Test kits and timer components

Abstract

To provide a test kit that enables intuitive understanding of the time required to determine the presence or absence of an antigen. [Solution] A test kit 100 for testing for the presence or absence of an antigen, comprising a collection member 110 for collecting a specimen from a subject, a reagent container 120 containing a liquid reagent L1 capable of extracting antigens from the specimen and for producing a mixed liquid of the specimen and the liquid reagent L1, a determination member 130 for determining the presence or absence of the antigen from the mixed liquid, a timer member S2, and an individual packaging box 190, wherein the timer member S2 is a bottomed cylindrical body having a bottom portion at one end and an opening at the other end, and comprising a staining liquid container 160 containing staining liquid L2, and a sheet member 180 which can be inserted into the staining liquid container 160 from the opening and whose length from one end to the other end is longer than the length from the bottom portion to the opening, wherein the sheet member 180 is characterized in that when one end of the sheet member 180 is immersed in staining liquid L2, the staining liquid L2 penetrates to the other end and changes color.

Description

[Technical Field]

[0001] The present invention relates to a test kit and a timer component included in the test kit. [Background technology]

[0002] Test kits for antigens of the novel coronavirus, influenza virus, and the like have been known for some time. Test kits for antigens include a determination element for determining the presence or absence of the antigen. The determination element generally determines the presence or absence of the antigen using immunochromatography (see, for example, Patent Document 1).

[0003] The determination member includes a test strip and a housing that houses the test strip. The housing is formed with a drop window through which a mixture of a sample (e.g., a nasal swab) and a liquid reagent is dropped, and a determination window through which the determination result can be visually confirmed. The drop window is located upstream of the test strip, and the determination window is located downstream of the test strip.

[0004] The test strip is provided with, in order from the upstream side, a labeled antibody, a first fixed antibody, and a second fixed antibody. The labeled antibody migrates with the mixed solution, and if the mixed solution contains an antigen, it binds to the antigen to form a complex. The first fixed antibody binds to the antigen in the complex, and the second fixed antibody binds to the labeled antibody. The complex develops color when it binds to the first fixed antibody, causing the so-called test line to appear. On the other hand, the labeled antibody develops color when it binds to the second fixed antibody, causing the so-called control line to appear. The subject can visually confirm the test line and control line through the test window.

[0005] The time from when the mixed solution is dropped into the dropping window until the test line or control line appears in the judgment window (time to determine whether the antigen is present or not) is about 5 to 15 minutes. However, because the judgment element does not change at all until these lines appear, there is a problem that the subject cannot intuitively grasp the time to determine whether the antigen is present or not (for example, the time elapsed since the start of the judgment or the time remaining until the end of the judgment). [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Japanese Patent Publication No. 2022-119435 Summary of the Invention [Problem to be solved by the invention]

[0007] The present invention was made in consideration of the above circumstances, and its objective is to provide a test kit and timer component that allows users to intuitively grasp the time required to determine whether an antigen is present or absent. [Means for solving the problem]

[0008] In order to solve the above problems, the test kit according to the present invention comprises: A test kit for testing for the presence or absence of an antigen, a collection member for collecting a sample from a subject; a reagent container containing a liquid reagent capable of extracting the antigen from the specimen, for generating a mixture of the specimen and the liquid reagent; a determination member for determining the presence or absence of the antigen in the mixed solution; A timer member; an individual packaging box that houses the sampling member, the reagent container, the determination member, and the timer member; The timer member is a staining liquid container which is a cylindrical body with a bottom having a bottom surface at one end and an opening at the other end and which contains staining liquid; a sheet member that can be inserted into the staining liquid container through the opening and has a length from one end to the other end that is longer than a length from the bottom surface portion to the opening, The sheet member is characterized in that when the one end is immersed in the dye solution, the dye solution penetrates to the other end and changes color.

[0009] With this configuration, when one end of the sheet member is immersed in the staining liquid, the staining liquid permeates to the other end, causing a color change. By designing and adjusting the sheet member and staining liquid so that the staining liquid permeates to the other end in approximately 5 to 15 minutes, which is the time required to determine the presence or absence of an antigen, the subject can intuitively grasp the time required to determine the presence or absence of an antigen by looking at the sheet member.

[0010] The test kit comprises: a temperature measuring member for measuring a body surface temperature of the subject; The temperature measuring member is A flexible substrate and a plurality of temperature indicating members that are arranged in a row at predetermined intervals on one surface of the substrate and that cause a color change at different temperatures; The substrate may be configured to indicate a temperature threshold at which the color change occurs.

[0011] In the test kit, The timer member further includes a cylindrical pipe member that is shorter than the sheet member, the pipe member is insertable into the staining liquid container through the opening, The sheet member can be configured to be insertable into the pipe member.

[0012] In the test kit, The pipe member may be transparent or semi-transparent so that the color change of the sheet member is visible.

[0013] In the test kit, The individual packaging box may be configured to have a cut line for inserting and fixing the staining liquid container.

[0014] In order to solve the above problem, the timer member according to the present invention comprises: A timer member for measuring the time required to determine the presence or absence of an antigen, a staining liquid container having an opening and containing a staining liquid; a cylindrical pipe member that can be inserted into the staining liquid container through the opening; a sheet member that can be inserted into the pipe member, The sheet member is longer than the pipe member, and when immersed in the dyeing solution, the dyeing solution permeates the sheet member and the color changes. [Effects of the Invention]

[0015] According to the present invention, a test kit and timer component can be provided that allow the user to intuitively grasp the time required to determine whether an antigen is present or not. [Brief explanation of the drawings]

[0016] [Figure 1] 1 is a diagram showing the configuration of a test kit according to the present invention. [Figure 2] 1 is a diagram showing a determination member of the present invention. [Figure 3] 1 is a diagram showing a temperature measuring element according to the present invention; [Figure 4] 10A to 10C are diagrams illustrating how to use the timer member of the present invention. [Figure 5] 10A and 10B are diagrams showing an example of a determination result obtained by the determination member of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0017] Hereinafter, embodiments of a test kit and a timer member according to the present invention will be described with reference to the accompanying drawings.

[0018] 1 shows a test kit 100 according to one embodiment of the present invention. The test kit 100 is used to test for the presence or absence of antigens of the novel coronavirus, influenza A virus, and influenza B virus.

[0019] The test kit 100 includes a sampling member 110, a reagent container 120, a determination member 130, a disposal bag 140, a temperature measurement member 150, a staining liquid container 160, a pipe member 170, a sheet member 180, and an individual packaging box 190.

[0020] In the test kit 100, the first set S1, which is composed of the sampling member 110, the reagent container 120, the determination member 130, and the disposal bag 140, is a known component. On the other hand, the second set S2, which is composed of the staining liquid container 160, the pipe member 170, and the sheet member 180, corresponds to the "timer member" of the present invention.

[0021] The sampling member 110 is a member for sampling a specimen (for example, a nasal swab) from a subject. The sampling member 110 is, for example, a sterilized cotton swab. The sterilized cotton swab is individually packaged in a sterilization pack (not shown).

[0022] The reagent container 120 is a container that contains a liquid reagent L1 that can extract antigens from a specimen. The liquid reagent L1 is also called a diluted test liquid. In the reagent container 120, the sampling member 110 that has sampled the specimen is immersed in the liquid reagent L1 in the reagent container 120, thereby generating a mixture of the specimen and the liquid reagent L1.

[0023] The determination member 130 is a member for determining the presence or absence of an antigen in a mixed liquid. The determination member 130 is also called a test plate. As shown in Fig. 2, the determination member 130 includes a housing 131, and a first drip window 132, a first determination window 133, a second drip window 134, and a second determination window 135 provided in the housing 131.

[0024] The housing 131 contains a first test strip for antigen testing for the novel coronavirus and a second test strip for antigen testing for influenza virus types A and B. A first drop window 132 is provided upstream of the first test strip, and a first determination window 133 is provided downstream. A second drop window 134 is provided upstream of the second test strip, and a second determination window 135 is provided downstream. For antigen testing for the novel coronavirus, the mixed liquid is dropped into the first drop window 132, while for antigen testing for influenza virus types A and B, the mixed liquid is dropped into the second drop window 134.

[0025] The first test strip is provided with, in order from the upstream side, a first labeled antibody, a first fixed antibody, and a second fixed antibody. The first labeled antibody migrates with the mixed solution, and if the mixed solution contains a novel coronavirus antigen, it binds to the antigen to form a first complex. The first fixed antibody binds to the antigen in the first complex, and the second fixed antibody binds to the first labeled antibody. The first complex binds to the first fixed antibody, developing a color and causing a test line (T) to appear. The first labeled antibody binds to the second fixed antibody, developing a color and causing a control line (C) to appear. The subject can visually confirm the test line (T) and control line (C) through the first judgment window 133.

[0026] The second test strip is provided with, in order from upstream to downstream, a second labeled antibody, a third fixed antibody, a fourth fixed antibody, and a fifth fixed antibody. The second labeled antibody migrates with the mixed solution and, if the mixed solution contains an influenza virus type A antigen, binds to the antigen to form a second complex A. If the mixed solution contains an influenza virus type B antigen, it binds to the antigen to form a second complex B. The third fixed antibody binds to the antigen in the second complex A, the fourth fixed antibody binds to the antigen in the second complex B, and the fifth fixed antibody binds to the second labeled antibody. The second complex A binds to the third fixed antibody and develops color, causing the first test line (T1) to appear. The second complex B binds to the fourth fixed antibody and develops color, causing the second test line (T2) to appear. The second labeled antibody binds to the fifth fixed antibody and develops color, causing the control line (C) to appear. The subject can visually check the first test line (T1), the second test line (T2), and the control line (C) through the second judgment window 135.

[0027] The disposal bag 140 is a bag for disposing of the inspected determination member 130, etc. For example, after the inspection is completed, the determination member 130 is disinfected with bleach, alcohol, etc., and then placed in the disposal bag 140 and disposed of.

[0028] The temperature measuring member 150 is a member for measuring the body surface temperature of a subject. Fig. 3(A) shows the front surface of the temperature measuring member 150 before measurement, Fig. 3(B) shows the back surface of the temperature measuring member 150 before measurement, and Fig. 3(C) shows the front surface of the temperature measuring member 150 after measurement. Note that the back surface of the temperature measuring member 150 is entirely black, but the color (black) is omitted in Fig. 3(B).

[0029] The temperature measuring member 150 includes a flexible substrate 151 and temperature indicating members 152a-152f. The temperature indicating members 152a-152f are arranged in a row at predetermined intervals on one surface of the substrate 151 (the back surface in this embodiment), and cause color changes at different temperatures. The temperature indicating members 152a-152f are made of, for example, cholesteric liquid crystal. Specifically, the temperature indicating members 152a-152f are formed by fixing encapsulated cholesteric liquid crystal to the back surface of the substrate 151 with a transparent adhesive and then covering it with a transparent protective layer.

[0030] In this embodiment, the temperature indicator 152a changes color at 35° C., the temperature indicator 152b at 36° C., the temperature indicator 152c at 37° C., the temperature indicator 152d at 38° C., the temperature indicator 152e at 39° C., and the temperature indicator 152f at 40° C. The temperature thresholds at which the color changes occur are printed or otherwise indicated on the other surface of the base material 151 (the front surface in this embodiment).

[0031] The temperature measuring member 150 can measure the body surface temperature of the subject by, for example, placing the back side of the temperature measuring member 150 against the body (e.g., the forehead) of the subject for a predetermined period of time (e.g., 20 seconds). In Fig. 3(C), the color of the temperature indicator member 152c has changed, so the temperature measuring member 150 indicates that the body surface temperature of the subject is 37°C.

[0032] The staining liquid container 160 is a container that contains the staining liquid L2. The staining liquid container 160 is a cylindrical body with a bottom at one end (lower end) and an opening at the other end (upper end), and is provided with a cap that closes the opening. The staining liquid L2 permeates the sheet member 180 by capillary action, and colors the sheet member 180. The staining liquid L2 is composed of a solvent (e.g., water) and a colorant (e.g., iodine solution, food coloring, or laboratory dye), and may further contain additives (e.g., a viscosity adjuster and / or a surfactant).

[0033] The pipe member 170 is a cylindrical body that can be inserted into the staining liquid container 160 through the opening of the staining liquid container 160. The length from the bottom to the top of the pipe member 170 is longer than the length from the bottom to the top of the staining liquid container 160. The pipe member 170 is preferably transparent or translucent so that the subject can visually observe the change in color of the sheet member 180. The pipe member 170 is made of, for example, plastic.

[0034] The sheet member 180 is a rectangular sheet (for example, paper) that is colored by the dye liquid L2 that permeates it. The sheet member 180 is longer than the pipe member 170 and is sized so that it can be inserted into the pipe member 170. When one end (bottom end) of the sheet member 180 is immersed in the dye liquid L2, the dye liquid L2 permeates through capillary action and eventually reaches the other end (top end). The portion of the sheet member 180 that has been permeated with the dye liquid L2 is colored.

[0035] The individual packaging box 190 is a box that stores the sampling member 110, the reagent container 120, the determination member 130, the disposal bag 140, the temperature measurement member 150, the staining liquid container 160, the pipe member 170, and the sheet member 180. The individual packaging box 190 is provided with a container holding section 191 on which a plurality of cut lines are formed. The container holding section 191 forms an insertion hole when the cut lines are pressed in, and holds the staining liquid container 160 inserted into the insertion hole.

[0036] Next, how to use the test kit 100 will be described.

[0037] The subject collects a specimen (nasal swab) using the collection member 110, inserts the collection member 110 (the portion from which the specimen has been collected) into the reagent container 120, and prepares a mixture of the specimen and liquid reagent L1. The subject then dispenses the prepared mixture into the first and second dispense windows 132 and 134 of the determination member 130.

[0038] The subject inserts the staining liquid container 160 with the cap removed into the container holder 191 of the individual box 190 immediately after dripping the mixed liquid or before dripping the mixed liquid (see FIG. 4(A)).

[0039] The subject inserts sheet member 180 into pipe member 170, aligning the lower end of pipe member 170 with the lower end of sheet member 180 so that the upper end of sheet member 180 protrudes from the upper end of pipe member 170. The subject then inserts pipe member 170 and sheet member 180 in this state into staining liquid container 160 so that the lower ends are immersed in staining liquid L2 (see FIG. 4(B)). This starts measurement of the determination time.

[0040] In the second set S2 consisting of the dyeing liquid container 160, the pipe member 170, and the sheet member 180, with the lower end of the pipe member 170 aligned with the lower end of the sheet member 180, it takes approximately 5 to 15 minutes from immersion in the dyeing liquid L2 until the colored portion of the sheet member 180 exceeds the upper end of the pipe member 170.

[0041] In this embodiment, the staining solution L2, pipe member 170, and sheet member 180 are adjusted and designed so that the above-mentioned time is approximately 5 minutes. Fig. 4(C) shows the state approximately 3 minutes after the start of measurement, and Fig. 4(D) shows the state approximately 5 minutes after the start of measurement. In this way, the subject can intuitively grasp the assessment time (the elapsed time from the start of assessment and the remaining time until the end of assessment) by looking at the sheet member 180.

[0042] Figure 5 shows an example of the determination result. Figure 5(A) shows a case where none of the antigens of the novel coronavirus, influenza virus type A, and influenza virus type B are detected. Figure 5(B) shows a case where only the antigen of the novel coronavirus is detected. Figure 5(C) shows a case where only the antigen of influenza virus type A is detected. Figure 5(D) shows a case where only the antigen of influenza virus type B is detected. Figure 5(E) shows a case where both the antigen of the novel coronavirus and the antigen of influenza virus type A are detected. Figure 5(F) shows a case where both the antigen of the novel coronavirus and the antigen of influenza virus type B are detected. Note that if the control line (C) does not appear, the test is invalid.

[0043] Although the embodiments of the test kit and timer member according to the present invention have been described above, the present invention is not limited to the above embodiments.

[0044] The test kit according to the present invention is a test kit for testing for the presence or absence of an antigen, and comprises: a collection member for collecting a specimen from a subject; a reagent container containing a liquid reagent capable of extracting the antigen from the specimen and for producing a mixed liquid of the specimen and the liquid reagent; a determination member for determining the presence or absence of the antigen from the mixed liquid; a timer member; and an individual packaging box for storing the collection member, reagent container, determination member, and timer member; the timer member is a bottomed cylindrical body having a bottom portion at one end and an opening at the other end, and comprises: a staining liquid container containing a staining liquid; and a sheet member that can be inserted into the staining liquid container through the opening and has a length from one end to the other end that is longer than the length from the bottom portion to the opening; and the configuration of the sheet member can be modified as appropriate, as long as, when one end of the sheet member is immersed in the staining liquid, the staining liquid penetrates to the other end and changes color.

[0045] The test kit of the present invention may also be used to test for the presence or absence of antigens other than those of the novel coronavirus, influenza A virus, and influenza B virus.

[0046] In addition, the timer member of the present invention is a timer member for measuring the determination time for the presence or absence of an antigen, and comprises a staining liquid container having an opening and containing staining liquid, a cylindrical pipe member that can be inserted into the staining liquid container through the opening, and a sheet member that can be inserted into the pipe member, and the configuration of the sheet member can be changed as appropriate as long as it is longer than the pipe member and changes color when immersed in staining liquid as the staining liquid penetrates it. [Explanation of symbols]

[0047] 100 test kits 110 Extraction Materials 120 Reagent containers 130 Judgment member 131 Housing 132 First drip window 133 First judgment window 134 Second drip window 135 Second Judgment Window 140 Disposal Bags 150 Temperature measuring element 151 Base material 152a to 152f Temperature indicating member 160 Dyeing solution container 170 Pipe members 180 Sheet material 190 individual boxes 191 Container holding part

Claims

1. A test kit for testing for the presence or absence of an antigen, a collection member for collecting a sample from a subject; a reagent container containing a liquid reagent capable of extracting the antigen from the specimen, for generating a mixture of the specimen and the liquid reagent; a determination member for determining the presence or absence of the antigen in the mixed solution; A timer member; an individual packaging box that houses the sampling member, the reagent container, the determination member, and the timer member; The timer member is a staining liquid container which is a cylindrical body with a bottom having a bottom surface at one end and an opening at the other end and which contains staining liquid; a sheet member that can be inserted into the staining liquid container through the opening and has a length from one end to the other end that is longer than a length from the bottom surface portion to the opening, When the one end of the sheet member is immersed in the dye solution, the dye solution penetrates to the other end and changes color. A test kit characterized by:

2. a temperature measuring member for measuring a body surface temperature of the subject; The temperature measuring member is A flexible substrate and a plurality of temperature indicating members that are arranged in a row at predetermined intervals on one surface of the substrate and that cause a color change at different temperatures; The substrate is marked with a temperature threshold at which the color change occurs. The test kit according to claim 1 .

3. The timer member further includes a cylindrical pipe member that is shorter than the sheet member, the pipe member is insertable into the staining liquid container through the opening, The sheet member can be inserted into the pipe member. The test kit according to claim 1 .

4. The pipe member is transparent or semi-transparent, and the color change of the sheet member is visible. The test kit according to claim 3 .

5. The individual packaging box is provided with a cut line for inserting and fixing the staining liquid container. The test kit according to claim 1 .

6. A timer member for measuring the time required to determine the presence or absence of an antigen, a staining liquid container having an opening and containing a staining liquid; a cylindrical pipe member that can be inserted into the staining liquid container through the opening; a sheet member that can be inserted into the pipe member, The sheet member is longer than the pipe member, and when immersed in the dyeing solution, the dyeing solution permeates the sheet member and the color changes. A timer member characterized by:

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