JP7344540B2 - Test equipment and methods - Google Patents

Description

The present invention relates to a test device and a test method for conducting a biomolecule detection test using test strip paper.

BACKGROUND ART Conventionally, there is a test device in which a liquid to be determined is absorbed into a test piece to which a reagent or an indicator is attached, and the test piece is visually observed in a state in which the reagent or the like and the liquid to be determined have reacted to make a determination.

An example of the above-mentioned test device is a test device used for immunological tests using a method (for example, immunochromatography) to detect biomolecules such as antigens in living organisms, in which a sample is passed through a porous test piece and a reagent is applied. There are known products that take advantage of the property of slowly flowing while melting (capillary phenomenon).

Immunochromatography is an immunoassay based on the principle of antigen-antibody reaction, in which a porous test piece on which a labeled antibody and a capture antibody are immobilized is prepared in advance, and a test liquid is absorbed into one end of the test piece. Biomolecules (antigens, etc.) in the test solution move through the membrane while forming immune complexes with labeled antibodies due to capillary action. When the immune complex is trapped by the capture antibody, the colored particles derived from the labeled antibody become concentrated and appear colored, which is visually determined as the extent of the antigen contained in the sample.

According to this method, a simple and rapid test can be performed using a simple test instrument, and it is currently widely used for detecting influenza viruses, O157, etc., and determining pregnancy.

An example of a test device using immunochromatography is a rectangular case with a droplet for the test liquid and a detection window for visually checking the condition of the test piece, and a test piece on which a labeled antibody and a capture antibody are immobilized in advance is sealed. (For example, see Patent Document 1).

In addition, when testing specimens using immunochromatography, there is also a technology that integrates the extraction site of the collected specimen and the chromatographic development site of the extract, and performs a series of detection operations with one detection instrument. Are known. Specifically, a configuration is known in which a liquid storage part in which a developing solution is sealed and a matrix placement part in which a matrix is placed are housed in one case (for example, see Patent Document 2). .

Patent No. 6217141 Japanese Patent Application Publication No. 2012-230025

However, the test device described in Patent Document 1, for example, has a problem in that it is not sufficiently safe depending on the object to be tested.

For example, when detecting bacteria such as O157 as a biomolecule, the bacteria are collected from the environment to which they are attached and cultured in a considerable number (for example, cultured 1000 times). Then, it is necessary to perform the test by dropping the test solution after culturing into a test device.

In this case, in a test device such as Patent Document 1, an operator operates a dropper containing a test liquid containing a high concentration of bacteria and drops the test liquid onto a test piece from a dripping window of the test device. Extreme care must be taken to avoid contact with the test liquid.

For this reason, inspections had to be carried out by skilled workers at specialized institutions. Furthermore, even if this is the case, the possibility of the test liquid scattering or leaking into the surrounding area or coming into contact with workers cannot be completely eliminated, and the risk of secondary contamination and infection cannot be avoided. There was a problem.

In addition, test strips need to be stored in a low humidity environment, and test strips and culture fluid have different storage periods when unused, so they cannot be stored in one case as described in Patent Document 2. It is difficult to properly store both types of test equipment. For example, when the storage period of one of them has expired, the other must be discarded or otherwise disposed of even if the other is unused, which poses a problem that leads to an increase in costs.

Particularly in recent years, there has been a high demand for frequent bacterial tests (checks) not only in specialized institutions but also in restaurants and the like, and there is an urgent need to reduce the cost of test equipment.

In view of these circumstances, the present invention prevents the scattering and leakage of test liquids, makes it possible to conduct tests simply and safely, and reduces costs by reducing the number of unused items that must be disposed of. The purpose is to provide test equipment and test methods that can contribute to the field.

The present invention provides a culture solution storage means whose lid part can be closed and which can accommodate in a sealed state a test solution obtained by culturing a specimen with a culture solution , a test piece capable of absorbing the test solution, and a culture solution storage means that accommodates the test sample. a separation means provided on the culture solution storage means, and an opening means provided on the test piece storage means, and the culture solution storage means and the test piece storage means are The culture medium storage means has a rotation regulating means which is a separate body and is engageable by fastening the screw , and which regulates the rotation of the screw in a direction in which the screw is disengaged after engagement. and the test strip accommodating means, the opening means irreversibly opens at least a portion of the separation means, thereby forming a flow path for the test liquid to reach the test strip. This is a unique test device.
The present invention also provides a culture solution storage means whose lid part can be closed and which can contain a test solution obtained by culturing a specimen in a culture solution in a sealed state, a test piece capable of absorbing the test solution, and a test piece capable of absorbing the test solution. , a separating means provided on the culture medium storage means, and an opening means provided on the test piece storage means, the culture medium storage means and the test piece storage means and is configured to be irreversibly engageable with each other, and when the culture medium storage means and the test piece storage means are engaged, the opening means opens at least a portion of the separation means. A flow path is formed for the test liquid to reach the test piece by irreversibly opening the , and has an operation part made of a hollow, substantially spherical body that can be elastically deformed, and an air blowing hole communicating with the operation part, The test instrument is characterized in that it includes an extrusion means for extruding the test liquid into the flow path by pressing the operation part .
Further, the present invention provides a culture solution storage means having an opening with a lid that can be closed, a bottom section and capable of containing a test solution in which a specimen is cultured in the culture solution, and a test piece capable of absorbing the test solution. , comprising a test piece storage means for storing the test piece, a separation means provided at the bottom of the culture solution storage means, and an opening means provided at the test piece storage means, and the culture solution storage means The means and the test strip accommodating means are separate bodies and configured to be irreversibly engageable, and as the culture medium accommodating means and the test strip accommodating means are engaged, the opening means By irreversibly opening at least a portion of the separation means, a flow path for the test liquid to reach the test piece is formed, and the inside of the culture medium storage means is spaced apart from the separation means and the separation means. It is divided into a culture solution containing part which is a closed space and a specimen solution storage part which is a space above it by another separating means provided, and the specimen solution storage part stores a solution containing the specimen , The culture solution enclosing section is characterized in that the culture solution is stored in advance, and the lid section is provided with another opening means that opens the other separation means when the culture solution storage means is closed. It is a test instrument.

Further, the present invention provides a culture solution storage means that has a separation means and can accommodate a test solution obtained by culturing a specimen with a culture solution , and the culture solution storage means is a separate body, and has an opening means. A test method using a test device having a test piece accommodating means, the step of sealing the test liquid in the culture medium accommodating means, and engaging the test piece accommodating means and the culture medium accommodating means by fastening screws. At the same time, the step of restricting the rotation of the screw in the direction of disengagement, and the engagement of the culture solution storage means with the test piece storage means, at least a part of the separation means by the release means. This is a test method characterized by comprising the step of irreversibly opening the test liquid and allowing the test liquid to reach the test piece .
Further, the present invention provides a culture solution storage means that has an opening and a bottom that can be closed with a lid and that can accommodate a test solution obtained by culturing a specimen with a culture solution, and a separate body that is separate from the culture solution storage means. A test method using a test device having a test piece storage means having an opening means, a separation means provided at the bottom of the culture solution storage means, and a separation means provided at a distance from the separation means. accommodating the culture solution in a sealed state in advance in a space partitioned by the separation means; accommodating the solution containing the specimen in a space above the other separation means in the culture solution accommodating means; The method further comprises the steps of: closing the lid, opening the other separating means using another opening means provided on the lid, and mixing the solution containing the specimen with the culture medium. This is a test method.

According to the present invention, it is possible to prevent the scattering and leakage of the test liquid, and to perform the test simply and safely.In addition, it is possible to contribute to cost reduction by reducing the number of items to be disposed of in an unused state. Equipment and test methods can be provided.

(A) A top view of a test instrument according to an embodiment of the present invention, (B) an exploded side sectional view, (C) a side sectional view, and (D) a side sectional view of the test instrument. 1 is a diagram showing a test method using a test device according to an embodiment of the present invention. 1 is a diagram showing a test method using a test device according to an embodiment of the present invention. FIG. 7 is an exploded side cross-sectional view of a test device according to another embodiment of the present invention. It is a figure showing the test method using the test instrument concerning other embodiments of the present invention. It is a figure showing the test method using the test instrument concerning other embodiments of the present invention. FIG. 7 is a side sectional view showing a test instrument according to another embodiment of the present invention. FIG. 7 is a side sectional view showing a test instrument according to another embodiment of the present invention.

Embodiments of the present invention will be described below with reference to the drawings. 1 to 8 are diagrams showing an example of an embodiment of the present invention, and in the diagrams, parts given the same reference numerals represent the same parts. Note that in each figure, some components are omitted as appropriate to simplify the drawings. Then, the size, shape, thickness, etc. of the member are appropriately exaggerated and expressed.

<Test equipment>
FIG. 1 is a diagram showing a test device 10 according to the present embodiment, and FIG. 1A is a plan view showing the external appearance of the test device 10 in a test state, and FIG. FIG. 10C is a side sectional view of the culture solution storage means 11 in a state where a test is performed, and FIG. FIG. Note that Figures (B) to (D) are cross-sectional views corresponding to the line AA in Figure (A).

As shown in FIGS. 1(A) and 1(B), the test instrument 10 of this embodiment includes a culture solution storage means 11, a separation means 15, an opening means 17, a test piece storage means 19, and a test piece 21. It has

As shown in Figures (B) and (C), the culture solution storage means 11 has a (substantially) cylindrical shape with a solution storage section 11A, and can contain a liquid such as the culture solution S1 in a sealed state. be. The culture solution storage means 11 is made of, for example, a resin material, and the upper opening 11B is capable of closing the lid 25. Specifically, the upper opening portion 11B and the lid portion 25 are configured to be irreversibly engageable by the first engaging portion 30. In the engaged state, the two are in close contact with each other without any gaps and are integrally connected.

In the example of the present embodiment, the first engaging part 30 is formed by a male screw 30A provided on the lower outer periphery of the lid part 25 and an inner periphery of the upper opening 11B of the approximately cylindrical culture solution storage means 11. It consists of a female thread 30B. Further, the material of the lid portion 25 (the male thread 30A thereof) is harder than the material of the culture solution storage means 11 (the female thread 30B thereof), and the diameter of the male thread 30A is set larger than the diameter of the female thread 30B. As a result, when fastening, the male thread 30A threads into the female thread 30B while cutting a part thereof, and is engaged irreversibly, that is, after the lid part 25 is closed, it cannot be opened (FIG. 3(C)).

Further, the first engaging portion 30 is regulated such that, for example, it rotates (screws) in the closing direction but cannot rotate in the opening direction (each time the rotation in the closing direction progresses, it rotates in the opening direction). It may be configured to engage irreversibly using a so-called ratchet structure, in which the rotation is restricted.

The culture solution S1 stored in the culture solution storage means 11 is capable of culturing a considerable number (for example, 1000 times) of the collected specimen. The culture solution storage means 11 (solution storage section 11A) is made of, for example, a colorless and transparent resin material.

As will be described in detail later, in this embodiment, a specimen is collected using a collection means (e.g., a cotton swab, a piece of paper, etc.), the collection means is immersed in a solution (water, etc.), and a solution containing the specimen (hereinafter referred to as specimen solution S2) is collected. ). Thereafter, the specimen can be cultured by mixing the specimen solution S2 into the culture solution S1 and leaving it for a predetermined period of time.

In other words, the culture solution storage means 11 can accommodate not only the culture solution S1, but also a sample solution S2 and a solution containing a considerable number of samples after culturing the sample. In this embodiment, a mixed solution in which the specimen solution S2 is mixed into the culture solution S1, and a solution containing a considerable number of specimens after culturing the specimens are hereinafter collectively referred to as a test solution S3. That is, the culture solution storage means 11 can accommodate a solution containing the culture solution S1 (at least one of the culture solution S1, the sample solution S2, and the test solution S3) in a sealed (airtight) state.

Further, the solution storage section 11A is provided with an identification means 35, for example. The identification means 35 will be described later, but is, for example, a display for determining the degree of culture of the test solution S3.

Further, although not shown, the culture solution storage means 11 may be provided with a metal plate or the like having high thermal conductivity on a part of its outer surface. Due to the metal plate, external heat is easily transmitted to the inside of the culture medium storage means 11 during culture, and the responsiveness of culture temperature control is improved, so that culture can be facilitated.

Referring to FIGS. 1A and 2B, the test strip accommodating means 19 has, for example, a substantially rectangular parallelepiped shape and is made of, for example, a resin material, and has an accommodating portion 190 in which the test strip 21 is accommodated. On the surface of the storage section 190 facing the test piece 21, there is a judgment window 191 that allows the judgment area of the test piece 21 to be judged (visually checked) from the outside, and a transpiration window that prevents the test liquid S3 from flowing back inside the test piece 21. 193 are provided.

The determination window 191 is covered with transparent resin, glass, etc., and the evaporation window 193 is open and communicates with the inside (open), but is small enough to allow vaporized test liquid S3 to evaporate. The inside test piece 21 cannot be touched through these windows.

The test piece 21 is, for example, a strip-shaped porous member capable of absorbing the test liquid S3 cultured by the culture liquid storage means 11, and in this example, it is a known test piece 21 used in an immunochromatography test.

Note that a guide G for visual judgment may be provided in a part of the judgment window 191 by printing or pasting a sticker. The guide G has a scale in which the level of color shading is divided into multiple levels (for example, 10 levels) to serve as an index of the coloring state of the test piece 21 (for example, the coloring state of the control antibody of the membrane filter). It is something that Further, instead of the level of color shading, only one reference color may be shown.

As shown in Figures (B) and (C), in the test instrument 10 of this embodiment, the culture medium storage means 11 and the test piece storage means 19 are separate and non-contact, and each It is now possible to handle it independently.

In other words, during the test, as shown in FIG. A solution S3 (culture solution S1 and sample solution S2) is stored in a sealed state. In this state, the culture solution storage means 11 can be stored in a thermostatic incubator or the like for a predetermined period of time, and the specimen can be cultured. In this way, the culture solution storage means 11 can contain the test solution S3 (culture solution S1, specimen solution) in a state in which it is not engaged with the test piece storage means 19, and can culture the test solution S3 (culture solution S1, specimen solution) independently of the test strip storage means 19. is possible.

After culturing, as shown in FIG. 3(D), the culture medium storage means 11 and the test piece storage means 19 are configured to be irreversibly engageable by the second engagement portion 31, and in the engaged state, both They fit tightly together without any gaps and are connected as one. In the example of the present embodiment, the second engaging portion 31 includes a male screw 31A provided so as to protrude from the upper surface of the end portion in the longitudinal direction of the test specimen accommodating means 19 (accommodating portion 190), It consists of a female thread 31B provided on the inner periphery of the bottom 11C.

Separation means 15 is provided on the bottom 11C of the culture solution storage means 11 so as to cover the upper end of the female thread 31B. The separation means 15 separates the culture solution storage means 11 so that the test solution S3 (culture solution S1 and/or specimen solution S2) in the culture solution storage means 11 cannot leak out until a test is performed using the test instrument 10. Functions as (part of) the bottom of. In other words, the solution storage section 11A is a section whose upper part can be closed with the lid part 25 and whose lower part is covered with the separating means 15 separate from the lid part 25.

The material of the male screw 31A of the test piece storage means 19 is harder than the material of the female screw 31B of the culture solution storage means 11, and the diameter of the male screw 31A is set larger than the diameter of the female screw 31B. Further, a lock 31C and a seal 31D are provided at the lower end of the male screw 31A (the part connected to the upper surface of the housing section 190). As a result, when fastening, the male screw 30A screws into the female screw 30B while cutting a part of it, and when the engagement is completed, the rotation is regulated by the lock 31C, irreversibly, that is, the test piece storage means 19 and the culture medium storage means. After the connection of 11, they are irremovably engaged (see (C) of the same figure).

Further, the second engaging portion 31 is regulated such that, for example, it rotates (screws) in the closing direction but cannot rotate in the opening direction (each time the rotation in the closing direction progresses, it rotates in the opening direction). It may be configured to engage irreversibly using a so-called ratchet structure, in which the rotation is restricted.

The test piece accommodating means 19 has an opening means 17 at the center of the male thread 31A. The opening means 17 has a cylindrical shape coaxial with the male screw 31A, and its tip (upper end) 17A has a sharp shape (in this example, it is cut off diagonally in a side view) so that the separating means 15 can be opened (pierced, broken). It has a needle-like or needle-like shape. Further, inside the opening means 17 and the male screw 31A, a hollow portion 23 is provided which communicates with both. The end of the test piece 21 is located directly below the hollow part 23, and the test liquid S3 can flow (drop) into the test piece 21 through the hollow part 23.

Further, the opening means 17 is made of a harder (higher strength) material than the separating means 15, and the opening means 17 is made of a material that is harder (higher strength) than the separating means 15. (state), at least the tip 17A of the opening means 17 is configured to be located above the separating means 15.

In this way, when the culture solution storage means 11 and the test piece storage means 19 are integrally connected at the second engaging portion 31, the opening means 17 penetrates the separation means 15. That is, at least a portion of the separating means 15 is irreversibly opened by the opening means 17, specifically by drilling or breaking.

When the opening means 17 penetrates the separating means 15, its tip reaches the solution storage section 11A. Thereby, the test liquid S3 can be dropped (inflowed) into the opening means 17 and the hollow part 23 of the male screw 31A. That is, by opening the separation means 15, a flow path 26 is formed through which the test liquid S3 in the culture medium storage means 11 reaches the test piece 21. The lock 31C provided below the male screw 31A of the test piece accommodating means 19 ensures that the test piece accommodating means 19 and the culture solution accommodating means 11 are engaged with each other in a manner that cannot be opened, and the seal 31D ensures that the second engaging portion To reliably prevent leakage of test liquid S3 from 31.

Here, the lid part 25 of this embodiment includes an extrusion means 37 that extrudes the test liquid S3 into the flow path 26. The extrusion means 37 has, for example, an operation section 371 made of a hollow, substantially spherical body that can be elastically deformed, and an air blowing hole 372 that penetrates through the lid section 25, and by pressing the operation section 371, the air inside the operation section 371 is expelled. This is a so-called blower that pushes out the test liquid S3 through the ventilation hole 372 into the solution storage section 11A, thereby pushing out the test liquid S3 into the flow path 26.

A very small amount of the test solution S3 (for example, about 45 μL to 150 μm, preferably about 60 μm to 100 μm, more preferably about 75 μm to 80 μm) is sufficient to drop the test liquid S3 onto the test piece 21, and if the dropped amount is too large, the test will not be accurate. becomes difficult. Therefore, the hollow portion 23 of the test piece accommodating means 19 of this embodiment is a hole having a diameter so small that the test piece 21 can be dropped therein. Therefore, depending on the state and amount of the test liquid S3, natural dropping may become difficult. In such a case, when the operator operates (presses) the extrusion means 37, an appropriate amount of the test liquid S3 can be extruded into the channel 26 and dripped onto the test piece 21.

<Biomolecule detection test method>
A biomolecule detection test method using the test instrument 10 of this embodiment will be described with reference to FIGS. 2 and 3.

First, as shown in Figure 2(A), in a collection environment (for example, a restaurant kitchen, etc.) where the presence of the target (to be detected) biomolecule (for example, pathogenic E. coli such as O157) is suspected, Collect the specimen. That is, using the sampling means 27 (for example, a cotton swab or a sampling piece), a desired location is wiped with the sampling means 27 to adhere the specimen. The sampling means 27 is enclosed in a specimen container 50 (for example, a sealed bag) containing a diluted solution (for example, water). As a result, the specimen is dispersed (mixed) and a diluted solution (sample solution S2) is generated ((B) in the same figure).

Thereafter, as shown in FIG. 3C, the culture solution storage means 11 of the test instrument 10 accommodates the required amount of culture solution S1 and sample solution S2, which are stored separately. Then, as shown in FIG. 3(A), it is closed with a lid part 25 to be in an airtight (sealed) state. The lid part 25 is irreversibly engaged with the culture solution storage means 11 and cannot be resealed. In this state, the culture solution storage means 11 is stored in, for example, a constant temperature incubator (not shown), and the specimen is cultured at a high concentration. For example, when the antigen is pathogenic E. coli such as O157, the culture is increased approximately 1000 times by culturing at a temperature of 37° C. for 3 hours.

Note that, for example, the culture solution storage means 11 may be provided with an identification means 35 for determining the presence or absence of a specimen (and/or the degree of cultivation). In this embodiment, as an example, the culture solution storage means 11 (solution storage section 11A) is made of, for example, a colorless and transparent resin material so that the state of the test solution S3 can be determined (visually recognized). In addition, the culture solution S1 is colorless and transparent in the initial state, and when a certain amount of specimen is mixed in, or when the culture has progressed to the extent that a test can be performed, the culture solution S1 reaches a predetermined level that can be tested as a test solution S3. The material used is one that becomes cloudy (or changes color or stains) when it reaches the desired temperature.

In this case, the solution storage section 11A is provided with identification means 35 for comparing the state of the test liquid S3 with the initial state (state at the start of the test). The identification means 35 is, for example, a display (mark) similar to the expected cloudiness (or discoloration, coloring, hereinafter) of the test liquid S3, and the display is visible in the initial state, but if the test liquid S3 is cloudy When it reaches a testable level, it is mixed with the test liquid S3 and becomes difficult to visually recognize (the mark appears to disappear), etc. ((B) in the same figure).

By providing such an identification means 35, it is possible to easily determine whether the test liquid S3 is ready for testing (whether the culture is progressing or not), regardless of the skill level of the operator conducting the test. This can improve the accuracy of the test and can also be used to call attention to the handling of the test device 10 after culturing.

After the culture solution S1 and the specimen solution S2 are sealed in the culture solution storage means 11, the culture solution storage means 11 is maintained in a sealed state and culture is performed. Therefore, there is no fear that the highly concentrated test solution S3 will leak outside, and the risk of the operator coming into contact with the test solution S3 can be avoided.

Further, in this embodiment, since the culture solution storage means 11 and the test piece storage means 19 are in a separate and independent state, the test piece storage means 19 (and The stored test pieces 21) can be stored and managed in an appropriate condition to prevent deterioration of performance.

After the culture is completed, the culture solution storage means 11, which is maintained in a sealed state, and the test piece storage means 19, which is in a separate and independent state, are irreversibly engaged ((C) in the same figure). . That is, the opening means 17 of the test piece accommodating means 19 is inserted inside the female thread 31B at the bottom of the culture solution accommodating means 11, and the female thread 31B and the male thread 31A are brought together. The male thread 31A engages with the female thread 31B by cutting a portion thereof, and is locked by a lock 31C. Thereby, the culture solution storage means 11 and the test piece storage means 19 are integrally engaged with each other in a manner that cannot be separated. Further, as a result, the opening means 17 irreversibly opens (breaks, perforates, penetrates) the separating means 15, and its tip reaches the inside of the test liquid S3. A flow path 26 for the test liquid S3 is formed by the hollow portion 23 of the opening means 17.

Then, the test liquid S3 is dropped onto the end of the test piece 21 via the flow path 26, and is absorbed into the test piece 21. At this time, if it is difficult to drip naturally by opening the separation means 15, apply an external force to the extrusion means 31 (by pressing) to extrude the test liquid S3, and drip an appropriate amount onto the test piece 21.

When an antigen is present in the test liquid S3, the antigen moves within the test strip 21 (not shown in the membrane filter) while forming an immune complex with the labeled antibody by capillary action. When the immune complex is trapped by the capture antibody, the colored particles derived from the labeled antibody become concentrated and develop a color, which can be visually determined as the extent of the antigen contained in the sample (Figure 1 (A). )reference).

The determination is made, for example, by referring to a guide G for visual determination provided in a part of the determination window 191 and comparing it with the coloring state of the test piece 21 . Alternatively, comparison may be made using a guide plate that is separate from the test instrument 10 and is printed with one or more levels of color shading.

Alternatively, the coloring state of the test piece 21 and the guide (guide plate) may be photographed with a mobile terminal (for example, a smartphone), and the images may be sent to a determination organization for determination. Alternatively, an application program for determination may be used to capture a captured image so that it can be immediately determined.

As described above, according to the configuration of this embodiment, everything from culturing the specimen to dropping the test liquid S3 onto the test piece 21 can be performed in a sealed environment.

Specifically, the test solution S3 (culture solution S1 and specimen solution S2) can be cultured in a sealed state, and the culture solution storage means 11 and the test piece storage means 19 are engaged during the test (immediately before the test). Then, the test device 10 becomes an integrated test device 10, and the separation means 15 at the bottom 11C of the culture solution storage device 11 is opened, and a flow path for the test solution S3 is created inside the test device 10 (inner region not exposed to the outside). 26 is formed. That is, none of the separation means 15 for sealing the test liquid S3 in the solution storage section 11A, the opening means 17 for opening it, and the flow path 26 are exposed to the outside. Thereby, the step of dropping the test liquid S3, which conventionally had the possibility of exposing the test liquid S3, can be completed in a substantially sealed environment. Therefore, even if the test liquid S3 contains a high concentration of bacteria, the test liquid S3 can be dropped onto the test piece 21 without being exposed to the outside, while preventing the test liquid S3 from scattering or leaking. In turn, secondary contamination and infection of workers and the working environment can be prevented.

In addition, since the test can be carried out simply and safely, the test can be carried out by an employee of a restaurant, for example, at a restaurant, etc., without relying on a specialized institution or a skilled worker.

Furthermore, since the test piece 21 is stored in the test piece storage means 19 that is separate from the culture solution storage means 11, the test piece 21 can be stored in an appropriate state until just before the test liquid S3 is dropped. Even if the culture medium accommodating means 11 is discarded, the culture medium accommodating means 11 can be processed independently as long as the two are not engaged, thus eliminating the need for the test piece 21 (test piece accommodating means 19). It is possible to prevent unnecessary disposal, etc., and contribute to cost reduction.

<Other embodiments of test equipment>
<Second embodiment>
Other embodiments of the test device 10 of the present invention will be described with reference to FIGS. 4 to 6. FIG. 4 is an exploded side sectional view showing an example of the test instrument 10 according to the second embodiment, in which (A) shows the lid part 25, (B) shows the culture solution storage means 11, and (C) shows the lid part 25. ) is a schematic cross-sectional view of the test piece accommodating means 19 corresponding to FIG. 1(B). Moreover, FIG. 5 and FIG. 6 are diagrams showing an example of a test method using the test instrument 10 according to the second embodiment.

Referring to FIGS. 4(A) and 4(B), the culture solution storage means 11 includes another separation means 55 that separates the sample solution S2 and the culture solution S1, and another separation means 55 that opens the other separation means 55. The opening means 57 may be provided.

That is, as shown in FIG. 3B, the solution storage section 11A in this example is further divided into a culture solution enclosing section 11D and a sample solution storage section 11E. The bottom of the culture solution enclosing part 11D is covered with a separation means (first separation means) 15, and the top surface is covered with another separation means (second separation means 55). S1 is enclosed.

Further, as shown in FIG. 2A, another opening means (second opening means 57) is provided in the lid part 25 so that the ventilation hole 372 extends downward and projects from the lid part 25. The second opening means 57 has a cylindrical shape coaxial with the male screw 30A, and its tip (lower end) 57A has a sharp shape (in this example, the side surface It has a diagonally cut-off shape or a needle-like shape when viewed. Here, when the second separating means 55 is opened by the second opening means 57, the size of the opening (perforation, breakage) is assumed to be larger than that of the second opening means 57 (see FIG. 6). Further, inside the second opening means 57, a hollow portion 53 communicating with the ventilation hole 372 is provided.

Furthermore, the second opening means 57 is made of a harder (higher strength) material than the second separating means 55, and when the engagement between the culture medium storage means 11 and the lid part 25 is completed, the second opening means 57 is At least the tip 57A is configured to be located below the second separation means 55 and above the first separation means 15. Furthermore, in a state in which the engagement between the culture solution storage means 11 and the test piece storage means 19 is completed, at least the tip 17A of the first opening means 17 is located above the first separation means 15 and above the second separation means 55. It is configured to be located below (see FIG. 6). The configuration other than this is the same as that of the above-described embodiment, so the explanation will be omitted.

The test method using the test device 10 in this case is as follows. First, as shown in FIG. 5(A), the culture solution storage means 11 stores and stores the culture solution S1 used for one test separately and separately from the test piece storage means 19 in a sealed state. Management is possible.

Then, during the test, the sample solution S2 is stored in the sample solution storage section 11E, as shown in FIG. The method for producing the sample solution S2 is the same as that in the first embodiment (FIGS. 2(A) and 2(B)). In this state, in the solution storage section 11A, the culture solution S1 is sealed in the culture solution enclosing section 11D in the lower layer, and the culture solution S1 is separated from the culture solution S1 in the sample solution storage section 11E in the upper layer. The sample solution S2 is accommodated in the same state.

Thereafter, as shown in FIGS. 6(A) and 6(B), the lid portion 25 is closed (screwed) onto the culture solution storage means 11. At the time of fastening, the male thread 30A cuts a part of the female thread 30B, and is engaged irreversibly, that is, after the lid part 25 is closed, it cannot be opened.

Further, in conjunction with this, the second opening means 57 irreversibly opens (breaks, perforates, penetrates) the second separating means 55, and its tip 57A reaches the culture solution S1 ((B) in the same figure). Since the second separating means 55 opens the second separating means 55 to a size larger than itself (diameter), the sample solution S2 and the culture solution S1 mix with each other from around the second opening means 57, and the test liquid S3 generated. In this state, the culture solution storage means 11 can be cultured.

After completion of the culture shown in FIG. 5C, the culture solution storage means 11 is irreversibly engaged with the test piece storage means 19 (FIG. 1D), similarly to the above-described embodiment.

As already mentioned, in a state in which the engagement between the culture solution storage means 11 and the lid part 25 is completed, at least the tip 57A of the second opening means 57 is located below the second separation means 55 and above the first separation means 15. It is configured to be located above the Furthermore, in a state in which the engagement between the culture solution storage means 11 and the test piece storage means 19 is completed, at least the tip 17A of the first opening means 17 is located above the first separation means 15 and above the second separation means 55. It is configured to be located at the bottom.

As a result, the first opening means 17 irreversibly opens (breaks, perforates, penetrates) the first separating means 15, and its tip reaches the inside of the test liquid S3. The hollow portion 23 of the first opening means 17 forms a flow path 26 for the test liquid S3. The configuration other than this is the same as that of the above-described embodiment, so the explanation will be omitted.

According to this embodiment, since the culture solution S1 is sealed in advance in the culture solution enclosing part 11D, the operator who conducts the test only needs to accommodate the sample solution S2 in the sample solution storage part 11E. It is possible to prevent the operator from coming into contact with either the culture solution S1 or the test solution S3.

Furthermore, since an appropriate amount of culture solution S1 for one test is sealed in advance, storage (management) of unused culture solution S1 becomes easy. Furthermore, since the culture solution S1 and the test piece 21 can be stored and managed separately, they can be managed using appropriate storage methods and storage deadlines.

<Third embodiment>

FIG. 7 is a schematic diagram showing the test instrument 10 of yet another embodiment, and is a cross-sectional schematic diagram showing the state before the start of the test (the state after the culture in the culture solution storage means 11 is completed). As shown in the figure, the test piece storage means 19 is provided at the longitudinal end of the storage section 190 so that the longitudinal direction and the axial direction of the male screw 31A are aligned (for example, aligned coaxially or aligned parallel to each other). ), the male screw 31A and the opening means (first opening means) 17 may be arranged. The housing portion 190 in this case may have a substantially rectangular parallelepiped shape or may have a cylindrical shape.

Note that the culture solution storage means 11 has the same structure as that of the first embodiment shown in FIG. 1, so a description thereof will be omitted. Moreover, the culture solution storage means 11 of this embodiment may have the same structure as that of the second embodiment shown in FIG.

<Fourth embodiment>

FIG. 8 is a schematic diagram showing a test instrument 10 according to yet another embodiment. This figure is a side sectional view showing an outline of the culture solution storage means 11 according to the fourth embodiment. The culture solution storage means 11 may have a shape and size that can accommodate a plurality of collection means 27 simultaneously, together with the diluted sample solution S0 (sample solution S2) and the culture solution S1. Specifically, for example, several to several dozen (preferably several to more than ten) stick-shaped collection means (cotton swabs) 27 or several to several dozen (preferably several to more than ten) ) may be capable of accommodating a paper strip-shaped collection means (collection piece) 27.

In this case, as shown in FIG. 4A, the diluted solution S0, the sampling means 27, and the culture solution S1 may be mixed into the empty solution storage section 11A during the test. The structure of the lid part 25 in this case is the same as that of the first embodiment shown in FIG.

Further, as shown in FIGS. 11B to 1D, the solution storage section 11A is divided into a culture solution enclosing section 11D and a specimen solution accommodation section 11E. may be sealed in a sealed state. More specifically, the culture solution enclosing part 11D is composed of, for example, a bag. Further, the sample solution storage section 11E is configured to have a shape and size that can accommodate the diluted solution S0 and a plurality of sampling means 27 at the same time.

In this case, the lid portion 25 has a second opening means 57 as in the second embodiment. Then, when the lid part 25 is engaged with the culture solution storage means 11 as shown in FIG. Test solution S3 is generated by mixing with S2 and culturing in that state. Note that the volumes of the culture solution S1, sample solution S2, and test solution S3 used in this embodiment are appropriately selected depending on the collection means (collection pieces) 27 of several to several tens of pieces. The test piece accommodating means 19 and the other configurations are the same as those in the first to third embodiments, so a description thereof will be omitted.

For example, in restaurants, etc., tests (inspections) are required every day (or frequently), but rather than identifying the location where bacteria exist, it is only necessary to simply test for the presence or absence of bacteria. There are also requests. In such cases, testing costs can be reduced if specimens collected from several to ten locations within the store can be simultaneously sealed and cultured in a single test. According to this embodiment, the culture solution storage means 11 is configured to be able to accommodate a plurality of (for example, 10 to 20) collection means 27 at the same time, which helps reduce costs in the case of simple tests at restaurants, etc. I can contribute.

In addition, in the above example, the evaporation window 193 is provided in the test piece storage means 19 in order to prevent the test liquid S3 from flowing back inside the test piece 21. If backflow can be prevented by modifying the shape of the piece 21 (for example, by making it sufficiently long in the longitudinal direction), the evaporation window 193 may not be provided.

By not providing the evaporation window 193, the interior of the test piece storage means 19 can be made into a substantially completely sealed space. That is, this is more suitable for preventing the test liquid S3 from scattering and leaking.

Further, in the above embodiment, the test instrument 10 used for a detection test of biomolecules by immunochromatography was explained as an example, but the test instrument 10 is not limited to the immunochromatography method. The test can be performed in the same manner even if the test device uses a test piece 21 that can be absorbed and display some kind of result.

Note that the test instrument 10 of the present invention is not limited to the embodiments described above, and it goes without saying that various changes can be made without departing from the gist of the present invention.

10 Test instrument 11 Culture solution storage means 11A Solution storage section 11B Upper opening 11C Bottom section 11D Culture solution enclosure section 11E Sample solution storage section 15 Separation means (first separation means)
17 Opening means (first opening means)
17A Tip 19 Test piece storage means 190 Storage part 191 Judgment window 193 Evaporation window 21 Test piece 23 Hollow part 25 Cover part 26 Channel 27 Collection means 30 First engaging part 30A Male thread 30B Female thread 31 Second engagement part 31A Male thread 31B Female screw 31C Lock 31D Seal 35 Identification means 37 Extrusion means 371 Operation section 372 Air hole 50 Specimen container 53 Hollow section 55 Second separation means 57 Second opening means 57A Tip S0 Diluted solution S1 Culture solution S2 Specimen solution S3 Test solution

Claims (13)

a culture solution storage means with a lid that can be closed and a test solution obtained by culturing a specimen in a culture solution in a sealed state;
a test piece capable of absorbing the test liquid;
a test piece accommodating means for accommodating the test piece;
Separation means provided in the culture solution storage means;
and an opening means provided in the test piece storage means,
The culture solution storage means and the test piece storage means are separate bodies, and can be engaged by fastening a screw , and after being engaged, rotation of the screw in a direction in which the screw is disengaged is restricted. It has a rotation regulating means to
Upon engagement of the culture solution storage means and the test piece storage means, the opening means irreversibly opens at least a portion of the separation means, thereby forming a flow path through which the test liquid reaches the test piece. be done,
A test instrument characterized by: The culture solution accommodating means is capable of accommodating the test solution in a non-engaged state with the test strip accommodating means.
The test device according to claim 1, characterized in that: The separating means is separate from the lid part,
The test instrument according to claim 1 or claim 2, characterized in that: the opening means irreversibly ruptures the separating means;
The test instrument according to any one of claims 1 to 3, characterized in that: a culture solution storage means with a lid that can be closed and a test solution obtained by culturing a specimen in a culture solution in a sealed state;
a test piece capable of absorbing the test liquid;
a test piece accommodating means for accommodating the test piece;
Separation means provided in the culture solution storage means;
and an opening means provided in the test piece storage means,
The culture solution storage means and the test piece storage means are separate bodies and are configured to be irreversibly engageable,
Upon engagement of the culture solution storage means and the test piece storage means, the opening means irreversibly opens at least a portion of the separation means, thereby forming a flow path through which the test liquid reaches the test piece. is,
An operation part made of a hollow, substantially spherical body that can be elastically deformed, and an extrusion means that has an air hole communicating with the operation part and pushes out the test liquid into the flow path by pressing the operation part.
A test instrument characterized by: The ventilation hole passes through the lid, and the operating portion is provided so as to protrude from the top surface of the lid .
The test device according to claim 5, characterized in that: A culture solution storage means having an opening that can be closed with a lid and a bottom, and capable of containing a test solution obtained by culturing a specimen with a culture solution;
a test piece capable of absorbing the test liquid;
a test piece accommodating means for accommodating the test piece;
Separation means provided at the bottom of the culture solution storage means;
and an opening means provided in the test piece storage means,
The culture solution storage means and the test piece storage means are separate bodies and are configured to be irreversibly engageable,
Upon engagement of the culture solution storage means and the test piece storage means, the opening means irreversibly opens at least a portion of the separation means, thereby forming a flow path through which the test liquid reaches the test piece. is,
The inside of the culture solution storage means is divided into a culture solution enclosure section, which is a closed space, and a sample solution storage section, which is a space above the separation section, by the separation means and another separation means provided apart from the separation means. , divided into
The specimen solution storage part stores a solution containing the specimen, the culture solution enclosing part stores the culture solution in advance,
The lid part includes another opening means for opening the other separation means when the culture solution storage means is closed .
A test instrument characterized by: By closing the lid on the culture solution storage means while maintaining separation from the test piece storage means, the test solution containing the specimen and the culture solution are mixed into the culture solution storage. configured to be retainable within the means;
The test device according to claim 7, characterized in that: A culture solution storage means having a separation means and capable of containing a test solution obtained by culturing a specimen with a culture solution ;
A test method using a test device having a test piece storage means that is separate from the culture solution storage means and has an opening means,
sealing the test solution in the culture solution storage means;
engaging the test piece accommodating means and the culture solution accommodating means by fastening a screw , and restricting rotation of the screw in a direction in which they are disengaged;
the step of irreversibly opening at least a portion of the separation means by the opening means upon engagement of the culture solution storage means and the test piece storage means, and allowing the test liquid to reach the test piece;
A test method characterized by: accommodating a solution containing the specimen, the culture solution, and the culture solution accommodating means in a state separated from the test piece accommodating means;
closing the culture solution storage means with a lid and culturing in a sealed state to obtain the test solution;
The test method according to claim 9, characterized in that: The lid has an operating section made of a hollow, substantially spherical body that can be elastically deformed, and an air hole communicating with the operating section, and by pressing the operating section, the test liquid is applied to the test piece. Push out into the flow path leading to
The test method according to claim 10, characterized in that: A culture solution storage means that has an opening and a bottom that can be closed with a lid, and is capable of containing a test solution obtained by culturing a specimen with a culture solution;
A test method using a test device having a test piece storage means that is separate from the culture solution storage means and has an opening means,
storing the culture solution in a sealed state in advance in a space defined by a separation means provided at the bottom of the culture solution storage means and another separation means provided apart from the separation means;
accommodating a solution containing the specimen in a space above the other separation means in the culture solution accommodating means;
closing the lid, opening the other separating means using another opening means provided on the lid, and mixing the solution containing the specimen and the culture solution;
has,
A test method characterized by: By closing the lid on the culture solution storage means while maintaining separation from the test piece storage means , the test solution containing the specimen and the culture solution are mixed into the culture solution storage. prepared within the means,
The test method according to claim 12, characterized in that: