JP6777468B2 - Inspection kit - Google Patents

Description

The present invention relates to a test kit.

As a device for collecting a sample such as saliva and determining whether or not the sample contains a substance to be measured such as a bacterium or a virus, for example, a device for immunochromatography is disclosed (for example, Patent Document 1). reference).

In the above device, a test strip composed of a sample addition member, a label holding member, a chromatographic membrane carrier, etc. is sandwiched in a case, and a sample dropped on the sample addition member is supplied to the label holding member to be colored as a label. After the particles (labeled substance) are bound to the substance to be measured, the presence or absence of the substance to be measured is visually determined by capturing and accumulating the particles (labeled substance) on an antibody immobilized on a chromatographic membrane carrier.

In such a device, convex portions are provided at opposite portions of the pair of cases that sandwich the test strip, and the convex portions bring the sample addition member and the label holding member into close contact with each other so that the sample addition member is dropped onto the sample addition member. The sample is efficiently supplied to the label holding member, and the labeled substance can be reliably bound to the substance to be measured.

Japanese Unexamined Patent Publication No. 2005-37384

However, in the conventional device as described above, the labeling substance held in the labeling holding member may be expanded in a large amount at one time in the chromatographic membrane carrier. Therefore, when the above-mentioned large amount of development occurs, the coloring of this large amount of labeling substance tends to be mistaken as being captured by the antibody on the chromatographic membrane alone, and despite the absence of the substance to be measured. However, there is a risk of causing a false judgment as if it exists.

The present invention has been made based on the above circumstances, and an object of the present invention is to provide a test kit capable of reliably determining the presence or absence of a substance to be detected (substance to be measured).

The present invention
(1) A sample dropping pad for dropping a liquid sample containing a substance to be detected, a labeling substance holding pad impregnated with a labeling substance that selectively binds to the substance to be detected and serves as a label, and the labeling. An immobilized membrane having an immobilized substance that immobilizes the substance to be detected to which the substance is bound is connected in this order, and the dropped liquid sample is sequentially developed toward the immobilized membrane on the immobilized membrane. An inspection kit including a test strip for detecting the substance to be detected.
The test strip has at least a portion of the labeling substance retention pad and a portion of the immobilized membrane overlapping each other.
A pressing portion for pressing a part of the overlapping portion in a direction orthogonal to the direction in which the liquid sample is developed is provided.
The detection of the substance to be detected is confirmed from the outside in the basin where the liquid sample develops in the immobilized membrane and in a basin other than the basin where the liquid sample develops immediately below the portion pressed by the pressing portion. Inspection kits, characterized by being possible,
(2) The inspection kit according to (1) above, wherein the pressing portions are arranged so as to press both ends in a direction orthogonal to the direction in which the liquid sample is developed at the overlapping portions.
(3) The labeled substance holding pad has a containing portion containing the labeling substance and a non-containing portion adjacent to the containing portion and not containing the labeling substance, and the sample dropping pad and the non-containing portion The test kit according to (1) or (2) above, wherein at least a part of the contained portion and the immobilized membrane are connected.
(4) The overlapping portion has a structure in which at least a part of the sample dropping pad, a part of the labeling substance holding pad, and a part of the immobilized membrane are laminated in this order in the above (1) or (2). Described test kit,
(5) The first case and
It is provided with a second case that is arranged to face the first case via a test strip and sandwiches the test strip.
An inspection kit provided in the first and / or second case so that the pressing portion presses a part of the overlapping portion in the direction orthogonal to the developing direction of the liquid sample.
(6) Equipped with a window for confirming the detection of the substance to be detected from the outside
The window portion faces the immobilized membrane of the first and / or second case, and faces a basin other than the basin directly below where the liquid sample flowing out from the portion pressed by the pressing portion develops. The test kit according to (5) above, and (7) a sample dropping pad for dropping a liquid sample containing the substance to be detected, and labeling that selectively binds to the substance to be detected and serves as a label. The labeled substance holding pad impregnated with the substance and the immobilized membrane having the immobilized substance for fixing the substance to be detected to which the labeled substance is bound are connected in this order, and the dropped liquid sample is fixed. A method for detecting a substance to be detected using an inspection kit provided with a test strip for detecting the substance to be detected on the immobilized membrane while sequentially developing toward the chemical membrane.
The test strip has at least a portion of the labeling substance retention pad and a portion of the immobilization membrane overlapping each other.
A pressing portion for pressing a part of the overlapping portion in a direction orthogonal to the direction in which the liquid sample is developed is provided.
Confirmation of detection of the substance to be detected from the outside in the basin where the liquid sample develops in the immobilized membrane and in a basin other than the basin where the liquid sample develops immediately below the portion pressed by the pressing portion. Concerning methods characterized by doing.

In the present specification, the "test strip" means a series of members composed of a sample dropping pad, a labeling substance holding pad, an immobilized membrane, and the like, and in which a liquid sample is normally distributed. Further, "a basin other than the basin where the liquid sample directly below the portion pressed by the pressing portion develops" means, for example, as shown in FIG. 3, in the development direction of the liquid sample or the like indicated by the arrow, the convex portion 911 ( It means the region P in the immobilized membrane 51 other than the region R (shaded hatched portion) in the plan view in the portion pressed by the pressing portion 910) and the immobilized membrane 51 located directly below (downstream) this portion. To do. In FIG. 3, L1 indicates the width of the area R, L2 indicates the width of the area P, and L3 indicates the width of the window portion 915 according to their respective positional relationships. Further, the "window portion" is a concept including both a through hole that is physically opened and a portion where the presence or absence of a substance to be detected can be observed or detected from the outside through a predetermined member.

Further, the "sample dropping pad" and the "labeled substance holding pad" in the present specification are merely functional distinctions, and do not necessarily have to be composed of individual members for each function. For example, the “sample dropping pad” and the “labeled substance holding pad” in the present specification are labels that selectively bind to the detected substance and serve as a label with the region where the liquid sample containing the detected substance is dropped. The concept includes an integral member having a region impregnated with a chemical substance.

Further, in the present specification, "at least a part of the labeling substance holding pad and a part of the immobilizing membrane overlap each other" is limited to a mode in which the labeling substance holding pad and the immobilizing membrane directly overlap each other. It is a concept including an embodiment in which a labeling substance holding pad and an immobilized membrane are overlapped with each other via another member different from these members.

The present invention can provide a test kit capable of reliably determining the presence or absence of a substance to be detected.

It is a schematic vertical sectional view which shows the 1st Embodiment of this invention. It is a schematic plan view of FIG. It is a partially enlarged schematic plan view for demonstrating the part of the window part of this invention. It is a schematic plan view which shows the modification of FIG. It is a schematic vertical sectional view which shows the 2nd Embodiment of this invention. It is a schematic plan view of FIG. It is a schematic vertical sectional view which shows the 3rd Embodiment of this invention. It is a schematic plan view of FIG.

<Inspection kit>
The test kit of the present invention includes a sample dropping pad for dropping a liquid sample containing a substance to be detected, and a labeling substance holding pad impregnated with a labeling substance that selectively binds to the substance to be detected and serves as a label. , An immobilized membrane having an immobilized substance for immobilizing the substance to be detected to which the labeled substance is bound is connected in this order, and the dropped liquid sample is sequentially developed toward the immobilized membrane and fixed. A test kit including a test strip for detecting the substance to be detected on the chemical membrane. The test strip is a portion where at least a part of the labeling substance retention pad and a part of the immobilized membrane overlap each other. A pressing portion that presses a part of the overlapping portion in a direction orthogonal to the developing direction of the liquid sample, and is a basin in which the liquid sample develops in the immobilized membrane. It is characterized in that the detection of the substance to be detected can be confirmed from the outside in a basin other than the basin where the liquid sample develops directly below the portion pressed by the portion.

Hereinafter, the first to third embodiments of the inspection kit will be described with reference to the drawings, but the present invention is not limited to the embodiments described in the drawings.

[First Embodiment]
FIG. 1 is a schematic vertical sectional view showing a first embodiment of the present invention. Further, FIG. 2 is a schematic plan view of FIG. As shown in FIGS. 1 and 2, the test kit 11 generally includes a test slip 21 having a sample dropping pad 31, a labeling substance holding pad 41, an immobilized membrane 51 and an absorbing pad 61, and a backing sheet 71. , A first case 81, and a second case 91.

In the test strip 21, the sample dropping pad 31, the labeling substance holding pad 41, the immobilized membrane 51 and the absorbing pad 61 are connected in this order, and the dropped liquid sample is sequentially developed toward the immobilized membrane 51. The substance to be detected is detected by the immobilized membrane 51.

The sample dropping pad 31 is a member on which a liquid sample containing a substance to be detected is dropped. The sample dropping pad 31 is provided with a dropping portion 31a on which a liquid sample is dropped. The sample dropping pad 31 is made of a material having a coarser mesh and lower water absorption than the labeling substance holding pad 41 and the immobilized membrane 51, which will be described later. Examples of the material constituting the sample dropping pad 31 include nylon, polyether sulfone, polyvinyl alcohol, polyester, glass fiber, polyolefin, cellulose, and a non-woven fabric formed of a mixed fiber thereof. In addition, examples of the substance to be detected include antigens such as influenza virus.

The labeling substance holding pad 41 is a member impregnated with a labeling substance that selectively binds to the substance to be detected and serves as a label. The labeled substance holding pad 41 is in contact with the sample dropping pad 31 via the interface k11 on the upstream side in the liquid sample developing direction, and is provided on the convex portion 912 and the first case 81 provided in the second case 91 described later. It is sandwiched between the convex portions 812 provided and pressed by the convex portions 812 and 912 over the entire width direction of the test strip 21 (direction orthogonal to the direction in which the liquid sample is developed). The labeled substance holding pad 41 receives the liquid sample dropped on the sample dropping pad 31, and the liquid sample and the labeled substance held in the labeled substance holding pad 41 are mixed to form an antibody. The antibody binds to the antibody by an antigen-antibody reaction. In the present embodiment, the labeling substance is uniformly impregnated over the entire labeling substance holding pad 41.

The labeling substance holding pad 41 is made of a material having finer eyes and higher water absorption than the above-mentioned sample dropping pad 31. As a result, the liquid sample can be reliably moved from the sample dropping pad 31 to the labeling substance holding pad 41. Examples of the material constituting the labeling substance holding pad 41 include nylon, polyether sulfone, polyvinyl alcohol, polyester, glass fiber, polyolefin, cellulose, and a non-woven fabric formed of a mixed fiber thereof.

The labeling substance is not particularly limited as long as it is selectively bound to the substance to be detected and is colored, and for example, insoluble carrier particles such as gold colloid, platinum colloid, colored particles, and fluorescent particles, enzyme-labeled ligand, and fluorescence. Examples thereof include substances to which labeled ligands and the like are physically or chemically bound. Specific examples of the labeling substance include, for example, an antibody to which colored particles are bound.

The immobilized membrane 51 is a member having an immobilized substance that immobilizes the substance to be detected to which the labeling substance is bound. The immobilized membrane 51 has a portion where a part of the labeling substance holding pad 41 and a part of the immobilized membrane 51 overlap each other. Specifically, the upstream side in the liquid sample developing direction is the interface k12. It is in contact with the labeling substance holding pad 41 via. The immobilized membrane 51 receives the liquid sample and the labeling substance mixed in the labeling substance holding pad 41 and develops the liquid sample and the labeling substance toward the absorption pad 61.

Specifically, the immobilized membrane 51 is formed of a material having a finer mesh and higher water absorption than the above-mentioned labeling substance holding pad 41. This makes it possible to reliably move the liquid sample from the labeling substance holding pad 41 to the immobilized membrane 51. Examples of the material constituting the immobilized membrane 51 include a porous material made of nitrocellulose and the like, a fiber material made of polyester and the like, and the like.

Further, the immobilized membrane 51 is provided with a detection zone 51a for detecting the substance to be detected. An immobilized substance is fixed in the detection zone 51a, and the immobilized substance selectively binds to the detected substance to fix the detected substance in the detection zone 51a. Here, the labeled substance is bound to the substance to be immobilized as described above. Therefore, the colored labeled substance can be accumulated in the detection zone 51a by fixing the substance to be detected in the detection zone 51a, and the substance to be detected can be detected by visually recognizing the color or detecting the labeled substance using a detection device. The presence or absence of a substance can be determined. Examples of the immobilized substance include antibodies and the like.

The shape of the detection zone 51a is not particularly limited, but as shown in FIG. 2, for example, it can be provided in a band shape extending in a direction orthogonal to the sample deployment direction of the immobilized membrane 51. Thereby, the determination can be easily and surely performed.

The immobilized membrane 51 may be provided with a control zone 51b for notifying that the liquid sample has arrived between the detection zone 51a and the absorption pad 61 described later. In such a case, for example, the control zone 51b is formed by immobilizing the control substance on the immobilized membrane 51, and the control labeling substance selectively bound to the control substance and to which the label is bound is labeled. It is impregnated in the substance holding pad 41. As a result, after the dropped liquid sample is mixed with the control labeling substance, the mixture reaches the control zone 51b, so that the control labeling substance is fixed by the control substance and the liquid sample is fixed in the detection zone 51a. It can be confirmed by visually recognizing the color or detecting the labeled substance by the detection device that the inspection has passed (the inspection is proceeding normally).

The absorption pad 61 is a member that absorbs at least a part of the liquid sample that develops the immobilized membrane 51. The absorption pad 61 has an upstream side of the absorption pad 61 in contact with the immobilized membrane 51 via the interface k13, and receives and absorbs a liquid sample or the like that develops in the immobilized membrane 51. Since the test slip 21 has the absorption pad 61, the absorption pad 61 can absorb the liquid sample or the like to promote the development (flow) of the liquid sample or the like in the immobilized membrane 51, and the sample dropping pad The liquid sample or the like dropped on 31 can be smoothly developed.

The absorption pad 61 is not particularly limited as long as it can absorb a large amount of liquid sample or the like, and for example, a non-woven fabric made of filter paper, glass fiber or the like, a water-absorbing polymer polymer sheet or the like can be adopted. ..

The backing sheet 71 is provided between the test strip 21 and the first case 81, and integrates the sample dropping pad 31, the labeling substance holding pad 41, the immobilized membrane 51, and the absorbing pad 61 constituting the test strip 21. Fix to. Specifically, the backing sheet 71 is provided with an adhesive layer 71a on one side of the backing sheet 71, and the sample dropping pad 31 and the labeling substance holding pad 41 in which the adhesive layer 71a constitutes the test strip 21. By adhering to the immobilized membrane 51 and the absorbing pad 61, the sample dropping pad 31 and the like are integrally fixed on the backing sheet 71. As the material for forming the backing sheet 71 and the pressure-sensitive adhesive layer 71a described above, for example, a known water-resistant material or the like can be adopted. As described above, since the inspection kit 11 includes the backing sheet 71, each pad can be reliably held.

In the first case 81, the test strip 21 is placed. The second case 91 is arranged so as to face the first case 81 via the test strip 21 and sandwiches the test strip 21. As the materials constituting the first and second cases 81 and 91, for example, polypropylene, ABS and the like can be adopted.

Here, a gap g is provided in at least a part between the backing sheet 71 and the first case 81 described above. As shown in FIG. 1, the gap g is formed by abutting the lower surface of the backing sheet 71 with the tips of the convex portions 81 to 813 provided on the first case 81. It is preferable that the gap g is formed so that the liquid sample or the like that has entered the gap g does not propagate due to surface tension. The distance between the gaps g is preferably 0.1 mm or more, more preferably 0.5 mm or more. As a result, it is possible to prevent the liquid sample from penetrating between the test strip 21 and the first case 81, suppress the loss of the liquid sample, and reliably detect the presence or absence of the substance to be detected. it can.

A pressing portion 910 is provided in the second case 91, and the pressing portion 910 is a direction in which a liquid sample is developed at a portion where a part of the labeling substance holding pad 41 and a part of the immobilized membrane 51 overlap each other. Only a part of the direction orthogonal to is pressed (see FIG. 2). Specifically, the pressing portion 910 is formed by providing the convex portions 911 in the second case 91, and both ends in a direction orthogonal to the development direction of the liquid sample at the portion where the convex portions 911 overlap each other. It is arranged so as to press only.

By providing the pressing portion 910 in this way, the labeling substance holding pad 41 and the immobilized membrane 51 can be brought into close contact with each other, and the liquid sample or the like from the labeling substance holding pad 41 to the immobilized membrane 51 can be brought into close contact with each other. Deployment can be performed reliably and smoothly. Further, since the pressing portion 910 (convex portion 911) is arranged so as to press both end portions, the overlapping portions can be pressed symmetrically with respect to the deployment direction, and the immobilized membrane 51 can be pressed. The liquid sample can be developed in a well-balanced manner toward the absorption pad 61.

Further, the second case 91 is provided with a sample charging port 914 for charging a liquid sample into the inspection kit 11. The sample charging port 914 is open at a position facing the dropping portion 31a of the sample dropping pad 31 in the second case 91, and the liquid sample can be charged into the dropping portion 31a via the sample charging port 914.

Further, the second case 91 is provided with a window portion 915 for confirming the detection of the substance to be detected from the outside, and the window portion 915 is a portion facing the immobilized membrane 51 and is provided by the pressing portion 910. It is arranged in a portion facing the basin P other than the basin R where the liquid sample immediately below the pressed portion develops. The window portion 915 includes, for example, a configuration in which an opening is formed in the second case 91, a member transparent to visible light, a configuration in which a member that transmits the fluorescence when the labeling substance fluoresces is arranged, and the like. Can be adopted. In the present embodiment, the window portion 915 having an opening formed in the second case 91 is used.

From the viewpoint of more reliably determining the presence or absence of the substance to be detected, it is preferable that the basin R is shielded so that the detection of the substance to be detected cannot be confirmed from the outside. In such an embodiment, for example, in the first and / or second cases, the color of the labeling substance that develops the basin R cannot be visually recognized (for example, the case is opaque, characters or symbols are printed on the case, or the case is printed. A mode composed of a material that prevents the detection of the labeled substance by the detection device (such as labeling), or a member (first and second) in which the basin R prevents the color from being visually recognized or the detection device from detecting the labeled substance. A mode in which it is covered with a shielding member other than the case of the above. Examples of the material or member that hinders the detection include those that hinder the transmission of a specific wavelength required for detection.

Next, a method for detecting the substance to be detected using the detection kit 11 of the present embodiment will be described. Here, an antigen is used as a substance to be detected, an antibody to which colored particles are bound as a labeling substance, and an antibody is used as an immobilized substance, and an antibody to which colored particles as a control labeling substance are bound in a labeling substance holding pad 41. An example in which (an antibody different from the antibody in the immobilized substance) and an antigen as a control substance (an antigen different from the antigen in the substance to be detected) in the control zone 51b will be described. The antigen as the substance to be detected and the antibody contained in the labeling substance, the antigen as the substance to be detected and the antibody as the immobilized substance, and the antibody contained in the labeling substance for control and the antigen as the control substance are , Each of which is bound by an antigen-antibody reaction.

First, a liquid sample is prepared, and when an appropriate amount of the liquid sample is charged into the dropping portion 31a of the sample dropping pad 31 via the sample charging port 914 of the inspection kit 11, this liquid sample permeates the sample dropping pad 31, and one of them. The portion develops toward the labeling substance holding pad 41.

The liquid sample that has reached the interface k11 then permeates into the labeling substance retention pad 41 through the interface k11, and the permeated liquid sample develops toward the immobilized membrane 51. At this time, the liquid sample is mixed with the labeling substance impregnated in the labeling substance holding pad 41 and the labeling substance for control, and when the liquid sample contains an antigen, it is combined with the antibody in the labeling substance by an antigen-antibody reaction. In the bound state, it develops toward the immobilized membrane 51 together with the labeling substance.

Next, the liquid sample or the like that has reached the interface k12 permeates into the immobilized membrane 51 through the interface k12. At this time, since the labeling substance holding pad 41 and the immobilized membrane 51 are pressed by the convex portion 911 and are in close contact with each other, the liquid sample or the like is quickly deployed on the immobilized membrane 51. Next, the liquid sample or the like developed on the immobilized membrane 51 expands toward the absorption pad 61, and sequentially passes through the detection zone 51a and the control zone 51b provided on the immobilized membrane 51.

In the detection zone 51a, when the liquid sample contains an antigen, the antigen bound to the labeling substance is further bound and fixed by the immobilized substance impregnated in the detection zone 51a. The labeled substance colored by this fixation is accumulated in the detection zone 51a, and the test kit 11 is a basin where the liquid sample in the immobilized membrane 51 develops, and is directly below the portion pressed by the pressing portion 910. Since the detection of the substance to be detected can be confirmed (visually or confirmed by a detection device) from the outside through the window 915 in the basin P other than the basin R where the liquid sample develops, the presence or absence of the antigen can be determined. Can be done.

On the other hand, a part of the liquid sample or the like passes through the detection zone 51a and reaches the control zone 51b, and is fixed in the control zone 51b with the control labeling substance mixed with the liquid sample by the labeling substance holding pad 41. It binds to and is immobilized with the control substance. Since the labeling substance for control is accumulated in the control zone 51b with this progress, the liquid sample has passed through the detection zone 51a by visually confirming the presence or absence of color in the control zone 51b through the window portion 915 ( (The inspection is proceeding normally) can be visually confirmed. Next, a part of the liquid sample or the like passes through the control zone 51b and is absorbed by the absorption pad 61.

By the way, when a liquid sample or the like is deployed from the labeling substance holding pad 41 into the immobilized membrane 51, a large amount of the labeling substance may be deployed in the immobilized membrane 51 at one time. This phenomenon is likely to occur when a liquid sample or the like finally passes through the interface k12. When this phenomenon occurs, a specific region having a high concentration of the labeling substance moves in the immobilized membrane 51, which may cause an erroneous determination. That is, despite the absence of the substance to be measured (antigen), coloring as if it were present is caused in the immobilized membrane 51.

However, the test kit 11 includes a pressing portion that presses a part of the overlapping portion in the direction orthogonal to the developing direction of the liquid sample, and is a basin in which the liquid sample develops in the immobilized membrane 51. Since the detection of the substance to be detected can be confirmed from the outside in the basin P other than the basin R where the liquid sample directly below the portion pressed by the portion 910 develops, at least the labeling substance without pressing of the pressing portion 910. It is possible to observe the basin where the stable development of the substance occurs from the outside, and it is possible to reliably determine the presence or absence of the substance to be detected. It should be noted that the reason why a large amount of the liquid sample or the like develops at one time by pressing the overlapping portion is that the liquid sample or the like tends to stay in the pressed portion of the interface k12, and the retained liquid sample or the like easily stays in the pressed portion. It is presumed that this is because it is temporarily deployed (released) when it finally passes.

[Second Embodiment]
FIG. 5 is a schematic vertical sectional view showing a second embodiment of the present invention. Further, FIG. 6 is a schematic plan view of FIG. As shown in FIGS. 5 and 6, the test kit 12 generally includes a test slip 22 having a sample dropping pad 31, a labeling substance holding pad 42, an immobilized membrane 51 and an absorbing pad 61, and a backing sheet 71. , A first case 81, and a second case 91.

In the present embodiment, the configuration of the labeling substance holding pad 42 is different from that of the first embodiment. Since the sample dropping pad 31, the immobilized membrane 51, the absorbing pad 61, the backing sheet 71, the first case 81 and the second case 91 have the same configurations as those of the first embodiment, they are the same parts. The same reference numerals are given to, and detailed description thereof will be omitted. Further, since the labeling substance holding pad 42 has the same configuration as that of the first embodiment except that the content portion of the labeling substance is different, detailed description other than the description relating to the above-mentioned content portion is omitted. To do.

The labeling substance holding pad 42 is a member impregnated with a labeling substance that selectively binds to the substance to be detected and serves as a label. The labeled substance holding pad 42 of the present embodiment has a containing portion 42a containing the labeled substance and a non-containing portion 42b adjacent to the containing portion 42a and containing no labeled substance, and is a sample dropping pad 31. The non-containing portion 42b is connected, and at least a part of the contained portion 42a and the immobilized membrane 51 are connected.

The labeled substance holding pad 42 of the present embodiment may have at least the entire interface k21 in contact with the non-containing portion 42b. Further, the ratio (for example, volume ratio) of the labeled substance-containing portion 42a and the non-labeled substance-containing portion 42b in the labeled substance holding pad 42 is not particularly limited as long as the above configuration is satisfied, and various ratios are taken. be able to.

Next, a method for detecting the substance to be detected using the detection kit 12 of the present embodiment will be described. In addition, here, a portion which exerts an action different from the action according to the detection method described in the first embodiment will be described.

First, when an appropriate amount of liquid sample is charged into the dropping portion 31a of the sample dropping pad 31 through the sample charging port 914 of the inspection kit 12, this liquid sample permeates the sample dropping pad 31, and a part of the liquid sample retains the labeling substance. Deploy toward pad 42.

The liquid sample that has reached the interface k21 is then deployed through the interface k21 into the labeling substance holding pad 42, and the developed liquid sample is mixed with the labeling substance and the labeling substance for control. And unfold towards the immobilized membrane 51. At this time, in the inspection kit 12, only the non-labeled substance-free portion 42b of the labeled substance holding pad 42 is in contact with the sample dropping pad 31, so that the labeled substance stays at the interface k21. However, since a large amount of development of the labeled substance due to the retention of the interface k21 does not occur at one time, erroneous determination of the detected substance can be suppressed, and the presence or absence of the detected substance can be determined more reliably. be able to.

Next, the liquid sample or the like that has reached the interface k22 develops in the immobilized membrane 51 through the interface k22, and proceeds in the same manner as in the first embodiment described above.

[Third Embodiment]
FIG. 7 is a schematic vertical sectional view showing a third embodiment of the present invention. Further, FIG. 8 is a schematic plan view of FIG. 7. As shown in FIGS. 7 and 8, the test kit 13 generally includes a test slip 23 having a sample dropping pad 31, a labeling substance holding pad 43, an immobilized membrane 51 and an absorbing pad 61, and a backing sheet 71. , A first case 83, and a second case 93.

In the present embodiment, the overlapping configuration of the sample dropping pad 31, the labeling substance holding pad 43, and the immobilized membrane 51 is different from that of the first embodiment. Since the configuration of each member such as the sample dropping pad 31 is the same as that of the first embodiment, these explanations will be omitted with reference to the description of the first embodiment.

In the present embodiment, the overlapping portion of the test strip 23 has a structure in which at least a part of the sample dropping pad 31, a part of the labeling substance holding pad 43, and a part of the immobilized membrane 51 are laminated in this order. .. In the present embodiment, the inspection kit 13 has an immobilized membrane 51, a labeling substance holding pad 43, and a sample dropping pad 31 laminated on a backing sheet 71, and these three-layered members are convex with a convex portion 831. It is integrally sandwiched with the portion 931 (pressing portion 930).

Next, a method for detecting the substance to be detected using the detection kit 13 of the present embodiment will be described. In addition, here, a portion which exerts an action different from the action according to the detection method described in the first embodiment will be described.

First, when an appropriate amount of liquid sample is charged into the dropping portion 31a of the sample dropping pad 31 via the sample charging port 914 of the inspection kit 13, this liquid sample permeates the sample dropping pad 31, and a part of the liquid sample retains the labeling substance. Deploy toward pad 43.

The liquid sample that has reached the interface k31 is then developed into the labeling substance holding pad 43 through the interface k31, and then mixed with the labeling substance and the control labeling substance, and is immobilized through the interface k32. Expand during 51. At this time, in the inspection kit 13, the sample dropping pad 31, the labeling substance holding pad 43, and the immobilized membrane 51 have the above-mentioned three-layer structure, and are integrally pressed by the convex portion 931 serving as the pressing portion 930. Therefore, the sample dropping pad 31 and the like can be integrally adhered to each other with a simple structure, and the development of the liquid sample and the like can be promoted to quickly and surely detect the presence or absence of the substance to be detected.

Next, the liquid sample or the like that has reached the interface k32 permeates into the immobilized membrane 51 through the interface k32, and proceeds in the same manner as in the first embodiment described above.

<Detection method for substances to be detected>
The method for detecting a substance to be detected of the present invention comprises a sample dropping pad for dropping a liquid sample containing the substance to be detected and labeling impregnated with a labeling substance that selectively binds to the substance to be detected and serves as a label. The substance retention pad and the immobilization membrane having the immobilization substance for immobilizing the substance to be detected to which the labeling substance is bound are connected in this order, and the dropped liquid sample is sequentially developed toward the immobilization membrane. However, it is a method of detecting a substance to be detected using a test kit provided with a test strip for detecting the substance to be detected on the immobilized membrane, and the test strip is at least a part of a labeling substance holding pad. The immobilized membrane has a portion in which the substance and a part of the immobilized membrane overlap each other, and is provided with a pressing portion for pressing a portion of the overlapped portion in a direction orthogonal to the direction in which the liquid sample develops. It is characterized in that the detection of the substance to be detected is confirmed from the outside in the basin where the liquid sample develops, and in the basin other than the basin where the liquid sample develops directly below the portion pressed by the pressing portion. To do.

Since the detailed description of the method for detecting the substance to be detected is the same as the description in [First Embodiment] in the above-mentioned <Inspection Kit> section, the above description will be referred to here. Is omitted.

It should be noted that the present invention is not limited to the configuration of the above-described embodiment, but is indicated by the scope of claims, and is intended to include all modifications within the meaning and scope equivalent to the scope of claims. Will be done.

For example, in the above-described embodiment, the test kits 11 to 13 including the first and second cases have been described, but the test kits without these cases are also within the scope of the present invention. Examples of such an embodiment include an inspection kit in which a part of the overlapping portions is pressed by a holding means such as a clip.

Further, when the above-mentioned holding means or shielding member is used, the test strip using these may be held in another case (case other than the first and second cases).

Further, in the above-described embodiment, the pressing portions 910, 920, and 930 are arranged so as to press both ends in the direction orthogonal to the developing direction of the liquid sample (the width direction of the test strip) at the overlapping portions. The test kits 11, 12, and 13 are described, but the present invention is not particularly limited as long as the pressing portion presses a part in the direction orthogonal to the development direction of the liquid sample at the overlapping portion. For example, the pressing portion is a test strip. The inspection kit may be provided so as to press the central portion in the width direction.

Further, in the above-described embodiment, the inspection kits 11 to 13 including the absorption pad 61 have been described, but as long as the liquid sample or the like dropped on the sample dropping pad 31 smoothly develops toward the immobilized membrane 51, An inspection kit that does not include the absorption pad 61 is also within the scope intended for the present invention.

Further, in the above-described embodiment, the sample dropping pad 31 and the labeling substance holding pads 41 and 42 are formed by the convex portions 912 and 922 in the entire width direction of the test strips 21 and 22 (direction orthogonal to the direction in which the liquid sample is developed). Although the inspection kits 11 and 12 that are pressed over the above are described, the portion that presses the sample dropping pad and the labeling substance holding pad is a part of the width direction of the test strip (perpendicular to the direction in which the liquid sample is developed). It may be a part of the direction to do).

Of these, in the case of an inspection kit in which the labeling substance is uniformly impregnated over the entire labeling substance holding pad, the liquid sample is developed in the pressing portion 940, for example, as shown in FIG. It is preferable that the window portion 915 is not provided in the basin R1 immediately below the basin. As a result, it is possible to further reduce erroneous determination due to the retention of the labeled substance at the interface between the sample dropping pad and the labeled substance holding pad, and it is possible to more reliably determine the presence or absence of the substance to be detected.

Further, in the above-described embodiment, the inspection kits 11 to 13 provided with the backing sheet 71 have been described, but the sample dropping pad, the labeling substance holding pad and the immobilized membrane satisfy the above-mentioned relationship and the effect of the present invention can be obtained. The test kit may not include the backing sheet 71 as long as it is not impaired.

Further, in the above-described embodiment, the inspection kits 11 to 13 in which both the sample input port 914 and the window portion 915 are provided in the second cases 91 and 93 have been described, but at least one of these has been described. The test kit provided in the first case is also within the scope of the present invention.

g Gap 11, 12, 13 Inspection kit 21, 22, 23 Test strip 31 Sample dropping pad 41, 42, 43 Labeling substance retention pad 42a Containing part 42b Uncontaining part 51 Immobilization membrane 61 Absorption pad 71 Backing sheet 81, 83 First case 91, 93 Second case 910, 920, 930 Pressing part 915 Window part

Claims (7)

A sample dropping pad for dropping a liquid sample containing a substance to be detected, a labeling substance holding pad for selectively binding to the substance to be detected and impregnated with a labeling substance to be a label, and the labeling substance are combined. An immobilized membrane having an immobilized substance that fixes the substance to be detected is connected in this order, and the dropped liquid sample is sequentially developed toward the immobilized membrane while being detected by the immobilized membrane. A test kit with test strips to detect substances
The test strip has at least a portion of the labeling substance retention pad and a portion of the immobilized membrane overlapping each other.
A pressing portion for pressing a part of the overlapping portion in a direction orthogonal to the direction in which the liquid sample is developed is provided.
Wherein among basin the liquid sample is deployed in immobilized membrane, wherein the pressing portion with only the basin except basin deploying said liquid sample just below the pressed site, the detection from the outside of the substance to be detected An inspection kit characterized by being identifiable. The inspection kit according to claim 1, wherein the pressing portion is arranged so as to press both ends in a direction orthogonal to the direction in which the liquid sample develops at the overlapping portion. The labeled substance holding pad has a containing portion containing the labeling substance and a non-containing portion adjacent to the containing portion and not containing the labeling substance, and the sample dropping pad and the non-containing portion are connected to each other. The test kit according to claim 1 or 2, wherein at least a part of the contained portion and the immobilized membrane are connected. The test kit according to claim 1 or 2, wherein the overlapping portion has a structure in which at least a part of the sample dropping pad, a part of the labeling substance holding pad, and a part of the immobilized membrane are laminated in this order. .. The first case and
It is provided with a second case that is arranged to face the first case via a test strip and sandwiches the test strip.
Any of claims 1 to 4 provided in the first and / or second cases so that the pressing portion presses a part of the overlapping portion in the direction orthogonal to the developing direction of the liquid sample. The test kit described in item 1. Equipped with a window for confirming the detection of the substance to be detected from the outside
The window portion faces the immobilized membrane of the first and / or second case, and the liquid flowing out from the portion pressed by the pressing portion in the basin where the liquid sample in the immobilized membrane develops. The test kit according to claim 5, which is arranged in a portion facing only a basin other than the basin directly below the sample unfolds. A sample dropping pad for dropping a liquid sample containing a substance to be detected, a labeling substance holding pad for selectively binding to the substance to be detected and impregnated with a labeling substance to be a label, and the labeling substance are combined. An immobilized membrane having an immobilized substance for immobilizing the substance to be detected is connected in this order, and the dropped liquid sample is sequentially developed toward the immobilized membrane and detected by the immobilized membrane. A method for detecting a substance to be detected using a test kit provided with a test strip for detecting the substance.
The test strip has at least a portion of the labeling substance retention pad and a portion of the immobilization membrane overlapping each other.
A pressing portion for pressing a part of the overlapping portion in a direction orthogonal to the direction in which the liquid sample is developed is provided.
Of the basin in which the liquid sample in the immobilized membrane is deployed, the attached from the pressed portion by the pressing portion only basin except basin the liquid sample is developed in the immediately below, the detection of the substance to be detected from the outside A method characterized by confirmation.

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