Sample analysis device and method for determining soil of placement part configured

Abstract

The invention relates to a sample analyzer and a method for determining fouling of a placement part constituting the sample analyzer. In a sample analyzer, cleaning of a placement portion can be efficiently and appropriately performed. A sample analyzer (1), which is an example of an embodiment, is provided with: a transport unit (10) that has a test paper holder (11) on which a test paper (100) is placed, and that moves the test paper holder (11); an imaging unit (20) that images the test paper (100) placed on the test paper holder (11) at an imaging position (P3); and a control unit (50) that analyzes the test strip image (300). The imaging unit (20) captures an image of the test paper holder (11), and the control unit (50) analyzes the captured image of the test paper holder (11) and detects dirt on the test paper holder (11).

Description

Technical Field

[0001] The present invention relates to a sample analyzer for analyzing components in a sample using a test paper, and a method for determining contamination of a placing portion constituting the sample analyzer. Background Art

[0002] In the past, there are known sample analysis devices that analyze the components contained in a sample based on a reaction caused by contacting a sample such as urine or saliva with a test paper (for example, refer to Patent Document 1). Among such sample analysis devices, there are semi-automatic devices and fully automatic devices. In the case of a semi-automatic device, the tester immerses the test paper in the sample and places the test paper on the loading portion of the device. In the case of a fully automatic device, after the test paper is automatically placed on the loading portion, the sample is dripped on the test paper. In either case, the image obtained by photographing the test paper placed on the loading portion is analyzed to analyze the components contained in the sample.

[0003] Prior art literature

[0004] Patent Literature

[0005] Patent Document 1: Japanese Patent Application Publication No. 2017-72567

[0006] Problems to be solved by the invention

[0007] In any semi-automatic or fully automatic sample analyzer, there is a situation where samples such as urine and saliva adhere to the loading part where the test paper is placed. Therefore, the loading part is cleaned regularly. In the sample analyzer, it is an important issue to be able to clean the loading part efficiently and appropriately. Summary of the invention

[0008] Means for solving problems

[0009] The sample analysis device (1, 2) of the present invention is configured to photograph a test paper 100 and analyze the image of the test paper 100 to analyze the sample, and is characterized in that it comprises: a conveying unit 10, wherein the conveying unit has a loading unit 11 for loading the test paper 100, and moves the loading unit 11 to a shooting position P3 of the test paper 100; a control unit 50, wherein the control unit analyzes the image of the test paper 100 taken; and a shooting unit 20, wherein the shooting unit 20 is configured to be able to photograph the loading unit 11, and the control unit 50 analyzes the image of the loading unit 11 taken to detect dirt on the loading unit 11.

[0010] According to the above configuration, the image of the placement section 11 can be analyzed to automatically detect dirt on the placement section 11. Therefore, the placement section 11 can be cleaned efficiently and appropriately. For example, the operator does not need to check whether the placement section 11 is dirty, and can clean the placement section 11 where dirt is detected based on the detected information.

[0011] The method for detecting dirt on a loading portion of the present invention is a method for determining dirt on a loading portion 11 in a sample analysis device (1, 2) having a photographing portion 20 and a loading portion 11 for loading a test paper 100, and is characterized in that the loading portion 11 is photographed and the photographed image of the loading portion 11 is analyzed to detect dirt on the loading portion 11.

[0012] Effects of the Invention

[0013] According to the sample analysis device of the present invention, the placement portion can be cleaned efficiently and appropriately. If the sample adheres to the placement portion and dirt accumulates, for example, it may affect the measurement results or cause hygiene problems, but according to the sample analysis device of the present invention, the occurrence of such problems can be more reliably suppressed. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 This is a diagram showing a schematic configuration of a sample analyzer as an example of an embodiment.

[0015] Figure 2 It is a perspective view showing the appearance of the sample analysis device.

[0016] Figure 3 It is a perspective view showing the internal structure of the sample analysis device.

[0017] Figure 4 It is a side view showing the internal structure of the sample analysis device.

[0018] Figure 5 It is a three-dimensional diagram of the test strip holder.

[0019] Figure 6 It is a perspective view showing an example of a test paper.

[0020] Figure 7 This is a block diagram showing the structure of a sample analysis device.

[0021] Figure 8 This is a flowchart showing an example of sample analysis processing.

[0022] Fig. 9 (a) and (b) are diagrams showing examples of display screens showing sample analysis results.

[0023] Fig.10 This is a diagram showing an example of a measurement screen.

[0024] Fig.11 (a) to (e) are diagrams showing an example of a test paper image selection screen displayed on the screen.

[0025] Fig.12 (a) to (c) are diagrams showing examples of enlarged display screens of test paper images.

[0026] Fig.13 This is a flowchart showing an example of the display process of the test strip image.

[0027] Fig.14 (a) to (c) are diagrams showing examples of error display screens.

[0028] Fig.15 This is an example of a mark indicating a site where an abnormality has occurred.

[0029] Fig.16 This is a flowchart showing an example of abnormality display processing.

[0030] Fig.17 This is a diagram for explaining a dirt detection function of a test paper holder in a sample analyzer as an example of an embodiment.

[0031] Fig.18 This is a diagram for explaining a dirt detection function of a test paper holder in a sample analyzer as an example of an embodiment.

[0032] Fig.19 (a) to (d) are diagrams showing an example of a display screen showing a cleaning mode of a test strip holder and information related to dirt on the holder.

[0033] Fig. 20 (a) to (d) are diagrams showing an example of a determination screen for the cleaning state of the test paper holder.

[0034] Fig.21 This is a flowchart showing an example of the automatic detection and cleaning process of the test strip holder.

[0035] Fig. 22 This is a flowchart showing an example of the dirt detection process of the test paper holder.

[0036] Fig.23 It is a diagram showing a schematic configuration of a sample analyzer as another example of the embodiment.

[0037] Description of Reference Numerals

[0038] 1.2 Sample analysis device

[0039] 10Conveying unit

[0040] 11Test paper holder

[0041] 11a Containment Section

[0042] 11b base plate

[0043] 11c side wall

[0044] 11d extension

[0045] 11e protrusion

[0046] 12Conveying mechanism

[0047] 12a Ring belt

[0048] 12b, 12c pulley

[0049] 13, 25 drive device

[0050] 20 Photography Department

[0051] 20a Shooting unit

[0052] 21 Light Source

[0053] 22 camera elements

[0054] 23 Support body

[0055] 24 rails

[0056] 30 Display input unit

[0057] 31a, 31b Results List Screen

[0058] 32 Measurement screen

[0059] 33a~33e selection screen

[0060] 34 Enlarge the display screen

[0061] 35 Error display screen

[0062] 36Result details screen

[0063] 37a Maintenance screen

[0064] 37b Cleaning mode selection screen

[0065] 37c, 37e progress information screen

[0066] 37d test result screen

[0067] 37f Cleaning judgment screen

[0068] 40Test paper detection department

[0069] 50 Control Department

[0070] 51 Operation unit

[0071] 52 Storage

[0072] 55 substrate

[0073] 60 Printing Department

[0074] 70 frame

[0075] 70a upper cover

[0076] 70b lower cover

[0077] 70c front cover

[0078] 71, 72, 73 openings

[0079] 75 pull-out unit

[0080] 76 Pallets

[0081] 77 concavity

[0082] 78 Locking lever

[0083] 80 Recycling Department

[0084] 90 Robotic Arm

[0085] 91 dispensing device

[0086] 92 Storage Department

[0087] 100 test strips

[0088] 101 Base Material

[0089] 102 reagent pad

[0090] 103 Identification Mark

[0091] 104 grip

[0092] 110 samples

[0093] 111 Wiping Paper

[0094] 120 judgment area

[0095] 300 test strip images

[0096] 310 List

[0097] 311a, 311b screen switching button

[0098] 312 Display condition switch button

[0099] 313 Select Button

[0100] 314 Scroll Button

[0101] 315 Result details display button

[0102] 316 Filter settings button

[0103] 317 Search Button

[0104] 318 Information Sharing Button

[0105] 320 indicator

[0106] 321 List

[0107] 322 Measurement button

[0108] 330 Filter toggle button

[0109] 331 First Choice Button

[0110] 332 Second selection button

[0111] 333 Third choice button

[0112] 334Fourth selection button

[0113] 335 Fifth Selection Button

[0114] 336 Sixth selection button

[0115] 337b, 337d type selection button

[0116] 338b, 338d Batch selection buttons

[0117] 340 Action Buttons

[0118] 341 Back button

[0119] 360 List

[0120] 361 First Label

[0121] 362, 362a, 362b, 362c second label

[0122] 370 bracket cleaning button

[0123] 371 Automatic detection cleaning selection button

[0124] 372 Manual cleaning selection button

[0125] 373Continuous cleaning selection button

[0126] 375 Bracket Image

[0127] 376 Dirt Part Label

[0128] 377 Cleaning completed button DETAILED DESCRIPTION

[0129] Hereinafter, the sample analysis device and the sample analysis method of the present invention will be described in detail with reference to the accompanying drawings. The embodiment described below is only an example, and the present invention is not limited to the following embodiment. In addition, the present invention also includes a method in which the components of the multiple embodiments and modified examples described below are selectively combined.

[0130] Figure 1 1 is a schematic diagram for explaining the schematic structure of a sample analysis device 1 and the outline of a sample analysis method as an example of an embodiment of the present invention. Figure 1 As shown, the sample analysis device 1 is a device for analyzing the sample 110 by photographing the test paper 100 immersed in the sample 110, and includes a conveying unit 10 and a photographing unit 20. The conveying unit 10 has a test paper holder 11 as a loading unit for the operator to load the test paper 100. A plurality of test paper holders 11 are provided in the conveying unit 10. The conveying unit 10 moves the test paper holder 11 to convey the test paper 100 to the photographing position P3, and the photographing unit 20 photographs the test paper 100 at the photographing position P3. The photographing unit 20 includes a light source 21 and a photographing element 22.

[0131] The sample analyzer 1 further includes a test paper detection unit 40 for detecting the test paper 100 placed on the test paper holder 11, and a recovery unit 80 for recovering the test paper 100 after the image is taken. In the sample analyzer 1, the operator places the test paper 100 on the test paper holder 11 at a loading position P1 determined. The detection position P2 of the test paper 100 detected by the test paper detection unit 40 is set between the loading 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 loading 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 recovered by the recovery unit 80.

[0132] The sample 110 analyzed by the sample analyzer 1 is a liquid that can be immersed in the test paper 100, and is a liquid sample collected from a person such as saliva, body fluid, and urine. In the following, it is described that the sample 110 is urine and the sample analyzer 1 is used for urine testing. It should be noted that the sample 110 includes a sample to be tested and a sample for precision control. In the sample analyzer 1, the operator immerses the test paper 100 in urine as the sample 110, wipes off the urine attached to the test paper 100, and then places the test paper 100 on the test paper holder 11 at the placing position P1. Specifically, the excess urine attached to the test paper 100 is wiped off with the wiping paper 111, and the test paper is placed on the test paper holder 11 with the reagent pad 102 facing upward.

[0133] The sample analyzer 1 automatically transports the test paper 100 placed on the test paper holder 11 from the placement position P1 to the imaging position P3 to image the test paper 100 and analyzes the sample 110 based on the image of the test paper 100. As described above, the operator needs to prepare the test paper 100 placed on the test paper holder 11, that is, the test paper 100 soaked in urine and wiped off the excess urine. The sample analyzer 1 is called a semi-automatic device compared to the sample analyzer 2 described later, which automatically places the test paper 100 on the placement portion and drips the sample 110 on the test paper 100.

[0134] The test paper detection unit 40 detects the test paper 100 placed on the test paper holder 11 at the 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 the normal measurement mode in which the automatic detection cleaning mode described later is not performed. The imaging unit 20 photographs the test paper holder 11 in a manner of photographing the entire test paper holder 11. The test paper detection unit 40 uses, for example, an optical sensor having a light emitting unit and a light receiving unit.

[0135] Below, refer to Figure 2 to Figure 4 The structure of the sample analyzer 1 will be described in detail. Figure 2 It is a diagram showing the appearance of the sample analyzer 1 . Figure 3 as well as Figure 4 is a diagram showing the internal structure of the sample analysis device 1. Figure 3 The figure shows a state where the upper cover 71 a of the frame body 70 is removed.

[0136] In the following, for the sake of convenience, terms indicating directions are used. Figure 2 to Figure 4 In the XYZ orthogonal coordinate system shown, the X direction is the direction along the conveying direction of the test paper 100, the Z direction is the direction along the vertical direction, and the Y direction is the direction orthogonal to the X direction and the Z direction. It should be noted that the X direction is sometimes referred to as the left-right direction, the Y direction is referred to as the front-back direction, and the Z direction is referred to as the up-down direction. The direction in which the pull-out portion 75 described later is pulled out is set to the front, and the left and right are the left and right when the sample analyzer 1 is viewed from the front.

[0137] like Figure 2 to Figure 4 As shown in FIG. 1 , the sample analyzer 1 includes a frame 70 that covers the internal structure of the device, such as the conveying unit 10 and the imaging unit 20. The frame 70 includes an upper cover 70a, a lower cover 70b, and a front cover 70c, and forms the 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 constituting the conveying unit 10. Through the opening 71 of the upper cover 70a, the operator can place the test paper 100 on the test paper holder 11 disposed inside the device. The position where the opening 71 is formed is a placement position P1 where the test paper 100 is placed on the test paper holder 11.

[0138] The sample analyzer 1 further includes a display input unit 30. The display input unit 30 functions as a display unit for displaying the analysis results of the sample 110 and an input unit for inputting a predetermined instruction. The display input unit 30 is composed of a touch panel. It should be noted that the display unit and the input unit may be provided separately. In addition, the sample analyzer 1 includes a control unit 50 (see below). Figure 7 ) of the microcomputer and the printing unit 60. The printing unit 60 is a printer that prints the analysis result of the sample 110.

[0139] The sample analyzer 1 has a shape that is longer in the X direction (left-right direction) than in the Y direction (front-back direction) and the Z direction (up-down direction), and the right side of the device is one level higher than the left side. The imaging unit 20, the display input unit 30, and the printing unit 60 are arranged on the right side of the sample analyzer 1, and the display input unit 30 and the printing unit 60 are arranged on the upper surface of the sample analyzer 1. The placement position P1 of the test paper 100 is set on the left side of the sample analyzer 1. In addition, the substrate 55 is arranged from the right side to the left side of the sample analyzer 1.

[0140] The sample analyzer 1 is a small analyzer that can be placed on a table in an examination room, a diagnosis room, etc. and can be easily carried by one person, and is configured to be able to transport the test paper 100 to the imaging position P3 at any time. Since the transport unit 10 has a plurality of test paper holders 11, even during image analysis of one test paper 100, the test paper 100 can be placed on the test paper holder 11 at the placement position P1, and the test paper holder 11 on which the test paper 100 is placed can be transported toward the imaging position P3. The transport unit 10 is configured so that the plurality of test paper holders 11 circulate and move along the X direction of the device.

[0141] The sample analysis device 1 is provided with a pull-out portion 75 including a tray 76 to which the conveying portion 10 is fixed, and is configured to be able to pull out the conveying portion 10 forward. The tray 76 is fixed to the front surface cover 70c of the frame 70, and is pulled out by pulling the front surface cover 70c forward. The front surface cover 70c and the tray 76 together constitute the pull-out portion 75. A recess 77 into which a finger can be inserted is formed on the front surface cover 70c as a handle. In addition, a locking rod 78 for locking the movement of the pull-out portion 75 is provided at a position adjacent to the recess 77. By providing the pull-out portion 75, the conveying portion 10 can be pulled out from the inside of the device for cleaning.

[0142] The conveying unit 10 includes a plurality of test paper holders 11 for placing the test paper 100, a conveying mechanism 12 for the test paper holders 11, and a driving device 13. The test paper holders 11 are configured to be placed by the operator on the test paper 100. On each test paper holder 11, one test paper 100 is placed at the placing position P1. As described above, the position of the opening 71 formed in the upper cover 70a is the placing position P1. The opening 71 is formed to a size that allows the entire test paper holder 11 to be exposed.

[0143] The test paper 100 is placed on the test paper holder 11 with the gripping portion 104 of the test paper 100 extending from the holder (see the following description). Figure 5 , 6 ). In addition, the gripping portion 104 of the test paper 100 is in a state of protruding from the inside of the frame 70 to the front of the device. In this case, the operator can operate the gripping portion 104 from the outside of the device, and can easily place the test paper 100 at an appropriate position on the test paper holder 11. The left side of the sample analyzer 1 has a shape that is recessed backwards compared to the right side, and a slit-shaped opening 72 for the gripping portion 104 to pass through is formed at the upper end of the front cover 70c.

[0144] The opening 71 of the upper cover 70a is formed in a slit shape along the front-back direction (Y direction) from the front end of the upper cover 70a. The opening 72 of the front cover 70c is formed continuously with the opening 71 from the placement position P1 to the portion of the device protruding forward. In this case, even when the gripping portion 104 of the test paper 100 protrudes forward from the inside of the device, it is possible to prevent the test paper 100 from contacting the frame 70.

[0145] The conveying mechanism 12 is a mechanism for conveying the test paper holder 11, and includes an endless belt 12a, a pulley 12b, and a pulley 12c. The endless belt 12a is a belt-shaped body formed in an annular shape. On the endless belt 12a, a plurality of test paper holders 11 are mounted independently of each other. Adjacent test paper holders 11 are arranged close to each other with a gap to the extent that they do not contact each other. The pulleys 12b and 12c are arranged to be spaced apart in the X direction, and their respective rotation axes are along the Y direction. The pulley 12c is a driving pulley driven by the driving device 13, and the pulley 12b is a driven pulley.

[0146] The endless belt 12a is mounted on the pulleys 12b and 12c and rotates by the drive of the pulley 12c. As the endless belt 12a rotates, the test paper holder 11 mounted on the endless belt 12a moves in a circular motion along the X direction, and the test paper 100 placed on the test paper holder 11 is transported from the loading position P1 on the left side of the device to the shooting position P3 on the right side of the device. Afterwards, the test paper holder 11 that has transported the test paper 100 returns to the loading position P1 again. The recovery unit 80 (refer to Figure 1) is arranged near the pulley 12c. When the test paper holder 11 is turned over at the position of the pulley 12c, the test paper 100 after the image is taken falls to the collection unit 80 and is collected.

[0147] As described above, the placement position P1 where the test paper 100 is placed on the test paper holder 11 and the shooting position P3 where the test paper 100 is shot by the shooting unit 20 are separated in the X direction. As will be described in detail later, the test paper 100 includes a plurality of reagent pads 102. When the test paper 100 is moved from the placement position P1 to the shooting position P3, a predetermined component in the sample 110 reacts with a reagent contained in the reagent pad 102 of the test paper 100. Therefore, the time for the test paper 100 to move from the placement position P1 to the shooting position P3 is set to a time for the reaction to occur neither too much nor too little and for the reagent pad 102 to develop color appropriately.

[0148] The driving device 13 is a device that drives the pulley 12c to rotate. The driving device 13 is, for example, a stepping motor that drives the pulley 12c intermittently. As a result, the test paper holder 11 installed on the endless belt 12a moves intermittently from the loading position P1 toward the shooting position P3, and the test paper holder 11 can be stopped at the loading position P1 and the shooting position P3 for a specified time. The specified time, that is, the working interval of the driving device 13, is preferably set to a short time within a range that does not hinder the loading of the test paper 100 on the test paper holder 11 and the shooting of the test paper 100. An example of the specified time is 5 seconds to 10 seconds. An example of the driving time of the driving device 13 is 0.3 seconds to 1 second.

[0149] The imaging unit 20 includes a light source 21 , an imaging element 22 , and a support body 23 . Figure 4 The imaging unit 20 shown in the example includes a pair of light sources 21, which are arranged to face each other in the X direction and sandwich an imaging element 22. The two light sources 21 and the imaging element 22 are supported by a support 23 and arranged above the conveying unit 10. The imaging unit 20a composed of 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 unit 20 includes a driving device 25 that moves the imaging unit 20a along the guide rails 24.

[0150] The light source 21 includes a light emitting element for illuminating the photographed object. By arranging a pair of light sources 21 at obliquely above and to the left and right of the photographing position P3 to illuminate the test paper 100, the test paper 100 can be illuminated more evenly. The type of the light source 21 is not particularly limited, but the light source 21 preferably uses a small light emitting diode (LED) that generates less heat. It should be noted that in the sample analysis device 1, since the color rendering degree of the reagent pad 102 of the test paper 100 is measured, the light emitting element constituting the light source 21 uses a light emitting element that outputs white light. A diffusion plate for uniformizing the light output from the light emitting element can also be provided in the light source 21.

[0151] 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 conveying portion 10 with the light receiving surface facing downward. In the present embodiment, the imaging range of the imaging element 22 is set to a size capable of capturing a portion of the test paper 100. Here, the imaging range refers to a range that can be captured when the position of the imaging element 22 is fixed. The imaging element 22 captures the test paper 100 while moving along the guide rail 24 in the long side direction (Y direction) of the test paper holder 11. In this case, the imaging element 22 can be disposed close to the test paper 100, and the sample analysis device 1 can be miniaturized.

[0152] The Y-direction length of the shooting range of the imaging element 22 is shorter than the length of the test paper 100, and is set to be, for example, about a quarter of the length of the test paper 100. The X-direction length of the shooting range of the imaging element 22 is preferably greater than the width of the test paper holder 11, and may be a length that can capture three test paper holders 11 including the test paper holders 11 adjacent to both sides. An example of the size of the shooting range of the imaging element 22 is 30 mm×30 mm.

[0153] 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, a charge corresponding to the intensity of the light is generated, and the imaging element 22 takes out the size of the charge as an electrical signal, thereby detecting the light intensity of each pixel. The imaging element 22 converts the detected light intensity into 256 grayscale shading data (density value), for example, and generates an image based on the data.

[0154] The support body 23 supports the light source 21 and the imaging element 22 in a state where the positional relationship between the pair of light sources 21 and the imaging element 22 remains unchanged. Furthermore, the support body 23 is mounted on a pair of guide rails 24 in a state where it can slide and move in the Y direction. Therefore, even if the support body 23 moves in the Y direction along the guide rails 24, the lighting conditions when the imaging element 22 photographs the test paper 100 do not substantially change.

[0155] The driving device 25 is a motor that moves the imaging unit 20a along the guide rail 24. The driving device 25 can move the imaging unit 20a continuously or intermittently by repeatedly moving and stopping for a predetermined time. The imaging element 22 of the imaging unit 20a photographs all the reagent pads 102 of the test paper 100 while moving in the Y direction. In addition, the imaging element 22 photographs the identification mark 103 of the test paper 100 (see the following description). Figure 6 ).

[0156] The display input unit 30 is a device that has both the function of a display unit and the function of an input unit. An example of a preferred display input unit 30 is a touch panel display. An opening 73 for exposing the surface of the display is formed on the upper cover 70a of the frame 70. The surface of the display is arranged roughly coplanar with the upper surface of the upper cover 70a on the right side of the higher-level sample analysis device 1. The type of display can be any one of a liquid crystal display and an organic EL display, and is not particularly limited. The details of the screen displayed on the display input unit 30 will be described later.

[0157] As described above, the substrate 55 is a printed circuit board equipped with a microcomputer constituting the control unit 50, and is connected to the conveying unit 10, the imaging unit 20, the display input unit 30, the test paper detection unit 40, and the printing unit 60 so as to be communicable. As will be described in detail later, the control unit 50 comprehensively controls the operation of the sample analysis device 1, and analyzes the test paper image obtained by the imaging unit 20 to perform analysis of the sample 110. In addition, the control unit 50 causes the display input unit 30 to display the test paper image, and performs control related to dirt detection of the test paper holder 11. The substrate 55 is arranged in the frame 70 at a position closer to the rear of the device than the conveying unit 10, but the shape and arrangement of the substrate 55 are not particularly limited.

[0158] Reference Figure 5 as well as Figure 6 , the test paper holder 11 and the test paper 100 are described in detail. Figure 5 It is a three-dimensional diagram of the test paper holder 11. Figure 6 It is a three-dimensional diagram of the test paper 100 .

[0159] like Figure 5 As shown, the test paper holder 11 is a tray-shaped holder having a bottom plate 11b which is rectangular when viewed from above and a pair of side walls 11c which are respectively erected at both ends of the bottom plate 11b in the width direction. In addition, the test paper holder 11 has a pair of extensions 11d extending from the upper ends of each side wall 11c toward the outside of the width direction of the holder. A receiving portion 11a surrounded by the bottom plate 11b and a pair of side walls 11c on three sides is formed on the test paper holder 11. The receiving portion 11a is a recessed portion for placing the test paper 100. The upper surface of the bottom plate 11b on which the test paper 100 is placed is one level lower, and the side walls 11c are respectively arranged on the left and right sides thereof, so that the test paper 100 can be prevented from falling off during the movement of the test paper holder 11.

[0160] Two rib-shaped protrusions 11e are formed on the upper surface of the bottom plate 11b. The two protrusions 11e are formed at intervals in the length direction of the test paper holder 11, and support the test paper 100 respectively. That is, the test paper 100 is placed on the protrusions 11e. In this case, the test paper 100 is supported at two locations, and even when 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 interval between each protrusion 11e only needs to be a length that can stably support the test paper 100.

[0161] The shape of the protrusion 11e is not particularly limited, but it is preferred that the width gradually narrows toward the end of the protrusion 11e and the cross section in the width direction has a triangular shape. Figure 5 In the example shown, the protrusion 11e is formed over the side wall 11c and the extension 11d, but the protrusion 11e may be formed only on the bottom plate 11b. The protrusion 11e is a portion in contact with the test paper 100, so when the determination area 120 of the dirt detection described later is limited to a part of the loading surface of the test paper holder 11, the portion where the protrusion 11e is formed may be used as the determination area. Here, the loading surface of the test paper holder 11 refers to the surface on which the test paper 100 is loaded vertically upward at the loading position P1, and unless otherwise specified, it includes not only the upper surface of the bottom plate 11b but also the upper surface of the extension 11d.

[0162] The width W1 of the receiving portion 11a is, for example, 1.5 to 3.0 times the width of the test paper 100 at the narrowest portion where the protrusion 11e is formed. As a specific example of the width W1, it is 5 mm to 20 mm. It should be noted that although the width W1 of the receiving portion 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, sometimes the test paper 100 comes into contact with the extension portion 11d, and the sample 110 may adhere to the extension portion 11d. The length of the test paper holder 11 may also be shorter than the length of the test paper 100, and the test paper 100 is placed in a state where the holding portion 104 extends from the test paper holder 11.

[0163] 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 improved, and it is easy to extract the image of the test paper 100 from the image captured by the imaging unit 20. In addition, if the color of the test paper holder 11 is black, it is also easy to detect dirt attached to the test paper holder 11.

[0164] like Figure 6As shown, the test paper 100 has a rectangular substrate 101 when viewed from above and a reagent pad 102 arranged on one side of the substrate 101. In this embodiment, the test paper 100 is immersed in the sample 110 by the operator, and the sample 110 is impregnated with 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 length direction of the substrate 101. Therefore, it is possible to use one test paper 100 to analyze a variety of components contained in the sample 110. The reagent pad 102 contains a reagent that reacts with the components of the analysis object, and the reagent pad 102 develops color when the sample 110 immersed in the test paper 100 contains the components of the analysis object. The sample analysis device 1 analyzes the image of the reagent pad 102 and performs semi-quantification of the components in the sample 110.

[0165] The test paper 100 has a plurality of reagent pads 102, and the reagent pads 102 contain reagents that react with occult blood, sugar, protein, ketone bodies, nitrite, creatinine, albumin, urobilinogen, and leukocytes contained in urine, for example. The color of each reagent pad 102 changes according to the concentration of the analysis object component contained in the urine. Generally, the higher the concentration, the darker the color. Therefore, by analyzing the color development degree of the reagent pad 102, the semi-quantitative analysis of the analysis object component can be performed. In addition, the test paper 100 can also have a reagent pad 102 that can analyze the pH of urine. The number of reagent pads 102 is not particularly limited, and as an example, it is 10 to 15.

[0166] On the test paper 100, for example, a reagent pad 102 which is a quadrilateral when viewed from the front is configured at a prescribed interval in the length direction of the substrate 101. Each reagent pad 102 is preferably configured to fully suppress the abnormal interval of the bridge described later. The prescribed interval is, for example, a length shorter than the length of one side of the reagent pad 102, and the interval of each reagent pad 102 is substantially equidistant. In addition, an identification mark 103 is provided on the face of the substrate 101 provided with the reagent pad 102. The identification mark 103 represents identification information such as the type and batch number of the test paper 100, and is composed of one-dimensional codes such as bar codes, two-dimensional codes such as QR codes (registered trademarks) or their combination.

[0167] 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 top view quadrilateral having a side of 3 mm to 7 mm, and has a thickness of 0.5 mm to 2 mm. On the single side of the substrate 101, a plurality of reagent pads 102 are configured in the range exceeding the center of the length direction from the first end of the length direction of the substrate 101, and an identification mark 103 is provided between the second end of the length direction of the substrate 101 and the reagent pad 102. The surface of the substrate 101 in the part where the reagent pad 102 is not present is used as a reference value in the image analysis of the reagent pad 102. An example of the appropriate color of the substrate surface is white.

[0168] The range from the second end in the length direction of the substrate 101 to the reagent pad 102 is a gripping portion 104 of the test paper 100 gripped by the operator. The length of the gripping portion 104 is not particularly limited, but as a preferred example, it is 30% to 45% of the total length of the substrate 101. When the operator prepares the test paper 100 to be placed on the test paper holder 11, the operator holds the gripping portion 104 without touching the reagent pad 102 with his hand, and completely immerses the reagent pad 102 in the sample 110.

[0169] Reference Figure 7 , the structure of the control system of the sample analyzer 1 will be described in detail. Figure 7 It is a block diagram showing a schematic configuration of the sample analyzer 1 .

[0170] like Figure 7 As shown, the sample analysis device 1 includes a control unit 50 for comprehensively controlling the operation of the device. The control unit 50 is connected to the conveying unit 10, the photographing unit 20, the display input unit 30, the test paper detection unit 40, and the printing unit 60 so as to be communicable, and is configured to send control signals to each device. In addition, the control unit 50 obtains information required for control from each device. In this embodiment, the control unit 50 is mounted on the substrate 55 and accommodated in the frame 70, but part of the function of the control unit 50 can also be constructed by a server or the like outside the device.

[0171] The control unit 50 includes a computing unit 51 and a storage unit 52, and is composed of, for example, a microcomputer including a CPU, a RAM, a ROM, an interface, etc. The control unit 50 controls the operation of various devices constituting the sample analyzer 1 by executing a program stored in the storage unit 52 through the computing unit 51 (CPU). As will be described in detail later, the storage unit 52 stores the test paper image in association with at least one measurement information selected from measurement date and time information, operator information, identification information of the test paper 100, and identification information of the sample 110. The sample 110 includes a sample to be tested and a precision control sample of a known concentration, and the identification information of the sample 110 includes identification information of the sample to be tested and identification information of the precision control sample.

[0172] The control unit 50 controls the driving device 13 of the conveying unit 10 to move the test paper holder 11 from the loading position P1 to the shooting position P3. At this time, when the test paper 100 loaded on the test paper holder 11 is detected at the detection position P2, the image of the test paper 100 is obtained by the shooting unit 20 at the shooting position P3. The control unit 50 controls the light source 21, the shooting element 22 and the driving device 25 of the shooting unit 20 to move the shooting unit 20a in the Y direction while shooting the entire test paper 100. Then, the control unit 50 analyzes the test paper image obtained by the shooting unit 20 to analyze the sample 110.

[0173] When the control unit 50 obtains the detection information of the test paper 100 from the test paper detection unit 40, the control unit 50 starts shooting while moving the shooting unit 20a at the origin position in the Y direction at the timing when the test paper 100 is conveyed to the shooting position P3. The shooting unit 20a can shoot the test paper 100 while moving continuously, or can stop multiple times and shoot the test paper 100 at each stop position. When the shooting of the test paper 100 is completed, the control unit 50 returns the shooting unit 20a to the origin position.

[0174] As will be described in detail later, the control unit 50 displays a plurality of test paper images selected by the display input unit 30 on one screen of the display input unit 30. In addition, the control unit 50 detects the type of abnormality and the location where the abnormality occurs in the test paper image, and displays information indicating the type of abnormality and the location where the abnormality occurs together with the test paper image on the display input unit 30. In addition, the control unit 50 analyzes the image of the test paper holder 11 obtained by the imaging unit 20 to detect dirt on the test paper holder 11.

[0175] Before analyzing the test paper image, the control unit 50 performs image processing such as correction processing, synthesis processing, and extraction processing. Since the brightness within the shooting range of the imaging element 22 is usually uneven in the central part and the peripheral part of the shooting range, the control unit 50 can also use a brightness correction table to perform correction processing. In addition, since the imaging element 22 shoots the test paper 100 while moving in the Y direction, the control unit 50 synthesizes multiple images obtained by the imaging element 22 to generate a test paper image. In this specification, unless otherwise specified, the test paper image refers to a synthetic image that captures the entire test paper 100.

[0176] The above-mentioned extraction process is a process of extracting the image of the test paper 100 from the composite image. The composite image includes not only the image of the test paper 100 but also the image of the test paper holder 11. Therefore, 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 representing the outer edge of the test paper 100, rotates the composite image to an appropriate angle based on the inclination of the extracted rectangle, detects the edge of the image of the test paper 100, and extracts 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.

[0177] As described above, the control unit 50 analyzes the test paper image to analyze the sample 110. Specifically, based on the color development degree of the reagent pad 102 included in the test paper image, it is determined whether there is an analysis target component in the sample 110, and if the target component exists, its approximate content is determined. The operator immerses the test paper 100 in the sample 110, wipes off the excess sample 110 and places it on the test paper holder 11. Before the test paper 100 is transported to the shooting position P3, the reagent of the reagent pad 102 reacts with the analysis target component in the sample 110, and the reagent pad 102 develops color.

[0178] Usually, a reading device for reading the identification information of the sample 110 is connected to the sample analyzer 1. A barcode label containing the identification information of the sample 110 is attached to a container such as a urine sampling cup or a urine sampling tube that contains the sample 110. The reading device reads the barcode label and sends the sample ID, which is the identification information of the sample 110, to the control unit 50. The reading device can use a barcode reader. The sample ID is read, for example, before the test paper 100 is immersed in the sample 110.

[0179] Figure 8 This is a flowchart showing an example of a sample analysis method using the sample analysis device 1 . Figure 8 The control sequence from when the operator places the test paper 100 on the test paper holder 11 at the placement position P1 of the sample analyzer 1 to when the test paper 100 is discarded is shown.

[0180] like Figure 8 As shown, in step S1, the control unit 50 receives the 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 the detection signal of the test paper 100 to the control unit 50. The process of step S1 is performed on each test paper holder 11. When the control unit 50 obtains the detection signal of the test paper 100 (Yes in step S1), the process proceeds to step 2. On the other hand, when the control unit 50 does not obtain the detection signal of the test paper 100 (No in step S1), the process proceeds to step S8.

[0181] In step S2, the control unit 50 moves the test paper 100 to the shooting position P3. The control unit 50 drives the driving device 13 of the conveying unit 10 intermittently under predetermined conditions to convey the test paper holder 11 carrying the test paper 100 from the detection position P2 to the shooting position P3. It should be noted that the conveying unit 10 is configured such that a plurality of test paper holders 11 mounted on the endless belt 12a cyclically move along the X direction. Therefore, the control unit 50 not only moves the test paper holder 11 carrying the test paper 100, but also moves all the test paper holders 11 from the loading position P1 to the shooting position P3 via the detection position P2.

[0182] In step S3, the control unit 50 controls the photographing unit 20 to photograph the test paper holder 11 carrying the test paper 100. Specifically, when the test paper holder 11 with the test paper 100 detected in step S1 reaches the photographing position P3, the photographing unit 20a is moved from the origin position in the Y direction to start photographing. 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 with the test paper 100 detected at the detection position P2 reaches the photographing position P3.

[0183] In step S4, the control unit 50 performs image processing on the test paper image obtained by the imaging element 22 of the imaging unit 20. It should be noted that the image data obtained by the imaging element 22 is sent to the control unit 50. As described above, as an example of image processing, correction processing, synthesis processing, and extraction processing can be cited. In step S3, since the imaging element 22 photographs the test paper 100 while moving in the Y direction, the control unit 50 synthesizes a plurality of images to generate a test paper image.

[0184] In step S5, the control unit 50 analyzes the test paper image after image processing to determine whether there is an analysis target component in the sample 110, and if the component is present, to determine its approximate content. The approximate content of the component in the urine obtained in the urine test of this embodiment is generally referred to as a semi-quantitative value. In addition, the control unit 50 determines whether there is an abnormality in the measurement. When the control unit 50 detects an abnormality in the measurement through the analysis of the test paper image, the display input unit 30 displays the type and location of the abnormality. The control unit 50 can also control the printing unit 60 to print the analysis results containing the semi-quantitative values ​​of each analysis target component for each sample 110.

[0185] In step S6, the control unit 50 stores the analysis result (analysis result) of the test strip image in the storage unit 52. The control unit 50 stores the semi-quantitative value, abnormality detection information, the test strip image used for analysis, etc. in association with at least one measurement information selected from the identification information of the sample 110 (sample ID), the identification information of the test strip 100 (test strip type, test strip batch), the measurement date and time information, the operator information, etc. in the storage unit 52. As described in detail later, the operator can display the target test strip image on the display input unit 30 based on the sample ID, the operator information, etc.

[0186] In step S7, the control unit 50 moves the photographed test paper 100 from the photographing position P3 to the discarding position. The test paper holder 11 returns from the photographing position P3 to the loading position P1, but at this time, it turns over at the position of the pulley 12c. At this time, the photographed test paper 100 falls from the test paper holder 11 to the recovery unit 80 and is discarded, and the empty test paper holder 11 is transported to the loading position P1.

[0187] In step S8, when the measurement mode is continued, the control unit 50 repeats the processing of steps S1 to S7 (No in step S8). When the measurement mode is released by the operator's operation on the display input unit 30, the control unit 50 stops the conveying unit 10 and ends the measurement (Yes in step S8). When the test paper 100 is not detected at the detection position P2 within a predetermined time, the control unit 50 may also release the measurement mode, stop the conveying unit 10, and end the measurement.

[0188] It should be noted that the processing of steps S1 to S7 is performed simultaneously. For example, while the image analysis of the previous test paper 100 is being performed, the next test paper 100 is conveyed to the imaging position P3 and the next test paper 100 is detected by the test paper detection unit 40 .

[0189] Below, refer to Figures 9 to 16 , the display screen of the test paper image and the display method of the test paper image are described in detail.

[0190] Fig. 9 An example of a display screen showing (a) a list of sample analysis results and (b) a display screen showing a test strip image. It should be noted that the acquisition of operation signals from the touch panel as the display input unit 30 and the display of various screens based on the operation signals are performed under the control of the control unit 50 .

[0191] like Fig. 9 As shown in (a), in the result overview screen 31a, the index of the analysis result is displayed in a list format. In the list 310 of the result overview screen 31a, the measurement date and time, the identification information of the operator, the identification information of the test paper 100, the sample ID, the serial number and the browsing history information are displayed in sequence from the right side of the screen. The operator's identification information column displays, for example, the login ID to the sample analyzer 1 when the measurement is performed, but the operator's name, etc. can also be displayed. The operator's information is useful for correcting the inspection method. It should be noted that the "Rev" mark indicates that any item of the measurement result is positive.

[0192] In the list 310, the type of the test paper 100 is displayed as identification information of the test paper 100. The sample analysis device 1 is capable of measuring a plurality of test papers 100, and this information is used when displaying the test paper image 300 for information of each type of the test paper 100. The sample ID and the serial number are identification information of the sample 110. The sample ID is inherent information assigned to each sample, and the serial number indicates a serial number (continuous number) when the power of the device is turned on. Fig. 9 In the example shown in (a), "No." indicates the inspected sample, "C." indicates the quality control sample, and "#" indicates the emergency sample.

[0193] The result list screen 31a also displays screen switching buttons 311a and 311b, a display condition switching button 312, a selection button 313, a scroll button 314, a result detail display button 315, a filter setting button 316, a search button 317, and an information sharing button 318. The result detail display button 315 is a button for displaying the details of the analysis result of the sample selected in the list 310. By pressing the result detail display button 315, the screen of the display input unit 30 is switched to a result detail screen 36 (see below) containing the semi-quantitative value of the sample. Fig.14 ) In addition, the information sharing button 318 is a button for transmitting the analysis result to an external device connected to the sample analyzer 1 by wire or wirelessly.

[0194] In the result overview screen 31a, a list 310 is arranged in the center of the screen, and buttons are arranged around the list 310. The list 310 is a list of indices indicating the analysis results of the sample 110. Since the analysis results of the sample 110 are obtained by analyzing the test paper image 300, the list 310 can be said to be a list of analysis results. In the list 310, the measurement information of each sample is displayed in sequence according to the conditions selected by the display condition switching button 312. Fig. 9 In the example shown in (a), data is displayed in the order of sample ID, with data having a newer measurement date and time being displayed at the top of the list 310 .

[0195] 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, in the result list screen 31a, when the screen switching button 311b displayed as "Strip" is pressed, the screen of the display input unit 30 can be switched to the result list screen 31b. By providing the screen switching buttons 311a and 311b, the switching of the screen becomes easy and the usability is improved.

[0196] The number of data that can be displayed simultaneously in the list 310 of the result list screen 31a is limited to a predetermined number (for example, 7 to 15), but measurement information exceeding the predetermined number can be checked by operating the scroll button 314. The number of test paper images 300 that can be displayed simultaneously in the result list screen 31b may be the same as the predetermined number of the list 310, but Fig. 9 In the example shown, the number of test strip images 300 is small. In this case, each test strip image 300 can be displayed larger, making comparison and reference easier. In the result list screen 31b, multiple test strip images 300 that cannot be displayed simultaneously can also be checked by operating the scroll button 314.

[0197] like Fig. 9 As shown in (b), in the result overview screen 31b, a plurality of test strip images 300 are displayed in parallel instead of the list 310. In the result overview screens 31a and 31b, the display other than the list 310 and the test strip images 300 is the same in both screens. In the result overview screen 31b, a plurality of test strip images 300 are displayed together with the sample ID and the serial number. By arranging and displaying a plurality of test strip images 300 in one screen, for example, when an abnormality occurs in the analysis result of the quality control sample, it is easy to identify the cause of the abnormality.

[0198] The control unit 50 preferably displays the plurality of test strip images 300 in the same orientation on the result list screen 31b in such a manner that the reagent pads 102 of the same type of each test strip 100 are arranged in a row in the plurality of test strip images 300. In this case, comparison and reference of the plurality of test strip images 300 becomes easy. Fig. 9 In the example shown in (b), images of the same type of test strips 100 are all displayed, and the test strip images 300 are arranged in a manner such that the same type of reagent pads 102 are arranged in the vertical direction of the screen and the identification marks 103 are also arranged in the vertical direction. The number of test strip images 300 that can be displayed simultaneously on the result list screen 31b can be appropriately changed according to the size of the display input unit 30, etc., and is not particularly limited, and is 5 to 10 as an example.

[0199] As described above, when the screen switching button 311b is operated in the result list screen 31a, the control unit 50 switches the screen of the display input unit 30 to the result list screen 31b, and displays a plurality of test paper images 300 in parallel. The control unit 50 also has a function of causing the display input unit 30 to display a plurality of test paper images 300 selected by the operation of the display input unit 30. The control unit 50 displays a list 310 in the result list screen 31a, and displays a plurality of test paper images 300 selected by the operator from the list 310. It should be noted that, when the display object selected in the result list screen 31a is one, one test paper image 300 is displayed in the result list screen 31b.

[0200] In this embodiment, by pressing the selection button 313, the display object of the test strip image 300 can be selected. In the first selection mode, the display object can be selected by pressing the measurement information column of each sample in the list 310. Then, by pressing the screen switching button 311b in the state where the sample is selected, only the test strip image 300 of the sample selected by the operator from the list 310 is displayed in the result list screen 31b.

[0201] The details will be described later. Alternatively, the action button 340 may be displayed by operating the selection button 313 (see the following description). Fig.12 ). The action button 340 is a button for moving to the enlarged display screen 34 that can enlarge the test paper image 300. Alternatively, the action button 340 originally displayed in the result list screen 31a, 31b can be enabled by operating the selection button 313 and selecting the display object. The action button 340 can be operated in a state where at least one display object is selected.

[0202] The list 310 includes measurement date and time information, operator information, identification information of the test strip 100, and identification information of the sample (including a serial number for identifying the sample to be tested and the quality control sample), so the operator can select the display object of the test strip image 300 based on the measurement information. The control unit 50 can also display the list 310 containing only the information of a specific sample selected from the measurement information. For example, the control unit 50 can display the list 310 containing only the information of the quality control sample and display a plurality of test strip images 300 selected from the list.

[0203] In this embodiment, by pressing the filter setting button 316, the display object of the test strip image 300 can be selected based on the measurement information. When the control unit 50 obtains the operation signal of the filter setting button 316, the screen of the display input unit 30 is switched to the selection screen 33a (see the following description). Fig.11 ), and displays a plurality of test paper images 300 corresponding to the measurement information selected through the selection screen 33a. Through this function, the operator can display only the target test paper image 300 based on one or more measurement information.

[0204] The search button 317 is a button for searching for analysis results of a target sample by inputting information such as a sample ID and an operator. The operator can also use the search button 317 to select a display target of the test strip image 300 from the measurement information.

[0205] Fig.10 An example of a measurement screen is shown below. Fig.10 As shown, the indicator 320, the list 321 and the measurement button 322 are displayed in the measurement screen 32. The measurement screen 32 is a screen displayed when the sample 110 is measured. The operator can start the measurement of the sample 110 and stop the measurement by operating the measurement button 322. It should be noted that in the measurement screen 32, a search button 317 and the like can also be provided in the same manner as the result list screens 31a and 31b.

[0206] The indicator 320 is a guide display for notifying the operator of the timing of immersion of the test paper 100 in the sample 110, wiping of the sample 110 attached to the test paper 100, and placement of the test paper 100 on the test paper holder 11. When the operator presses the measurement start button 322, guidance based on the indicator 320 is performed, and the operator can prepare the test paper 100 to be placed on the test paper holder 11 according to the guidance. The sample ID of the sample 110 being measured or completed is displayed in the list 321. For example, when the sample ID is read by a barcode reader, the sample ID is displayed in the list 321.

[0207] Fig.11 An example of a selection screen for filtering the display objects of analysis results based on measurement information is shown. Fig.11 As shown in (a), in the selection screen 33a, a filter display selection button 330 for selecting whether to perform filter display of analysis results is displayed at the top of the screen. Further, below the filter display selection button 330, a plurality of selection buttons for selecting measurement information as filter conditions to be displayed are arranged.

[0208] The filter display selection button 330 includes two buttons, "Perform" and "Do not perform" the filter display. The filter display selection button 330 is, for example, a radio button. By selecting the button for filtering the display "Perform", other selection buttons can be operated, and the filter setting (selection of measurement information) of the display object can be performed. The control unit 50 stores the filtering conditions as the selected measurement information in the storage unit 52. Then, according to the filtering conditions, a list 310 of specific samples is displayed in the result overview screen 31a, and a specific test paper image 300 is displayed in the result overview screen 31b. On the other hand, when the button for filtering the display "Do not perform" is selected, other selection buttons cannot be operated, and the test paper image 300 is displayed in the result overview screen 31b in the order of sample ID or serial number.

[0209] In the selection screen 33a, 6 selection buttons for selecting measurement information are displayed. The first selection button 331 is a selection button for the measurement date and time. By operating the first selection button 331, it is possible to select any measurement date and time, such as today, yesterday, April 3, 2023, April 4 to 7, 2023, or a specific time period such as 9:00 to 11:00. The second selection button 332 is a selection button for the sample ID. By operating the second selection button 332, based on the sample ID, a specific sample can be selected from the sample to be tested, or a specific sample can be selected from the precision management sample.

[0210] The third selection button 333 is an operator selection button. By operating the third selection button 333, an operator who has prepared the test paper 100 placed on the test paper holder 11 and has performed the measurement of the sample 110 can be selected. In the sample analysis device 1 as a semi-automatic device, sometimes the inspection method has a great influence on the analysis result, especially when the less experienced operator performs the measurement, for example, it is assumed that the analysis result of the precision management sample deviates from the appropriate range and measurement errors are likely to occur. By screening the operator to display the test paper image 300, it is easy to find out the reason why the appropriate analysis result was not obtained. In addition, correction and training of the inspection method are also effective.

[0211] The fourth selection button 334 is a selection button for the quality control sample. Usually, the 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 is switched to Fig.11 (b) shows the selection screen 33b. Fig.11 As shown in (b), on the selection screen 33b, 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 are displayed.

[0212] exist Fig.11 In the example shown in (b), three check boxes are displayed as the type selection button 337b. The operator can select a specific quality control sample from a variety of quality control samples by checking the box of the quality control sample he wants to display. When the lot number selection button 338b of the selection screen 33b is pressed, the screen of the display input unit 30 is switched to Fig.11 (c) shows the selection screen 33c. Fig.11 As shown in (c), a plurality of check boxes corresponding to the respective lot numbers of the quality control samples are displayed on the selection screen 33c.

[0213] As the identification information of the precision management sample, the identification information of each container (hereinafter referred to as "vial") filled with the precision management sample can also be selected. It should be noted that the precision management sample is generally modulated in the same batch in an amount that can be filled into multiple vials. In the storage unit 52, for example, the identification information of each vial of the same batch number is stored together with the type and batch number of the precision management sample. As described in detail later, if the identification information of the vial is stored in advance, it is easy to determine the measurement abnormality caused by immersion in the same vial that exceeds the number of uses.

[0214] The fifth selection button 335 is a selection button for the test paper 100. When the fifth selection button 335 is pressed, the screen of the display input unit 30 switches to Fig.11 (d) shows the selection screen 33d. Fig.11As shown in (d), on the selection screen 33d, a type selection button 337d for selecting the type of the test strip 100 and a lot number selection button 338d for selecting the lot number of the test strip 100 are displayed. Fig.11 In the example shown in (d), three check boxes are displayed as the type selection button 337d. The operator can select a specific test paper 100 from a plurality of test papers 100 by checking the box of the test paper 100 to be displayed.

[0215] When the lot number selection button 338d of the selection screen 33d is pressed, the screen of the display input unit 30 switches to Fig.11 (e) shows the selection screen 33e. Fig.11 As shown in (e), in the selection screen 33e, a plurality of check boxes corresponding to the lot numbers of the test strips 100 are displayed. Fig.11 In the example shown in (e), a check box for the lot number of the type "9A" of the test strip 100 not selected in the selection screen 33d is also displayed. However, even if the lot number is selected, "9A" will not be displayed unless "9A" is selected in the selection screen 33d.

[0216] The sixth selection button 336 is a selection button for the serial number of the sample and the classification of the analysis result. By operating the sixth selection button 336, it is possible to select the classification of the analysis result to be displayed for each serial number. As a specific example, it is possible to select a sample under test or a precision control sample that has produced a measurement error, or to select a sample that has produced a measurement error for various samples. Fig.11 In the example shown in (a), as the sixth selection button 336, a list of check boxes including a row of serial numbers and a column of classification of analysis results is displayed.

[0217] Fig.12 3 is a diagram showing an example of an enlarged display screen of the test paper image 300. Fig.12 As shown in (a), in the result list screen 31a, an action button 340 is displayed for switching to an action mode in which the test strip image 300 of the selected sample can be enlarged and displayed. For example, the operator can filter the display objects of the test strip image 300 in the selection screen 33a, and then select the test strip image 300 to be enlarged and displayed in the first result list screen 31a or the second result list screen 31b. Fig.12 In the example shown in (a), two samples are selected in the result list screen 31a. When the action button 340 is pressed in this state, the screen of the display input unit 30 switches to Fig.12 (b) and (c) show the enlarged display screen 34.

[0218] Fig.12 (b) shows the state before the zoom operation. Fig.12 (c) represents the state after the zoom operation. In the zoom display screen 34, the test paper image 300 corresponding to the sample selected in the result list screen 31a is displayed together with the sample ID, the sequence number and the measurement date and time. In the zoom display screen 34, the operator information can also be displayed. A plurality of test paper images 300 can be displayed in the zoom display screen 34, but the maximum display number of the test paper images 300 in the zoom display screen 34 is preferably limited to an appropriate number according to the screen size of the display input unit 30, and is set to 2 to 5 as an example. A plurality of test paper images 300 are preferably displayed in parallel in the same direction in a manner that the reagent pads 102 of the same type of each test paper 100 are arranged in a row.

[0219] A return button 341 is displayed on the enlarged display screen 34. The return button 341 is a button for returning to the original screen, and when the return 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 displayed just before the enlarged display screen 34 is moved. In other words, the return button 341 is a button for canceling the operation mode.

[0220] The control unit 50 enlarges and displays a portion of the test paper image 300 based on the enlargement instruction of the display input unit 30. The enlargement instruction is performed, for example, by clicking on the portion of the test paper image 300 that is to be enlarged. Alternatively, the enlargement instruction may be performed by other operations such as a double-click 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 also be set, and a button for enlarging and reducing the test paper image 300 may also be provided in the enlarged display screen 34.

[0221] When the control unit 50 performs an operation to magnify a portion of the test paper image 300, the control unit 50 magnifies and displays a portion of the test paper image 300 including the portion corresponding to the operation signal at a specified magnification. The magnification of the test paper image 300 is, for example, one or more predetermined fixed magnifications. When a portion of the test paper image 300 is clicked, the portion and its vicinity are magnified and displayed at a predetermined magnification. Alternatively, the magnification can be changed according to the number of operations so that the magnification becomes higher when further clicks are performed. In addition, the magnification can also be changed arbitrarily.

[0222] The magnified display of the test paper image 300 is preferably synchronized in a plurality of images. When the control unit 50 obtains a magnification instruction for one of the plurality of test paper images 300 displayed on the magnified display screen 34, the same portion is magnified and displayed for all images at the same magnification. In addition, when the control unit 50 obtains a reduction instruction for one test paper image 300, the same portion is reduced and displayed for all images at the same magnification. In this case, the target portions of the plurality of test paper images 300 can be quickly and easily compared and referenced.

[0223] The control unit 50 further magnifies and displays another part of the test paper image 300 based on the change instruction of the display area of ​​the display input unit 30. Fig.11 In the enlarged display screen 34 shown in (c), a part of the test paper image 300 is enlarged, but the enlarged display area can be changed by, for example, sliding the finger touching the screen to the left and right. It should be noted that the operation for inputting the change instruction of the display area is not limited to the sliding operation. When the control unit 50 performs the operation of changing the display area in the enlarged display screen 34, the enlarged display part is changed based on the operation signal.

[0224] Fig.13 FIG. 4 is a flowchart showing an example of display processing of the test paper image 300. Fig.13 , after the display input unit 30 displays the result list screen 31a, a control sequence is shown until the test paper image 300 is enlarged and displayed through narrowing down the display objects based on the selection screen 33a, but the presence or absence of this narrowing down does not affect the enlarged display process itself.

[0225] like Fig.13 As shown, in step S11, the control unit 50 causes the display input unit 30 to display the result list screen 31a. The control unit 50 displays the result list screen 31a based on, for example, the operation of the display input unit 30 by the operator, but the result list screen 31a may be displayed when the measurement of the sample 110 is completed. In addition, the result list screen 31a may be set as a default screen when the sample analyzer 1 is started. In the result list screen 31a, the measurement information of each sample is displayed in a list format as a list of analysis results, and a screen switching button 311b is displayed.

[0226] When the control unit 50 obtains the operation signal of the screen switching button 311b, the screen of the display input unit 30 is switched to the result list screen 31b, and multiple test paper images 300 are displayed in parallel. In the result list screen 31b, multiple test paper images 300 are displayed in a row in the same type of reagent pads 102 of each test paper 100, and the screen switching button 311a is displayed. In addition, in the result list screen 31b, sample ID, serial number, etc. are displayed near each test paper image 300 in a way that each test paper image 300 can be identified. In addition, information such as the number and name of the reagent pad 102 can also be displayed in the result list screen 31b.

[0227] In step S12, the control unit 50 receives a filter instruction for display objects. The filter instruction is input by operating the filter setting button 316 and each selection button in the selection screen 33a. When the control unit 50 obtains the filter instruction (Yes in step S12), the process proceeds to step S13. On the other hand, when the control unit 50 does not obtain the filter instruction (No in step S12), the process proceeds to step S14.

[0228] When the filter setting button 316 is pressed in 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. Next, when the filter display selection button 330 for "perform" the filter display is selected in the selection screen 33a, the first selection button 331 to the sixth selection button 336 can be operated. The control unit 50 stores the filter conditions selected by the operation of the first selection button 331 to the sixth selection button 336.

[0229] In step S13, the control unit 50 filters the display objects of the result overview screens 31a and 31b according to the above-mentioned filtering conditions, and only displays the selected samples in the result overview screens 31a and 31b. In the result overview screen 31a, a list 310 containing only the samples selected in step S12 is displayed, and in the result overview screen 31b, only the test paper image 300 selected in step S12 is displayed. It should be noted that even if the filtering in steps S12 and S13 is not performed, the test paper image 300 can be enlarged and displayed, but in order to facilitate the retrieval of the enlarged display object, it is preferred to enter step S14 via steps S12 and S13.

[0230] In step S14, the control unit 50 receives an instruction to enlarge the test paper image 300. The enlargement instruction is input by clicking on a portion of the test paper image 300 that is to be enlarged. In the present embodiment, since the enlargement instruction is input in the enlarged display screen 34, as a prerequisite for enlarged display of the test paper image 300, it is necessary to select an enlarged display object in the result list screens 31a and 31b, and to transfer the screen to the enlarged display screen 34 by operating the action button 340. When the control unit 50 obtains the operation signal of the action button 340, it switches the screen of the display input unit 30 to the enlarged display screen 34.

[0231] In step S15, the control unit 50 enlarges and displays a portion of the test paper image 300 according to the above-mentioned enlargement instruction. For example, when a portion of the test paper image 300 is clicked, the control unit 50 enlarges and displays a portion of the test paper image 300 including the portion. At this time, it is preferred to synchronize the magnification and the magnification range for the multiple test paper images 300 displayed in the enlarged display screen 34. That is, when the enlargement instruction is obtained for one of the multiple test paper images 300, the same portion is enlarged and displayed at the same magnification for all images. In addition, when a sliding operation to change the display area is performed in the enlarged display screen 34, the control unit 50 changes the enlarged display portion.

[0232] When the control unit 50 obtains an operation signal of the return button 341 of 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 displayed immediately before the enlarged display screen 34 is moved to, and the operation mode is terminated. It should be noted that the information displayed on the display input unit 30 may be externally output to the display unit of an external device connected to the sample analyzer 1. In this case, the same screen as that of the display input unit 30 can be displayed on the display unit of the external device.

[0233] Fig.14 FIG. 1 is a diagram showing an example of an error display screen. Fig.14 As shown in (a), when 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 that the measurement is abnormal is displayed on the display input unit 30. The error display screen 35 displays information indicating the abnormality, such as "Insufficient wiping". In addition, an error code "5030a" indicating the type of abnormality may be displayed.

[0234] When the control unit 50 detects an abnormality in the measurement through the analysis of the test paper image, the measurement screen 32 can be switched to the error display screen 35, or the error display screen 35 can be popped up on the measurement screen 32. After the operator confirms the abnormal content in the error display screen 35, by pressing the "OK" button at the lower right of the screen, the screen of the display input unit 30 can be returned to the measurement screen 32. In this case, when the measurement is completed, the screen can be switched to the result overview screen 31a to confirm the details of the abnormality. Alternatively, the measurement of the sample 110 can be interrupted, and the search button 317 can be operated to immediately confirm the details of the abnormality.

[0235] like Fig.14 As shown in (b), a mark indicating that a measurement abnormality has occurred is displayed in the list 310 of the result list screen 31a. Fig.14 In the example shown in (b), the column of the sample that has produced the color abnormality is marked with an "!". In addition, in the list 310, the mark "Err" is sometimes displayed to indicate that a measurement error has occurred and no measurement result has been obtained. The control unit 50 can also display different marks in the list 310 according to the type of abnormality. By displaying the mark in the list 310, the operator can easily understand the sample that has produced the measurement abnormality. In addition, the operator can display the result detail screen 36 containing the abnormal content by selecting a sample marked with "!" and pressing the result detail display button 315.

[0236] like Fig.14 As shown in (c), in the result detailed screen 36, a first label 361 and a second label 362 are displayed together with a list 360 including the semi-quantitative values ​​of the sample. In addition, the result detailed screen 36 also displays measurement information such as the sample ID, serial number, measurement date and time, and the type of the test strip 100. The first label 361 is a mark indicating that a measurement abnormality has occurred, and includes the text "Error" and the error code "5030a" indicating the type of abnormality. The second label 362 is a mark indicating the location where the abnormality occurred in the test strip 100, and is displayed superimposed on the test strip image 300.

[0237] The control unit 50 detects the type of abnormality and the location of the abnormality appearing in the test strip image 300, and displays the information indicating the type of abnormality and the location of the abnormality together with the test strip image 300 in the result detail screen 36. It should be noted that in the result detail screen 36, the test strip image 300 can be displayed only for samples that have produced measurement abnormalities, or can be displayed for all samples. The control unit 50 detects the abnormality of the analysis result by analyzing the test strip image 300, and stores the type of abnormality and the location of the abnormality in the storage unit 52.

[0238] The control unit 50 may also display different second labels 362 according to the type of abnormality. Fig.14 In the example shown in (c), as the second label 362, a four-frame mark spanning two reagent pads 102 is displayed, but the shape, size, and color of the mark can also be changed according to the abnormal type, and different texts and marks can also be displayed. In this case, the abnormal type can be grasped from the second label 362. For example, the color of the mark can also be changed according to the abnormal type, with red indicating color development abnormality, orange indicating color unevenness abnormality, green indicating bridge abnormality, and blue indicating immersion abnormality. It should be noted that the details about these abnormalities will be described later.

[0239] Fig.15 This shows an example of a mark (second label 362) having different shapes according to the type of abnormality. The shape of the mark indicating the abnormality occurrence location is not limited to Fig.14 (c) shows a quadrilateral shape, such as Fig.15 As shown, the mark 362 may be a line, a circle (single circle), a double circle, etc., or a polygon other than a quadrilateral. For example, a line mark 362a indicates a bridging abnormality, and a single circle mark 362b indicates an abnormality caused by the presence of foreign matter such as dust. In addition, a double circle mark 362c indicates an abnormality caused by the residue of the sample 110. The second label 362 may also be a full or shaded mark, but is preferably a mark surrounding the abnormality occurrence site.

[0240] Fig.16 This is a flowchart showing an example of abnormality display processing.

[0241] like Fig.16 As shown, in step S21, the control unit 50 determines whether there is an abnormality by analyzing the test paper image 300. When the control unit 50 detects an abnormality in the test paper image 300 (Yes in step S21), the process proceeds to step S22. On the other hand, when the control unit 50 does not detect an abnormality (No in step S21), the series of abnormality display processing ends.

[0242] In step S22, the control unit 50 stores the type and location of the detected abnormality in association with measurement information such as the sample ID in the storage unit 52. The control unit 50 can determine the type of abnormality by analyzing the test strip image 300, for example, and store an error code corresponding to the determined type of abnormality.

[0243] In step S23, the control unit 50 performs an error display to inform the operator that an abnormality is detected during measurement. As a specific example, an error display screen 35 is displayed on the display input unit 30. The error display screen 35 displays information indicating the type of abnormality, and a countermeasure, etc. may also be displayed.

[0244] In step S24, the control unit 50 receives an instruction to display the details of the abnormality. The instruction to display the details of the abnormality is input, for example, by operating the result detail display button 315. When the control unit 50 obtains an instruction to display the details (Yes in step S24), the process proceeds to step S25. On the other hand, when the control unit 50 does not obtain an instruction to display the details (No in step S24), step S25 is skipped and this series of abnormality display processing ends.

[0245] In step S25, the control unit 50 causes the display input unit 30 to display information indicating the type of abnormality and the location where the abnormality occurred. When the control unit 50 obtains an operation signal of the result detail display button 315, it switches the screen of the display input unit 30 to the result detail screen 36 including the first label 361 and the second label 362. The first label 361 prominently displays that an abnormality has occurred during the measurement. The second label 362 displays the location where the abnormality has occurred on the test paper image 300.

[0246] The control unit 50 may display the second label 362 with the shape, size, and color of the mark changed according to the type of abnormality, and may also change the text and mark of the mark. The operator can quickly confirm the abnormality occurrence site through the second label 362 displayed on the test paper image 300, and can also grasp the type of abnormality based on the first label 361, the second label 362, or the test paper image 300. Moreover, by comparing the test paper image 300 containing the abnormal site and the normal test paper image 300 side by side, the cause of the measurement abnormality can be efficiently grasped.

[0247] The following describes in detail the measurement abnormality detected by analyzing the test strip image 300. In addition, a method for identifying the cause of abnormality by comparing and referencing the test strip image 300 and a method for identifying the cause of abnormality in the analysis result of the quality control sample are described with specific examples.

[0248] As measurement abnormalities detected by analyzing the test paper image 300, there can be cited immersion abnormalities, bridging abnormalities, color unevenness abnormalities, color development abnormalities, etc. The causes of these abnormalities include situations caused by precision management samples, situations caused by the test paper 100, situations caused by the sample analysis device 1, and situations caused by the inspection technique. In addition, due to these reasons, the analysis results of the precision management samples sometimes vary greatly. Among them, measurement abnormalities caused by inspection techniques are most likely to occur, and inspection techniques are likely to become the cause of abnormal analysis results. By arranging multiple test paper images 300 in parallel for comparison and reference, it becomes easy to distinguish the causes.

[0249] In the sample analyzer 1, a test strip image 300 indicating a normal analysis result may be stored in advance as a reference. Alternatively, the operator may register the test strip image 300 as a reference. When an abnormality occurs in measurement or an abnormality occurs in the analysis result of the quality control sample, by using the image of the reference as one of the multiple test strip images 300 for comparison and reference, for example, the abnormality or the cause of the abnormality can be more efficiently and accurately identified.

[0250] The above-mentioned impregnation abnormality is caused by the presence of the reagent pad 102 that is not in sufficient contact with the sample 110. Since the color development reaction does not occur in the reagent pad 102 that is not immersed in the sample 110, it is impossible to obtain a correct analysis result. Insufficient impregnation into the sample 110 is likely to occur in the reagent pad 102 close to the holding portion 104. In addition, the reflected light intensity of the dry reagent pad 102 is greater than the reflected light intensity of the wet reagent pad 102. Therefore, the impregnation abnormality can be detected based on the color (reflected light intensity) of the reagent pad 102 close to the holding portion 104.

[0251] The above-mentioned bridging is abnormal because adjacent reagent pads 102 are connected to each other via sample 110. In this case, because the reagents impregnated in each reagent pad 102 are mixed with each other, therefore, the analysis result may be affected. Since the base material 101 of the test paper 100 is white, if there is sample 110 between adjacent reagent pads 102, then compared with the situation that there is no sample 110, the reflected light intensity decreases. The bridging is detected abnormally based on the variation of this reflected light intensity. In addition, even if the reagent pads 102 are not connected to each other via sample 110, when sample 110 remains on the base material 101, this state can also be detected as wiping abnormality.

[0252] The color unevenness abnormality is caused by color unevenness in the reagent pad 102. For example, due to the adhesion of powder of other reagent pads 102, other garbage or dust, sediment components in the sample 110, etc. to the reagent pad 102, the unevenness of the reagent pad 102, etc., the color unevenness of the reagent pad 102 may occur, which affects the analysis result. Based on the deviation of the concentration value of each pixel constituting the image data of the reagent pad 102, as a specific example, based on the difference between the maximum value and the minimum value of the concentration value, the ratio, the variance value, etc., the color unevenness abnormality is detected.

[0253] The above-mentioned color abnormality is a state in which the color of the reagent pad 102 deviates greatly from the respective reference color. It is considered that the cause of the color abnormality is the deterioration of the test paper 100, the color reaction inhibitory substance contained in the sample 110, the excessive immersion into the sample 110, etc. In this case, a correct analysis result cannot be obtained. The color abnormality in each reagent pad 102 is detected based on the size of the color difference between the RGB value of the image data of the reagent pad 102 and each reference color in the color coordinate space.

[0254] For example, when poor discoloration or uneven color is confirmed in the reagent pad 102 near the gripping portion 104 of the test paper 100, when the reagent pad 102 is excessively discolored, when the sample 110 remains on the substrate 101, and when bridging occurs, it is suspected that the abnormal measurement or abnormal analysis result is caused by the inspection method. In this case, it is preferable to compare the test paper image 300 with the test paper image 300 under the following conditions for reference.

[0255] <Comparison object>

[0256] 1) The batch number of test strip 100 is the same

[0257] 2) The batch number of the quality control samples is the same

[0258] 3) Different operators

[0259] By comparing and referencing the test paper images 300 involved in the measurements with only different operators but the same other conditions, the influence of the inspection method on the analysis result becomes clear. When the reagent pad 102 near the gripping portion 104 is confirmed to have poor color change or uneven color for the test paper image 300 related to a specific operator, it is presumed that the test paper 100 is insufficiently impregnated into the sample 110. Excessive color change of the reagent pad 102 is presumed to be excessive impregnation, and the residue of the sample 110 on the substrate 101 is presumed to be insufficient wiping of the test paper 100.

[0260] In addition, in the measurement using the precision control sample, each reagent pad 102 changes color in the same manner, and no residue of the sample 110 on the substrate 101 is confirmed. However, when the color change of a specific reagent pad 102 is different, it is suspected that the precision control sample of the same medicine bottle has been immersed for more than the number of times used. Specifically, the color change of the reagent pad 102 for analyzing occult blood (BLD), glucose (GLU), and pH is different, and the other reagent pads 102 change color appropriately. In this case, it is preferred to compare and reference the test paper image 300 with the test paper image 300 under the following conditions.

[0261] <Comparison object>

[0262] 1) The batch number of test strip 100 is the same

[0263] 2) The batch number of the precision management samples is the same and the same medicine bottle

[0264] 3) Same operator

[0265] The number of times the quality control sample is used is set to 5 times, for example, but the test paper 100 may be dipped in an amount exceeding the number of times used by mistake. When compared with the test paper image 300 captured in the measurement of the quality control sample of the same medicine bottle, if only the test paper image 300 with the problem contains the above-mentioned abnormality, it is presumed that the quality control sample has been used for a number of times exceeding the predetermined number of times. It should be noted that, if the frequency of occurrence of the problem is high in the measurement of a specific operator, it is also effective to use the test paper image 300 based on the measurement of a different operator as the comparison object.

[0266] In addition, in the measurement of the quality control sample using the same lot number, each reagent pad 102 changes color in the same manner and no sample 110 residue is confirmed on the substrate 101. However, if the color change of the reagent pads 102 is different as a whole, or if one or two reagent pads 102 change color unevenly, it is suspected that the test paper 100 is defective. In this case, it is preferable to compare the test paper image 300 with the test paper image 300 under the following conditions for reference.

[0267] <Comparison object>

[0268] 1) The batch number of the test strip 100 is different / or the same

[0269] 2) The batch number of the quality control samples is the same

[0270] 3) Same operator

[0271] By comparing the images of the test strips 100 with different batch numbers, if it is determined that the frequency of occurrence of the above-mentioned problem is high when using the test strips 100 of the same batch number as the test strip 100 with the problematic test strip image 300, it is inferred that there is a defect in the test strip 100 of the batch number. In addition, when comparing the images of the test strips 100 of the same batch number, if uneven discoloration of the reagent pad 102 is confirmed only in the problematic test strip image 300, it is inferred that the abnormality is specific to the test strip 100 caused by the adhesion of powder, other garbage, dust, etc. of other reagent pads 102.

[0272] In addition, in the measurement using the same lot number of test strips 100, each reagent pad 102 changes color in the same manner, and no sample 110 residue is confirmed on the substrate 101, but the color change of the reagent pad 102 is different as a whole, it is suspected that the quality control sample is defective. In this case, it is preferable to compare the test strip image 300 with the test strip image 300 under the following conditions for reference.

[0273] <Comparison object>

[0274] 1) The batch number of test strip 100 is the same

[0275] 2) The batch numbers of the quality control samples are different / or the batch numbers are the same but the bottles are different

[0276] 3) Same operator

[0277] By comparing the test strip image 300 with the quality control sample of a different batch number, if it is determined that the frequency of occurrence of the above-mentioned problem is high when the quality control sample of the same batch number as the quality control sample of the test strip image 300 with the problem is used, it is inferred that there is a defect in the quality control sample of the batch number. In addition, when comparing the test strip image 300 with the quality control sample of the same batch number but different medicine bottles, if the above-mentioned problem is confirmed only in the test strip image 300 with the problem, it is inferred that it is caused by the specific abnormality of the medicine bottle.

[0278] As described above, by displaying a plurality of test strip images 300 in parallel on the display input unit 30 and comparing and referencing them, for example, when a measurement abnormality occurs or when an analysis result of a precision control sample is abnormal, the cause of the abnormality or large change can be efficiently identified. In the sample analyzer 1 as a semi-automatic device, in particular, the deviation of the operator's inspection technique may have a significant impact on the analysis result, but by comparing the test strip images 300 obtained by each operator, it is easy to find the problem of the inspection technique and correct it. If the test strip images 300 involved in the measurement with only different operators but the same other conditions are compared and referenced, the influence of the inspection technique on the analysis result becomes clear, and therefore, this function of the sample analyzer 1 is also suitable for training of the inspection technique.

[0279] As described above, the function of displaying multiple test strip images 300 in parallel for comparison and reference is not only effective for identifying the causes of abnormal measurements and analysis results of precision management samples, correcting and training inspection techniques, and confirming batch differences of precision management samples and test strips 100, but is also effective for monitoring components in the urine of the same patient.

[0280] Below, refer to Figure 17 to Figure 22 , the structure and dirt detection method related to the dirt detection of the test paper holder 11 are described in detail.

[0281] like Fig.17 as well as Fig.18 As shown, the sample analyzer 1 is configured to photograph the test paper holder 11 of the conveying unit 10 by the photographing unit 20. The photographing unit 20 photographs the test paper 100 placed on the test paper holder 11, but at this time, 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. As will be described in detail later, the image analysis of the test paper holder 11 and the dirt detection of the test paper holder 11 are performed by the function of the control unit 50.

[0282] As described above, the sample analysis device 1 is a semi-automatic device in which the operator immerses the test paper 100 in the sample 110, wipes off the sample 110 attached 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 sufficiently, the sample 110 may sometimes adhere to the test paper holder 11 and dirty the test paper holder 11. The sample analysis device 1 is provided with a pull-out portion 75, and the transport portion 10 is cleaned by pulling the entire transport portion 10 out of the device and immersing it in a cleaning solution, etc., but it is required to be able to clean the test paper holder 11 efficiently and appropriately. It should be noted that when the transport portion 10 is immersed in the cleaning solution, white bleaching powder dirt may sometimes be generated due to insufficient wiping.

[0283] According to the sample analyzer 1, dirt on the test paper holder 11 is automatically detected, and the test paper holder 11 can be cleaned efficiently. In this embodiment, since the sample 110 is urine, there is also a problem of odor, and it is preferable to be able to quickly clean the test paper holder 11 when it is dirty. A plurality of test paper holders 11 are provided, but dirt detection can be quickly and reliably performed using the image of the test paper holder 11 obtained by the imaging unit 20.

[0284] 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 while cleaning, and the continuous cleaning mode is a mode in which the test paper holder 11 is automatically and continuously transported while cleaning. In either case, the operator must determine whether the test paper holder 11 is contaminated. In contrast, in the automatic detection cleaning mode, contamination is automatically detected by image analysis of the test paper holder 11. The automatic detection cleaning mode can also be performed during the measurement of the sample 110.

[0285] From the viewpoint of miniaturization and cost reduction of the device, the sample analyzer 1 does not have a function of automatically cleaning the test paper holder 11. Therefore, the test paper holder 11 is cleaned by, for example, an operator wiping dirt off the test paper holder 11 with a paper towel or the like. That is, the automatic detection cleaning mode of the sample analyzer 1 is a mode that assists the cleaning operation of the test paper holder 11.

[0286] In the automatic detection and cleaning mode, the sample analyzer 1 performs a cleaning auxiliary action of automatically detecting the test paper holder 11 that needs to be cleaned and placing the test paper holder 11 at a cleaning position that can be cleaned. In the present embodiment, the placement position P1 of the test paper 100 where the opening 71 of the frame 70 is formed becomes the cleaning position. As the cleaning auxiliary action, the sample analyzer 1 preferably also performs an action of displaying the location of the test paper holder 11 where dirt exists on the display input unit 30, and an action of rechecking the dirt after cleaning.

[0287] When the dirt detection of the test paper holder 11 is performed during the measurement of the sample 110, the control unit 50 can also control the shooting unit 20 to shoot the test paper holder 11 without the test paper 100, and analyze the image of the test paper holder 11 to detect the dirt of the test paper holder 11. In this case, the test paper 100 will not hinder the dirt detection of the test paper holder 11. It should be noted that it is possible to detect whether the test paper 100 is placed on the test paper holder 11 by the test paper detection unit 40. In addition, 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, which has not detected the test paper 100 at the detection position P2, reaches the shooting position P3.

[0288] When the dirt detection of the test paper holder 11 is performed during the measurement of the sample 110, the control unit 50 may also control the shooting unit 20 to shoot the test paper holder 11 on which the test paper 100 is placed, so as to detect the dirt on the test paper holder 11. In this case, part of the test paper holder 11 is extracted by image processing. The test paper holder 11 without the test paper 100 may have never been used, while the test paper holder 11 on which the test paper 100 is placed may have been used at least once and is likely to have dirt attached to it. In addition, if the dirt detection of the test paper holder 11 on which the test paper 100 is placed is not performed, it is also conceivable that the problem of dirt accumulation may occur when the same test paper holder 11 is used continuously.

[0289] The control unit 50 controls the photographing unit 20 to start photographing the test paper holder 11 while moving the photographing unit 20a in the Y direction when the target test paper holder 11 is conveyed to the photographing position P3. The photographing unit 20 is configured to be able to photograph the entire test paper holder 11. Since the test paper 100 is arranged in the receiving portion 11a of the test paper holder 11, the photographing range of the photographing element 22 can also be limited to the range of the receiving portion 11a. However, since the sample 110 may also be attached to the extension portion 11d, it is preferred to photograph the entire test paper holder 11.

[0290] When the contamination detection of the test paper holder 11 is performed during the measurement of the sample 110 , the control unit 50 may capture images of all the test paper holders 11 regardless of the presence or absence of the test paper 100 to detect the contamination of the test paper holder 11 .

[0291] As described above, when the length in the X direction of the shooting range of the shooting element 22 is a length equivalent to the length of three test paper holders 11 including the test paper holders 11 adjacent to both sides, dirt detection can also be performed using the image of the test paper holders 11 adjacent to both sides taken together when the test paper 100 is photographed. For example, when the test paper holder 11 carrying the test paper 100 reaches the shooting position P3, the control unit 50 shoots three test paper holders 11 including the test paper holder 11 and the test paper holders 11 adjacent to both sides at once, and performs dirt detection on the three test paper holders 11. That is, dirt detection can be performed using the image of the test paper holder 11 taken when the image of the test paper 100 is obtained.

[0292] The control unit 50 detects dirt on the test paper holder 11 by analyzing the image of the test paper holder 11. However, similarly to the case of analyzing the sample 110, image processing such as correction processing, synthesis processing, and extraction processing is performed before image analysis. The image captured by the imaging unit 20 includes an image of the test paper 100 and an image around 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.

[0293] exist Fig.18 In the example shown, for the test paper holder 11 on which the test paper 100 is not placed, the central portion in the width direction of the receiving portion 11a is set as the determination area 120 for dirt detection. On the other hand, for the test paper holder 11 on which the test paper 100 is placed, both ends in the width direction of the receiving portion 11a are set as the determination area 120. The determination area 120 is a range for image analysis for dirt detection, and can be set to a portion of the placement surface of the test paper holder 11, or to a large range exceeding 50% of the placement surface. The determination area 120 can also be set to a portion in the length direction of the test paper holder 11, such as a portion where the protrusion 11e is formed.

[0294] For example, the control unit 50 uses the entire loading surface in the direction of the imaging element 22 as the detection target area of ​​dirt for the test paper holder 11 on which the test paper 100 is not loaded. In this case, the entire loading surface becomes the determination area 120, but as described later, the loading surface is divided into a plurality of determination areas 120 for image analysis. It should be noted that, when the test paper 100 is loaded, the entire loading surface except 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 to which dirt is easily attached, more rapid dirt detection can be performed, but if the entire loading surface is used as the determination area 120, dirt on the test paper holder 11 can be detected more reliably.

[0295] The control unit 50 executes a series of processes for detecting dirt on the test paper holder 11 when the sample analyzer 1 is activated or shut down. The automatic detection cleaning mode is based on the cleaning mode selection screen 37b (see Fig.19 ), but it can also be automatically executed as one of the startup operations when the power of the sample analyzer 1 is turned on. In addition, the automatic detection and cleaning mode can also be automatically executed as one of the shutdown operations of the sample analyzer 1. The automatic detection and cleaning mode is executed at a timing when the measurement of the sample 110 is not being performed, such as a gap between measurements, at startup, or at shutdown, but it can also be executed during the measurement of the sample 110 as described above.

[0296] The control unit 50 controls the conveying unit 10 to move the test paper holder 11 detected with dirt by image analysis of the test paper holder 11 to the cleaning position. In the present embodiment, as described above, the loading position P1 becomes the cleaning position. Under the control of the control unit 50, the conveying unit 10 can, for example, convey the test paper holder 11 detected with dirt to the cleaning position at any time, or convey the test paper holder 11 detected with dirt to the cleaning position after all the test paper holders 11 are detected with dirt.

[0297] The control unit 50 may also control the conveying unit 10 based on the instruction of the display input unit 30 to move the test paper holder 11 in which dirt is detected to the cleaning position. For example, dirt detection of each test paper holder 11 may be performed during the measurement of the sample 110, and based on the instruction of the operator, information related to the detected dirt of the test paper holder 11 is provided, and the test paper holder 11 is moved to the cleaning position. Under the control of the control unit 50, the conveying unit 10 conveys the test paper holder 11 in which dirt is detected to the cleaning position, for example, based on the operation of the display input unit 30. In this case, the operator can move the test paper holder 11 in which dirt is detected to the cleaning position at any timing, such as when the measurement is finished or when it is closed.

[0298] The control unit 50 can also move the cleaned test paper holder 11 from the cleaning position to the shooting position P3, shoot the cleaned test paper holder 11 again, and detect the dirt of the test paper holder 11 again. In this case, since the cleaning state can be confirmed by image analysis of the test paper holder 11, more reliable cleaning can be performed. That is, under the control of the control unit 50, the conveying unit 10 conveys the test paper holder 11 on which dirt is detected to the cleaning position, and then conveys the cleaned test paper holder 11 to the shooting position P3. Under the control of the control unit 50, the shooting unit 20 shoots the cleaned test paper holder 11.

[0299] The stop time of the test paper holder 11 at the cleaning position may also be a predetermined time, but since the time required for cleaning varies depending on the degree of dirt on the test paper holder 11, etc., it is preferred that the operator can arbitrarily change it. Fig.19 ), the next test paper holder 11 is conveyed to the cleaning position, and the cleaned test paper holder 11 is conveyed toward the photographing position P3. That is, the control unit 50 makes the test paper holder 11 standby at the cleaning position until there is an instruction from the display input unit 30. In this case, the operator can arbitrarily determine the cleaning time.

[0300] The control unit 50 causes the display input unit 30 to display information related to the detected dirt on the test paper holder 11. Thus, the operator can easily recognize that the test paper holder 11 is dirty based on the information displayed by the display input unit 30. When the control unit 50 detects dirt on the test paper holder 11, the display input unit 30 can display the information at any time, or can display the information in a summary after dirt detection is performed on all the test paper holders 11. In addition, the control unit 50 can also cause the display input unit 30 to display information related to the dirt on the test paper holder 11 based on the instruction of the display input unit 30.

[0301] The control unit 50 also preferably causes the display input unit 30 to display at least one selected from the location where dirt exists and the degree of dirt on the test paper holder 11. The control unit 50 provides information on which test paper holder 11 is dirty and which part of the test paper holder 11 has dirt. Thus, the operator can easily identify the part to be cleaned, and usability is further improved.

[0302] The control unit 50 detects dirt based on the difference between the pixel value in the image of the test paper holder 11 and the pixel value in the reference image of the test paper holder 11 in a state where there is no dirt. The pixel value is the value of the light intensity detected by each pixel (pixel) of the imaging element 22, and is stored as a concentration value taking any value from 0 to 255. In this embodiment, as the concentration value, RGB values ​​are used, which represent the light intensity of red, green, and blue with values ​​of 0 to 255, respectively.

[0303] Since the test paper holder 11 is black, the RGB value of the reference image (hereinafter referred to as the "reference RGB value") is a value where any one of RGB is close to 0, and as an example, is 0 to 50. For dirt attached to the test paper holder 11, for example, urine dirt is yellow and bleaching powder dirt is white, so the RGB value of the reflected light based on the part where the dirt is attached is larger than the reference RGB value. When the difference between the RGB value in the image of the test paper holder 11 of the dirt detection object (hereinafter referred to as the "object RGB value") and the reference RGB value is a large value and exceeds the specified boundary condition, it can be inferred that dirt exists in the part corresponding to the object RGB value.

[0304] The determination of the presence or absence of dirt by image analysis of the test paper holder 11 is preferably performed by dividing the loading surface into a plurality of determination areas 120, and comparing the RGB value with the reference RGB value for each determination area 120. Each determination area 120 is an area containing a plurality of pixels. It should be noted that the sizes of the determination areas 120 do not need to be the same as each other, and may also be different depending on the position of the loading surface. The determination of the presence or absence of dirt can be performed for each pixel or for the entire loading surface, but by determining the presence or absence of dirt for each determination area 120 containing a plurality of pixels, it is possible to suppress false detection of dirt, and to display the location where dirt is present.

[0305] The control unit 50 calculates the average value of the target RGB value in each determination area 120, and uses the average value to obtain the difference α from the reference RGB value. Furthermore, when the ratio of the difference α to the reference RGB value exceeds a predetermined threshold value β, it is determined that dirt exists in the determination area 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 when the difference α exceeds the threshold value γ, it is determined that dirt exists in the determination area 120 where α>γ.

[0306] In the case where the image of the test paper holder 11 of the dirt detection object includes a determination area 120 determined to be dirty, the control unit 50 stores the test paper holder 11 in the storage unit 52 as a holder to be cleaned. In addition, the position of the determination area 120 determined to be dirty is stored as a location where dirt is present. The control unit 50 can also calculate the degree of dirt by comparing the above-mentioned difference α with multiple thresholds. As a specific example, when the difference α exceeds a second threshold value greater than the threshold β, the degree of dirt is determined to be greater than when the difference α is below the second threshold value. In this case, the former is stored as a numerical value representing the degree of dirt in a manner of dirt level 2 and the latter as dirt level 1.

[0307] Fig.19 1 is a diagram showing an example of a display screen showing a cleaning mode of the test strip holder 11 and information on contamination of the test strip holder 11 . Fig.19 (a) shows a maintenance screen 37a for performing maintenance on the sample analyzer 1. In the maintenance screen 37a, a rack cleaning button 370 for cleaning the test paper rack 11 is displayed as one of the maintenance items. By pressing the rack cleaning button 370, the screen of the display input unit 30 is switched to Fig.19 (b) shows the cleaning mode selection screen 37b.

[0308] like Fig.19 As shown in (b), in the cleaning mode selection screen 37b, there are displayed 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 for automatically detecting dirt by image analysis of the test paper holder 11 as described above, and can also be executed during the measurement of the sample 110. Fig.19 The information related to the contamination of the test paper holder 11 shown in (d) can be displayed at any timing based on the instruction of the display input unit 30. When the contamination of the test paper holder 11 is detected during the measurement of the sample 110, the result is stored, and the information related to the contamination is displayed after the measurement of the sample 110 is completed.

[0309] Fig.19 (c) and Fig.19(d) represent the progress information screen 37c and the detection result screen 37d respectively. If the automatic detection cleaning mode is executed when the measurement of the sample 110 is not performed, the screen of the display input unit 30 is switched to the progress information screen 37c. Information indicating that the dirt detection of the test paper holder 11 is being performed is displayed in the progress information screen 37c. When the dirt detection process is completed for all the test paper holders 11, the screen of the display input unit 30 is switched to the detection result screen 37d. It should be noted that when the test paper holder 11 is cleaned after the measurement is completed or when it is closed, the waiting time for the dirt detection can be shortened by performing the dirt detection of the test paper holder 11 during the measurement of the sample 110.

[0310] like Fig.19 As shown in (d), a holder image 375, a dirt location label 376, and a cleaning completion button 377 are displayed in the detection result screen 37d. By displaying the holder image 375, the degree of dirt on the test paper holder 11 can be confirmed in the display input unit 30. In addition, in the detection result screen 37d, at least one selected from text, numbers, and marks indicating the degree of dirt can also be displayed. The dirt location label 376 is used to display information of the part where dirt is detected, and is preferably displayed superimposed on the holder image 375.

[0311] exist Fig.19 In the example shown in (d), a plurality of square-frame-shaped dirt location labels 376 are displayed in a manner surrounding the dirt on the holder image 375. It should be noted that the shape of the dirt location label 376 is not limited to a square frame, and can also be changed according to the degree, shape, size, etc. of the dirt. In addition, the color of the dirt location label 376 can also be changed according to the degree, shape, size, etc. of the dirt. The number of test paper holders 11 in which dirt is detected is also displayed in the detection result screen 37d. Fig.19 "1 / 7" in (d) means that dirt to be cleaned is detected for 7 test paper holders 11, and the result of the first one is displayed.

[0312] The information on the detection result screen 37d preferably corresponds to the information on the test paper holder 11 disposed at the cleaning position. The control unit 50 causes the display input unit 30 to display the detection result screen 37d of the corresponding test paper holder 11 when the test paper holder 11 reaches the cleaning position. The operator can clean the test paper holder 11 based on the information displayed on the detection result screen 37d, and when the cleaning of the test paper holder 11 is completed, press the cleaning completion button 377. When the cleaning completion button 377 is pressed, the control unit 50 controls the conveying unit 10 to move the next test paper holder 11 where dirt is detected to the cleaning position, and moves the cleaned test paper holder 11 toward the shooting position P3.

[0313] Fig. 201 is a diagram showing an example of a determination screen for the cleaning state of the test paper holder 11 . Fig. 20 (a) shows the detection result screen 37d of the seventh of the seven test paper holders 11 that have detected dirt to be cleaned. When the last test paper holder 11 is cleaned and the cleaning completion button 377 is pressed, the screen of the display input unit 30 is switched to Fig. 20 (b) The progress information screen 37e shown. In this embodiment, the cleaned test paper holder 11 is transported to the shooting position P3 to be shot again, and the 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 shot and the analysis result is obtained. The progress information screen 37e displays information indicating that the cleaning completion check is being performed.

[0314] When the cleaning completion check performed by photographing and analyzing the image of the test paper holder 11, i.e., the re-detection process of the dirt on the test paper holder 11, is completed, the screen of the display input unit 30 is switched to the cleaning determination screen 37f. Fig. 20 (c) shows that the cleaning is completed on the cleaning determination screen 37f. Fig. 20 When the "OK" button is pressed in the cleaning determination screen 37f shown in (c), the screen of the display input unit 30 returns to the maintenance screen 37a.

[0315] On the other hand, when dirt is detected on the cleaned test paper holder 11, Fig. 20 As shown in (d), a message indicating that dirt still remains is displayed on the cleaning determination screen 37f. Fig. 20 When the "OK" button is pressed in the cleaning determination screen 37f shown in (d), the test paper holder 11 that is not cleaned sufficiently and has been detected to be dirty is transported to the cleaning position, and the screen of the display input unit 30 is switched to the detection result screen 37d. In this case, the operator needs to confirm the information on the detection result screen 37d and clean the test paper holder 11 again.

[0316] Fig.21 1 is a flowchart showing an example of the automatic detection and cleaning process of the test paper holder 11 .

[0317] like Fig.21 As shown, in step S31, the control unit 50 sets the test paper holder 11 as the object of dirt detection. Hereinafter, all the test paper holders 11 are set as the object of dirt detection. In the case where the test paper holder 11 as the object of dirt 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 object of dirt detection based on the instruction of the display input unit 30.

[0318] In step S32, the control unit 50 moves the test paper holder 11 of the dirt detection object to the shooting position P3. In this embodiment, since all the test paper holders 11 are the dirt detection objects, the test paper holders 11 are transported to the shooting position P3 in sequence. The control unit 50 drives the driving device 13 of the transport unit 10 intermittently under predetermined conditions to transport the test paper holder 11 to the shooting position P3. It should be noted that the control unit 50 identifies which test paper holder 11 is located at which position.

[0319] In step S33, the control unit 50 controls the imaging unit 20 to capture the loading surface of the test paper holder 11. For example, the control unit 50 moves the imaging unit 20a in the Y direction while capturing the entire loading surface of the test paper holder 11. In addition, the control unit 50 processes the image acquired by the imaging element 22, extracts the range of one test paper holder 11, and synthesizes multiple images to generate one holder image 375 (see FIG. Fig.19 (d) etc.).

[0320] In step S34, the control unit 50 analyzes the holder image 375 to perform dirt detection processing. For example, when the holder image 375 includes a determination area 120 where dirt exists, the control unit 50 stores the test paper holder 11 corresponding to the holder image 375 as a holder to be cleaned. In addition, the position of the determination area 120 is stored as a location where dirt exists.

[0321] In step S35, the control unit 50 determines whether the shooting of all the test paper holders 11 is completed. When the shooting of all the test paper holders 11 is completed (yes in step S35), the process proceeds to step S36. On the other hand, when the shooting of all the test paper holders 11 is not completed (no in step S35), the process returns to step S32. It should be noted that when the automatic detection cleaning mode of the test paper holder 11 is executed during the 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.

[0322] In step S36, when the information that the bracket needs to be cleaned is stored in step S34 (Yes in step S36), the control unit 50 advances the process to step S37. On the other hand, when the information that the bracket needs to be cleaned is not stored (No in step S36), the display input unit 30 displays a message notifying that the automatic detection cleaning mode has ended, skipping steps S37 to S39 and ending a series of processes.

[0323] In step S37, the control unit 50 moves the holder to be cleaned to the cleaning position. In this embodiment, the placement position P1 of the test paper 100 is the cleaning position. The control unit 50 drives the driving device 13 of the conveying unit 10 to convey the holder to be cleaned to the cleaning position.

[0324] In step S38, the control unit 50 causes the display input unit 30 to display information related to the dirt on the test paper holder 11. The control unit 50 displays the detection result screen 37d including the holder image 375 and the dirt location label 376 as information related to the dirt. The operator can clean the test paper holder 11 with a paper towel or the like while observing the holder image 375 and the dirt location label 376 on the detection result screen 37d. In this way, the test paper holder 11 can be cleaned quickly and appropriately. A cleaning completion button 377 is displayed on the detection result screen 37d, and the operator presses the cleaning completion button 377 when the cleaning of the test paper holder 11 is completed.

[0325] In step S39, the control unit 50 determines whether the cleaning of all the test paper holders 11 in which dirt is detected is completed. Specifically, when the operation signals of the cleaning completion button 377 are obtained for the number of holders to be cleaned, it is determined that the cleaning of all the test paper holders 11 is completed (step S39 is yes), and a series of processes are ended. On the other hand, when the number of operation signals of the cleaning completion button 377 obtained is less than the number of holders to be cleaned, since there are test paper holders 11 that have not been cleaned (step S39 is no), the process returns to step S37.

[0326] When the cleaning completion button 377 is pressed, the control unit 50 controls the conveying unit 10 to move the next test paper holder 11 to be cleaned to the cleaning position, and causes the display input unit 30 to display information related to the dirt on the test paper holder 11. The control unit 50 can also move the cleaned test paper holder 11 to the shooting position P3 to shoot again, and perform dirt detection on the test paper holder 11 again. In this case, the cleaning status can be confirmed by image analysis of the test paper holder 11. When dirt is detected in the cleaned test paper holder 11, the test paper holder 11 is conveyed to the cleaning position again.

[0327] Fig. 22 1 is a flowchart showing an example of the contamination detection process of the test paper holder 11 .

[0328] like Fig. 22As shown, in step S341, the control unit 50 divides the stent image 375 captured in step S33 into a plurality of determination areas 120, and obtains the RGB value of each pixel constituting the image data for each determination area 120. In this embodiment, the entire mounting surface is divided into a plurality of determination areas 120. The size of each determination area 120 is not particularly limited, but each determination area 120 includes a plurality of pixels.

[0329] In step S342, the control unit 50 calculates the average value of the RGB value for each determination area 120, and in step S343, compares the average value of the RGB value of each determination area 120 with the reference RGB value of the reference image of the test paper holder 11 in the absence of dirt. In step S343, it is determined whether the difference α between the average value of the RGB value of each determination area 120 and the reference RGB value exceeds a specified threshold value γ. It should be noted that in step S343, it is also possible to determine whether the ratio of the difference α to the reference RGB value exceeds a specified threshold value β. In addition, it is also possible to compare only the B value of the RGB value of each determination area 120 with the B value of the reference RGB value to perform dirt determination.

[0330] When the difference α between the average value of the RGB value of each determination area 120 and the reference RGB value exceeds the threshold value γ (Yes in step S343), the control unit 50 determines that dirt exists in the determination area 120 where α>γ in step S344. Furthermore, when the determination area 120 determined to exist dirt is included in the support image 375 of the analysis object, the test paper support 11 corresponding to the support image 375 is stored as a support to be cleaned. In addition, the position of the determination area 120 determined to exist dirt is stored as a location where dirt exists.

[0331] On the other hand, when the determination area 120 where α>γ is not included in the holder image 375 (No in step S343), the control unit 50 skips step S344 and ends the dirt detection process. That is, when the determination area 120 where α>γ is not included in the holder image 375, it is determined that there is no dirt to be cleaned on the test paper holder 11 corresponding to the holder image 375.

[0332] As described above, by analyzing the image of the test paper holder 11 to automatically detect the dirt on the test paper holder 11, the test paper holder 11 can be properly cleaned efficiently. The operator can execute the automatic detection and cleaning mode when the sample analyzer 1 is started, shut down, in the interval between measurements of the sample 110, or during the measurement of the sample 110. When the dirt to be cleaned is detected by the image analysis of the test paper holder 11, information including the part of the holder to be cleaned where the dirt exists is displayed on the display input unit 30, and the holder to be cleaned is transported to the cleaning position. Therefore, the operator can quickly and reliably clean the holder to be cleaned while observing the information displayed on the display input unit 30.

[0333] When the sample adheres to the test paper holder 11 and dirt accumulates, for example, there is a possibility that the analysis result may be affected or a hygienic problem may occur. However, according to the sample analyzer 1, the occurrence of such problems can be more reliably suppressed.

[0334] It should be noted that the above-mentioned embodiment can be appropriately modified in design within the scope that does not impair the purpose of the present invention. For example, the sample analysis device 1 is configured to be able to display multiple test paper images 300 in parallel on the display input unit 30 for comparison and reference, but the sample analysis device as another example of the embodiment may not have the function of displaying multiple test paper images 300 in parallel. In addition, the sample analysis device as another example of the embodiment may have a second imaging unit for imaging the loading unit 11 in addition to the imaging unit 20. However, since the imaging unit 20 is configured to be able to capture the entire loading unit 11, from the viewpoint of miniaturization and low cost of the device, it is preferred to use the image obtained by the imaging unit 20 to perform dirt detection on the loading unit 11.

[0335] The sample analyzer 1 is a semi-automatic device in which an operator prepares a test paper 100 containing a sample 110 and places the test paper on the test paper holder 11. However, the structure of the sample analyzer of the present invention can also be applied to Fig.23 The fully automatic device shown.

[0336] Fig.23 1 is a diagram showing a schematic structure of a sample analyzer 2 as another example of an embodiment. The sample analyzer 2 is a fully automatic device that automatically places a test paper 100 on a test paper holder 11 and drips a 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.

[0337] On the other hand, the sample analyzer 2 is different 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 dropping the sample 110 on the test paper 100, and a storage unit 92 for the test paper 100. For example, a urine sampling 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 introduced into the sample analyzer 2.

[0338] In the sample analyzer 2, similarly to the sample analyzer 1, after the test paper 100 is placed on the test paper holder 11 at the placement position P1, it is transported to the photographing position P3 to photograph the test paper 100, and the sample 110 is analyzed by image analysis of the test paper 100. It should be noted that in the sample analyzer 2, the test paper 100 is not immersed in the sample 110, and the sample 110 is not 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 90 with the reagent pad 102 facing upward, and at the dripping position P4, the dispensing device 91 drips the sample 110 onto the reagent pad 102 of the test paper 100.

[0339] Similarly, in the sample analyzer 2, when the sample 110 is dropped onto the test paper 100, the sample 110 may adhere to the test paper holder 11 and dirty the test paper holder 11. Therefore, it is preferable to equip the sample analyzer 2 with a function of automatically detecting the cleaning mode in order to efficiently and appropriately clean the test paper holder 11. In addition, in order to efficiently grasp the cause of abnormality when an abnormality occurs in the analysis result, it is preferable to equip the sample analyzer 2 with a function of displaying a plurality of test paper images 300 in parallel.

Claims

1. A sample analysis device, configured to photograph a test paper and analyze the sample by analyzing the image of the test paper, wherein: The sample analysis device comprises: a conveying unit having a placing portion for placing the test paper, and moving the placing portion to a photographing position of the test paper; a control unit, the control unit analyzing the photographed image of the test paper; and a photographing unit configured to photograph the mounting unit, The control unit analyzes the captured image of the placement unit to detect contamination of the placement unit.

2. The sample analysis device according to claim 1, wherein: The sample analysis device further includes a display unit. The control unit causes the display unit to display information related to the detected dirt on the placement unit.

3. The sample analysis device according to claim 2, wherein: The control unit causes the display unit to display at least one selected from a location on the placement unit where dirt exists and a degree of dirt.

4. The sample analysis device according to claim 1, wherein: The transport unit moves the placement unit, where dirt is detected, to a cleaning position.

5. The sample analysis device according to claim 4, wherein: The transport unit transports the cleaned loading portion from the cleaning position to the photographing position. The photographing unit photographs the cleaning-completed loading portion. The control unit analyzes an image of the placement unit that has been cleaned to detect contamination of the placement unit.

6. The sample analysis device according to claim 1, wherein: The control unit detects dirt based on a difference between a pixel value in the image of the placing portion and a pixel value in a reference image of the placing portion in a state where no dirt exists.

7. The sample analysis device according to claim 1, wherein: The sample analyzer further includes an input unit for inputting a predetermined instruction. The control unit controls the transport unit based on an instruction from the input unit to move the placement unit where dirt is detected to a cleaning position.

8. The sample analysis device according to claim 1, wherein: The conveying unit is provided with a plurality of the placing units.

9. The sample analysis device according to claim 1, wherein: The photographing unit photographs the placing portion where the test paper is not placed. The control unit analyzes an image of the placement portion on which the test paper is not placed to detect contamination of the placement portion.

10. The sample analysis device according to claim 1, wherein: The photographing unit photographs the placing portion on which the test paper is placed. The control unit extracts and analyzes a region of the placement portion from an image of the placement portion on which the test paper is placed, thereby detecting contamination of the placement portion.

11. The sample analysis device according to claim 1, wherein: During the measurement of the sample, a series of processes for detecting contamination of the placement portion are performed.

12. The sample analysis device according to claim 1, wherein: A series of processes for detecting contamination of the placement portion are executed when the sample analyzer is activated or shut down.

13. The sample analysis device according to any one of claims 1 to 12, wherein: The placement portion is configured so that an operator can place the test paper thereon.

14. The sample analysis device according to any one of claims 1 to 12, wherein: The test strips include a variety of reagent pads that are impregnated with a sample by the operator.

15. A method for determining contamination of a placing portion in a sample analyzer, the sample analyzer comprising an imaging unit and the placing portion on which a test paper is placed, wherein: In the method, photographing the loading portion, The image of the placement portion taken is analyzed to detect dirt on the placement portion.

Images