Sample testing equipment

Abstract

To improve inspection efficiency.SOLUTION: A specimen inspection device according to an embodiment performs inspection by using an inspection cartridge storing a sample, and the specimen inspection device comprises a housing, a holding unit, an opening, and a temperature adjustment unit. The holding unit holds the inspection cartridge. The opening is provided in the housing, and a sample container is inserted into the opening. The temperature adjustment unit adjusts the temperature of a sample in the sample container inserted into the opening.SELECTED DRAWING: Figure 4A

Description

[Technical Field]

[0001] An embodiment of the present invention relates to a sample testing device. [Background technology]

[0002] A known specimen testing device analyzes a target substance contained in a specimen collected from a subject by utilizing an antigen-antibody reaction. Such a specimen testing device includes, for example, magnetic particles having an antibody immobilized thereon that specifically binds to the target substance (antigen), an optical waveguide having an antibody immobilized thereon that specifically binds to the target substance, and a magnetic field application unit that generates a magnetic field. The target substance is bound to the surface of the optical waveguide by the antigen-antibody reaction, and measurement is performed based on the amount of light received through the optical waveguide after the target substance has bound.

[0003] FIG. 10 is a diagram illustrating an example of a specimen testing apparatus. As shown in FIG. 10, the specimen testing apparatus 20 includes an optical waveguide sensor chip 200, a light source 210, a light receiving element 211, a first magnetic field application unit 220, a second magnetic field application unit 221, and a control circuit 230. A first antibody 201 is immobilized on a portion of the surface of the optical waveguide sensor chip 200. A sample 203 to be measured is a liquid containing an antigen 204 contained in a specimen collected from a subject and magnetic microparticles 206 to which a second antibody 205 is immobilized, and is dropped from a sample dropping port 207. The optical waveguide sensor chip 200 is fixed and held in a test cartridge 208.

[0004] In the sample 203, the antigen 204 undergoes an antigen-antibody reaction with the second antibody 205. Then, in order to cause an antigen-antibody reaction between the antigen 204 and the first antibody 201, the control circuit 230 causes the second magnetic field application unit 221 to apply a magnetic field, generating a magnetic force in the direction of the second magnetic field application unit. This causes the magnetic particles 206, together with the second antibody 205 and the antigen 204, to be attracted to the first antibody 201. As a result, the antigen-antibody reaction between the antigen 204 and the first antibody 201 can be promoted. Note that during the antigen-antibody reaction, the control circuit 230 stops the application of the magnetic field by the second magnetic field application unit 221. Next, in order to separate the magnetic particles 206 that have not undergone the antigen-antibody reaction from the vicinity of the first antibody 201, the control circuit 230 causes the first magnetic field application unit 220 to apply a magnetic field, generating a magnetic force in the direction of the first magnetic field application unit. As a result, only the first antibody 201 and the magnetic microparticles 206 to which the second antibody 205 is bound via the antigen 204 remain in the vicinity of the optical waveguide 209, and the first antibody 201 and the magnetic microparticles 206 to which the second antibody 205 is not bound via the antigen 204 are pulled away from the vicinity of the optical waveguide 209.

[0005] Light emitted from light source 210 propagates through optical waveguide sensor chip 200 and is received by light receiving element 211. Light receiving element 211 measures the amount of light propagated through optical waveguide sensor chip 200. If first antibody 201 and magnetic microparticles 206 to which second antibody 205 is bound via antigen 204 remain near optical waveguide 209, the efficiency of light absorption or scattering increases in evanescent light near first antibody 201 on the optical waveguide, and the amount of light received by light receiving element 211 decreases. The sample testing device uses this characteristic to measure the presence or absence of an antigen-antibody reaction. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Japanese Patent Application Laid-Open No. 2015-118055 [Patent Document 2] Japanese Patent Application Publication No. 2018-9884 Summary of the Invention [Problem to be solved by the invention]

[0007] The problem to be solved by the present invention is to improve inspection efficiency. [Means for solving the problem]

[0008] A sample testing device according to an embodiment performs testing using a test cartridge that contains a sample, and includes a housing, a holding unit, an opening, and a temperature adjustment unit. The holding unit holds the test cartridge. The opening is provided in the housing and allows a sample container to be inserted. The temperature adjustment unit adjusts the temperature of the sample in the sample container inserted into the opening. [Brief explanation of the drawings]

[0009] [Figure 1A] FIG. 1A is a diagram illustrating an example of an opening and a temperature adjusting unit according to the first embodiment. [Figure 1B] FIG. 1B is a diagram illustrating an example of an opening and a temperature adjusting unit according to the first embodiment. [Figure 2] FIG. 2 is a flowchart showing an inspection procedure performed by an inspector according to the first embodiment. [Figure 3] FIG. 3 is a flowchart showing an inspection procedure performed by an inspector according to the first embodiment. [Figure 4A] FIG. 4A is a schematic diagram showing an example of the sample testing apparatus according to the first embodiment. [Figure 4B] FIG. 4B is a schematic diagram showing an example of the sample testing apparatus according to the first embodiment. [Figure 4C] FIG. 4C is a schematic diagram showing an example of the sample testing apparatus according to the first embodiment. [Figure 5] FIG. 5 is a schematic diagram showing an example of the internal configuration of the sample testing apparatus according to the first embodiment. [Figure 6] FIG. 6 is a schematic view showing an example of a holder according to another embodiment. [Figure 7]FIG. 7 is a schematic diagram showing an example of a sample testing apparatus according to another embodiment. [Figure 8] FIG. 8 is a diagram showing an example of an opening and a temperature adjusting section according to another embodiment. [Figure 9] FIG. 9 is a schematic diagram showing an example of the internal configuration of a sample testing apparatus according to another embodiment. [Figure 10] FIG. 10 is a diagram illustrating an example of a specimen testing apparatus. DETAILED DESCRIPTION OF THE INVENTION

[0010] Hereinafter, embodiments of the sample testing device will be described in detail with reference to the accompanying drawings. The sample testing device according to the present application is not limited to the embodiments shown below. The embodiments can be combined with other embodiments or conventional techniques as long as no contradiction occurs. In the following description, similar components will be assigned common reference numerals, and redundant description will be omitted.

[0011] (First embodiment) The specimen testing device according to this embodiment is a specimen testing device that performs testing using a test cartridge that contains a sample, and improves testing efficiency. Specifically, the specimen testing device according to this embodiment adjusts the temperature of the sample to increase the efficiency of the antigen-antibody reaction, thereby improving detection sensitivity and shortening the testing time, thereby improving testing efficiency.

[0012] As described above, the specimen testing device binds a target substance (antigen) to the surface of an optical waveguide through an antigen-antibody reaction using an antibody that specifically binds to the target substance, and performs testing based on the amount of light received through the optical waveguide after the antigen has bound. The reaction efficiency of an antigen-antibody reaction varies depending on temperature. For example, in the case of proteins, the reaction efficiency is said to be high at temperatures between 37°C and 42°C, which are equivalent to body temperature. Therefore, in the present application, temperature is adjusted to promote the antigen-antibody reaction during the testing process.

[0013] Here, the specimen testing device according to this embodiment can adjust the temperature of the antigen-antibody reaction between the antigen and the antibody fixed to the magnetic microparticles, and the antigen-antibody reaction between the antigen and the antibody fixed to the test cartridge (optical waveguide sensor chip). Specifically, the specimen testing device adjusts the temperature of the specimen and the reagent before the antigen-antibody reaction, thereby promoting the antigen-antibody reaction. Furthermore, the specimen testing device adjusts the temperature of the specimen and the reagent during the antigen-antibody reaction, thereby promoting the antigen-antibody reaction. These are described below.

[0014] First, a case where the antigen-antibody reaction is promoted by adjusting the temperature of the sample and reagent before the antigen-antibody reaction will be described. In such a case, the sample testing device according to the first embodiment includes a housing, a holding unit that holds the test cartridge inside the housing, an opening that is provided in the housing and into which a sample container is inserted, and a temperature adjusting unit that adjusts the temperature of the sample in the sample container inserted into the opening.

[0015] The housing is the exterior of the specimen testing device and houses various devices such as a holder that holds a test cartridge. The holder is, for example, a mount, and holds the test cartridge within the housing. The opening is where a sample container that mixes the test target substance (antigen) with a reagent is inserted and holds the inserted reagent container. The temperature adjustment unit adjusts the temperature of the sample (antigen and reagent) in the sample container inserted into the opening.

[0016] 1A and 1B are diagrams illustrating an example of an opening and a temperature adjustment unit according to the first embodiment. For example, the opening according to this embodiment is a holder 2 into which a bottle 1 containing a sample is inserted. The sample to be dropped into the sample drop port of the test cartridge is contained in the bottle 1. When performing a test using a sample testing device, an examiner first collects a sample from a subject and prepares the sample by mixing the collected sample with a reagent. For example, the examiner places the sample collected from the subject in a bottle 1 containing a test reagent and stirs it to mix the sample with the reagent. For example, when measuring influenza virus, the membrane protein of the influenza virus is broken down using a reagent such as a surfactant, and the nucleoprotein is eluted into the reagent. In this case, the antigen described above corresponds to this nucleoprotein.

[0017] 1A, in the sample testing apparatus according to this embodiment, a first temperature adjustment unit 3 is provided inside the holder 2, and adjusts the temperature of the sample and reagent inside the bottle 1 when the bottle 1 is stored in the holder 2. For example, an examiner places a sample collected from a subject into the bottle 1 containing the reagent to mix the sample and reagent, and then stores the bottle 1 in the holder 2.

[0018] Here, the bottle 1 is inserted into the holder 2 so that the drop opening of the bottle 1, which allows the sample to be dropped from the bottle 1 into the test cartridge, faces upward. For example, as shown in Fig. 1A, the holder 2 is inserted so that the tip of the nozzle of the bottle 1 faces upward. This prevents the sample from spilling from the dropping nozzle.

[0019] The first temperature adjustment unit 3 changes the temperature depending on the type of sample. Specifically, the first temperature adjustment unit 3 adjusts the temperature to a set temperature depending on the type of antigen. For example, if the antigen is a protein, the first temperature adjustment unit 3 adjusts the temperature of the sample to 45°C or less. The first temperature adjustment unit 3 also adjusts the output so that the temperature becomes the set temperature. For example, the first temperature adjustment unit 3 has a temperature sensor and adjusts the output so that the temperature acquired by the temperature sensor becomes the set temperature.

[0020] The first temperature adjustment unit 3 can be realized by resistance heating (Joule heat) or induction heating (electromagnetic induction) in which the bottle 1 and the first temperature adjustment unit 3 are in contact or close proximity, or by dielectric heating or infrared heating in which the bottle 1 and the first temperature adjustment unit 3 are not in contact. For example, in the case of resistance heating, the first temperature adjustment unit 3 is formed of a conductor, and heat is generated when a current flows through the resistance of this conductor, warming the specimen and reagent via the bottle 1.

[0021] In the case of induction heating, the bottle 1 is made of a metal such as steel, stainless steel, or copper, a carbon material, or a material containing any of these. The first temperature adjustment unit 3 has a coil, and by passing an alternating current through this coil, an alternating magnetic field is generated in the material of the bottle 1, generating eddy currents that heat the specimen and reagent.

[0022] Furthermore, for example, dielectric heating refers to so-called microwaves. The first temperature adjustment unit 3 applies a high-frequency voltage to simultaneously align the molecular orientations of the specimen and reagent, then changes the direction of the voltage to invert the molecular dipoles, bringing the molecules into contact with each other and generating frictional heat to heat the specimen and reagent.

[0023] Furthermore, for example, infrared heating is performed using a halogen heater or a carbon heater, and the first temperature control unit 3 irradiates the specimen and reagent with infrared rays, causing the molecules to vibrate with the infrared energy, thereby converting the irradiated infrared rays into thermal energy and warming the specimen and reagent.

[0024] The above-mentioned example is merely an example, and the first temperature adjustment unit 3 is not limited to the above-mentioned example. For example, in addition to the above-mentioned example, the first temperature adjustment unit 3 can also heat the specimen and reagent by utilizing the thermoelectric effect of a Peltier element or the like.

[0025] As described above, the first temperature adjustment unit 3 can adjust the temperature of the sample, including the specimen and reagent, by resistance heating, induction heating, dielectric heating, infrared heating, thermoelectric effect, or the like. Here, when resistance heating, induction heating, dielectric heating, or thermoelectric effect is used, which brings the bottle 1 and the first temperature adjustment unit 3 into contact or close proximity, the first temperature adjustment unit 3 can adjust the temperature of the specimen and reagent in a short time. Furthermore, when dielectric heating or infrared heating, which brings the bottle 1 and the first temperature adjustment unit 3 into non-contact, is used, a sufficient gap can be provided between the bottle 1 and the first temperature adjustment unit 3, allowing for application even if the shape or size of the bottle 1 changes. For example, this is suitable when the shape or size of the bottle 1 varies depending on the measurement target. The first temperature adjustment unit may adjust the temperature of the sample directly, or may adjust the temperature of the container (bottle 1) as a result. Adjusting the temperature of the container may be considered adjusting the temperature of the sample.

[0026] As shown in Fig. 1A, the first temperature adjustment unit 3 can be configured to adjust the temperature regardless of whether the bottle 1 is stored in the holder 2 or not, but can also be configured to adjust the temperature when the bottle 1 is stored in the holder 2. In such a case, the specimen testing device further includes a detection unit that detects the insertion of the sample container into the opening, and a control unit that controls the temperature adjustment by the temperature adjustment unit based on the detection result by the detection unit. For example, as shown in Fig. 1B, the holder 2 is provided with a bottle detection unit 4, which is an example of a detection unit, and a temperature control circuit 5, which is an example of a control unit.

[0027] The bottle detection unit 4 detects that the bottle 1 has been stored in the holder 2 and outputs a detection signal to the temperature control circuit 5. Specifically, the bottle detection unit 4 outputs the detection signal to the temperature control circuit 5 while the bottle 1 is stored in the holder 2. Here, the bottle detection unit 4 can be realized using a mechanical limit sensor, an optical sensor, or the like. However, the type of sensor is not limited to these, as long as it can detect the storage of the bottle 1.

[0028] The temperature control circuit 5 controls the first temperature adjustment unit 3 in accordance with the output of the bottle detection unit 4. Specifically, when the temperature control circuit 5 receives a detection signal from the bottle detection unit 4 indicating that the bottle 1 has been stored in the holder 2, it causes the first temperature adjustment unit 3 to start temperature adjustment. Furthermore, while the temperature control circuit 5 is receiving an output from the bottle detection unit 4, it causes the first temperature adjustment unit 3 to continue temperature adjustment. Then, when the temperature control circuit 5 no longer receives a detection signal from the bottle detection unit 4, it causes the first temperature adjustment unit 3 to stop temperature adjustment.

[0029] In this way, by controlling the temperature to be adjusted only when the bottle 1 is stored in the holder 2, the first temperature adjustment unit 3 can be turned off when the bottle 1 is not stored in the holder 2, thereby reducing power consumption. This is particularly effective when the first temperature adjustment unit 3 uses induction heating or dielectric heating. On the other hand, by always adjusting the temperature with the first temperature adjustment unit turned on as shown in Figure 1A, it is possible to omit complex control, which is particularly effective when using resistance heating or infrared heating.

[0030] 1A and 1B is provided in a housing. Specifically, the holder 2 is provided on the top surface of the housing or inside the housing. This point will be described in detail later.

[0031] Next, the details of the procedure to be followed by the examiner when adjusting the temperature will be described with reference to Figs. 2 and 3. Figs. 2 and 3 are flowcharts showing the examination procedure to be performed by the examiner according to the first embodiment. As shown in Fig. 2, the examiner first removes the bottle 1 and the examination cartridge from the bag (step S21), and collects a specimen from the subject (step S22). For example, the examiner collects a nasal swab or the like using a cotton swab.

[0032] The examiner then places the collected specimen into bottle 1 and mixes it with the reagent in bottle 1 (step S23), and attaches a nozzle-equipped cap to bottle 1 (step S24). After that, the examiner stores bottle 1 with the nozzle-equipped cap in holder 2 (step S25). The specimen testing device according to this embodiment is equipped with the above-mentioned first temperature adjustment unit 3 in holder 2, and adjusts the temperature of the sample according to the type of antigen placed in bottle 1.

[0033] Here, the time for which the bottle 1 is stored in the holder 2 can be set in advance. For example, the time for which the bottle 1 is stored in the holder 2 is set based on the time it takes for the sample to reach the target temperature.

[0034] Meanwhile, the tester attaches the test cartridge removed from the bag in step S21 to a holder (mount) inside the housing (step S26). Then, the tester drops the sample whose temperature has been adjusted in step S25 into the test cartridge (step S27) and discards the bottle 1. The magnetic microparticles and the antibodies fixed thereto in the sample to be dropped into the test cartridge may be previously enclosed in a cap attached to the bottle 1, or may be contained in the reagent.

[0035] The tester then operates the specimen testing device to measure the antigen-antibody reaction in the test cartridge using the optical waveguide sensor chip, and determines whether the target substance is present, i.e., whether it is positive or negative, and outputs the result (step S28). After completing the measurement, the tester collects and discards the test cartridge (step S29), thereby completing the test.

[0036] In addition, one method of operating the specimen testing device of this embodiment is to first store bottle 1 in holder 2 and adjust the temperature, then place the specimen collected from the subject into bottle 1 containing the reagent, mix the specimen and the reagent, and attach a drip nozzle to drip the sample into the testing cartridge.

[0037] In such a case, as shown in Fig. 3, the examiner first removes the bottle 1 and the test cartridge from the bag (step S31), and stores the bottle 1 in the holder 2 (step S32). Here, the first temperature adjusting unit 3 arranged in the holder 2 adjusts the temperature of the reagent in the bottle 1.

[0038] The examiner then collects a specimen such as a nasal swab from the subject (step S33), places the collected specimen in bottle 1, and mixes it with the reagent in bottle 1 (step S34). After that, the examiner attaches a nozzle-equipped cap to bottle 1 (step S35). Note that steps S36 to S39 in FIG. 3 are the same procedures as steps S26 to S29 in FIG. 2, and detailed description thereof will be omitted.

[0039] As described above, by using the specimen testing apparatus according to this embodiment, the specimen and reagent can be warmed in step S25. Alternatively, the reagent can be warmed in step S32. As a result, the antigen-antibody reaction in step S28 or step S38 can be promoted, improving the detection sensitivity of the specimen testing apparatus and shortening the testing time. Furthermore, since the reagent temperature during testing can be kept constant regardless of the storage temperature of the testing reagent (for example, about 5°C in a refrigerator, or about 20°C at room temperature), accurate test results can be obtained stably.

[0040] Furthermore, in the past, after step S24, step S26 was sometimes performed while holding bottle 1 in one hand, but by adding step S25 (or step S32), it is possible to store bottle 1 in a stable holder 2, improving ease of use for the examiner. Furthermore, the risk of spilling the sample and reagent is reduced, and the need to redo the step S22 (recollection of the sample) can be reduced.

[0041] As described above, the sample testing apparatus according to this embodiment includes a holder 2 provided with a first temperature adjustment unit 3 that adjusts the temperature of the sample in the bottle 1. This holder 2 can be provided in a part of the housing that is directly accessible from the outside of the sample testing apparatus. Figures 4A to 4C are schematic diagrams showing an example of a sample testing apparatus 10 according to the first embodiment.

[0042] As shown in FIG. 4A, the sample testing apparatus 10 includes a housing 10a, an input interface 10b, and a display unit 10c. For example, as shown in FIG. 4A, the sample testing apparatus 10 includes a holder 2 with a first temperature control unit 3 provided on the top surface of the housing 10a. This allows sample bottles to be warmed before testing in a location that is easily accessible from the outside, and reduces the degree to which the sample temperature drops before testing begins. Furthermore, because the bottle 1 of the next subject to be tested is placed in the housing 10a, the risk of mistaking the bottle 1 containing the sample collected from the subject for that of another subject is reduced. Furthermore, as shown in FIG. 4A, by providing a label on the bottle 1 and writing the subject's name or a number associated with the subject on the label, the risk of mistaking the bottle 1 can be further reduced.

[0043] Moreover, holder 2 is stored in housing 10a so that the tip of the nozzle, which is the sample dropping port of bottle 1, faces upward, thereby preventing the sample from spilling. Furthermore, holder 2 can also be provided so as to be detachable from housing 10a. In this way, even if a specimen or the like is spilled inside holder 2, holder 2 can be removed from housing 10a and washed with water, and the recessed opening of holder 2 can be kept hygienic.

[0044] The input interface 10b accepts operations such as sample selection, numerical input, and mode switching. For example, the input interface 10b accepts input of a set temperature. The input interface 10b can be realized by a switch, a button, a touchpad that performs input operations by touching the operation surface, a touch monitor that integrates a display screen and a touchpad, a non-contact input circuit using an optical sensor, and a voice input circuit. The input interface 10b is connected to a control circuit (not shown), and converts input operations received from an operator into electrical signals and outputs them to the control circuit.

[0045] The display unit 10c displays a GUI (Graphical User Interface) that allows the tester to input various setting requests using the input interface 10b, and also displays display information on the sample testing apparatus 10. The display unit 10c also displays various messages and display information to notify the operator of the processing status and processing results of the sample testing apparatus 10. The display unit 10c also has a speaker and can output audio. The display unit 10c is an example of a notification unit.

[0046] For example, the display unit 10c notifies information indicating that the sample can be dropped from the bottle 1 into the test cartridge. As one example, the display unit 10c displays the temperature adjustment time by the first temperature adjustment unit 3. In such a case, a control circuit (not shown) that controls the display by the display unit 10c receives a detection signal from the bottle detection unit 4 indicating that the bottle 1 has been stored in the holder 2. Then, the control circuit causes the display unit 10c to display the elapsed time since receiving the detection signal, or a countdown timer for a predetermined time triggered by the reception of the detection signal. This allows the tester to determine whether the temperature of the sample has been sufficiently adjusted, thereby more reliably promoting the antigen-antibody reaction.

[0047] The display unit 10c can acquire the temperature of the sample bottle and display the acquired temperature, in addition to or instead of displaying the temperature adjustment time. In such a case, a control circuit that controls the display by the display unit 10c acquires temperature information acquired by a temperature sensor included in the first temperature adjustment unit 3. Then, the control circuit displays the acquired temperature information on the display unit 10c.

[0048] Here, the sample testing apparatus 10 has a loading unit as a movable unit for attaching, detaching, and replacing test cartridges. Specifically, the sample testing apparatus 10 includes a loading unit for placing a test cartridge at a measurement position near a light source, a light-receiving element, and the like provided inside the housing. For example, the loading unit is tray 10d shown in FIG. 4B. Tray 10d includes a mount for holding a test cartridge, and is inserted into or removed from housing 10a in response to an operator's operation. For example, after a predetermined time has elapsed since storing bottle 1 in holder 2, the operator pulls out tray 10d as shown in the right diagram of FIG. 4B, drips a sample into the drip port of the test cartridge held by the mount, and then stores tray 10d in housing 10a.

[0049] For example, in the case of a specimen testing device 10 having a loading section as shown in Figure 4B, by providing the holder 2 on the top surface of the housing 10a, the holder 2 can maintain a fixed position even when the loading section moves, thereby reducing sample leakage that occurs when the loading section moves and maintaining the hygiene of the housing 10a.

[0050] In the above example, the holder 2 is provided on the upper surface of the housing 10a. However, the embodiment is not limited to this, and the holder 2 may be provided inside the housing 10a. For example, when the sample testing apparatus 10 is configured to include an upper housing 10e and a lower housing 10f as shown in FIG. 4C, the holder 2 is provided inside the housing.

[0051] The sample testing apparatus 10 shown in Figure 4C is configured so that the upper housing 10e moves relative to the lower housing 10f. In such a case, for example, a mount is provided on the lower housing 10f, and the tester slides the upper housing 10e relative to the lower housing 10f to expose the mount provided on the lower housing 10f and attaches a test cartridge to the exposed mount. That is, the loading section in Figure 4C is the upper housing 10e and the lower housing 10f, and by changing the position of the upper housing 10e relative to the lower housing 10f, the test cartridge can be placed at the measurement position.

[0052] In the case of such a sample testing apparatus 10, the holder 2 is provided on the upper surface of the lower housing 10f, for example, as shown in FIG. 4C . That is, the holder 2 is exposed by sliding the upper housing 10e relative to the lower housing 10f. The operator slides the upper housing 10e relative to the lower housing 10f to expose the mount and holder 2, attaches the test cartridge to the mount, and stores the bottle 1 in the holder 2. Then, after a predetermined time has passed since storing the bottle 1 in the holder 2, the tester drips a sample into the drip port of the test cartridge held by the mount, slides the upper housing 10e in the opposite direction relative to the lower housing 10f, and starts measurement. In this way, by providing the holder 2 on the lower housing 10f, the possibility of the sample contained in the bottle 1 spilling can be reduced.

[0053] Next, a case where the antigen-antibody reaction is promoted by adjusting the temperature of the sample and reagent during the antigen-antibody reaction will be described. In such a case, the sample testing device according to the first embodiment includes, in addition to the first temperature adjustment unit 3, a second temperature adjustment unit that adjusts the temperature of the sample in the test cartridge held by the mount.

[0054] Figure 5 is a schematic diagram showing an example of the internal configuration of the sample testing apparatus 10 according to the first embodiment. As shown in Figure 5, the sample testing apparatus 10 includes a light source 110, a light receiving element 111, a first magnetic field application unit 120, a second magnetic field application unit 121, a control circuit 130, a mount 140 having a holder 140a, and a second temperature adjustment unit 150. The sample testing apparatus 10 performs testing on a test cartridge 108 held by the mount 140.

[0055] The test cartridge 108 is provided with a reaction chamber for accommodating a sample, and the sample, whose temperature has been adjusted in a bottle 1 housed in a holder 2, is dropped from a sample dropping port. The optical waveguide sensor is fixedly held in the test cartridge 108.

[0056] The light source 110 emits light toward the test cartridge 108. The light source 110 is, for example, a light emitting diode (LED) or a laser diode (LD). The light receiving element 111 receives the light from the test cartridge 108 and measures the light intensity. The light receiving element 111 is, for example, a photodiode.

[0057] The first magnetic field application unit 120 generates a magnetic field and applies the generated magnetic field to a sensing area in the test cartridge 108, thereby changing the positions of the magnetic particles in the sensing area. For example, the first magnetic field application unit 120 applies a magnetic field to the test cartridge 108, thereby moving the magnetic particles in a direction toward the first magnetic field application unit 120 (first direction).

[0058] The second magnetic field application unit 121 generates a magnetic field and applies the generated magnetic field to a sensing area in the test cartridge 108, thereby changing the positions of the magnetic particles in the sensing area. For example, the second magnetic field application unit 121 applies a magnetic field to the test cartridge 108, thereby moving the magnetic particles in a direction toward the second magnetic field application unit 121 (second direction).

[0059] The mount 140 is disposed between the first magnetic field application unit 120 and the second magnetic field application unit 121, and holds the test cartridge 108. Specifically, the mount 140 has a holder 140a for fixedly holding the test cartridge, and holds the test cartridge 108 attached to the holder 140a.

[0060] The control circuit 130 controls the timing of generating a magnetic field and the timing of stopping generation of the magnetic field in each of the first magnetic field application unit 120 and the second magnetic field application unit 121. Specifically, the control circuit 130 controls the start and stop of application of a magnetic field by the first magnetic field application unit 120 and the second magnetic field application unit 121 by controlling the current flowing through the coil (not shown) of each magnetic field application unit while the test cartridge 108 is attached to the mount 140. The control circuit 130 also performs control in response to various requests received by the input interface 10b.

[0061] The second temperature adjustment unit 150 adjusts the temperature of the sample dropped into the test cartridge 108. For example, as shown in FIG. 5, the second temperature adjustment unit 150 is mounted on a mount 140. Here, like the first temperature adjustment unit 3, the second temperature adjustment unit 150 can be realized by at least one of resistance heating, induction heating, dielectric heating, infrared heating, and thermoelectric effect. The second temperature adjustment unit 150 can also adjust the output so that the temperature becomes a set temperature. For example, the second temperature adjustment unit 150 has a temperature sensor and adjusts the output so that the temperature acquired by the temperature sensor becomes the set temperature. The second temperature adjustment unit may adjust the temperature of the sample directly, or may adjust the temperature of the container (test cartridge 108) to thereby adjust the temperature of the sample. Adjusting the temperature of the container may be considered as adjusting the temperature of the sample.

[0062] Although not shown, a test cartridge detection unit may be provided on the mount 140, and the temperature adjustment of the second temperature adjustment unit 150 may be turned on and off in response to a detection signal from the test cartridge detection unit. In such a case, the test cartridge detection unit detects that the test cartridge 108 has been mounted on the mount 140, and outputs a detection signal to the temperature control circuit 5. The temperature control circuit 5 controls the on and off of the second temperature adjustment unit 150 in response to the reception of a detection signal from the test cartridge detection unit, similar to the control over the first temperature adjustment unit 3.

[0063] As a result, the sample, whose temperature has been adjusted in the bottle before being dropped into the test cartridge 108, can be maintained at a predetermined temperature, such as approximately 40°C, inside the test cartridge 108 by the second temperature adjustment unit 150. In other words, the predetermined temperature can be maintained even in the step S28 in the flow diagram of FIG. 2, further promoting the antigen-antibody reaction. Furthermore, the second temperature adjustment unit 150 only needs to maintain the sample dropped into the test cartridge 108 at a roughly constant temperature, and does not necessarily need to measure the sample temperature. Therefore, the sample temperature can be adjusted with simpler control. Furthermore, since the temperature of the second temperature adjustment unit 150 can be set to approximately 40°C, safety for the user is also improved.

[0064] The following describes an example of measurement using the specimen testing apparatus 10. In the specimen testing apparatus 10, a specimen collected from a subject and a sample containing magnetic microparticles are dropped into a reaction chamber from a sample dropping port of the test cartridge 108. Here, in the sample, antigens contained in the specimen and antibodies immobilized on the magnetic microparticles bind to each other through an antigen-antibody reaction.

[0065] Then, the control circuit 130 controls the second magnetic field application unit 121 to apply a magnetic field to the test cartridge 108. This causes the magnetic particles to move toward the optical waveguide sensor. That is, the antigen that has bound to the antibody fixed to the magnetic particles through an antigen-antibody reaction is moved toward the optical waveguide sensor, thereby promoting the antigen-antibody reaction between the antigen and the antibody fixed to the optical waveguide sensor. Note that during the antigen-antibody reaction between the antigen and the antibody fixed to the optical waveguide sensor, the control circuit 130 stops the application of the magnetic field by the second magnetic field application unit 121.

[0066] In the sample testing apparatus 10 according to this embodiment, the temperature of the sample in the bottle 1 is adjusted by the first temperature adjustment unit 3, so that the temperature of the sample dropped into the test cartridge 108 is at an appropriate temperature, thereby facilitating the antigen-antibody reaction described above. Furthermore, in the sample testing apparatus 10 according to this embodiment, the temperature of the sample in the test cartridge 108 can be adjusted by the second temperature adjustment unit 150, so that the antigen-antibody reaction described above can be further promoted. As a result, the sample testing apparatus 10 can also shorten the testing time.

[0067] Then, once the antigen-antibody reaction has taken place, the control circuit 130 controls the first magnetic field application unit 120 to apply a magnetic field to the test cartridge 108. This allows magnetic particles that have not bound to the sensor because an antigen-antibody reaction could not occur between the antibody and antigen fixed to the optical waveguide sensor to be removed from the vicinity of the optical waveguide sensor, thereby improving the test accuracy. Note that the magnetic field applied from the first magnetic field application unit 120 is controlled to an intensity that does not separate the magnetic particles that have bound to the antibody fixed to the optical waveguide sensor through the antigen-antibody reaction.

[0068] Thereafter, the light source 110 emits light toward the test cartridge 108. The light emitted from the light source 110 propagates while reflecting inside the optical waveguide sensor. Here, near-field light such as evanescent light is generated in the optical waveguide sensor by the light propagating while reflecting inside the optical waveguide sensor. Near-field light is light generated at the interface between the optical waveguide sensor and the reaction chamber when light is totally reflected at the interface. The near-field light is absorbed and scattered by magnetic nanoparticles bound to the outermost surface of the optical waveguide sensor by an antigen-antibody reaction. Here, the absorption and scattering efficiency of the near-field light increases depending on the amount of magnetic nanoparticles.

[0069] Therefore, the amount of magnetic nanoparticles in the vicinity of the optical waveguide sensor can be obtained by calculating the rate of decrease in light intensity based on the light intensity measured by the light receiving element 111 and the reference light intensity. Then, the amount and concentration of antigens in the sample can be calculated based on the obtained amount of magnetic nanoparticles.

[0070] Similarly to the first temperature adjustment unit 3, the second temperature adjustment unit 150 can also change the set temperature depending on the type of antigen. For example, if the antigen is a protein, the second temperature adjustment unit 150 adjusts the temperature of the sample to 45°C or less. The input interface 10b, for example, is used to change the set temperatures of the first temperature adjustment unit 3 and the second temperature adjustment unit 150. For example, the examiner inputs the set temperature or selects the sample via the input interface 10b while looking at the display unit 10c. This causes the control circuit 130 to change the set temperature of at least one of the first temperature adjustment unit 3 and the second temperature adjustment unit 150.

[0071] Alternatively, for example, identification information (QR code (registered trademark), characters, etc.) is used to change the set temperatures in the first temperature adjustment unit 3 and the second temperature adjustment unit 150. In such a case, the control circuit 130 acquires the identification information attached to the bottle 1. Then, under the control of the control circuit 130, the first temperature adjustment unit 3 and the second temperature adjustment unit 150 adjust the temperature of the sample in the bottle 1 based on the identification information. For example, identification information such as characters, a label (QR code (registered trademark)), or an RF-ID (radio frequency identifier) ​​is affixed to the bottle 1, and the first temperature adjustment unit 3 and the second temperature adjustment unit 150 adjust the temperature based on this identification information.

[0072] Here, if letters or labels are affixed to bottle 1, they are read by, for example, a camera, and the read identification information is acquired by sample testing apparatus 10. That is, a camera is connected to sample testing apparatus 10, and control circuit 130 acquires the identification information read by the camera and changes the set temperature of at least one of first temperature adjustment unit 3 and second temperature adjustment unit 150 so that the temperature corresponds to the acquired identification information.

[0073] Furthermore, when an RF-ID is attached to the bottle 1, for example, the ID is read by a reader, and the read identification information is acquired by the sample testing apparatus 10. That is, the sample testing apparatus 10 has a reader, and the control circuit 130 acquires the identification information read by the reader and changes the set temperature of at least one of the first temperature adjustment unit 3 and the second temperature adjustment unit 150 so that the temperature corresponds to the acquired identification information.

[0074] Here, the identification information such as characters, labels, RF-ID, etc. includes, for example, information about the test subject (e.g., the target protein, etc.). The control circuit 130 changes the set temperature of at least one of the first temperature adjustment unit 3 and the second temperature adjustment unit 150 according to the test subject included in the acquired identification information. The set temperature is set in advance for each test subject and is stored in the sample testing device 10.

[0075] The position where the identification information is affixed is not limited to the bottle 1. For example, information about the test object is identified and displayed on the test cartridge 108, and the identification is photographed with a camera, and the control circuit 130 changes the set temperature of at least one of the first temperature adjustment unit 3 and the second temperature adjustment unit 150 according to the test object photographed.

[0076] As described above, by changing the set temperature depending on the type of test subject (antigen), it is possible to adjust the temperature to a suitable level to promote the antigen-antibody reaction of the sample, and further improve the detection sensitivity of the sample testing device 10 and shorten the testing time.

[0077] Furthermore, the above-mentioned identification information can include not only information about the test object but also information about the test subject. For example, a label for identifying the test subject is affixed to the bottle 1. In such a case, the control circuit 130 acquires the identification information read by the camera and associates the information about the test subject contained in the acquired identification information with the information about the test results. This enables the sample testing apparatus 10 to prevent sample mix-ups.

[0078] As described above, according to the first embodiment, the mount 140 holds the test cartridge 108 inside the housing. The holder 2 is provided in the housing, and the bottle 1 is inserted into the holder 2. The first temperature adjustment unit adjusts the temperature of the sample in the bottle 1 inserted into the holder 2. Therefore, the sample testing device 10 according to the first embodiment can adjust the temperature of the sample and reagent, promoting antigen-antibody reactions and improving testing efficiency.

[0079] Furthermore, according to the first embodiment, the holder 2 is provided on the upper surface of the housing 10a. Therefore, the sample testing device 10 according to the first embodiment can adjust the temperature near the device without using a separate device for adjusting the temperature, enabling efficient temperature adjustment.

[0080] Furthermore, according to the first embodiment, the holder 2 is provided inside the housing. Therefore, the sample testing device 10 according to the first embodiment can adjust the temperature near the device without using a separate device for adjusting the temperature, enabling efficient temperature adjustment.

[0081] Furthermore, according to the first embodiment, the bottle 1 is inserted into the holder 2 so that the nozzle of the bottle 1, which drips the sample from the bottle 1 into the test cartridge 108, faces upward. Therefore, the sample testing device 10 according to the first embodiment prevents the sample from spilling, reduces the effort required to re-collect the sample, and improves testing efficiency.

[0082] Furthermore, according to the first embodiment, the first temperature adjustment unit 3 and the second temperature adjustment unit 150 change the temperature depending on the type of sample. Therefore, the sample testing apparatus 10 according to the first embodiment makes it possible to carry out an antigen-antibody reaction at an optimal temperature depending on the type of sample.

[0083] Furthermore, according to the first embodiment, the first temperature adjustment unit 3 and the second temperature adjustment unit 150 adjust the temperature of the sample to 45° C. or less. Therefore, the specimen testing apparatus 10 according to the first embodiment enables antigen-antibody reactions to occur at an appropriate temperature in tests targeting proteins.

[0084] Furthermore, according to the first embodiment, the bottle detection unit 4 detects the insertion of the bottle 1 into the holder 2. The temperature control circuit 5 controls the temperature adjustment by the first temperature adjustment unit 3 based on the detection result by the bottle detection unit 4. Therefore, the sample testing device 10 according to the first embodiment makes it possible to reduce power consumption.

[0085] Furthermore, according to the first embodiment, the display unit 10c notifies information indicating that the sample can be dropped from the bottle 1 into the test cartridge 108. Therefore, the specimen testing device 10 according to the first embodiment can determine whether temperature adjustment has been performed sufficiently, and can more reliably promote the antigen-antibody reaction.

[0086] Furthermore, according to the first embodiment, the second temperature adjustment unit 150 adjusts the temperature of the sample in the test cartridge 108 held by the mount 140. Therefore, the specimen testing device 10 according to the first embodiment can adjust the temperature of the sample undergoing an antigen-antibody reaction, thereby enabling further improvement in testing efficiency.

[0087] Furthermore, according to the first embodiment, the control circuit 130 acquires the identification information attached to the bottle 1. The first temperature adjustment unit 3 and the second temperature adjustment unit 150 adjust the temperature of the sample based on the identification information. Therefore, the sample testing device 10 according to the first embodiment can adjust the temperature to a suitable level to promote the antigen-antibody reaction of the sample, thereby enabling further improvement in testing efficiency.

[0088] (Other embodiments) Although the first embodiment has been described above, the present invention may be embodied in various different forms other than the first embodiment described above.

[0089] In the above-described embodiment, an example has been described in which only one holder 2 is provided, but the embodiment is not limited to this, and multiple holders 2 may be provided. This allows the bottles to be arranged in order of test when the number of test subjects increases, such as during an influenza epidemic, improving ease of use for the user. Furthermore, when multiple holders 2 are provided, the display unit 10c can display, for each bottle 1, the elapsed time since the bottle was stored in the holder 2 or a countdown timer. This allows the order of tests to be followed and reduces the risk of subjects being mixed up.

[0090] Furthermore, for example, one holder 2 may be provided so that multiple bottles 1 can be inserted therein. FIG. 6 is a schematic diagram showing an example of a holder 2 according to another embodiment. For example, as shown in FIG. 6, the holder 2 is provided so that multiple bottles 1 can be inserted therein. Here, the holder 2 may be provided with a bottle conveying unit 2a that conveys the inserted bottle in a predetermined direction (toward the left in the figure). The bottle conveying unit 2a arranges the multiple bottles in the order in which they were inserted. That is, when an inspector inserts a bottle 1 into the holder 2 shown in FIG. 6, the bottle conveying unit 2a conveys the inserted bottle to the left in the figure. As a result, the bottles 1 inserted into the holder 2 shown in FIG. 6 are lined up from the left in the order in which they were inserted.

[0091] Therefore, the inspector can follow the inspection order by removing the bottles 1 in order starting from the left. Furthermore, the holder 2 shown in FIG. 6 can provide space on the right side for inserting bottles. Also, because the bottles are automatically transported by the bottle transport unit 2a, the inspector does not need to be strict about the position in which the bottle is inserted. The bottle transport unit 2a can be realized, for example, by rollers driven by a motor or a belt conveyor.

[0092] Furthermore, in the above-described embodiment, a sample testing apparatus 10 including a first temperature adjustment unit 3 and a second temperature adjustment unit 150 has been described. However, the embodiment is not limited to this, and a sample testing apparatus 10 including only one of the temperature adjustment units may be used. That is, the sample testing apparatus 10 may include only the first temperature adjustment unit 3 and adjust the temperature of the sample and reagent before the antigen-antibody reaction, or may include only the second temperature adjustment unit 150 and adjust the temperature of the sample and reagent during the antigen-antibody reaction.

[0093] In the above-described embodiment, the holder 2 is described as having a recess as an opening into which the bottle 1 can be inserted. However, the embodiment is not limited to this, and for example, a recess into which the bottle 1 can be inserted may be formed on the top surface of the housing 10a. In such a case, the first temperature adjustment unit 3 is provided inside the recess on the top surface of the housing 10a.

[0094] In the above-described embodiments, a sample testing device in which the holder 2 is provided on the upper surface of the housing 10a and which includes a tray 10d for attaching, detaching, and replacing test cartridges, and a sample testing device in which the upper housing 10e including the display unit 10c moves relative to the lower housing 10f have been described. However, the embodiments are not limited to these, and various other types of sample testing devices can be realized.

[0095] Fig. 7 is a schematic diagram showing an example of a sample testing apparatus 10 according to another embodiment. For example, as shown in Fig. 7, the sample testing apparatus 10 according to another embodiment includes a holder 2 provided on the top surface of a housing 10a including an input interface 10b and a display unit 10c, and an upper housing 10e that is provided so as to be movable independently of the input interface 10b and the display unit 10c. For example, as shown in Fig. 7, the upper housing 10e moves so as to be inserted below the input interface 10b and the display unit 10c, thereby moving relative to the lower housing 10f.

[0096] Here, the sample testing device 10 according to other embodiments can have multiple holders 2 on the top surface of the housing 10a. For example, as shown in FIG. 7, the sample testing device 10 can have three or more holders 2 on the top surface of the housing 10a.

[0097] In the above-described embodiment, the bottle detector is provided at the bottom of the holder 2. However, the embodiment is not limited to this, and the bottle detector may be provided on the side, for example. FIG. 8 is a diagram showing an example of an opening and a temperature adjustment unit according to another embodiment. For example, as shown in FIG. 8, the holder 2 is provided with a bottle detector 6, which is an example of a detector, and a temperature control circuit 5, which is an example of a controller.

[0098] Here, for example, the bottle detection unit 6 is an optical sensor such as a photoreflector, and detects the presence or absence of the bottle 1 based on the light reflected from the bottle 1. As an example, the bottle detection unit 6 is a photoreflector having an LED and a phototransistor, where light is emitted from the LED and the phototransistor detects the reflected light that hits a reflective object. Here, the bottle detection unit 6 detects the presence or absence of a reflective object (bottle 1) based on the amount of reflected light detected by the phototransistor.

[0099] The temperature control circuit 5 controls the first temperature adjustment unit 3 in accordance with the output of the bottle detection unit 4. Specifically, when the temperature control circuit 5 receives a detection signal from the bottle detection unit 4 indicating that the bottle 1 has been stored in the holder 2, it causes the first temperature adjustment unit 3 to start temperature adjustment. Furthermore, while the temperature control circuit 5 is receiving an output from the bottle detection unit 4, it causes the first temperature adjustment unit 3 to continue temperature adjustment. Then, when the temperature control circuit 5 no longer receives a detection signal from the bottle detection unit 4, it causes the first temperature adjustment unit 3 to stop temperature adjustment.

[0100] In this way, by using an optical sensor as the bottle detection unit, the presence or absence of the bottle 1 can be detected without coming into contact with the bottle 1, and mechanical failure can be avoided.

[0101] In the above example, the case where temperature adjustment is started when the bottle 1 is stored in the holder 2 has been described, but temperature adjustment may also be performed continuously. That is, when the power of the sample testing apparatus 10 is turned on, the temperature control circuit 5 starts temperature adjustment by the first temperature adjustment unit 3, and continues temperature adjustment regardless of whether the bottle 1 is stored in the holder 2 or not. Similarly, the temperature control circuit 5 can also control the temperature adjustment by the second temperature adjustment unit 150 so that temperature adjustment is performed continuously.

[0102] In the above-described embodiment, the temperature adjustment time (e.g., elapsed time, a countdown timer, etc.) and the temperature of the bottle 1 are displayed as information indicating that a sample can be dropped from the bottle 1 into the test cartridge. However, the embodiment is not limited to this, and the display unit 10c can display various other information as information indicating that a sample can be dropped from the bottle 1 into the test cartridge.

[0103] For example, a control circuit (not shown) that controls the display by the display unit 10c causes the display unit 10c to display information such as "Testing possible" after a predetermined time has elapsed since receiving a detection signal indicating that the bottle 1 has been stored in the holder 2. Also, for example, the control circuit acquires temperature information of the bottle 1 (or the reagent in the bottle 1) acquired by a temperature sensor included in the first temperature adjustment unit 3, and causes the display unit 10c to display information such as "Testing possible" when the temperature reaches a predetermined temperature.

[0104] Here, the control circuit can also cause the display unit 10c to display information indicating that the sample cannot be dropped from the bottle 1 into the test cartridge. For example, the control circuit can cause the display unit 10c to display a warning such as "not warmed up yet" if the bottle 1 is removed before a predetermined time has elapsed since receiving a detection signal indicating that the bottle 1 has been stored in the holder 2, or if the bottle 1 is removed before the temperature of the bottle 1 (or the reagent in the bottle 1) reaches a predetermined temperature.

[0105] Furthermore, the temperature adjustment unit (first temperature adjustment unit 3 and second temperature adjustment unit 150) described in the above-mentioned embodiment may be composed of a heat generating unit that generates heat and a heat conducting unit that conducts the heat generated by the heat generating unit to the bottle 1 or the inspection cartridge.

[0106] 9 is a schematic diagram showing an example of the internal configuration of a sample testing apparatus according to another embodiment. For example, as shown in FIG. 9, the second temperature adjustment unit 150 is composed of a heater plate 150a and a heater 150b. The heater plate 150a is made of a material with high thermoelectric conductivity (e.g., copper or aluminum) and transfers heat generated by the heater 150b to the test cartridge. The heater 150b generates heat by the above-mentioned resistance heating, induction heating, dielectric heating, infrared heating, or the thermoelectric effect.

[0107] According to at least one of the embodiments described above, it is possible to improve the inspection efficiency.

[0108] Although several embodiments of the present invention have been described, these embodiments are presented as examples and are not intended to limit the scope of the invention. These embodiments can be implemented in various other forms, and various omissions, substitutions, and modifications can be made without departing from the spirit of the invention. These embodiments and their modifications are included within the scope and spirit of the invention, as well as within the scope of the invention described in the claims and their equivalents. [Explanation of symbols]

[0109] 1 bottle 2 holder 3. First temperature control unit 4 Bottle detector 5 Temperature control circuit 10. Sample testing equipment 10a housing 10b input interface 10c Display section 140 Mount 150 Second temperature adjustment unit

Claims

1. A specimen testing device that performs testing using a test cartridge that contains a sample, The housing and a holder for holding a test cartridge having an antibody immobilized therein that undergoes an antigen-antibody reaction with an antigen contained in a specimen in the sample; a detection unit that detects that the test cartridge is held in the holding unit; a temperature adjusting unit that starts adjusting the temperature of the sample in the test cartridge held in the holding unit when it is detected that the test cartridge is held in the holding unit; A specimen testing device comprising:

2. The sample testing apparatus according to claim 1 , wherein the temperature adjusting unit changes the temperature depending on the type of the sample.

3. The specimen testing apparatus according to claim 2 , wherein the temperature adjusting unit adjusts the temperature of the sample to 45° C. or less.

4. an acquisition unit that acquires identification information attached to the test cartridge; 4. The sample testing device according to claim 1, wherein the temperature adjusting unit adjusts the temperature of the sample in the test cartridge based on the identification information.

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