Specimen inspection device

Abstract

To provide a specimen inspection device with a simpler constitution.SOLUTION: A specimen inspection device comprises a placement part, a permanent magnet, a sensor part, and a display control part. The placement part places an inspection cartridge which includes a light-transmissive inspection region having a surface provided with a first substance specifically binding to an object substance, and which accommodates magnetic particulates containing a second substance specifically binding to an object substance in the inspection region, and a specimen. The permanent magnet is provided above the placement part, and attracts magnetic particulates containing the second substance that are not bound to the object substance. The sensor part is provided below the placement part, and detects an object substance in a specimen by optically sensing a state of magnetic particulates bound to the object substance. The display control part displays a detection result of the object substance in a display device.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Embodiments of the present invention relate to a specimen inspection apparatus.

Background Art

[0002] Conventionally, there has been known a specimen inspection apparatus that analyzes a target substance such as an antigen contained in a specimen collected from a subject by using an antigen-antibody reaction. As such a specimen inspection apparatus, for example, there are those having magnetic microparticles to which an antibody that specifically binds to a target substance is fixed and an optical waveguide to which an antibody that specifically binds to the target substance is fixed on the surface, and performing measurement based on the absorbance caused by the magnetic microparticles bound to the surface of the optical waveguide via an antigen by an antigen-antibody reaction.

[0003] In such a specimen inspection apparatus, a magnetic field may be generated in a first direction on the side where the optical waveguide is provided by a magnetic field application unit such as an electromagnetic coil, so as to attract magnetic particles to the side of the optical waveguide to which the antibody is fixed and promote the antigen-antibody reaction. Further, after the antigen-antibody reaction, a process may be performed to pull unreacted magnetic particles away from the optical waveguide by generating a magnetic field in a second direction opposite to the first direction by the magnetic field application unit.

[0004] By the way, in order to generate magnetic fields in two directions, it is required to provide two magnetic field application units so as to face each other with the optical waveguide interposed therebetween. Generally, since the magnetic field application unit is a member having a large size, when the magnetic field application unit is provided as described above, the size of the specimen inspection apparatus may increase. Further, the magnetic field application unit also has a large weight, and the portability of the apparatus may be impaired. For this reason, for example, in a scene where a qualitative test for an infectious disease is performed in a medical examination room or the like of a medical facility, it may be difficult to use.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0006] The problem to be solved by the present invention is to provide a specimen inspection device with a simpler configuration.

Means for Solving the Problems

[0007] The specimen inspection device according to the embodiment includes a placement unit, a permanent magnet, a sensor unit, and a display control unit. The placement unit has a light-transmissive inspection area provided with a first substance that specifically binds to a target substance on its surface, and places an inspection cartridge that houses magnetic microparticles containing a second substance that specifically binds to the target substance and a sample on the inspection area. The permanent magnet is provided above the placement unit and attracts magnetic microparticles containing a second substance that is not bound to the target substance. The sensor unit is provided below the placement unit and detects the target substance in the sample by optically sensing the state of the magnetic microparticles bound to the target substance. The display control unit causes the detection result of the target substance to be displayed on a display device.

Brief Description of the Drawings

[0008]

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Embodiments for Carrying Out the Invention

[0009] Hereinafter, embodiments of the specimen inspection apparatus will be described in detail with reference to the accompanying drawings. Note that the specimen inspection apparatus according to the present application is not limited to the following embodiments. Also, the embodiments can be combined with other embodiments and the prior art as long as there is no contradiction in the content. Also, in the following description, the same components are given common reference numerals and redundant descriptions are omitted.

[0010] (First Embodiment) The specimen inspection apparatus according to the present embodiment is a specimen inspection apparatus that performs an inspection using an inspection cartridge that houses a sample.

[0011] The specimen inspection apparatus 10 according to the present embodiment binds a target substance to a sensor chip provided in an inspection cartridge by an antigen-antibody reaction using an antibody that specifically binds to an antigen (hereinafter also referred to as a target substance) to be inspected, and determines the presence or absence of the target substance bound to the surface of the sensor chip from the sensing result of a sensor such as a CMOS (Complementary Metal-Oxide-Semiconductor) sensor.

[0012] First, the overall configuration of the specimen inspection apparatus 10 according to the present embodiment will be described. FIG. 1 is a schematic diagram showing an example of the configuration of the specimen inspection apparatus 10 according to the first embodiment. As shown in FIG. 1, the specimen inspection apparatus 10 has a substantially box-shaped housing 100.

[0013] On one side of the housing 100, an installation port 11 and an extraction port 12 are provided. The installation port 11 is provided on the front side of the housing 100 (the negative Y-axis direction side in FIG. 1). The installation port 11 is an opening provided for inserting the inspection cartridge 200, which will be described later, into the housing 100a. The inspection cartridge 200 is installed at the conveyance start position where the conveyor 13, which will be described later, starts conveyance when it is inserted into the installation port 11.

[0014] The extraction port 12 is provided on the back side of the housing 100 (the positive Y-axis direction side in FIG. 1). The extraction port 12 is an opening provided for taking out the inspection cartridge 200 from inside the housing 100a. Specifically, the extraction port 12 is provided at a position corresponding to the measurement position where the inspection of the target substance is performed inside the housing 100, and it is possible to take out the inspection cartridge 200 that has completed the inspection.

[0015] Also, a conveyor 13 is provided inside the housing 100. The conveyor 13 is an example of a conveyance mechanism. A pair of conveyors 13 are arranged on both sides inside the housing 100. Also, the pair of conveyors 13 are provided facing each other in the short side direction of the housing 100 so as to extend in the longitudinal direction of the housing 100 inside the housing 100. The conveyor 13 conveys the inspection cartridge 200 installed at the conveyance start position inside the housing 100 to the measurement position inside the housing 100 when it is inserted into the installation port 11. The measurement position inside the housing 100 is an example of a placement portion.

[0016] Also, a CMOS sensor 14 is provided below the measurement position inside the housing 100. The CMOS sensor 14 is an example of a sensor unit and an imaging element. The CMOS sensor 14 is provided between the pair of conveyors 13 in the short side direction of the housing 100. The CMOS sensor 14 captures an image of the inspection cartridge 200 conveyed to the measurement position by the conveyor 23.

[0017] The CMOS sensor 14 has a lens 121 for photographing the test cartridge 200 placed at the measurement position. The CMOS sensor 14 also has a light source (not shown) for assisting in the photographing. The light source is, for example, a white LED (Light Emitting Diode), a xenon lamp, or the like. By illuminating the test cartridge 200 placed at the measurement position with the light source, it is possible to prevent the test cartridge 200 from being photographed darkly.

[0018] Also, a magnet 15 is provided above the measurement position inside the housing 100. The magnet 15 is an example of a permanent magnet. The magnet 15 is provided between a pair of conveyors 13 in the short side direction of the housing 100. The magnet 15 removes unreacted magnetic particles from the surface of the sensor chip 202.

[0019] Also, an input interface 16 (touch panel) and a display 17 are provided on the upper surface of the housing 100 in a state visible to the user.

[0020] Here, the test cartridge 200 and the sample dropped onto the test cartridge 200 will be described.

[0021] FIG. 2 is a diagram showing an example of a sample container 1 for accommodating a sample according to the present embodiment. The sample container 1 is a container for accommodating a sample collected from a subject. The sample is, for example, nasal pharyngeal swab fluid, saliva, serum, plasma, etc. of the subject.

[0022] The nozzle cap 1B is a member for making it possible to drop the sample accommodated in the bottle 1A by attaching it to the bottle 1A.

[0023] For example, when performing an inspection using the specimen inspection apparatus 10, the inspector first collects a specimen from the subject. Next, the inspector prepares a sample by mixing the collected specimen with a reagent. For example, the inspector puts the specimen collected from the subject into a bottle 1A containing the inspection reagent and stirs it to mix the specimen and the reagent. In this embodiment, the inspection reagent contains magnetic microparticles and a second antibody (described later) that is immobilized thereon and specifically binds to the target substance.

[0024] For example, when measuring SARS-CoV-2, a reagent composed of a surfactant or the like breaks the membrane protein of SARS-CoV-2 and elutes the nucleoprotein into the reagent. In this case, the antigen described above corresponds to this nucleoprotein.

[0025] The inspector attaches a nozzle cap 1B to the bottle 1A containing the adjusted sample, turns the nozzle downward, and presses the belly of the bottle 1A as if pinching it to drop an amount of the adjusted sample required for the inspection onto the inspection cartridge 200.

[0026] Next, the inspection cartridge 200 according to this embodiment will be described. FIGS. 3 and 4 are schematic views showing an example of the configuration of the inspection cartridge 200 according to the first embodiment. FIG. 3 is a view of the inspection cartridge 200 seen from the surface side (drop surface side) of the sample. FIG. 4 is a view of the inspection cartridge 200 seen from the back side (measurement surface side).

[0027] As shown in FIGS. 3 and 4, the inspection cartridge 200 according to this embodiment has a sample dropping portion 201 and a sensor chip 202. The sample dropping portion 201 is a part for dropping the adjusted sample. For example, the inspector drops the adjusted sample contained in the bottle 1A from the nozzle of the nozzle cap 1B onto the sample dropping portion 201.

[0028] The sensor chip 202 is a member for detecting a target substance in a sample. The sensor chip 202 is, for example, an optical waveguide type sensor chip. As an example, the optical waveguide type sensor chip is a chip in which an optical waveguide and a protective member are formed by thin film technology on an optically transparent substrate such as an acrylic resin. For example, a first antibody that specifically binds to the target substance is provided on the surface of the optical waveguide of the sensor chip 202 (the side where the sample droplet lower part 201 is provided).

[0029] Here, the first antibody is an example of a first substance. Also, the region where the first antibody is provided on the surface of the optical waveguide is an example of an inspection region.

[0030] Note that magnetic microparticles and a second antibody may be encapsulated in the test cartridge 200. In this case, the reagent in the bottle 1A of the sample container 1 does not contain magnetic microparticles and the second antibody.

[0031] Also, the test cartridge 200 may be configured so that a plurality of target substances can be tested with a single test cartridge 200. For example, when measuring SARS-Cov-2 and influenza virus, a first antibody against the nucleoprotein of SARS-Cov-2 and a first antibody against the nucleoprotein of influenza virus are immobilized on the surface of the optical waveguide.

[0032] Also, when configuring the test cartridge 200 so that a plurality of target substances can be tested, an inspection region may be provided for each target substance. In this case, the type of the first antibody immobilized on the surface of the optical waveguide is changed for each region of the sensor chip 202.

[0033] For example, when measuring SARS-Cov-2 and influenza virus, only the first antibody against the nucleoprotein of SARS-Cov-2 is immobilized on the surface of the optical waveguide in a specific region of the sensor chip 202, and the first antibody against the nucleoprotein of influenza virus is immobilized in a region other than the specific region. Thereby, for the specific region, it can be set as the inspection region for SARS-Cov-2, and for the region other than the specific region, it can be set as the inspection region for influenza virus.

[0034] Returning to FIG. 1, the overall operation of the specimen inspection apparatus 10 will be described. For example, after the examiner drops the adjusted sample onto the sample dropping portion 201 of the inspection cartridge 200, the inspection cartridge 200 is inserted into the housing 100 with the surface (the surface on the side where the sample dropping portion 201 is provided) facing up and pushed into the housing 100 from the installation port 11 in the negative X-axis direction.

[0035] A stopper (not shown) may be provided inside the housing 100. In this case, a stopper is provided at the end on the negative X-axis side of the conveyance start position inside the housing 100 so that the inspection cartridge 200 does not move to the negative X-axis side of the stopper. As a result, the examiner can install the inspection cartridge 200 at the conveyance start position inside the housing 100 by pushing the inspection cartridge 200 until it hits the stopper.

[0036] The conveyor 13 conveys the inspection cartridge 200 placed at the conveyance start position inside the housing 100 to the measurement position inside the housing 100. The magnet 15 pulls up the unreacted magnetic particles among the magnetic particles accommodated in the inspection cartridge 200 placed at the measurement position inside the housing 100.

[0037] The CMOS sensor 14 photographs the surface of the sensor chip 202 of the inspection cartridge 200 present at the measurement position inside the housing 100 from the back side of the inspection cartridge 200 (the surface on the side where the sensor chip 202 is provided).

[0038] Although it will be described in detail later, only the magnetic particles bound to the target substance via the second antibody will bind to the surface of the optical waveguide of the sensor chip 202. Therefore, the specimen inspection apparatus 10 according to the present embodiment can measure (determine) the presence or absence of the target substance by photographing the magnetic particles bound to the surface of the sensor chip 202 with the CMOS sensor 14.

[0039] When the measurement result is derived, the display 17 displays the measurement result. For example, after the measurement result is displayed on the display 17, the inspector takes out the measured test cartridge 200 by pulling out the test cartridge 200 from the outlet 12.

[0040] A spring (not shown) may be provided inside the side surface of the housing 100 on the side where the outlet 12 is not provided. In this case, when the inspector pushes the test cartridge 200 from the outlet 12 in the negative X-axis direction with a finger, the spring contracts. When the inspector releases the finger pressing the test cartridge 200 in this state, the test cartridge 200 is pushed out in the positive X-axis direction by the force with which the spring tries to return to its original state. Thereby, the inspector can take out the test cartridge 200 from the outlet 12.

[0041] Here, the reason why the unreacted magnetic particles can be removed from the surface of the sensor chip 202 by the magnet 15 will be explained.

[0042] First, a second antibody that specifically binds to the target substance is immobilized on the magnetic particles contained in the adjusted sample. The second antibody is an example of the second substance. Therefore, when the target substance is contained in the sample, the target substance binds to the second antibody immobilized on the magnetic particles. Further, the target substance bound to the second antibody immobilized on the magnetic particles binds to the first antibody immobilized on the surface of the optical waveguide.

[0043] All the magnetic particles contained in the dropped and adjusted sample will be pulled up above where the magnet 15 is installed. However, for the magnetic particles fixing the second antibody to which the target substance is bound, the target substance will bind to the first antibody on the surface of the optical waveguide. Therefore, the magnetic particles fixing the second antibody to which the target substance is bound remain on the surface of the optical waveguide due to the binding force between the target substance and the first antibody even when receiving the magnetic force of the magnet 15.

[0044] Therefore, only the magnetic particles immobilized with the second antibody not bound to the target substance are pulled up by the magnet 15. That is, since only the unreacted magnetic particles are pulled up by the magnet 15, the unreacted magnetic particles can be removed from the surface of the sensor chip 202.

[0045] Next, the hardware configuration and functional configuration of the specimen inspection apparatus 10 according to the present embodiment will be described. FIG. 5 is a block diagram showing an example of the configuration of the specimen inspection apparatus 10 according to the first embodiment.

[0046] As shown in FIG. 5, the specimen inspection apparatus 10 includes a conveyor 13, a CMOS sensor 14, an input interface 16, a display 17, a memory circuit 18, and a processing circuit 19. These components are interconnected via, for example, a BUS.

[0047] The conveyor 13 conveys the inspection cartridge 200 under the control of the processing circuit 19. For example, when a conveyance start button (not shown) provided on the housing 100 by the user is pressed, the conveyor 13 is driven by the processing circuit 19 to start the conveyance of the inspection cartridge 200.

[0048] Also, in the present embodiment, the conveyor 13 conveys the inspection cartridge 200 so as to reach the measurement position in the housing 100 when a predetermined time determined for each target substance has elapsed since the start of conveyance. Here, the predetermined time determined for each target substance is determined according to the reactivity of the target substance with the first antibody and the second antibody. In other words, the predetermined time is determined according to the reaction time suitable for the antigen-antibody reaction of the target substance.

[0049] The CMOS sensor 14 senses the sensor chip 202 of the inspection cartridge 200 under the control of the processing circuit 19. For example, when it is detected by the processing circuit 19 that the CMOS sensor 14 is placed at the measurement position in the housing 100, the CMOS sensor 14 captures an image of the sensor chip 202.

[0050] The input interface 16 receives operations for selecting a sample, inputting numerical values, switching modes, and the like. For example, the input interface 16 receives an input operation to start the conveyance of the test cartridge 200.

[0051] The input interface 16 is realized by a switch, a button, a touch pad for performing an input operation by touching an operation surface, a touch monitor in which a display screen and a touch pad are integrated, a non-contact input circuit using an optical sensor, an audio input circuit, and the like. In the present embodiment, the input interface 16 is a touch panel laminated on the display 17.

[0052] For example, the input interface 16 converts an input operation received from an examiner into an electrical signal and outputs it to a processing circuit 19 described later.

[0053] The display 17 is a display device that displays various information. The display 17 is, for example, an LED display or the like. For example, the display 17 displays a determination result regarding a target substance.

[0054] In the example of FIG. 1, the display 17 performs tests for SARS-CoV-2 and influenza virus and displays the results that SARS-CoV-2 is positive and influenza virus is negative. In the present embodiment, it is assumed that when the concentration of the target substance in the sample exceeds the threshold, it is expressed as positive, and when it is below the threshold, it is expressed as negative.

[0055] Also, for example, the display 17 displays a GUI (Graphical User Interface) for performing various operations related to the sample inspection device 10. In the present embodiment, the function of the above-described conveyance start button is realized by the GUI and the input interface 16.

[0056] The memory circuit 18 stores various data. For example, the memory circuit 18 stores various programs for realizing various functions by being read and executed by the processing circuit 19. For example, the memory circuit 18 is realized by a semiconductor memory element such as a RAM (Random Access Memory), a flash memory, a hard disk, an optical disk, or the like.

[0057] The processing circuit 19 controls the operation of the specimen inspection apparatus 10 in response to an input operation received from an inspector via the input interface 16. For example, the processing circuit 19 is realized by a processor.

[0058] The processing circuit 19 reads and executes the program stored by the memory circuit 18, thereby executing a system control function 191, a conveyance control function 192, an acquisition function 193, a determination function 194, and a display control function 195.

[0059] Here, the conveyance control function 192 is an example of a conveyance control unit. Also, the determination function 194 is an example of a sensor unit. The display control function 195 is an example of a display control unit.

[0060] The system control function 191 controls various functions of the processing circuit 19 based on an input operation received from an inspector via the input interface 16. For example, the system control function 191 receives a selection input of a target substance (inspection item). Note that the system control function 191 may receive a selection input of a target substance by reading a barcode attached to the inspection cartridge 200 with a reading device that reads code symbols such as barcodes.

[0061] Also, for example, the system control function 191 receives an operation input for starting the conveyance of the inspection cartridge 200 from an inspector via the input interface 16. Here, the inspector performs a conveyance start input after installing the inspection cartridge 200 at the conveyance start position within the housing 100. Therefore, it can also be said that the system control function 191 has detected that the inspection cartridge 200 is installed at the conveyance start position within the housing 100.

[0062] Also, for example, after a predetermined time determined for each target substance has elapsed since the conveyance of the inspection cartridge 200 was started, the system control function 191 controls the CMOS sensor 14 to capture an image of the area including the sensor chip 202 of the inspection cartridge 200. In other words, when the inspection cartridge 200 is installed at the measurement position within the housing 100, the system control function 191 captures an image of the area including the sensor chip 202 of the inspection cartridge 200.

[0063] The conveyance control function 192 controls the conveyor 13 to control the conveyance of the inspection cartridge 200. For example, when the system control function 191 receives an input of a conveyance start operation of the inspection cartridge 200 from an inspector via the input interface 16, the conveyance control function 192 controls the driving of the conveyor 13 to start the conveyance of the inspection cartridge 200.

[0064] Also, the conveyance control function 192 controls the driving of the conveyor 13 so that the inspection cartridge 200 moves to the measurement position within the housing 100 over a predetermined time determined for each target substance.

[0065] In this embodiment, the conveyance of the inspection cartridge 200 is started according to an instruction from an inspector, but the conveyance of the inspection cartridge 200 may be started automatically. For example, a sensor such as a contact sensor may be provided within the housing 100, and it may be detected from the sensing result that the inspection cartridge 200 has been installed at the conveyance start position. In this case, when it is detected that the inspection cartridge 200 has been installed at the conveyance start position, the conveyance control function 192 starts the conveyance of the inspection cartridge 200.

[0066] The acquisition function 193 acquires the sensing result of sensing the sensor chip 202. For example, the acquisition function 193 acquires the image of the sensor chip 202 captured by the CMOS sensor 14 as the sensing result.

[0067] Based on the sensing result obtained by the acquisition function 193, the determination function 194 detects the target substance in the sample. For example, when the number of pixels showing color values within a predetermined range exceeds a threshold value in a predetermined area in the image obtained by the acquisition function 193, the determination function 194 determines that the test result of the target substance is positive. On the other hand, when the number of pixels showing color values within a predetermined range is equal to or less than the threshold value, the determination function 194 determines that the test result of the target substance is negative.

[0068] Here, for example, the predetermined area is an area in the image that captures the surface of the optical waveguide to which the first antibody is immobilized. Also, for example, the color values within a predetermined range are values determined according to the color of the magnetic particles. In this case, the pixels showing the color values within the predetermined range are considered to represent the presence of the magnetic particles. From this, it can be considered that the larger the number of pixels showing the color values within the predetermined range, the larger the number of magnetic particles present on the surface of the optical waveguide.

[0069] Moreover, the fact that the number of magnetic particles present on the surface of the optical waveguide is large indicates that there is a large amount of the target substance bound to the second antibody immobilized on the magnetic particles. Therefore, in the image obtained by the acquisition function 193, it can be estimated that the higher the number of pixels showing the color values within the predetermined range, the higher the concentration of the target substance in the sample.

[0070] From this, in this embodiment, the number of pixels showing the color values within a predetermined range in a predetermined area in the image taken when a sample containing the target substance at the threshold concentration is accommodated in the test cartridge 200 is used as the threshold for determining whether the concentration of the target substance in the sample exceeds the threshold.

[0071] Note that the above is an example of the determination method, and the determination method is not limited thereto. For example, an image taken when a sample not containing the target substance is accommodated in the test cartridge 200 (hereinafter also referred to as a negative image) and an image taken when a sample containing the target substance at the threshold concentration is accommodated in the test cartridge 200 (hereinafter also referred to as a positive image) may be used.

[0072] When performing determination using a negative image and a positive image, first, the determination function 194 compares the image acquired by the acquisition function 193 (hereinafter also referred to as the acquired image) with the negative image and the positive image pre-stored in the memory circuit 18 or the like, using known image recognition techniques or the like.

[0073] Then, when the similarity between the acquired image and the positive image is higher than the similarity between the acquired image and the negative image, the determination function 194 determines that the test result of the target substance is positive. On the other hand, when the similarity between the acquired image and the negative image is higher than the similarity between the acquired image and the positive image, the determination function 194 determines that the test result of the target substance is negative.

[0074] Note that a control circuit for the CMOS sensor 14 may be provided separately from the processing circuit 19. In this case, the control circuit for the CMOS sensor 14 may have functions corresponding to the function of the system control function 191 regarding the control of the CMOS sensor 14, the acquisition function 193, and the determination function 194. The CMOS sensor 14 and the control circuit for the CMOS sensor 14 in this case are an example of a sensor unit.

[0075] The display control function 195 performs control to cause a display device to display various information. For example, the display control function 195 performs control to cause the display 17 to display a display representing the determination result by the determination function 194. Also, for example, the display control function 195 performs control to cause the display 17 to display a GUI.

[0076] Next, an example of the process executed by the specimen inspection apparatus 10 will be described. FIG. 6 is a flowchart showing an example of the process executed by the specimen inspection apparatus 10 according to the first embodiment. As a premise, it is assumed that the examiner has installed the test cartridge 200 containing the adjusted sample at the conveyance start position within the housing 100.

[0077] First, the system control function 191 receives the conveyance start input of the test cartridge 200 (step S101). For example, the system control function 191 receives the operation input for starting the conveyance of the test cartridge 200 from the examiner via the input interface 16.

[0078] Next, the conveyance control function 192 starts the conveyance of the inspection cartridge 200 (step S102). For example, the conveyance control function 192 controls the drive of the conveyor 13 and starts the conveyance of the inspection cartridge 200 installed at the conveyance start position. Next, the conveyance control function 192 determines whether a predetermined time determined for each target substance has elapsed (step S103). If the predetermined time has not elapsed (step S103: No), the process of step S103 is repeated.

[0079] On the other hand, when the predetermined time has elapsed (step S103: Yes), the system control function 191 controls the CMOS sensor 14 to take a picture of the inspection cartridge 200 (step S104). For example, the system control function 191 controls the CMOS sensor 14 and takes a picture of the area including the sensor chip 202 of the inspection cartridge 200 conveyed to the measurement position in the housing 100 by the conveyor 13 from the measurement surface side of the inspection cartridge 200.

[0080] Note that the system control function 191 may take a picture after a certain time has elapsed since the inspection cartridge 200 reached the measurement position in the housing 100. Thereby, the possibility that unreacted magnetic particles remain on the surface of the sensor chip 202 and a negative result is erroneously determined as a positive result can be reduced.

[0081] Next, the acquisition function 193 acquires the image taken by the CMOS sensor 14 (step S105). For example, the acquisition function 193 acquires an image of the area including the sensor chip 202 of the inspection cartridge 200 taken by the CMOS sensor 14.

[0082] Note that the acquisition function 193 may determine whether the sensor chip 202 is reflected in the acquired image using a known image recognition technique or the like. Further, when it is determined that the sensor chip 202 is not reflected, the display control function 195 may display a warning message indicating that a conveyance failure of the inspection cartridge 200 has occurred on the display 17.

[0083] Further, the display control function 195 may cause the display 17 to display a message prompting the inspector to manually move the inspection cartridge 200 to the measurement position within the housing 100. In this case, when it is detected that the inspection cartridge 200 has been installed at the measurement position, the system control function 191 may control the CMOS sensor 14 to perform imaging of the sensor chip 202 again. Note that whether the inspection cartridge 200 has been installed at the measurement position can be detected by providing a sensor such as a contact sensor at the measurement position within the housing 100 or the like.

[0084] Next, the determination function 194 determines the inspection result based on the image acquired by the acquisition function 193 (step S106). For example, when the number of pixels indicating the color values within a predetermined range in a predetermined region of the image acquired in step S105 exceeds the threshold value, the determination function 194 determines that the inspection result of the target substance is positive. On the other hand, when the number of pixels indicating the color values within the predetermined range is equal to or less than the threshold value, the determination function 194 determines that the inspection result of the target substance is negative.

[0085] Next, the display control function 195 performs control to cause the display 17 to display the determination result of step S106 (step S107), and ends this process.

[0086] As described above, the specimen inspection apparatus 10 according to the first embodiment includes an inspection cartridge 200 having a sensor chip 202 having an optical waveguide on the surface of which a first antibody that specifically binds to a target substance is immobilized. The inspection cartridge 200 houses magnetic particles to which a second antibody that specifically binds to the sample and the target substance is immobilized. Further, the specimen inspection apparatus 10 removes unreacted magnetic particles from the surface of the optical waveguide with the magnet 15 which is a permanent magnet, senses the sensor chip 202 with the CMOS sensor 14, and determines the inspection result of the target substance based on the sensing result.

[0087] In this embodiment, the unreacted magnetic particles are removed using the magnetic force of a permanent magnet. As a member for removing unreacted magnetic particles, an electromagnetic coil is also known. However, generally, an electromagnetic coil needs to pass an electric current to generate a magnetic field, so it is likely to become large-sized. Therefore, a device equipped with an electromagnetic coil is highly likely to have its portability impaired. On the other hand, a permanent magnet can form a magnetic field without receiving supply of a magnetic field or an electric current from the outside. For this reason, if an equivalent magnetic field is generated, the member can be made smaller than an electromagnetic coil. Therefore, it can be said that the size of the device can be reduced by using a permanent magnet. That is, according to the specimen inspection device 10 according to this embodiment, a specimen inspection device with a simpler configuration can be provided.

[0088] Also, the specimen inspection device 10 according to this embodiment conveys the inspection cartridge 200 from the conveyance start position to the measurement position over a predetermined time determined for each target substance. The predetermined time is the time for reacting the target substance with the second antibody. For this reason, after an appropriate reaction time has elapsed for the target substance, the unreacted magnetic particles can be removed and the sensing of the sensor chip 202 can be performed.

[0089] (Second Embodiment) In the above-described first embodiment, the form in which the magnet 15 is provided above the measurement position in the housing 100 and the sensor chip 202 is automatically photographed after a predetermined time (reaction time) determined for each target substance has elapsed has been described. In the second embodiment, the form in which the inspector manually installs the magnet 15 after a predetermined time determined for each target substance has elapsed and then photographs the sensor chip 202 will be described.

[0090] Hereinafter, the points different from the above-described embodiments will mainly be described, and detailed descriptions of the points common to the already described content will be omitted. Also, each of the embodiments described below may be implemented individually or may be implemented in an appropriate combination.

[0091] First, the overall configuration of the specimen inspection apparatus 10a according to the second embodiment will be described. FIG. 7 is a schematic diagram showing an example of the configuration of the specimen inspection apparatus 10a according to the second embodiment. As shown in FIG. 7, the specimen inspection apparatus 10a has a housing 100a.

[0092] An installation port 11a is provided on one side surface of the housing 100a. The installation port 11a is provided on the back side of the central position in the longitudinal direction of the housing 100a. The installation port 11a is an opening provided for installing the inspection cartridge 200 at a predetermined measurement position inside the housing 100a.

[0093] A CMOS sensor 14 is provided below the measurement position inside the housing 100a. Also, an input interface 16 (touch panel) and a display 17a visible to the user are provided on the upper surface of the housing 100a.

[0094] The display 17a is substantially the same as the display 17 in the first embodiment, but is different from the first embodiment in that it has a notification lamp 171. The notification lamp 171 notifies the examiner of various information. For example, the notification lamp 171 notifies that a predetermined time has elapsed since the inspection cartridge 200 was installed at the measurement position inside the housing 100.

[0095] Also, as shown in FIG. 7, in this embodiment, the magnet 15 is not inside the housing 100a, but is housed in a magnet holder 151 provided separately from the housing 100a. Also, an installation space for installing the magnet holder 151 is provided on the upper surface of the housing 100a.

[0096] The examiner can detachably install the magnet 15 housed in the magnet holder 151 above the measurement position inside the housing 100a by installing the magnet holder 151 in the installation space. Therefore, the examiner can lift the unreacted magnetic particles among the magnetic particles housed in the inspection cartridge 200 by installing the magnet holder 151 in the installation space with the inspection cartridge 200 installed at the measurement position.

[0097] In addition, a sensor (not shown) such as a contact sensor is provided in the installation space of the housing 100a. Thus, it is possible to detect from the sensing result of the sensor that the magnet holder 151 is installed in the installation space.

[0098] Hereinafter, the overall operation of the specimen inspection apparatus 10a according to the second embodiment will be described. For example, after the inspector drops the adjusted sample onto the sample dropping portion 201 of the inspection cartridge 200, the inspector inserts the inspection cartridge 200 into the housing 100a with the surface facing up and pushing it into the housing 100a from the installation port 11a in the negative X-axis direction.

[0099] When a predetermined time has elapsed since the inspection cartridge 200 was installed at the measurement position in the housing 100a, the notification lamp 141 notifies the inspector to that effect under the control of the processing circuit 19a. The inspector who has received the notification installs the magnet holder 151 in the installation space on the upper surface of the housing 100a. As a result, the magnet 15 is positioned above the measurement position in the housing 100a. The magnet 15 pulls up the unreacted magnetic particles among the magnetic particles accommodated in the inspection cartridge 200 placed at the measurement position in the housing 100a.

[0100] The CMOS sensor 14 photographs the surface of the sensor chip 202 of the inspection cartridge 200 existing at the measurement position in the housing 100a from the back side of the inspection cartridge 200.

[0101] When the measurement result is derived based on the photographing result, the display 17 displays the measurement result. For example, after the measurement result is displayed on the display 17, the inspector takes out the measured inspection cartridge 200 by pulling out the inspection cartridge 200 from the installation port 11a.

[0102] Next, the hardware configuration and functional configuration of the specimen inspection apparatus 10a according to the second embodiment will be described. FIG. 8 is a block diagram showing an example of the configuration of the specimen inspection apparatus 10 according to the second embodiment.

[0103] As shown in FIG. 8, the specimen inspection apparatus 10a according to the second embodiment includes a CMOS sensor 14, an input interface 16, a display 17a, a memory circuit 18, a processing circuit 19a, and a buzzer 20. These components are interconnected via, for example, a BUS. Since the CMOS sensor 14, the input interface 16, the display 17a, and the memory circuit 18 are the same as those in the first embodiment, the description thereof is omitted. The processing circuit 19a will be described later.

[0104] The notification lamp 171 of the display 17a lights up or goes out under the control of the processing circuit 19a. For example, the notification lamp 171 blinks in red under the control of the processing circuit 19a to notify the inspector that a predetermined time has elapsed since the inspection cartridge 200 was placed at the measurement position within the housing 100.

[0105] Note that the blinking color of the notification lamp 171 is not limited to red. Also, the notification lamp 171 may notify the inspector by lighting up.

[0106] The buzzer 20 emits a sound under the control of the processing circuit 19a. For example, the buzzer 20 emits a notification sound to inform that a predetermined time has elapsed since the inspection cartridge 200 was placed at the measurement position within the housing 100 under the control of the processing circuit 19a.

[0107] The processing circuit 19a reads and executes the program stored in the memory circuit 18 to execute a system control function 191a, an acquisition function 193, a determination function 194, a display control function 195, and a notification control function 196. Since the acquisition function 193, the determination function 194, and the display control function 195 are the same as those in the first embodiment, the description thereof is omitted.

[0108] Here, the notification control function 196 according to the second embodiment is an example of a first notification unit.

[0109] The system control function 191a controls various functions of the processing circuit 19a based on the input operation received from the inspector via the input interface 16. For example, the system control function 191a receives an input from the inspector via the input interface 16 indicating that the test cartridge 200 has been placed at the measurement position within the housing 100a.

[0110] Also, for example, when the system control function 191a detects that the magnet holder 151 has been placed in the installation space based on the sensing result of a sensor such as a contact sensor, the system control function 191a controls the CMOS sensor 14 to photograph the sensor chip 202 of the test cartridge 200.

[0111] Note that sensors such as contact sensors may not be provided on the upper surface of the housing 100a. In this case, for example, after a predetermined time has elapsed since the system control function 191a receives a notification indicating that the test cartridge 200 has been placed within the housing 100a, if it is determined that the magnet holder 151 has been placed in the installation space after a certain period of time has passed, the system control function 191a photographs the sensor chip 202.

[0112] The notification control function 196 performs various notifications to the inspector. For example, after the system control function 191a receives an input indicating that the test cartridge 200 has been placed at the measurement position within the housing 100a, when a predetermined time has elapsed, the notification control function 196 controls the buzzer 20 to generate a notification sound. Also, in this case, the notification control function 196 controls the notification lamp 171 to blink in red.

[0113] Note that instead of receiving an input indicating that the test cartridge 200 has been placed at the measurement position within the housing 100a, the system control function 191a may receive an input from the inspector indicating that a sample has been dropped onto the sample dropping portion 201 of the test cartridge 200 by the inspector. Also, the time when the inspector receives an input indicating that a sample has been dropped onto the test cartridge 200 may be regarded as the time when the sample has been dropped onto the test cartridge 200.

[0114] Here, the fact that a sample has been dropped onto the test cartridge 200 can be rephrased as the fact that magnetic particles and the sample are contained in the test cartridge 200. Therefore, in the above case, it can be said that the notification control function 196 performs a process of notifying the examiner that a time corresponding to the target substance has elapsed after the magnetic particles and the sample are contained in the test cartridge 200.

[0115] Next, the process executed by the specimen inspection apparatus 10a according to the second embodiment will be described. FIG. 9 is a flowchart showing an example of the process executed by the specimen inspection apparatus 10 according to the second embodiment. As a premise, it is assumed that the examiner has placed the test cartridge 200 containing the adjusted sample at the measurement position within the housing 100a.

[0116] First, the system control function 191a receives an input indicating that the test cartridge 200 has been installed (step S201). For example, the system control function 191a receives an input from the examiner via the input interface 16 indicating that the test cartridge 200 has been placed at the measurement position within the housing 100a.

[0117] Next, the notification control function 196 starts counting time (step S202). Next, the notification control function 196 determines whether a predetermined time defined for each target substance has elapsed based on the time count started in step S202 (step S203). If the predetermined time has not elapsed (step S203: No), the process of step S203 is repeated.

[0118] On the other hand, when the predetermined time has elapsed (step S203: Yes), the notification control function 196 notifies that the predetermined time has elapsed (step S204). For example, the notification control function 196 controls the buzzer 20 to generate a notification sound to notify the examiner that the predetermined time has elapsed. Also, the notification control function 196 controls the notification lamp 171 to blink in red to notify the examiner.

[0119] Next, the system control function 191a determines whether the magnet holder 151 is installed in the installation space of the housing 100a (step S205). For example, the system control function 191a detects that the magnet holder 151 is installed in the installation space of the housing 100a based on the sensing result of a sensor such as a contact sensor provided on the upper surface of the housing 100a.

[0120] If it is not detected that the magnet holder 151 is installed (step S205: No), the process of step S205 is repeated. Note that if it is not detected that the magnet holder 151 is installed even after a certain period of time has elapsed, the notification control function 196 may notify the inspector to install the magnet holder 151 in the installation space.

[0121] If it is detected that the magnet holder 151 is installed (step S205: Yes), the process proceeds to step S206. Since the processes of steps S206 to S208 are the same as the processes of steps S105 to S107 in FIG. 6, the description thereof is omitted.

[0122] As described above, the specimen inspection apparatus 10a according to the second embodiment receives an input indicating that the inspection cartridge 200 is installed, and notifies the inspector to that effect after a predetermined time has elapsed since the input was received. Further, the specimen inspection apparatus 10a detects that the magnet 15 is installed above the inspection cartridge 200 by the notified inspector, and then performs sensing of the sensor chip 202.

[0123] In this embodiment, even if the conveyor 13 is not provided, after a proper predetermined time (reaction time) corresponding to the target substance has elapsed and unreacted magnetic particles are removed, sensing of the sensor chip 202 can be performed. Therefore, it is possible to further reduce the size of the apparatus.

[0124] Incidentally, the above-described first and second embodiments can also be appropriately modified and implemented by changing a part of the configuration or function of the specimen inspection apparatus 10. Therefore, below, some modification examples according to the above-described embodiments will be described as other embodiments. Note that below, the points different from the above-described embodiments will mainly be described, and detailed descriptions of the points common to the already described content will be omitted. Further, the modification examples described below may be implemented individually or in appropriate combinations.

[0125] (Modification Example) In the above-described second embodiment, the magnet 15 is housed in the magnet holder 151, and the form in which the examiner installs the magnet holder 151 on the upper surface of the housing 100a to lift unreacted magnetic particles with the magnet 15 was described. In this modification example, a form in which unreacted magnetic particles are lifted by installing the test cartridge 200 below the magnet 15 provided in the housing 100a will be described.

[0126] FIG. 10 is a schematic diagram showing an example of the configuration of the specimen inspection apparatus 10a according to the modification example. As shown in FIG. 10, the specimen inspection apparatus 10a includes a cartridge holder 111 provided separately from the housing 100b. Further, a gap for inserting the cartridge holder 111 is provided in the housing 100b. The gap is provided between the magnet 15 and the CMOS sensor 14 in the Z-axis direction of FIG. 10. Further, in this modification example, the magnet 15 is provided below the display 17a provided on the upper surface of the housing 100b.

[0127] The cartridge holder 111 houses the test cartridge 200 containing the adjusted sample. The cartridge holder 111 is formed of a light-transmissive material such as acrylic resin. The cartridge holder 111 includes an installation port 11b. The installation port 11b is an opening for housing the test cartridge 200 in the cartridge holder 111.

[0128] For example, the inspector drops the adjusted sample onto the sample dropping part 201 of the inspection cartridge 200. Then, the inspector inputs via the input interface 16 that the accommodation of the magnetic particles and the sample in the inspection cartridge 200 is completed. After the input, the inspector inserts the inspection cartridge 200 into the cartridge holder 111 from the installation port 11b and accommodates the inspection cartridge 200 at a predetermined position within the cartridge holder 111.

[0129] When an input is made by the inspector that the accommodation of the magnetic particles and the sample in the inspection cartridge 200 is completed, the system control function 191a receives the input. The system control function 191a in this case is an example of a reception unit.

[0130] Also, the notification control function 196 starts counting time when the above input is received. Then, when the predetermined time defined for each target substance has elapsed from that point in time, the notification control function 196 controls the buzzer 20 and the notification lamp 171 to give a notification prompting the inspector to place the inspection cartridge 200 on the housing 100b. The notification control function 196 in this case is an example of a second notification unit.

[0131] The inspector who has received the notification inserts the cartridge holder 111 containing the inspection cartridge 200 into the housing 100b through the gap of the housing 100b. Sensors such as contact sensors are provided within the housing 100b. The sensor detects that the cartridge holder 111 is installed at a predetermined position within the housing 100b.

[0132] When the sensor detects that the cartridge holder 111 is installed at a predetermined position within the housing 100b, the system control function 191a performs imaging of the sensor chip 202 in the same manner as in the second embodiment.

[0133] According to this modification example, similar to the second embodiment, even without providing the conveyor 13, after a proper predetermined time has elapsed according to the target substance, the unreacted magnetic particles can be removed, and then the sensor chip 202 can be photographed. Further, in this modification example, since the display 17a is located above the magnet 15 and the cartridge holder 111 can be accommodated in the housing 100a, it is possible to make the apparatus smaller than the second embodiment.

[0134] In the above-described embodiments and modification examples, each processing function of the processing circuit 19(19a) has been described. Here, for example, each of the above-described processing functions is stored in the storage circuit 18 in the form of a program executable by a computer. The processing circuit 19 reads each program from the storage circuit 18 and executes each read program, thereby realizing the processing function corresponding to each program. In other words, the processing circuit 19(19a) in the state of having read each program will have each processing function shown in FIGS. 1 and 7.

[0135] Note that in FIGS. 1 and 7, an example in which each processing function is realized by a single processing circuit 19(19a) has been described, but the embodiment is not limited to this. For example, the processing circuit 19(19a) may be configured by combining a plurality of independent processors, and each processor may execute each program to realize each processing function. Further, each processing function of the processing circuit 19(19a) may be realized by being appropriately distributed or integrated into a single or a plurality of processing circuits.

[0136] Also, the term "processor" used in the description of each of the above-described embodiments means, for example, a CPU (Central Processing Unit), a GPU (Graphics Processing Unit), or a circuit such as an Application Specific Integrated Circuit (ASIC), a Programmable Logic Device (for example, a Simple Programmable Logic Device (SPLD), a Complex Programmable Logic Device (CPLD), and a Field Programmable Gate Array (FPGA)).

[0137] Here, instead of storing the program in the memory, it may be configured to directly incorporate the program into the circuit of the processor. In this case, the processor realizes its function by reading and executing the program incorporated in the circuit. Also, each processor of the present embodiment is not limited to being configured as a single circuit for each processor, and may be configured as one processor by combining a plurality of independent circuits to realize its function.

[0138] According to at least one of the embodiments described above, it is possible to provide a specimen inspection apparatus with a simpler configuration.

[0139] Although some embodiments of the present invention have been described, these embodiments are presented as examples and are not intended to limit the scope of the invention. These embodiments can be implemented in various other forms, and various omissions, replacements, and changes can be made without departing from the gist of the invention. These embodiments and their modifications are included in the scope and gist of the invention, as well as in the invention described in the claims and the equivalent scope thereof.

Description of Reference Numerals

[0140] 1 Sample Container 1A Bottle 1B Nozzle - attached Cap 10 Specimen Inspection Device 11, 11a, 11b Installation Ports 12 Outlet 13 Conveyor 14 CMOS Sensor 15 Magnet 16 Input Interface 17, 17a Display 18 Memory Circuit 19, 19a Processing Circuit 20 Buzzer 100 Housing 111 Cartridge Holder 151 Magnet Holder 171 Notification Lamp 191, 191a System Control Function 192 Conveyance Control Function 193 Acquisition Function 194 Judgment Function 195 Display Control Function 196 Notification Control Function 200 Inspection Cartridge

Claims

1. A test cartridge having a light-transmissive inspection area provided on its surface with a first substance that specifically binds to a target substance, and containing magnetic microparticles containing a second substance that specifically binds to the target substance and a sample thereon, a placement portion for placing the test cartridge, A permanent magnet provided above the placement portion for attracting magnetic microparticles containing the second substance that is not bound to the target substance, A sensor unit provided below the placement portion for detecting the target substance in the sample by optically sensing the state of the magnetic microparticles bound to the target substance, A display control unit for causing a display device to display the detection result of the target substance, A specimen inspection device comprising the above.

2. An insertion port for inserting the test cartridge, A transport mechanism for transporting the test cartridge inserted into the insertion port to the placement portion, A transport control unit for controlling the transport mechanism to transport the test cartridge to the placement portion when the test cartridge is inserted into the insertion port, The specimen inspection device according to claim 1, comprising the above.

3. Further comprising a magnet holder for holding the permanent magnet, The magnet holder is configured to be detachable above the placement portion, The specimen inspection device according to claim 1.

4. The placement portion is a gap provided between the permanent magnet and the sensor unit, The test cartridge is placed on the placement portion by being inserted into the gap, The specimen inspection device according to claim 1.

5. The transport control unit controls the transport mechanism to transport the test cartridge to the placement portion after waiting for a time corresponding to the target substance after the test cartridge is inserted into the insertion port, The specimen inspection device according to claim 2.

6. Further comprising a first notification unit for notifying an examiner when a time corresponding to the target substance has elapsed after the test cartridge is placed on the placement portion, The specimen inspection device according to claim 3.

7. A reception unit for receiving an input at the timing when the accommodation of the magnetic microparticles and the sample in the test cartridge is completed, Further comprising a second notification unit for notifying the examiner to insert the test cartridge into the gap when a time corresponding to the target substance has elapsed after the reception unit receives the input, The specimen inspection device according to claim 4.

8. The first notification unit notifies the examiner by causing a buzzer to produce a sound. The specimen inspection apparatus according to claim 6.

9. The first notification unit notifies the examiner by causing a lamp to blink. The specimen inspection apparatus according to claim 6.

10. The second notification unit notifies the examiner by causing a buzzer to produce a sound. The specimen inspection apparatus according to claim 7.

11. The second notification unit notifies the examiner by causing a lamp to blink. The specimen inspection apparatus according to claim 7.

12. The sensor unit includes an imaging device. The imaging device captures an image of the inspection area. The specimen inspection apparatus according to any one of claims 1 to 11.

Images