either side of it at once, and performs dirt detection for the three test paper holders 11. In other words, dirt detection can be performed using the image of the test paper holder 11 that is captured when the image of the test paper 100 is acquired.

[0157] The control unit 50 detects contamination of the test paper holder 11 by analyzing the image of the test paper holder 11, but performs image processing such as correction, synthesis, and extraction prior to image analysis, as in the case of analyzing the sample 110. The image captured by the imaging unit 20 includes an image of the test paper 100 and an image of the surroundings of the test paper holder 11. In this case, the image of the test paper holder 11 is extracted from the image captured by the imaging unit 20.

[0158] 18, for a test paper holder 11 on which no test paper 100 is placed, the widthwise center of the accommodation section 11a is set as the determination area 120 for stain detection. On the other hand, for a test paper holder 11 on which a test paper 100 is placed, both widthwise ends of the accommodation section 11a are set as the determination area 120. The determination area 120 is the range in which image analysis for stain detection is performed, and can be set as part of the placement surface of the test paper holder 11, or can be set over a wide range exceeding 50% of the placement surface. The determination area 120 may be set as part of the length of the test paper holder 11, such as the part where the protrusion 11e is formed.

[0159] For example, for a test paper holder 11 on which no test paper 100 is placed, the control unit 50 sets the entire mounting surface facing the image sensor 22 as the detection target area for dirt. In this case, the entire mounting surface becomes the determination area 120, but as described below, the mounting surface is divided into multiple determination areas 120 for image analysis. Note that when a test paper 100 is placed on the test paper holder 11, the entire mounting surface excluding the test paper 100 becomes the determination area 120. For example, if the determination area 120 is limited to a part of the test paper holder 11 that is prone to dirt, dirt can be detected more quickly, but if the entire mounting surface is set as the determination area 120, dirt on the test paper holder 11 can be detected more reliably.

[0160] The control unit 50 executes a series of processes for detecting dirt on the test paper holder 11 when the sample analyzer 1 starts up or shuts down. The automatic detection cleaning mode is executed based on an operation on a cleaning mode selection screen 37b (see FIG. 19) described below, but may also be executed automatically as one of the startup operations when the power of the sample analyzer 1 is turned on. The automatic detection cleaning mode may also be executed automatically as one of the shutdown operations of the sample analyzer 1. The automatic detection cleaning mode is executed when the sample 110 is not being measured, for example, between measurements, at startup, or at shutdown, but can also be executed during the measurement of the sample 110 as described above.

[0161] The control unit 50 controls the transport unit 10 to move the test paper holder 11 for which dirt has been detected by image analysis of the test paper holder 11 to the cleaning position. In this embodiment, as described above, the placement position P1 is the cleaning position. Under the control of the control unit 50, the transport unit 10 may transport the test paper holder 11 for which dirt has been detected to the cleaning position as needed, or may transport the test paper holder 11 for which dirt has been detected to the cleaning position after dirt detection has been performed on all test paper holders 11.

[0162] The control unit 50 may control the transport unit 10 to move the test paper holder 11 in which a stain has been detected to the cleaning position based on an instruction from the display input unit 30. For example, the control unit 50 may detect stains on each test paper holder 11 during the measurement of the sample 110, and provide information on the detected stains on the test paper holder 11 and move the test paper holder 11 to the cleaning position based on an instruction from the operator. Under the control of the control unit 50, the transport unit 10 transports the test paper holder 11 in which a stain has been detected to the cleaning position based on, for example, the operation of the display input unit 30. In this case, the operator can move the test paper holder 11 in which a stain has been detected to the cleaning position at any timing, such as when the measurement is completed or when the device is shut down.

[0163] The control unit 50 may further move the cleaned test paper holder 11 from the cleaning position to the imaging position P3, and take an image of the cleaned test paper holder 11 again to detect dirt on the test paper holder 11 again. In this case, the cleaning state can be confirmed by image analysis of the test paper holder 11, so that more reliable cleaning can be achieved. That is, under the control of the control unit 50, the transport unit 10 transports the test paper holder 11 in which dirt has been detected to the cleaning position, and then transports the cleaned test paper holder 11 to the imaging position P3. Under the control of the control unit 50, the imaging unit 20 captures an image of the cleaned test paper holder 11.

[0164] The time for which the test paper holder 11 is stopped at the cleaning position may be a predetermined fixed time, but since the time required for cleaning varies depending on the degree of dirt on the test paper holder 11, it is preferable that the operator can change this time as desired. In this embodiment, when the operator presses the cleaning completion button 377 (see FIG. 19) described below, the next test paper holder 11 is transported to the cleaning position, and the cleaned test paper holder 11 is transported toward the imaging position P3. In other words, the control unit 50 keeps the test paper holder 11 waiting at the cleaning position until an instruction is received from the display input unit 30. In this case, the operator can decide the cleaning time as desired.

[0165] The control unit 50 causes the display input unit 30 to display information about the detected stains on the test paper holder 11. This allows the operator to easily recognize that the test paper holder 11 is stained from the information displayed on the display input unit 30. When stains on the test paper holder 11 are detected, the control unit 50 may cause the display input unit 30 to display the information as needed, or may perform stain detection on all test paper holders 11 and then display the information collectively. Furthermore, the control unit 50 may cause the display input unit 30 to display information about stains on the test paper holder 11 based on an instruction from the display input unit 30.

[0166] It is preferable that the control unit 50 further displays at least one selected from the location of the stain on the test paper holder 11 and the degree of the stain on the display input unit 30. The control unit 50 provides information on which test paper holder 11 is stained and which part of the test paper holder 11 the stain is present in. This allows the operator to easily recognize the part that needs to be cleaned, further improving usability.

[0167] The control unit 50 detects stains based on the difference between pixel values ​​in the image of the test paper holder 11 and pixel values ​​in a reference image of the test paper holder 11 in a state where no stains are present. The pixel values ​​are values ​​of light intensity detected by each pixel of the image sensor 22, and are stored as density values ​​taking any value between 0 and 255, for example. In this embodiment, RGB values ​​showing the light intensity of red, green, and blue, respectively, are used as density values ​​between 0 and 255.

[0168] Since the test paper holder 11 is black, the RGB values ​​of the reference image (hereinafter referred to as "reference RGB values") are all close to 0 for RGB, for example between 0 and 50. Dirt on the test paper holder 11 is, for example, yellow for urine stains and white for limescale stains, so the RGB values ​​of the reflected light from the stained area are greater than the reference RGB values. If the difference between the RGB values ​​in the image of the test paper holder 11 that is the target for stain detection (hereinafter referred to as "target RGB values") and the reference RGB values ​​is large and exceeds a predetermined boundary condition, it can be estimated that dirt is present in the area that corresponds to the target RGB values.

[0169] The presence or absence of dirt is preferably determined by image analysis of the test paper holder 11 by dividing the mounting surface into a plurality of determination regions 120 and comparing the RGB value of each determination region 120 with a reference RGB value. Each determination region 120 is an area including a plurality of pixels. The sizes of the determination regions 120 do not need to be the same, and may differ depending on the position on the mounting surface. The presence or absence of dirt can be determined for each pixel or for the entire mounting surface. However, by determining the presence or absence of dirt for each determination region 120 including a plurality of pixels, it is possible to suppress erroneous detection of dirt and to display the location where dirt exists.

[0170] The control unit 50 calculates the average value of the target RGB values ​​in each judgment region 120, and uses this average value to find the difference α from the reference RGB value. Then, if the ratio of the difference α to the reference RGB value exceeds a predetermined threshold value β, it is determined that a stain is present in the judgment region 120 where α>β. An example of the threshold value β is 50%. Alternatively, the difference α may be compared with a predetermined threshold value γ, and if the difference α exceeds the threshold value γ, it may be determined that a stain is present in the judgment region 120 where α>γ.

[0171] When the image of the test paper holder 11 to be detected for dirt contains a judgment area 120 in which dirt is judged to exist, the control unit 50 stores the test paper holder 11 in the memory unit 52 as a holder requiring cleaning. The control unit 50 also stores the position of the judgment area 120 in which dirt is judged to exist as the location where dirt exists. The control unit 50 may further determine the degree of dirt by comparing the difference α with a plurality of threshold values. As a specific example, when the difference α exceeds a second threshold value that is larger than the threshold value β, it may be judged that the degree of dirt is greater than when the difference α is equal to or smaller than the second threshold value. In this case, the former is stored as a dirt level 2, and the latter is stored as a dirt level 1, which are values ​​indicating the degree of dirt.

[0172] Figure 19 shows an example of a display screen showing the cleaning mode of the test paper holder 11 and information on stains on the test paper holder 11. Figure 19(a) shows a maintenance screen 37a for performing maintenance of the sample analyzer 1. The maintenance screen 37a displays a holder cleaning button 370 for cleaning the test paper holder 11 as one of the maintenance items. By pressing the holder cleaning button 370, the screen of the display input unit 30 switches to a cleaning mode selection screen 37b shown in Figure 19(b).

[0173] As shown in Fig. 19(b), the cleaning mode selection screen 37b displays an automatic detection cleaning selection button 371, a manual cleaning selection button 372, and a continuous cleaning selection button 373. The automatic detection cleaning mode executed by pressing the automatic detection cleaning selection button 371 is a mode in which dirt is automatically detected by image analysis of the test paper holder 11 as described above, and can be executed even during measurement of the sample 110. Information on dirt on the test paper holder 11 as shown in Fig. 19(d) can be displayed at any timing based on an instruction from the display input unit 30. When dirt on the test paper holder 11 is detected during measurement of the sample 110, the result is stored, and the information on the dirt is displayed after the measurement of the sample 110 is completed.

[0174] 19(c) and 19(d) show the progress information screen 37c and the detection result screen 37d, respectively. When the automatic detection and cleaning mode is executed while the sample 110 is not being measured, the screen of the display input unit 30 switches to the progress information screen 37c. The progress information screen 37c displays information indicating that the dirt detection of the test paper holders 11 is being performed. When the dirt detection process is completed for all the test paper holders 11, the screen of the display input unit 30 switches to the detection result screen 37d. When the test paper holders 11 are cleaned after the measurement is completed or during shutdown, the waiting time for the dirt detection can be shortened by detecting the dirt on the test paper holders 11 during the measurement of the sample 110.

[0175] As shown in Fig. 19(d), the detection result screen 37d displays a holder image 375, a dirty location label 376, and a cleaning completion button 377. By displaying the holder image 375, the degree of dirt on the test paper holder 11 can be confirmed on the display input unit 30. The detection result screen 37d may also display at least one selected from letters, numbers, and marks that indicate the degree of dirt. The dirty location label 376 is information for indicating the portion where dirt was detected, and is preferably displayed superimposed on the holder image 375.

[0176] In the example shown in Fig. 19(d), multiple rectangular frame-shaped stain location labels 376 are displayed surrounding the stain on the holder image 375. The shape of the stain location labels 376 is not limited to a rectangular frame, and may be changed according to the degree, shape, size, etc. of the stain. The color of the stain location labels 376 may be changed according to the degree, shape, size, etc. of the stain. The detection result screen 37d further displays the number of test paper holders 11 in which stains were detected. "1 / 7" in Fig. 19(d) means that stains to be cleaned were detected on seven test paper holders 11, and the result for the first of these is displayed.

[0177] The information on the detection result screen 37d preferably corresponds to information on the test paper holder 11 placed at the cleaning position. When the test paper holder 11 arrives at the cleaning position, the control unit 50 causes the display input unit 30 to display the detection result screen 37d for the corresponding test paper holder 11. The operator can clean the test paper holder 11 based on the information displayed on the detection result screen 37d, and when cleaning of the test paper holder 11 is completed, presses the cleaning completion button 377. When the cleaning completion button 377 is pressed, the control unit 50 controls the transport unit 10 to move the next test paper holder 11 for which dirt has been detected to the cleaning position, and moves the cleaned test paper holder 11 toward the imaging position P3.

[0178] FIG. 20 is a diagram showing an example of a judgment screen for the cleaning state of the test paper holder 11. FIG. 20(a) shows a detection result screen 37d for the seventh of the seven test paper holders 11 in which dirt to be cleaned was detected. When cleaning of the last test paper holder 11 is completed and the cleaning completion button 377 is pressed, the screen of the display input unit 30 switches to a progress information screen 37e shown in FIG. 20(b). In this embodiment, the cleaned test paper holder 11 is transported to the imaging position P3 and imaged again, and dirt detection of the test paper holder 11 is performed again. Therefore, the progress information screen 37e continues until the last test paper holder 11 is imaged and the analysis result is obtained. The progress information screen 37e displays information indicating that the cleaning completion check is being performed.

[0179] When the cleaning completion check by imaging the test paper holder 11 and analyzing the image is completed, that is, when the process of re-detecting dirt on the test paper holder 11 is completed, the screen of the display input unit 30 switches to a cleaning judgment screen 37f. If no dirt is detected on the cleaned test paper holder 11, the cleaning judgment screen 37f displays information indicating the completion of cleaning, as shown in Fig. 20(c). When the "OK" button is pressed on the cleaning judgment screen 37f shown in Fig. 20(c), the screen of the display input unit 30 returns to the maintenance screen 37a.

[0180] On the other hand, if dirt is detected on a cleaned test paper holder 11, the cleaning judgment screen 37f will display information indicating that dirt still remains, as shown in Fig. 20(d). When the "OK" button is pressed on the cleaning judgment screen 37f shown in Fig. 20(d), the test paper holder 11 that is not cleaned sufficiently and on which dirt has been detected will be transported to the cleaning position, and the screen of the display input unit 30 will switch to the detection result screen 37d. In this case, the operator needs to check the information on the detection result screen 37d and clean the test paper holder 11 again.

[0181] FIG. 21 is a flow chart showing an example of the automatic detection and cleaning process for the test paper holder 11. In FIG.

[0182] As shown in Fig. 21, in step S31, the control unit 50 sets the test paper holder 11 as the target for stain detection. In the following, it is assumed that all test paper holders 11 are set as the target for stain detection. If the test paper holder 11 as the target for stain detection can be selected, for example, a selection screen is displayed on the display input unit 30. The control unit 50 sets the test paper holder 11 as the target for stain detection based on an instruction from the display input unit 30.

[0183] In step S32, the control unit 50 moves the test paper holder 11 that is the target for stain detection to the imaging position P3. In this embodiment, all test paper holders 11 are the target for stain detection, so the test paper holders 11 are transported to the imaging position P3 one by one. The control unit 50 intermittently drives the drive device 13 of the transport unit 10 under preset conditions to transport the test paper holder 11 to the imaging position P3. The control unit 50 recognizes which test paper holder 11 is in which position.

[0184] In step S33, the control unit 50 controls the imaging unit 20 to capture an image of the mounting surface of the test paper holder 11. For example, the control unit 50 captures an image of the entire mounting surface of the test paper holder 11 while moving the imaging unit 20a in the Y direction. The control unit 50 also performs image processing on the image acquired by the imaging element 22 to extract the range of one test paper holder 11 and synthesize the multiple images to generate one holder image 375 (see FIG. 19(d) etc.).

[0185] In step S34, the control unit 50 performs a stain detection process by analyzing the holder image 375. For example, when the holder image 375 includes a determination area 120 where stains exist, the control unit 50 stores the test paper holder 11 corresponding to the holder image 375 as a holder that needs cleaning. Also, the control unit 50 stores the position of the determination area 120 as a location where stains exist.

[0186] In step S35, the control unit 50 determines whether or not imaging of all the test paper holders 11 has been completed. If imaging of all the test paper holders 11 has been completed (Yes in step S35), the process proceeds to step S36. On the other hand, if imaging of all the test paper holders 11 has not been completed (No in step S35), the process returns to step S32. Note that when the automatic detection and cleaning mode of the test paper holders 11 is executed during measurement of the sample 110, steps S32 to S34 may be repeated throughout the measurement. In this case, when the measurement of the sample 110 is completed, the process proceeds to step S36.

[0187] In step S36, if the information of the holder needing cleaning was stored in step S34 (Yes in step S36), the control unit 50 advances the process to step S37. On the other hand, if the information of the holder needing cleaning was not stored (No in step S36), the control unit 50 causes the display input unit 30 to display information informing the end of the automatic detection cleaning mode, skips steps S37 to S39, and ends the series of processes.

[0188] In step S37, the control unit 50 moves the cleaning-required holder to the cleaning position. In this embodiment, the cleaning position is the placement position P1 of the test paper 100. The control unit 50 drives the drive device 13 of the transport unit 10 to transport the cleaning-required holder to the cleaning position.

[0189] In step S38, the control unit 50 causes the display input unit 30 to display information about the stains on the test paper holder 11. The control unit 50 causes the detection result screen 37d to be displayed, which includes a holder image 375 and a stain location label 376 as information about the stains. The operator can clean the test paper holder 11 using a paper towel or the like while looking at the holder image 375 and the stain location label 376 on the detection result screen 37d. This allows the test paper holder 11 to be cleaned quickly and appropriately. A cleaning complete button 377 is displayed on the detection result screen 37d, and the operator presses the cleaning complete button 377 when cleaning of the test paper holder 11 is completed.

[0190] In step S39, the control unit 50 judges whether cleaning of all test paper holders 11 where dirt was detected has been completed. Specifically, when the control unit 50 receives operation signals of the cleaning completion button 377 equal to the number of holders that need to be cleaned, it judges that cleaning of all test paper holders 11 has been completed (Yes in step S39) and ends the series of processes. On the other hand, if the number of operation signals of the cleaning completion button 377 received is less than the number of holders that need to be cleaned, this means that there are test paper holders 11 that have not been cleaned (No in step S39), and the process returns to step S37.

[0191] When the cleaning completion button 377 is pressed, the control unit 50 controls the transport unit 10 to move the next test paper holder 11 that needs cleaning to the cleaning position, and causes the display input unit 30 to display information about the dirt on that test paper holder 11. The control unit 50 may move the cleaned test paper holder 11 to the imaging position P3 and take an image again to detect dirt on the test paper holder 11 again. In this case, the cleaning state can be confirmed by image analysis of the test paper holder 11. If dirt is detected on the cleaned test paper holder 11, the test paper holder 11 is transported to the cleaning position again.

[0192] FIG. 22 is a flow chart showing an example of a process for detecting dirt on the test paper holder 11.

[0193] 22, in step S341, the control unit 50 divides the holder image 375 captured in step S33 into a plurality of determination regions 120, and acquires the RGB values ​​of each pixel constituting the image data for each determination region 120. In this embodiment, the entire placement surface is divided into a plurality of determination regions 120. Although the size of each determination region 120 is not particularly limited, each determination region 120 includes a plurality of pixels.

[0194] In step S342, the control unit 50 calculates the average value of the RGB values ​​for each judgment area 120, and in step S343, compares the average value of the RGB values ​​of each judgment area 120 with the reference RGB values ​​of the reference image of the test paper holder 11 in a state where no dirt is present. In step S343, it is determined whether or not the difference α between the average value of the RGB values ​​of each judgment area 120 and the reference RGB value exceeds a predetermined threshold value γ. Note that in step S343, it may also be determined whether or not the ratio of the difference α to the reference RGB value exceeds a predetermined threshold value β. It is also possible to compare only the B value of the RGB values ​​of each judgment area 120 with the B value of the reference RGB value to perform the dirt determination.

[0195] If the difference α between the average RGB value of each judgment area 120 and the reference RGB value exceeds the threshold value γ (Yes in step S343), the control unit 50 determines in step S344 that the judgment area 120 where α>γ contains dirt. If the holder image 375 to be analyzed contains a judgment area 120 that is determined to contain dirt, the control unit 50 stores the test paper holder 11 corresponding to the holder image 375 as a holder that needs cleaning. The control unit 50 also stores the position of the judgment area 120 that is determined to contain dirt as the location where dirt exists.

[0196] On the other hand, if the holder image 375 does not include the determination region 120 of α>γ (No in step S343), the control unit 50 skips step S344 and ends the stain detection process. In other words, if the determination region 120 of α>γ is not included in the holder image 375, it is determined that the test paper holder 11 corresponding to the holder image 375 does not have any stains to be cleaned.

[0197] As described above, by automatically detecting dirt on the test paper holder 11 by analyzing the image of the test paper holder 11, it is possible to efficiently clean the test paper holder 11 appropriately. The operator can execute the automatic detection and cleaning mode when the sample analyzer 1 starts up, when shutting down, between measurements of the sample 110, or during the measurement of the sample 110. When dirt to be cleaned is detected by image analysis of the test paper holder 11, information including the location of the dirt on the holder that needs to be cleaned is displayed on the display input unit 30, and the holder that needs to be cleaned is transported to the cleaning position. Therefore, the operator can quickly and accurately clean the holder that needs to be cleaned while looking at the information displayed on the display input unit 30.

[0198] If a sample adheres to the test paper holder 11 and dirt accumulates, this can affect the analysis results and cause hygiene problems, for example, but the sample analyzer 1 can more reliably prevent the occurrence of such problems.

[0199] The above embodiment can be modified as appropriate without impairing the object of the present invention. For example, although the sample analyzer 1 is configured to be able to execute the automatic detection and cleaning mode, a sample analyzer as another example of the embodiment does not need to have the function of the automatic detection and cleaning mode.

[0200] In addition, the sample analysis device 1 is a semi-automatic device in which a test paper 100 containing a sample 110 is prepared by an operator and placed in a test paper holder 11, but the configuration of the sample analysis device of the present invention can also be applied to a fully automatic device such as the example shown in Figure 23.

[0201] 23 is a diagram showing a schematic configuration of a sample analyzer 2 according to another embodiment. The sample analyzer 2 is a fully automatic device that automatically places the test paper 100 on the test paper holder 11 and deposits the sample 110 onto the test paper 100. The sample analyzer 2 is similar to the sample analyzer 1 in that it includes a transport unit 10 including a plurality of test paper holders 11, an imaging unit 20 including a light source 21 and an imaging element 22, and a recovery unit 80.

[0202] On the other hand, the sample analyzer 2 differs from the sample analyzer 1 in that it includes a robot arm 90 for placing the test paper 100 on the test paper holder 11, a dispensing device 91 for applying a sample 110 to the test paper 100, and a storage unit 92 for the test paper 100. For example, a urine collection tube containing the sample 110 and a cleaning agent container containing a cleaning agent 111 for cleaning the nozzle of the dispensing device 91 are placed in the sample analyzer 2.

[0203] In the sample analyzer 2, similarly to the case of the sample analyzer 1, the test paper 100 is placed on the test paper holder 11 at the placement position P1, then transported to the imaging position P3 to capture an image of the test paper 100, and the sample 110 is analyzed by image analysis of the test paper 100. Note that in the sample analyzer 2, the test paper 100 is not immersed in the sample 110, and no sample 110 is attached to the test paper 100 at the placement position P1. The test paper 100 is placed on the test paper holder 11 by the robot arm 90 with the reagent pad 102 facing upward, and the dispensing device 91 dispenses the sample 110 onto the reagent pad 102 of the test paper 100 at the application position P4.

[0204] In the sample analyzer 2 as well, when the sample 110 is applied to the test strip 100, the sample 110 may adhere to the test strip holder 11, causing the test strip holder 11 to become dirty. For this reason, it is preferable for the sample analyzer 2 to be equipped with an automatic detection and cleaning mode function in order to efficiently clean the test strip holder 11 appropriately. It is also preferable for the sample analyzer 2 to be equipped with a function for displaying multiple test strip images 300 in parallel in order to efficiently identify the cause of any abnormality in the analysis results. [Explanation of symbols]

[0205] 1,2 Sample analysis device 10. Conveyor 11 Test paper holder 11a Storage section 11b Bottom plate 11c side wall 11d Extension 11e protrusion 12 Transport mechanism 12a endless belt 12b, 12c Pulley 13,25 Drive unit 20 Imaging unit 20a Imaging unit 21 Light source 22 Image sensor 23 Support 24 Guide rail 30 Display and input section 31a,31b Result list screen 32 Measurement screen 33a~33e Selection screen 34 Enlarged display screen 35 Error display screen 36 Result details screen 37a Maintenance screen 37b Cleaning mode selection screen 37c,37e Progress information screen 37d Detection result screen 37f Cleaning judgment screen 40 Test paper detection unit 50 Control section 51 Arithmetic section 52 Storage section 55 Substrate 60 Printing section 70 Case 70a Top cover 70b Lower cover 70c front cover 71, 72, 73 Openings 75 Drawer section 76 Tray 77 Recess 78 Lock lever 80 Collection Department 90 Robot Arm 91 Dispensing device 92 Storage Department 100 Test Papers 101 Base material 102 Reagent Pad 103 Identification 104 Gripping part 110 Samples 111 Wipe Paper 120 Judgment area 300 Test Paper Images 310 List 311a, 311b Screen switching button 312 Display condition switching button 313 Selection button 314 Scroll button 315 Result details display button 316 Filter Settings Button 317 Search button 318 Information sharing button 320 Indicator 321 List 322 Measurement button 330 Filtering switch button 331 First selection button 332 Second selection button 333 3rd selection button 334 4th selection button 335 5th selection button 336 6th selection button 337b, 337d Type selection button 338b, 338d Lot selection button 340 Motion Button 341 Back button 360 List 361 1st Label 362, 362a, 362b, 362c Second Label 370 Holder cleaning button 371 Auto detect cleaning selection button 372 Manual cleaning selection button 373 Continuous cleaning selection button 375 Holder Images 376 Dirt Location Label 377 Cleaning complete button

Claims

1. an imaging unit for imaging the test paper; A control unit that analyzes the test strip image obtained by imaging; a display unit that displays the analysis result of the test strip image; an input unit for inputting a predetermined instruction; Equipped with The control unit causes the display unit to display the test strip images selected by the input unit.

2. a storage unit for storing the test strip image in association with at least one measurement information selected from measurement date and time information, operator information, identification information of the test strip, identification information of a quality control sample, and identification information of a test sample; The sample analyzer of claim 1 , wherein the control unit causes the display unit to display a screen for selecting the measurement information, and causes the display unit to display a plurality of the test strip images corresponding to the measurement information selected by the input unit.

3. The sample analyzer according to claim 1 , wherein the control unit causes a list of the analysis results to be displayed on the display unit, and causes a plurality of the test strip images selected from the list of the analysis results by the input unit to be displayed on the display unit.

4. The sample analysis device of claim 1, wherein the control unit causes a list of the analysis results relating to quality control samples to be displayed on the display unit, and causes a plurality of the test strip images selected from the list of analysis results by the input unit to be displayed on the display unit.

5. The test paper includes a plurality of types of reagent pads that are impregnated with a sample; The sample analyzer according to claim 1 , wherein the control unit causes the display unit to display the plurality of test strip images in the same orientation so that the reagent pads of the same type of the test strips are aligned in a row in the plurality of test strip images.

6. The sample analyzer according to claim 1 , wherein the control unit enlarges and displays a portion of the test strip image based on an enlargement instruction from the input unit.

7. The sample analyzer according to claim 6 , wherein the control unit enlarges and displays the same portions of the plurality of test strip images at the same magnification, based on an instruction to enlarge one of the test strip images from the input unit.

8. The sample analyzer according to claim 6 , wherein the control unit enlarges and displays another part of the test strip image based on an instruction to change the display area by the input unit.

9. The sample analyzer according to claim 1 , wherein the control unit detects the type of abnormality and the location of the abnormality appearing in the test strip image, and causes the display unit to display information indicating the type of abnormality and the location of the abnormality together with the test strip image.

10. The sample analyzer of claim 9 , wherein the control unit causes a different mark to be displayed for each type of abnormality.

11. The sample analysis device according to claim 2, wherein the control unit causes the display unit to display a plurality of the test strip images corresponding to measurements in which at least one selected from the lot number of the test strip, the lot number of the quality control sample, the vial of the quality control sample, and the operator information is the same.

12. The sample analysis device of claim 11, wherein the control unit causes the display unit to display a plurality of test strip images, at least one of which corresponds to a different measurement selected from the lot number of the test strip, the lot number of the quality control sample, the vial of the quality control sample, and the operator.

13. The sample analyzer according to any one of claims 1 to 12, further comprising a placement section on which the test paper is placed by an operator.

14. 13. The sample analyzer according to claim 1, wherein the test paper includes a plurality of types of reagent pads into which a sample is impregnated by an operator.

15. taking an image of the test strip, analyzing the obtained test strip image, and storing the test strip image; Selecting a plurality of specific images from the plurality of stored test strip images; The sample analysis method further comprises displaying the plurality of specific images on the display unit.

Images