Inspection method and inspection device

Abstract

To allow for rapid and cost-effective inspection of whether a subject is infected with a virus.SOLUTION: This inspection method includes: a step for mixing the saliva of a subject and a reagent including a marker-attached specific antibody; a step for irradiating a liquid mixture of the saliva and the reagent with first light of a predetermined wavelength; a step for detecting the intensity of second light generated by the irradiation with the first light; and a step for determining, on the basis of the detected light intensity, whether viruses are included in the saliva of the subject, wherein the reagent includes at least any one specific antibody among a fluorescent marker-attached specific antibody or a coloring marker-attached specific antibody.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present invention relates to an inspection method and an inspection apparatus. [Background technology]

[0002] It is desirable to be able to quickly test whether a subject is infected with a virus that has a spike protein-containing antigen, such as the new coronavirus, and various methods have been proposed (see, for example, Patent Documents 1 and 2). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2020-80806 A [Patent Document 2] Patent Publication No. 2021-167805 Summary of the Invention [Problem to be solved by the invention]

[0004] However, the testing methods currently in use take a long time, about 5 hours for PCR tests and about 15 minutes for antigen tests, and are also expensive. Therefore, a more appropriate method for detecting the virus in an unspecified number of subjects was desired.

[0005] The present invention has been made in consideration of these points, and has an object to enable rapid, low-cost testing of whether or not a subject is infected with a virus. [Means for solving the problem]

[0006] In a first aspect of the present invention, there is provided a testing method comprising the steps of: mixing saliva of a subject and a reagent containing a marker-attached specific antibody on one surface of a test stick; irradiating a first light of a predetermined wavelength onto the mixture of the saliva and the reagent; detecting the intensity of a second light generated by irradiating the first light onto a complex in which the marker-attached specific antibody is multiply bound to a virus having a spike protein-attached antigen; and determining whether or not the virus is contained in the saliva of the subject based on the detected light intensity, wherein the reagent contains at least one of a specific antibody with a fluorescent marker or a specific antibody with a dye marker as the marker-attached specific antibody, the specific antibody with the fluorescent marker being bound to an antibody for binding to the spike protein-attached antigen of the virus and a fluorophore that generates fluorescence when irradiated with the first light, and the specific antibody with the dye marker being bound to the antibody for binding to the spike protein-attached antigen of the virus and a dye that reflects or absorbs the first light.

[0007] The reagent includes a specific antibody with a first dye marker in which the antibody is bound to a first dye of a first color, and a specific antibody with a second dye marker in which the antibody is bound to a second dye of a second color different from the first color, and in the determining step, it may be determined that the virus is contained in the saliva of the subject based on the second light generated from one of the conjugates containing light of the first color and light of the second color.

[0008] In the step of detecting the intensity of the second light, the second light may be imaged, and in the step of determining, it may be determined that the virus is contained in the saliva of the subject based on the fact that pixels of the first color and pixels of the second color are included among pixels of an imaging area in which the binding body is imaged from the captured image.

[0009] The method may further include a step of spraying a buffer solution or water onto the mixture of the saliva and the reagent, and in the step of irradiating the first light, the first light may be irradiated onto the mixture sprayed with the buffer solution or water.

[0010] The method may further include a step of applying a magnetic field to at least a portion of the mixture after the step of irradiating the first light so that the binding body moves to a predetermined region, and the step of detecting the intensity of the second light may include detecting the intensity of the second light generated from the predetermined region by the irradiation of the first light, and the reagent may further include, as the marker-specific antibody, a specific antibody with a magnetic marker in which the antibody for binding to the spike protein-related antigen of the virus is bound to a magnetic body.

[0011] A groove of a predetermined shape may be provided in an area on the one side of the test rod where the saliva and the reagent are mixed, and in the step of applying the magnetic field, the magnetic field may be applied so as to move the binder along the longitudinal direction of the groove of the test rod, thereby moving the binder to the predetermined area in the groove.

[0012] After the first light is irradiated to the predetermined region in the step of irradiating the first light, the combined body may be moved in the step of applying a magnetic field, while the intensity of the second light received from the combined body moving in the predetermined region may be detected in a step of detecting the intensity of the second light.

[0013] In the mixing step, the reagent containing the specific antibody with the marker may be sprayed onto the saliva that the subject has applied to the test stick.

[0014] In the mixing step, the reagent containing the marker-attached specific antibody may be dropped onto the saliva that the subject has applied to the test stick.

[0015] In the mixing step, the reagent corresponding to the type of the marker-attached specific antibody among the plurality of reagents which differ for each type of the marker-attached specific antibody may be sprayed or dropped.

[0016] The mixing step may include a step of the subject applying the saliva of the subject to the one side of the test stick to which the reagent containing the marker-attached specific antibody has been applied in advance.

[0017] The method may further include vibrating the test bar after the mixing step.

[0018] The test stick may have a material that is transparent to the first light and the fluorescence, and in the step of irradiating the first light, the first light may be irradiated from a side of the test stick opposite to the side on which the subject has applied the saliva.

[0019] In a second aspect of the present invention, the present invention includes an insertion port for inserting a test rod having saliva applied to one surface thereof by a subject, an application section for applying a reagent containing a marker-attached specific antibody to the area of ​​the test rod inserted into the insertion port where the saliva is applied, and mixing the saliva with the reagent, a light source section for irradiating a first light onto a mixture of the saliva and the reagent, a detection section for detecting a second light generated by irradiating the first light onto a complex formed by multiple binding of the marker-attached specific antibody with a virus having a spike protein-attached antigen, and a detection section for detecting whether the virus is present in the subject based on the intensity of the detected light. the reagent includes, as the marker-attached specific antibody, at least one of a specific antibody with a fluorescent marker and a specific antibody with a dye marker, the specific antibody with the fluorescent marker being bound to an antibody for binding to the spike protein-attached antigen of the virus and a fluorophore that generates fluorescence when irradiated with the first light, and the specific antibody with the dye marker being bound to the antibody for binding to the spike protein-attached antigen of the virus and a dye that reflects or absorbs the first light.

[0020] The reagent may include a specific antibody with a first dye marker in which the antibody is bound to a first dye of a first color, and a specific antibody with a second dye marker in which the antibody is bound to a second dye of a second color different from the first color, and the determination unit may determine that the virus is contained in the saliva of the subject based on the second light generated from one of the binders containing light of the first color and light of the second color.

[0021] The detection unit may have an imaging unit that captures the second light, and the determination unit may determine that the virus is contained in the saliva of the subject based on the fact that pixels of the first color and pixels of the second color are included among pixels of an imaging area in which the binding body is captured in an image captured by the imaging unit.

[0022] The apparatus may further include a sprayer that sprays a buffer solution or water into the mixture of the saliva and the reagent.

[0023] The reagent may further include a magnetic field application unit that applies a magnetic field to at least a portion of the mixed solution so that the bound body moves to a predetermined region, the detection unit detects the intensity of the second light generated from the predetermined region by irradiation with the first light, and the reagent may further include, as the marker-attached specific antibody, a specific antibody with a magnetic marker in which the antibody for binding to the spike protein-attached antigen of the virus is bound to a magnetic body.

[0024] A groove of a predetermined shape may be provided in the area where the subject applies the saliva to the test rod, and the magnetic field application unit may apply the magnetic field so that the binding body moves along the longitudinal direction of the groove of the test rod, thereby moving the binding body to the predetermined area in the groove.

[0025] The groove provided in the test bar may have a width that narrows toward an end in the longitudinal direction of the groove.

[0026] The end of the groove provided in the test bar may have a V-shape or U-shape that protrudes more toward the end in the longitudinal direction of the groove in a plan view.

[0027] The attachment section may include a sprayer that sprays the reagent containing the specific antibody with the marker onto the saliva that the subject has attached to the test stick.

[0028] The attachment section may have a plurality of sprayers that spray the reagent corresponding to the type of the marker-attached specific antibody, and each of the plurality of sprayers may spray the reagent onto the saliva attached to the test stick.

[0029] The attachment portion may include a dropping portion for dropping the reagent containing the marker-attached specific antibody onto the saliva attached to the test stick.

[0030] The device may further include a plurality of the insertion ports arranged in one direction, a moving unit which sequentially moves the attachment unit, the light source unit, and the detection unit to a plurality of positions corresponding to the plurality of the insertion ports in the one direction, and a control unit which controls the attachment unit, the light source unit, the detection unit, and the moving unit to move the attachment unit to a position corresponding to each of the insertion ports by the moving unit, and then attach the reagent by the attachment unit, and move the light source unit and the detection unit to a position corresponding to each of the insertion ports by the moving unit, and then irradiate the first light by the light source unit and detect the intensity of the second light by the detection unit, and the determination unit may sequentially determine whether or not the virus is contained in the saliva of a plurality of the subjects based on the detection results of the detection unit which has been moved to a plurality of positions corresponding to the plurality of the insertion ports.

[0031] The test device may further include a vibration unit that vibrates the test stick to mix the saliva and the reagent.

[0032] The test stick may have a material that is transparent to the first light and the second light, and the light source unit may irradiate the first light from a side of the test stick opposite to the side on which the subject has applied the saliva. Effect of the Invention

[0033] The present invention has the advantage that it is possible to quickly test whether a subject is infected with a virus at low cost. [Brief description of the drawings]

[0034] [Figure 1] 1 shows an outline of a method for examining a subject using an examination apparatus 100 according to this embodiment. [Diagram 2] 1 shows an example of the configuration of an inspection device 100 according to the present embodiment. [Diagram 3] An example of a mixture of saliva from a subject 10 and a reagent containing a specific antibody 40 with a marker is shown. [Figure 4] 1 shows an example of the configuration of a test bar 20 according to this embodiment. [Diagram 5] 1 shows an example of an operation flow of the inspection device 100 according to the present embodiment. [Figure 6] 1 shows a modified example of the test bar 20 according to the present embodiment. [Figure 7] 11 shows a modified example of the operation flow of the inspection device 100 according to the present embodiment. [Figure 8] 1 shows an example of a distribution of the number of particles relative to the particle size of particles detected by the inspection device 100 according to this embodiment. [Figure 9] 1 shows an example in which the distribution of the number of particles relative to the particle size of particles detected by the inspection device 100 according to this embodiment is normalized. [Figure 10] An example of binding of a virus 30 to a marker-attached specific antibody 40 according to this embodiment is shown. [Figure 11] A first example for comparison is shown. [Figure 12] A second example for comparison is shown. [Figure 13] A third example for comparison is shown. [Figure 14] An optical microscope image shows an example of the formation of a bond 50 according to this embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] <Outline of Testing Method for Subjects Using Testing Device 100> 1 shows an outline of a method for testing a subject using a testing device 100 according to this embodiment. The testing device 100 tests whether a subject 10 is infected with a virus having a spike protein-bearing antigen, such as the novel coronavirus.

[0036] The subject 10 deposits his / her saliva on a predetermined position on one surface of the test stick 20 ((1) in FIG. 1). The subject 10 deposits his / her saliva by, for example, licking the test stick 20. Alternatively, the subject 10 or a person other than the subject 10 may place the test stick 20 in the subject 10's mouth and deposit the subject 10's saliva onto the test stick 20.

[0037] Then, the subject 10 inserts the test stick 20 with the saliva attached thereto into the insertion port 110 of the testing device 100 ((2) in FIG. 1). The testing device 100 tests whether or not the saliva attached to the test stick 20 inserted into the insertion port 110 contains a virus having an antigen with a spike protein ((3) in FIG. 1).

[0038] The testing device 100 may be provided with a plurality of insertion ports 110. In this case, a plurality of different subjects 10 may insert test sticks 20 with their own saliva attached thereto into the plurality of insertion ports 110, respectively. Then, the testing device 100 tests whether or not the saliva attached to the plurality of test sticks 20 inserted into the plurality of insertion ports 110 contains a virus.

[0039] Display unit 190 of testing device 100 displays the test results of testing device 100 ((4) in FIG. 1). As described above, with testing device 100 according to this embodiment, it is possible to test whether or not subject 10 is infected with a virus by inserting test stick 20 having saliva from subject 10 attached thereto into insertion port 110 of testing device 100. Such testing device 100 will now be described.

[0040] <Configuration example of inspection device 100> 2 shows an example of the configuration of the testing device 100 according to this embodiment. The testing device 100 mixes the saliva and the reagent attached to the test stick 20, and then applies a magnetic field to the mixture of the saliva and the reagent while irradiating the mixture with light of a predetermined wavelength to test whether the saliva contains viruses. The testing device 100 includes an insertion port 110, an attachment unit 120, a vibration unit 130, a light source unit 140, a magnetic field application unit 150, a detection unit 160, a storage unit 170, a control unit 180, and a display unit 190.

[0041] The test stick 20 to which the subject 10 has attached his / her saliva is inserted into the insertion port 110. It is desirable that a guide or the like is provided inside the insertion port 110 or the testing device 100 to stabilize the position of the inserted test stick 20. It is desirable that the insertion port 110 and / or the test stick 20 are provided with a guide or the like so that the test stick 20 is inserted into the insertion port 110 with the saliva-attached surface of the test stick 20 facing a predetermined direction. The insertion port 110 and / or the test stick 20 may have a cross-sectional shape processed so that the test stick 20 cannot be inserted unless the saliva-attached surface is oriented in a predetermined direction.

[0042] The attachment section 120 attaches a reagent containing a specific antibody with a marker to the area of ​​the test stick 20 inserted into the insertion port 110 where saliva is attached, and mixes the saliva with the reagent. Here, the reagent contains multiple types of specific antibodies with a marker. Such specific antibodies with a marker will be described with reference to FIG. 3.

[0043] <An example of a mixture of saliva and a reagent containing a specific antibody 40 with a marker> FIG. 3 shows an example of a mixture of saliva from a subject 10 and a reagent containing a marker-attached specific antibody 40. FIG. 3 shows an example in which a virus 30 is contained in the saliva from the subject 10. The virus 30 has multiple spike protein-attached antigens 31. One example of the virus 30 is the novel coronavirus. Such a virus 30 has a diameter of about 10 nm, which is too small to be immediately confirmed by direct observation using a microscope or the like.

[0044] The marker-attached specific antibody 40 also has a diameter of about several tens of nm, which is too small to be immediately confirmed by direct observation using a microscope, etc. The marker-attached specific antibody 40 has a plurality of antibodies 41 and a marker 42. The marker-attached specific antibody 40 is bound to the plurality of antibodies 41 such that the plurality of antibodies 41 are arranged around the periphery and the marker 42 is located inside.

[0045] The antibody 41 binds to the spike protein-attached antigen 31 of the virus 30. For example, when the attachment portion 120 mixes the saliva of the subject 10 with a reagent and the virus 30 comes into contact with the marker-attached specific antibody 40, the spike protein-attached antigen 31 of the virus 30 binds to the antibody 41 of the marker-attached specific antibody 40.

[0046] In this case, a conjugate 50 between the virus 30 and the marker-attached specific antibody 40 is formed. Since the virus 30 has a plurality of spike protein-attached antigens 31 and the marker-attached specific antibody 40 has a plurality of antibodies 41, when a plurality of viruses 30 are present in the mixed liquid, a conjugate 50 is formed in which a plurality of viruses 30 and a plurality of marker-attached specific antibodies 40 are multiple-bound. The diameter of such a multiple-bound conjugate may be about several hundred nm. Furthermore, a plurality of such conjugates 50 are formed in the mixed liquid. Note that since the antibodies 41 do not bind to each other, if a plurality of viruses 30 are not present in the mixed liquid, a conjugate 50 large enough to be directly observed is not formed.

[0047] The marker 42 is an indicator used to facilitate detection of such a conjugate 50. The marker 42 is, for example, a magnetic body, a fluorescent body, a dye, or the like. In this embodiment, the marked specific antibody 40 using a magnetic body as the marker 42 is called a magnetically marked specific antibody. In other words, the magnetically marked specific antibody is a marked specific antibody 40 in which an antibody for binding to the spike protein-attached antigen 31 of the virus 30 is bound to a magnetic body. A magnetic body is a substance that is magnetized in response to an external magnetic field applied thereto.

[0048] Moreover, a specific antibody 40 with a marker using a fluorescent material as the marker 42 is called a specific antibody with a fluorescent marker. In other words, a specific antibody with a fluorescent marker is a specific antibody 40 with a marker to which an antibody for binding to the spike protein antigen 31 of the virus 30 and a fluorescent material are bound. A fluorescent material is a substance that generates fluorescence with a wavelength longer than a predetermined wavelength when irradiated with light with a wavelength shorter than a predetermined wavelength. When such a specific antibody with a fluorescent marker is used, the light with a wavelength shorter than the predetermined wavelength is defined as the first light, and the fluorescent light is defined as the second light. The first light is light having energy greater than a predetermined energy, and in this case functions as excitation light.

[0049] Furthermore, a specific antibody 40 with a dye as the marker 42 is called a specific antibody with a dye marker. In other words, a specific antibody with a dye marker is a specific antibody 40 with a dye marker, in which an antibody for binding to the antigen 31 with the spike protein of the virus 30 is bound to a dye that reflects or absorbs the first light. When such a specific antibody with a dye marker is used, the reflected light in which the dye reflects the first light, or the transmitted light in which the first light passes through the dye, is regarded as the second light.

[0050] The reagent includes a specific antibody with a magnetic marker as the specific antibody with a marker 40. The reagent further includes at least one of a specific antibody with a fluorescent marker or a specific antibody with a dye marker as the specific antibody with a marker. The above specific antibody with a marker 40 has been discovered by the applicants. In this embodiment, first, an example in which the specific antibody with a marker 40 includes a specific antibody with a magnetic marker and a specific antibody with a fluorescent marker will be described.

[0051] The attachment unit 120 mixes the above-mentioned reagent with the saliva on one surface of the test stick 20. The attachment unit 120 has, for example, a sprayer that sprays a reagent containing the marker-attached specific antibody 40 onto the saliva that the subject 10 has attached to the test stick 20. The attachment unit 120 may have multiple sprayers.

[0052] The sprayer sprays the reagent in a mist onto the area of ​​the test stick 20 where saliva is attached. The sprayer is, for example, a head part of an inkjet printer, a spray nozzle, or the like that sprays the reagent by the piezoelectric effect of a piezoelectric device, heating, pressure from a pump, or the like. Such a sprayer can reduce the amount of reagent used while efficiently attaching the reagent to the area where saliva is attached, thereby mixing the reagent with the saliva.

[0053] The vibration unit 130 mixes the saliva and the reagent by vibrating the test stick 20 to which the reagent has been attached by the attachment unit 120. The vibration unit 130 vibrates the test stick 20 so as to agitate the saliva and the reagent. In this way, the vibration unit 130 can reduce uneven mixing of the saliva and the reagent.

[0054] The testing device 100 may include a heating unit that heats the test stick 20. Heating can vibrate the molecules contained in the saliva and the reagent (Brownian motion), facilitating binding between the virus 30 and the marker-attached specific antibody 40. In other words, the heating unit heats the molecules contained in the saliva and the reagent to cause molecular motion, shortening the distance between the spike protein-attached antigen 31 of the virus 30 and the antibody 41 of the marker-attached specific antibody 40, thereby improving the probability of binding between the virus 30 and the marker-attached specific antibody 40.

[0055] The light source unit 140 irradiates the first light onto at least a part of the area of ​​the test stick 20 where saliva is attached, thereby irradiating the first light onto a mixture of saliva and reagent. The light source unit 140 has a laser, an LED, or the like. The light source unit 140 outputs, for example, light that functions as excitation light for a fluorescent material contained in a specific antibody with a fluorescent marker as the first light. The light source unit 140 may output, as the first light, light that is reflected or absorbed by a pigment contained in a specific antibody with a pigment marker.

[0056] It is preferable that the light output by the light source unit 140 that functions as excitation light for the phosphor and the light reflected or absorbed by the pigment have the same wavelength. The light source unit 140 outputs, for example, ultraviolet light as the first light. The light source unit 140 may output visible light as the first light. Furthermore, the light source unit 140 may output light of multiple wavelengths as the first light.

[0057] Irradiation with the first light from the light source unit 140 causes the fluorescent material contained in the specific antibody with a fluorescent marker to generate fluorescence (second light). Since the diameter of the fluorescent material is small, at tens of nm or less, the intensity of the generated second light is also small. In contrast, since the multiple-linked conjugate 50 contains multiple specific antibodies with fluorescent markers, the intensity of the second light generated from the conjugate 50 can be several tens to several hundreds of times higher.

[0058] The magnetic field applying unit 150 applies a magnetic field to the mixture of saliva and a reagent. For example, the magnetic field applying unit 150 applies a magnetic field of a predetermined magnitude to a region of the test bar 20 where the light source unit 140 irradiates the first light. The magnetic field applying unit 150 applies a magnetic field parallel to the first direction as shown by the arrow in FIG. 2. For example, the magnetic field applying unit 150 has a plurality of coils arranged to sandwich the test bar 20. The magnetic field applying unit 150 applies a magnetic field to the mixture by causing currents to flow through the plurality of coils. Alternatively, the magnetic field applying unit 150 may have a movable permanent magnet, and apply a magnetic field to the mixture by bringing the permanent magnet close to the test bar 20.

[0059] As described above, the marker-attached specific antibody 40 contains a magnetic marker-attached specific antibody, so when a magnetic field in a first direction is applied to the mixed liquid, the magnetic marker-attached specific antibody in the mixed liquid is subjected to a force in the first direction. The marker-attached specific antibody 40 floats in the mixed liquid, so it moves in the first direction. Furthermore, the multiply-bound conjugate 50 contains multiple specific antibodies with magnetic markers, so it moves in the first direction. Such movement of the magnetic marker-attached specific antibody and conjugate 50 is called magnetophoresis. The fluorescent marker-attached specific antibody does not contain a magnetic substance, so it does not move even when a magnetic field is applied.

[0060] In other words, the magnetic field applying unit 150 applies a magnetic field to at least a part of the mixed liquid so that the conjugate 50 in which the marker-attached specific antibody 40 is multiply bound to the virus 30 having the spike protein-attached antigen 31 moves to a predetermined region. Here, the predetermined region is the region on the first direction side of the region of the test stick 20 to which saliva adheres, as described later. When the magnetic field applying unit 150 applies a magnetic field, the conjugate 50 in the mixed liquid moves to the predetermined region. In other words, when the magnetic field applying unit 150 applies a magnetic field, a plurality of conjugates 50 can be collected in a predetermined region of the mixed liquid.

[0061] The detection unit 160 detects the intensity of the second light generated from the predetermined region by irradiation with the first light. Since the plurality of conjugates 50 are gathered in the predetermined region of the mixed liquid, the intensity of the second light generated by irradiation with the first light is several hundred to several thousand times greater than the intensity of the second light in the absence of the conjugates 50. Therefore, the detection unit 160 can receive and easily detect the second light generated from the plurality of conjugates 50.

[0062] The detection unit 160 is, for example, a photodiode, a CCD, etc. Note that it is desirable that the optical system, such as the light source unit 140 and the detection unit 160, is fixed to the fixing unit 162. This makes it possible to reduce misalignment that occurs in the optical system due to impact, changes over time, etc. In addition, the attachment unit 120 may also be fixed to the fixing unit 162.

[0063] The storage unit 170 is a storage medium including a read only memory (ROM) and a random access memory (RAM). The storage unit 170 may also include a large-capacity storage device such as a hard disk drive (HDD) and / or a solid state drive (SSD). For example, when a computer functions as the control unit 180, the storage unit 170 may store information such as an operating system (OS) that causes the computer to function, and programs. The storage unit 170 may also store various information including a database that is referenced when a program is executed.

[0064] The storage unit 170 may also store intermediate data, calculation results, thresholds, reference values, parameters, and the like that are generated (or used) by the inspection device 100 during the operation of the device 100. The storage unit 170 may also supply the stored data to a request source in response to a request from each unit in the inspection device 100.

[0065] The control unit 180 controls each unit of the inspection device 100. The control unit 180 is, for example, a CPU (Central Processing Unit). The control unit 180 has a determination unit 181 and a display control unit 182. In other words, the CPU executes a program stored in the storage unit 170 to function as the control unit 180 having the determination unit 181 and the display control unit 182.

[0066] The determination unit 181 determines whether or not the virus 30 is contained in the saliva of the subject 10 based on the detected light intensity. When the virus 30 having the spike protein-bearing antigen 31 is contained in the saliva of the subject 10, a bond 50 is formed in the mixed liquid, and the light intensity detected by the detection unit 160, for example, exceeds the threshold value as described above.

[0067] In contrast, when the virus 30 is not contained in the saliva of the subject 10, the light intensity detected by the detection unit 160 is weak light generated from each specific antibody with an individual fluorescent marker, and is therefore below the threshold. Therefore, the determination unit 181 can determine whether or not the virus 30 is contained in the saliva of the subject 10 by comparing the level of the light intensity detected by the detection unit 160 with the threshold.

[0068] The display control unit 182 controls the display unit 190 to display the determination result of the determination unit 181. For example, when the virus 30 is contained in the saliva of the subject 10, the display control unit 182 causes the display unit 190 to display "positive" or "suspected positive" at a position corresponding to the test stick 20 of the subject 10. When the virus 30 is not contained in the saliva of the subject 10, the display control unit 182 causes the display unit 190 to display "negative" at a position corresponding to the test stick 20 of the subject 10.

[0069] The display unit 190 is a display such as a liquid crystal display provided in the inspection device 100. Alternatively, the display unit 190 may be a display device, a monitor device, or the like separate from the inspection device 100. Furthermore, the inspection device 100 may be connected to a network, and the display unit 190 may be provided at a position remote from the inspection device 100. In this case, information indicating the determination result may be transmitted to a mobile terminal carried by the subject, and the determination result may be displayed on a display screen of the mobile terminal. Furthermore, the inspection results of the inspection device 100 may be accumulated in a database or the like via a network.

[0070] As described above, the testing device 100 according to this embodiment collects the conjugates 50, which are multiple bonds between a plurality of viruses 30 and a plurality of marker-attached specific antibodies 40, in a predetermined region by applying a magnetic field. As a result, the testing device 100 can increase the light intensity of weak fluorescence generated from a single marker-attached specific antibody 40 by irradiating it with excitation light to a light intensity of several hundred times or more, and can easily determine whether or not viruses 30 with a diameter of about 10 nm are present in the saliva.

[0071] The above-described inspection device 100 may have a plurality of insertion openings 110, and a plurality of different test sticks 20 may be inserted into each of the insertion openings 110. In this case, it is preferable that the inspection device 100 is capable of moving the attachment unit 120, the light source unit 140, and the detection unit 160 to sequentially inspect the plurality of test sticks 20.

[0072] For example, the multiple insertion openings 110 are arranged in one direction. The inspection device 100 further includes a moving unit that sequentially moves the attachment unit 120, the light source unit 140, and the detection unit 160 to multiple positions corresponding to the multiple insertion openings 110 in one direction. The moving unit, for example, moves the attachment unit 120, the light source unit 140, and the detection unit 160 individually. Furthermore, when the light source unit 140 and the detection unit 160 are fixed to the fixed unit 162, the moving unit may move them together with the fixed unit 162 in one direction.

[0073] The control unit 180 controls the moving unit to repeat the operation and movement of the attachment unit 120, the light source unit 140, and the detection unit 160 so as to sequentially inspect the multiple test rods 20. In this case, it goes without saying that the magnetic field application unit 150 is disposed so as to apply a magnetic field parallel to the first direction to the multiple test rods 20.

[0074] Alternatively, when the inspection device 100 has a plurality of insertion ports 110, the inspection device 100 may be provided with a plurality of attachment units 120, light source units 140, and detection units 160. For example, the inspection device 100 is provided with a number of sets of attachment units 120, light source units 140, and detection units 160 corresponding to the number of insertion ports 110, the same as the number of insertion ports 110. In this case, the sets of attachment units 120, light source units 140, and detection units 160 inspect the test rods 20 inserted into the corresponding insertion ports 110. This allows the inspection device 100 to inspect a plurality of test rods 20 in parallel.

[0075] In the above embodiment of the test device 100, an example has been described in which a magnetic field is applied to the mixture of saliva and a reagent to move the conjugate 50 to a predetermined area. Here, the test device 100 may use a processed test stick 20 to gather a plurality of conjugates 50 in a narrower area.

[0076] <Example of the configuration of the test bar 20> Fig. 4 shows an example of the configuration of a test stick 20 according to this embodiment. Fig. 4A shows a front view of an attachment surface 21 to which saliva from a subject 10 is attached. Fig. 4B shows a cross-sectional view taken along line CC in Fig. 4A. In the test stick 20 of Fig. 4A, the area to which the subject attaches saliva is shown by a dotted line as an attachment area 22. A groove 23 having a predetermined shape is provided in the attachment area 22.

[0077] The groove 23 is desirably provided in the test bar 20 so that the extension direction is parallel to the first direction in which the magnetic field application unit 150 applies a magnetic field. For example, the test bar 20 is inserted into the insertion port 110 parallel to the longitudinal direction of the test bar 20. The test bar 20 is placed in the inspection device 100 so that the first direction in which the magnetic field application unit 150 applies a magnetic field is the X direction in Fig. 4A. Here, the X direction in Fig. 4A is a direction that is approximately perpendicular to the insertion direction of the test bar 20 and approximately parallel to the attachment surface 21.

[0078] The groove 23 is provided so that the extension direction is approximately perpendicular to the longitudinal direction of the test bar 20. This allows the magnetic field application unit 150 to apply a magnetic field so that the binder 50 moves along the longitudinal direction of the groove 23 of the test bar 20, thereby moving the binder 50 to a predetermined region in the groove 23. In other words, the groove 23 has a function of guiding the movement of the binder 50.

[0079] Also, it is desirable that the groove 23 provided in the test bar 20 is provided so that the width becomes narrower as it approaches the end in the longitudinal direction of the groove 23. In this way, the groove 23 guides the binder 50 to move to a narrower region. Furthermore, the end of the groove 23 provided in the test bar 20 may have a protruding V-shape or U-shape in plan view as it approaches the end in the longitudinal direction of the groove 23. In this way, the groove 23 can collect the binder 50 in the protruding region at the end in the longitudinal direction.

[0080] 4A shows an example in which the end of the groove 23 has a V-shape. In addition, in FIG. 4A, the protruding region of the longitudinal end is indicated by diagonal lines as a predetermined observation region 24. When the magnetic field application unit 150 applies a magnetic field in a first direction, a plurality of combination bodies 50 can be gathered in such an observation region 24. When the light source unit 140 irradiates the observation region 24 with a first light, the detection unit 160 can detect a second light having a stronger intensity.

[0081] The test stick 20 is preferably made of a material that is transparent to the first light and the second light. For example, at least the observation area 24 of the test stick 20 is made of a transparent material. In this case, the light source unit 140 can irradiate the first light from the surface opposite to the attachment surface 21 of the test stick to which the subject 10 has attached saliva. This improves the degree of freedom in the arrangement of the optical system, such as the light source unit 140 and the detection unit 160. In addition, such a test stick 20 allows the transmitted light of the first light in the observation area 24 to be detected, as described later.

[0082] The test stick 20 may also have a water retention agent 25 for absorbing saliva. At least a portion of the water retention agent 25 may be embedded in the groove 23. The test stick 20 may also have a filter 26 for reducing contamination of the mixed liquid with dust or the like. The filter 26 is provided, for example, so as to overlap the water retention agent 25.

[0083] Here, operations such as application of a magnetic field by the magnetic field application unit 150, movement of the combined body 50 due to the application of the magnetic field, and detection of the second light by the detection unit 160 take approximately a few seconds or less. Therefore, the inspection device 100 can output the inspection result for one test rod 20 in a few seconds to a dozen seconds, which is several tens to several thousands times faster than the conventional method. The inspection method of such an inspection device 100 will be described next.

[0084] <An example of an operation flow of the inspection device 100> Fig. 5 shows an example of an operational flow of the testing device 100 according to this embodiment. The testing device 100 tests whether or not the saliva attached to the test stick 20 contains viruses 30 by executing the operational flow shown in Fig. 5. Note that the operational flow in Fig. 5 is an operation performed after a plurality of test sticks 20 to which saliva from the subject 10 is attached are inserted into a plurality of insertion ports 110, respectively.

[0085] First, the control unit 180 controls the movement unit to move the attachment unit 120 to a position corresponding to the insertion port 110 in order to test the test stick 20 to be tested that has been inserted into the insertion port 110 (S51). Next, the saliva of the subject 10 is mixed with a reagent containing a marker-attached specific antibody 40 on one surface of the test stick 20 (S52). Here, the marker-attached specific antibody 40 includes a magnetic marker-attached specific antibody and a fluorescent marker-attached specific antibody. The control unit 180, for example, controls the attachment unit 120 to spray a reagent containing a marker-attached specific antibody onto the saliva attached to the test stick 20.

[0086] Next, the control unit 180 controls the vibration unit 130 to vibrate the test stick 20 (S53). If a virus 30 having an antigen 31 with a spike protein is present in the saliva of the subject 10, the operations of S52 and S53 cause the marker-attached specific antibody 40 and the virus 30 to multiple-bond in the mixture of the saliva and the reagent to form a plurality of conjugates 50. The conjugates 50 include a plurality of specific antibodies with magnetic markers, a plurality of specific antibodies with fluorescent markers, and a plurality of viruses 30.

[0087] Next, the control unit 180 controls the light source unit 140 to irradiate the mixed liquid of the saliva and the reagent with a first light of a predetermined wavelength (S54). For example, the control unit 180 moves the light source unit 140 and the detection unit 160 to a position corresponding to the first insertion port, and then turns on the light source unit 140. Note that the control unit 180 may have moved the light source unit 140 and the detection unit 160 at the stage of S51.

[0088] Next, the control unit 180 controls the magnetic field application unit 150 to apply a magnetic field in a first direction to at least a part of the mixture of saliva and reagent (S55). As a result, the binder 50 receives a force in the first direction and moves to a predetermined region. For example, the binder 50 moves along the longitudinal direction of the groove 23 of the test bar 20 using the groove 23 as a guide. The magnetic field application unit 150 applies a magnetic field in a first direction parallel to the longitudinal direction of the groove 23, so that a plurality of binders 50 can be gathered in an observation region 24 at the longitudinal end of the groove 23, which is a predetermined region.

[0089] Next, the control unit 180 controls the detection unit 160 to detect the intensity of the second light received from a predetermined region by irradiation with the first light (S56). The detection unit 160 detects, as the second light, the fluorescence generated from the phosphor contained in the conjugate 50 collected in the observation region 24 by irradiation with the first light, which is excitation light.

[0090] Next, the determination unit 181 determines whether or not the virus 30 is contained in the saliva of the subject 10 based on the detected light intensity (S57). If the virus 30 is contained in the saliva of the subject 10, the detection unit 160 detects a fluorescence intensity exceeding a threshold value, and the determination unit 181 can easily determine the presence or absence of the virus 30. Then, the display control unit 182 causes the display unit 190 to display the determination result (S58).

[0091] The testing device 100 repeats the operations from S51 to S58 until testing of the test sticks 20 to be tested that have been inserted into all of the insertion ports 110 is completed (S59: No). For example, the control unit 180 continues testing the test stick 20 inserted into the insertion port 110 adjacent to the insertion port 110 into which the test stick 20 for which testing has been completed in S51 is inserted, as the next test stick. The determination unit 181 then sequentially determines whether or not the virus 30 is contained in the saliva of the multiple subjects 10 based on the detection results of the detection unit 160 that has been moved to multiple positions corresponding to the multiple insertion ports 110. When testing of the test sticks 20 to be tested that have been inserted into all of the insertion ports 110 is completed, the testing device 100 ends the test (S59: Yes).

[0092] According to the above-described operation of the testing device 100 of this embodiment, it is possible to quickly test whether or not a plurality of subjects 10 are infected with the virus 30. Here, the test stick 20 may be made of any rod-shaped material to which the saliva of the subject 10 can be attached, and can be manufactured at a lower cost than conventional test kits.

[0093] In addition, to prevent infection, the test stick 20 may be discarded after use. In this case, it is preferable that the multiple insertion ports 110 are integrally formed and are detachably provided from the testing device 100. This allows the operator of the testing device 100 to handle the multiple test sticks 20 and the multiple insertion ports 110 without touching the test sticks 20 by removing the integrated insertion port 110 from the testing device 100. Therefore, the operator of the testing device 100 can safely and easily replace the insertion port 110 of the testing device 100. In addition, the operator can quickly prepare for the next test using the testing device 100.

[0094] In the above-described testing device 100 according to the present embodiment, an example has been described in which the reagent contains a specific antibody with a magnetic marker and a specific antibody with a fluorescent marker as the marker-bound specific antibody 40, but the present invention is not limited to this. For example, the reagent may contain a specific antibody with a magnetic marker and a specific antibody with a dye marker as the marker-bound specific antibody 40.

[0095] The specific antibody with the dye marker has a dye that reflects the first light. Therefore, when the first light is irradiated to the mixed liquid in S54 and a magnetic field is applied to the mixed liquid in S55 to move the conjugate 50 to the observation region 24, the detection unit 160 detects the reflected light from the dye as the second light in S56. As a result, the determination unit 181 can determine in S57 that the virus 30 is contained in the saliva of the subject 10, for example, because the light intensity detected by the detection unit 160 exceeds a threshold value.

[0096] The specific antibody with the dye marker may have a dye that absorbs the first light. In this case, the detection unit 160 detects the absorbance of the first light by the mixed liquid. For example, the detection unit 160 detects the reflected light reflected from the dye as the second light. In this case, when the dye is absorbed, the intensity of the second light detected by the detection unit 160 decreases. As a result, in S57, the determination unit 181 can determine that the virus 30 is contained in the saliva of the subject 10, for example, when the light intensity detected by the detection unit 160 becomes equal to or lower than a threshold value. In addition, the determination unit 181 may use a value obtained by dividing the intensity of the second light by the intensity of the irradiated first light as the absorbance of the first light. In this case, the determination unit 181 determines that the virus 30 is contained in the saliva of the subject 10, when the absorbance becomes equal to or lower than a threshold value.

[0097] The detection unit 160 may detect the transmitted light of the first light transmitted through the mixed liquid as the second light. For example, when the first light is irradiated to the mixed liquid in S54, and a magnetic field is applied to the mixed liquid in S55 to move the conjugate 50 to the observation region 24, the detection unit 160 detects the transmitted light after being absorbed by the dye as the second light in S56. In this case, the determination unit 181 may determine in S57 that the virus 30 is contained in the saliva of the subject 10 in response to the light intensity detected by the detection unit 160 becoming equal to or lower than the threshold. The determination unit 181 may also calculate the transmittance of the second light, and determine that the virus 30 is contained in the saliva of the subject 10 in response to the transmittance becoming equal to or lower than the threshold.

[0098] Furthermore, the dye of the specific antibody with the dye marker changes its absorption rate depending on the wavelength of the irradiated light. Therefore, the light source unit 140 may have a plurality of light sources with different wavelengths, and sequentially irradiate the observation area 24 with the light of the plurality of light sources as the first light. The detection unit 160 sequentially detects the reflected light or transmitted light of the plurality of first lights, and the determination unit 181 calculates a plurality of absorbances corresponding to the plurality of detection results by the detection unit 160. In this way, the determination unit 181 can acquire the absorbance characteristics for each wavelength of the light received from the observation area 24, and can determine whether or not the conjugate 50 is present in the observation area 24 according to the absorbance characteristics. In this way, the determination unit 181 can determine that the virus 30 is contained in the saliva of the subject 10 based on the detection result of the detection unit 160.

[0099] The test stick 20 is preferably made of a material that is transparent to the first light. In this case, for example, in S54, the light source unit 140 irradiates the first light from one side of the test stick 20, and in S56, the detection unit 160 can detect the second light from the other side of the test stick 20. As an example, the light source unit 140 irradiates the first light from the side of the test stick 20 opposite to the attachment surface 21 to which the subject 10 has attached saliva. This allows for an improvement in the degree of freedom in the arrangement of the light source unit 140 and the detection unit 160.

[0100] The reagent may also include a specific antibody with a magnetic marker, a specific antibody with a fluorescent marker, and a specific antibody with a dye marker as the marker-attached specific antibody 40. In this case, the detection unit 160 detects at least one of the following light as the second light: fluorescence generated from the specific antibody with a fluorescent marker, reflected light generated from the specific antibody with a dye marker, and transmitted light through the specific antibody with a dye marker. The detection unit 160 may detect two or more types of light. In this case, the testing device 100 is provided with a plurality of detection units 160.

[0101] For example, the detection unit 160 has a first detection unit that detects fluorescence and a second detection unit that detects reflected light. Then, the determination unit 181 determines whether or not the virus 30 is contained in the saliva of the subject 10 based on the detection result of the first detection unit and the detection result of the second detection unit. For example, when the intensity of the fluorescence detected by the first detection unit exceeds a threshold and the intensity of the reflected light detected by the second detection unit exceeds a threshold, the determination unit 181 determines that the virus 30 is contained in the saliva of the subject 10.

[0102] Furthermore, the determination unit 181 may determine a "false positive" or "retest" when one of the intensity of the fluorescence detected by the first detection unit and the intensity of the reflected light detected by the second detection unit exceeds a threshold value and the other does not exceed the threshold value. Similarly, the detection unit 160 may have a first detection unit that detects the fluorescence, a second detection unit that detects the reflected light, and a third detection unit that detects the transmitted light. The determination unit 181 can more reliably determine whether or not the virus 30 is contained in the saliva of the subject 10 based on the intensities of multiple types of light.

[0103] As described above, the testing device 100 according to the present embodiment has been described as an example in which a reagent containing multiple types of marker-attached specific antibodies 40 is mixed with the saliva of the subject 10, but the present invention is not limited to this. For example, the testing device 100 may mix multiple reagents containing different types of marker-attached specific antibodies 40 with the saliva of the subject 10.

[0104] In this case, the attachment unit 120 has multiple sprayers that spray reagents corresponding to the types of specific antibodies with markers. For example, the attachment unit 120 has a first sprayer that sprays a reagent containing a specific antibody with a magnetic marker, a second sprayer that sprays a reagent containing a specific antibody with a fluorescent marker, and a third sprayer that sprays a reagent containing a specific antibody with a dye marker. The multiple sprayers each spray a reagent onto the saliva attached to the test stick 20. The multiple sprayers spray the reagents, for example, at the same timing or at different timings.

[0105] This allows the testing device 100 to mix saliva with two or three types of marker-attached specific antibodies 40 by switching between them. For example, when receiving a command from the operator to perform a test with higher accuracy, the testing device 100 performs the test using three types of marker-attached specific antibodies 40. Furthermore, when receiving a command from the operator to perform a test at a higher speed, the testing device 100 may perform the test using two types of marker-attached specific antibodies 40.

[0106] In the above description of the testing device 100 according to the present embodiment, an example in which the adhesion unit 120 sprays a reagent has been described, but the invention is not limited to this. Alternatively, the adhesion unit 120 may have a dripping unit that drips a reagent containing a marker-attached specific antibody onto the saliva attached to the test stick 20. In this case, the adhesion unit 120 may have a plurality of dripping units that drip reagents corresponding to the types of marker-attached specific antibodies. The plurality of dripping units drip the reagent at the same timing or at different timings, for example. The adhesion unit 120 can mix the saliva of the subject 10 with the reagent even when such a dripping unit is used.

[0107] The above description has been given of an example of the testing device 100 according to the present embodiment in which the detection unit 160 detects the second light in S56 after the magnetic field is applied to the mixed liquid in S55 and the conjugate 50 moves to the observation region 24, but the present invention is not limited to this. When conjugates 50 of a certain size or more and / or a certain number or more of conjugates 50 are formed in the mixed liquid of the saliva of the subject 10 and the reagent, the detection unit 160 may detect the second light of an intensity equal to or greater than a threshold value even while the conjugates 50 are being moved.

[0108] Therefore, the control unit 180 may irradiate the predetermined region with the first light in S54, and then apply a magnetic field to move the combined body 50 in S55, while causing the detection unit 160 to detect the intensity of the second light received from the combined body 50 moving in the predetermined region in S56. The control unit 180 may, for example, cause the detection unit 160 to start the detection operation immediately after the magnetic field application unit 150 applies the magnetic field.

[0109] As a result, even if the binder 50 is moving, when the intensity of the second light detected by the detection unit 160 exceeds the threshold value, the determination unit 181 can determine that the virus 30 is contained in the saliva of the subject 10. In addition, the determination unit 181 can also determine whether or not the virus 30 is contained in the saliva of the subject 10 based on the change over time in the intensity of the second light detected by the detection unit 160.

[0110] For example, if the virus 30 is present in the saliva of the subject 10, the intensity of the second light increases over time. On the other hand, if the virus 30 is not present in the saliva of the subject 10, the intensity of the second light hardly changes over time. Therefore, the determination unit 181 can determine that the virus 30 is present in the saliva of the subject 10 based on the change in the intensity of the second light over time.

[0111] Alternatively, the detection unit 160 may have an imaging unit such as a CCD and capture an image of a predetermined region. Since the combined body 50 moves when the magnetic field application unit 150 applies a magnetic field, the bright spots of the second light generated from the combined body 50 move over time in the predetermined region. Therefore, the detection unit 160 captures the movement of the multiple bright spots of the second light as a moving image. The determination unit 181 can determine whether the multiple combined bodies 50 are moving by performing image analysis on the data of such a moving image. Therefore, the determination unit 181 can determine that the virus 30 is contained in the saliva of the subject 10 according to the movement of the bright spots of the second light over time.

[0112] As described above, the magnetic field applying section 150 applies a magnetic field and the detecting section 160 starts a detection operation, so that the testing device 100 can test whether the subject 10 is infected with the virus 30 more quickly.

[0113] In the above description, the inspection device 100 applies the first light to a predetermined region in S54 and then applies a magnetic field to the mixed liquid in S55, but the present invention is not limited to this example. The inspection device 100 may apply a magnetic field to the mixed liquid in S55 to move the combined body 50, and then apply the first light to a predetermined region. In this case, S54 and S55 in the operation flow in FIG. 5 are interchanged.

[0114] In the above embodiment of the testing device 100, an example has been described in which the attachment unit 120 attaches a reagent to the area of ​​the test stick 20 where saliva is attached, and the saliva and the reagent are mixed, but the present invention is not limited to this. For example, a reagent containing a marker-attached specific antibody 40 may be attached to the test stick 20 in advance.

[0115] In this case, when the subject 10 applies his / her saliva to the application surface 21 of the test stick 20, the saliva and the reagent are mixed. Therefore, by using a test stick 20 on which a reagent containing a marker-attached specific antibody 40 has been applied in advance to the application surface 21, the subject's saliva and the reagent can be mixed. In this case, the application unit 120 operates to more reliably mix the subject's saliva and the reagent.

[0116] Alternatively, if the test stick 20 is used to sufficiently mix the saliva of the subject with the reagent, the attachment unit 120 does not need to operate. In this case, for example, the operations of S51 and S52 in FIG. 5 can be omitted, and the test time can be shortened. Also, the test device 100 does not need to be provided with the attachment unit 120. In this case, the manufacturing cost of the test device 100 can be reduced.

[0117] In the above description of the testing device 100 according to this embodiment, an example has been described in which the test stick 20 is provided with the groove 23 and the observation area 24. Here, a plurality of grooves 23 and observation areas 24 may be provided on the test stick 20. It is desirable for the subject 10 to apply saliva to a plurality of areas of the test stick 20 corresponding to the plurality of grooves 23 and observation areas 24. The application unit 120 applies a reagent to the plurality of areas to which the saliva has been applied. This allows the testing device 100 to sequentially test a plurality of areas.

[0118] For example, the attachment unit 120 attaches the same reagent to multiple regions. This allows the testing device 100 to efficiently perform the same test multiple times. Alternatively, the attachment unit 120 may attach different reagents to each region. For example, if there is a different reagent for each virus 30 to be detected, the testing device 100 can efficiently perform tests for each virus 30 in sequence.

[0119] In the above embodiment of the testing device 100, an example has been described in which the magnetic field application unit 150 applies a magnetic field to gather the binders 50 in a localized area, but the present invention is not limited to this. Alternatively, a reagent containing the marker-attached specific antibody 40 may be attached in advance to the localized observation area 24 of the test rod 20. Such a test rod 20 will now be described.

[0120] <Modifications of the test bar 20> Fig. 6 shows a modified test stick 20 according to the present embodiment. In the test stick 20 of this modification, parts that operate in substantially the same manner as those in the test stick 20 according to the present embodiment shown in Fig. 4 are given the same reference numerals, and duplicated explanations will be omitted. The modified test stick 20 has a groove 23 in the observation area 24. A water retention agent 25 is provided in the groove 23. A reagent containing a marker-attached specific antibody 40 is attached to the water retention agent 25.

[0121] In this case, when the subject 10 applies his / her saliva to the attachment surface 21 of the test stick 20, the saliva and the reagent are mixed in the observation area 24. When such a test stick 20 is inserted into the insertion port 110, a bond 50 is generated in the observation area 24, so the attachment unit 120 and the magnetic field application unit 150 do not need to operate. In this case, for example, the operations of S51, S52, and S55 in FIG. 5 can be omitted, and the test time can be shortened. Also, the attachment unit 120 and the magnetic field application unit 150 do not need to be provided in the test device 100. In this case, the manufacturing cost of the test device 100 can be reduced.

[0122] When generating the conjugate 50 in the local observation region 24 of the test stick 20, the marker-attached specific antibody 40 may be attached to the observation region 24 using the attachment unit 120. The attachment unit 120 may further include a sprayer that sprays a solution such as a buffer solution or water onto the observation region 24. The buffer solution is, for example, PBS (phosphate buffered saline). The operation flow of such a testing device 100 will be described below.

[0123] <Modification of Operation Flow of Inspection Apparatus 100> Fig. 7 shows a modified example of the operational flow of the testing device 100 according to the present embodiment. In the operational flow of this modified example, operations that are substantially the same as those in the operational flow of the testing device 100 according to the present embodiment shown in Fig. 5 are assigned the same reference numerals, and duplicated explanations will be omitted. The operational flow of Fig. 7 is an operation performed after the saliva of the subject 10 is applied to the test stick 20 shown in Fig. 6 and the test stick 20 is inserted into the insertion port 110.

[0124] First, the control unit 180 controls the moving unit to move the attachment unit 120 to a position corresponding to the insertion port 110 (S51). Then, the control unit 180 controls the sprayer to spray a solution such as a buffer solution or water into the observation area 24 (S71). This makes it possible to wash away the marker-bound specific antibody 40 other than the conjugate 50 from the observation area 24. Next, the control unit 180 controls the attachment unit 120 to spray a reagent containing the marker-bound specific antibody 40 into the observation area 24 of the test stick 20 (S72). This makes it possible to more reliably generate the conjugate 50.

[0125] Next, the control unit 180 controls the vibration unit 130 to vibrate the test stick 20 (S53). The control unit 180 may vibrate the test stick 20 before or after the operation of S71. Then, the control unit 180 controls the sprayer to spray a solution such as a buffer solution or water into the observation area 24 (S73). This washes away the marker-attached specific antibodies 40 other than the conjugates 50 from the observation area 24. As a result, if the saliva contains viruses 30, multiple conjugates 50 can be produced in the observation area 24.

[0126] Next, the control unit 180 controls the light source unit 140 to irradiate the mixture of saliva and reagent with the first light (S54). Here, the light source unit 140 irradiates the observation area 24. Next, the control unit 180 controls the detection unit 160 to detect the intensity of the second light received from the observation area 24 by the irradiation of the first light (S56). Then, the determination unit 181 determines whether or not the virus 30 is contained in the saliva of the subject 10 based on the detected light intensity (S57).

[0127] As described above, according to the operation flow of this modified example, the testing device 100 can generate the conjugate 50 in the local observation area 24 of the test stick 20, making it possible to perform testing without the operation of collecting the conjugate 50. In addition, since the attachment unit 120 sprays the reagent in the local observation area 24, the amount of reagent used can be reduced.

[0128] Furthermore, the testing device 100 does not need to use a specific antibody with a magnetic marker to collect the conjugate 50. For example, the reagent includes a specific antibody with a fluorescent marker as the marker-attached specific antibody 40, and the detection unit 160 detects the fluorescence generated from the fluorescent material as the second light. Alternatively, the reagent may include a specific antibody with a dye marker as the marker-attached specific antibody 40, and the detection unit 160 may detect the reflected light and / or transmitted light of the first light as the second light. The reagent may include a specific antibody with a fluorescent marker and a specific antibody with a dye marker as the marker-attached specific antibody 40.

[0129] The reagent may include a specific antibody with a magnetic marker to detect the virus 30. The magnetic body is magnetized by an externally applied magnetic field. When more magnetic bodies gather, more magnetism is generated. Therefore, the inspection device 100 may apply a magnetic field to the observation area 24 by the magnetic field application unit 150 instead of irradiating the first light in S54.

[0130] The detection unit 160 detects the generated magnetism. In this case, the detection unit 160 has a magnetic sensor. This allows the inspection device 100 to magnetically detect the combination 50.

[0131] When the inspection device 100 magnetically detects the combined body 50, the magnetic field applying unit 150 may apply an AC magnetic field to the observation area 24. The magnetic field applying unit 150 may sweep the frequency of the AC magnetic field. A magnetic body has a magnetic resonance frequency that is specific to the magnetic body. Therefore, when the magnetic field applying unit 150 sweeps the frequency of the AC magnetic field, the magnetism generated by the magnetic body fluctuates significantly near the magnetic resonance frequency.

[0132] When the detection unit 160 detects such a variation, the determination unit 181 can determine that the virus 30 is contained in the saliva of the subject 10. The testing device 100 may use both the magnetic detection test of the conjugate 50 using the specific antibody with a magnetic marker and the optical detection of the conjugate 50 using the specific antibody with a fluorescent marker and / or the specific antibody with a dye marker.

[0133] In the above operational flow of this modified example, an example has been described in which a reagent containing a marker-bearing specific antibody 40 is attached to the local observation area 24 of the test rod 20, but the present invention is not limited to this. A reagent containing a specific antibody without a marker 42 may also be attached to the local observation area 24 of the test rod 20.

[0134] The specific antibody without a marker has a plurality of antibodies 41 arranged around it and does not have a marker 42 inside it. The specific antibody without a marker binds to the antigen 31 with the spike protein of the virus 30, similar to the specific antibody 40 with a marker, to form a conjugate 50. Even when such a specific antibody is used, the test device 100 attaches a reagent containing the specific antibody 40 with a marker to the observation area 24 in S72, so that the specific antibody 40 with a marker can be added to the conjugate 50 without the marker 42 to form the conjugate 50 including the marker 42. As a result, even if a different marker 42 is used for each test device 100, it is possible to test whether the virus 30 is contained in the saliva of the subject 10 using a common test stick 20.

[0135] <Example of using specific antibodies with dye markers> In the above description of the testing device 100 according to this embodiment, an example has been described in which the reagent includes a specific antibody with a dye marker as the marker-specific antibody 40. Here, the reagent may include different types of specific antibodies with dye markers. The reagent includes, for example, a specific antibody with a first dye marker in which an antibody is bound to a first dye of a first color, and a specific antibody with a second dye marker in which an antibody is bound to a second dye of a second color different from the first color.

[0136] In this case, it is preferable that the first light is light including a first color light and a second color light. For example, the first light is white light. When such a first light is irradiated to a specific antibody with a first dye marker and a specific antibody with a second dye marker, the reflected light of the first color light and the second color light or the transmitted light with reduced intensities of the first color light and the second color light becomes the second light. For example, the first color is red, the second color is blue, and the first light is white light or light having a light intensity distribution similar to white light.

[0137] The first light is, for example, sunlight. The first light may be light irradiated by the light source unit 140, such as an LED, a fluorescent lamp, a lamp, or the like. When the first light is sunlight, the light source unit 140 may not be required. When the light source unit 140 is an LED, a fluorescent lamp, a lamp, or the like, the first light may be continuously turned on. For example, the light source unit 140 may be a light source that functions as an interior light that illuminates the interior of a room. Alternatively, the light source unit 140 may be a strobe that the imaging unit has. As described above, when the first light is light that includes a first color (red) light and a second color (blue) light, the detection unit 160 detects reflected light that includes red light and blue light, or transmitted light in which the intensity of the irradiated red light and blue light has been reduced, as the second light.

[0138] Therefore, the determination unit 181 may determine that the virus 30 is contained in the saliva of the subject in response to the first color light and the second color light being contained in the second light generated from one conjugate 50. For example, the determination unit 181 determines whether or not a pixel of the first color and a pixel of the second color light are contained in an optical microscope image of one conjugate 50.

[0139] Alternatively, the determination unit 181 may perform numerical processing on the captured images of a plurality of conjugates 50 to statistically determine whether or not one conjugate 50 contains a specific antibody with a first dye marker and a specific antibody with a second dye marker. For example, the detection unit 160 has an imaging unit such as a camera or a CCD, and captures an image of the second light generated from a predetermined region. Then, the determination unit 181 determines that the virus 30 is contained in the saliva of the subject based on the fact that the pixels of the imaging region in which the conjugate 50 is captured from the captured image captured by the imaging unit include pixels of the first color and pixels of the second color.

[0140] In this case, it is preferable that the determination unit 181 extracts boundaries from the captured image to extract an imaged region in which a plurality of conjugates 50 are captured. Note that, in the process of producing a reagent, particles each having several specific antibodies with the same color dye markers bound thereto may be mixed into the reagent, and such particles may be extracted as noise by boundary extraction.

[0141] Therefore, the determination unit 181 calculates the standard deviation of the pixel color gamut for each extracted region. For example, a region of a particle to which several specific antibodies with red dye markers are bound will have almost all red pixels, so the standard deviation of the red color gamut tends to be smaller. Similarly, a region of a particle to which several specific antibodies with blue dye markers are bound will have almost all blue pixels, so the standard deviation of the blue color gamut will be smaller. On the other hand, the conjugate 50 contains a specific antibody with a first dye marker and a specific antibody with a second dye marker, so it contains red pixels and blue pixels, resulting in variation in color dispersion.

[0142] Therefore, the standard deviation of the red color gamut of the conjugate 50 is greater than the standard deviation of the particles bound to the specific antibody with a red pigment marker, and the standard deviation of the blue color gamut is greater than the standard deviation of the particles bound to the specific antibody with a blue pigment marker. Therefore, the determination unit 181 may determine that the virus 30 is contained in the saliva of the subject when the number of areas having a standard deviation greater than the threshold value among the extracted areas in the red color gamut and / or the blue color gamut exceeds a predetermined number.

[0143] Furthermore, the determination unit 181 may further calculate a probability density distribution of the standard deviation for each color gamut. By using the probability density distribution, the determination unit 181 can more accurately determine whether or not a conjugate 50 having multiple pigments is present, regardless of the number of particles. For example, the determination unit 181 determines that the virus 30 is contained in the subject's saliva when the half-width of the probability density distribution is equal to or greater than a threshold value. Alternatively, the determination unit 181 may determine that the virus 30 is contained in the subject's saliva when the integral value of the probability density distribution in a predetermined range (equal to or greater than a predetermined standard deviation) is equal to or greater than a threshold value.

[0144] Alternatively, the determination unit 181 may use Euclidean distance, Mahalanobis sail distance, etc. In general, when a population is uniformly distributed in a circular shape on a two-dimensional coordinate system, it is possible to determine whether or not a sample belongs to the population by determining the Euclidean distance from an unknown sample and discriminating the distance against a threshold value. In reality, the population may be distributed in, for example, an ellipse, so by correcting this and treating it as a circular population (coordinate transformation), determining the Mahalanobis sail distance, and comparing it with a threshold value, it is possible to determine whether or not a sample belongs to the population.

[0145] As described above, the testing device 100 can test whether or not the virus 30 is contained in the saliva of the subject 10 even if a reagent containing different types of specific antibodies with dye markers is used. It goes without saying that the testing device 100 may move the conjugate 50 to a predetermined region using a reagent containing different types of specific antibodies with dye markers and specific antibodies with magnetic markers.

[0146] In addition, if the reagent contains almost no particles bound to specific antibodies with the same color dye marker, the reagent may contain only one type of specific antibody with a dye marker in which the antibody is bound to a single color dye. In this case, the determination unit 181 calculates the size of the extracted region and obtains the distribution of the number of particles relative to the size of the region (particle size).

[0147] Fig. 8 shows an example of the distribution of the number of particles relative to the particle size of the particles detected by the inspection device 100 according to this embodiment. Fig. 8 shows an example of the distribution when the bond 50 is formed, indicated as "Spike," and an example of the distribution when the bond 50 is not formed, indicated as "Control."

[0148] When the bond 50 is formed, the region (particle size) of the extracted particles becomes larger, and the number of ranges with large particle sizes is greater than when the bond 50 is not formed. Therefore, the determination unit 181 may determine that the virus 30 is contained in the saliva of the subject when the integral value of a predetermined range (a range in which the particle size is larger than a predetermined value) in the acquired distribution exceeds a threshold value.

[0149] Further, the determination unit 181 may normalize the distribution of the number of particles with respect to the particle size. FIG. 9 shows an example of normalizing the distribution of the number of particles with respect to the particle size detected by the inspection apparatus 100 according to the present embodiment. Here, the normalization is to normalize by the number of particles of a specific particle size (a < X ≦ b). FIG. 9 shows an example of normalizing the distribution in FIG. 8 by the number of particles of 0 < X ≦ 100.

[0150] As shown in FIG. 8, before normalization, the number of the smallest particles in the distribution of the Control group is very large, and it is difficult to recognize a large difference in particles between the Control group and the Spike group. However, as shown in FIG. 9, for example, when normalized by the number of the smallest particles of 0 < X ≦ 100, the ratio of large particles becomes clear. Thus, by normalizing, it is possible to quantitatively evaluate the reagent amount in which the number of the conjugates 50 is large among the total number of particles.

[0151] <Example of forming conjugate 50> In the above-described present embodiment, it has been explained that the conjugate 50 is formed by the binding of the virus 30 and the marker-conjugated specific antibody 40. Here, an example in which the conjugate 50 is actually formed using a simulated coronavirus (sample A) as the virus 30 will be described.

[0152] Sample A is a sample with a particle diameter of 10 nm, which is a pseudo-coronavirus obtained by binding an antigen (delta-type novel coronavirus spike protein, virus receptor binding region) to gold beads with a diameter of 10 nm. Sample B is a sample in which a monoclonal antibody is immobilized on a marker with a diameter of 335 nm to obtain the marker-conjugated specific antibody 40. An electron microscope image after mixing such a sample A and sample B in a micro test tube (1.5 mL) and stirring for about several seconds is shown in FIG. 10.

[0153] FIG. 10 shows an example in which the antigen 31 with the spike protein of the virus 30 is bound to the antibody 41 of the marker-conjugated specific antibody 40 according to the present embodiment. It can be seen from FIG. 10 that a plurality of sample As are bound to one sample B. In the example of FIG. 10, the number of conjugations of sample A close to sample B was 19.

[0154] Figure 11 shows a first example for comparison. Figure 11 shows an electron microscope image of sample A' and sample B mixed in a micro test tube (1.5 mL) and stirred for a few seconds. Here, sample A' is a sample in which a control protein (antigen) unrelated to the spike protein is bound to gold beads. In Figure 11, it can be seen that almost no sample A' is bound to one sample B.

[0155] Figure 12 shows a second example for comparison. Figure 12 shows an electron microscope image of sample A and sample B' mixed in a micro test tube (1.5 mL) and stirred for a few seconds. Here, sample B' is a sample bound to a specific monoclonal antibody against a protein unrelated to the spike protein. In Figure 12, it can be seen that no sample A is bound to one sample B'.

[0156] Figure 13 shows a third example for comparison. Figure 13 shows an electron microscope image of sample A' and sample B' mixed in a micro test tube (1.5 mL) and stirred for about a few seconds. In Figure 13, it can be seen that almost no sample A' is bound to one sample B'. By comparing Figures 10 to 13, it can be seen that the spike protein-attached antigen 31 of the virus 30 binds to the antibody 41 of the marker-attached specific antibody 40.

[0157] FIG. 14 shows an example of the formation of a conjugate 50 according to this embodiment in an optical microscope image at approximately 4000 times magnification. FIG. 14(A) shows an optical microscope image after mixing sample A' and sample B described in FIG. 11. FIG. 14(B) shows an optical microscope image after mixing sample A and sample B described in FIG. 10. Note that sample B (specific antibody with marker 40) was a mixture of a specific antibody with marker 40 containing red pigment beads and a specific antibody with marker 40 containing blue pigment beads. Note that because the reagent is liquid, the thickness is large and the focus is blurred, and there are some places where the particle size of sample B appears large due to aberration.

[0158] In Fig. 14(A), small diameter particles are scattered, and it can be seen that a conjugate 50 is not formed. In Fig. 14(B), particles with diameters exceeding 5 μm are observed, and it can be seen that a conjugate 50 is formed. It can also be seen that individual red and blue pigment beads are scattered in Fig. 14(A), and that the red and blue pigment beads are bound via gold beads with spike proteins in Fig. 14(B). As described above, it was found that a conjugate 50 can be formed by mixing a pseudovirus 30 and a marker-attached specific antibody 40.

[0159] Although the present invention has been described above using the embodiments, the technical scope of the present invention is not limited to the scope described in the above embodiments, and various modifications and changes are possible within the scope of the gist of the present invention. For example, all or part of the device can be configured by distributing or integrating functionally or physically in any unit. In addition, new embodiments resulting from any combination of multiple embodiments are also included in the embodiments of the present invention. The effect of the new embodiment resulting from the combination combines the effect of the original embodiment. [Explanation of symbols]

[0160] 10 Subjects 20 Test Bars 21 Adhesion Surface 22 Attachment Area 23 Groove 24 Observation Area 25 Water retention agent 26 Filters 30 Virus 31 Antigens with spike proteins 40 Marker-specific antibodies 41 Antibodies 42 Marker 50 Conjugate 100 Inspection Equipment 110 Insertion port 120 Attachment 130 Vibration section 140 Light source section 150 Magnetic field application unit 160 Detection unit 162 Fixed part 170 Storage section 180 Control Unit 181 Judgment Department 182 Display control section 190 Display section

Claims

1. mixing the subject's saliva with a reagent containing a specific antibody with a marker on one side of the test stick; irradiating a mixture of the saliva and the reagent with a first light having a predetermined wavelength; A step of detecting the intensity of a second light generated by irradiating the first light onto a complex in which the marker-attached specific antibody is multiply bound to a virus having a spike protein-attached antigen; determining whether the virus is present in the saliva of the subject based on the detected light intensity; having The reagent contains, as the specific antibody with a marker, at least one of a specific antibody with a fluorescent marker and a specific antibody with a dye marker; the specific antibody with a fluorescent marker is bound to an antibody for binding to the spike protein antigen of the virus and a fluorescent substance that generates fluorescence when irradiated with the first light, The dye-marker-attached specific antibody is attached to the antibody for binding to the spike protein-attached antigen of the virus and a dye that reflects or absorbs the first light. Testing method.

2. the reagent includes a specific antibody having a first dye marker, in which the antibody is bound to a first dye of a first color, and a specific antibody having a second dye marker, in which the antibody is bound to a second dye of a second color different from the first color, In the determining step, it is determined that the virus is contained in the saliva of the subject in response to the second light generated from one of the conjugates containing the first color light and the second color light. The inspection method according to claim 1 .

3. In the step of detecting the intensity of the second light, an image of the second light is captured; In the determining step, it is determined that the virus is contained in the saliva of the subject in accordance with the fact that pixels of the first color and pixels of the second color are included among pixels of an imaging region in which the binding body is imaged from the captured image. The inspection method according to claim 2.

4. The method further includes a step of spraying a buffer solution or water onto the mixture of the saliva and the reagent, The inspection method according to claim 1 , wherein in the step of irradiating with the first light, the mixed liquid into which the buffer solution or water has been sprayed is irradiated with the first light.

5. The method further includes applying a magnetic field to at least a portion of the mixture after the step of irradiating with the first light so that the binding body moves to a predetermined region, The step of detecting the intensity of the second light includes detecting an intensity of the second light generated from the predetermined region by irradiation of the first light, The reagent further includes, as the marker-attached specific antibody, a specific antibody with a magnetic marker in which the antibody for binding to the spike protein-attached antigen of the virus is bound to a magnetic body. The inspection method according to any one of claims 1 to 4.

6. a groove having a predetermined shape is provided in a region where the saliva and the reagent are mixed on the one surface of the test stick; In the step of applying a magnetic field, the magnetic field is applied so that the binding body moves along a longitudinal direction of the groove of the test bar, thereby moving the binding body to the predetermined region of the groove. The inspection method according to claim 5.

7. After the first light is irradiated onto the predetermined region in the step of irradiating the first light, the combined body is moved in the step of applying the magnetic field, and an intensity of the second light received from the combined body moving in the predetermined region is detected in a step of detecting an intensity of the second light. The inspection method according to claim 6.

8. 8. The testing method according to claim 1, wherein in the mixing step, the reagent containing the specific antibody with the marker is sprayed onto the saliva that the subject has applied to the test stick.

9. 8. The testing method according to claim 1, wherein in the mixing step, the reagent containing the marker-attached specific antibody is dropped onto the saliva that the subject has attached to the test stick.

10. 10. The testing method according to claim 8, wherein in the mixing step, the reagent corresponding to the type of the marker-bearing specific antibody among a plurality of reagents different for each type of the marker-bearing specific antibody is sprayed or dropped.

11. 11. The testing method according to claim 1, wherein the mixing step includes a step in which the subject deposits the saliva of the subject onto one side of the test stick to which the reagent containing the marker-attached specific antibody has already been attached.

12. 12. The method of claim 1, further comprising the step of vibrating the test bar after the mixing step.

13. the test stick has a material that is transparent to the first light and the fluorescent light; In the step of irradiating the test stick with the first light, the test stick is irradiated with the first light from a surface opposite to a surface to which the subject has attached the saliva. The inspection method according to any one of claims 1 to 12.

14. an insertion port for a subject to insert a test stick with saliva on one side; an attachment section that attaches a reagent containing a specific antibody with a marker to the area of ​​the test stick inserted into the insertion port to which the saliva is attached, and mixes the saliva with the reagent; a light source unit that irradiates a first light onto a mixed liquid obtained by mixing the saliva and the reagent; a detection unit for detecting a second light generated by irradiating the first light to a complex formed by multiple binding of the marker-attached specific antibody to a virus having a spike protein-attached antigen; a determination unit that determines whether or not the virus is contained in the saliva of the subject based on the detected light intensity; Equipped with The reagent contains, as the specific antibody with a marker, at least one of a specific antibody with a fluorescent marker and a specific antibody with a dye marker; the specific antibody with a fluorescent marker is bound to an antibody for binding to the spike protein antigen of the virus and a fluorescent substance that generates fluorescence when irradiated with the first light, The dye-marker-attached specific antibody is attached to the antibody for binding to the spike protein-attached antigen of the virus and a dye that reflects or absorbs the first light. Inspection equipment.

15. the reagent includes a specific antibody having a first dye marker, in which the antibody is bound to a first dye of a first color, and a specific antibody having a second dye marker, in which the antibody is bound to a second dye of a second color different from the first color, the determination unit determines that the virus is contained in the saliva of the subject in response to the second light generated from one of the conjugates containing the first color light and the second color light.

15. The inspection apparatus according to claim 14.

16. the detection unit has an imaging unit that images the second light, the determination unit determines that the virus is contained in the saliva of the subject in response to a fact that a pixel of the first color and a pixel of the second color are included among pixels of an imaging region in which the binding body is imaged from the image captured by the imaging unit.

16. The inspection apparatus according to claim 15.

17. The testing device according to claim 14 , further comprising a sprayer that sprays a buffer solution or water into the mixture of the saliva and the reagent.

18. a magnetic field applying unit configured to apply a magnetic field to at least a portion of the mixture so that the binding body moves to a predetermined region; The detection unit detects an intensity of the second light generated from the predetermined region by irradiation with the first light, The reagent further includes, as the marker-attached specific antibody, a specific antibody with a magnetic marker in which the antibody for binding to the spike protein-attached antigen of the virus is bound to a magnetic body.

18. An inspection device according to any one of claims 14 to 17.

19. a groove having a predetermined shape is provided in the area where the subject applies the saliva to the test stick; The magnetic field application unit applies the magnetic field so that the combined body moves along the longitudinal direction of the groove of the test bar, thereby moving the combined body to the predetermined region in the groove.

20. The inspection apparatus of claim 18.

20. 20. The inspection device of claim 19, wherein the groove in the test bar narrows toward an end of the groove in the longitudinal direction.

21. 21. The inspection device according to claim 19, wherein the end of the groove provided in the test bar has a V-shape or U-shape that protrudes more in a plan view as it approaches the end in the longitudinal direction of the groove.

22. 22. The testing device according to claim 14, wherein the attachment section has a sprayer that sprays the reagent containing the marker-attached specific antibody onto the saliva that the subject has attached to the test stick.

23. the attachment unit has a plurality of sprayers for spraying the reagents corresponding to the types of the marker-attached specific antibodies, Each of the multiple sprayers sprays the reagent onto the saliva attached to the test stick.

23. An inspection device according to any one of claims 14 to 22.

24. 23. The testing device according to claim 14, wherein the attachment section has a dripping section for dripping the reagent containing the marker-attached specific antibody onto the saliva attached to the test stick.

25. A plurality of the insertion openings arranged in one direction; a moving unit that sequentially moves the attachment unit, the light source unit, and the detection unit to a plurality of positions corresponding to the plurality of insertion openings in the one direction; a control unit that controls the attachment unit, the light source unit, the detection unit, and the movement unit, and causes the movement unit to move the attachment unit to positions corresponding to each of the insertion openings, and then causes the attachment unit to attach the reagent, and causes the movement unit to move the light source unit and the detection unit to positions corresponding to each of the insertion openings, and then causes the light source unit to irradiate the first light, and causes the detection unit to detect an intensity of the second light; Further comprising: the determination unit sequentially determines whether or not the virus is contained in the saliva of the plurality of subjects based on detection results of the detection unit moved to a plurality of positions corresponding to the plurality of insertion openings.

25. An inspection device according to any one of claims 14 to 24.

26. 26. The testing device according to claim 14, further comprising a vibration unit that vibrates the test stick to mix the saliva and the reagent.

27. The test bar has a material that is transparent to the first light and the second light, The light source unit irradiates the first light from a surface of the test stick opposite to a surface on which the subject has applied the saliva.

27. An inspection device according to any one of claims 14 to 26.

Images